register of marketing authorisations - 2018 · zambia medicines regulatory authority register of...

296
ZAMBIA MEDICINES REGULATORY AUTHORITY REGISTER OF MARKETING AUTHORISATIONS - 2018 S/No Product Name Generic Name Category of Distribution Dosage Form Marketing Authorisation Number Marketing Authorisation Holder 1 Miconazole Nitrate Ceam - 1 A Pharma cream Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany 2 Cetirizine 10 - 1 A Pharma tablets Cetirizine Dihydrochloride 10mg POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany 3 Ateblock - 25 Tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India 4 Ateblock - 50 Tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences, India 5 Ateblock - 100 Tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India 6 Nosieze Tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India 7 Neumox Capsules Amoxicillin Trihydrate 500mg POM Capsule Oral 116/006 AB Lifesciences, India 8 RL-500 Compound Sodium Lactate Infusion Sodium Lactate + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate POM Solution for infusion 316/001 Abacus Parenteral Drugs Ltd, India 9 NS - 500 Sodium Chloride BP Infusion Sodium Chloride 0.9%w/v POM Solution for infusion 316/002 Abacus Parenteral Drugs Ltd, India 10 DS-500 Glucose Infusion Dextrose 5.0g POM Solution for infusion 316/003 Abacus Parenteral Drugs Ltd, India 11 X-Beta Eye/Ear Drops Betamethasone Soduim Phosphate 0.1% w/v POM Solution for Topical Use 316/004 Abacus Parenteral Drugs Ltd, India 12 X- Beta - N Eye/Ear Drops Betamethasone Soduim Phosphate 0.1% w/v + Neomycin sulphate 0.5% w/v POM Solution for Topical Use 316/005 Abacus Parenteral Drugs Ltd, India 13 X-Sone -N Eye/Ear Drops Neomycin Sulphate 0.35% w/v + Dexamethasone Phosphate 0.1% w/v POM Solution for Topical Use 316/006 Abacus Parenteral Drugs Ltd, India 14 Abnal Nasal Drops Sodium Chloride 0.9% w/v P Solution for Topical Use 316/007 Abacus Parenteral Drugs Ltd, India 15 Abtol 20% Intravenous Infusion Mannitol 20 %w/v POM Solution for infusion 316/008 Abacus Parenteral Drugs Ltd, India 16 Kaletra Solution Lopinavir 80mg + Ritonavir 20mg, per 5ml POM Solution for Oral Use 128/002 Abbott Laboratories S.A (Pty) Ltd, South Africa 17 Klacid P 125 Granules for Suspension Clarithromycin 125mg POM Granules for Suspension 128/004 Abbott Laboratories S.A (Pty) Ltd, South Africa 18 Klacid P 250 Granules for Suspension Clarithromycin 250mg POM Granules for Suspension 128/005 Abbott Laboratories S.A (Pty) Ltd, South Africa MEDICINES FOR HUMAN USE Page 1 of 296

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Page 1: REGISTER OF MARKETING AUTHORISATIONS - 2018 · ZAMBIA MEDICINES REGULATORY AUTHORITY REGISTER OF MARKETING AUTHORISATIONS - 2018 37 Myprodol Capsules Paracetamol 250mg + Ibuprofen

ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

S/No Product Name Generic Name Category of

Distribution

Dosage Form Marketing

Authorisation

Number

Marketing Authorisation Holder

1Miconazole Nitrate Ceam - 1 A Pharma

cream

Miconazole Nitrate 20mg POM Cream Topical 046/002 1 A Pharma Gmbh, Germany

2 Cetirizine 10 - 1 A Pharma tablets Cetirizine Dihydrochloride 10mg POM Tablet Uncoated 046/003 1 A Pharma Gmbh, Germany

3 Ateblock - 25 Tablets Atenolol 25mg POM Tablet Uncoated 116/001 AB Lifesciences, India

4 Ateblock - 50 Tablets Atenolol 50mg POM Tablet Uncoated 116/002 AB Lifesciences, India

5 Ateblock - 100 Tablets Atenolol 100mg POM Tablet Uncoated 116/003 AB Lifesciences, India

6 Nosieze Tablets Carbamazepine 400mg POM Tablet Uncoated 116/004 AB Lifesciences, India

7 Neumox Capsules Amoxicillin Trihydrate 500mg POM Capsule Oral 116/006 AB Lifesciences, India

8

RL-500 Compound Sodium Lactate

Infusion

Sodium Lactate + Sodium

Chloride + Potassium Chloride +

Calcium Chloride Dihydrate

POM Solution for

infusion

316/001 Abacus Parenteral Drugs Ltd,

India

9 NS - 500 Sodium Chloride BP InfusionSodium Chloride 0.9%w/v POM Solution for

infusion

316/002 Abacus Parenteral Drugs Ltd,

India

10 DS-500 Glucose InfusionDextrose 5.0g POM Solution for

infusion

316/003 Abacus Parenteral Drugs Ltd,

India

11 X-Beta Eye/Ear DropsBetamethasone Soduim

Phosphate 0.1% w/v

POM Solution for

Topical Use

316/004 Abacus Parenteral Drugs Ltd,

India

12X- Beta - N Eye/Ear Drops

Betamethasone Soduim

Phosphate 0.1% w/v + Neomycin

sulphate 0.5% w/v

POM Solution for

Topical Use

316/005 Abacus Parenteral Drugs Ltd,

India

13X-Sone -N Eye/Ear Drops

Neomycin Sulphate 0.35% w/v +

Dexamethasone Phosphate

0.1% w/v

POM Solution for

Topical Use

316/006 Abacus Parenteral Drugs Ltd,

India

14 Abnal Nasal DropsSodium Chloride 0.9% w/v P Solution for

Topical Use

316/007 Abacus Parenteral Drugs Ltd,

India

15Abtol 20% Intravenous Infusion

Mannitol 20 %w/v POM Solution for

infusion

316/008 Abacus Parenteral Drugs Ltd,

India

16 Kaletra SolutionLopinavir 80mg + Ritonavir

20mg, per 5ml

POM Solution for Oral

Use

128/002 Abbott Laboratories S.A (Pty) Ltd,

South Africa

17Klacid P 125 Granules for Suspension

Clarithromycin 125mg POM Granules for

Suspension

128/004 Abbott Laboratories S.A (Pty) Ltd,

South Africa

18Klacid P 250 Granules for Suspension

Clarithromycin 250mg POM Granules for

Suspension

128/005 Abbott Laboratories S.A (Pty) Ltd,

South Africa

MEDICINES FOR HUMAN USE

Page 1 of 296

Page 2: REGISTER OF MARKETING AUTHORISATIONS - 2018 · ZAMBIA MEDICINES REGULATORY AUTHORITY REGISTER OF MARKETING AUTHORISATIONS - 2018 37 Myprodol Capsules Paracetamol 250mg + Ibuprofen

ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

19 Forane Liquid Isoflurane 99.9% w/w POM Solution for

Inhalation

128/015 Abbott Laboratories S.A (Pty) Ltd,

South Africa

20Aluvia 250/50mg Tablets

Lopinavir 200mg + Ritonavir

50mg

POM Tablet Film

Coated

128/026 Abbott Laboratories S.A (Pty) Ltd,

South Africa

21 Aluvia 100/25mg TabletsLopinavir 100mg + Ritonavir

25mg

POM Tablet Film

Coated

128/027 Abbott Laboratories S.A (Pty) Ltd,

South Africa

22 Ultane LiquidSevoflurane 100% v/v POM Solution for

Inhalation

128/029 Abbott Laboratories S.A (Pty) Ltd,

South Africa

23 Norvir 100 TabletsRitonavir USP 100mg POM Tablet, Film

Coated

128/030 Abbott Laboratories S.A (Pty) Ltd,

South Africa

24 Hidrasec CapsulesRacecaggherdotril 100mg POM Capsule, Oral 128/031 Abbott Laboratories S.A (Pty) Ltd,

South Africa

25Hidrasec Children Sachets

Racecaggherdotril 30mg POM Powder for

Suspension,

Oral

128/032 Abbott Laboratories S.A (Pty) Ltd,

South Africa

26Hidrasec Infant Sachets

Racecaggherdotril 10mg POM Powder for

Suspension,

Oral

128/033 Abbott Laboratories S.A (Pty) Ltd,

South Africa

27Survanta Intratracheal Suspension, 4ml

Vial

Total Phospholipids 25mg, per

ml

POM Suspension,

Intratracheal

128/034 Abbott Laboratories S.A (Pty) Ltd,

South Africa

28 Mariprist Combikit TabletsMifepristone 200mg +

Misoprostal 200mcg

POM Tablet,

Uncoated

296/001 Acme Formulation Pvt Ltd, India

29 Misoclear Tablets Misoprostal 200mcg POM Tablet Uncoated 296/002 Acme Formulation Pvt Ltd, India

30 Sabax Osmitrol 20% InjectionMannitol 20% w/v POM Solution,

Infusion

097/004 Adcock Ingram Pharmaceuticals

Ltd, South Africa

31 Sabax Sodium Chloride 0.9% InjectionSodium Chloride 0.9% w/v POM Solution,

Infusion

097/005 Adcock Ingram Pharmaceuticals

Ltd, South Africa

32Sabax Glucose 5% + Sodium Chloride

0.9% Injection

Dextrose 5 %w/v + Soduim

Chloride 0.9 %w/v

POM Solution,

Infusion

097/006 Adcock Ingram Pharmaceuticals

Ltd, South Africa

33Sabax Ringer Lactate Injection

Sodium chloride + Sodium

lactate + Potassium chloride +

Calcium chloride

POM Solution,

Infusion

097/007 Adcock Ingram Pharmaceuticals

Ltd, South Africa

34 Sabax Dianeal Injection, 1.5%Peritoneal dialysis solution 1.5% POM Solution,

Injection

097/008 Adcock Ingram Pharmaceuticals

Ltd, South Africa

35 Sabax Dianeal Injection, 2.5%Peritoneal dialysis solution 2.5% POM Solution,

Injection

097/009 Adcock Ingram Pharmaceuticals

Ltd, South Africa

36Sabax Dianeal Injection, 4.25%

Peritoneal dialysis solution

4.25%

POM Solution,

Injection

097/010 Adcock Ingram Pharmaceuticals

Ltd, South Africa

Page 2 of 296

Page 3: REGISTER OF MARKETING AUTHORISATIONS - 2018 · ZAMBIA MEDICINES REGULATORY AUTHORITY REGISTER OF MARKETING AUTHORISATIONS - 2018 37 Myprodol Capsules Paracetamol 250mg + Ibuprofen

ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

37 Myprodol CapsulesParacetamol 250mg + Ibuprofen

200mg + Codeine 10mg

P Capsule Oral 097/011 Adcock Ingram Pharmaceuticals

Ltd, South Africa

38Lotem Suspension

Paracetamol 250mg + Ibuprofen

200mg

P Suspension for

Oral Use

097/012 Adcock Ingram Pharmaceuticals

Ltd, South Africa

39Syndol Tablets

Caffeine 30 mg + Codeine 10 mg

+ Doxylamine 5 mg +

Paracetamol 450 mg

P Tablet oral 111/005 Adcock Ingram Pharmaceuticals

Ltd, South Africa

40

Betapyn Tablets

Paracetamol 450 mg + Codeine

phosphate 10 mg + Doxylamine

succinate 5 mg + Caffeine

alkaloid 50 mg

P Tablet oral 111/008 Adcock Ingram Pharmaceuticals

Ltd, South Africa

41 Medikeel A Throat LozengesCetylpyridinium chloride 1.5 mg +

benzocaine 12 mg

GS Lozenges 111/009 Adcock Ingram Pharmaceuticals

Ltd, South Africa

42 Cepacol Throat Regular Lozenges Benzocaine 10 mg +

Cetylpyridinium chloride 1.47 mg

GS Lozenges 111/014 Adcock Ingram Pharmaceuticals

Ltd, South Africa

43

Alcophyllex Mixture

Theophylline 16.667 mg +

Hydroxyethyl Theophylline 1.667

mg + Diphenhydramine HCl

6.667 mg + Ammonium Chloride

120 mg + Sodium Citrate 50

mg/5 ml

POM Syrup 111/022 Adcock Ingram Pharmaceuticals

Ltd, South Africa

44 Cepacol Antibacterial MouthwashCetylpyridinium Chloride 50 mg +

Alcohol 15.8 % v/v

GS Solution for

Topical Use

111/023 Adcock Ingram Pharmaceuticals

Ltd, South Africa

45 Cepacol Throat Menthol Lozenges Cetylpyridinium Chloride 1.47 mg

+ Benzyl Alcohol 6.5 mg

GS Lozenges 111/024 Adcock Ingram Pharmaceuticals

Ltd, South Africa

46Bronchoped Syrup

Terbutaline 1.25mg + Ammonium

Chloride 60mg + Sodium Citrate

25mg

P Syrup 111/025 Adcock Ingram Pharmaceuticals

Ltd, South Africa

47Citro Soda Orange Granules

Sodium bicarbonate 1.716mg +

Tartaric acid 856mg + Citric acid

702mg + Sodium citrate 613mg

P Granules for

Suspension

111/026 Adcock Ingram Pharmaceuticals

Ltd, South Africa

48Citro Soda Granules

Sodium bicarbonate 1.716mg +

Tartaric acid 856mg + Citric acid

702mg + Sodium citrate 613mg

P Granules for

Suspension

111/027 Adcock Ingram Pharmaceuticals

Ltd, South Africa

49 Adco-Senna TabletsSennosides dry extract 60% eq.

to 13.50mg Senoside A & B

P Tablet Uncoated 111/028 Adcock Ingram Pharmaceuticals

Ltd, South Africa

50Locaine A Injection

Lignocaine Hydrochloride 20mg

+ Adrenaline Tartrate 12ug/ml

POM Solution for

Injection

111/029 Adcock Ingram Pharmaceuticals

Ltd, South Africa

Page 3 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

51 Adco - Efavirenz 600 TabletsEfavirenz 600mg POM Tablet Film

Coated

111/030 Adcock Ingram Pharmaceuticals

Ltd, South Africa

52Adco Efavirenz 200 Capsules

Efavirenz 200mg POM capsule Oral 111/031 Adcock Ingram Pharmaceuticals

Ltd, South Africa

53Medi - keel A Blackcurrant Throat

Lozenges

Benzocaine 12.0mg +

Cetylpyridinium 1.5mg

P Lozenges 111/032 Adcock Ingram Pharmaceuticals

Ltd, South Africa

54Medi - Keel A Honey and Lemon Throat

Lozenges

Benzocaine 12.0mg +

Cetylpyridinium 1.5mg

P Lozenges 111/033 Adcock Ingram Pharmaceuticals

Ltd, South Africa

55Actophlem Cough Syrup

Theophylline 100mg + Etofyline

10mg + Diphenylpyramine 8mg +

Ammonium 720mg

P Syrup 111/034 Adcock Ingram Pharmaceuticals

Ltd, South Africa

56Prelone Syrup

Prednisolone 15mg/5ml POM Syrup 111/035 Adcock Ingram Pharmaceuticals

Ltd, South Africa

57 Dilinct Dry Cough SyrupDextromethophan Hydrobromide

Ph. Eur 15mg/5ml

P Syrup 111/036 Adcock Ingram Pharmaceuticals

Ltd, South Africa

58Dolo Doc Capsules

Tramadol Hydrochloride BP

50mg

POM Capsule Oral 060/001 Adlife Healthare Pvt Ltd, India

59 Amoxycillin Oral SuspensionAmoxycillin Trihdyrate

125mg/5ml

POM Suspension for

Oral Use

060/002 Adlife Healthare Pvt Ltd, India

60 Oxacid 200mg Capsules Ofloxacin 200mg POM Capsule oral 137/002 Aegis Limited, Cyprus

61Cifex Suspension

Cefixime Trihydrate 100mg/5ml POM Suspension for

Oral Use

137/003 Aegis Limited, Cyprus

62 Cifex 200 Tablets Cefixime 200mg POM Tablet Uncoated 137/004 Aegis Limited, Cyprus

63 Cefixime 400mg Tablets Cefixime Trihydrate 400mg POM Tablet Uncoated 137/005 Aegis Limited, Cyprus

64 Lasoprol 30 Capsules Lansoprazole 30 mg POM Capsule oral 137/001 Aegis Limited,Cyprus

65

Selenaid Forte Nutritional Supplement

Capsules

Alpha Lipoic Acid 18.75mg +

Beta Carotene 0.31mg + Betaine

(TMG) 12.5mg + Bioperine

0.3mg + Biotin 3mcg

P Capsule Hard

Gelatin

368/001L African Health Solutions Ltd

66 Chlorosim - 250 Capsules Chlorampehicol 250mg POM Capsule oral 090/011 Africure Pharmaceuticals Ltd

67 Doxyrone - 100 Capsules Doxycycline 100mg POM Capsule oral 090/012 Africure Pharmaceuticals Ltd

68 Metrosim 200mg Tablets Metronidazole 200mg POM Tablet 286/002 Africure Pharmaceuticals Ltd

69 Simfen 200mg Tablets Ibuprofen 200mg P Tablet 286/003 Africure Pharmaceuticals Ltd

70Compound Magnesium Trisilicate

Tablets BP

Magnesium Trisilicate 250mg +

Aluminium Hydroxide 120mg

GS Tablet 286/007 Africure Pharmaceuticals Ltd

71 Erythone 250mg Tablets Erythromycin 250mg POM Tablet 286/011 Africure Pharmaceuticals Ltd

72 Cipone 500mg Tablets Ciprofloxacin 500mg POM Tablet 286/012 Africure Pharmaceuticals Ltd

73 Simdol 500mg Tablets Paracetamol 500 mg P Tablet 286/014 Africure Pharmaceuticals Ltd

Page 4 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

74 Celltriaxon InjectionCeftriaxone Sodium USP 1g POM Powder for

Injection

406/002 Agila Specialties Pvt Limited.

75Agisept Antiseptic Lozenges

Dichlorobenzyl alcohol + Amyl

metacresol

GS Lozenges 176/001 Agio Pharmaceutical Limited,

India

76 Agisept Antiseptic LozengesDichlorobenzyl alcohol + Amyl

metacresol

GS Lozenges 176/002 Agio Pharmaceutical Limited,

India

77 Agisept Antiseptic (Classical) LozengesDichlorobenzyl alcohol + Amyl

metacresol

GS Lozenges 176/003 Agio Pharmaceutical Limited,

India

78 Diclogen TabletsDiclofenac Sodium 100mg P Tablet Uncoated 176/004 Agio Pharmaceutical Limited,

India

79 Salbutamol Lifeforce TabletsSalbutamol 2mg POM Tablet Uncoated 176/005 Agio Pharmaceutical Limited,

India

80 Griseofulvin 500 TabletsGriseofulvin 500mg POM Tablet Uncoated 176/006 Agio Pharmaceutical Limited,

India

81 Sepralin TabletsSulfamethoxazole BP 400 mg +

Trimethoprim BP 80mg

POM Tablet Uncoated 176/007 Agio Pharmaceutical Limited,

India

82 Nalidixic Acid Lifeforce tabletsNalidixic Acid 500mg POM Tablet Uncoated 176/008 Agio Pharmaceutical Limited,

India

83Cloxacillin Lifeforce Capsules

Cloxacllin 250mg POM Capsule Oral 176/009 Agio Pharmaceutical Limited,

India

84 Tetracycline Lifeforce CapsulesTetracycline 250mg POM Capsule Oral 176/010 Agio Pharmaceutical Limited,

India

85 Para Force TabletsParacetamol BP 500mg GS Tablet Uncoated 176/011 Agio Pharmaceutical Limited,

India

86 Ferrous Sulphate TabletsFerrous Sulphate 200mg P Tablet Film

coated

176/012 Agio Pharmaceutical Limited,

India

87 Chloramphenicol Lifeforce CapsulesChloramphenicol BP 250mg POM Capsule oral 176/013 Agio Pharmaceutical Limited,

India

88 Paraforce SuspensionParacetamol 125mg/5ml GS Suspension for

Oral Use

176/015 Agio Pharmaceutical Limited,

India

89 Paracetamol Agio SuspensionParacetamol 125mg/5ml GS Suspension for

Oral Use

176/015 Agio Pharmaceutical Limited,

India

90 Ferrous Sulphate and Folic Acid tabletsFerrous Sulphate 200mg + Folic

Acid 0.25mg

P Tablet Film

coated

176/016 Agio Pharmaceutical Limited,

India

91 Moxforce CapsulesAmoxicillin 250mg POM Capsule oral 176/017 Agio Pharmaceutical Limited,

India

92Doxycycline Life Capsules

Doxycycline 100mg POM Capsule oral 176/018 Agio Pharmaceutical Limited,

India

Page 5 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

93 Doxycycline Life CapsulesDoxycline 100mg BP POM Capsule oral 176/018 Agio Pharmaceutical Limited,

India

94Metroforce Tablets

Metronidazole 200mg POM Tablet Uncoated 176/019 Agio Pharmaceutical Limited,

India

95 Metronidazole Agio TabletsMetronidazole 200mg POM Tablets 176/019 Agio Pharmaceutical Limited,

India

96Compound Magnesium Trisilicate

Tablets

Aluminium Hydroxide 120mg +

Magnesium Trisilscate 250mg

P Tablet Uncoated 176/020 Agio Pharmaceutical Limited,

India

97 Ibufen TabletsIbuprofen 200mg P Tablet Uncoated 176/021 Agio Pharmaceutical Limited,

India

98 Nuamp CapsulesAmpicillin 250mg POM Capsule oral 176/022 Agio Pharmaceutical Limited,

India

99 Albendazole Lifeforce SuspensionAlbendazole BP 400mg/10ml P Suspension for

Oral Use

176/023 Agio Pharmaceutical Limited,

India

100 Gentamicin Lifeforce InjectionGentamicin 40mg/ml POM Solution for

Injection

176/024 Agio Pharmaceutical Limited,

India

101 Metoclopramide Lifeforce InjectionMetoclopramide BP 10mg/2ml POM Solution for

Injection

176/025 Agio Pharmaceutical Limited,

India

102Mobiram Injection

Diclofenac Sodium BP 75mg/3ml POM Solution for

Injection

176/026 Agio Pharmaceutical Limited,

India

103 Dicyclone Lifeforce InjectionDicyclomine Hydrochloride

20mg/2ml

POM Solution for

Injection

176/027 Agio Pharmaceutical Limited,

India

104 Clovirax CreamAcyclovir 5%w/v POM Cream Topical 176/028 Agio Pharmaceutical Limited,

India

105 Micoson 2% CreamMiconazole 2% w/v POM Cream Topical 176/029 Agio Pharmaceutical Limited,

India

106 Micoson 2% CreamMiconazole Nitrate 2% w/v POM Topical cream 176/029 Agio Pharmaceutical Limited,

India

107 Erycin TabletsErythromycin Stearate BP 250mg POM Tablet Uncoated 176/030 Agio Pharmaceutical Limited,

India

108 Methyldopa Lifeforce TabletsMethyldopa BP 250mg POM Tablet Film

coated

176/031 Agio Pharmaceutical Limited,

India

109 Salbutamol Lifeforce 4mg TabletsSalbutamol 4mg POM Tablet Uncoated 176/032 Agio Pharmaceutical Limited,

India

110 Rulicin 150mg TabletsRoxithromycin 150mg POM Tablet Uncoated 176/033 Agio Pharmaceutical Limited,

India

111B-Complex Agio Injection

B-Complex 10ml POM Solution for

Injection

176/034 Agio Pharmaceutical Limited,

India

Page 6 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

112 Dexamethasone - Agio InjectionDexamethasone BP 4mg/ml POM Solution for

Injection

176/035 Agio Pharmaceutical Limited,

India113 Agovir Tablets Aciclovir 200mg POM Tablet Uncoated 202/001 Agog Pharma Ltd, India

114 Compound Magnesium TabletsAluminium Hydroxide 120mg +

Magnesium Trisiliscate 250mg

GS Tablet Uncoated 202/002 Agog Pharma Ltd, India

115 Indo-25 Capsules Indomethacin BP 25mg P Capsule oral 202/003 Agog Pharma Ltd, India

116 Cipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 202/004 Agog Pharma Ltd, India

117 Trimago 480 TabletsSulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 202/005 Agog Pharma Ltd, India

118 Agofen 200mg TabletsIbuprofen 200mg P Tablet Film

coated

202/006 Agog Pharma Ltd, India

119 Agoxic Tablets Nalidixic Acid 500mg POM Tablet Uncoated 202/007 Agog Pharma Ltd, India

120 Metronidazole TabletsMetronidazole 200mg POM Tablet Film

coated

202/008 Agog Pharma Ltd, India

121 Diclofenac Sodium TabletsDiclofenac Sodium 100mg P Tablet Film

coated

202/009 Agog Pharma Ltd, India

122 Trimago 240 TabletsSulfamethoxazole 200mg

+Trimethoprim 40mg

POM Tablet Film

coated

202/010 Agog Pharma Ltd, India

123 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 202/011 Agog Pharma Ltd, India

124 Heath E.Tonic Syrup Haematinic preparation P Syrup 202/012 Agog Pharma Ltd, India

125 Agometro SuspensionMetronidazole 125mg/5ml POM Suspension for

Oral Use

202/013 Agog Pharma Ltd, India

126B-Cox Tablets

B Complex P Tablet Film

coated

202/015 Agog Pharma Ltd, India

127 Agomol Tablets Paracetamol 500mg GS Tablet Uncoated 202/016 Agog Pharma Ltd, India

128 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 202/017 Agog Pharma Ltd, India

129 Ago-C 100mg Tablets Ascorbic Acid BP 100mg GS Tablet Uncoated 202/018 Agog Pharma Ltd, India

130 Ago-C 500mg Tablets Ascorbic Acid BP 500mg GS Tablet Chewable 202/019 Agog Pharma Ltd, India

131 B-twin TabletsB Complex P Tablet Film

coated

202/020 Agog Pharma Ltd, India

132 Metronidazole InjectionMetronidazole 5mg/ml POM Solution for

infusion

203/001 Ahlcon Parenterals (India) Ltd,

India

133 Fluconazole InjectionFluconazole 2mg/ml POM Solution for

infusion

203/002 Ahlcon Parenterals (India) Ltd,

India

134 Ciprofloxacin InjectionCiprofloxacin 2mg/ml POM Solution for

infusion

203/003 Ahlcon Parenterals (India) Ltd,

India

135Darrow's Solution

Potassuim chloride + Sodium

chloride + Sodium lactate

POM Solution for

infusion

203/004 Ahlcon Parenterals (India) Ltd,

India

Page 7 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

136 Compound Sodium Lactate SolutionPotassuim Chloride + Sodium

Chloride + Sodium Lactate

POM Solution for

infusion

203/005 Ahlcon Parenterals (India) Ltd,

India137 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 115/001 Ajanta Pharma Limited, India

138 Fingurin Capsules Herbal extracts 407mg P Capsule Oral 115/001H Ajanta Pharma Limited, India

139 Indoflam Capsules Indomethacin BP 25mg P Capsule oral 115/002 Ajanta Pharma Limited, India

140 Apdyl-H Syrup Herbal extracts 335mg GS Syrup 115/002H Ajanta Pharma Limited, India

141 Apkef Capsules Cephalexin 250mg POM Capsule oral 115/003 Ajanta Pharma Limited, India

142 Tyflox Capsules Ciprofloxacin 250mg POM Capsule oral 115/004 Ajanta Pharma Limited, India

143 Thirty Plus Capsules Ginseng extract 1000mg P Capsule oral 115/004H Ajanta Pharma Limited, India

144 Apthromycin Tablets Erythromycin 250mg POM Tablet Uncoated 115/005 Ajanta Pharma Limited, India

145 Pinkoo Gripe WaterHerbal extracts 45mg GS Solution for Oral

Use

115/005H Ajanta Pharma Limited, India

146 Optifenac Tablets Diclofenac 25mg P Tablet Uncoated 115/006 Ajanta Pharma Limited, India

147 Rheumanib Ointment Herbal extracts 14% w/w GS Ointment topical 115/006H Ajanta Pharma Limited, India

148 Optifenac Tablets Diclofenac 50mg P Tablet Uncoated 115/007 Ajanta Pharma Limited, India

149 Apcillin 250 Capsules Ampicillin 250mg POM Capsule oral 115/008 Ajanta Pharma Limited, India

150 Apcillin 500 Capsules Ampicillin 500mg POM Capsule oral 115/009 Ajanta Pharma Limited, India

151 Novaten 50 Tablets Atenonol 50mg POM Tablet Uncoated 115/010 Ajanta Pharma Limited, India

152 Mobaid Tablets Herbal extracts 950mg P Tablet Uncoated 115/010H Ajanta Pharma Limited, India

153 Novaten 100 Tablets Atenolol 100mg POM Tablet Uncoated 115/011 Ajanta Pharma Limited, India

154 Cloxil 250 Capsules Cloxacillin 250mg POM Capsule oral 115/012 Ajanta Pharma Limited, India

155 Anthalben Tablets Mebendazole USP 100mg P Tablet Uncoated 115/013 Ajanta Pharma Limited, India

156 Apmox 250 Capsules Amoxicillin 250mg POM Capsule oral 115/014 Ajanta Pharma Limited, India

157 Cloxa-Plus CapsulesCloxacillin Sodium BP 250mg +

Ampicillin Trihydrate BP 250mg

POM Capsule oral 115/015 Ajanta Pharma Limited, India

158Supreme S.S. Tablet

Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 115/017 Ajanta Pharma Limited, India

159 Apcalis 10 TabletsTadalafil 10mg POM Tablet Film

coated

115/018 Ajanta Pharma Limited, India

160 Apcalis Plus 20 TabletsTadalafil 20mg POM Tablet Film

coated

115/019 Ajanta Pharma Limited, India

161Atorfit-10 Tablets

Artovastatin Calcium 10mg POM Tablet Film

coated

115/020 Ajanta Pharma Limited, India

162 Atorfit-20 TabletsArtovastatin Calcium 20mg POM Tablet Film

coated

115/021 Ajanta Pharma Limited, India

163Ather Injection

Alpha-ß Artemether 75mg/2ml POM Solution for

Injection

115/030 Ajanta Pharma Limited, India

164 Kamagra Oral Gel Sildenafil Citrate 50mg POM Gel Oral 115/031 Ajanta Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

165 Anacox Plus LD TabletsIsoniazid BP 75mg + Rifampicin

BP 150mg

POM Tablet Film

coated

115/035 Ajanta Pharma Limited, India

166 Kamagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 115/036 Ajanta Pharma Limited, India

167 Kamagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 115/037 Ajanta Pharma Limited, India

168 Artefan 20/120mg TabletsArtemether 20 mg +

Lumefantrine 120mg

POM Tablet Uncoated 115/038 Ajanta Pharma Limited, India

169 Kamagra Oral Jelly 50mg Orange Sildenafil Citrate 50mg POM Gel Oral 115/039 Ajanta Pharma Limited, India

170 Tibinil-P Tablets Pyrazinamide 500mg POM Tablet Uncoated 115/040 Ajanta Pharma Limited, India

171 Apoxin Tablets Amoxicillin 250mg POM Tablet Uncoated 115/041 Ajanta Pharma Limited, India

172 Tibinil-E 200 Tablets Ethambutol 200mg POM Tablet Uncoated 115/042 Ajanta Pharma Limited, India

173 Tibnil E-400 Tablets Ethambutol 400mg POM Tablet Uncoated 115/043 Ajanta Pharma Limited, India

174Combisunate Forte Kit Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 115/044 Ajanta Pharma Limited, India

175Combisunate Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 115/045 Ajanta Pharma Limited, India

176 Artefan 40/240mg TabletsArtemether 40 mg+ Lumefantrine

240mg

POM Tablet Uncoated 115/046 Ajanta Pharma Limited, India

177Artefan Dispersible 20/120 Tablets

Artemether 20mg + Lumefantrine

120mg

POM Tablet

Dispersible

115/047 Ajanta Pharma Limited, India

178 Adrops Eye Drops Moxifloxacin HCl 0.5% w/v POM Eye Drops 115/048 Ajanta Pharma Limited, India

179 Lacoma Eye Drops Lantanoprost 50mcg POM Eye Drops 115/048 Ajanta Pharma Limited, India

180Lacoma - T Eye Drops

Lantanoprost 50mcg + Timolol

6.834mg

POM Eye Drops 115/049 Ajanta Pharma Limited, India

181Apmod 100/270 Tablets

Artesunate 100mg +

Amodiaquine Hydrochloride

270mg

POM Tablet Uncoated 115/050 Ajanta Pharma Limited, India

182 Apmod 50/135 TabletsArtesunate 50mg + Amodiaquine

135mg

POM Tablet Uncoated 115/051 Ajanta Pharma Limited, India

183Apmod 25/67.5 Tablets

Artesunate 25mg + Amodiaquine

67.5mg

POM Tablet Uncoated 115/052 Ajanta Pharma Limited, India

184 Artefan 80/480 TabletsArtemether 80 mg +

Lumefantrine 480mg

POM Tablet Uncoated 115/053 Ajanta Pharma Limited, India

185Artefan Suspension

Artemether 180mg +

Lumefantrine 1080mg

POM Suspension for

Oral Use

115/054 Ajanta Pharma Limited, India

186 Levotop 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 115/055 Ajanta Pharma Limited, India

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187Nurifer Capsules

Folic acid 100mg + Iron 1.5mg +

Vit B12 0.015mg + Vit C 75mg +

Zinc 61.8mg

P Capsule oral 115/056 Ajanta Pharma Limited, India

188 Zaha-250 Tablets Azithromycin 250mg POM Tablet Uncoated 115/057 Ajanta Pharma Limited, India

189 Zaha-500 Tablets Azithromycin 500mg POM Tablet Uncoated 115/058 Ajanta Pharma Limited, India

190 Zolanas-15 Capsules Lansoprazole 15mg POM Capsule oral 115/059 Ajanta Pharma Limited, India

191 Zolanas-30 Capsules Lansoprazole 30mg POM Capsule oral 115/060 Ajanta Pharma Limited, India

192 Ciprozole Forte TabletsCiprofloxacin 500mg + Tinidazole

600mg

POM Tablet Uncoated 115/061 Ajanta Pharma Limited, India

193Apflu Syrup

Paracetamol 120mg +

ChlorphenIramine 0.525mg +

Vitamin C 50mg

P Syrup 115/062 Ajanta Pharma Limited, India

194Apflu Tablet

Paracetamol 350mg +

Chlorpheniramine 2mg + Vitamin

C 100mg

POM Tablet Uncoated 115/063 Ajanta Pharma Limited, India

195 Aprazole Tablets Omeprazole 20mg POM Tablet Uncoated 115/064 Ajanta Pharma Limited, India

196 Atorfit-EZ TabletsAtorvastatin 10mg + Ezetimibe

10mg

POM Tablet Uncoated 115/065 Ajanta Pharma Limited, India

197 Fedate Syrup B Complex + Minerals P Syrup 115/066 Ajanta Pharma Limited, India

198Dazel-Kit Tablets

Fluconazole 150mg +

Azithromycin 1g + Secnidazole

1g

POM Tablet Uncoated 115/067 Ajanta Pharma Limited, India

199 Ridmal 40/320 TabletsDihydoartimimine 40mg +

Piperaquine 320mg

POM Tablet Uncoated 115/068 Ajanta Pharma Limited, India

200Kamagra -100 Efferscent Tablets -

Orange Flavour

Sildenafil Citrate 100mg POM Tablet

Effervescent

115/069 Ajanta Pharma Limited, India

201 Kamagra Oral Jelly Sildenafil Citrate 100mg POM Gel Oral 115/070 Ajanta Pharma Limited, India

202 Kamagra Oral Jelly - Pineapple Flavour Sildenafil Citrate 100mg POM Gel Oral 115/071 Ajanta Pharma Limited, India

203Kamagra Oral Jelly - Strawberry

Flavour

Sildenafil Citrate 100mg POM Gel Oral 115/072 Ajanta Pharma Limited, India

204 Instaclop 75 TabletsClopidogrel USP 75mg POM Tablet Film

coated

115/073 Ajanta Pharma Limited, India

205 Talimus 0.03% Ointment Tacrolimus 0.03% w/w POM Ointment topical 115/074 Ajanta Pharma Limited, India

206 Talimus 0.1% Ointment Tacrolimus 0.1% w/w POM Ointment topical 115/075 Ajanta Pharma Limited, India

207 Aderan 8 Tablets Candesartan cilexetil 8mg POM Tablet Uncoated 115/076 Ajanta Pharma Limited, India

208 Aderan 16 Tablets Candesartan cilexetil 16mg POM Tablet Uncoated 115/077 Ajanta Pharma Limited, India

209 Aderan 32 Tablets Candesartan cilexetil 32mg POM Tablet Uncoated 115/078 Ajanta Pharma Limited, India

210Acinac Plus Tablets

Aceclofenac 100mg +

Paracetamol 350mg

P Tablet oral 115/079 Ajanta Pharma Limited, India

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211 Apcalis SX 20 Orange Jelly Tadalafil 20mg POM Gel Oral 115/080 Ajanta Pharma Limited, India

212 Apcalis SX 20 Mint Jelly Tadalafil 20mg POM Gel Oral 115/081 Ajanta Pharma Limited, India

213Zaha Suspension

Azithromycin Dihydrate USP

200mg

POM Suspension for

Oral Use

115/089 Ajanta Pharma Limited, India

214 Instaclop Plus CapsulesAspirin BP 75mg + Clopidogrel

Bisulphate USP 75mg

POM Capsule oral 115/090 Ajanta Pharma Limited, India

215 Met-XL 100 TabletsMetoprolol Succinate 100mg POM Tablet extended

release

115/091 Ajanta Pharma Limited, India

216 Adacin GelAdapalene 0.1% w/w +

Clindamycin 1% w/wPOM Gel Topical 115/092 Ajanta Pharma Limited, India

217 Addrops DX Eye Drops Moxifloxacin + Dexamethasone POM Eye Drops 115/093 Ajanta Pharma Limited, India

218Artefan 80/480 Tablets

Artemether 80mg + Lumefantrine

480 mgPOM

Tablet Film

Coated115/094 Ajanta Pharma Limited, India

219Melacare Cream 15mg

Tritinoin 0.025%w/w +

Mometasone Furoate 0.1%w/w +

Hydroquinone 2% w/w

POM Cream Topical 115/095 Ajanta Pharma Limited, India

220 Ajanta's Stamina Herbal Extract P Capsule oral 115/HM008 Ajanta Pharma Limited, India

221Colirucus Gentadexa Ear/Eye Drops

Gentamicin + Dexamethasone +

Tetryzoline (0.65mg/100ml)

POM Ear/Eye Drops 158/001 Alcon Cusi SA Spain

222 Oftalmotrin Eye DropsTrimethoprim + Polymyxin B

(1.1g)

POM Eye Drops 158/002 Alcon Cusi SA Spain

223 Curicrom Eye Drops Sodium Cromoglycate 2% w/v POM Eye Drops 158/003 Alcon Cusi SA Spain

224 Cusicrom Eye Drops Disodium cromoglycate 4% w/v POM Eye Drops 158/004 Alcon Cusi SA Spain

225 Colircusi Chloramphenicol Eye Drops Chloramphenicol 0.5% POM Eye Drops 158/005 Alcon Cusi SA Spain

226 Cusimolol Eye Drops Timolol 0.5% w/v POM Eye Drops 158/006 Alcon Cusi SA Spain

227 Cusicrom 4% Eye Drops Sodium Cromoglycate 4% w/v POM Eye Drops 009/004 Alcon Laboratories SA Pty Ltd

228 Cyclogyl 15 Eye Drops cyclopentolate Hydrochloride 1%

w/v

POM Eye Drops 009/024 Alcon Laboratories SA Pty Ltd

229 Maxidex Ointment Dexamethasone 0.1% w/w POM Ointment topical 009/031 Alcon Laboratories SA Pty Ltd

230Maxitrol Ointment

Neomycin sulphate 3,500IU +

Dexamethasone 1mg +

Polymyxin B sulphate 6,000 IU

POM Ointment topical 009/033 Alcon Laboratories SA Pty Ltd

231 Mydriacyl Eye Drops Tropicamide 0.5% w/v POM Solution 009/034 Alcon Laboratories SA Pty Ltd

232Naphcon Eye Drops

Naphazoline Hydrochloride

0.025% + Pheniramine maleate

0.3%

POM Eye Drops 009/035 Alcon Laboratories SA Pty Ltd

233 Tetracaine 0.5% Eye Drops Lignocaine 0.5% w/v POM Eye Drops 009/037 Alcon Laboratories SA Pty Ltd

234 Tobrex Ointment Tobramycin 0.3% w/v POM Ointment topical 009/039 Alcon Laboratories SA Pty Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

235 Tobradex OintmentTobramycin 0.3% +

Dexamethasone 0.1%

POM Ointment topical 227/001 Alcon Laboratories SA Pty Ltd

236Tobradex Eye Drops

Tobramycin 0.3% +

Dexamethasone 0.1%

POM Eye Drops 227/002 Alcon Laboratories SA Pty Ltd

237 Brozeet SolutionBromhexine 4.2mg + Terbutaline

1.575mg, per 5ml

P Solution for Oral

Use

215/001 Alembic Chemical Works Co.

Limited, India

238 Benzathine Penicillin 2.4 MU InjectionBenzathine Penicillin 2.4 Mega

Units

POM Powder for

Injection

215/002 Alembic Chemical Works Co.

Limited, India

239Zeet Expectorant Syrup

Bromhexine 4mg +

Guaiphenesin 50mg +

Diphenylhydramine 8mg, per 5ml

P Syrup 215/003 Alembic Chemical Works Co.

Limited, India

240Clarithro-250 Tablets

Clarithromycin 250mg POM Tablet Uncoated 215/004 Alembic Chemical Works Co.

Limited, India

241

Glycodin Cough Syrup

Codeine Phosphate 3.75mg +

Alcohol 10mg + Menthol 0.07ml

+ Terpene Hydrate 10mg per 5ml

P Syrup 215/005 Alembic Chemical Works Co.

Limited, India

242 Lomeg 10 TabletsLoratadine 10mg POM Tablet Uncoated 215/006 Alembic Chemical Works Co.

Limited, India

243 Procain Penicillin 3MU InjectionProcaine Penicillin 3MU POM Powder for

Injection

215/007 Alembic Chemical Works Co.

Limited, India

244Fortified Procaine Penicillin 4MU

Injection

Procain Penicillin 4MU POM Powder for

Injection

215/008 Alembic Chemical Works Co.

Limited, India

245 Benzyl Penicillin 5MU InjectionBenzyl Penicillin 5MU POM Powder for

Injection

215/009 Alembic Chemical Works Co.

Limited, India

246Sparta Tablets

Sparfloxacin 200mg POM Tablet Uncoated 215/010 Alembic Chemical Works Co.

Limited, India

247 Azithral 200 LiquidAzithromycin 200mg POM Solution for Oral

Use

215/011 Alembic Chemical Works Co.

Limited, India

248 Althrocin S 250 Oral SolutionAzithromycin 2050mg POM Solution for Oral

Use

215/012 Alembic Chemical Works Co.

Limited, India

249 Omezol-20 CapsulesOmeprazole 20mg POM Capsule oral 215/013 Alembic Chemical Works Co.

Limited, India

250 Ciprown-500 TabletsCiprofloxacin 500mg POM Tablet Uncoated 215/014 Alembic Chemical Works Co.

Limited, India

251 Azithral-250 TabletsAzithromycin 250mg POM Tablet Uncoated 215/015 Alembic Chemical Works Co.

Limited, India

252Ugel Liquid

Magaldrate 84mg + Simethicone

4.080mg, per ml

POM Suspension for

Oral Use

215/016 Alembic Chemical Works Co.

Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

253 Ugel Chewable TabletsMagaldrate 400mg +

Simethicone 20mg

P Tablet Chewable 215/017 Alembic Chemical Works Co.

Limited, India

254Fortafen Tablets

Aceclofenac 100mg POM Tablet Film

coated

215/018 Alembic Chemical Works Co.

Limited, India

255 Azithral - 500 TabletsAzithromycin Dihydrate 500mg POM Tablet Film

coated

215/019 Alembic Chemical Works Co.

Limited, India

256Glisen MF 2 Tablets

Glimepiride USP 2mg +

Metformin Hydrochloride USP

500mg

POM Tablet Film

coated

215/020 Alembic Chemical Works Co.

Limited, India

257Glisen MF 1 Tablets

Glimepiride USP 1mg +

Metformin Hydrochloride USP

500mg

POM Tablet Film

coated

215/021 Alembic Chemical Works Co.

Limited, India

258 Neolap Eye DropsOlopatadine Hydrochloride USP

0.2% w/v

POM Eye Drops 215/022 Alembic Chemical Works Co.

Limited, India

259 Moxofi Eye DropsMoxifloxacin Hydrochloride

5.4mg

POM Eye Drops 215/023 Alembic Chemical Works Co.

Limited, India

260 Dorembic Eye DropsDoizolamide HCl USP 2.0%w/v POM Eye Drops 215/024 Alembic Chemical Works Co.

Limited, India

261 Augdor Eye DropsDozolamide Hcl USP 2% w/v +

Timolol maleate USP 0.5%w/v

POM Eye Drops 215/025 Alembic Chemical Works Co.

Limited, India

262 Vel Drop GelCarboxymethylcellulose Sodium

1%/w/v

POM Eye Drops 215/026 Alembic Chemical Works Co.

Limited, India

263Alemtob Eye Drops

Tobramycin USP 0.3%w/v POM Solution for

Topical Use

215/027 Alembic Chemical Works Co.

Limited, India

264Alemtob-D Eye Drops

Tobramycin 0.3%w/v +

Dexamethasone 0.1%w/v

POM Solution for

Topical Use

215/028 Alembic Chemical Works Co.

Limited, India

265 Owin D Eye DropsOfloxacin 0.3%w/v +

Dexamethasone 0.1%w/v

POM Solution for

Topical Use

215/029 Alembic Chemical Works Co.

Limited, India

266 Vel Eye DropsCarboxymethylcellulose Sodium

0.5%w/v

POM Eye Drops 215/030 Alembic Chemical Works Co.

Limited, India267 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 166/001 Alkem Laboratories Ltd, India

268Erythromycin Suspension

Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

166/002 Alkem Laboratories Ltd, India

269 Broadmex-250 Capsules Amoxicillin 250mg POM Capsule oral 166/003 Alkem Laboratories Ltd, India

270 Formin-500mg Tablets Metformin 500mg POM Tablet Uncoated 166/004 Alkem Laboratories Ltd, India

271 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 166/005 Alkem Laboratories Ltd, India

272Taxim 1g Injection

Cefotaxime 1g POM Powder for

Injection

166/006 Alkem Laboratories Ltd, India

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273 Decacef SuspensionCephalexin 125mg, per 5ml POM Powder for Oral

Suspension

166/007 Alkem Laboratories Ltd, India

274 Decacef 500 Capsules Cephalexin 500mg POM Capsule oral 166/008 Alkem Laboratories Ltd, India

275 Chloramphenicol Oral SuspensionChloramphenicol 125mg, per 5ml POM Suspension for

Oral Use

166/009 Alkem Laboratories Ltd, India

276 Alcipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 166/010 Alkem Laboratories Ltd, India

277 Amoxicillin SuspensionAmoxicillin 125mg, per 5ml POM Powder for Oral

Suspension

166/011 Alkem Laboratories Ltd, India

278 Anpicillin Oral SuspensionAmpicillin 125mg, per 5ml POM Suspension for

Oral Use

166/012 Alkem Laboratories Ltd, India

279 Cloxacillin Oral SuspensionCloxacillin 125mg, per 5ml POM Powder for Oral

Suspension

166/013 Alkem Laboratories Ltd, India

280 Omeprazole-20 Capsules Omeprazole 20mg POM Capsule oral 166/014 Alkem Laboratories Ltd, India

281 T-Prim 80/400mg TabletsTrimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 166/015 Alkem Laboratories Ltd, India

282Cloxacillin 250 Injection

Cloxacillin 250mg POM Powder for

Injection

166/016 Alkem Laboratories Ltd, India

283 Decacef 250 Capsules Cephalexin 250mg POM Capsule oral 166/017 Alkem Laboratories Ltd, India

284 Broadclox-500 Capsules Ampicillin + Cloxacillin 500mg POM Capsule oral 166/018 Alkem Laboratories Ltd, India

285 Amitriptylline TabletsAmitriptylline Hydrochloride

25mg

POM Tablet Uncoated 252/001 Alpharma Ltd, United Kingdom

286 Allopurinol Tablets Allopurinol 100mg POM Tablet Uncoated 252/002 Alpharma Ltd, United Kingdom

287Atenolol 25 Tablets

Atenolol 25mg POM Tablet Film

coated

252/003 Alpharma Ltd, United Kingdom

288Atenolol 50 Tablets

Atenolol 50mg POM Tablet Film

coated

252/004 Alpharma Ltd, United Kingdom

289 Atenolol TabletsAtenolol 100mg POM Tablet Film

coated

252/005 Alpharma Ltd, United Kingdom

290 Bendrofluazide Tablets Bendrofluazide 5mg POM Tablet Uncoated 252/006 Alpharma Ltd, United Kingdom

291 Captopril Tablets Captopril 25mg POM Tablet Uncoated 252/007 Alpharma Ltd, United Kingdom

292 Co-Amilozide TabletsHydrochlorothiazide 50mg +

Amiloride 5mg

POM Tablet Uncoated 252/008 Alpharma Ltd, United Kingdom

293 Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 252/009 Alpharma Ltd, United Kingdom

294 Glyceryl Trinitrate Tablets Glyceryl Trinitrate 0.5mg POM Tablet Uncoated 252/010 Alpharma Ltd, United Kingdom

295 Isosorbide Mononitrate Tablets Isosorbide mononitrate 10mg POM Tablet Uncoated 252/011 Alpharma Ltd, United Kingdom

296 Metformin Tablets Metformin 500mg POM Tablet Uncoated 252/012 Alpharma Ltd, United Kingdom

297 Verapamil Tablets Verapamil Hydrochloride 40mg POM Tablet Uncoated 252/013 Alpharma Ltd, United Kingdom

298 Spironolactone 25 Tablets Spironolactone 25mg POM Tablet Uncoated 252/014 Alpharma Ltd, United Kingdom

299 Spironolactone 50 Tablets Spironolactone 50mg POM Tablet Uncoated 252/015 Alpharma Ltd, United Kingdom

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

300 Amovit C Calcium TabletsAscorbic Acid 500 + Calcium

Carbonate 1000

P Tablet Uncoated 020/003 Amoun Pharmaceuticals

Company, Egypt

301Amovit C Tablets

Ascorbic Acid 1000mg P Tablet Uncoated 020/004 Amoun Pharmaceuticals

Company, Egypt

302

B.B.C Spray

Benzocaine 1500 mg+

Benzydamine hydrochloride

150mg + Cetalkonium chloride,

per 100ml

GS Spray for Topical

Use

020/005 Amoun Pharmaceuticals

Company, Egypt

303 Baby CreamOlive Oil 10mg + Zinc Oxide

20mg, per 100g

GS Cream Topical 020/006 Amoun Pharmaceuticals

Company, Egypt

304 Collycrom 4% Eye DropsSodium Cromoglycate 4.0% w/v POM Eye Drops 020/007 Amoun Pharmaceuticals

Company, Egypt

305Enemax Enema Solution

Monosodium phosphate 6mg +

Disodium phosphate 16mg

POM Solution for

Topical Use

020/008 Amoun Pharmaceuticals

Company, Egypt

306Xenos Fruit Effervescent Granules

Sodium Bicarbonate 2.7mg +

Citric Acid 0.76mg + Tartaric

Acid 1.257mg

GS Granules for

Oral Use

020/009 Amoun Pharmaceuticals

Company, Egypt

307 For Hair and Nails CapsulesGS Capsule oral 020/010 Amoun Pharmaceuticals

Company, Egypt

308 Glucose TabletsGlucose 3mg+ Ascorbic Acid

120mg

GS Tablet Uncoated 020/011 Amoun Pharmaceuticals

Company, Egypt

309Michaelon Tablets

Paracetamol 400mg+

Pseudoephedrine 60mg +

Carbinoxaine Maleate 4mg

P Tablet Uncoated 020/012 Amoun Pharmaceuticals

Company, Egypt

310 Minalax TabletsBisacodyl 3mg + Dioctyl -

Sodium Sulphosuccinate 100mg

P Tablet Uncoated 020/013 Amoun Pharmaceuticals

Company, Egypt

311 My Sweet Baby SyrupDill Oil + Caraway Oil +

Cardamon Oil + Peppermint Oil

GS Syrup 020/014 Amoun Pharmaceuticals

Company, Egypt

312 Vitamount for Women CapsulesMultivitamin GS Capsule oral 020/015 Amoun Pharmaceuticals

Company, Egypt

313 Vitamount SyrupMultivitamin GS Syrup 020/016 Amoun Pharmaceuticals

Company, Egypt

314 Viva-Max 3mg TabletsMelatonin + Pyrodoxine Hcl 3mg POM Tablet Uncoated 020/017 Amoun Pharmaceuticals

Company, Egypt

315Safe Pill

Levonorgestrel 1.5mg P Tablet Film

coated

404/001 Anant Pharmaceuticals Ltd

316Enerject-12 Injection

Vitamin B12 2500mcg, Folic acid

0.7mg, Niacinamide 12 mg,

Benzyl Alcohol 1% v/v

POM Solution for

Injection

279/001 Anglo-French Drugs & Industries

Ltd,India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

317 Beplex Forte TabletsVit B Complex + Vit C+ Biotin

260mcg

GS Tablet Film

coated

279/002 Anglo-French Drugs & Industries

Ltd,India

318Beplex Forte Injection

Multivitamin POM Solution for

Injection

279/003 Anglo-French Drugs & Industries

Ltd,India

319 Maxamin Forte TabletsVitamins + Minerals GS Tablet Uncoated 279/004 Anglo-French Drugs & Industries

Ltd,India320 Zincofer Capsules Haematinic preparation P Capsule oral 248/001 Apex Laboratories Ltd, India

321 Betzee CreamBetamethasone 0.05%w/w +

Zinc 2.5%w/w

POM Cream Topical 248/002 Apex Laboratories Ltd, India

322Betzee G Cream

Betamethasone 0.05%w/w +

Gentamicin 0.10%w/w+ Zinc

2.5%w/w

POM Cream Topical 248/003 Apex Laboratories Ltd, India

323Betzee-M Cream

Betamethasone 0.05%w/w +

Miconazole 2%w/w + Zinc

2.5%w/w

POM Cream Topical 248/004 Apex Laboratories Ltd, India

324Betzee-GM Cream

Betamethasone 0.05%w/w+

Miconazole2%w/w + Gentamicin

0.10%w/w+ Zinc 2.5%w/w

POM Cream Topical 248/005 Apex Laboratories Ltd, India

325Betzee-S Ointment

Betamethasone0.05%w/w +

Salicylic acid 3%w/w+ Zinc

2.5%w/w

POM Ointment topical 248/006 Apex Laboratories Ltd, India

326 Lozee Cream clobetasone 0.05% w/w POM Cream Topical 248/007 Apex Laboratories Ltd, India

327Lozee-GM Cream

Clobetasone 0.05% +

Gentamicin 0.10% + Miconazole

2.0% + Zinc 1.0%w/w

POM Cream Topical 248/008 Apex Laboratories Ltd, India

328Zincovit Syrup

Multivitamins GS Syrup for Oral

Use

248/009 Apex Laboratories Ltd, India

329 Zincovit Tablets Multivitamins GS Tablet Uncoated 248/010 Apex Laboratories Ltd, India

330 Zincovit DropsMultivitamins GS Suspension for

Oral Use

248/011 Apex Laboratories Ltd, India

331Zincofer Liquid

Haematinic preparation P Suspension for

Oral Use

248/012 Apex Laboratories Ltd, India

332 Nalidixic Acid Tablets Nalidixic acid 500mg POM Tablet Uncoated 248/013 Apex Laboratories Ltd, India

333 Monocef-O Tablets Cefpodoxine 200mg POM Tablet Uncoated 256/001 Aristo Pharmaceuticals Ltd, India

334Ar- Ampi Powder

Ampicillin 125mg, per 5ml POM Powder for

suspension

187/001 Arubhi International, India

335 Ar-Grisco 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 187/002 Arubhi International, India

336 Ar-Griseo 250 Tablets Griseofulvin 250mg POM Tablet Uncoated 187/003 Arubhi International, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

337 Ar-Ampicloc CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule Oral 187/004 Arubhi International, India

338Ar-Ampiclox 125 Syrup

Ampicillin 62.5mg + Cloxacillin

62.5mg

POM Syrup 187/005 Arubhi International, India

339 Ar-Clovir Tablets Acyclovir 200mg POM Tablet Uncoated 187/006 Arubhi International, India

340 Ar-Clox Capsules Cloxacillin 250mg POM Capsule Oral 187/009 Arubhi International, India

341 Ar-Cloxa Syrup Cloxacillin 125mg, per 5ml POM Syrup 187/010 Arubhi International, India

342 Ar-Fol 5 Tablets Folic acid 5mg P Tablet Uncoated 187/011 Arubhi International, India

343Arol Solution

Sodium chloride + Sodium citrate

+ Possium chloride + Glucose

GS Powder for Oral

Solution

187/012 Arubhi International, India

344 Ar-Cetamol Tablets Paracetamol 500mg P Tablet Uncoated 187/013 Arubhi International, India

345 Ar-Sal Tablets Salbutamol 4mg POM Tablet Uncoated 187/014 Arubhi International, India

346 Ar-Ibu TabletsIbuprofen 200mg P Tablet Film

coated

187/015 Arubhi International, India

347 Ar-Zole Capsules Fluconazole 150mg POM Capsule oral 187/016 Arubhi International, India

348 Ar-Ozine TabletsPromethazine 25mg P Tablet Film

coated

187/017 Arubhi International, India

349 Ar-Cotri TabletsTrimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 187/018 Arubhi International, India

350 Ar-Pyra Tablets Pyrantel pamoate 125mg P Tablet Uncoated 187/019 Arubhi International, India

351 Ar Cee Tablets Ascorbic Acid 200mg GS Tablet Uncoated 187/020 Arubhi International, India

352 Ar-Gliben - 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 187/021 Arubhi International, India

353 Ar-Pred Tablets Prednisolone 5mg POM Tablet Uncoated 187/022 Arubhi International, India

354 Ar-Dar TabletsPyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 187/023 Arubhi International, India

355 Ar-Peridol Tablets Haloperidol 5mg POM Tablet Uncoated 187/024 Arubhi International, India

356 Ar-Omycin Tablets Erythromycin 250mg POM Tablet Uncoated 187/025 Arubhi International, India

357 AR-Zole Capsules Fluconazole 200mg POM Capsule Oral 187/026 Arubhi International, India

358 Ar-Floxacin TabletsCiprofloxacin 500mg POM Tablet Film

coated

187/027 Arubhi International, India

359 Ar-Tetra Capsules Tetracycline 250mg POM Capsule Oral 187/028 Arubhi International, India

360 Ar-Diclo Tablets Diclofenac 100mg P Tablet Uncoated 187/029 Arubhi International, India

361 Ar- Pramide Tablets Loperamide 2mg POM Tablet Uncoated 187/030 Arubhi International, India

362 Ar-Mazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 187/031 Arubhi International, India

363Ar-Thylodopa Tablets

Methyldopa 250mg POM Tablet Film

coated

187/032 Arubhi International, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

364Ar-Antacid Tablets

Aluminium hydroxide BP 120mg

+ Magnesium trisilscate BP

250mg

GS Tablet Chewable 187/033 Arubhi International, India

365 Ar-Hyoscine Tablets Hyoscine Butybromide 10mg POM Tablet Uncoated 187/034 Arubhi International, India

366 Ar-Grisceo 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 187/035 Arubhi International, India

367 Ar-Metro Tablets Metronidazole 200mg POM Tablet Uncoated 187/036 Arubhi International, India

368 Ar-Vitacee Tablets Ascorbic Acid 100mg GS Tablet Uncoated 187/037 Arubhi International, India

369 Arbimazole Tablets Carbimazole 5mg POM Tablet Uncoated 187/038 Arubhi International, India

370 Ardidol Tablets Propranolol 40mg POM Tablet Uncoated 187/039 Arubhi International, India

371 Arhexol 2mg Tablets Benzhexol 2mg POM Tablet Uncoated 187/040 Arubhi International, India

372 Arhexol 5mg Tablets Benzhexol 5mg POM Tablet Uncoated 187/041 Arubhi International, India

373 Arnadix Tablets Nalidixic Acid 500mg POM Tablet Uncoated 187/042 Arubhi International, India

374 Arphen Tablets Chlorpheniramine 4mg P Tablet Uncoated 187/043 Arubhi International, India

375 Artopril Tablets Captopril 25mg POM Tablet Uncoated 187/044 Arubhi International, India

376 Paradol Tablets Paracetamol 500mg GS Tablet Uncoated 187/045 Arubhi International, India

377 Ar-Pyron SuspensionPyrantel Pamoate 50mg, per 1ml P Suspension for

Oral Use

187/046 Arubhi International, India

378 AR-INDO 25 Capsules Indomethacin 25mg P Capsule oral 187/047 Arubhi International, India

379 Ar-Ampi 250 Caspules Ampicillin 250mg POM Capsule oral 187/048 Arubhi International, India

380 Ar-Amox 250 Capsules Amoxicillin 250mg POM Capsule oral 187/049 Arubhi International, India

381 Diclonac Tablets Diclofenac 50mg P Tablet Uncoated 187/050 Arubhi International, India

382 Formin Tablets Metformin 500mg POM Tablet Uncoated 187/051 Arubhi International, India

383 Sharp Shoot Tablets Sildenafil 50mg POM Tablet Uncoated 187/052 Arubhi International, India

384 Sharp Shoot Tablets Sildenafil 100mg POM Tablet Uncoated 187/053 Arubhi International, India

385 Aramino Tablets Aminophylline 100mg POM Tablet Uncoated 187/054 Arubhi International, India

386 Armide Tablets Furosemide 40mg POM Tablet Uncoated 187/055 Arubhi International, India

387 Ar-Pirin TabletsAspirin 75mg POM Tablet Sustained

Release

187/056 Arubhi International, India

388 Chloprazin Tablets Chlorpromazine 25mg POM Tablet Uncoated 187/057 Arubhi International, India

389 Cimedin Tablets Cimetidine 200mg POM Tablet Uncoated 187/058 Arubhi International, India

390 Digox Tablets Digoxin 0.25mg POM Tablet Uncoated 187/059 Arubhi International, India

391 Vita - B6 Tablets Pyridoxine 50 mg POM Tablet Uncoated 187/060 Arubhi International, India

392 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 184/001 Arvind Remedies Limited, India

393 Cloxacillin Capsules Cloxacillin 250mg POM Capsule Oral 184/002 Arvind Remedies Limited, India

394 Phenobarbital Tablets Phenobarbitone 30mg POM Tablet Uncoated 184/003 Arvind Remedies Limited, India

395Rifampicin + Isoniazid Tablets

Rifampicin 150mg+ Isoniazid

75mg

POM Tablet Uncoated 184/004 Arvind Remedies Limited, India

396 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 184/005 Arvind Remedies Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

397 Promethazine Tablets Promethazine 25mg P Tablet Uncoated 184/006 Arvind Remedies Limited, India

398 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 184/007 Arvind Remedies Limited, India

399Diclofenac BP Enteric Coated Tablets

Diclofenac 50mg P Tablet Enteric

Coated

184/008 Arvind Remedies Limited, India

400Sulfadoxine USP + Pyrimethamine

Tablets

Pyrimethamine 25mg +

Sulfadoxine USP 500mg

P Tablet Uncoated 184/010 Arvind Remedies Limited, India

401 Suganril Tablets Piroxicam 20mg POM Tablet Uncoated 101/001 Asence Pharma Pvy Ltd., India.

402 Zodid InjectionDiclofenac 75mg, per 3ml POM Solution for

Injection

101/002 Asence Pharma Pvy Ltd., India.

403 Zobid SR Tablets Diclofenac 100mg P Tablet Uncoated 101/003 Asence Pharma Pvy Ltd., India.

404 Nifedipine 10 Tablets Nifedipine 10mg POM Tablet Uncoated 101/004 Asence Pharma Pvy Ltd., India.

405 Pocilin 4 Mega InjectionPenicillin G + Procaine

Benzylpenicillin 4MU

POM Powder for

Injection

101/005 Asence Pharma Pvy Ltd., India.

406Trimin Injection

B Complex POM Solution for

Injection

101/006 Asence Pharma Pvy Ltd., India.

407Amoxicillin Oral Suspension

Amoxicillin 25mg, per 5ml POM Powder for Oral

Suspension

101/007 Asence Pharma Pvy Ltd., India.

408 Compound Magnesium TabletsAluminium hydroxide 120 +

Magnesium trisilscate 250mg

GS Tablet Uncoated 101/008 Asence Pharma Pvy Ltd., India.

409Cofnil-N Expectorant Syrup

Codein 10mg +

Chlorpheniramine 4mg + Methol

1.5mg, per 5ml

P Syrup 101/009 Asence Pharma Pvy Ltd., India.

410Amphotericin B Injection

Amphotericin B 5mg POM Solution for

Injection

101/010 Asence Pharma Pvy Ltd., India.

411 Streptocin InjectionStreptomycin 5 g POM Powder for

Injection

101/011 Asence Pharma Pvy Ltd., India.

412 Amoxicillin Trihydrate Capsules Amoxicillin 250mg POM Capsule oral 101/012 Asence Pharma Pvy Ltd., India.

413 Hemomin Capsules Haemantic preparation P Capsule oral 101/013 Asence Pharma Pvy Ltd., India.

414Oral Rehydration Salt

Sodium Chloride + Sodium

Citrate + Possium Chloride +

Glucose

GS Powder for Oral

Solution

101/014 Asence Pharma Pvy Ltd., India.

415 Phenoxymethyl Penicillin V TabletsPhenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 101/015 Asence Pharma Pvy Ltd., India.

416 Fluphenazine Decanoate InjectionFluphenazine 25mg POM Solution for

Injection

101/017 Asence Pharma Pvy Ltd., India.

417Sulphabiotic Dusting Powder

Sulphacetamide 75mg +

Neomycin 5mg + Gramicidin

0.5mg

POM Powder for

Topical use

101/018 Asence Pharma Pvy Ltd., India.

418 Tetracycline Eye Ointment Tetracycline 1%w/w POM Eye Ointment 101/019 Asence Pharma Pvy Ltd., India.

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

419 Neuclar - 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 101/020 Asence Pharma Pvy Ltd., India.

420 Nipine SR TabletsNifedipine 20mg POM Tablet extended

release

101/021 Asence Pharma Pvy Ltd., India.

421

Trimin Tablets

Thiamine Mononitrate USP

100mg + Pyridoxine

Hydrochloride BP30mg +

Cyanocobalamine 100mcg

P Tablet Film

coated

101/022 Asence Pharma Pvy Ltd., India.

422Maxiplex Tablets

Thiamine Mononitrate 10mg +

Riboflavine + Pyridoxine

Hydrochloridel + Niacinamide

P Tablet Film

coated

101/023 Asence Pharma Pvy Ltd., India.

423 Quinine Sulphate TabletsQuinine Sulphate 300mg POM Tablet Uncoated 145/001 Aspen Pharmacare Limited, South

Africa

424 Amiloretic H.S TabletsHydrochlorothiazide 2.5mg +

Amiloride 25mg

POM Tablet Uncoated 145/002 Aspen Pharmacare Limited, South

Africa

425Arthrexin 25 Suppositories

Indomethacin 25mg P Suppository 145/003 Aspen Pharmacare Limited, South

Africa

426

Panamor 100 SR Tablets

Diclofenac 100mg P Tablet Film

coated,

Sustained

Release

145/005 Aspen Pharmacare Limited, South

Africa

427 Purbac Adult TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 145/006 Aspen Pharmacare Limited, South

Africa

428 Purata -10 TabletsOxazepam 10mg POM Tablet Uncoated 145/007 Aspen Pharmacare Limited, South

Africa

429 Pur-Bloka TabletsPropranolol 40mg POM Tablet Uncoated 145/008 Aspen Pharmacare Limited, South

Africa

430Mybulen Tablets

Codeine 10mg + Paracetamol

350mg + Ibuprofen 200mg

P Tablet Uncoated 145/009 Aspen Pharmacare Limited, South

Africa

431 Degramol 200 TabletsCarbamazepine 200mg POM Tablet Uncoated 145/010 Aspen Pharmacare Limited, South

Africa

432 Arthrexin-100 SuppositoriesIndomethacin 100mg P Suppository 145/011 Aspen Pharmacare Limited, South

Africa

433 Wormgo TabletsMebendazole 100mg P Tablet Uncoated 145/013 Aspen Pharmacare Limited, South

Africa

434 Cardifen-10 CapsulesNifedipine 10mg POM Capsule oral 145/014 Aspen Pharmacare Limited, South

Africa

435Venteze Syrup

Salbutamol 2mg, per 5ml POM Syrup 145/015 Aspen Pharmacare Limited, South

Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

436 Venteze InhalerSalbutamol 100mcg POM Powder for

Inhalation

145/016 Aspen Pharmacare Limited, South

Africa

437Purmycin 125 Suspension

Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

145/017 Aspen Pharmacare Limited, South

Africa

438 Hypotone TabletsMethyldopa 250mg POM Tablet Uncoated 145/018 Aspen Pharmacare Limited, South

Africa

439 Trichazole TabletsMetronidazole 5mg POM Tablet Uncoated 145/020 Aspen Pharmacare Limited, South

Africa

440 Glycomin TabletsGlibenclamide 5mg POM Tablet Uncoated 145/021 Aspen Pharmacare Limited, South

Africa

441 Amiloretic TabletsAmiloride Hydrochloride 50mg POM Tablet Uncoated 145/022 Aspen Pharmacare Limited, South

Africa

442 Woodward's Gripe WaterSodium Bicarbonate + Dill oil GS Solution for Oral

Use

145/023 Aspen Pharmacare Limited, South

Africa

443 Lenisolone TabletsPrednisolone 5mg POM Tablet Uncoated 145/024 Aspen Pharmacare Limited, South

Africa

444 AP Stavudine15 CapsulesStavudine 15mg POM Capsule oral 145/025 Aspen Pharmacare Limited, South

Africa

445Aspen Lamizid Tablets

Lamivudine 150mg + Zidovudine

300mg

POM Tablets 145/029 Aspen Pharmacare Limited, South

Africa

446 Aspen Lamivudine TabletsLamivudine 150mg POM Tablet Uncoated 145/030 Aspen Pharmacare Limited, South

Africa

447 Aspen Lamivudine SyrupLamivudine 10mg, per ml POM Syrup 145/031 Aspen Pharmacare Limited, South

Africa

448 Aspen Zidovudine TabletsZidovudine 300mg POM Tablet Uncoated 145/032 Aspen Pharmacare Limited, South

Africa

449 Aspen Zidovudine SyrupZidovudine 50mg, per 5ml POM Syrup 145/033 Aspen Pharmacare Limited, South

Africa

450 Aspen Nevirapine TabletsNevirapine 200mg POM Tablet Uncoated 145/034 Aspen Pharmacare Limited, South

Africa

451Aspen Lamzid + Nevirapine Combipack

Tablets

Lamivudine 150mg + Zidovudine

300mg/Nevirapine 200mg

POM Tablet Uncoated 145/035 Aspen Pharmacare Limited, South

Africa

452 Aspen Didanosine 50mg TabletsDidanosine 50mg POM Tablet Uncoated 145/036 Aspen Pharmacare Limited, South

Africa

453 Aspen Didanosine 100mg TabletsDidanosine 100mg POM Tablet Uncoated 145/037 Aspen Pharmacare Limited, South

Africa

454Aspen Didanosine 150mg Tablets

Didanosine 150mg POM Tablet Uncoated 145/038 Aspen Pharmacare Limited, South

Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

455 Viread TabletsTenofovir 300mg POM Tablet Film

coated

145/039 Aspen Pharmacare Limited, South

Africa

456Truvada Tablets

Emtricitabine 200mg + Tenofovir

300mg

POM Tablet Film

coated

145/040 Aspen Pharmacare Limited, South

Africa

457 Aspen Didanosine 25mg TabletsDidanosine 25mg POM Tablet Uncoated 145/041 Aspen Pharmacare Limited, South

Africa

458 Prezista TabletsDarunavir 300mg POM Tablet Uncoated 145/042 Aspen Pharmacare Limited, South

Africa

459 Intelence TabletsEtravirine 100mg POM Tablet Uncoated 145/043 Aspen Pharmacare Limited, South

Africa

460 Prezista TabletsDarunavir 600mg POM Tablet Film

coated

145/044 Aspen Pharmacare Limited, South

Africa

461 Hycorcin 100mg InjectionHydrocortisone 100mg POM Powder for

Injection

145/045 Aspen Pharmacare Limited, South

Africa

462 Isolift 10mg TabletsEscitalopram oxalate 10mg POM Tablet Film

coated

145/046 Aspen Pharmacare Limited, South

Africa

463 Isolift 20mg TabletsEscitalopram oxalate 20mg POM Tablet Film

coated

145/047 Aspen Pharmacare Limited, South

Africa

464Tracruim Injection

Atracurium 10mg, per ml POM Solution for

Injection

179/024 Aspen Pharmacare Limited, South

Africa

465 Lanoxin TabletsDigoxin 0.25mg POM Tablet Uncoated 179/029 Aspen Pharmacare Limited, South

Africa

466 Topilept 25 TabletsTopiramate 25mg POM Tablet Film

coated

179/053 Aspen Pharmacare Limited, South

Africa

467 Topilept 50 TabletsTopiramate 50mg POM Tablet Film

coated

179/054 Aspen Pharmacare Limited, South

Africa

468 Topilept 100 TabletsTopiramate 100mg POM Tablet Film

coated

179/055 Aspen Pharmacare Limited, South

Africa

469 Nimbex InjectionCisatracurium besylate 2mg, per

ml

POM Solution for

Injection

179/060 Aspen Pharmacare Limited, South

Africa

470 Lanzine (ODT) TabletsOlanzepine 10mg POM Tablet Film

coated

179/070 Aspen Pharmacare Limited, South

Africa

471Co-Rampil Tablets

Ramipril BP 5mg +

Hydrochlorothiazide USP 12.5mgPOM Tablet Uncoated 179/070

Aspen Pharmacare Limited, South

Africa

472 Lanprox Solution For InfusionLevofloxacin Hemihydrate

250mg, per 50ml

POM Solution for

infusion

179/071 Aspen Pharmacare Limited, South

Africa

473Bidogrel 75mg Tablets

Clopidogrel Bisulfate 75mg POM Tablet Film

coated

179/072 Aspen Pharmacare Limited, South

Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

474 Co-Rampil TabletsRamipril 5mg +

Hydrochlorothiazide 25mg

POM Tablet Uncoated 179/073 Aspen Pharmacare Limited, South

Africa

475Stavudine 30mg +

Lamivudine/Nevirapine Tablets

Stavudine 150mg + Lamivudine

+ Nevirapine 300mg

POM Tablet Uncoated 222/007MT Aspen Pharmacare Limited, South

Africa

476 Quinas TabletsQuinine 300mg POM Tablet Film

coated

290/004 Astra Lifecare Pvt Limited

477 Astrim TabletsTrimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 290/010 Astra Lifecare Pvt Limited

478 Aspiclox CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 290/012 Astra Lifecare Pvt Limited

479 Asmox Capsules Amoxicilin Trihydrate 250mg POM Capsule oral 290/013 Astra Lifecare Pvt Limited

480 Asfulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 290/014 Astra Lifecare Pvt Limited

481As-B Tablets

Nicotinamide15mg + Riboflavin

1mg + Thiamine Mononitrate

1mg

P Tablet 290/015 Astra Lifecare Pvt Limited

482Femin-P Pessaries

Nystatin 100,000 IU Pharmacy

Medicine

Tablet Vaginal 290/016 Astra Lifecare Pvt Limited

483 Lumether TabletsArtemether 120mg +

Lumefantrine 20mg

POM Tablet Uncoated 290/001 Astra Lifecare Pvt Limited, India

484 Ascodyl TabletsBisacodyl 5mg P Tablet Film

coated

290/002 Astra Lifecare Pvt Limited, India

485 Ascopan TabletsHyocine butylbromide 10mg POM Tablet Film

coated

290/003 Astra Lifecare Pvt Limited, India

486 Asmol Tablets Paracetamol 500mg P Tablet Uncoated 290/005 Astra Lifecare Pvt Limited, India

487 Asdoxin Capsules Doxycycline 100mg POM Capsule oral 290/006 Astra Lifecare Pvt Limited, India

488 Asid Capsules Omeprazole 20mg POM Capsule oral 290/007 Astra Lifecare Pvt Limited, India

489 Gynest Pessaries Clotrimazole 100mg POM Tablet Vaginal 290/008 Astra Lifecare Pvt Limited, India

490 Painol - P TabletsParacetamol 650mg + Caffeine

50mg

P Tablet Uncoated 290/009 Astra Lifecare Pvt Limited, India

491 Asfen -FC Tablets Ibuprofen 200mg P Tablet Uncoated 290/011 Astra Lifecare Pvt Limited, India

492 Inderal 10mg Tablets Propranolol 10mg POM Tablet Uncoated 023/009 Astra Zeneca UK Limited

493 Inderal 40mg Tablets Propranolol 40mg POM Tablet Uncoated 023/010 Astra Zeneca UK Limited

494 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/013 Astra Zeneca UK Limited

495 Paludrine 100mg Tablets Proguanil 100mg POM Tablet Uncoated 023/014 Astra Zeneca UK Limited

496 Tenormin 50mg Tablets Atenolol 50mg POM Tablet Uncoated 023/021 Astra Zeneca UK Limited

497 Tenormin 100mg Tablets Atenolol 100mg POM Tablet Uncoated 023/022 Astra Zeneca UK Limited

498Tenoretic 100/25mg Tablets

Atenolol 100mg + Chlorthalidone

25mg

POM Tablet Uncoated 023/023 Astra Zeneca UK Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

499 Tenoret 50/12.4mg TabletsAtenolol 50mg + Chlorthalidone

12.4mg

POM Tablet Uncoated 023/024 Astra Zeneca UK Limited

500 Zestril 5mg Tablets Lisinopril 5mg POM Tablet Uncoated 023/026 Astra Zeneca UK Limited

501 Zestril 10mg Tablets Lisinopril 10mg POM Tablet Uncoated 023/027 Astra Zeneca UK Limited

502 Zestril 20mg Tablets Lisinopril 20mg POM Tablet Uncoated 023/028 Astra Zeneca UK Limited

503 Nolvadex 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 023/031 Astra Zeneca UK Limited

504 Oxis TurbuhalerFormoterol 4.5mg POM Powder for

Inhalation

023/039 Astra Zeneca UK Limited

505 Oxis 9mg TurbuhalerFormoterol 9mg POM Powder for

Inhalation

023/040 Astra Zeneca UK Limited

506 Pulmcort 100 TurbuhalerBudesonide 100mg POM Powder for

Inhalation

023/041 Astra Zeneca UK Limited

507 Pulmcort 200 TurbuhalerBudesonide 200mg POM Powder for

Inhalation

023/042 Astra Zeneca UK Limited

508 Pulmcort 400 TurbuhalerBudesonide 400mg POM Powder for

Inhalation

023/043 Astra Zeneca UK Limited

509 Losec Mumps 20 TabletsOmeprazole 20mg POM Tablet Film

coated

023/044 Astra Zeneca UK Limited

510 Zestrorectic TabletsHydrochlorothiazide 12.5mg +

Lisinopril 20mg

POM Tablet Uncoated 023/045 Astra Zeneca UK Limited

511 Zoladex 3.6mg Injection Goserelin acetate implant 3.6mg POM Implant,

Injection

023/046 Astra Zeneca UK Limited

512 Symbicort TurbuhalerFormoterol 4.5mcg + Budesonide

80mcg

POM Powder for

Inhalation

023/047 Astra Zeneca UK Limited

513 Arimidex 10mg Tablets Anastrozole 10mg POM Tablet Uncoated 023/051 Astra Zeneca UK Limited

514Nexium 20 Tablets

Esomeprazole 20mg POM Tablet Film

coated

023/052 Astra Zeneca UK Limited

515 Nexium 40 TabletsEsomeprazole 40mg POM Tablet Film

coated

023/053 Astra Zeneca UK Limited

516 Zmox Capsules Amoxicillin 250mg POM Capsule oral 127/001 Aurobindo Pharma Limited, India

517 Recipro 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 127/002 Aurobindo Pharma Limited, India

518 Recipro 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 127/003 Aurobindo Pharma Limited, India

519Zcil 250 Injection

Ampicillin 250mg POM Powder for

Injection

127/004 Aurobindo Pharma Limited, India

520 Renor 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 127/005 Aurobindo Pharma Limited, India

521 Aurocef Capsules Cephalexin 250mg POM Capsule oral 127/006 Aurobindo Pharma Limited, India

522Zuclox Capsules

Cloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 127/007 Aurobindo Pharma Limited, India

523 Cloxil Capsules Cloxacillin 250mg POM Capsule oral 127/008 Aurobindo Pharma Limited, India

524 Zolcer Capsules Omeprazole 200mg POM Capsule oral 127/009 Aurobindo Pharma Limited, India

Page 24 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

525 Lamivox 150 Tablets Lamivudine 150mg POM Tablet Uncoated 127/010 Aurobindo Pharma Limited, India

526 Stavex 40 Capsules Stavudine 40mg POM Capsule oral 127/011 Aurobindo Pharma Limited, India

527 Nevirex 200 Tablets Nevirapine 200mg POM Tablet Uncoated 127/012 Aurobindo Pharma Limited, India

528 Indivex 400 Tablets Indinavir 400mg POM Tablet Uncoated 127/013 Aurobindo Pharma Limited, India

529 Didavex 100 Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/014 Aurobindo Pharma Limited, India

530 Zidovex - L TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 127/015 Aurobindo Pharma Limited, India

531 Stavex 30 L TabletsLamivudine 150mg + Stavudine

30mg

POM Tablet Uncoated 127/016 Aurobindo Pharma Limited, India

532 Stavex 40 L TabletsLamivudine 150mg + Stavudine

40mg

POM Tablet Uncoated 127/017 Aurobindo Pharma Limited, India

533 Nelvex 250 Tablets Nelfinavir 250mg POM Tablet Uncoated 127/018 Aurobindo Pharma Limited, India

534 Aurocef 250 Oral SuspensionCephalexin 250mg, per 5ml POM Suspension for

Oral Use

127/019 Aurobindo Pharma Limited, India

535 Aurocef 125 Oral SuspensionCephalexin 125mg, per 5ml POM Suspension for

Oral Use

127/020 Aurobindo Pharma Limited, India

536 Cetax 1000 InjectionCefotaxime 1000mg POM Powder for

Injection

127/021 Aurobindo Pharma Limited, India

537 Erythromycin SuspensionErythromycin 125mg, per 5ml POM Suspension for

Oral Use

127/022 Aurobindo Pharma Limited, India

538 Chloramphenicol InjectionChloramphenicol 1000mg POM Powder for

Injection

127/023 Aurobindo Pharma Limited, India

539Triaxone 1000 Injection

Ceftriaxone 1000mg POM Powder for

Injection

127/024 Aurobindo Pharma Limited, India

540Cloxil 500 Injection

Cloxacillin 500mg POM Powder for

Injection

127/025 Aurobindo Pharma Limited, India

541 Lamivudine + Zidovudine TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 127/026 Aurobindo Pharma Limited, India

542 Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 127/027 Aurobindo Pharma Limited, India

543 Stavudine 30 Capsules Stavudine 30mg POM Capsule oral 127/028 Aurobindo Pharma Limited, India

544 Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 127/029 Aurobindo Pharma Limited, India

545 Efavirenz 600 Tablets Efavirenz 600mg POM Tablet Uncoated 127/030 Aurobindo Pharma Limited, India

546 Lamivudine 150mg Tablets Lamivudine 150mg POM Tablet Uncoated 127/031 Aurobindo Pharma Limited, India

547 Lamivudine 300mg Tablets Lamivudine 300mg POM Tablet Uncoated 127/032 Aurobindo Pharma Limited, India

548 Zidovudine Oral SolutionZidovudine 50mg, per 5ml POM Solution for Oral

Use

127/033 Aurobindo Pharma Limited, India

549Lamivudine Oral Solution

Lamivudine 10mg, per ml POM Solution for Oral

Use

127/034 Aurobindo Pharma Limited, India

Page 25 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

550 Nevirapine Oral SolutionNevirapine 50mg, per 5ml POM Solution for Oral

Use

127/035 Aurobindo Pharma Limited, India

551 Zidovudine Tablets Zidovudine 200mg POM Tablet Uncoated 127/036 Aurobindo Pharma Limited, India

552Stavudine + Lamivudine 30/150mg

Tablets

Stavudine 30mg +

Lamivudine150mg

POM Tablet Uncoated 127/037 Aurobindo Pharma Limited, India

553 Stavudine + Lamivudine TabletsStavudine 40mg + Lamivudine

150mg

POM Tablet Uncoated 127/038 Aurobindo Pharma Limited, India

554 Abacavir Tablets Abacavir 300mg POM Tablet Uncoated 127/039 Aurobindo Pharma Limited, India

555 Stavudine Oral SolutionStavudine 1mg, per ml POM Solution for Oral

Use

127/040 Aurobindo Pharma Limited, India

556 Abacavir Sulphate Oral SolutionAbacavir 20mg, per ml POM Solution for Oral

Use

127/041 Aurobindo Pharma Limited, India

557 Stavudine 20mg Capsules Stavudine 20mg POM Capsule oral 127/042 Aurobindo Pharma Limited, India

558 Stavudine 15mg Capsules Stavudine 15mg POM Capsule oral 127/043 Aurobindo Pharma Limited, India

559 Efavirenz 100mg Capsules Efavirenz 100mg POM Capsule oral 127/044 Aurobindo Pharma Limited, India

560Lamivudine + Zidovudine + Nevirapine

Tablets

Lamivudine 150mg + Zidovudine

300mg + Nevirapine 200mg

POM Tablet Uncoated 127/045 Aurobindo Pharma Limited, India

561Lamivudine + Zidovudine + Efavirenz

Tablets

Lamivudine 150mg + Zidovudine

300mg + Efavirenz 600mg

POM Tablet Uncoated 127/046 Aurobindo Pharma Limited, India

562 Efavirenz 200mg Capsules Efavirenz 200mg POM Capsule oral 127/047 Aurobindo Pharma Limited, India

563 Kardam 10 Tablets Amlodipine 10mg POM Tablet Uncoated 127/049 Aurobindo Pharma Limited, India

564 Kardam 5 Tablets Amlodipine 5mg POM Tablet Uncoated 127/050 Aurobindo Pharma Limited, India

565Koact Oral Suspension

Amoxicillin 125mg + Clavulanic

acid 31.25mg , per 5ml

POM Suspension for

Oral Use

127/051 Aurobindo Pharma Limited, India

566 Koact Oral SuspensionAmoxicillin 250mg + Clauvulanic

acid 62.5mg, per 5ml

POM Suspension for

Oral Use

127/052 Aurobindo Pharma Limited, India

567Cefurxime 750 Injection

Cefuroxime 750mg POM Powder for

Injection

127/053 Aurobindo Pharma Limited, India

568 Cefurxime 1500 InjectionCefuroxime 1500mg POM Powder for

Injection

127/054 Aurobindo Pharma Limited, India

569 Didanosine Chewable Tablets Didanosine 100mg POM Tablet Chewable 127/055 Aurobindo Pharma Limited, India

570 Didanosine Chewable Tablets Didanosine 150mg POM Tablet Chewable 127/056 Aurobindo Pharma Limited, India

571 Didanosine Chewable Tablets Didanosine 200mg POM Tablet Chewable 127/057 Aurobindo Pharma Limited, India

572 Zcil 500mg InjectionAmpicillin 500mg POM Powder for

Injection

127/059 Aurobindo Pharma Limited, India

573 Aurocef 500mg Capsules Cephalexin 500mg POM Capsule oral 127/060 Aurobindo Pharma Limited, India

574Zmox Oral Suspension

Amoxicillin 125mg, per 5ml POM Suspension for

Oral Use

127/061 Aurobindo Pharma Limited, India

Page 26 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

575 Zcil Oral SuspensionAmpicillin 125mg, per 5ml POM Suspension for

Oral Use

127/062 Aurobindo Pharma Limited, India

576Combact 480mg Tablets

Sulphamethoxazole 400mg

+Trimethoprim 80mg

POM Tablet Uncoated 127/063 Aurobindo Pharma Limited, India

577 Combact SuspensionTrimethoprim 40mg +

Sulfamethoxazole 200mg

POM Suspension for

Oral Use

127/064 Aurobindo Pharma Limited, India

578 Cefuxime 125 Tablets Cefuroxime 125mg POM Tablet Uncoated 127/065 Aurobindo Pharma Limited, India

579 Cefuxime 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 127/066 Aurobindo Pharma Limited, India

580 Cefuxime 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 127/067 Aurobindo Pharma Limited, India

581 Koact 375 TabletsAmoxicillin 250mg + Clavulanic

acid 125mg

POM Tablet Uncoated 127/068 Aurobindo Pharma Limited, India

582Koact 625 Tablets

Amoxicillin 500mg + Clavulanic

acid 125mg

POM Tablet Uncoated 127/069 Aurobindo Pharma Limited, India

583 Koact 1000 TabletsAmoxicillin 875mg + Clavulanic

acid 125mg

POM Tablet Uncoated 127/070 Aurobindo Pharma Limited, India

584Stavudine + Lamivudine + Nevirapine

Tablets

Stavudine 30mg + Lamivudine

150mg + Nevirapine 200mg

POM Tablet Uncoated 127/071 Aurobindo Pharma Limited, India

585Didanosine Delayed Released

Capsules

Didanosine 400mg POM Capsule oral 127/072 Aurobindo Pharma Limited, India

586 Didanosine Capsules Didanosine 250mg POM Capsule oral 127/073 Aurobindo Pharma Limited, India

587Emtricitabine + Tenofovir Tablets

Tenofivir Disoproxil Fumerate

200mg + Emtricitabine 300mg

POM Tablet Uncoated 127/074 Aurobindo Pharma Limited, India

588 Lopinavir/Ritonavir TabletsLopinavir 200mg + Ritonavir

50mg

POM Tablet Uncoated 127/075 Aurobindo Pharma Limited, India

589 Angiram 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 127/076 Aurobindo Pharma Limited, India

590 Angiram 5 Tablets Ramipril 5mg POM Tablet Uncoated 127/077 Aurobindo Pharma Limited, India

591 Angiram 10 Tablets Ramipril 10mg POM Tablet Uncoated 127/078 Aurobindo Pharma Limited, India

592 Aroxicam 7.5 Tablets Meloxicam 7.5mg POM Tablet Uncoated 127/079 Aurobindo Pharma Limited, India

593 Aroxicam 15 Tablets Meloxicam 15mg POM Tablet Uncoated 127/080 Aurobindo Pharma Limited, India

594 Auro Metformin 500 Tablets Metformin 500mg POM Tablet Uncoated 127/081 Aurobindo Pharma Limited, India

595 Auro Metformin 850 Tablets Metformin 850mg POM Tablet Uncoated 127/082 Aurobindo Pharma Limited, India

596 Tenofivir Disoproxil Fumarate TabletsTenofovir 300mg POM Tablet Film

coated

127/083 Aurobindo Pharma Limited, India

597Lamivudine & Tenofovir Disoproxil

Fumarate Tablets

Lamivudine 300mg + Tenofovir

Disoproxil Fumarate 300mg

POM Tablet Film

coated

127/084 Aurobindo Pharma Limited, India

598Efavirenz + Emtricitabine + Tenofovir

Tablets

Efavirenz 600mg + Emtricitabine

200mg + Tenofovir 300mg

POM Tablet Uncoated 127/085 Aurobindo Pharma Limited, India

599Efavirenz + Lamivudine + Tenofovir

Tablets

Efavirenz 600mg + Emtricitabine

300mg + Tenofovir 300mg

POM Tablet Uncoated 127/086 Aurobindo Pharma Limited, India

Page 27 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

600 Tissop CapsulesIndomethacin 25mg P Capsule oral 178/001 Aurochem Laboratories Pvt,

Limited, India

601Feverlet Tablets

Paracetamol 500mg GS Tablet Uncoated 178/002 Aurochem Laboratories Pvt,

Limited, India

602 Nutrigel SuspensionAntacid 550mg GS Suspension for

Oral Use

178/003 Aurochem Laboratories Pvt,

Limited, India

603 Perfopil 50 TabletsSildenafil 50mg POM Tablet Uncoated 178/004 Aurochem Laboratories Pvt,

Limited, India

604 Cerocip 250 TabletsCiprofloxacin 250mg POM Tablet Uncoated 178/005 Aurochem Laboratories Pvt,

Limited, India

605 Cerocip 500 TabletsCiprofloxacin 500mg POM Tablet Uncoated 178/006 Aurochem Laboratories Pvt,

Limited, India

606 Rumifen 200 TabletsIbuprofen 200mg P Tablet Uncoated 178/007 Aurochem Laboratories Pvt,

Limited, India

607 Melamine TabletsSulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 178/008 Aurochem Laboratories Pvt,

Limited, India

608 Defnil-SR TabletsDiclofenac 100mg P Tablet Uncoated 178/009 Aurochem Laboratories Pvt,

Limited, India

609Telmentic Suspension

Pyrantel Pamoate 250mg, per

5ml

P Suspension for

Oral Use

178/010 Aurochem Laboratories Pvt,

Limited, India

610 Telmentic TabletsPyrantel Pamoate 125mg P Tablet Uncoated 178/011 Aurochem Laboratories Pvt,

Limited, India

611 Mucof Cough LozengesHerbal Extracts P Lozenges 178/012 Aurochem Laboratories Pvt,

Limited, India

612 Repisprin-300 TabletsAspirin 300mg P Tablet Uncoated 178/013 Aurochem Laboratories Pvt,

Limited, India

613 Betaclox SolutionCloxacillin 125mg, per 5ml POM Solution for Oral

Use

178/014 Aurochem Laboratories Pvt,

Limited, India

614Dr Home Cough Syrup

Paracetamol 120mg +

Chlorpheniramine 0.5mg +

Phenylephrine 2.5mg, per 5ml

P Syrup 178/015 Aurochem Laboratories Pvt,

Limited, India

615 Lymphocin SuspensionErythromycin 125mg, per 5ml POM Suspension for

Oral Use

178/016 Aurochem Laboratories Pvt,

Limited, India

616

Alcof Syrup

Chlorpheniramine 2.2mg +

Ammonium Chloride 110mg +

Sodium citrate 50mg + Menthol

1.1mg, per 5ml

P Syrup 178/017 Aurochem Laboratories Pvt,

Limited, India

617Chlorpheniramine 4 Tablets

Chlorpheniramine 4mg P Tablet Uncoated 178/018 Aurochem Laboratories Pvt,

Limited, India

Page 28 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

618 Chlorpheniramine 2 TabletsChlorpheniramine 2mg P Tablet Uncoated 178/019 Aurochem Laboratories Pvt,

Limited, India

619Welvit Syrup

Multivitamins GS Syrup 178/023 Aurochem Laboratories Pvt,

Limited, India

620 Zobinace SolutionMetronidazole 125mg, per 5ml POM Solution for Oral

Use

178/024 Aurochem Laboratories Pvt,

Limited, India

621 Neuroflex TabletsVitamin B Complex P Tablet Uncoated 178/025 Aurochem Laboratories Pvt,

Limited, India

622 Rocort-H CreamHydrocortisone 2%w/w POM Cream Topical 178/026 Aurochem Laboratories Pvt,

Limited, India

623 Adnicor TabletsPrednisolone 5mg POM Tablet Uncoated 178/027 Aurochem Laboratories Pvt,

Limited, India

624 Bisix TabletsPyridoxine 50mg POM Tablet Uncoated 178/028 Aurochem Laboratories Pvt,

Limited, India

625 Aurovir CreamAcyclovir 5%w/w POM Cream Topical 178/029 Aurochem Laboratories Pvt,

Limited, India

626 Normal Saline SolutionSodium chloride 0.9% w/v POM Solution for

infusion

015/001 Autosterile (EA) Limited, Kenya

627Autosterile 10% Glucose Injection

Dextrose 10% w/v POM Solution for

infusion

015/002 Autosterile (EA) Limited, Kenya

628Autosterile 5% Glucose + 0.9% Sodium

Chloride Injection

Dextrose 5% w/v + Sodium

Chloride 0.9% w/v

POM Solution for

infusion

015/003 Autosterile (EA) Limited, Kenya

629Autosterile Half Strength Darrows

Injection

Sodium Chloride + Sodium

lactate + Potassium Chloride

POM Solution for

infusion

015/004 Autosterile (EA) Limited, Kenya

630 Glucose 5% InjectionDextrose 5% w/v POM Solution for

Injection

015/005 Autosterile (EA) Limited, Kenya

631Ringers Lactate Injection

Sodium Chloride + Sodium

Lactate + Potassium Chloride +

Calcium Chloride

POM Solution for

infusion

015/006 Autosterile (EA) Limited, Kenya

632Ringers Lactate Infusion

Sodium Chloride + Sodium

Lactate + Calcium Chloride +

Potassium Chloride

POM Solution for

infusion

096/001 Autosterile Pvt Limited, Zimbabwe

633 Glucose InfusionGlucose 5% w/v POM Solution for

infusion

096/002 Autosterile Pvt Limited, Zimbabwe

634 Sodium Chloride InfusionSodium chloride 0.9% w/v POM Solution for

infusion

096/003 Autosterile Pvt Limited, Zimbabwe

635Stamaril Vaccine

Yellow Fever virus strain 17D/AB

237- Live attenuated

POM Suspension for

Injection

049/001 Aventis Pasteur SA Pty Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

636 Imovax Meningo A + C VaccineMeningococcal A + C

Polysaccharide vaccine

POM Solution for

Injection

049/002 Aventis Pasteur SA Pty Limited

637Trimovax Vaccine

Measles + Mumps + Rubella -

Live attenuated

POM Suspension for

Injection

049/003 Aventis Pasteur SA Pty Limited

638Typhim VI Vaccine

Purified VI capsular

polysaccaride of Salmonella typhi

type 2

POM Suspension for

Injection

049/004 Aventis Pasteur SA Pty Limited

639 Tetavax VaccineTetanus toxoid- Purified POM Suspension for

Injection

049/005 Aventis Pasteur SA Pty Limited

640 Diabend Tablets Gliclazide 80mg POM Tablet Uncoated 288/001 Bal Pharma Limited, India

641 Grisoral 250mg Tablets Griseofulvin 250mg POM Tablet oral 288/002 Bal Pharma Limited, India

642 Regamol 500mg Tablets Paracetamol 500mg GS Tablet oral 288/003 Bal Pharma Limited, India

643 Dynamox - 250 Capsules Amoxicillin 250mg POM Capsule oral 288/004 Bal Pharma Limited, India

644 Dynamox - 500 Capsules Amoxicillin 500mg POM Capsule oral 288/005 Bal Pharma Limited, India

645 Ibuprofen TabletsIbuprofen 400mg P Tablet Film

coated

288/006 Bal Pharma Limited, India

646 Seregra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 288/007 Bal Pharma Limited, India

647 Seregra-100 Tablets Sildenafil 100mg POM Tablet Uncoated 288/008 Bal Pharma Limited, India

648 Diclofenac Sodium TabletsDiclofenac 50mg P Tablet Enteric

Coated

288/009 Bal Pharma Limited, India

649 Mycoral Oral GelMiconazole 2% w/w POM Gel Oral 009/014 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

650 Hyoscine Butyl Bromide TabletsHyoscine butyl bromide 20mg POM Tablet Uncoated 009/047 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

651 Cephalexin SuspensionCephalexin 125mg/5mls POM Suspension for

Oral Use

009/074 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

652Cephalexin 250mg Capsules

Cephalexin 250mg POM Capsule oral 009/075 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

653 Cephalexin 500mg CapsulesCephalexin 500mg POM Capsule oral 009/076 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

654 Ampicillin 250mg CapsulesAmpicillin 250mg POM Capsule oral 009/077 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

655 Ampicillin 500mg CapsulesAmpicillin 500mg POM Capsule oral 009/078 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

656 Rifampicin CapsulesRifampicin 150mg POM Capsule oral 009/079 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

657Rifampicin Capsules

Rifampicin 300mg POM Capsule oral 009/080 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

658 Amoxycillin CapsulesAmoxycillin 250mg POM Capsule oral 009/081 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

659Amoxycillin 250mg Capsules

Amoxycillin 500mg POM Capsule oral 009/082 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

660 Doxycycline CapsulesDoxycycline 100mg POM Capsule oral 009/083 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

661 Piroxicam CapsulesPiroxicam 10mg POM Capsule oral 009/084 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

662 Cloxamp GranulesCloxacillin 250mg + Ampicillin

250mg

POM Suspension for

Oral Use

009/085 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

663 Mefenamic Acid CapsulesMefenamic acid 250mg POM Capsule oral 009/086 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

664 Tetracycline CapsulesTetracycline 250mg POM Capsule oral 009/087 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

665 Paracetamol 500mg TabletsParacetamol 500mg GS Tablet Uncoated 009/089 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

666 Glibenclamide TabletsGlibenclamide 5mg POM Tablet Uncoated 009/090 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

667Pyrazinamide Tablets

Pyrazinamide 500mg POM Tablet Uncoated 009/091 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

668 Gamsidar TabletsSulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 009/092 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

669 Paracetamol 100mg TabletsParacetamol 100mg GS Tablet Uncoated 009/093 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

670 Alluopurinol TabletsAllopurinol 300mg POM Tablet Uncoated 009/094 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

671 Metronidazole TabletsMetronidazole 200mg POM Tablet Uncoated 009/095 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

672 Ethambutol TabletsEthambutol 400mg POM Tablet Uncoated 009/097 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

673 Gamuretic TabletsAmiloride 5mg +

Hydrochlorothiazide 50mg

POM Tablet Uncoated 009/098 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

674 Griseofulvin TabletsGriseofulvin 500mg POM Tablet Uncoated 009/099 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

675 Promethazine InjectionPromethazine 25mg, per ml POM Solution for

Injection

009/100 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

676Streptomycin Injection

Streptomycin 1g POM Powder for

Injection

009/101 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

677 Cloxacillin InjectionCloxacillin 250mg POM Powder for

Injection

009/102 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

678Atropine Injection

Atropine 0.6mg, per ml POM Solution for

Injection

009/103 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

679 Gentamycin InjectionGentamycin 10mg, per ml POM Solution for

Injection

009/104 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

680 Gentamycin InjectionGentamycin 40mg, per ml POM Solution for

Injection

009/105 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

681 Kanamycin InjectionKanamycin 1g POM Powder for

Injection

009/107 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

682 Allopurinol TabletsAllopurinol 100mg POM Tablet Uncoated 009/109 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

683 Ketamine InjectionKetamine 50mg, per ml POM Solution for

Injection

009/110 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

684 Frusemide InjectionFrusemide 10mg, per ml POM Solution for

Injection

009/111 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

685 Metoclopramide InjectionMetoclopramide 5mg, per ml POM Solution for

Injection

009/112 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

686Chlorpromazine Injection

Chlorpromazine 25mg, per ml POM Solution for

Injection

009/113 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

687 Praziquantel TabletsPraziquantel 600mg POM Tablet Uncoated 009/114 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

688 Metronidazole InjectionMetronidazole 0.5% w/v POM Solution for

Injection

009/115 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

689 Isoniazid TabletsIsoniazid 100mg POM Tablet Uncoated 009/117 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

690 Ibuprofen TabletsIbuprofen 400mg P Tablet Uncoated 009/118 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

691 Pethidine 50mg/ml InjectionPethidine 50mg, per ml POM Solution for

Injection

009/119 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

692 Propranolol TabletsPropranolol 40mg POM Tablet Uncoated 009/120 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

693 Phenobarbitone TabletsPhenobarbitone 30mg POM Tablet Uncoated 009/123 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

694 Phenobarbitone TabletsPhenobarbitone 60mg POM Tablet Uncoated 009/124 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

695Pethidine 25mg/Ml Injection

Pethidine 25mg, per ml POM Solution for

Injection

009/125 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

Page 32 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

696 Cloxamp InjectionCloxacillin + Ampicillin 500mg POM Powder for

Injection

009/126 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

697Cefotaxime Injection

Cefotaxime 500mg POM Powder for

Injection

009/128 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

698 Ampicilllin InjectionAmpicillin 250mg POM Powder for

Injection

009/130 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

699 Glucose InjectionGlucose 50% w/v POM Solution for

infusion

009/131 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

700 Ciprofloxacin TabletsCiprofloxacin 250mg POM Tablet Uncoated 009/134 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

701 Diazepam InjectionDiazepam 5mg, per ml POM Solution for

Injection

009/135 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

702 Hyoscine Butyl Bromide InjectionHyoscine butyl bromide 20mg,

per ml

POM Solution for

Injection

009/136 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

703 Norethisterone TabletsNorethisterone 5 mg POM Tablet Uncoated 009/137 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

704 Proguanil TabletsProguanil 100mg POM Tablet Uncoated 009/138 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

705Propantheline Tablets

Propantheline 15mg POM Tablet Uncoated 009/139 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

706 Quinine Dihydrochloride InjectionQuinine 300mg, per ml POM Solution for

Injection

009/140 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

707 Quinine Suphate TabletsQuinine 300mg POM Tablet Uncoated 009/141 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

708 Wormcid SuspensionMebendazole 100mg, per 5ml P Suspension for

Oral Use

009/142 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

709 Metformin TabletsMetformin 500mg POM Tablet Uncoated 009/143 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

710 Ketazole GelKetoconazole 100mg POM Gel Oral 009/145 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

711

Gamma Cough Syrup

Diphenhydramine Hydrochloride

14mg + Ammonium Chloride

135mg + Sodium Citrate 52mg

Menthol 1.1mg, per 5mls

P Syrup 009/146 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

712 Phytomenadione 10mg, per ml InjectionPhytomenadione 10mg, per ml POM Solution for

Injection

009/148 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

713Ketoconazole Tablets

Ketoconazole 200mg POM Tablet Uncoated 009/149 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

Page 33 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

714 Benzhexol TabletsBenzhexol 2mg POM Tablet Uncoated 009/150 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

715Promethazine Injection

Promethazine 10mg, per ml POM Solution for

Injection

009/151 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

716 Dexmethasone InjectionDexmethasone 4mg, per ml POM Solution for

Injection

009/152 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

717 Phytomenadione 2mg, per ml injectionPhytomenadione 2mg, per ml POM Solution for

Injection

009/153 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

718 Enalapril TabletsEnalapril 5mg POM Tablet Uncoated 009/154 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

719 Benzhexol TabletsBenzhexol 5mg POM Tablet Uncoated 009/155 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

720 Nifedipine TabletsNifedipine 10mg POM Tablet Uncoated 009/156 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

721 Bendroflumethiazide TabletsBendroflumethiazide 5mg POM Tablet Uncoated 009/157 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

722 Theophylline Compound TabletsTheophylline 120mg + Ephedrine

hydrochloride 11mg

POM Tablet Uncoated 009/158 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

723Acyclovir Tablets

Acyclovir 200mg POM Tablet Uncoated 009/159 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

724 Timolol Eye DropsTimolol 0.25% w/v POM Eye Drops 009/160 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

725 Gentamycin Eye DropsGentamycin 0.3% w/v POM Eye Drops 009/161 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

726 Acetazolamide TabletsAcetazolamide 250mg POM Tablet Uncoated 009/162 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

727 Chloramphenicol SuspensionChloramphenicol 125mg, per 5ml POM Suspension for

Oral Use

009/163 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

728 Biscodyl TabletsBisacodyl 5mg POM Tablet Uncoated 009/165 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

729 Metoclopramide TabletsMetoclopramide 10mg POM Tablet Uncoated 009/166 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

730 Nystatin TabletsNystatin 500,000 I.U. POM Tablet Uncoated 009/167 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

731 Nitrofurantoin TabletsNitrofurantoin 100mg POM Tablet Uncoated 009/168 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

732Loperamide Tablets

Loperamide 2mg POM Tablet Uncoated 009/169 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

Page 34 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

733 Mebendazole TabletsMebendazole 100mg P Tablet Uncoated 009/170 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

734Fluconazole 2mg Injection

Fluconazole 2mg, per ml POM Solution for

Injection

009/171 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

735 Cetylpyridinium Throat LozengesCetylpyridinium 1.4mg P Tablet Uncoated 009/172 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

736 Aminophylline TabletsAminophylline 100mg POM Tablet Uncoated 009/173 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

737 Ascobic Acid TabletsAscorbic acid 100mg GS Tablet Uncoated 009/174 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

738 Atenolol 100mg TabletsAtenolol 100mg POM Tablet Uncoated 009/175 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

739 Betasone Eye DropsBetamethasone 0.1% w/v POM Eye Drops 009/176 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

740 Diclofenac 50mg TabletsDiclofenac 50mg P Tablet Uncoated 009/177 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

741 Digoxin 0.25mg TabletsDigoxin 0.25mg POM Tablet Uncoated 009/178 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

742Digoxin 0.25mg Injection

Digoxin 0.25mg POM Solution for

Injection

009/179 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

743Duosept Hospital Concentration

Solution

Chlorhexidine 1.5% w/v +

Cetrimide 15% w/v

GS Solution for

sterilisation

009/180 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

744 Eyecrom Eye/Ear DropsSodium Cromoglycate 2% w/v POM Eye Drops 009/181 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

745 Fentanyl 50mcg/2ml InjectionFentanyl 50mcg, per 2ml POM Solution for

Injection

009/182 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

746 Fungicid CreamClotrimazole 1% w/w POM Cream Topical 009/183 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

747 Gammcort CreamHydrocortisone 1% w/w POM Cream Topical 009/184 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

748 Nalbuphine InjectionNalbuphine 10mg, per 2mls POM Solution for

Injection

009/185 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

749 Sterdidex SolutionGlutaraldehyde 2% w/v GS Solution for

sterilisation

009/186 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

750Tac Cough Syrup

Chlorpheniramine 2mg +

Ammonium chloride 135mg +

Sodium citrate 59.26mg

P Syrup 009/187 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

751Waxpel Ear Drops

Dioctly Sulphosuccinate sodium

312mg

P Ear Drops 009/188 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

Page 35 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

752 Atenolol 50mg TabletsAtenolol 50mg POM Tablet Uncoated 009/189 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

753B Zinc Dispersible Tablets

Zinc sulphate 20mg P Tablet

Dispersible

009/190 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

754Baxylin 4Flu Cough Syrup

Diphenhydramine Hydrochloride

6.25mg + Paracetamol 250mg +

Pseudoephedrine 11.5mg

P Syrup 009/191 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

755 Baxylin Dry Cough SyrupDextromethophan Hydrobromide

15mg

P Syrup 009/192 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

756 Baxylin Pediatric Cough SyrupDiphenhydramine Hydrochloride

7mg, per 5ml

P Syrup 009/193 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

757Baxylin Wet Cough Syrup

Guaphenesin 100mg, per 5ml P Syrup 009/194 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

758

Baxylin with Codeine Cough Syrup

Diphenhydramine Hydrochloride

12.5mg + Codeine Phosphate

10mg + Ammonium Chloride

125mg

P Syrup 009/195 Baxy Pharmaceutical

Manufacturing Ltd, Zambia

759 Ultravist 300 InjectionIopromide 300mg, per ml POM Solution for

infusion

140/015 Bayer (Pty) Limited, South Africa

760 Gadovist® (1.0 mmol/ml) InjectionGadobutrol 604 mg, per ml (1.0

mmol/, per ml)

POM Solution for

infusion

140/017 Bayer (Pty) Limited, South Africa

761Microgynon Tablets

Ethinylestradiol 0.03mg +

Levonorgestrel 0.15mg

POM Tablet Uncoated 140/004 Bayer East Africa Ltd

762 Primolut – N Tablets Norethisterone 5mg POM Tablet Uncoated 140/005 Bayer East Africa Ltd

763 Diane – 35 TabletsEthinyestradiol 0.035mg +

Cyproterone 2mg

POM Tablet Uncoated 140/007 Bayer East Africa Ltd

764 Noristerat InjectionNorethisterone 200mg, per ml POM Solution for

injection

140/008 Bayer East Africa Ltd

765 Gyno Trovogen OvulesIsoconazole Nitrate 600mg POM Suppositories

Vaginal

140/009 Bayer East Africa Ltd

766Bayer Aspirin Cardio 1 tablets

Acetyl Salicylic Acid 100mg POM Tablet Enteric

Coated

227/005 Bayer East Africa Ltd

767 Claritine Syrup Loratidine 5mg, per 5ml POM Syrup 042/001 Bayer Health Care

768 Neo - Penotran Forte OvulesMetronidazole 750mg +

Miconazole 200mg

POM Ovule Vaginal 140/010 Bayer Schering Pharma, Germany

769Combination 3 Tablets

Ethinylestradiol 0.15mg +

Levonogestrel 0.03mg + Ferrous

Fumurate 75mg

POM Tablet Film

coated

140/011 Bayer Schering Pharma, Germany

Page 36 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

770 Yaz TabletsEthinylestradiol 0.02mg +

Drospirenone 3.00mg

POM Tablet Film

coated

140/012 Bayer Schering Pharma, Germany

771Microgynon ED Fe Tablets

Levonogesterel 0.15mg +

Ethinylestradiol 0.03mg +

Ferrous Sulphate 75mg

POM Tablet Film

coated

140/013 Bayer Schering Pharma, Germany

772 Microlut TabletsLevonogestrel 0.03mg POM Tablet Film

coated

140/014 Bayer Schering Pharma, Germany

773 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/001 BDH Industries Ltd, India

774 Hydrocortisone Ophthalmic SuspensionHydrocortisone 1%w/v POM Eye Suspension 199/002 BDH Industries Ltd, India

775 Chloramphenicol Eye Drops Chloramphenicol 0.5%w/v POM Eye Drops 199/003 BDH Industries Ltd, India

776 Atenol Tablets Atenolol 50mg POM Tablet Uncoated 199/004 BDH Industries Ltd, India

777 Atenol Tablets Atenolol 100mg POM Tablet Uncoated 199/005 BDH Industries Ltd, India

778 Folid Tablets Folic acid 5mg GS Tablet Uncoated 199/006 BDH Industries Ltd, India

779 Fortrim-A TabletsSulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 199/007 BDH Industries Ltd, India

780 Hydrocortisone Acetate Cream Hydrocortisone 1%w/v POM Cream Topical 199/008 BDH Industries Ltd, India

781 Hydrocortisone Ointment Hydrocortisone 1% POM Ointment topical 199/009 BDH Industries Ltd, India

782 Indosule Capsules Indomethacin 25mg P Tablet Uncoated 199/010 BDH Industries Ltd, India

783 Metadil Tablets Chlorpheniramine 4mg P Tablet Uncoated 199/011 BDH Industries Ltd, India

784 Metamol Tablets Paracetamol 500mg GS Tablet Uncoated 199/012 BDH Industries Ltd, India

785 Metapred Tablets Prednisolone 5mg POM Tablet Uncoated 199/013 BDH Industries Ltd, India

786 Acyclovir Cream Acyclovir 5%w/w POM Tablet Uncoated 199/014 BDH Industries Ltd, India

787 Micozol Cream Miconazole 2% POM Cream Topical 199/015 BDH Industries Ltd, India

788 Tolfet SolutionTolnaftate 1%w/v POM Solution for

Topical Use

199/016 BDH Industries Ltd, India

789 Metacycline Ointment Tetracycline 1%w/v POM Eye Ointment 199/017 BDH Industries Ltd, India

790 Ciprofloxacin Eye Drops Ciprofloxacin 0.3% POM Eye Drops 199/018 BDH Industries Ltd, India

791 Metaskinton OintmentBenzoic Acid BP 6%w/w +

Salicylic Acid BP 3%w/w

P Ointment topical 199/019 BDH Industries Ltd, India

792Hydrocortisone Acetate Ophthalmic

Ointment

Hydrocortisone 1%w/w POM Eye topical 199/020 BDH Industries Ltd, India

793 Cevin Tablets Ascorbic Acid 500mg GS Tablet Uncoated 199/021 BDH Industries Ltd, India

794 Mebendazole Tablets Mebendazole 200mg P Tablet Uncoated 199/022 BDH Industries Ltd, India

795 Metagliben Tablets Glibenclamide 5mg POM Tablet Uncoated 199/023 BDH Industries Ltd, India

796 Salbamol-4 Salbutamol 4mg POM Tablet Uncoated 199/024 BDH Industries Ltd, India

797 Metamycin Ointment Chloramphehicol 1%w/v POM Eye Ointment 199/025 BDH Industries Ltd, India

798 Xiprox 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 199/026 BDH Industries Ltd, India

Page 37 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

799 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 199/027 BDH Industries Ltd, India

800 Metazole Tablets Metronidazole 200mg POM Tablet Uncoated 199/028 BDH Industries Ltd, India

801 Nalop-20mg Tablets Enalapril 20mg POM Tablet Uncoated 199/029 BDH Industries Ltd, India

802 Napril-10 Tablets Enalapril 10mg POM Tablet Uncoated 199/030 BDH Industries Ltd, India

803 Acetazolamide Tablets Acetazolamide 250mg POM Tablet Uncoated 199/031 BDH Industries Ltd, India

804 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 199/032 BDH Industries Ltd, India

805 Hydrex-50 Tablets Hydrochlorothiazide 50mg POM Tablet Uncoated 199/033 BDH Industries Ltd, India

806 CTM Cream Clotrimazole 1%w/w POM Cream Topical 199/034 BDH Industries Ltd, India

807Ferrous Sulphate and Folic Acid

Tablets

Ferrous sulphate 200mg + Folic

acid 5mg

POM Tablet Uncoated 199/035 BDH Industries Ltd, India

808 Metalax Tablets Bisacodyl 5mg POM Tablet Uncoated 199/036 BDH Industries Ltd, India

809 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 199/037 BDH Industries Ltd, India

810 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 199/038 BDH Industries Ltd, India

811 Metphage - 500 Tablets Metformin 500mg POM Tablet Uncoated 199/039 BDH Industries Ltd, India

812 Alkay - ER TabletsPotassium chloride 600mg POM Tablet extended

release

199/040 BDH Industries Ltd, India

813 Pi-dine SolutionPovidone Iodine 10%w/v GS Solution for

Topical Use

199/041 BDH Industries Ltd, India

814 Quinine Sulphate BP Tablets Quinine Sulphate BP 300mg POM Tablet Uncoated 310/007 BDH Industries Ltd, India

815Mifepristone 25mg Tablets

Mifepristone 25mg POM Tablet Uncoated 001/001 Beijing Zizhu Pharmaceutical

Company Ltd, China

816 Misoprostol 200mg TabletsMisoprostol 200mg POM Tablet Uncoated 001/002 Beijing Zizhu Pharmaceutical

Company Ltd, China

817Mifepristone 200mg Tablets

Mifepristone 200mg POM Tablet Uncoated 001/003 Beijing Zizhu Pharmaceutical

Company Ltd, China818 Miconazole Cream Miconazole cream 2% w/w POM Cream Topical 241/001 Beltapharm SPA, Italy

819

Anti-Haemorrhoid Ointment

Betamethasone dipropionate

0.5%w/w + Phenylephrine

ch/orhydrate 0.1 %w/w +

Lidocaine chlorhydrate 2w/w

POM Ointment topical 241/002 Beltapharm SPA, Italy

820 Clotrimazole PowderTrimethoprim 40mg +

Sulphamethoxazole 200mg/5ml

POM Powder for Oral

Solution

241/003 Beltapharm SPA, Italy

821 Metronidazole PowderMetronidazole 125mg, per 5ml POM Powder for Oral

Solution

241/004 Beltapharm SPA, Italy

822 Nystatin SuspensionNystatin 100,000I.U., per ml POM Suspension for

Oral Use

241/005 Beltapharm SPA, Italy

823Action Tablets

Aspirin 600mg + Caffeine 50mg

+ Paracetamol 300mg

GS Tablet Uncoated 102/001 Beta Healthcare International

Limited, Kenya

Page 38 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

824Action Junior Strawberry Flavoured

Tablets

Paracetamol 120mg GS Tablet Uncoated 102/002 Beta Healthcare International

Limited, Kenya

825Strepsils Regular Lozenges

Amylmetacresol 0.6mg + 2,4

Dichlorobenzyl alcohol 1.2mg

GS Lozenges 102/003 Beta Healthcare International

Limited, Kenya

826 Strepsils Honey & Lemon LozengesAmylmetacresol 0.6mg + 2,4

Dichlorobenzyl alcohol 1.2mg

GS Lozenges 102/004 Beta Healthcare International

Limited, Kenya

827 Paracetamol TabletsParacetamol 500mg GS Tablet Uncoated 102/005 Beta Healthcare International

Limited, Kenya

828

Goodmorning Cough Tablet

Tolu 0.04ml + Capsium

Oleoresin 0.03ml + Creosote

2.2mg + Anise oil 1.1mg +

Liquorice 56.35mg

GS Tablet Uncoated 102/006 Beta Healthcare International

Limited, Kenya

829

Goodmorning Lung Tonic

Tolu 0.56ml + Capsium Ticnture

0.25ml + Creosote 66.65mg +

Anise oil 13.85mg + Liquorice

25mg

GS Syrup 102/007 Beta Healthcare International

Limited, Kenya

830 Asprin TabletsAspirin 300mg P Tablet Uncoated 102/009 Beta Healthcare International

Limited, Kenya

831 Aspro TabletsAspirin 324mg GS Tablet Uncoated 102/010 Beta Healthcare International

Limited, Kenya

832 Betaquine TabletsAmodiaquine 260mg POM Tablet Uncoated 102/011 Beta Healthcare International

Limited, Kenya

833Opele Lotion

Benzyl benzoate 25g, per 100ml P Lotion for

Topical Use

102/012 Beta Healthcare International

Limited, Kenya

834

Salimia Linment Ointment

Methyl salicylate 5.0ml +

Turpentine oil 25ml + Capiscum

oleoresin 2.25mg + Camphor

2.0mg

GS Ointment topical 102/013 Beta Healthcare International

Limited, Kenya

835 Beta Gripe WaterSodium bicarbonate 60mg + Dill

seed oil 2.15mg

GS Solution for Oral

Use

102/014 Beta Healthcare International

Limited, Kenya

836 Prunol Cough SyrupTincture Ipecacuanha 0.12ml,

per 5ml

GS Syrup 102/015 Beta Healthcare International

Limited, Kenya

837

Glucolin Powder

Vitamin D 125IU + Calcium

Glycerophosphate 0.5g +

Dextrose Monohydrate qs to100g

GS Powder for Oral

Solution

102/016 Beta Healthcare International

Limited, Kenya

838Glucolin Dynomite Powder

Vitamin C 0.012g + Dextrose

Monohydrate qs to 15g

GS Powder for Oral

Solution

102/017 Beta Healthcare International

Limited, Kenya

Page 39 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

839 Betasil Regular LozengesAmylmetacresol 0.6mg+ 2,4

Dichlorobenzyl Alcohol 1.2

GS Lozenges 102/019 Beta Healthcare International

Limited, Kenya

840Beta Herbal Lozenges

Amylmetacresol 0.6mg + 2.4

Dichlorobenzyl Alchol 1.2mg

GS Lozenges 102/020 Beta Healthcare International

Limited, Kenya

841Memcap Tablets

Glycyrrhiza Globra 20mg +

Terminalia 5mg + Zingiber 5mg +

Curcuma 2mg + Metha 7mg

P Tablet Uncoated 102/021L Beta Healthcare International

Limited, Kenya

842 Salima CreamHerbal Extracts GS Cream Topical 102/022L Beta Healthcare International

Limited, Kenya

843

Woodwards Gripe Water

Dill Seed Oil 2.15mg + Sodium

Bicarbonate 60mg

GS Solution for Oral

Use

102/023 Beta Healthcare International

Limited, Kenya

844 Betabs Prednisolone TabletsPrednisolone 5mg POM Tablet Uncoated 168/001 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

845 Betapen SuspensionPhenoxymethyl Penicillin V

125mg, per 5ml

POM Suspension for

Oral Use

168/002 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

846 Betapen TabletsPhenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 168/003 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

847 Candarspor CreamClotrimazole 1gm, per 100gm POM Cream Topical 168/004 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

848

Clear Cough Syrup

Sodium Citrate 135mg +

Ammonium Chloride 135mg +

Diphenhydramine HCL

14.1mg/5ml

P Syrup 168/005 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

849 Codef SyrupCodeine 7.5mg + Ephedrine

15mg + Mepyramine 20mg/15ml

P Syrup 168/006 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

850 Drilix SyrupPseudoephedrine 30mg P Syrup 168/007 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

851Lo-acid Suspension

Dried Aluminium Hydrochloride

120mg + Magnesium Trisilicate

250mg

GS Suspension 168/008 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

852

B-dol Tablets SC

Codeine Phosphate 10mg +

Caffeine 30mg + Doxylamine

Succinate 5mg + Paracetamol

450mg

P Tablet Uncoated 168/009 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

853 Betabs Chewy TabletsAscorbic Acid 250mg GS Tablet Uncoated 168/010 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

854Betafed Syrup

Pseudoephedrine Hydrochloride

30mg/5ml + Tripiolidine

Hydrochloride 1.25mg, per 5ml

P Syrup 168/011 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

855 Betalin SyrupAmmonium chloride 136mg +

Diphenhydramine HCL 14mg/5ml

P Syrup 168/012 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

856

Trifen Expectorant Adult Syrup

Pseudoephedrine Hydrochloride

20mg + Codeine Phosphare

7.5mg + Trivrolidine

Hydrochloride 1.25mg

P Syrup 168/013 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

857

Trifen Expectorant Child Syrup

Pseudoephedrine Hydrochloride

12mg + Codeine Phosphate 3mg

+ Triprolidine Hydrochloride

0.6mg + Guaiphenesin, per 5ml

P Syrup 168/014 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

858 Viteral SyrupMultivitamins GS Syrup 168/015 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

859Septadine Solution

Povidone Iodine 10%w/v GS Solution for

Topical Use

168/016 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

860Septadine Ointment

Povidone Iodine 10%w/v GS Ointment topical 168/017 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

861 Betaretic TabletsHydrochlorthiazide 50mg +

Amiloride 5mg

POM Tablet Uncoated 168/018 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

862 Painagon TabletsParacetamol 320mg + Codeine

8mg + Promethazine

P Tablet Uncoated 168/019 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

863 Pre-Natal Forte CapsulesVitamins + Minerals P Capsule oral 168/020 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

864 Painagon SyrupParacetamol + Codeine +

Caffeine

P Syrup 168/021 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

865

Flustat Syrup

Paracetamol 500mg +

Dextromethorphan Hydrobromide

15mg + Phenylpropanolamine

HCL 25mg/20ml

P Syrup 168/022 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

866

Flustat Capsules

Ascorbic Acid 75mg +

Paracetamol 300mg + Caffeine

30mg + Chlorpheniramine

Maleate 2mg + Phenylephrine

HCL 5mg

P Capsule oral 168/023 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

867Be-Tabs Mepyraderm Cream

Mepyramine maleate 0.2g, per

10g

P Cream Topical 168/024 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

868 Be-Tabs Pyridoxine TabletsPyridoxine Hydrochloride 25mg POM Tablet Uncoated 168/025 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

869

Be-Tabs Antacids Suspension

Magnesium Triscillate 500mg +

Magnesium Carbonate Light

500mg + Sodium Carbonate

500mg, per 10ml

GS Suspension for

Oral Use

168/026 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

870 Be-Tabs Folic Acid TabletsFolic Acid 5mg POM Tablet Uncoated 168/027 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

871Crystacist Solution 100mg

Potassium Citrate 1.2g + Citric

acid Monohydrate 200mg, per

15ml

P Solution for Oral

Use

168/028 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

872 Wormstop TabletsMebendazole 500mg P Tablet Uncoated 168/029 Be-Tabs Pharmaceuticals (Pty)

Ltd, South Africa

873 Propovan InjectionPropofol 1% POM Solution for

Injection

233/001 Bharat Biotech Ltd, India

874Thymogam Globulin Injection

Antihymocyte Globulin- equine

250mg, per 100mg

POM Solution for

Injection

233/003 Bharat Biotech Ltd, India

875Regen-D Gel

Recombinant Human Epidermal

Growth Factor 150mcg, per gram

POM Gel Topical 279/046 Bharat Biotech Ltd, India

876

Rhomo Oil

Rhus toxicodendron 10% +

Bryonia alba 20% +

Terebinthena oleum 20% +

Camphor 20% + Menthol 10% +

Thymol 10% + Symphytum

officinalis 10%

GS Solution for

Topical Use

371/001 Bhargava Phytolab Pvt, India

877 Angel Gloss Cream Herbal Preparation P Cream Topical 389/001L Bhargava Phytolab Pvt, India

878

Gass Off Tablets

Aluminium Hydroxide 100mg +

Bismuth Carbonicum 75mg +

Magnesium Hydroxide 100mg +

Natrum Bicarbonicum 75mg +

Herbal Extracts

GS Tablets

chewable

389/002L Bhargava Phytolab Pvt, India

879 Meniphib Tablets Herbal preparation P Tablets film

coated

389/003L Bhargava Phytolab Pvt, India

880 Co-Ex Syrup Herbal Preparation P Syrup 389/004 Bhargava Phytolab Pvt, India

881Ciplast 10mg Injection

Cisplatin 10mg POM Powder for

Injection

240/001 Biochem Pharmaceuticals

industries Ltd, India

882Cycloxan 1g Injection

Cyclophosphamide 1g POM Solution for

Injection

240/002 Biochem Pharmaceuticals

industries Ltd, India

Page 42 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

883 Cycloxan 500mg InjectionCyclophosphamide 500mg POM Powder for

Injection

240/003 Biochem Pharmaceuticals

industries Ltd, India

884Flucracil 500mg/10ml Injection

Fluorouracil 500mg, per 10ml POM Solution for

Injection

240/004 Biochem Pharmaceuticals

industries Ltd, India

885 Tamodex Citrate TabletsTamoxifen 10mg POM Tablet Uncoated 240/005 Biochem Pharmaceuticals

industries Ltd, India

886 Bioposide 100mg InjectionEtoposide 100mg, per 5ml POM Powder for

Injection

240/006 Biochem Pharmaceuticals

industries Ltd, India

887 Biotrexate 2.5mg TabletsMethotrexate 2.5mg POM Tablet Uncoated 240/007 Biochem Pharmaceuticals

industries Ltd, India

888 Biotrexate InjectionMethotrexate 25mg, per ml POM Solution for

Injection

240/008 Biochem Pharmaceuticals

industries Ltd, India

889 Cisplat 50mg InjectionCisplatin 50mg POM Powder for

Injection

240/010 Biochem Pharmaceuticals

industries Ltd, India

890 Cycloxan 50mg InjectionCyclophosphamide 50mg POM Solution for

Injection

240/011 Biochem Pharmaceuticals

industries Ltd, India

891 Doxorubicin InjectionDoxorubicin 50mg POM Solution for

Injection

240/012 Biochem Pharmaceuticals

industries Ltd, India

892Fluracil 250mg/10ml Injection

Fluorouracil 500mg, per 10ml POM Solution for

Injection

240/013 Biochem Pharmaceuticals

industries Ltd, India

893 Petaxel 30mg/5ml InjectionPaclitaxel 6mg, per ml POM Powder for

Injection

240/015 Biochem Pharmaceuticals

industries Ltd, India

894 Biocristin InjectionVincristine 1mg POM Powder for

Injection

240/016 Biochem Pharmaceuticals

industries Ltd, India

895 Tamodex 20 TabletsTamoxifen 20mg POM Tablet Uncoated 240/017 Biochem Pharmaceuticals

industries Ltd, India

896 Pataxel 260 InjectionPaclitaxel 6mg, per ml POM Powder for

Injection

240/018 Biochem Pharmaceuticals

industries Ltd, India

897 Biovorin InjectionFolic acid 50mg, per 5ml POM Solution for

Injection

240/019 Biochem Pharmaceuticals

industries Ltd, India

898 Biocarb 150 InjectionCarboplatin 10mg, per ml POM Powder for

Injection

240/020 Biochem Pharmaceuticals

industries Ltd, India

899 Biocarb 450 InjectionCarboplatin 450mg POM Powder for

Injection

240/021 Biochem Pharmaceuticals

industries Ltd, India

900 Cycloxan 50mg TabletsCyclophosphamide 50mg POM Tablet Uncoated 240/022 Biochem Pharmaceuticals

industries Ltd, India

901Cycloxan 200 Injection

Cyclophosphamide 200mg POM Solution for

Injection

240/023 Biochem Pharmaceuticals

industries Ltd, India

Page 43 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

902 Oncolet TabletsLetrozole 2.5mg POM Tablet Film

coated

240/024 Biochem Pharmaceuticals

industries Ltd, India

903Cycloxan Tablets

Cyclophosphamide 50mg POM Tablet Film

coated

290/022 Biochem Pharmaceuticals

industries Ltd, India

904 Insugen -R Injection Insulin 100IU, per ml POM Suspension for

Injection

305/001 Biocon Limited, India

905 Insugen -30/70 (Biphasic) Injection Insulin 30/70 POM Suspension for

Injection

305/002 Biocon Limited, India

906 Insugen - N (NPH) Injection Insulin 100IU POM Suspension for

Injection

305/003 Biocon Limited, India

907 Biomol TabletsParacetamol BP 500mg P Tablet Uncoated 020/001 Biodeal Laboratories Pvt Ltd,

India

908 Biovir CreamAciclovir BP 5% w/w POM Cream Topical 020/002 Biodeal Laboratories Pvt Ltd,

India

909One Q Gummy with Colostrum (Lemon

Flavour)

Colostrum Powder 30mg P Capsule oral 353/001L Biofact Life SND. BHD Ltd,

Malysia

910One Q Gummy with Vitamin C (Orange

Flavour)

Vitamin C 40mg P Capsule oral 353/002L Biofact Life SND. BHD Ltd,

Malysia

911One Q Gummy with Multivitamins

(Strawberry Flavour)

Multivitamins & Minerals P Capsule oral 353/003L Biofact Life SND. BHD Ltd,

Malysia

912 One Q Gummy with Omega 3Omega 3 8.6mg Total EPA&

DHA 7.9mg

P Capsule oral 353/004L Biofact Life SND. BHD Ltd,

Malysia

913One Q Gummy with Acai Berry And

Luten

Acai Berry 25mg + Lutein 10%

powder 10mg

P Capsule oral 353/005L Biofact Life SND. BHD Ltd,

Malysia

914 Synalar GelFluocinolone Acetonide Ph. Eur.

0.025% w/w

P Gel Topical 023/018 Bioglan Laboratories Limited, UK

915 Synalar C CreamFluocinolone Acetonide 0.025%

+ Clioquinol 3%

P Cream Topical 023/019 Bioglan Laboratories Limited, UK

916 Synalar CreamFluocinolone Acetonide Ph. Eur.

0.025% w/w

P Cream Topical 023/032 Bioglan Laboratories Limited, UK

917 Synalar OintmentFluocinolone Acetonide Ph. Eur.

0.025% w/w

P Ointment topical 023/033 Bioglan Laboratories Limited, UK

918Synalar N Cream

(Fluocinolone Acetonide 0.25mg

+ Neomycin Sulphate 3500 IU),

per gram)

P Cream Topical 023/034 Bioglan Laboratories Limited, UK

919Synalar N Ointment

Fluocinolone Acetonide 0.25mg,

per g) + Neomycin Sulphate

(3500 IU, per g)

P Ointment topical 023/035 Bioglan Laboratories Limited, UK

920 Cetavlex Antiseptic Cream Cetrimide Solution BP P Cream Topical 235/001 Bioglan Laboratories Limited, UK

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

921

Supracal Tablets

Calcium Citrate 1000mg +

Magnesium Hydroxide 239.9mg

+ Zinc Sulphate Monohydrate

10.978mg

P Tablet Uncoated 304/001 Bioplus Lifesciences Ltd, India

922 Gvfluc 200 Capsules Fluconazole 200mg POM Capsule oral 245/001 Bliss GVS Pharma Ltd, India

923 Gvither Oral SuspensionArtemether 300mg, per 100ml POM Suspension for

Oral Use

245/002 Bliss GVS Pharma Ltd, India

924Funbact A Cream

Clotrimazole 1.0%w/w +

Neomycin sulphate 0.5%w/w +

Betamethasone 0.05%w/w

POM Cream Topical 245/003 Bliss GVS Pharma Ltd, India

925 Comit-50 Tablets Sildenafil 50mg POM Tablet Uncoated 245/004 Bliss GVS Pharma Ltd, India

926 Lofnac 100 Tablets Diclofenac 100mg P Tablet Uncoated 245/005 Bliss GVS Pharma Ltd, India

927Lofnac Gel

Diclofenac 1.16%w/w + Linseed

Oil 3%w/w + Methyl Salicylate

10%w/w + Menthol 5%w/v

P Gel Topical 245/006 Bliss GVS Pharma Ltd, India

928 Gvither Forte InjectionArtemether 80mg, per ml POM Powder for

Injection

245/010 Bliss GVS Pharma Ltd, India

929Gsunate Kit Tablets

Artesunate tablet 200mg +

Amodiaquine HCl BP tablet

600mg

POM Tablet Uncoated 245/011 Bliss GVS Pharma Ltd, India

930Alaxin Kit Tablets

Amodiaquine BP 600mg tablet +

Dihydroartemisinin 160mg tablets

POM Tablet Uncoated 245/012 Bliss GVS Pharma Ltd, India

931Lonart Tablets

Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 245/013 Bliss GVS Pharma Ltd, India

932 Lonart Forte TabletsArtemether 40mg + Lumefantrine

240mg

POM Tablet Uncoated 245/014 Bliss GVS Pharma Ltd, India

933 Lonart SuspensionArtemether 20mg +

Lumefantrine 120mg, per 5ml

POM Suspension for

Oral Use

245/015 Bliss GVS Pharma Ltd, India

934 Clamoxin 125 SuspensionAmoxicillin 125mg + Clavulanic

Acid 125mg, per 5ml

POM Suspension for

Oral Use

245/016 Bliss GVS Pharma Ltd, India

935Clamoxin 250 Suspension

Amoxicillin 250mg + Clavulanic

Acid 62.5mg, per 5ml

POM Suspension for

Oral Use

245/017 Bliss GVS Pharma Ltd, India

936 Today Pill Levonorgestrel 0.75mg POM Tablet Uncoated 245/018 Bliss GVS Pharma Ltd, India

937 Lofnac - 50 Tablets Diclofenac 50mg P Tablet Uncoated 245/019 Bliss GVS Pharma Ltd, India

938Lofnac - P Tablets

Diclofenac 50mg + Paracetamol

500mg

P Tablet Uncoated 245/020 Bliss GVS Pharma Ltd, India

939Paludoxin Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 245/021 Bliss GVS Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

940Lonart Dispersible Tablets For Infants

And Children

Artemether 20mg +

Lumefantrine120mg

POM Tablet

Dispersible

245/022 Bliss GVS Pharma Ltd, India

941Vagid -CL Suppositories

Clindamycin 100mg +

Clotrimazole 200mg

POM Suppository 245/023 Bliss GVS Pharma Ltd, India

942 Glycerin Suppositories Glycerin 90%w/w P Suppository 245/024 Bliss GVS Pharma Ltd, India

943 Slipizem -5 Suppositories Diazepam 5mg POM Suppository 245/025 Bliss GVS Pharma Ltd, India

944

Amitone Syrup

Vitamin B12 2.5 mg + Vitamin B1

1mg + Niacinamide 15mg +

Vitamin B2 1.5mg + Vitamin B 6

0.5mg + Sorbitol 70% + Lysine

50mg + Choline 30mg

P Syrup 245/026 Bliss GVS Pharma Ltd, India

945Gynofer B12 Syrup

Ferric Ammonium Citrate 200mg

+ Folic Acid 1.5mg + Vitamin B12

50mg

P Syrup 245/028 Bliss GVS Pharma Ltd, India

946 Sirofen Syrup Ibuprofen 20mg P Syrup 245/031 Bliss GVS Pharma Ltd, India

947Rinogrip Granules

Paracetamol 0.500g +

Chlorpheniramine 0.025g +

Ascorbic Acid 0.2g

P Granules for

Suspension

245/032 Bliss GVS Pharma Ltd, India

948 Recticin 100 Suppositories Indomethacin 100mg POM Suppository 264/001 Bliss GVS Pharma Ltd, India

949Anomex Suppositories

Allantoin 0.5% + Zinc Oxide 5%

+ Lidocaine 3% + Hydrocortisone

0.25%

POM Suppository 264/002 Bliss GVS Pharma Ltd, India

950 Vagid Pessaries Clotrimazole 100mg POM Tablet Vaginal 264/003 Bliss GVS Pharma Ltd, India

951Alaxin Oral Suspension

Dihydroartemisinin 160mg, per

80ml

POM Suspension 245/007 BlissGVS Pharma Ltd, India

952 Alaxin Tablets Dihydroartemisinin 60mg POM Tablet Uncoated 245/008 BlissGVS Pharma Ltd, India

953 Gsunate Forte Tablets Artesuate 100mg POM Tablet Uncoated 245/009 BlissGVS Pharma Ltd, India

954 Bgmet Tablets Metformin 500mg POM Tablet Uncoated 245/027 BlissGVS Pharma Ltd, India

955 Azitrine Tablets Azithromycin 250mg POM Tablet Uncoated 245/029 BlissGVS Pharma Ltd, India

956 P-Alaxin TabletsDihydroartemisinin 80mg +

Piperaquine Phosphate 320mg

POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India

957 Glycoben Tablets Glibenclamide 5mg POM Tablet Uncoated 245/030 BlissGVS Pharma Ltd, India

958Chloramphenicol 1% Opthalmic

Ointment USP

Chloramphehicol 10mg POM Eye Ointment 245/033 BlissGVS Pharma Ltd, India

959 Hilderm - CH CreamSilver Sulphadiazine 1%w/w +

Chitosan2%w/w

POM Cream Topical 245/034 BlissGVS Pharma Ltd, India

960Tetracycline 1% Opthalmic Ointment

USP

Tetracycline 10mg POM Eye Ointment 245/035 BlissGVS Pharma Ltd, India

961 BG-Sol Cream Clobetasol propionate 0.05%w/w POM Cream Topical 245/036 BlissGVS Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

962 Maitri Vaginal LubricantPEG 1500 80%w/w + PEG 1000

20%w/w

P Tablet Vaginal 245/037 BlissGVS Pharma Ltd, India

963 Asnorbin - 1000 Tablets Ascorbic Acid 1000mg P Tablet Uncoated 245/038 BlissGVS Pharma Ltd, India

964BG-Cold Tablets

Paracetamol 500mg + Caffeine

30mg + Chlorpheniramine 5mg +

Phenylephrine 2mg

P Tablet Uncoated 245/039 BlissGVS Pharma Ltd, India

965 Pip - Off Gel Clindamycin Phosphate 1.0%w/v POM Gel Topical 245/040 BlissGVS Pharma Ltd, India

966

BG-Glutamin Syrup

L-Glutamic Acid 100mg +

Thiamine Hydrochloride 4.5mg +

Pyridoxine Hydrochloride 1.5mg

+ Cyano 5mcg

P Syrup 245/041 BlissGVS Pharma Ltd, India

967 P-Alaxin SuspensionDihydroartemisinin 80mg +

Piperaquine Phosphate 640mg

POM Suspension 245/042 BlissGVS Pharma Ltd, India

968 Lonart DS TabletsArtemether 80mg + Lumefantrine

480mg

POM Tablet Uncoated 245/043 BlissGVS Pharma Ltd, India

969 BG - Fenamex SuspesionMefenamic Acid 100mg, per 5ml P Suspension for

Oral Use

245/046 BlissGVS Pharma Ltd, India

970 Gacet - 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 254/045 BlissGVS Pharma Ltd, India

971

BG-Glutamin Tablets

L-Glutamic Acid BP 250mg +

Thiamine Hydrochloride BP

10mg + Pyridoxine Hydrochloride

BP 3mg + Cyanocobalamine

10mcg

P Tablet Oral 254/046 BlissGVS Pharma Ltd, India

972 Secnagyl Tablets Secnidazole 1.0g POM Tablet Uncoated 254/047 BlissGVS Pharma Ltd, India

973

Vitavit Multivitamin Syrup

Vitamin A 1000IU + Vitamin D3

200IU + Vitamin B1 1.5mg +

Vitamin B2 1.0 mg + Vitamin B6

1.0mg + Vitamin C 30.0mg +

Nicotinamide 10.0mg +

Panthenol 5.0mg

P Syrup 254/048 BlissGVS Pharma Ltd, India

974

Broxol Syrup

Ambroxol Hydrochloride BP

15mg + Guaiphenesin BP 50mg

+ Terbutaline Sulphate BP 1.5mg

+ Menthol BP 1mg

P Syrup 254/049 BlissGVS Pharma Ltd, India

975 Upracid -40 TabletsPantoprazole sodium

sesquihydrate BP 40mg

POM Tablet Uncoated 254/050 BlissGVS Pharma Ltd, India

976Sanfurox - DS 125 Suspension

Cefuroxime Axetil USP 125mg,

per 5ml

POM Powder for Oral

Suspension

254/051 BlissGVS Pharma Ltd, India

977 Comit -100 Tablets Sildenafil Citrate I.H 100mg POM Tablet Uncoated 254/052 BlissGVS Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

978 BG - MET 850 TabletsMetformin Hydrochloride BP

850mg

POM Tablet Uncoated 254/053 BlissGVS Pharma Ltd, India

979 X-Tone Forte Syrup Amino Acids and Minerals POM Syrup 254/054 BlissGVS Pharma Ltd, India

980 Agycin 500 TabletsAzithromycin Dihydrate USP

500mg

POM Tablet Uncoated 254/055 BlissGVS Pharma Ltd, India

981 Finmol Plus CapsulesParacetamol 325mg + Ibuprofen

BP 200mg + Caffeine 30mg

P Tablet Uncoated 254/056 BlissGVS Pharma Ltd, India

982 Vagid 500 Clotrimazole BP 500mg POM Tablet Vaginal 254/057 BlissGVS Pharma Ltd, India

983 Prodone Imazole Capsules Pantoprazole 40mg +

Domperidone BP 30mg

POM Capsule oral 254/058 BlissGVS Pharma Ltd, India

984 Conlax-5 Suppositories Bisacodyl USP 5mg POM Suppository 254/059 BlissGVS Pharma Ltd, India

985 Conlax-10 Suppositories Bisacodyl USP 10mg POM Suppository 254/060 BlissGVS Pharma Ltd, India

986 Fibrotin TabletsFenofibrate BP 160mg POM Tablet Film

coated

254/061 BlissGVS Pharma Ltd, India

987 Comit-100 Oral Jelly Sildenafil 100mg POM Gel Oral 254/062 BlissGVS Pharma Ltd, India

988Adrenaline-Fresenius Injection

Adrenaline 1.0mg, per ml POM Solution for

Injection

254/001 Bodene(PTY) Ltd, South Africa

989 Chlorpromazine Hydrochloride InjectionChlorpromazine 25mg, per ml POM Solution for

Injection

254/002 Bodene(PTY) Ltd, South Africa

990 Dextrose-Fresenius InjectionDextrose 50% w/v POM Solution for

infusion

254/003 Bodene(PTY) Ltd, South Africa

991 Dobutamine-Fresenius InjectionDobutamine 250mg, per 20ml POM Solution for

Injection

254/004 Bodene(PTY) Ltd, South Africa

992Ergometrine Maleate -Fresenius

Injection

Ergometrine 0.5mg, per ml POM Solution for

Injection

254/005 Bodene(PTY) Ltd, South Africa

993 Fentanyl-Frenesius InjectionFentanyl 100mcg, per 2ml POM Solution for

Injection

254/006 Bodene(PTY) Ltd, South Africa

994 Furosemide-Fresenius InjectionFurosemide 20mg, per 2ml POM Solution for

Injection

254/007 Bodene(PTY) Ltd, South Africa

995Heparin sodium 25,000IU, per ml

Injection

Heparin 25000IU , per ml POM Solution for

Injection

254/008 Bodene(PTY) Ltd, South Africa

996Heparin 5,000IU, per ml Sodium

Injection

Heparin 5000IU, per ml POM Solution for

Injection

254/009 Bodene(PTY) Ltd, South Africa

997Intramed Mannitol 20 Injection

Mannitol 100g, per 500ml POM Solution for

infusion

254/010 Bodene(PTY) Ltd, South Africa

998 Intramed Sodium Bicarbonate InjectionSodium Bicarbonate 4.25g, per

50ml

POM Solution for

infusion

254/011 Bodene(PTY) Ltd, South Africa

999Intramed Trichazole Injection

Metronidazole 500mg, per 100ml POM Solution for

infusion

254/012 Bodene(PTY) Ltd, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1000 Ketamine InjectionKetamine 50mg, per ml POM Solution for

Injection

254/013 Bodene(PTY) Ltd, South Africa

1001Lignocaine 1% Injection

Lignocaine 10mg, per 2ml POM Solution for

Injection

254/014 Bodene(PTY) Ltd, South Africa

1002 Lignocaine 2% Injection, 20mlLignocaine 20mg, per ml POM Solution for

Injection

254/015 Bodene(PTY) Ltd, South Africa

1003 Lignocaine 2% Injection, 5mlLignocaine 100mg, per 5ml POM Solution for

Injection

254/016 Bodene(PTY) Ltd, South Africa

1004 Morphine Sulphate 10 InjectionMorphine 10mg, per ml POM Solution for

Injection

254/017 Bodene(PTY) Ltd, South Africa

1005 Morphine Sulphate 15 InjectionMorphine 15mg, per ml POM Solution for

Injection

254/018 Bodene(PTY) Ltd, South Africa

1006Naloxone Neonatal-Fresenius

0.02mg/ml Injection

Naloxone 0.042mg, per 2ml POM Solution for

Injection

254/019 Bodene(PTY) Ltd, South Africa

1007 Naloxone-Fresenius 0.4mg/ml InjectionNaloxone 0.42mg, per ml POM Solution for

Injection

254/020 Bodene(PTY) Ltd, South Africa

1008 Neostigmine 0.5 InjectionNeostigmine 0.5mg, per ml POM Solution for

Injection

254/021 Bodene(PTY) Ltd, South Africa

1009Neostigmine 2.5 Injection

Neostigmine 2.5mg, per ml POM Solution for

Injection

254/022 Bodene(PTY) Ltd, South Africa

1010 Pancuronium Bromide InjectionPancuronium 4mg, per 2ml POM Solution for

Injection

254/023 Bodene(PTY) Ltd, South Africa

1011 Pethidine 100 InjectionPethidine 100mg, per 2ml POM Solution for

Injection

254/024 Bodene(PTY) Ltd, South Africa

1012 Pethidine 50 InjectionPethidine 50mg, per ml POM Solution for

Injection

254/025 Bodene(PTY) Ltd, South Africa

1013 Promethazine InjectionPromethazine 25mg, per ml POM Solution for

Injection

254/026 Bodene(PTY) Ltd, South Africa

1014 Quinine InjectionQuinine 300mg, per ml POM Solution for

Injection

254/027 Bodene(PTY) Ltd, South Africa

1015 Suxamethonium Chloride InjectionSuxamethonium 100mg, per 2ml POM Solution for

Injection

254/028 Bodene(PTY) Ltd, South Africa

1016 Thiopentone Sodium InjectionThiopentone 500mg, per 20ml POM Solution for

Injection

254/029 Bodene(PTY) Ltd, South Africa

1017Fresenius - Hyoscine Butyl Bromide

Injection

Hyoscine ButylBromide 20mg,

per ml

POM Solution for

Injection

254/040 Bodene(PTY) Ltd, South Africa

1018Promethazine Hydrochloride Fresenius

Injection

Promethazine 50mg, per 2ml POM Solution for

Injection

254/042 Bodene(PTY) Ltd, South Africa

Page 49 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1019 Viramune TabletsNevirapine 200mg POM Tablet Uncoated 119/001 Boehringer Ingelheim

Pharmaceuticals (Pty) Ltd, SA

1020Viramune Suspension

Nevirapine 50mg, per 5ml POM Suspension 119/002 Boehringer Ingelheim

Pharmaceuticals (Pty) Ltd, SA

1021Acidex Oral Suspension

Sodium Bicarbonate 133.5mg +

Sodium Alginate 250mg +

Calcium Carbonate 80mg

P Suspension for

Oral Use

318/001 Bricved Ltd,Republic of Ireland

1022

Pinoplex Fortified Blood Tonic

Vitamin B1 5mg + Vitamin B2

2mg + Vitamin B6 2mg + Vitamin

B12 6mcg + Nicotinamide 20mg

+ Calcium Pantothenate 10mg

+Liver extract 1.175% w/v + Folic

Acid 0.3mg +Sodium

Glycerophosphate 300mg

+Potassium Glycerophosphate

BPC 49 20mg +Manganese

Sulphate 4mg + Ferric

Ammonium Sulphate 73mg +

Caffeine 57mg Citric Acid

177mg/30mls

P Syrup 318/002 Bricved Ltd,Republic of Ireland

1023HB 12 Syrup

Haemoglobin powder 0.5g +

Vitamin B12 20mcg, per 5mls

P Syrup 318/003 Bricved Ltd,Republic of Ireland

1024 Emitino InjectionOndansetron 2mg POM Powder for

Injection

065/001 Cachet Pharmaceuticals Ltd, India

1025 Emitino Mouth Dissolving Tablets Ondansetron 4mg POM Tablet Uncoated 065/002 Cachet Pharmaceuticals Ltd, India

1026 Emitino SolutionOndansetron 2mg, per 5ml POM Solution for Oral

Use

065/003 Cachet Pharmaceuticals Ltd, India

1027 I-Up InjectionIron Sucrose 100mg, per 5ml POM Solution for

Injection

065/004 Cachet Pharmaceuticals Ltd, India

1028Canem 500mg Injection

Meropenem 500mg POM Powder for

Injection

065/005 Cachet Pharmaceuticals Ltd, India

1029Erycach Suspension

Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

065/006 Cachet Pharmaceuticals Ltd, India

1030 Erycach 250 TabletsErythromycin 250mg POM Tablet Film

coated

065/007 Cachet Pharmaceuticals Ltd, India

1031 Celza 250mg Tablets Cefuroxime 250mg POM Tablet Uncoated 065/008 Cachet Pharmaceuticals Ltd, India

1032 Celza 500mg Tablets Cefuroxime 500mg POM Tablet Uncoated 065/009 Cachet Pharmaceuticals Ltd, India

Page 50 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1033 Acinet 600mg TabletsAmoxycillin Trihydrate 500mg +

Clavulanate Potassium 100mg

POM Tablet Uncoated 065/010 Cachet Pharmaceuticals Ltd, India

1034Acinet 625mg Tablets

Amoxicillin Trihydrate 500mg +

Clavulanate Potassium 125mg

POM Tablet Uncoated 065/011 Cachet Pharmaceuticals Ltd, India

1035 Acinet 228.5mg SuspensionAmoxycillin Trihydrate 200mg +

Clavulanate Potassium 28.5mg

POM Suspension for

Oral Use

065/012 Cachet Pharmaceuticals Ltd, India

1036

Cachnerve Capsules

Alpha Lipoic Acid 100mg +

Gamma Linolenic Acid 60mg +

Pyridoxine 3mg +

Methycobalamin 1.5mg +

Chromium 50mg

P Capsule oral 065/013 Cachet Pharmaceuticals Ltd, India

1037Eascof Expectorant Syrup

Bromhexine 4mg + Salbutamol

2mg + Guaifenesin 100mg +

Menthol 1mg

P Syrup 065/014 Cachet Pharmaceuticals Ltd, India

1038 Trama 50 Capsules Tramadol 50mg POM Capsule oral 065/015 Cachet Pharmaceuticals Ltd, India

1039 Tramacetal TabletsTramadol 37.5mg +

Paracetamol 25mg

POM Tablet Uncoated 065/016 Cachet Pharmaceuticals Ltd, India

1040Cach - ART 20/120 Tablets

Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 065/017 Cachet Pharmaceuticals Ltd, India

1041 Cachpar SuspensionParacetamol 125mg, per 5mg GS Suspension for

Oral Use

065/018 Cachet Pharmaceuticals Ltd, India

1042 Celza Dry SyrupCefuroxime 125mg, per 5ml POM Powder for Oral

Suspension

065/019 Cachet Pharmaceuticals Ltd, India

1043 Acinet 1000mg TabletsAmoxycillin 875mg +

Clavulanate 125mg

POM Tablet Uncoated 065/020 Cachet Pharmaceuticals Ltd, India

1044 Cabalin -75 Capsules Pregabalin 75mg POM Capsule oral 065/021 Cachet Pharmaceuticals Ltd, India

1045

Actilosa Dry Syrup

(Probiotics: L.Acidophi/u +

B.longum + B.bifidum + B.lactis)

5 billions Prebiotics

inulin(FOS)Fructo

Oligosaccharide 25mq)

P Powder for Oral

Suspension

065/022 Cachet Pharmaceuticals Ltd, India

1046

Actilosa Capsules

(Probiotics:

L.Acidophilu+B.longum +

B.bifidughm + Blactice) 5 billions

prebiotics inulin(FOS)Fructo

Oliqosaccharide) 25mq

P Capsule oral 065/023 Cachet Pharmaceuticals Ltd, India

1047Canem Powder For Injection

Meropenem Trihydrate 1g POM Powder for

Injection

065/024 Cachet Pharmaceuticals Ltd, India

Page 51 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1048 Moximon CapsulesAmoxicillin Trihydrate 250mg POM Caplets oral

Uncoated

065/025 Cachet Pharmaceuticals Ltd, India

1049

Lysoflam Gel

Linseed oil 3.0% w/v +

Diclofenac Diethylamine 1.16%

w/v + Methyl Salicylate 12.0%

w/v + Menthol 5.5% w/v

P Gel Topical 065/026 Cachet Pharmaceuticals Ltd, India

1050 Traxol 1000 Ceftriaxone for Injection USP

1000mg

POM Solution for

Injection

065/027 Cachet Pharmaceuticals Ltd, India

1051 Perflobid 400 TabletsPefloxacin 400mg POM Tablet Uncoated 113/001 Cadilla Pharmaceuticals Limited,

India

1052 Vivorax TabletsAcyclovir 200mg POM Tablet Uncoated 113/002 Cadilla Pharmaceuticals Limited,

India

1053Aciloc 300 Tablets

Ranitidine 300mg POM Tablet Film

coated

113/003 Cadilla Pharmaceuticals Limited,

India

1054 Aciloc 150 TabletsRanitidine 150mg POM Tablet Uncoated 113/004 Cadilla Pharmaceuticals Limited,

India

1055 Amdepin 10 TabletsAmlodipine 10mg POM Tablet Uncoated 113/005 Cadilla Pharmaceuticals Limited,

India

1056 Amidepin 5 TabletsAmlodipine Besylate 5mg POM Tablet Uncoated 113/006 Cadilla Pharmaceuticals Limited,

India

1057 Ciprodac InfusionCiprofloxacin 2mg, per ml POM Solution for

Infusion

113/007 Cadilla Pharmaceuticals Limited,

India

1058 Lovalip 20mg TabletsLovastatin 20mg POM Tablet Uncoated 113/009 Cadilla Pharmaceuticals Limited,

India

1059 Ciprodac 250mg TabletsCiprofloxacin 250mg POM Tablet Uncoated 113/011 Cadilla Pharmaceuticals Limited,

India

1060 Olit 20 CapsulesOmeprazole 20mg POM Capsule oral 113/012 Cadilla Pharmaceuticals Limited,

India

1061Pirofen 20 Capsules

Piroxicam 20mg POM Capsule oral 113/013 Cadilla Pharmaceuticals Limited,

India

1062 Fluzon InfusionFluconazole 2mg, per 1ml POM Solution for

infusion

113/014 Cadilla Pharmaceuticals Limited,

India

1063Fluzon 150mg Tablets

Fluconazole 150mg POM Tablet Uncoated 113/015 Cadilla Pharmaceuticals Limited,

India

1064 Fluzon 100mg TabletsFluconazole 100mg POM Tablet Uncoated 113/016 Cadilla Pharmaceuticals Limited,

India

1065Wormin A 400mg Tablets

Albendazole 400mg POM Tablet Uncoated 113/017 Cadilla Pharmaceuticals Limited,

India

Page 52 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1066 Roxibid 150 TabletsRoxithromycin 150mg POM Tablet Uncoated 113/018 Cadilla Pharmaceuticals Limited,

India

1067Gempar 300 Capsules

Gemfibrozil 300mg POM Capsule oral 113/019 Cadilla Pharmaceuticals Limited,

India

1068 Oritaxim 1000mg InjectionCefotaxime 1000mg POM Powder for

Injection

113/020 Cadilla Pharmaceuticals Limited,

India

1069 Envas 2.5mg TabletsEnalapril 2.5mg POM Tablet Uncoated 113/021 Cadilla Pharmaceuticals Limited,

India

1070 Cefamor 250mg CapsulesCephalexin 250mg POM Capsule oral 113/022 Cadilla Pharmaceuticals Limited,

India

1071 Wormin SuspensionMebendazole 100mg, per 5ml P Suspension for

Oral Use

113/023 Cadilla Pharmaceuticals Limited,

India

1072 Cefamor 500mg CapsulesCephalexin 500mg POM Capsule oral 113/024 Cadilla Pharmaceuticals Limited,

India

1073 Dolac 10mg TabletsKetorolac 10mg POM Tablet Uncoated 113/025 Cadilla Pharmaceuticals Limited,

India

1074

Vasograin Tablets

Ergotamine Tartrate 1mg +

Prochlorperazine Maleate 2.5mg

+ Caffeine 100mg + Paracetamol

250mg

POM Tablet Uncoated 113/026 Cadilla Pharmaceuticals Limited,

India

1075 Pirofen 10mg CapsulesPiroxicam 10mg POM Capsule oral 113/027 Cadilla Pharmaceuticals Limited,

India

1076 Glamide 5mg TabletsGlibenclamide 5mg POM Tablet Uncoated 113/028 Cadilla Pharmaceuticals Limited,

India

1077 Fludac 20mg CapsulesFluxetine 20mg POM Capsule oral 113/029 Cadilla Pharmaceuticals Limited,

India

1078 Wormin 100mg TabletsMebendazole 100mg P Tablet Uncoated 113/030 Cadilla Pharmaceuticals Limited,

India

1079Norfen 400mg Tablets

Norfloxacin 400mg POM Tablet Uncoated 113/031 Cadilla Pharmaceuticals Limited,

India

1080 Cadiprim 480mg TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 113/032 Cadilla Pharmaceuticals Limited,

India

1081Cadiprim 240 Mg Suspension

Trimethoprim 40mg +

Sulphamethoxazole 200mg

POM Suspension for

Oral Use

113/033 Cadilla Pharmaceuticals Limited,

India

1082 Wormin-A SuspensionAlbendazole 200mg, per 5ml POM Suspension 113/035 Cadilla Pharmaceuticals Limited,

India

1083Cadiphen 4mg Tablets

Chlorpheniramine 4mg P Tablet Uncoated 113/037 Cadilla Pharmaceuticals Limited,

India

Page 53 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1084 Decon Nasal DropsXylometazoline 0.1%w/v POM Nasal drops 113/039 Cadilla Pharmaceuticals Limited,

India

1085Decon Pediatric Nasal Drops

Xylometazoline 0.05% POM Nasal drops 113/040 Cadilla Pharmaceuticals Limited,

India

1086 Ibunate 400 TabletsIbuprofen 400mg P Tablet Uncoated 113/041 Cadilla Pharmaceuticals Limited,

India

1087 Nilide 100mg TabletsNimesulide 100mg POM Tablet Uncoated 113/042 Cadilla Pharmaceuticals Limited,

India

1088Dexasone Eye/Ear Drops

Neomycin Sulphate 0.35%w/v +

Dexamethasone Sodium

Phosphate 0.1%w/v

POM Ear/Eye Drops 113/043 Cadilla Pharmaceuticals Limited,

India

1089Trigan-D Tablets

Paracetamol 500mg +

Dicyclomine 20mg

P Tablet Uncoated 113/044 Cadilla Pharmaceuticals Limited,

India

1090EC-350 Capsules

Ascorbic Acid 150mg + Vitamin

E 25mg +Selenium 75mg +Alpha

Lipoic Acid 100mg

POM Capsule oral 113/045 Cadilla Pharmaceuticals Limited,

India

1091 Mycocox TabletsIsoniazid 150mg + Rifampicin

150mg

POM Tablet Uncoated 113/046 Cadilla Pharmaceuticals Limited,

India

1092 Scat 200mg TabletsSparfloxacin 200mg POM Tablet Uncoated 113/047 Cadilla Pharmaceuticals Limited,

India

1093 Domperon SuspensionDomperidone 5mg, per 5ml POM Solution for Oral

Use

113/049 Cadilla Pharmaceuticals Limited,

India

1094Herbisept Herbal Cream

Herbal extract 30mg P Cream Topical 113/050 Cadilla Pharmaceuticals Limited,

India

1095Oritaxim 250mg Injection

Cefotaxime 250mg POM Powder for

Injection

113/051 Cadilla Pharmaceuticals Limited,

India

1096 Axone 1000 InjectionCeftriaxone 1g POM Powder for

Injection

113/052 Cadilla Pharmaceuticals Limited,

India

1097 Zycin Dry SyrupAzithromycin 200mg, per 5ml POM Syrup 113/053 Cadilla Pharmaceuticals Limited,

India

1098 Zycin CapsulesAzithromycin 250mg POM Capsule oral 113/054 Cadilla Pharmaceuticals Limited,

India

1099 Zycin DT TabletsAzithromycin 100mg POM Tablet Uncoated 113/055 Cadilla Pharmaceuticals Limited,

India

1100 Lorcap Eye/Ear DropsPilocarpine 20mg POM Ear/Eye Drops 113/056 Cadilla Pharmaceuticals Limited,

India

1101PVA Tears Eye Drops

Polyvinyl alcohol 14mg, per 10ml P Eye Drops 113/057 Cadilla Pharmaceuticals Limited,

India

Page 54 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1102 Gentamycin Eye DropsGentamicin 3mcg, per ml POM Ear/Eye Drops 113/058 Cadilla Pharmaceuticals Limited,

India

1103Cadiprim Eye/Ear Drops

Polymyxin B 10000iu +

Trimethroprim 1mg, per ml +

Polyvinyl Alcohol 1%v/v

POM Ear/Eye Drops 113/059 Cadilla Pharmaceuticals Limited,

India

1104 Cadilac Eye DropsKetoralac 5mcg, per ml POM Ear/Eye Drops 113/060 Cadilla Pharmaceuticals Limited,

India

1105 Sanvic Opthalmic Solutions Eye Drops.Hydroxypropylmethyl cellulose

2%w/v

POM Eye Drops 113/061 Cadilla Pharmaceuticals Limited,

India

1106 Cefogen 750 InjectionCefuroxime 750mg POM Powder for

Injection

113/062 Cadilla Pharmaceuticals Limited,

India

1107Sanbeta Eye Drops

Betamethasone 1mg, per ml POM Eye Drops 113/063 Cadilla Pharmaceuticals Limited,

India

1108 Mycobutol 800mg TabletsEthambutol 800mg POM Tablet Uncoated 113/065 Cadilla Pharmaceuticals Limited,

India

1109Decon Eye Drops

Naphazoline Hydrochloride

0.01%w/w

POM Eye Drops 113/066 Cadilla Pharmaceuticals Limited,

India

1110Tmide Plus Eye Drops

Benzalkonuim Chloride

0.01%w/v + Phenylephrine

5%w/v + Tropicamide 0.8%w/v

POM Eye Drops 113/067 Cadilla Pharmaceuticals Limited,

India

1111 Rabeloc InjectionRabeprazole 20mg, per ml POM Solution for

Injection

113/068 Cadilla Pharmaceuticals Limited,

India

1112Rabeloc 10 Tablets

Rabeprazole 10mg POM Tablet Uncoated 113/069 Cadilla Pharmaceuticals Limited,

India

1113Rabeloc-20 Tablets

Rabeprazole 20mg POM Tablet Uncoated 113/070 Cadilla Pharmaceuticals Limited,

India

1114 Scat Eye/Ear DropsSparfloxacin 0.3% POM Ear/Eye Drops 113/071 Cadilla Pharmaceuticals Limited,

India

1115 Locid SuspensionAluminium Hydroxide +

Magnesium Trisilscate 474mg

GS Suspension for

Oral Use

113/072 Cadilla Pharmaceuticals Limited,

India

1116 Tambac 50 SuspensionCefpodoxime 50mg, per 5ml POM Suspension for

Oral Use

113/073 Cadilla Pharmaceuticals Limited,

India

1117 Nodon 5 TabletsNebivolol 5mg POM Tablet Uncoated 113/074 Cadilla Pharmaceuticals Limited,

India

1118 Piozulin 15 TabletsPioglitazone 15mg POM Tablet Uncoated 113/075 Cadilla Pharmaceuticals Limited,

India

1119Piozulin 30 Tablets

Pioglitazone 30mg POM Tablet Uncoated 113/076 Cadilla Pharmaceuticals Limited,

India

Page 55 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1120Cadiphen Expectorant

Chlorpheniramine 80mg +

Ammonium 100mg + Sodium

Citrate 44mg + Menthol 0.8mg

P Solution for Oral

Use

113/077 Cadilla Pharmaceuticals Limited,

India

1121

Haem-Up Gems Capsules

Folic Acid 1.5mg + Ferrous

Fumarate 200mg + Cupric

Sulfate 2.5mg + Manganese

Sulfate 2.5mg

P Capsule oral 113/078 Cadilla Pharmaceuticals Limited,

India

1122

Haem-Up Syrup

Folic Acid 0.5mg + Ferric

Ammonium Citrate 160mg +

Cupric Sulphate 30 mcg +

Manganese Sulphate 30 mcg

P Solution for Oral

Use

113/079 Cadilla Pharmaceuticals Limited,

India

1123 Aciloc InjectionRanitidine 25mg POM Powder for

Injection

113/080 Cadilla Pharmaceuticals Limited,

India

1124 Amtba 500 TabletsTinidazole 500mg POM Tablet Uncoated 113/081 Cadilla Pharmaceuticals Limited,

India

1125Calnif Retard

Nifedipine 20mg POM Tablet Uncoated 113/082 Cadilla Pharmaceuticals Limited,

India

1126Cefamor Dry Syrup

Cephalexin 125 mg, per 5 ml POM Syrup 113/083 Cadilla Pharmaceuticals Limited,

India

1127Dexaquin Ointment

Idochlorohydroxyquinolone

3%w/w + Dexamethasone

0.05%w/w

POM Ointment topical 113/084 Cadilla Pharmaceuticals Limited,

India

1128 Domperon TabletsDomperidone 10mg POM Tablet Uncoated 113/085 Cadilla Pharmaceuticals Limited,

India

1129 Envas 10mg TabletsEnalapril 10mg POM Tablet Uncoated 113/086 Cadilla Pharmaceuticals Limited,

India

1130 Envas 5mg TabletsEnalapril 5mg POM Tablet Uncoated 113/087 Cadilla Pharmaceuticals Limited,

India

1131Ocupress 2.5mg/ml Ophthalmic

Solution

Timolol 2.5mg, per ml POM Eye Drops 113/088 Cadilla Pharmaceuticals Limited,

India

1132 Ocupress 5mg/ml Ophthalmic SolutionTimolol 5mg, per ml POM Eye Drops 113/089 Cadilla Pharmaceuticals Limited,

India

1133 Tricort InjectionTriamcinolone 40mg POM Solution for

Injection

113/090 Cadilla Pharmaceuticals Limited,

India

1134 Wormin 500mg TabletsMebendazole 500mg P Tablet Uncoated 113/091 Cadilla Pharmaceuticals Limited,

India

1135Allerstat 180 Tablets

Fexofenadine 180mg P Tablet Uncoated 113/092 Cadilla Pharmaceuticals Limited,

India

Page 56 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1136 Allerstat 120 TabletsFexofenadine 120mg P Tablet Uncoated 113/093 Cadilla Pharmaceuticals Limited,

India

1137Cupid 50 Tablets

Sildenafil 50mg POM Tablet Film

coated

113/094 Cadilla Pharmaceuticals Limited,

India

1138Polycap Capsules

Simvastatin 20mg + Ramipril

5mg + Atenolol 50mg +

Hydrochlorothiazide 12.5mg

POM Capsule oral 113/095 Cadilla Pharmaceuticals Limited,

India

1139 Cadigrel TabletsClopidogrel 75mg POM Tablet Uncoated 113/096 Cadilla Pharmaceuticals Limited,

India

1140 Onsett 2ml InjectionOndansetron hydrochloride 2mg,

per ml

POM Solution for

Injection

113/097 Cadilla Pharmaceuticals Limited,

India

1141Onsett 4 Tablets

Ondansetron Hydrochloride 4mg POM Tablet Uncoated 113/098 Cadilla Pharmaceuticals Limited,

India

1142 Onsett 8 TabletsOndansetron Hydrochloride 8mg POM Tablet Uncoated 113/099 Cadilla Pharmaceuticals Limited,

India

1143Teli -80 Tablets

Telmisartan 80mg POM Tablet Uncoated 113/100 Cadilla Pharmaceuticals Limited,

India

1144 Teli-40 TabletsTelmisartan 40mg POM Tablet Uncoated 113/101 Cadilla Pharmaceuticals Limited,

India

1145 Teli -H TabletsTelmisartan 40mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 113/102 Cadilla Pharmaceuticals Limited,

India

1146 Caditor 20 TabletsAtorvastalin Calcium 20mg POM Tablet Uncoated 113/103 Cadilla Pharmaceuticals Limited,

India

1147 Tambac 100 TabletsCefpodoxime Proxetil 100mg POM Tablet Uncoated 113/104 Cadilla Pharmaceuticals Limited,

India

1148 Tambac 200 TabletsCefpodoxime Proxetil 200mg POM Tablet Uncoated 113/105 Cadilla Pharmaceuticals Limited,

India

1149 Dolac 30 Injection Ketorolac Tromethamine USP

30mg

POM Solution for

Injection

113/106 Cadilla Pharmaceuticals Limited,

India

1150Procticad

Lactitol Monohydrate 10gm, per

15ml

POM Solution for Oral

Use

113/107 Cadilla Pharmaceuticals Limited,

India

1151 Camedol TabletsParacetamol 500mg GS Tablet Uncoated 271/001 Cameo Healthcare(L) Pvt Ltd,

India

1152 Cafem- 200 TabletsIbuprofen 200mg P Tablet Uncoated 271/002 Cameo Healthcare(L) Pvt Ltd,

India

1153 Camelox-250 CapsulesCloxacillin BP 250mg POM Capsule oral 271/003 Cameo Healthcare(L) Pvt Ltd,

India

1154Camelox-125 Oral Suspension

Cloxacillin BP 125mg, per 5ml POM Powder for Oral

Suspension

271/004 Cameo Healthcare(L) Pvt Ltd,

India

Page 57 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1155 Camecillin-250 CapsulesAmpicillin BP 250mg POM Capsule oral 271/005 Cameo Healthcare(L) Pvt Ltd,

India

1156Camecillin-125 Oral Suspension

Ampicillin BP 125mg, per 5ml POM Powder for Oral

Suspension

271/006 Cameo Healthcare(L) Pvt Ltd,

India

1157 Camoxy-250mg CapsuleAmoxicillin 250mg POM Capsule oral 271/007 Cameo Healthcare(L) Pvt Ltd,

India

1158 Camoxy-125 Oral SuspensionAmoxicillin BP 125mg, per 5ml POM Powder for Oral

Suspension

271/008 Cameo Healthcare(L) Pvt Ltd,

India

1159 Indocame CapsulesIndomethacin 25mg P Capsule oral 271/009 Cameo Healthcare(L) Pvt Ltd,

India

1160 Cotricam 240 Oral SuspensionCo-trimoxazole 240mg POM Powder for Oral

Suspension

271/010 Cameo Healthcare(L) Pvt Ltd,

India

1161 Vitacam B6 TabletsPyridoxine Hydrochloride 50mg P Tablet Uncoated 271/011 Cameo Healthcare(L) Pvt Ltd,

India

1162 Camvit-B TabletsVitamin B complex P Tablet Uncoated 271/012 Cameo Healthcare(L) Pvt Ltd,

India

1163 Cametrin TabletsPyrantel Pamoate POM Tablet Uncoated 271/013 Cameo Healthcare(L) Pvt Ltd,

India

1164Cold Off Junior Syrup

Paracetamol + Chlopheniramine P Syrup 271/014 Cameo Healthcare(L) Pvt Ltd,

India

1165 Camflam TabletsParacetamol BP + Ibuprofen BP P Tablet Uncoated 271/015 Cameo Healthcare(L) Pvt Ltd,

India

1166 Fenacam 50 TabletsDiclofenac Sodium 50mg P Tablet Uncoated 271/016 Cameo Healthcare(L) Pvt Ltd,

India

1167 Malsycam TabletsSulfadoxine BP + Pyrimethamine

BP 525MG

POM Tablet Uncoated 271/017 Cameo Healthcare(L) Pvt Ltd,

India

1168 Dixicam 500 TabletsNalidixic Acid 500mg POM Suspension for

Oral Use

271/018 Cameo Healthcare(L) Pvt Ltd,

India

1169 Cotricam TabletsTrimethoprim 80 +

Sulphamethoxazole 400mg

POM Tablet Uncoated 271/019 Cameo Healthcare(L) Pvt Ltd,

India

1170 Metrocam TabletsMetronidazole BP 200mg POM Tablet Uncoated 271/020 Cameo Healthcare(L) Pvt Ltd,

India

1171 Flucocam 200 CapsulesFluconazole 200mg POM Capsule oral 271/022 Cameo Healthcare(L) Pvt Ltd,

India

1172 Vitacam C TabletsAscorbic Acid BP 100mg GS Tablet Uncoated 271/023 Cameo Healthcare(L) Pvt Ltd,

India

1173Maxivit Tablets

Multivitamin GS Tablet Uncoated 271/024 Cameo Healthcare(L) Pvt Ltd,

India1174 Amocillin 250mg Capsules Amoxicillin 250mg POM Capsule oral 024/001 Caps (Private) Ltd, Zimbabwe

Page 58 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1175 Amocillin 500mg Capsules Amoxicillin 500mg POM Capsule oral 024/002 Caps (Private) Ltd, Zimbabwe

1176 Amocillin 125mg/5ml SuspensionAmoxicillin 125mg, per 5ml POM Suspension for

Oral Use

024/003 Caps (Private) Ltd, Zimbabwe

1177 Amocillin 250mg/5ml SuspensionAmoxicillin 250mg, per 5ml POM Suspension for

Oral Use

024/004 Caps (Private) Ltd, Zimbabwe

1178 Benzylpencillin 1 Mega InjectionBenzyl Penicillin 1 MU POM Powder for

Injection

024/005 Caps (Private) Ltd, Zimbabwe

1179 Benzylpencillin 5 Mega InjectionBenzyl Penicillin 5 MU POM Powder for

Injection

024/006 Caps (Private) Ltd, Zimbabwe

1180 Capcycline 250mg Capsules Cloxacillin 250mg POM Capsule oral 024/007 Caps (Private) Ltd, Zimbabwe

1181 Chlornicol 250mg Capsules Chloramphenicol 250mg POM Capsule oral 024/008 Caps (Private) Ltd, Zimbabwe

1182Chlornicol 1g Injection

Chloramphenicol 1g POM Powder for

Injection

024/009 Caps (Private) Ltd, Zimbabwe

1183 Chlornicol 125mg/5ml SuspensionChloramphenicol 125mg, per 5ml POM Suspension for

Oral Use

024/010 Caps (Private) Ltd, Zimbabwe

1184Co-Trimoxazole Peadiatric Tablets

Trimethoprim 40mg +

Sulphamethoxazole 200mg

POM Tablet Uncoated 024/014 Caps (Private) Ltd, Zimbabwe

1185 Co-Trimoxazole SuspensionTrimethoprim +

Sulphamethoxazole

POM Suspension for

Oral Use

024/015 Caps (Private) Ltd, Zimbabwe

1186 Co-Trimoxazole TabletsTrimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 024/016 Caps (Private) Ltd, Zimbabwe

1187 Dizam InjectionDiazepam 10mg, per ml POM Solution for

Injection

024/017 Caps (Private) Ltd, Zimbabwe

1188 Dizam 2mg Tablets Diazepam 2mg POM Tablet Uncoated 024/018 Caps (Private) Ltd, Zimbabwe

1189 Dizam 5mg Tablets Diazepam 5mg POM Tablet Uncoated 024/019 Caps (Private) Ltd, Zimbabwe

1190 Dolex 200mg Capsules Oflaxacin + Aflaxacin 200mg POM Capsule oral 024/020 Caps (Private) Ltd, Zimbabwe

1191 Dolex 400mg Capsules Oflaxacin + Aflaxacin 400mg POM Capsule oral 024/021 Caps (Private) Ltd, Zimbabwe

1192 Doxyclin Capsules Doxycycline 100mg POM Capsule oral 024/022 Caps (Private) Ltd, Zimbabwe

1193 Equemote 50mg Capsules Sulpiride 50mg POM Capsule oral 024/023 Caps (Private) Ltd, Zimbabwe

1194 Famicillin 250mg Capsules Ampicillin 250mg POM Capsule oral 024/024 Caps (Private) Ltd, Zimbabwe

1195 Famicillin 500mg Capsules Ampicillin 500mg POM Capsule oral 024/025 Caps (Private) Ltd, Zimbabwe

1196 Famicillin 125mg/5ml SuspensionAmpicillin 125mg, per 5ml POM Suspension for

Oral Use

024/026 Caps (Private) Ltd, Zimbabwe

1197 Famicillin InjectionAmpicillin POM Powder for

Injection

024/027 Caps (Private) Ltd, Zimbabwe

1198Famicillin 250mg/5ml Suspension

Ampicillin 250mg, per 5ml POM Suspension for

Oral Use

024/028 Caps (Private) Ltd, Zimbabwe

1199 Ferous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Uncoated 024/029 Caps (Private) Ltd, Zimbabwe

1200 Hydrochlorothiazide Tablets Hydrochlorothiazide 25mg POM Tablet Uncoated 024/030 Caps (Private) Ltd, Zimbabwe

Page 59 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1201 Hydrochlorothiazide Tablets Hydrochlorothiazide 50mg POM Tablet Uncoated 024/031 Caps (Private) Ltd, Zimbabwe

1202 Hypotens Tablets Trifluoperazine 250mg POM Tablet Uncoated 024/032 Caps (Private) Ltd, Zimbabwe

1203Kanamycin Injection

Kanamycin 250mg POM Powder for

Injection

024/033 Caps (Private) Ltd, Zimbabwe

1204 Malasone Tablets Pyrimethamine + Dapsone P Tablet Uncoated 024/034 Caps (Private) Ltd, Zimbabwe

1205 Methocid 25mg Capsules Indomethacin 25mg P Capsule oral 024/035 Caps (Private) Ltd, Zimbabwe

1206 Methocid 50mg Caspules Indomethacin 50mg P Capsule oral 024/036 Caps (Private) Ltd, Zimbabwe

1207 Methocid Suppositories Indomethacin 100mg POM Suppository 024/037 Caps (Private) Ltd, Zimbabwe

1208Metronidazole Suspension

Metronidazole 200mg, per 5mls POM Suspension for

Oral Use

024/038 Caps (Private) Ltd, Zimbabwe

1209 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 024/039 Caps (Private) Ltd, Zimbabwe

1210 Metronidazole 400 Mg Tablets Metronidazole 400mg POM Tablet Uncoated 024/040 Caps (Private) Ltd, Zimbabwe

1211 Mezenol DS TabletsTrimethoprim +

Sulphamethoxazole

POM Tablet Uncoated 024/041 Caps (Private) Ltd, Zimbabwe

1212 Paracetamol Syrup Paracetamol 120mg, per 5ml GS Syrup 024/042 Caps (Private) Ltd, Zimbabwe

1213 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 024/043 Caps (Private) Ltd, Zimbabwe

1214 Parecon Forte InjectionCyanocobalamine 1mg, per ml POM Solution for

Injection

024/044 Caps (Private) Ltd, Zimbabwe

1215 Procillin InjectionProcaine Benzyl Penicillin

300mg/ml

POM Solution for

Injection

024/045 Caps (Private) Ltd, Zimbabwe

1216 Purinol Tablets Allopurinol 100mg POM Tablet Uncoated 024/046 Caps (Private) Ltd, Zimbabwe

1217 Rexigen 10mg Tablets Propranalol 10mg POM Tablet Uncoated 024/047 Caps (Private) Ltd, Zimbabwe

1218 Rexigen 40mg Tablets Propranalol 40mg POM Tablet Uncoated 024/048 Caps (Private) Ltd, Zimbabwe

1219 Rexigen 80mg Tablets Propranalol 80mg POM Tablet Uncoated 024/049 Caps (Private) Ltd, Zimbabwe

1220 Rexigen 160mg Tablets Propranalol 160mg POM Tablet Uncoated 024/050 Caps (Private) Ltd, Zimbabwe

1221 Streptosol 5g/15ml InjectionStreptosol 5g, per 15ml injection POM Solution for

Injection

024/051 Caps (Private) Ltd, Zimbabwe

1222 Tetracycline Eye OintmentTetracycline Hydrochloride

30mg, per g

POM Eye Ointment 024/052 Caps (Private) Ltd, Zimbabwe

1223 Ultracillin LA Injection Benzathine Penicillin 2.4MU POM Tablet Uncoated 024/053 Caps (Private) Ltd, Zimbabwe

1224Urazide Tablets

Amiloride Hydrochloride 5mg +

Hydrochlorothiazide 50mg

POM Tablet Uncoated 024/054 Caps (Private) Ltd, Zimbabwe

1225Water For Injection

Water for injection POM Solution for

Injection

024/055 Caps (Private) Ltd, Zimbabwe

1226 Xylonor InjectionLignocaine Hydrochloride 2% +

Norepinephrine

POM Solution for

Injection

024/056 Caps (Private) Ltd, Zimbabwe

1227 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 024/057 Caps (Private) Ltd, Zimbabwe

Page 60 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1228

Histalix D Syrup

Dextromethorphan Hydrobromide

9mg + Diphenylhydramine

10mg+ Ammonium Chloride

90mg

P Syrup 024/058 Caps (Private) Ltd, Zimbabwe

1229 Phenobarbitone Tablets Phenobarbitone 30mg POM Tablet Uncoated 024/059 Caps (Private) Ltd, Zimbabwe

1230 Allergon Cream Mepyramine 400mg P Cream Topical 024/060 Caps (Private) Ltd, Zimbabwe

1231Flumel Tablets

Paracetamol 500mg +

Chlorpheniramine 2mg +

Phenylephrine 10mg

P Tablet Uncoated 024/061 Caps (Private) Ltd, Zimbabwe

1232

4C's Cold Syrup

Paracetamol 120mg +

Chlorpheniramine 2mg +

Phenylephrine 2.5mg +

Dextromethorphan 0.5mg per

5mls

P Syrup 024/062 Caps (Private) Ltd, Zimbabwe

1233Histalix Syrup

Codeine Phosphate 9mg +

Ammonium Chloride 90mg +

Diphenhydramine 10mg, per 5ml

P Syrup 024/063 Caps (Private) Ltd, Zimbabwe

1234 Kefrox Oral SuspensionCefuroxime Axetil 125mg, per

5ml

POM Powder for Oral

Suspension

343/001 CCL Pharmaceuticals (PVT) Ltd,

India

1235 Kefrox TabletsCefuroxime Axetil 500mg POM Tablet Uncoated 343/002 CCL Pharmaceuticals (PVT) Ltd,

India

1236 Lucal 15 InjectionLeucovorin 15mg, per 3ml POM Solution for

Injection

073/001MT Celon Laboratories Limited

12375 Flucel 500 Injection

Fluorouracil 500mg, per 10ml POM Powder for

Injection

073/002MT Celon Laboratories Limited

1238 Celginase 1000 InjectionL-Asparaginase 10,000 IU POM Powder for

Injection

073/003MT Celon Laboratories Limited

1239

Centavit Syrup

Vitamin A USP 1000 IU +

Vitamin B1 BP 1.5 mg +

Riboflavine Sodium Phosphate

BP 1.5 mg + Nicotinamide BP 10

mg + Vitamin B12 USP 2.5 mcg

+ Vitamin C BP 40 mg+ Vitamin

D3 BP 200 IU, per 5ml

GS Syrup 061/001 Centaur Pharmaceuticals (Pvt

Limited, India

Page 61 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1240

Protobex Syrup

Soya Protein Hydrolysate 1.0g +

Iron Choline Citrate 15mg+

Cyanocobalamine 5mcg +

Thiamine Nitrate 2.5mg +

Riboflavin 2.5mg + Pyridoxine

Hydrochloride 1.5mg +

Niacinamide 25mg + Panthenol

3mg + Zinc Sulphate eq to zinc

7.5mg

P Syrup 061/002 Centaur Pharmaceuticals (Pvt

Limited, India

1241Sinarest Linctus

Dextromethorphan 10mg +

Chlopheniramine 2mg + Menthol

1.5mg

P Solution for Oral

Use

061/003 Centaur Pharmaceuticals (Pvt

Limited, India

1242

Kofarest Syrup

Terbutalin Sulphate 2.5mg +

Ambroxol Hydrochloride 30mg +

Guaiphenesin 100mg + Menthol

5mg, per 10ml

P Syrup 061/004 Centaur Pharmaceuticals (Pvt

Limited, India

1243 Diclogenta Eye DropsDiclofenac Sodium 1mg +

Gentamycin Sulphate 3mg

POM Solution for

Topical Use

061/005 Centaur Pharmaceuticals (Pvt

Limited, India

1244 Eyevir Eye OintmentAcyclovir 3% POM Eye Ointment 061/006 Centaur Pharmaceuticals (Pvt

Limited, India

1245I-Gesic Eye Drops

Diclofenac Sodium USP 0.1%w/v POM Eye Drops 061/007 Centaur Pharmaceuticals (Pvt

Limited, India

1246Kofarest Lozenges

Dextromethorphan 5mg +

Cetylpyridium 1.3mg + Menthol

5.2mg

P Lozenges 061/008 Centaur Pharmaceuticals (Pvt

Limited, India

1247 Leeflox Eye/Ear DropsLevofloxacin 0.5% POM Ear/Eye Drops 061/009 Centaur Pharmaceuticals (Pvt

Limited, India

1248

Ocurest - AH Eye Drops

Phenylephrine Hydrochloride

0.12% w/v + Naphazoline

Hydrochloride 0.05%w/v +

Chlorpheniramine Maleate 0.1%

w/v + Menthol 0.0005% w/v +

Camphor 0.01%w/v

POM Solution for

Topical Use

061/010 Centaur Pharmaceuticals (Pvt

Limited, India

1249Ocutob D Eye Drops

Tobramycin Sulphate 0.3% +

Dexamethasone 0.1% +

Benzalkonium Chloride 0.01%

POM Eye Drops 061/011 Centaur Pharmaceuticals (Pvt

Limited, India

1250Ocuwet Eye Drops

Polyvinyl Alcohol 1.4% +

Povidone 0.6% + Benzalkonium

Chloride 0.01%

POM Eye Drops 061/012 Centaur Pharmaceuticals (Pvt

Limited, India

Page 62 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1251 Opticol Eye DropsChloramphenicol 0.5%w/v POM Solution for

Topical Use

061/013 Centaur Pharmaceuticals (Pvt

Limited, India

1252Catarest Eye Drops

Potassium Iodide 3.3%w/v +

Sodium Chloride 0.83%w/v +

Calcium Chloride 1.0%w/v

POM Eye Drops 061/014 Centaur Pharmaceuticals (Pvt

Limited, India

1253

Livosil-B Capsules

Silymarin 70 mg + Thiamine

Mononitrate 5 mg + Riboflavin 5

mg + Pyridoxine Hydrochloride

1.5 mg + Niacinamide 25 mg

+Calcium Panthothenate 7.5 mg

+Vitamin B12 5 mcg

P Capsule oral 061/015 Centaur Pharmaceuticals (Pvt

Limited, India

1254 Manoll Syrup Herbal Extracts P Syrup 370/001L Charak Pharma Pvt Ltd.

1255 Ojus Syrup Herbal Extracts P Syrup 370/002L Charak Pharma Pvt Ltd.

1256 Addyzoa Tablets Herbal Extracts P Tablet Uncoated 370/003L Charak Pharma Pvt Ltd.

1257 M2 Tone Tablets Herbal Extracts P Tablet Uncoated 370/004L Charak Pharma Pvt Ltd.

1258 Hyponidd Tablets Herbal Extracts P Tablet Uncoated 370/005L Charak Pharma Pvt Ltd.

1259 Arthrelia Tablets Herbal Extracts P Tablet Uncoated 370/006L Charak Pharma Pvt Ltd.

1260 Vigomax Forte TabletsHerbal Extracts P Tablet Film

coated

370/007L Charak Pharma Pvt Ltd.

1261 LO.Ivomyn Tablets Herbal Extracts P Tablet Uncoated 370/008L Charak Pharma Pvt Ltd.

1262 Pilief Tablets Herbal Extracts P Tablet Uncoated 370/009L Charak Pharma Pvt Ltd.

1263 Richelth Tablets Herbal Extracts P Tablet Uncoated 370/010L Charak Pharma Pvt Ltd.

1264 Kofol SF Syrup Herbal Extracts P Tablet Uncoated 370/011L Charak Pharma Pvt Ltd.

1265 Paedritone Syrup Herbal Extracts P Syrup 370/012L Charak Pharma Pvt Ltd.

1266 Athrella Ointment Herbal Extracts P Ointment topical 370/014L Charak Pharma Pvt Ltd.

1267 Pilief Ointment Herbal Extracts P Ointment topical 370/015L Charak Pharma Pvt Ltd.

1268 Vitamin A 1500µg TabletsVitamin A acetate 1500µg P Tablet Film

coated

402/001 Chempure Pty Ltd

1269Iron Plus Capsules

Iron BisGlycinate Chelate 10mg

+ Activated Folate 400mcg +

Vtamin B12 100mcg

P Capsule oral 402/002 Chempure Pty Ltd

1270Chromium Polynicotinate Tablets

Chromium Polynicotinate

200mcg

P Tablet Uncoated 402/003L Chempure Pty Ltd

1271Full Spectrum Vitamin E 400mg

Capsules

Mixed Tocotrienols + Mixed

Tocopherols 400mg

P Capsule oral 402/004L Chempure Pty Ltd

1272 Ubiquinol CO-Q10 Capsules Ubiquinol 50mg P Capsule oral 402/005L Chempure Pty Ltd

1273

Calcium Glycinate with Vitamin D3 and

Boron Tablets

Calcium Glycinate 750mg +

Vitamin D3 200IU + Boron 500µg

P Tablet Film

coated

402/006L Chempure Pty Ltd

Page 63 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1274 Krill Oil Omega-3 Capsules 500mg + 110mg + 60mg P Capsule oral 402/007L Chempure Pty Ltd

1275 Magnesium Glycinate TabletsMagnesium Glycinate 1110mg +

Boron 500mcg

P Tablet Film

coated

402/008L Chempure Pty Ltd

1276Irvingia Plus Fat Burner Capsules

Irvingia extract 100mg +

Berberine 200mg + Kelp extract

17mg + Zinc 5mg + Panax

P Capsule oral 402/009L Chempure Pty Ltd

1277

Libido & Performance Enhancer for

Men Capsules

L-arginine Hydrochloride

4425mg + Tongkat ali 37.5mg +

Tribulus terrestris 125mg +

Pana

P Capsule oral 402/010L Chempure Pty Ltd

1278 Double Vitamin C CapsulesVitamin C-water soluble 233mg

+ Vitamin C-fat soluble 100mg

GS Capsule oral 402/011L Chempure Pty Ltd

1279Methyl-Sulfonyl-Methane (MSM)

Capsules

Methylsulfonylmethane 700mg Pharmacy

Medicine

Capsule oral 402/012L Chempure Pty Ltd

1280Calmlite with Relora® and Theanine

Capsules

Relora 250mg + Theanine

125mg

P Capsule oral 402/013L Chempure Pty Ltd

1281Folic Acid Natural Folate Tablets

Folic Acid 500mcg Pharmacy

Medicine

Tablet Uncoated 402/014L Chempure Pty Ltd

1282 Iodin Plus Ointment Povidone-Iodine 5 % w/w P Ointment topical 381/001 Cian Health Care Pvt Ltd.

1283 Zidovir 100 Capsules Zidovudine 100mg POM Capsule oral 099/001 Cipla Limited, India

1284 Ciplox 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 099/002 Cipla Limited, India

1285 Ciplox 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 099/003 Cipla Limited, India

1286 Ciplox Eye Ointment Ciprofloxacin 0.3%w/w POM Eye Ointment 099/004 Cipla Limited, India

1287 Ciplox Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 099/005 Cipla Limited, India

1288 Profenac Eye Drops Diclofenac 0.1%w/v POM Eye Drops 099/006 Cipla Limited, India

1289 Fungicip Cream Clotrimazole 1%w/v POM Cream Topical 099/007 Cipla Limited, India

1290 Fungicip - 100 Tablets Clotrimazole 100mg POM Tablet Vaginal 099/008 Cipla Limited, India

1291 Fungicip 200 Tablets Clotrimazole 200mg POM Tablet Vaginal 099/009 Cipla Limited, India

1292 Triomune 30 TabletsStavudine 30mg + Nevirapine

200mg + Lamivudine 150mg

POM Tablet Uncoated 099/010 Cipla Limited, India

1293 Lamivir-S 30 TabletsLamivudine 150mg + Stavudine

30mg

POM Tablet Uncoated 099/011 Cipla Limited, India

1294 Lamivir-S 40 TabletsLamivudine 150mg + Stavudine

40mg

POM Tablet Uncoated 099/012 Cipla Limited, India

1295 Efivir -200 Tablets Efavirenz 200mg POM Tablet Uncoated 099/013 Cipla Limited, India

1296 Nelvir Tablets Nelfinavir 250mg POM Tablet Uncoated 099/014 Cipla Limited, India

1297 Lamivir Tablets Lamivudine 150mg POM Tablet Uncoated 099/015 Cipla Limited, India

1298Zidovir Solution

Zidovudine 50mg, per 5ml POM Solution for Oral

Use

099/016 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1299 Nevimune Oral SuspensionNevirapine 50mg, per 5ml POM Suspension for

Oral Use

099/018 Cipla Limited, India

1300 Indivan 200mg Capsules Indinavir 200mg POM Capsule oral 099/019 Cipla Limited, India

1301 Duovir N TabletsZidovudine 300mg + Lamivudine

150mg + Nevirapine 200mg

POM Tablet Uncoated 099/020 Cipla Limited, India

1302 Stavir 30 Tablets Stavudine 30mg POM Tablet Uncoated 099/021 Cipla Limited, India

1303 Stavir 40 Tablets Stavudine 40mg POM Tablet Uncoated 099/022 Cipla Limited, India

1304 Lamivir 50mg/ml Oral SolutionLamivudine 50mg, per 5ml POM Solution for Oral

Use

099/023 Cipla Limited, India

1305 Divir 100 Tablets Didanosine 100mg POM Tablet Uncoated 099/024 Cipla Limited, India

1306 Spectin InjectionSpectinomycin 2g POM Powder for

Injection

099/025 Cipla Limited, India

1307 Tadacip 10 Tablets Tadalafil 10mg POM Tablet Uncoated 099/026 Cipla Limited, India

1308 Lovacard 20 Tablets Levostatin 20mg POM Tablet Uncoated 099/027 Cipla Limited, India

1309 Cipril 5 Tablets Lisinopril 5mg POM Tablet Uncoated 099/028 Cipla Limited, India

1310 Novatax 1000 InjectionCefotaxime 1000mg POM Powder for

Injection

099/029 Cipla Limited, India

1311 Simcard 10 Tablets Simvastatin 10mg POM Tablet Uncoated 099/030 Cipla Limited, India

1312 Acivir 200 Dispersible Tablets Acyclovir 200mg POM Tablet Uncoated 099/032 Cipla Limited, India

1313 Asthalin 100mcg/Spray InhalerSalbutamol 100mcg POM Solution for

Inhalation

099/033 Cipla Limited, India

1314 Falcithar 40 InjectionArtemether 40mg POM Solution for

Injection

099/034 Cipla Limited, India

1315Falcithar 80 Injection

Artemether 80mg POM Solution for

Injection

099/035 Cipla Limited, India

1316 Forcan 150mg Capsules Fluconazole 150mg POM Capsule oral 099/036 Cipla Limited, India

1317 Forcan 200mg Capsules Fluconazole 200mg POM Capsule oral 099/037 Cipla Limited, India

1318 Vasopril -10 Tablets Enalapril 10mg POM Tablet Uncoated 099/038 Cipla Limited, India

1319 Vasopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 099/039 Cipla Limited, India

1320 Acivir Eye Ointment Acyclovir 3% POM Eye Ointment 099/040 Cipla Limited, India

1321 Alerid Tablets Cetirizine 10mg POM Tablet Uncoated 099/041 Cipla Limited, India

1322Cipcal 250 Tablets

Calcium Carbonate 625mg +

Vitamin D3 1.66mg

P Tablet Uncoated 099/042 Cipla Limited, India

1323 Ciplacef InjectionCeftriaxone 1000mg POM Powder for

Injection

099/043 Cipla Limited, India

1324 Cytocristin InjectionVincristine 1g POM Solution for

Injection

099/044 Cipla Limited, India

1325 Dr Smiths Evening Primrose Capsules Evening Primrose extract P Capsule oral 099/045 Cipla Limited, India

1326 Falcinil 100 Tablets Artesunate 100mg POM Tablet Uncoated 099/046 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1327 Fincar 5mg Tablets Finasteride 5mg POM Tablets oral 099/047 Cipla Limited, India

1328 Gentacip Eye Drops Gentamycin 0.35%w/v POM Eye Drops 099/048 Cipla Limited, India

1329 Glinil Tablets Glibenclamide 5mg POM Tablet Uncoated 099/049 Cipla Limited, India

1330 Hipres-100 Tablets Atenolol 100mg POM Tablet Uncoated 099/050 Cipla Limited, India

1331 Hipres-50 Tablets Atenolol 50mg POM Tablet Uncoated 099/051 Cipla Limited, India

1332 Ocutin 0.25% Ophthalmic Drops Timolol 0.25%w/v POM Eye Drops 099/052 Cipla Limited, India

1333 Ocutin 0.5% Ophthalmic Drops Timolol 0.5%w/v POM Eye Drops 099/053 Cipla Limited, India

1334 Osteocip TabletsChondroitin 400mg +

Glucosamine 663.2mg

P Tablet Enteric

Coated

099/054 Cipla Limited, India

1335 Photericin B InjectionAmphotericin B 50mg, per 15ml POM Solution for

Injection

099/055 Cipla Limited, India

1336 Profenac 100 SR Tablets Diclofenac 100mg P Tablet Uncoated 099/056 Cipla Limited, India

1337 Quinarsol InjectionQuinine 300mg POM Solution for

Injection

099/057 Cipla Limited, India

1338 Roko 2 Tablets Loperamide 2mg POM Tablet Uncoated 099/058 Cipla Limited, India

1339 Synclar 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 099/059 Cipla Limited, India

1340 Theoday 400mg Tablets Theophylline 2mg POM Tablet Uncoated 099/060 Cipla Limited, India

1341 Ultac 300 Tablets Ranitidine 300mg POM Tablet Uncoated 099/061 Cipla Limited, India

1342 Zinoral Shampoo Ketoconazole 2% POM Shampoo 099/062 Cipla Limited, India

1343Triomune 30 Tablets

Lamivudine 150mg + Stavudine

30mg + Nevirapine 200mg

POM Tablet Uncoated 099/063 Cipla Limited, India

1344 Acivir Cream Acyclovir 5%w/w POM Cream Topical 099/064 Cipla Limited, India

1345 Natucil Powder Isphagula Husk 3.25g P Sachet 099/065 Cipla Limited, India

1346 Ciproric-100 Tablets Allopurinol 100mg POM Tablet Uncoated 099/067 Cipla Limited, India

1347 Ergogin InjectionMethylergonovine 0.208mg, per

ml

POM Solution for

Injection

099/068 Cipla Limited, India

1348 Dexacip InjectionDexamethasone 4.38mg, per ml POM Solution for

Injection

099/069 Cipla Limited, India

1349 Spasmocip CapsulesParacetamol 325mg +

Dextromethophan 65mg

P Capsule oral 099/070 Cipla Limited, India

1350 Cipladine Ointment Povidone Iodine 5%w/w GS Ointment topical 099/071 Cipla Limited, India

1351Digusil MPS Tablets

Aluminium Hydroxide +

Magnesium Hydroxide +

Dimethicone 400mg

GS Tablet Uncoated 099/072 Cipla Limited, India

1352Burnheal Cream

Silver Sulfadiazine 1%w/w +

Chlorhexidine 0.2%w/w

P Cream Topical 099/073 Cipla Limited, India

1353 Proflox 400 Tablets Profloxacin 400mg POM Tablet Uncoated 099/075 Cipla Limited, India

1354Theo Asthalin Tablets

Salbutamol 2mg + Theophylline

100mg

POM Tablet Uncoated 099/076 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1355 Aerocort InhalerSalbutamol 110 mg +

Beclometasone 51.67mcg

POM Powder for

Inhalation

099/077 Cipla Limited, India

1356 Silagra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 099/078 Cipla Limited, India

1357 Aqua Tears DropsPovidone 6mg + polyvinyl alchol

14mg, per ml

POM Eye Drops 099/079 Cipla Limited, India

1358 Alerid Syrup Cetirizine 5mg, per 5ml POM Syrup 099/080 Cipla Limited, India

1359 Ciplactin Tablet Cyproheptadine 4mg P Tablet Uncoated 099/081 Cipla Limited, India

1360 Novaclav 625 TabletsAmoxicillin 500 + Clavulanate

Potassium 125mg

POM Tablet Uncoated 099/083 Cipla Limited, India

1361 Pyradox TabletsSulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 099/084 Cipla Limited, India

1362Halotrin Tablets

Halofantrine Hydrochloride

250mg

POM Tablet Uncoated 099/085 Cipla Limited, India

1363 Dr Smith Vitamin Capsules Alpha Tocopherol 400mg POM Capsule oral 099/087 Cipla Limited, India

1364 Theo Asthalin TabletsTheophylline 300mg +

Salbutamol 4.8mg

POM Tablet Uncoated 099/088 Cipla Limited, India

1365 Novaclav 375 TabletsAmoxicillin 250mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 099/089 Cipla Limited, India

1366 Vitacip CapsulesGinseng + Minerals +

Multivitamins

GS Capsule oral 099/090 Cipla Limited, India

1367 Asthalin SR Tablets Salbutamol 4mg POM Tablet Uncoated 099/092 Cipla Limited, India

1368 Cephadex-500 Tablets Cephalexin 500mg POM Capsule oral 099/093 Cipla Limited, India

1369 Cephadex 250 Capsules Cephalexin 250mg POM Capsule oral 099/094 Cipla Limited, India

1370C-Vit Chewable Tablets

Sodium Ascorbate 394 mg +

Ascorbic Acid 150mg

GS Tablet Chewable 099/095 Cipla Limited, India

1371 Betavit AFR Capsules Vitamins P Capsule oral 099/096 Cipla Limited, India

1372 Ritomune Tablets Ritonavir 100mg POM Tablet Uncoated 099/099 Cipla Limited, India

1373 Duovir TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 099/101 Cipla Limited, India

1374 Nevimune 200 Tablets Nevirapine 200mg POM Tablet Uncoated 099/102 Cipla Limited, India

1375 Ciplin TabletsSulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 099/103 Cipla Limited, India

1376 Lumartem TabletsArtemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 099/104 Cipla Limited, India

1377 Dr Smith's Garlic Oil Capsules Garlic Oil 0.25%w/w GS Capsule oral 099/105 Cipla Limited, India

1378

Urisoda Granules

Sodium Bicarbonate 44.03 % +

Sodium Citrate 15.75 % +

Tartaric Acid 22.25 % + Citric

Acid 17.88 %

GS Powder for Oral

Solution

099/106 Cipla Limited, India

Page 67 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1379 Dr. Smith's Vitamin E Capsules Alpha Tocopherol 200mg POM Capsule oral 099/107 Cipla Limited, India

1380 Triomune Baby TabletsLamivudine 30mg + Nevirapine

50mg + Stavudine 6mg

POM Tablet Uncoated 099/108 Cipla Limited, India

1381 Triomune Junior TabletsLamivudine 60mg + Nevirapine

100mg + Stavudine 12mg

POM Tablet Uncoated 099/109 Cipla Limited, India

1382 Lamivir S Baby Dispersible TabletsLamivudine 30mg + Stavudine

6mg

POM Tablet

Dispersible

099/110 Cipla Limited, India

1383 Lamivir S Junior Dispersible TabletsLamivudine USP 12mg +

Stavudine USP 60mg

POM Tablet

Dispersible

099/111 Cipla Limited, India

1384 Stavir Dry Syrup Stavudine 1mg, per ml POM Syrup 099/112 Cipla Limited, India

1385 Novaclav Dry SyrupAmoxicillin 125mg + Clavulanic

Acid 31.25mg, per 5ml

POM Syrup 099/113 Cipla Limited, India

1386 Ciplox IV InfusionCiprofloxacin 2mg, per ml POM Solution for

infusion

099/115 Cipla Limited, India

1387 Flazole InjectionMetronidazole 500mg, per 100ml POM Solution for

Injection

099/116 Cipla Limited, India

1388 Cipcorlin InjectionHydrocortisone 100mg POM Powder for

Injection

099/117 Cipla Limited, India

1389 Cytoplatin InjectionCisplatin 50mg POM Powder for

Injection

099/118 Cipla Limited, India

1390 Cytotam 10mg Tablets Tamoxifen 10mg POM Tablet Uncoated 099/119 Cipla Limited, India

1391 Bleomcip InjectionBleomycin 15 units POM Powder for

Injection

099/120 Cipla Limited, India

1392Etosid Injection

Etoposide 100mg, per 5ml POM Powder for

Injection

099/121 Cipla Limited, India

1393 Cytotam 20g Tablets Tamoxifen 20mg POM Tablet Uncoated 099/122 Cipla Limited, India

1394 Cytocarb 150 InjectionCarboplatin 150mg, per 15ml POM Powder for

Injection

099/123 Cipla Limited, India

1395 Decarb 200 InjectionDacarbazine 200mg POM Powder for

Injection

099/124 Cipla Limited, India

1396 Ciplactin Syrup Cyproheptadine 2mg P Syrup 099/125 Cipla Limited, India

1397 Naxid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 099/126 Cipla Limited, India

1398 Tenvir TabletsTenofovir Disoproxil Fumarate

300 mg

POM Tablet Film

coated

099/127 Cipla Limited, India

1399 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 099/128 Cipla Limited, India

1400 Lamivudine 10mg/ml Oral SolutionLamivudine 10mg, per ml POM Solution for Oral

Use

099/129 Cipla Limited, India

1401 Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 099/130 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1402 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Film

coated

099/131 Cipla Limited, India

1403 Tinidazole Tablets Tinidazole 500mg POM Tablet Uncoated 099/138 Cipla Limited, India

1404 Pylokit TabletsLansoprazole 30mg + Tinidazole

500mg + Clarithromycin 250mg

POM Tablet Uncoated 099/139 Cipla Limited, India

1405 Ibugesic Plus Tablets Paracetamol 200mg + Ibuprofen

325mg

P Tablet Uncoated 099/140 Cipla Limited, India

1406 Urimax 0.2mg Tablets Tamsulosin Hydrochloride 0.2mg POM Tablets oral 099/141 Cipla Limited, India

1407 Ergogin Tablets Methylergonovine 0.125mg POM Tablet Uncoated 099/142 Cipla Limited, India

1408 Synclar Dry Syrup Clarithromycin 125mg, per 5ml POM Syrup 099/143 Cipla Limited, India

1409 Nystatin Oral SuspensionNystatin 100,000 IU, per ml POM Suspension for

Oral Use

099/144 Cipla Limited, India

1410 Profenac InjectionDiclofenac 25mg, per 3ml POM Solution for

Injection

099/146 Cipla Limited, India

1411 Gentacip InjectionGentamycin 40mg, per ml POM Solution for

Injection

099/147 Cipla Limited, India

1412 Asthalin CFC-Free InhalerSalbutamol 100mcg, per spray POM Powder for

Inhalation

099/148 Cipla Limited, India

1413 Ciplin SuspensionSulphamethoxazole 200mg +

Trimethoprim 40mg

POM Suspension for

Oral Use

099/151 Cipla Limited, India

1414Beclate 50 Inhaler

Beclomethasone 50mcg, per

spray

POM Powder for

Inhalation

099/152 Cipla Limited, India

1415 Beclate 50 InhalerBeclomethasone 50mcg, per

dose

POM Powder for

Inhalation

099/153 Cipla Limited, India

1416Sulfamon Plus Tablets

Artesunate 50mg +

Pyrimethamine 25mg +

Sulfadoxine 500mg

POM Tablet Uncoated 099/154 Cipla Limited, India

1417Sulphamon Plus Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg +

Artesunate 50mg

POM Tablet Uncoated 099/155 Cipla Limited, India

1418 Abacavir Tablets 300mgAbacavir tablets 300mg POM Tablet Film

coated

099/157 Cipla Limited, India

1419 Indivan 400mg Capsules Indinavir 400mg POM Capsule oral 099/158 Cipla Limited, India

1420 Stavir 15 Capsules Stavudine 15mg POM Capsule oral 099/159 Cipla Limited, India

1421 Stavir 20 Capsules Stavudine 20mg POM Capsule oral 099/160 Cipla Limited, India

1422 Divir 25 TabletsDidanosine 25mg POM Tablet

Dispersible

099/161 Cipla Limited, India

1423Divir 150 Tablets

Didanosine 150mg POM Tablet

Dispersible

099/162 Cipla Limited, India

Page 69 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1424 Divir 200 TabletsDidanosine 200mg POM Tablet

Dispersible

099/163 Cipla Limited, India

1425 Zidovudine 100mg Capsules Zidovudine 100mg POM Capsule oral 099/164 Cipla Limited, India

1426 Oncodox 10 InjectionDoxorubicin 10mg, per 2.5ml POM Powder for

Injection

099/165 Cipla Limited, India

1427 Oncodox 50 InjectionDoxorubicin 50mg, per 5ml POM Powder for

Injection

099/166 Cipla Limited, India

1428 Amoxicillin Oral SuspensionAmoxicillin 125mg, per 5ml POM Powder for Oral

Suspension

099/167 Cipla Limited, India

1429 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 099/168 Cipla Limited, India

1430 Ginette 35 TabletsEthinyl Estradiol 0.035mg +

Cyproterone 2mg

POM Tablet Uncoated 099/169 Cipla Limited, India

1431 Cefix Ds Oral SuspensionCefixime 50mg, per 5ml POM Powder for Oral

Suspension

099/170 Cipla Limited, India

1432 Warf 5 Tablets Warfarin 5mg POM Tablet Uncoated 099/171 Cipla Limited, India

1433Chloraxin Injection

Chloramphenicol 1g POM Powder for

Injection

099/172 Cipla Limited, India

1434 Paracip 500 Tablets Paracetamol 500mg GS Tablet Uncoated 099/173 Cipla Limited, India

1435 Frusix InjectionFurosemide 10mg, per ml POM Solution for

Injection

099/174 Cipla Limited, India

1436 Ibugesic- 400 Tablets Ibuprofen 400mg P Tablet Uncoated 099/175 Cipla Limited, India

1437 Tenvir-EM TabletsTenofovir 300mg + Emtricitabine

200mg

POM Tablet Uncoated 099/177 Cipla Limited, India

1438 Lanzol 30 Capsules Lansoprazole 30mg POM Capsule oral 099/178 Cipla Limited, India

1439Digusil MPS Liquid

Alumimium Hydroxide 250mg +

Magnesium Hydroxide 250mg +

Dimethicone 50mg, per 5ml

GS Solution for Oral

Use

099/179 Cipla Limited, India

1440 Flomist Nasal SprayFluticasone 50mcg, per spray POM Solution for

Inhalation

099/180 Cipla Limited, India

1441 Lumet Forte TabletsArtemether 40mg + Lumefantrine

240mg

POM Tablet Uncoated 099/181 Cipla Limited, India

1442 Seaking Cod Liver Oil Capsules Cod-liver oil 300mg GS Capsule oral 099/182 Cipla Limited, India

1443 Terbi SprayTerbinafine 1%w/w POM Spray for Topical

Use

099/183 Cipla Limited, India

1444 Divir-50 TabletsDidanosine 50mg POM Tablet

Dispersible

099/184 Cipla Limited, India

1445Viraday Tablets

Tenofovir 300mg + Emtricitabine

200mg + Efavirenz 600mg

POM Tablet Film

coated

099/185 Cipla Limited, India

1446 Gatiquin-400mg Tablets Gatifloxacin 400mg POM Tablet Uncoated 099/186 Cipla Limited, India

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1447 Gatiquin-200mg Tablets Gatifloxacin 200mg POM Tablet Uncoated 099/187 Cipla Limited, India

1448Prolyte Oral Rehydration

Sodium chloride + Sodium citrate

+ Patassium chloride + Dextrose

GS Powder for Oral

Solution

099/188 Cipla Limited, India

1449C-Fizz 500 Tablets

Ascorbic Acid 500mg GS Effervescent

Tablets

099/189 Cipla Limited, India

1450 Parafizz TabletsParacetamol 500mg GS Effervescent

Tablets

099/190 Cipla Limited, India

1451 Falcimon B/L TabletsArtesunate 50mg + Amodiaquine

153mg

POM Tablet Film

coated

099/191 Cipla Limited, India

1452 Abacavir Sulfate Oral SolutionAbacavir 20mg, per ml POM Solution for Oral

Use

099/192 Cipla Limited, India

1453 Lopimune TabletsLopinavir 200mg + Ritonavir

50mg

POM Tablet Film

coated

099/193 Cipla Limited, India

1454 Misoprost -25 Tablets Misoprostol 25mcg POM Tablet Uncoated 099/194 Cipla Limited, India

1455 Misoprost - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 099/195 Cipla Limited, India

1456 C - Fizz 1000 TabletsAscorbic Acid 1000mg GS Tablet

Dispersible

099/196 Cipla Limited, India

1457 Oflox-200 TabletsOfloxacin 200mg POM Tablet Film

coated

099/197 Cipla Limited, India

1458 Oflox -400 TabletsOfloxacin 400mg POM Tablet Film

coated

099/198 Cipla Limited, India

1459 Levofloxacin 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 099/199 Cipla Limited, India

1460 Levofloxacin 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 099/200 Cipla Limited, India

1461 Zoldria InjectionZoledronic Acid 4.0mg POM Solution for

Injection

099/201 Cipla Limited, India

1462Ethionamide Tablets USP 250mg

Ethionamide 250mg POM Tablet Enteric

Coated

099/202 Cipla Limited, India

1463 Glimcip - 1 Tablets Glimepiride 1mg POM Tablet Uncoated 099/203 Cipla Limited, India

1464 Glimcip-2 Tablets Glimepiride 2mg POM Tablet Uncoated 099/204 Cipla Limited, India

1465 Atorlip-20 Tablets Atorvastatin 20mg POM Tablet Uncoated 099/205 Cipla Limited, India

1466 Cresar - 40 Tablets Telmisartan 40mg POM Tablet Uncoated 099/206 Cipla Limited, India

1467 Cresar - 20 Tablets Telmisartan 20mg POM Tablet Uncoated 099/207 Cipla Limited, India

1468 Atorlip - 40 Tablets Atorvastatin 40mg POM Tablet Uncoated 099/208 Cipla Limited, India

1469 Atorlip- 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 099/209 Cipla Limited, India

1470 Minovit - P Tablets Multivitamins GS Tablet Uncoated 099/210 Cipla Limited, India

1471Rapid Relief Lozenges

Menthol 7.1mg + Peppermint

7.1mg

GS Lozenges 099/211 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1472 Abamune 60 TabletsAbacavir 60mg POM Tablet

Dispersible

099/212 Cipla Limited, India

1473Cof-Ryl Cough Syrup

Diphenhydramine 25mg P Solution for Oral

Use

099/213 Cipla Limited, India

1474Sinu Flu Tablets

Paracetamol 400mg +

Phenylephrine 5mg +

Mepyramine 8mg

P Tablet Uncoated 099/214 Cipla Limited, India

1475 Ciplin DS TabletsTrimethoprim 800mg +

Sulphamethoxazole 180mg

POM Tablet Uncoated 099/215 Cipla Limited, India

1476 Abamune-L Baby TabletsAbacavir 60mg + Lamivudine

30mg

POM Tablet Uncoated 099/216 Cipla Limited, India

1477Abacavir Sulphate & Lamivudine

Tablets 600/300mg

Abacavir Sulphate 600mg +

Lamivudine 300mg

POM Tablet Film

coated

099/217 Cipla Limited, India

1478 Duovir Baby TabletsLamivudine 30mg + Zidovudine

60mg

POM Tablet Film

coated

099/218 Cipla Limited, India

1479 PILL 72 Levonogestrel BP 0.75mg POM Tablet Uncoated 099/219 Cipla Limited, India

1480 I-Pill Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 099/220 Cipla Limited, India

1481 Montair-5 CW Tablets Montelukast Sodium BP 5mg POM Tablet Uncoated 099/221 Cipla Limited, India

1482 Praziquantel Tablets USP 600mg Praziquantel USP 600mg POM Tablets oral 099/222 Cipla Limited, India

1483 Seroflo 250 InhalerSalmeterol 25mcg + Fluticasone

250mcg

POM Solution for

Inhalation

099/223 Cipla Limited, India

1484 Paraffiz 1000 Effervescent TabletsParacetamol 1000mg POM Tablet

Effervescent

099/224 Cipla Limited, India

1485

Efavirenz, Lamivudine and Tenofovir

Disoproxil Fumarate Tablets

Efavirenz 600mg + Lamivudine

300mg + Tenofovir Disoproxil

Fumarate 300mg

POM Tablet Film

coated

099/225 Cipla Limited, India

1486Nasehaler Nasal Spray

Mometasone Furoate Nasal

Spray 50 mcg

POM Nasal spray 099/227 Cipla Limited, India

1487 Seroflo 125 InhalerSalmeterol 25mcg + Fluticasone

125mcg

POM Solution for

Inhalation

099/228 Cipla Limited, India

1488

Q-TIB Tablets

Sulfamethoxazole 800mg +

Trimethoprim 160mg + Isoniazid

300mg + Pyridoxine

Hydrochloride 25mg

POM Tablet Uncoated 099/228 Cipla Limited, India

1489

Lamivudine and Tenofovir Disoproxil

Fumarate Tablets 300/300 Mg

Lamivudine 300 mg and

Tenofovir Disoproxil Fumarate

Tablets 300mg

POM Tablet Film

coated

099/229 Cipla Limited, India

1490Nifelat Retard Tablet Nifedipine 20mg POM

Tablet Film

Coated099/230 Cipla Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1491Trioday Tablets

Efavirenz 600mg + Lamivudine

300mg + Tenofivir Disoproxyl

Fumurate 300mg

POM Tablet Film

coated

099/226 Cipla Quality Chemical Industries

Limited (Cipla QCIL)

1492 Anmol SyrupParacetamol 125mg, per 5ml GS Syrup 002/001 Ciron Drugs & Pharmaceuticals

Ltd, India

1493 Betnew Ear/Eye DropsBetamethasone 0.1% +

Neomycin 0.5% w/v

POM ear/eye Drops 002/002 Ciron Drugs & Pharmaceuticals

Ltd, India

1494 Chlorpheniramine TabletsChlorpheniramine Maleate 4mg P Tablet Uncoated 002/003 Ciron Drugs & Pharmaceuticals

Ltd, India

1495 Cirogan SyrupPromethazine Hydrochloride oral

solution 5mg, per 5ml

P solution 002/004 Ciron Drugs & Pharmaceuticals

Ltd, India

1496Cirovit Syrup

Multivitamins GS Syrup 002/005 Ciron Drugs & Pharmaceuticals

Ltd, India

1497

Cold Plus Syrup

Paracetamol BP 125mg +

Chlopheniramine Maleate BP

2.5mg + Phenylephirine HCL BP

2.5mg

P Syrup 002/006 Ciron Drugs & Pharmaceuticals

Ltd, India

1498Co-trimoxazole Paediatric Oral

Suspension

Sulfamethoxazole 200 mg +

Trimethoprime 40 mg

POM Suspension for

oral use

002/007 Ciron Drugs & Pharmaceuticals

Ltd, India

1499Dexamethasone Ear/Eye Drops

Dexamethasone Sodium

Phosphate Ophthalmic Solution

USP 0.1%w/v

POM Ear/Eye Drops 002/008 Ciron Drugs & Pharmaceuticals

Ltd, India

1500 Dextrose InjectionDextrose 50% USP POM Solution for

Injection

002/009 Ciron Drugs & Pharmaceuticals

Ltd, India

1501

Kofex Syrup

Menthol 0.55mg +

Diphenhydramine Hydrochloride

7mg + Ammonium Chloride

67.50mg + Sodium Citrate

28.50mg

P Syrup 002/010 Ciron Drugs & Pharmaceuticals

Ltd, India

1502 Kofex Cough TabletsMenthol + Eucalyptus + Liquorice

+ Anise oil + Metha oil

P Tablet Uncoated 002/011 Ciron Drugs & Pharmaceuticals

Ltd, India

1503

Kofmint Syrup

Peppermint oil BP 0.035ml +

Menthol BP5mg + Alcohol

2.4%w/v + Benzoic Acid BP

0.18%w/v

P Syrup 002/012 Ciron Drugs & Pharmaceuticals

Ltd, India

1504 Mebendazole Oral SuspensionMebendazole 100mg, per 5ml P Suspension for

Oral Use

002/013 Ciron Drugs & Pharmaceuticals

Ltd, India

1505Cirovin Nasal Drops 0.1%

Xylometazoline Hydrochloride

0.1%

P Nasal drops 002/014 Ciron Drugs & Pharmaceuticals

Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1506 Cirovin Nasal Drops 0.5%Xylometazoline Hydrochloride

0.5%

P Nasal drops 002/015 Ciron Drugs & Pharmaceuticals

Ltd, India

1507Chloramphenicol Eye Drops 0.5

Chloramphenicol 0.5w/v POM Eye Drops 002/016 Ciron Drugs & Pharmaceuticals

Ltd, India

1508 Chlorpheniramine TabletsChlopheniramine Maleate USP

4mg

POM Tablet Uncoated 002/017 Ciron Drugs & Pharmaceuticals

Ltd, India

1509 Ibuprofen TabletsIbuprofen BP 200mg P Tablet Film

coated

002/018 Ciron Drugs & Pharmaceuticals

Ltd, India

1510 Erythromycin Dry PowderErythromycin 125mg, per 5ml POM Powder for Oral

Suspension

002/019 Ciron Drugs & Pharmaceuticals

Ltd, India

1511 Propranolol TabletsPropranolol BP 40mg POM Tablet Uncoated 002/021MT Ciron Drugs & Pharmaceuticals

Ltd, India

1512 Hydralazine TabletsHydralazine Hydrochloride BP

25mg

POM Tablet Uncoated 002/022MT Ciron Drugs & Pharmaceuticals

Ltd, India

1513 Fluconazole CapsulesFluconazole 200mg POM Capsule oral 002/023 Ciron Drugs & Pharmaceuticals

Ltd, India

1514 Ket InjectionKetamine Hydrochloride IP

50mg, per ml

POM Solution for

Injection

002/024 Ciron Drugs & Pharmaceuticals

Ltd, India

1515Cirowax Ear Drops

Paradichlorobenzene 2%w/v P Solution for

Topical Use

002/025 Ciron Drugs & Pharmaceuticals

Ltd, India

1516 Amphotericin B 50mg/ Vial InjectionAmphotericin B 50mg POM Powder for

Injection

002/025MT Ciron Drugs & Pharmaceuticals

Ltd, India

1517 Metronidazole Oral SuspensionMetronidazole 250mg, per 5ml POM Suspension for

Oral Use

002/026 Ciron Drugs & Pharmaceuticals

Ltd, India

1518 Digoxin TabletsDigoxin 0.25mg POM Tablet Uncoated 002/026MT Ciron Drugs & Pharmaceuticals

Ltd, India

1519 Ciprofloxacin TabletsCiprofloxacin BP 250mg POM Tablet Uncoated 002/027MT Ciron Drugs & Pharmaceuticals

Ltd, India

1520 Peridol TabletsHaloperidol 5mg POM Tablet Uncoated 002/028 Ciron Drugs & Pharmaceuticals

Ltd, India

1521 Oparin InjectionHeparin Sodium BP 5000 IU, per

ml

POM Solution for

Injection

002/029MT Ciron Drugs & Pharmaceuticals

Ltd, India

1522 Hydrocortisone InjectionHydrocortisone Sodium

Succinate BP 100mg, per ml

POM Powder for

Injection

002/030MT Ciron Drugs & Pharmaceuticals

Ltd, India

1523 Flucanol InjectionFluconazole USP 2mg, per ml POM Solution for

Injection

194/002 Claris injectable Ltd, India

1524Propofol 1% Intravenous Injection

Propofol 10mg POM Solution for

Injection

194/003 Claris injectable Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1525 Ketajex IV InjectionKetamine BP 50mg, per ml POM Solution for

Injection

194/004 Claris injectable Ltd, India

1526Cefo Injection

Cefotaxime 1gm POM Powder for

Injection

194/005 Claris injectable Ltd, India

1527 Thiopental InjectionThiopental Sodium 1g POM Powder for

Injection

194/006 Claris injectable Ltd, India

1528 Bupican InjectionBupivacaine Hydrochloride BP

0.5w/v

POM Solution for

Injection

194/007 Claris injectable Ltd, India

1529 Curaxone InjectionCeftriaxone Sodium 1000mg POM Solution for

Injection

194/010 Claris injectable Ltd, India

1530 Dflam InjectionDiclofenac Sodium 25mg, per ml POM Solution for

Injection

194/012 Claris injectable Ltd, India

1531 Remetin InjectionMetoclopramide 5mg, per ml POM Solution for

Injection

194/014 Claris injectable Ltd, India

1532 Dopamine InjectionDopamine concentrate BP 40mg,

per ml

POM Solution for

Injection

194/008 Claris injectableLtd, India

1533 Hestar 200 Pestastarch InfusionHydroxyethyl Starch 6%w/v POM Solution for

Injection

194/001 Claris Otsuka Private Limited

1534Sensinil Injection

Lidocaine BP 21.3mg, per ml POM Solution for

Injection

194/011 Claris Otsuka Private Limited

1535 Protex Men Fresh Bar Soap Anti bacterial soap GSL Solid Soap 383/001L Colgate-Palmolive. RSA

1536 Protex Men Herbal 100 Bar SoapAnti bacterial soap with herbal

extracts

GSL Solid Soap 383/002L Colgate-Palmolive. RSA

1537 Protex Men Herbal 175g Bar SoapAnti bacterial soap with herbal

extracts

GSL Solid Soap 383/003L Colgate-Palmolive. RSA

1538 Protex Men Aloe Bar Soap Antibacterial soap with Aloe vera GSL Solid Soap 383/004L Colgate-Palmolive. RSA

1539 Protex Men Power Bar Soap Antibacterial soap GSL Solid Soap 383/005L Colgate-Palmolive. RSA

1540 Protex African Therapy Bar Soap Antibacterial soap GSL Solid Soap 383/006L Colgate-Palmolive. RSA

1541 Protex Deep Clean 100g Bar Soap Antibacterial soap GSL Solid Soap 383/007L Colgate-Palmolive. RSA

1542 Protex Men Sport Bar Soap Antibacterial soap GSL Solid Soap 383/008L Colgate-Palmolive. RSA

1543 Protex Men Energy Bar Soap Antibacterial soap GSL Solid Soap 383/009L Colgate-Palmolive. RSA

1544 Protex Men Propolis Bar Soap Antibacterial soap with Propolis GSL Solid Soap 383/010L Colgate-Palmolive. RSA

1545 Protex Men Classic Bar Soap Antibacterial soap GSL Solid Soap 383/011L Colgate-Palmolive. RSA

1546 Protex Deep Clean 175g Bar Soap Antibacterial soap GSL Solid Soap 383/012L Colgate-Palmolive. RSA

1547 Protex Fresh Shower Gel Antibacterial shower gel GSL Gel Topical 383/013L Colgate-Palmolive. RSA

1548Protex Vit E Shower Gel

Antibacterial shower gel with

Vitamin E

GSL Gel Topical 383/014L Colgate-Palmolive. RSA

1549Protex Men Sport Shower Gel

Antibacterial shower gel with

Vitamin E

GSL Gel Topical 383/015L Colgate-Palmolive. RSA

Page 75 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1550 Protex Fresh Men Energy Shower GelAntibacterial shower gel with

Vitamin E

GSL Gel Topical 383/016L Colgate-Palmolive. RSA

1551Ferrous Sulphate Tablets

Dried Ferrous Sulphate 200mg P Tablet Film

coated

201/001 Colorama Pharmaceuticals Ltd,

UK

1552 Loperamide TabletsLoperamide 2mg POM Tablet Uncoated 201/002 Colorama Pharmaceuticals Ltd,

UK

1553 Tetracycline Eye Ointment Tetracycline Hydrochloride

1%w/w

POM Ointment topical 201/003 Colorama Pharmaceuticals Ltd,

UK

1554 Tetracyline CapsulesTetracycline 1% POM Capsule oral 201/004 Colorama Pharmaceuticals Ltd,

UK

1555 Forzid TabletsMetformin 500mg + Gliclazide

80mg

POM Tablet Uncoated 201/005 Colorama Pharmaceuticals Ltd,

UK

1556 Pymint Oral SuspensionPyrantel Pamoate 25mg, per ml POM Suspension for

Oral Use

201/008 Colorama Pharmaceuticals Ltd,

UK

1557 Trolox TabletsMetronidazole 100mg +

Norfloxacin 200mg

POM Tablets Oral 201/009 Colorama Pharmaceuticals Ltd,

UK

1558

Tocure Skin Cream 15mg Tube

Tolnaftate 10mg +

Iodochlorhydroxyquinolone 10mg

+ Gentamycin 1mg +

Betamethasone 0.61mg

POM Topical cream 201/010 Colorama Pharmaceuticals Ltd,

UK

1559 Trolox SuspensionMetronidazole 100mg +

Norfloxacin 100mg, per 5ml

POM Suspension for

Oral Use

201/011 Colorama Pharmaceuticals Ltd,

UK

1560 Pymint TabletsPyrantel pamoate 125mg POM Tablets oral 201/012 Colorama Pharmaceuticals Ltd,

UK

1561 Odopa TabletsMethyldopa 250mg POM Tablet Uncoated 201/013 Colorama Pharmaceuticals Ltd,

UK

1562 Lopine TabletsAmlodipine 5mg + Atenolol 50mg POM Tablet Uncoated 201/014 Colorama Pharmaceuticals Ltd,

UK

1563Pymint Oral Suspension

Pyrantel pamoate 25mg, per ml P Suspension for

Oral Use

201/015 Colorama Pharmaceuticals Ltd,

UK

1564 Trolox TabletsMetronidazole 200mg +

Norfloxacin 200mg

POM Tablet Uncoated 201/016 Colorama Pharmaceuticals Ltd,

UK

1565Tocure Cream

Tolnaftate +

Iodochlorhydroxyquinolone +

Gentamycin + Betamethazone

POM Cream Topical 201/017 Colorama Pharmaceuticals Ltd,

UK

1566 Trolox SuspensionMetronidazole 100mg +

Norfloxacin 100mg, per 5ml

POM Suspension for

Oral Use

201/018 Colorama Pharmaceuticals Ltd,

UK

1567Pymint Tablets

Pyrantel Pamoate 125mg P Tablet Uncoated 201/019 Colorama Pharmaceuticals Ltd,

UK

Page 76 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1568 Hydrocortisone Acetate CreamHydrocortisone 1% POM Cream Topical 201/021 Colorama Pharmaceuticals Ltd,

UK

1569Canaderm-V6 Tablets

Clotrimazole BP 100mg POM Tablet Uncoated 201/023 Colorama Pharmaceuticals Ltd,

UK

1570 Onystin-V TabletsNystatin 100,000 IU POM Tablet Uncoated 201/024 Colorama Pharmaceuticals Ltd,

UK

1571 Cobet CreamBetamethasone Valearate BP

0.1%w/w

P Cream Topical 201/025 Colorama Pharmaceuticals Ltd,

UK

1572 Onapril TabletsEnalapril Maleate 20mg POM Tablet Uncoated 201/026 Colorama Pharmaceuticals Ltd,

UK

1573 Onapril TabletsEnalapril Maleate 5mg POM Tablet Uncoated 201/027 Colorama Pharmaceuticals Ltd,

UK

1574 Onapril TabletsEnalapril Maleate 10mg POM Tablet Uncoated 201/028 Colorama Pharmaceuticals Ltd,

UK

1575Recartix Capsules

Diacerein 50 mg + Glucosamine

750 mg + Methylsulfonylmethane

250 mg

P Capsule oral 263/001 Comed chemicals Ltd, India

1576 Caldob Capsules Calcium Dobesilate 500mg P Capsule oral 263/002 Comed chemicals Ltd, India

1577 Lyser D TabletsDiclofenac 50mg + Serrapeptase

10mg

POM Tablet Uncoated 263/003 Comed chemicals Ltd, India

1578Simvax 20 Tablets

Simvastatin 20mg POM Tablet Film

coated

263/004 Comed chemicals Ltd, India

1579 Simvax 10 TabletsSimvastatin 10mg POM Tablet Film

coated

263/005 Comed chemicals Ltd, India

1580 Ceso-40 Tablets Esomeprazole 40mg POM Tablet Uncoated 263/006 Comed chemicals Ltd, India

1581 Osex Capsules Hydroxyapatite P Capsule oral 263/007 Comed chemicals Ltd, India

1582 Recartix Forte TabletsGlucosamine 250mg +

Condroitin 200mg + Minerals

P Tablet Uncoated 263/008 Comed chemicals Ltd, India

1583 Proloc D Capsules Pantoprazole + Domperidone POM Capsule oral 263/009 Comed chemicals Ltd, India

1584Dolomed MR Tablets

Chlorzoxazone 250mg +

Paracetamol 325mg + Ibuprofen

400mg

P Tablet Uncoated 263/010 Comed chemicals Ltd, India

1585 Cornizole Denta GelMetronidazole Benzoate BP 1%

w/v

POM Gel Topical 379/001 Coral Laboratories Ltd

1586 Dermagaurd Cream Clotrimazole USP 1%w/w POM Cream Topical 379/002 Coral Laboratories Ltd

1587 Power Appetite Syrup Cyproheptidine 2mg, per 5ml P Syrup 379/003 Coral Laboratories Ltd

1588 Mylax-L Syrup Lactulose 10gm P Syrup 303/001 Corona Remedies Pvt Limited

1589Asera P Tablets

Aceclofenac 100mg +

Paracetamol 500mg

P Tablet Uncoated 303/002 Corona Remedies Pvt Limited

Page 77 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1590 Cetcor Tablets Cetirizine 10mg P Tablet Uncoated 303/003 Corona Remedies Pvt Limited

1591 Varinil 5 Tablets Amlodipine Besylate 5mg POM Tablet Uncoated 317/001 Cosmos Limited, Kenya

1592Avastatin-10 Tablets

Atorvastalin Calcium Trihydrate

10mg

POM Tablet Film

coated

317/002 Cosmos Limited, Kenya

1593 Avastatin-20 TabletsAtorvastalin Calcium Trihydrate

20mg

POM Tablet Uncoated 317/003 Cosmos Limited, Kenya

1594 Vidol Film Coated TabletsCarvedilol BP 6.25mg POM Tablet Film

coated

317/004 Cosmos Limited, Kenya

1595 Varinil 10 Tablets Amlodipine Besylate USP 10mg POM Tablet Uncoated 317/005 Cosmos Limited, Kenya

1596 Vidol 25 TabletsCarvedilol BP 25mg POM Tablet Film

coated

317/006 Cosmos Limited, Kenya

1597 Zithrox 500 Tablets Azithromycin 500mg POM Tablet Uncoated 317/007 Cosmos Limited, Kenya

1598 Celprotec 200 Mcg Misoprostol 200 mcg POM Tablet Uncoated 405/001 Cospharm Investments (Pty) Ltd

1599Softrim Tablets

Trimethoprim 25mg +

Sulfamethoxazole 500mg

POM Tablet Uncoated 180/001 Crown Exports, India

1600Quintex Tablets

Pyrimthamine 80mg +

Sulfadoxine 400mg

POM Tablet Uncoated 180/002 Crown Exports, India

1601 Crogyl 200 Tablets Metronidazole BP 200mg POM Tablet Uncoated 180/003 Crown Exports, India

1602 Paridol 500 Tablets Paracetamol BP 500mg P Tablet Uncoated 180/004 Crown Exports, India

1603 Amicare 250 Capsules Ampicillin Trihydrate 250mg POM Capsule oral 180/005 Crown Exports, India

1604 Cromin Tablets Chlorpheniramine Maleate 4mg P Tablet Uncoated 180/006 Crown Exports, India

1605 Ciprocrown 500 TabletsCiprofloxacin Hydrochloride

500mg

POM Tablet Uncoated 180/007 Crown Exports, India

1606 Ibusoft 200 Tablets Ibuprofen 200mg P Tablet Uncoated 180/008 Crown Exports, India

1607Claricid Tablets

Dried Aluminium Hydrochloride

120mg + Magnesium Trisilicate

250mg

P Tablet Uncoated 180/010 Crown Exports, India

1608 Vitacrown Syrup Multivitamin P Syrup 180/011 Crown Exports, India

1609 Becofit Tablets Vitamon B Complex P Tablet Uncoated 180/012 Crown Exports, India

1610 Erysoft Syrup Betamethasone 0.05%w/w POM Tablet Uncoated 180/013 Crown Exports, India

1611

Cofdry Syrup

Diphenhydramine Hydrochloride

14mg + Ammonium Chloride

138mg + Sodium Citrate

57.03mg + Menthol 1.14mg/5ml

P Syrup 180/014 Crown Exports, India

1612 Amoxicillin SuspensionAmoxicillin 125mg, per 5ml POM Suspension for

Oral Use

079/001 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1613Cefotaxime Injection

Cefotaxime 1.0g POM Powder for

Injection

079/002 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

Page 78 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1614 Diclofenac InjectionDiclofenac Sodium 75mg, per

5ml

POM Solution for

Injection

079/003 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1615Doxycycline Tablets

Doxycycline 100mg POM Tablet Uncoated 079/004 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1616 Magnesium Sulphate InjectionMagnesium Sulphate 50%, per

10ml

POM Solution for

Injection

079/005 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1617 Promethazine InjectionPromethazine 50mg, per 2ml POM Solution for

Injection

079/006 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1618 Benzylpenicillin InjectionBenzyl Penicillin 5000000 IU POM Powder for

Injection

079/007 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1619 Ciprofloxacin TabletsCiprofloxacin 250mg POM Tablet Uncoated 079/008 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1620 Acyclovir TabletsAcyclovir 200mg POM Tablet Uncoated 079/009 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1621 Oxytocin InjectionOxytocin 10 IU, per 10ml POM Solution for

Injection

079/010 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1622 Procaine Benzyl Penicillin InjectionProcaine Benzyl Penicillin

3000000 IU

POM Powder for

Injection

079/011 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1623Atenolol Tablets

Atenolol 50mg POM Tablet Uncoated 079/012 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1624 Aminophylline InjectionAminophylline 200mg, per 10ml POM Solution for

Injection

079/013 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1625 Penicillin G Benzathine InjectionPenicillin G Benzathine

2.4000000 IU

POM Powder for

Injection

079/014 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1626Dexamethasone Sodium Phosphate

Injection

Dexamethasone 8mg, per 2ml POM Solution for

Injection

079/015 CSPC Ouyi Pharmaceuticals Co.

Ltd, China

1627 Artesian 20 Injection Artemether 20mg, per ml POM solution for

injection

151/001 Dafra Pharma GmbH, Switzerland

1628 Artesiane Suppositories Artemether 40 mg POM Suppository 151/002 Dafra Pharma GmbH, Switzerland

1629 Artesiane Oral Suspension Artemether 300mg, per 100ml POM Suspension 151/003 Dafra Pharma GmbH, Switzerland

1630Co-Artesian® Powder for Oral

Suspension 60ml

Artemether 180mg, per 60ml +

Lumefantrine 1080mg, per 60ml

POM Powder for

Suspension oral

151/006 Dafra Pharma GmbH, Switzerland

1631Co-Artesian® Powder for Oral

Suspension 120ml

Artemether 360mg, per 120ml +

Lumefantrine 2160mg, per 120ml

POM Powder for

Suspension oral

151/006 Dafra Pharma GmbH, Switzerland

1632 Co-Arinate 100 TabletsArtesunate + Pyrimethamine +

Sulfamethoxypyrazine

POM Tablet Uncoated 151/008 Dafra Pharma GmbH, Switzerland

1633 Arinate 50 Tablets Artesuate 50mg POM Tablet Uncoated 151/009 Dafra Pharma GmbH, Switzerland

1634 Arinate 100 Tablets Artesuate 100mg POM Tablet Uncoated 151/010 Dafra Pharma GmbH, Switzerland

1635 Artesiane 80 Injection Artemether 80mg, per ml POM Tablet 151/011 Dafra Pharma GmbH, Switzerland

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1636 Dafra Vit PowderMultivitamin P Powder for Oral

Use

151/012 Dafra Pharma GmbH, Switzerland

1637 Aneaban Capsules Bacillus Subtilis PB6 complex POM Capsule oral 151/015 Dafra Pharma GmbH, Switzerland

1638 Amonate FDC Junior Tablets Amodiaquine + Artesunate POM Tablet Uncoated 151/016 Dafra Pharma GmbH, Switzerland

1639 Fortaline® (Omega-3) Capsules OMega 3 oils POM Syrup 151/018 Dafra Pharma GmbH, Switzerland

1640 Pico Stick Insect RepellentDiethyl-M-Toluamide 10% + P-

Methane-3,8-diol 10%

GS Solution for

Topical Use

151/019 Dafra Pharma GmbH, Switzerland

1641 Artesian 100 Injection Artemether 100mg, per ml POM injection 151/020 Dafra Pharma GmbH, Switzerland

1642 Parol Syrup Paracetamol 250mg GS Syrup 151/021 Dafra Pharma GmbH, Switzerland

1643 Parol Tablets Paracetamol 500mg GS Tablet Uncoated 151/022 Dafra Pharma GmbH, Switzerland

1644 Cipronat 250mg Tablets Ciprofloxacin 250mg POM Tablet Uncoated 151/023 Dafra Pharma GmbH, Switzerland

1645 Cipronat 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 151/024 Dafra Pharma GmbH, Switzerland

1646 Cipronat 700 Tablets Ciprofloxacin 700mg POM Tablet Uncoated 151/025 Dafra Pharma GmbH, Switzerland

1647 Dafraclav 228 TabletsAmoxicillin 200mg + Clavulanic

Acid 28mg

POM Tablet Uncoated 151/026 Dafra Pharma GmbH, Switzerland

1648 Dafraclav SuspensionAmoxicillin 400mg + Clavulanic

Acid 57mg

POM Suspension for

Oral Use

151/027 Dafra Pharma GmbH, Switzerland

1649Dafraclav 625 Tablets

Amoxicillin 500mg + Clavulanic

Acid 125mg

POM Tablet Uncoated 151/028 Dafra Pharma GmbH, Switzerland

1650 Dafraclav 1000 TabletsAmoxicillin 875mg + Clavulanic

Acid 125mg

POM Tablet Uncoated 151/029 Dafra Pharma GmbH, Switzerland

1651 Pedifen Tablets Ibuprofen 400mg P Tablet Uncoated 151/030 Dafra Pharma GmbH, Switzerland

1652 Amifer Iron Syrup Iron 40mg, per ml P Syrup 151/031 Dafra Pharma GmbH, Switzerland

1653Artesiane 40 Injection

Artemether 40mg, per ml POM Solution for

Injection

151/032 Dafra Pharma GmbH, Switzerland

1654 Pico Roll-On Insect RepellantDiethyl-M-Toluamide 20% GS Solution for

Topical Use

151/034 Dafra Pharma GmbH, Switzerland

1655 Pico SprayDiethy-M-Toluamide 50% GS Solution for

Topical Use

151/035 Dafra Pharma GmbH, Switzerland

1656Co-Arinate® Junior

Artesunate 100 mg +

Sulfamethoxypyrazine 250 mg +

Pyrimethamine 12.5 mg

POM Tablet Uncoated 151/121 Dafra Pharma GmbH, Switzerland

1657Co-Arinate® Adult

Artesunate 200 mg +

Sulfamethoxypyrazine 500 mg +

Pyrimethamine 25 mg

POM Tablet Uncoated 151/122 Dafra Pharma GmbH, Switzerland

1658 Loratan 10 Tablets Loratadine 10mg P Tablet Uncoated 322/001 Dar Al Dawa Pharmaceuticals

1659 Aphrodil - 50 Tablets Sildenafil Citrate I.H 50mg POM Tablet Uncoated 322/002 Dar Al Dawa Pharmaceuticals

1660 Clomifert Tablets Clomiphene Citrate BP 50mg POM Tablet Uncoated 322/003 Dar Al Dawa Pharmaceuticals

1661 Risdone 1mg Tablet Risperidone USP 1mg POM Tablet Uncoated 322/004 Dar Al Dawa Pharmaceuticals

Page 80 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1662 Risdone 2mg Tablets Risperidone USP 2mg POM Tablet Uncoated 322/005 Dar Al Dawa Pharmaceuticals

1663 Diapride 2mg Tablets Glimepiride 2mg POM Tablet Uncoated 322/006 Dar Al Dawa Pharmaceuticals

1664Dad Teething Gel

Lignocaine Hydrochloride 3.3mg

+ Cetylpridinium Chloride 1.0mg

P Gel Oral 322/007 Dar Al Dawa Pharmaceuticals

1665 Proctoheal New OintmentLidocaine BP 20mg +

Fluocinolone 0.1mg

P Ointment rectal 322/008 Dar Al Dawa Pharmaceuticals

1666 Mycoheal Oral Gel Miconazole Nitrate 40g POM Gel Oral 322/009 Dar Al Dawa Pharmaceuticals

1667 Loratan Syrup Loratadine 5mg, per 5ml P Syrup 322/010 Dar Al Dawa Pharmaceuticals

1668 Paracetamol 500 TabletsParacetamol 500mg GS Tablet Uncoated 055/002 Dawa Phamaceuticals Limited,

Kenya

1669 Multivitamin TabletsMultivitamins GS Tablet Uncoated 055/003 Dawa Phamaceuticals Limited,

Kenya

1670 Eflaron 200 TabletsMetronidazole 200mg POM Tablet Uncoated 055/004 Dawa Phamaceuticals Limited,

Kenya

1671 Eflaron 0.5 Infusion Metronidazole 0.5%w/v POM Solution for

infusion

055/006 Dawa Phamaceuticals Limited,

Kenya

1672 Penicillin V TabletsPhenoxymethyl Penicillin 250mg POM Tablets oral 055/007 Dawa Phamaceuticals Limited,

Kenya

1673 Fidemycin CapsulesTetracycline 250mg POM Capsule oral 055/010 Dawa Phamaceuticals Limited,

Kenya

1674Dawacin Injection

Kanamycin 1gm POM Powder for

Injection

055/011 Dawa Phamaceuticals Limited,

Kenya

1675 Hycin TabletsHyoscine ButylBromide 10mg P Tablet Uncoated 055/012 Dawa Phamaceuticals Limited,

Kenya

1676Dawagenta Injection

Gentamycin 80mg, per 2ml POM Solution for

Injection

055/013 Dawa Phamaceuticals Limited,

Kenya

1677 Cindomet CapsulesIndomethacin 25mg P Capsule oral 055/014 Dawa Phamaceuticals Limited,

Kenya

1678 Dawasprin TabletsAcetyl Salicylic Acid 300mg P Tablet Uncoated 055/015 Dawa Phamaceuticals Limited,

Kenya

1679 Amidiostat PowderAmprolium Sulphate 100g POM Powder for Oral

Solution

055/017 Dawa Phamaceuticals Limited,

Kenya

1680 Aphaquine SuspensionAmodiaquine 65.30mg POM Suspension for

Oral Use

055/018 Dawa Phamaceuticals Limited,

Kenya

1681 Fanlar TabletsSulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 055/019 Dawa Phamaceuticals Limited,

Kenya

1682Dawanol Tablets

Aspirin + Paracetamol + Caffeine GS Tablet Uncoated 055/020 Dawa Phamaceuticals Limited,

Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1683 Curamol Plus CapletsParacetamol + Caffeine GS Caplets oral

Uncoated

055/021 Dawa Phamaceuticals Limited,

Kenya

1684Dawacort Injection

Hydrocortisone 100mg POM Powder for

Injection

055/022 Dawa Phamaceuticals Limited,

Kenya

1685 Vitamin B TabletsB Complex 12mg P Tablet Uncoated 055/023 Dawa Phamaceuticals Limited,

Kenya

1686 Dablin TabletsSalbutamol 4mg POM Tablet Uncoated 055/024 Dawa Phamaceuticals Limited,

Kenya

1687 Dawastin SuspensionNystatin 100,000iu POM Suspension for

Oral Use

055/025 Dawa Phamaceuticals Limited,

Kenya

1688 Dawaphenicol InjectionChloramphenicol 1g POM Powder for

Injection

055/026 Dawa Phamaceuticals Limited,

Kenya

1689 Dawa-CPM TabletsChlorpheniramine 4mg P Tablet Film

coated

055/027 Dawa Phamaceuticals Limited,

Kenya

1690 Dawa Ascorbic Acid TabletsAscorbic Acid 100mg GS Tablet Uncoated 055/028 Dawa Phamaceuticals Limited,

Kenya

1691 Rinacet SyrupCetirizine 5mg P Syrup 055/029 Dawa Phamaceuticals Limited,

Kenya

1692Stopacid Chewable Tablets

Aluminium Hydroxide 120mg +

Magnesium Trisilicate 250mg +

Peppermint 0.003ml

POM Tablet Chewable 055/030 Dawa Phamaceuticals Limited,

Kenya

1693 Dermazine CreamSilver Sulphadiazine 1%w/w P Cream Topical 055/031 Dawa Phamaceuticals Limited,

Kenya

1694 Ibupar SuspensionIbuprofen 100mg + Paracetamol

120mg

P Suspension for

Oral Use

055/032 Dawa Phamaceuticals Limited,

Kenya

1695

Fast Act Gel

Diclofenac Diethyl Amine

1.16%w/w + Methyl Salicylate

10% w/w + Menthol 5% w/w +

Linseed Oil 3% w/w

P Gel Topical 055/033 Dawa Phamaceuticals Limited,

Kenya

1696 Topquine MixtureQuinine dihydrochloride 50mg,

per 5ml

POM Suspension for

Oral Use

055/034 Dawa Phamaceuticals Limited,

Kenya

1697

Dacough Mucolytic Syrup

Salbutamol 2mg + Bromohexine

Hydrochloride 4mg +

Guaiphenesin 100mg + Menthol

1mg

P Syrup 055/035 Dawa Phamaceuticals Limited,

Kenya

1698Dacold Syrup

Paracetamol 120mg +

Chlopheniramine 2mg +

Psuedoephedrine 10mg

P Syrup 055/036 Dawa Phamaceuticals Limited,

Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1699Dacold Capsules

Paracetamol 400mg + Cafeine

30mg + Psuedoephedrine 30mg

+ Chlorpheniramine 4mg

P Capsule oral 055/037 Dawa Phamaceuticals Limited,

Kenya

1700 Dawavite SyrupVitamin A 1500 IU + Thiamine

0.5mg + Riboflavin 0.5mg

GS Syrup 055/038 Dawa Phamaceuticals Limited,

Kenya

1701 Dazole B CreamClotrimazole 1.0%w/w +

Betamethasone 0.1%w/w

POM Cream Topical 055/039 Dawa Phamaceuticals Limited,

Kenya

1702 DAWADUR 2.4 InjectionBenzathine BenzylPenicillin 2.4

Mega

POM Powder for

Injection

055/040 Dawa Phamaceuticals Limited,

Kenya

1703 Penicillin G Sodium 5 InjectionBenzyl Penicillin Sodium BP

5Mega Units

POM Powder for

Injection

055/041 Dawa Phamaceuticals Limited,

Kenya

1704Procaine Penicillin Fortified Injection

Procaine Benzyl Penicillin BP 4

Mega Units

POM Powder for

Injection

055/042 Dawa Phamaceuticals Limited,

Kenya

1705 Dawadoxyn CapsulesDoxycycline Hydrochloride BP

100mg

POM Capsule oral 055/043 Dawa Phamaceuticals Limited,

Kenya

1706Miclocin Cream

Miconazole Nitrate 2.0%w/w +

Clobetasol 0.5%w/w +

Gentamicin 0.1%w/w

POM Cream Topical 055/044 Dawa Phamaceuticals Limited,

Kenya

1707 Topquine TabletsQuinine Sulphate 300mg POM Tablet Film

coated

055/045 Dawa Phamaceuticals Limited,

Kenya

1708 Curamol Suspension Paracetamol BP 100mg, per 5ml GS Suspension for

Oral Use

055/046 Dawa Phamaceuticals Limited,

Kenya

1709Acepar Caplets

Paracetamol BP 500mg +

Aceclofenac BP 100mg

GS Caplets oral

Uncoated

055/047 Dawa Phamaceuticals Limited,

Kenya

1710Dawalyte Oral Rehydration Salt

Sodium Chloride BP + Potassium

Chloride BP + TriSodium Citrate

BP

GS Powder for Oral

Solution

055/048 Dawa Phamaceuticals Limited,

Kenya

1711

ALLERDROP EYE DROPS

Boric Acid 1.25% + Sodium

Chloride 0.05% + Zinc Sulphate

0.12% + Chlorpheniramine

Maleate 0.01% + Naphazoline

Hydrochloride 0.056% +

Chlorbutol 0.35%

POM Solution for

Topical Use

362/001 DCI Pharmaceuticals Limited

1712 Cynocob Forte InjectionCyanocobalamine 1000mcg POM Solution for

Injection

362/002 DCI Pharmaceuticals Limited

1713 Diciran InjectionRanitidine Hydrochloride 25mg,

per ml

POM Solution for

Injection

362/003 DCI Pharmaceuticals Limited

1714 Dicimycin Eye Drops Chloraphenicol POM Ear Drops 362/004 DCI Pharmaceuticals Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1715Betnor Eye/Ear Drop

Betamethasone Soduim

Phosphate BP + Neomycin

Sulphate BP

POM Solution for

Topical Use

362/005 DCI Pharmaceuticals Limited

1716 Dicinac Eye Drop Diclofenac BP POM Eye Drops 362/006 DCI Pharmaceuticals Limited

1717B-Plus Injection

Vitamin B Complex POM Solution for

Injection

362/007 DCI Pharmaceuticals Limited

1718 Optob Eye DropsTobramycin USP POM Solution for

Topical Use

362/008 DCI Pharmaceuticals Limited

1719

Deltavit Syrup Appetite Stimulant And

General Tonic

Cyproheptadine Hydrochloride

2mg + Thiamine Hydrochloride

1.2mg + Riboflavin (as 5-

phosphate) 1.2mg + Pyridoxine

Hydrochloride 1.2mg +

Nicotinamide 1.2mg

P Solution for Oral

Use

067/001 Deltapharm, Egypt

1720 Kids Vitamin Syrup Multivitamins GS Syrup 067/002 Deltapharm, Egypt

1721 Dolphin 12.5 Suppository Diclofenac Sodium 12.5mg POM Suppository 067/003 Deltapharm, Egypt

1722 Dolphin 25 Suppository Diclofenac Sodium 25mg POM Suppository 067/004 Deltapharm, Egypt

1723 Dolphin 75 Suppository Diclofenac Sodium 75mg POM Suppository 067/005 Deltapharm, Egypt

1724 Nifedi-Denk 10 Retard TabletsNifedipine 10mg POM Tablet Enteric

Coated

130/001 Denk Pharma, Germany

1725 Nifedi-Denk 20 Retard TabletsNifedipine 20mg POM Tablet Enteric

Coated

130/002 Denk Pharma, Germany

1726 Diclo-Denk 25 TabletsDiclofenac 25mg P Tablet Enteric

Coated

130/003 Denk Pharma, Germany

1727 Diclo-Denk 50 TabletsDiclofenac 50mg P Tablet Film

coated

130/004 Denk Pharma, Germany

1728 Diclo-Denk 100 Retard TabletsDiclofenac 100mg P Tablet Enteric

Coated

130/005 Denk Pharma, Germany

1729Diclo-Denk 75mg Injection

Diclofenac 75mg, per 3ml POM Solution for

Injection

130/006 Denk Pharma, Germany

1730 Diclo-Denk 100 Suppositories Diclofenac Sodium 100mg P Suppository 130/007 Denk Pharma, Germany

1731 Rani-Denk 150 TabletsRanitidine Hydrochloride 150mg POM Tablet Film

coated

130/008 Denk Pharma, Germany

1732 Rani-Denk 300 TabletsRanitidine Hydrochloride 300mg POM Tablet Film

coated

130/009 Denk Pharma, Germany

1733 Acyclovir-Denk 200 Tablets Acyclovir 200mg POM Tablet Uncoated 130/010 Denk Pharma, Germany

1734 Acyclovir Denk Cream Acyclovir 5%w/w POM Cream Topical 130/011 Denk Pharma, Germany

1735 Clotri-Denk 100 Vaginal Tablets Clotrimazole 100mg POM Tablet Vaginal 130/012 Denk Pharma, Germany

1736 Clotri-Denk 1% Cream Clotrimazole 1% POM Cream Topical 130/013 Denk Pharma, Germany

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1737 Loperamide Denk TabletsLoperamide Hydrochloride 2mg POM Tablet Enteric

Coated

130/014 Denk Pharma, Germany

1738Metformin-Denk 500 Tablets

Metformin 500mg POM Tablet Film

coated

130/015 Denk Pharma, Germany

1739 Dolo-Denk Gel Etofenamate 100mg, per g P Gel Topical 130/016 Denk Pharma, Germany

1740 Para-Denk 125mg Suppositories Paracetamol 125mg P Suppository 130/019 Denk Pharma, Germany

1741 Para-Denk 250mg Suppositories Paracetamol 250mg P Suppository 130/020 Denk Pharma, Germany

1742 Atenolol Denk Tablets Atenolol 50mg POM Tablet Uncoated 130/021 Denk Pharma, Germany

1743 Paradenk 4% SyrupParacetaoml syrup 4mg, per

100mg

P Syrup 130/022 Denk Pharma, Germany

1744 Para-Denk 500 Tablets Paracetamol 500mg P Tablet Uncoated 130/023 Denk Pharma, Germany

1745 Captopril/Hydrochlorothiazide TabletsHydrochlorothiazide 50mg +

Captopril 25mg

POM Tablet Uncoated 130/024 Denk Pharma, Germany

1746 Furodenk 40 Tablets Frusemide 40mg POM Tablet Uncoated 130/025 Denk Pharma, Germany

1747 Vera-Denk 240 Retard Tablets Verapamil 240mg POM Tablet Uncoated 130/026 Denk Pharma, Germany

1748 Famotidine Denk TabletsFamotidine 40mg POM Tablet Film

coated

130/027 Denk Pharma, Germany

1749 Amoxi-Denk 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 130/028 Denk Pharma, Germany

1750 Cipro-Denk TabletsCiprofloxacin 500mg POM Tablet Film

coated

130/029 Denk Pharma, Germany

1751 Ibuprofen Denk 400 Tablets Ibuprofen 400mg P Tablets oral 130/030 Denk Pharma, Germany

1752Asunate Denk 100 Plus Tablets

Pyrimethamine 12.5mg +

Sulphamethoxypyrazine 250mg +

Artesuate 100mg

POM Tablet Uncoated 130/032 Denk Pharma, Germany

1753 Asunate Denk 200 Tablets Artesunate 200mg POM Tablet Uncoated 130/033 Denk Pharma, Germany

1754 Vit-B-Denk TabletsPyridoxine 200mg + Thiamine

100mg

POM Tablet Uncoated 130/034 Denk Pharma, Germany

1755 Armether Denk 180 SuspensionBeta Artemether 180mg , per

100ml

POM Suspension for

Oral Use

130/035 Denk Pharma, Germany

1756 Simva-Denk 40mg Tablets Simvastatin 40mg POM Tablet Uncoated 130/039 Denk Pharma, Germany

1757 Simva-Denk 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 130/040 Denk Pharma, Germany

1758 Amilo-Denk 5mg Tablets Amlodipine 5mg POM Tablet Uncoated 130/041 Denk Pharma, Germany

1759 Amilo-Denk 10mg Tablets Amlodipine 10mg POM Tablet Uncoated 130/042 Denk Pharma, Germany

1760 Ena-Denk 10mg Tablets Enalapril 10mg POM Tablet Uncoated 130/043 Denk Pharma, Germany

1761 Ena-Denk 20mg Tablets Enalapril 20mg POM Tablet Uncoated 130/044 Denk Pharma, Germany

1762 Toras-Denk 5mg Tablets Torasemide 5mg POM Tablet Uncoated 130/046 Denk Pharma, Germany

1763 Toras Denk 10 Tablets Torasemide 10mg POM Tablet Uncoated 130/047 Denk Pharma, Germany

1764 Amether-Denk Suppocap Artemether 40mg POM Suppository 130/048 Denk Pharma, Germany

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1765 Paraco-Denk 500/30mg TabletsParacetamol 500mg + Codeine

30mg

P Tablet Uncoated 130/049 Denk Pharma, Germany

1766Paraco-Denk1000/60mg Tablets

Paracetamol 1000mg + Codeine

60mg

P Suppository 130/050 Denk Pharma, Germany

1767Asu -Denk Fixed Dose Tablets

Artesunate 200mg +

Sulfamethoxypyrazine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 130/052 Denk Pharma, Germany

1768 Losar Denk 50 TabletsLosartan 50mg POM Tablet Enteric

Coated

130/053 Denk Pharma, Germany

1769 Losar - Denk 100 TabletsLosartan 100mg POM Tablet Enteric

Coated

130/054 Denk Pharma, Germany

1770Colosar -Denk 50/12.5mg Tablets

Lorsartan 50mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 130/055 Denk Pharma, Germany

1771 Metformin Denk 1000 Tablets Merformin 1000mg POM Tablet Uncoated 130/056 Denk Pharma, Germany

1772 Glimepride Denk Tablets Glimepiride 2mg POM Tablet Uncoated 130/058 Denk Pharma, Germany

1773 Flucona-Denk 100 Capsules Fluconazole 100mg POM Capsule oral 130/060 Denk Pharma, Germany

1774 Flucona -Denk 150 Capsules Fluconazole 150mg POM Capsule oral 130/061 Denk Pharma, Germany

1775Amoxicalv -Denk 500/62.5 Tablets

Amoxicillin Trihydrate 500mg +

Clavulanic Acid 62.5mg

POM Tablet Uncoated 130/062 Denk Pharma, Germany

1776 Tramadol Denk 50 Tablets Tramadol Hydrochloride 50mg P Tablet Uncoated 130/063 Denk Pharma, Germany

1777 Zolendro - Denk InjectionZoledronic Acid anhydrous BP

4mg, per 5ml

POM Solution for

Injection

130/064 Denk Pharma, Germany

1778Grani - Denk Inject

Granisetron Hydrochloride USP

1mg, per ml

POM Solution for

infusion

130/065 Denk Pharma, Germany

1779 Clopi-Denk 75 Tablets Clopidogrel 75mg POM Tablet Uncoated 130/066 Denk Pharma, Germany

1780 Ibuprofen Denk 600mg TabletsIbuprofen 600mg POM Tablet Film

coated

130/067 Denk Pharma, Germany

1781Colosar - Denk100/12.5 Tablets

Lorsartan Potassium Eur.Ph

100mg + Hydrochlorothiazide

Eur.Ph 12.5mg

POM Tablet Uncoated 130/068 Denk Pharma, Germany

1782 Anastrazole Denk 1 Tablets Anastrozole 1mg POM Tablet Uncoated 130/069 Denk Pharma, Germany

1783 Losar-Denk 25 Tablets Lorsatan Potassium 25mg POM Tablet Uncoated 130/070 Denk Pharma, Germany

1784Levo- Denk 500 Tablets

Levofloxacin Hemihydrate 500mg POM Tablet Uncoated 130/071 Denk Pharma, Germany

1785 Panto-Denk 40 Tablets Pantoprazole Sodium BP 40mg POM Tablet Uncoated 130/072 Denk Pharma, Germany

1786 Panto-Denk 20 Tablets Pantoprazole Sodium BP 40mg POM Tablet Uncoated 130/073 Denk Pharma, Germany

1787Levo Denk -250 Tablets

Levofloxacin Hemihydrate 250mg POM Tablet Uncoated 130/074 Denk Pharma, Germany

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1788 Amoxiclav-Denk 1000/125 TabletsAmoxicillin 1000mg+ Clavulanic

Acid 125mg

POM Tablet Uncoated 130/075 Denk Pharma, Germany

1789Valsar-Denk 320 Tablets

Valsartan 320mg POM Tablet Film

coated

130/076 Denk Pharma, Germany

1790 Valsr- Denk 80 TabletsValsartan 80mg POM Tablet Film

coated

130/077 Denk Pharma, Germany

1791 Magnes Active PowderMagnesium 300 mg P Powder for Oral

Solution

130/078 Denk Pharma, Germany

1792 Calcium Active Denk TabletsCalcium 500 mg P Tablet,

Effervescent

130/079 Denk Pharma, Germany

1793Fertilio Denk Tablets

Selenium, Zinc, Folic Acid,

Vitamin E, L-arginine, L-carnitine

and Coenzyme Q10

P Powder for Oral

Solution

130/080 Denk Pharma, Germany

1794 Ferro Vital+Denk CWIron 15 mg + Folic Acid 400 µg +

Vitamin C 30mg

P Tablet Uncoated 130/081 Denk Pharma, Germany

1795Magnes Direct Denk Sachets

Magnesium Hydroxide 400mg P Powder for Oral

Solution

130/083 Denk Pharma, Germany

1796 Prenatal Denk Folic Acid 800 µg, all B-vitamins

and Iodine 150 µg

P Tablet Uncoated 130/084 Denk Pharma, Germany

1797 Valsar-Denk 160 Tablets Valsartan 160mg POM Tablet Uncoated 130/085 Denk Pharma, Germany

1798 Valsar- Denk 40 Tablets Valsartan 40mg POM Tablet Uncoated 130/086 Denk Pharma, Germany

1799 Covalsar-DenkValsartan 320mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 130/087 Denk Pharma, Germany

1800Covalsar-Denk

Valsartan 160mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 130/088 Denk Pharma, Germany

1801 Metformin Denk 850 Tablets Metformin 850mg POM Tablets oral 130/131 Denk Pharma, Germany

1802 Mycoten® Cream Clotrimazole BP 1% 20g P topical cream 399/002 Drug International Limited

1803Biocoten® Cream

Gentamycin BP 1.0mg +

Dexamethasone BP 0.4mg +

Chlotrimazole BP 10.0mg

POM topical cream 399/001 Drugfield Pharmaceuticals Ltd

1804 Neurogesic® Greaseless Ointment Methylsalicylate BP 15% +

Menthol BP 5%

GS topical ointment 399/003 Drugfield Pharmaceuticals Ltd

1805 Chlorxy-G Gel Chlorhexidine Digluconate 7.1% GS topical gel 399/004 Drugfield Pharmaceuticals Ltd

1806 Goat's Milk TabletsGoat Milk 250mg P Tablet Uncoated 031/001L Dynapharm International (Zambia)

Limited

1807Di Sprulina Tablets

Sprulina 300mg P Tablet Uncoated 031/002L Dynapharm International (Zambia)

Limited

1808Yeeginkgo Tablets

Ginkgoo Biloba Extract 40mg P Tablet Uncoated 031/003L Dynapharm International (Zambia)

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1809 Tongkat Ali TabletsTongkat Ali Extract 100mg P Capsule oral 031/004L Dynapharm International (Zambia)

Limited

1810Di Liquid Chlorophyll Plus Guarana

Solution

Herbal Extracts P Solution for Oral

Use

031/005L Dynapharm International (Zambia)

Limited

1811 Dyna Tonic SyrupHerbal Extracts P Syrup 031/006L Dynapharm International (Zambia)

Limited

1812 Bee Pollen CapsuleBee Pollen 450mg P Capsule oral 031/007L Dynapharm International (Zambia)

Limited

1813 Dyna Rh CapsulesD-glucosamine 250mg P Capsule oral 031/008L Dynapharm International (Zambia)

Limited

1814 Ginseng CapsulesGinseng Powder 300mg P Capsule oral 031/009L Dynapharm International (Zambia)

Limited

1815 Yeegarlic CapsulesGarlic 160mg P Capsule oral 031/010L Dynapharm International (Zambia)

Limited

1816 Yeeyangyen TabletsGrape Seed Dry Extract 50mg P Tablet Uncoated 031/011L Dynapharm International (Zambia)

Limited

1817 Dyna C 250 TabletsAscobic Acid 250mg P Tablet Uncoated 031/012L Dynapharm International (Zambia)

Limited

1818Mancare Plus Capsules

Herbal Extracts P Capsule oral 031/013L Dynapharm International (Zambia)

Limited

1819

Daily-Vite Multivitamin Syrup

Vit A 2000IU + Vit D 400IU + Vit

B2 1.5mg + Vit B6 1.0mg + Vit

B12 3.0mcg + Niacinamide 10mg

+ Vit C 50mg + L-37.5mg

P Syrup 031/014 Dynapharm International (Zambia)

Limited

1820 Herba Warisani MaharaniHerbal Preparation P Tablet Film

coated

031/014L Dynapharm International (Zambia)

Limited

1821 Dyanil TabletsGlibenclamide 5mg POM Tablet Uncoated 031/015 Dynapharm International (Zambia)

Limited

1822Dyna Calcium Tablets

Calcium Lactate 39mg P Tablet Uncoated 031/016 Dynapharm International (Zambia)

Limited

1823 Metformin TabletsMetformin 500mg POM Tablet Uncoated 031/017 Dynapharm International (Zambia)

Limited

1824Milk Thistle Tablets

Silybum marianum 100mg P Tablet Uncoated 031/018L Dynapharm International (Zambia)

Limited

1825 Amoxicillin Capsules 250mgAmoxicillin 250mg POM Capsule oral 031/019 Dynapharm International (Zambia)

Limited

1826Amoxicillin Capsules 500mg

Amoxicillin 500mg POM Capsule oral 031/020 Dynapharm International (Zambia)

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1827 Cloxacillin Capsules 250mgCloxacillin 250mg POM Capsule oral 031/021 Dynapharm International (Zambia)

Limited

1828Dynafucin 500 Tablet

Griseofulvin 500mg POM Tablet Uncoated 031/022 Dynapharm International (Zambia)

Limited

1829 Doxycycline Capsule 100mgDoxycycline 100mg POM Capsule oral 031/023 Dynapharm International (Zambia)

Limited

1830 Dynidazole Tablet 200mgMetronidazole 200mg POM Tablet Uncoated 031/024 Dynapharm International (Zambia)

Limited

1831 Lomodium Tablets 2mgLoperamide 2mg POM Tablet Uncoated 031/025 Dynapharm International (Zambia)

Limited

1832 Prednisolone TabletPrednisolone 5mg POM Tablet Uncoated 031/026 Dynapharm International (Zambia)

Limited

1833 PRO- LSB TabletsProbiotics P Tablet Uncoated 031/027 Dynapharm International (Zambia)

Limited

1834 Dyna Serenoa TabletsSerenoa repens 80mg P Tablet Uncoated 031/028L Dynapharm International (Zambia)

Limited

1835 Dyna S TabletsHerbal Preparation P Tablet Uncoated 031/029L Dynapharm International (Zambia)

Limited

1836Sea Cucamber Plus Syrup

Herbal Preparation P Syrup 031/030L Dynapharm International (Zambia)

Limited

1837 Green Tea Extract CapsulesHerbal Preparation P Capsule oral 031/031L Dynapharm International (Zambia)

Limited

1838 Diproson LotionBetamethasone 0.05%w/w POM Lotion for

Topical Use

075/031 Dynapharm International (Zambia)

Limited

1839 Edmark Ginseng CoffeeGinseng Powder 1.5% per

Sachet

GS Granules for

Oral Use

312/001L Edmark International (Z)

Ltd,Malaysia

1840 Edmark Splina Liquid Chlorophyll DrinkChlorophyll 4 gms P Solution for Oral

Use

312/002L Edmark International (Z)

Ltd,Malaysia

1841Edmark MRT Complex Chocolate Drink

Isolated Soya Protein 39.83% +

Low Fat Milk 29.9% + L-Carnit

1.82%

GS Powder for Oral

Suspension

312/003L Edmark International (Z)

Ltd,Malaysia

1842 Edmark Red Yeast CoffeeRed Yeast Rice Powder 1.5% P Granules for

Oral Use

312/004L Edmark International (Z)

Ltd,Malaysia

1843 Edmark Shake OffInstant Oat 45% + Psyllium Husk

19.5% + Inulin 2%

P Granules for

Oral Use

312/005L Edmark International (Z)

Ltd,Malaysia

1844 DEC TabletsDiethyl Carbamazine Citrate

100mg

POM Tablet Film

coated

348/001 Eisai Pharmatechnology &

Manufacturing Pvt. Ltd

1845Shelcal-250 Tablets

Calcium 250mg + Vitamin D3

125iu

P Tablet Uncoated 285/001 Elder Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1846 Alonurish Acne Gel Herbal Extracts GS Gel Topical 285/001HM Elder Pharmaceuticals Ltd, India

1847A.M. P.M. Plus Dental Rinse

Triclosan 0.03% + Sodium

Benzoate 2% + Sodium Fluoride

0.05% w/v + Alcohol

GS Solution for Oral

Use

285/002HM Elder Pharmaceuticals Ltd, India

1848 Venex 300 Tablets Diosmin 300mg POM Tablet Uncoated 285/003 Elder Pharmaceuticals Ltd, India

1849 Alonurish Moisturising Cream Herbal extracts GS Cream Topical 285/003HM Elder Pharmaceuticals Ltd, India

1850 Venex 500 Tablets Diosmin 500mg POM Tablet Uncoated 285/004 Elder Pharmaceuticals Ltd, India

1851 Alonurish Scalp CleanserHerbal Extracts GS Solution for

Topical Use

285/004HM Elder Pharmaceuticals Ltd, India

1852 Conjugate 0.625 TabletsConjugated Oestrogen 0.625mg POM Tablet Film

coated

285/005 Elder Pharmaceuticals Ltd, India

1853A.M. P.M. Plus Junior Dental Rinse

Triclosan 0.03%+ Sodium

Benzoate 0.05% + Sodium

Fluoride + Alcohol

GS Solution for Oral

Use

285/005HM Elder Pharmaceuticals Ltd, India

1854 Shelcal-500 TabletsCalcium 500mg + Vitamin D3

125IU

P Tablet Uncoated 285/006 Elder Pharmaceuticals Ltd, India

1855 Alonurish Alnite Cream Herbal Extracts P Cream Topical 285/006HM Elder Pharmaceuticals Ltd, India

1856 Deviry 10 Tablets Medroxyprogesterone 10mg POM Tablet Uncoated 285/007 Elder Pharmaceuticals Ltd, India

1857 Alonurish Sunscreen LotionHerbal Extracts P Lotion for

Topical Use

285/007HM Elder Pharmaceuticals Ltd, India

1858 Edge 400 Capsules Vitamin E 400IU POM Capsule oral 285/008 Elder Pharmaceuticals Ltd, India

1859 Alonurish Face CleanserHerbal Extracts GS Solution for

Topical Use

285/008HM Elder Pharmaceuticals Ltd, India

1860New Zephrol Syrup

Ambroxol 15mg + Terbutaline

1.2mg + Guaiphenesin 50mg +

Menthol 2.5mg

POM Syrup 285/009 Elder Pharmaceuticals Ltd, India

1861

A.M. P.M. Special Dental Rinse

Triclosan 0.03%w/v + Sodium

Benzoate 2.0%w/v + Sodium

Fluoride 0.05%w/v + Thymol

0.2%w/v

GS Solution for Oral

Use

285/009HM Elder Pharmaceuticals Ltd, India

1862 Tiger Balm White Ointment Herbal Extracts GS Ointment topical 285/010HM Elder Pharmaceuticals Ltd, India

1863Shelcal Syrup

Calcium 250mg + Vitamin D3

125IU

P Syrup 285/011 Elder Pharmaceuticals Ltd, India

1864 Mucodyne Syrup Carbocisteine 260mg P Syrup 285/011HM Elder Pharmaceuticals Ltd, India

1865 Chymoral Forte TabletsProteolytic Enzyme Eoncentrate

100,000 I.U.

POM Tablet Uncoated 285/012 Elder Pharmaceuticals Ltd, India

1866 Solo Cough Syrup Herbal extracts 605mg P Syrup 285/012HM Elder Pharmaceuticals Ltd, India

1867 Eldervit Capsules Vitamins 349.5mg P Capsule oral 285/013 Elder Pharmaceuticals Ltd, India

1868 Jetmox - 250 Capsules Amoxicillin 250mg POM Capsule oral 285/014 Elder Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1869 Amifru-40 TabletsFurosemide 40mg + Amiloride

Hydrochoride 5mg

POM Tablet Uncoated 285/015 Elder Pharmaceuticals Ltd, India

1870 Hormorin Soft Gel Capsules 200mg Progesterone 200mg POM Capsule oral 285/016 Elder Pharmaceuticals Ltd, India

1871 Xtra-P TabletsAceclofenac 100mg +

Paracetamol 500mg

P Tablet Film

coated

285/017 Elder Pharmaceuticals Ltd, India

1872Elder Vit -12 Injection

Vitamin C 150mg + Vitamin B12

2500mcg + Folic Acid 0.7mg +

Niacinamide 1.2mg

POM Solution for

infusion

285/018 Elder Pharmaceuticals Ltd, India

1873 Carnisure-500 Tablets Levocarnitine 500mg POM Tablet Uncoated 285/019 Elder Pharmaceuticals Ltd, India

1874 Powertad 20 Tablets Tadalafil 20mg POM Tablet Uncoated 285/020 Elder Pharmaceuticals Ltd, India

1875 Powertad 10 Tablets Tadalafil 10mg POM Tablet Uncoated 285/021 Elder Pharmaceuticals Ltd, India

1876 Clair 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 285/022 Elder Pharmaceuticals Ltd, India

1877 Clair 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 285/023 Elder Pharmaceuticals Ltd, India

1878 Eprin -75 TabletsAspirin 75mg POM Tablet Enteric

Coated

285/024 Elder Pharmaceuticals Ltd, India

1879 Vitessen C Tablets Ascorbic Acid 500mg P Tablet Chewable 285/025 Elder Pharmaceuticals Ltd, India

1880 Antizip Capsules Nizatidine 150mg POM Capsule oral 174/001 Eli Lilly (SA) Pty Ltd

1881 Prozac TabletsFluoxetine Hdyrochloride EurP

20mg

POM Tablet Uncoated 174/002 Eli Lilly (SA) Pty Ltd

1882 Lilly-Cefador Tablets Cefaclor 375mg POM Tablet Uncoated 174/003 Eli Lilly (SA) Pty Ltd

1883 Lilly-Cefaclor SuspensionCefaclor 375mg, per 5ml POM Powder for Oral

Suspension

174/004 Eli Lilly (SA) Pty Ltd

1884 Lilly Cefaclor GranulesCefaclor Monohydrate USP

187mg, per ml

POM Suspension 174/005 Eli Lilly (SA) Pty Ltd

1885 Alugel SuspensionAluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

GS Suspension for

Oral Use

188/001 Elys Chemicals Industries Ltd,

Kenya

1886 Ampicillin CapsulesAmpicillin 250mg POM Capsule oral 188/002 Elys Chemicals Industries Ltd,

Kenya

1887Bukol Tablets

Hyoscine Butyl Bromide 10mg POM Tablet Uncoated 188/003 Elys Chemicals Industries Ltd,

Kenya

1888Chestcof Syrup

Glycyrrhiza + Menthol + Aniseed

oil + Peppermint oil +

Ipecacuanha + Capsicum

GS Syrup 188/004 Elys Chemicals Industries Ltd,

Kenya

1889 Elyclox CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 188/005 Elys Chemicals Industries Ltd,

Kenya

1890 Elymox CapsulesAmoxicillin POM Capsule oral 188/006 Elys Chemicals Industries Ltd,

Kenya

1891Elyvate Ointment

Betamethasone 0.5% POM Ointment topical 188/007 Elys Chemicals Industries Ltd,

Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1892 Elyvate CreamBetamethasone 0.5% POM Cream Topical 188/008 Elys Chemicals Industries Ltd,

Kenya

1893Fungistin Vaginal Tablets

Nystatin 1000000IU POM Tablet Vaginal 188/009 Elys Chemicals Industries Ltd,

Kenya

1894 Junior Aspirin TabletsAcetyl Salicylic Acid 80mg GS Tablet Uncoated 188/010 Elys Chemicals Industries Ltd,

Kenya

1895 Nitrofurantoin TabletsNitrofurantoin 100mg POM Tablet Uncoated 188/011 Elys Chemicals Industries Ltd,

Kenya

1896 Orodar TabletsSulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 188/012 Elys Chemicals Industries Ltd,

Kenya

1897 Promethazine TabletsPromethazine 25mg P Tablet Uncoated 188/013 Elys Chemicals Industries Ltd,

Kenya

1898 Quinine TabletsQuinine Sulphate 300mg POM Tablet Film

coated

188/014 Elys Chemicals Industries Ltd,

Kenya

1899 Elycort OintmentHydrocortisone 0.1g POM Ointment

Topical

188/015 Elys Chemicals Industries Ltd,

Kenya

1900 Elymox PowderAmoxicillin 125mg, per 5ml POM Suspension for

Oral Use

188/016 Elys Chemicals Industries Ltd,

Kenya

1901Cloxacillin Powder For Suspension

Cloxacillin 125mg, per 5ml POM Suspension for

Oral Use

188/017 Elys Chemicals Industries Ltd,

Kenya

1902 Ampicillin PowderAmpicillin 125mg, per 5ml POM Suspension for

Oral Use

188/018 Elys Chemicals Industries Ltd,

Kenya

1903 Elypen TabletsPhenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 188/019 Elys Chemicals Industries Ltd,

Kenya

1904 Whitefield OintmentSalicylic Acid + Benzoic Acid P Ointment topical 188/020 Elys Chemicals Industries Ltd,

Kenya

1905Lyte Oral Rehydration Salt

Sodium Chloride + Sodium

Citrate + Patassium Chloride +

Glucose

GS Powder for Oral

Solution

188/021 Elys Chemicals Industries Ltd,

Kenya

1906Wormol Tablets

Mebendazole 100mg P Tablet Uncoated 188/022 Elys Chemicals Industries Ltd,

Kenya

1907 Elydac SyrupVit A + Thiamine + Riboflavin +

Nicotinamide + Vit C + Vit D3

P Syrup 188/023 Elys Chemicals Industries Ltd,

Kenya

1908 Frusemide TabletsFrusemide 40mg POM Tablet Uncoated 188/024 Elys Chemicals Industries Ltd,

Kenya

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1909

Tripacof Syrup

Chlorpheniramine 1mg +

Diphenhydramine 5mg +

Promethazine 2.5mg +

Ephedrine 7.5mg + Ammonium

Chloride 40mg

P Syrup 188/025 Elys Chemicals Industries Ltd,

Kenya

1910 Vulmtrex TabletsLevamisole 40mg P Tablet Uncoated 188/026 Elys Chemicals Industries Ltd,

Kenya

1911 Vumtrex SuspensionLevamisole 40mg, per 5ml P Suspension for

Oral Use

188/027 Elys Chemicals Industries Ltd,

Kenya

1912 Mifupen TabletsAspirin 350mg BP + Caffeine

30mg BP

GS Tablet Uncoated 188/028 Elys Chemicals Industries Ltd,

Kenya

1913Chestcof Lozenges

Glycyrrhiza + Menthol + Aniseed

oil + Peppermint oil

GS Lozenges 188/029 Elys Chemicals Industries Ltd,

Kenya

1914 Antihistamin CreamMepyramine 0.306 gm P Cream Topical 188/030 Elys Chemicals Industries Ltd,

Kenya

1915Elytetra Ointment

Tetracycline 0.495gm POM Cream Topical 188/031 Elys Chemicals Industries Ltd,

Kenya

1916 Ibufen TabletsIbuprofen 200mg P Tablet Uncoated 188/032 Elys Chemicals Industries Ltd,

Kenya

1917 Multivitamin TabletsMultivitamins GS Tablet Enteric

Coated

188/033 Elys Chemicals Industries Ltd,

Kenya

1918 Elytetra CapsulesTetracycline 250MG POM Capsule oral 188/034 Elys Chemicals Industries Ltd,

Kenya

1919 Doxycycline CapsDoxycycline 100mg POM Capsule oral 188/035 Elys Chemicals Industries Ltd,

Kenya

1920 Sulphur OintmentSulphur 2g P Cream Topical 188/036 Elys Chemicals Industries Ltd,

Kenya

1921 Fungistat CreamMiconazole 0.3%w/v POM Cream Topical 188/037 Elys Chemicals Industries Ltd,

Kenya

1922Elocin Tablets

Erythromycin 250mg POM Tablet Uncoated 188/038 Elys Chemicals Industries Ltd,

Kenya

1923Himani Fast Relief Herbal Pain Relief

Ointment

Herbal Extracts GS Ointment topical 369/001L Emami Limited, India

1924 Himani Fast Relief Herbal Pain Balm Herbal Extracts GS Ointment topical 369/002L Emami Limited, India

1925 Himani Boroplus Antiseptic Cream Herbal Extracts GS Cream Topical 369/003L Emami Limited, India

1926 Emami Mentho Plus BalmHerbal Extracts GS Lotion for

Topical Use

369/004L Emami Limited, India

1927Himani Fast Relief Herbal Pain Relief

Spray

Herbal Extracts GS Spray for Topical

Use

369/005L Emami Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1928 Himani Fast Relief Herbal Vapour Rub Herbal Extracts GS Ointment topical 369/006L Emami Limited, India

1929 Rosiz 4 TabletsRosiglitazone 4mg POM Tablet Film

coated

125/040 Emcure Pharmaceuticals Limited,

India

1930 Augpen 375 TabletsAmoxicillin + Clavulanate

Potassium 375mg

POM Tablet Film

coated

195/001 Emcure Pharmaceuticals Limited,

India

1931 Augpen 625 TabletsAmoxicillin + Clavulanate

Potassium 625mg

POM Tablet Film

coated

195/002 Emcure Pharmaceuticals Limited,

India

1932 Ciprobiotic Eye/Ear DropsCiprofloxacin 3mg POM Ear/Eye Drops 195/003 Emcure Pharmaceuticals Limited,

India

1933 Zeflox Eye/Ear DropsNorfloxacin 15mg POM Ear/Eye Drops 195/004 Emcure Pharmaceuticals Limited,

India

1934Diclomove NDS Gel

Diclofenac 1%w/w P Gel Topical 195/005 Emcure Pharmaceuticals Limited,

India

1935 C-Tri InjectionCeftriaxone 1g POM Powder for

Injection

195/006 Emcure Pharmaceuticals Limited,

India

1936 Orofer Chewable TabletsFolic Acid + Iron P Tablet Film

coated

195/008 Emcure Pharmaceuticals Limited,

India

1937 Nusar 50 TabletsLosartan 50mg POM Tablet Film

coated

195/010 Emcure Pharmaceuticals Limited,

India

1938 Orofer DropsFerric oxide 50mg P Solution for Oral

Use

195/011 Emcure Pharmaceuticals Limited,

India

1939 Emtri TabletsLamivudine 200mg + Nevirapine

150mg + Stavudine 40mg

POM Tablet Uncoated 195/012 Emcure Pharmaceuticals Limited,

India

1940Ciprobiotic FC Cream

Ciprofloxacin 0.5%w/w +

Clotrimazole + Fluocinolone

Acetonide

POM Cream Topical 195/014 Emcure Pharmaceuticals Limited,

India

1941 Zosec CapsulesOmeprazole 20mg POM Capsule oral 195/015 Emcure Pharmaceuticals Limited,

India

1942 Ciprobiotic Forte TabletsCiprofloxacin 500mg POM Tablet Film

coated

195/017 Emcure Pharmaceuticals Limited,

India

1943 Agupen SuspensionAmoxicillin Trihydrate 500mg +

Clavulanic Acid 125mg

POM Suspension for

Oral Use

195/018 Emcure Pharmaceuticals Limited,

India

1944 Orofer SyrupCyanocobalamin 5mcg +

Elemental Iron 50mg

P Syrup 195/019 Emcure Pharmaceuticals Limited,

India

1945 Orofer CapFolic Acid + Iron P Capsule Oral 195/020 Emcure Pharmaceuticals Limited,

India

1946Orofer Capsules

Folic Acid + Iron P Capsule oral 195/021 Emcure Pharmaceuticals Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1947 Beclasone C CreamClioquinol BP + Beclomethasone

BP 15g

POM Cream Topical 195/022 Emcure Pharmaceuticals Limited,

India

1948Vifex Syrup

Salbutamol 1mg + Bromhexine

2mg + Guaiphenesin 50mg +

Menthol 0.5mg

P Syrup 195/024 Emcure Pharmaceuticals Limited,

India

1949 Caloshel TabletsColecalciferol 500mg +

Elemental Calcium

P Tablet Uncoated 195/026 Emcure Pharmaceuticals Limited,

India

1950 C-Tax 200 TabletsCefixime 200mg POM Tablet Film

coated

195/028 Emcure Pharmaceuticals Limited,

India

1951 C-Tax P 50 Dry Syrup Cefixime 50mg POM Suspension for

Oral Use

195/029 Emcure Pharmaceuticals Limited,

India

1952Atorec 10 Tablets

Atorvastatin 10mg POM Tablet Film

coated

195/030 Emcure Pharmaceuticals Limited,

India

1953 Atorec 20 TabletsAtorvastatin 20mg POM Tablet Film

coated

195/031 Emcure Pharmaceuticals Limited,

India

1954Acem-500mg

Clarithromycin 500mg POM Tablet Uncoated 195/033 Emcure Pharmaceuticals Limited,

India

1955 Asomex-2.5 TabletsAmlodipine 2.5mg POM Tablet Uncoated 195/034 Emcure Pharmaceuticals Limited,

India

1956 Asomex- 5 TabletsAmlodipine 5mg POM Tablet Uncoated 195/035 Emcure Pharmaceuticals Limited,

India

1957 Nusar H TabletsLosartan + Hydrochlorothiazide POM Tablets Oral 195/036 Emcure Pharmaceuticals Limited,

India

1958 Sylate 500 TabletsEtamsylate 500mg POM Tablet Uncoated 195/038 Emcure Pharmaceuticals Limited,

India

1959 Rosiz 2 TabletsRosiglitazone 2mg POM Tablet Film

coated

195/039 Emcure Pharmaceuticals Limited,

India

1960 Diclomove SR TabletsDiclofenac POM Tablet Uncoated 195/041 Emcure Pharmaceuticals Limited,

India

1961Dinor Tablets

Didanosine 100mg POM Tablet Chewable 195/042 Emcure Pharmaceuticals Limited,

India

1962 Lamir -150 TabletsLamivudine 150mg POM Tablet Film

coated

195/043 Emcure Pharmaceuticals Limited,

India

1963 Zidine CapsulesZidovudine 100mg POM Capsule oral 195/044 Emcure Pharmaceuticals Limited,

India

1964 Stadine - 40 CapsulesStavudine 40mg POM Capsule oral 195/045 Emcure Pharmaceuticals Limited,

India

1965Efcure Tablets

Efavirenz 600mg POM Tablet Uncoated 195/046 Emcure Pharmaceuticals Limited,

India

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1966 Emduo-40 TabletsLamivudine 150mg + Stavudine

40mg

POM Tablet Uncoated 195/047 Emcure Pharmaceuticals Limited,

India

1967Zidine Tablets

Zidovudine 300mg POM Tablet Uncoated 195/048 Emcure Pharmaceuticals Limited,

India

1968 Zidine Oral SolutionZidovudine 50mg, per 5ml POM Solution for Oral

Use

195/049 Emcure Pharmaceuticals Limited,

India

1969 Emtri SuspensionStavudine 10mg + Lamivudine

40mg + Nevirapine 70mg

POM Suspension for

Oral Use

195/051 Emcure Pharmaceuticals Limited,

India

1970 Vintor InjectionAlpha-Recombinant Human

Erythropoietin 2000IU

POM Solution for

Injection

195/052 Emcure Pharmaceuticals Limited,

India

1971 Emtri Junior TabletsLamivudine 40mg + Stavudine

10mg + Nevirapine 70mg

POM Tablet Uncoated 195/053 Emcure Pharmaceuticals Limited,

India

1972 Encifer InjectionFerric Hydroxide complex 2g, per

ml

POM Solution for

Injection

195/054 Emcure Pharmaceuticals Limited,

India

1973 Metpure-XLS-(-) Metoprolol 25mg POM Tablet Uncoated 195/056 Emcure Pharmaceuticals Limited,

India

1974 Metpure-XLS-(-) Metoprolol 50mg POM Tablet Uncoated 195/057 Emcure Pharmaceuticals Limited,

India

1975Panpure Tablets

S-Pantoprazole 20mg POM Tablet Uncoated 195/058 Emcure Pharmaceuticals Limited,

India

1976 Ibusoft 300Dexibuprofen 300mg P Tablet Film

coated

195/059 Emcure Pharmaceuticals Limited,

India

1977 Ibusoft 400Dexibuprofen 400mg P Tablet Film

coated

195/060 Emcure Pharmaceuticals Limited,

India

1978Lomoh-40 (Low Molecular Weight

Heparin) Injection

Enoxaparin 40mg POM Solution for

Injection

195/061 Emcure Pharmaceuticals Limited,

India

1979Lomoh -60 (Low Molecular Weight

Heparin) Injection

Enoxaparin 60mg POM Solution for

Injection

195/062 Emcure Pharmaceuticals Limited,

India

1980 MOFILET - 500 TabletsMycophenolate 500mg POM Tablet Uncoated 195/063 Emcure Pharmaceuticals Limited,

India

1981 Atazor 100 CapsulesAtazanavir 100mg POM Capsule oral 195/064 Emcure Pharmaceuticals Limited,

India

1982 Atazor 150 CapsulesAtazanavir 150mg POM Capsule oral 195/065 Emcure Pharmaceuticals Limited,

India

1983 Atazor 200 CapsulesAtazanavir 200mg POM Capsule oral 195/066 Emcure Pharmaceuticals Limited,

India

1984Emtri Tablets

Lamivudine 150mg + Stavudine

30mg + Nevirapine 200mg

POM Tablet Uncoated 195/067 Emcure Pharmaceuticals Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

1985 Vintor 4000 InjectionErythropoietin 4000 iu POM Solution for

Injection

195/068 Emcure Pharmaceuticals Limited,

India

1986Atazor 300 Capsules

Atazanavir Sulphate 300mg POM Capsule oral 195/069 Emcure Pharmaceuticals Limited,

India

1987 Antiplar TabletsClopidogrel BiSulphate 75mg POM Tablet Uncoated 195/070 Emcure Pharmaceuticals Limited,

India

1988 Atazor - R TabletsAtazanavir Sulphate 300mg +

Ritonivir 100mg

POM Tablet Uncoated 195/071 Emcure Pharmaceuticals Limited,

India

1989

Xplode Tablets

Cyanocobalamin 0.4 mcg +

Elemental Zinc 4 mg + Folic Acid

45 mcg + Panax ginseng extract

42.5 mg + Resveratrol 75 mg +

Vitamin C 20 mg

P Tablet Film

coated

195/072 Emcure Pharmaceuticals Limited,

India

1990 Cerizine TabletsLevocetirizine Hydrochloride BP

5mg

P Tablet Uncoated 195/073 Emcure Pharmaceuticals Limited,

India

1991Sustinex 30 Tablets

Dapoxetine 30mg POM Tablet Uncoated 195/074 Emcure Pharmaceuticals Limited,

India

1992 Proxym 300 TabletsEtodolac 300mg POM Tablet Film

coated

195/075 Emcure Pharmaceuticals Limited,

India

1993 Asomex-LT TabletsLosartan Pottassium

+Amilodipine Besilate

POM Tablet Uncoated 195/076 Emcure Pharmaceuticals Limited,

India

1994 Panpure IV InjectionS (-) Pantoprazole Sodium POM Powder for

Injection

195/077 Emcure Pharmaceuticals Limited,

India1995 Zoocef-200 Tablets Cefixime Trihydrate USP 200mg POM Tablet Uncoated 030/001 Emzor Exports Pvt Ltd, India

1996 Zoocef-100 Tablets Cefixime Trihydrate USP 100mg POM Tablet Uncoated 030/002 Emzor Exports Pvt Ltd, India

1997 Azith-250 TabletsAzithromycin Dihydrate USP

250mg

POM Tablet Uncoated 030/003 Emzor Exports Pvt Ltd, India

1998 Azith-500 TabletsAzithromycin Dihydrate USP

500mg

POM Tablet Uncoated 030/004 Emzor Exports Pvt Ltd, India

1999Rancip Tablets Ciprofloxacin 500mg POM Tablet Film

coated

278/001 Erica Pharma Pvt Ltd, India

2000Ericef Injection Ceftriaxone 1g POM Powder for

Injection

278/002 Erica Pharma Pvt Ltd, India

2001Ryvakelfin Tablets Pyrimthamine 25 + Sulfadoxine

500 mg

POM Tablet Uncoated 278/003 Erica Pharma Pvt Ltd, India

2002Erisunat Suspension Artesunate 160mg, per 80ml POM Suspension for

Oral Use

278/004 Erica Pharma Pvt Ltd, India

2003Lumether Suspension Lumefantrine 120mg +

Artemether 20mg

POM Suspension for

Oral Use

278/005 Erica Pharma Pvt Ltd, India

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2004Erinin Suspension Dihydroartemisinin 160mg, per

80ml

POM Suspension 278/006 Erica Pharma Pvt Ltd, India

2005 Ucon Capsules Fluconazole 200mg POM Capsule oral 278/007 Erica Pharma Pvt Ltd, India

2006 Optragen Eye Drops Gentamycin 0.3 % POM Eye Drops 278/008 Erica Pharma Pvt Ltd, India

2007Eriamp Suspension Ampicillin 250mg, per 5ml POM Suspension for

Oral Use

278/009 Erica Pharma Pvt Ltd, India

2008Erither Oral Suspension Artemether 180mg, per 5ml POM Solution for Oral

Use

278/010 Erica Pharma Pvt Ltd, India

2009Erilife Powder Oral Rehydration Salts 10.5g GS Powder for Oral

Solution

278/011 Erica Pharma Pvt Ltd, India

2010 Erinin Tablets Dihydroartemisin 60mg POM Tablet Uncoated 278/012 Erica Pharma Pvt Ltd, India

2011Eridol Oral Suspension Paracetamol 120mg, per 5ml GS Suspension for

Oral Use

278/013 Erica Pharma Pvt Ltd, India

2012 Erisunat Tablets Arthemether 100mg POM Tablet Uncoated 278/014 Erica Pharma Pvt Ltd, India

2013Erither Injection Artemether 80mg, per ml POM Solution for

Injection

278/015 Erica Pharma Pvt Ltd, India

2014Lumether Tablets Lumefantrine 120mg +

Artemether 20mg

POM Tablet Film

coated

278/016 Erica Pharma Pvt Ltd, India

2015Rypanta Tablets Pantoprazole Sesquihydrate

40mg

POM Tablet Enteric

Coated

278/017 Erica Pharma Pvt Ltd, India

2016 Ryvazole Capsules Omeprazole 20mg POM Capsule oral 278/018 Erica Pharma Pvt Ltd, India

2017Amoxer Oral Suspension Amoxicillin BP 250mg, per 5ml POM Suspension for

Oral Use

278/019 Erica Pharma Pvt Ltd, India

2018Tolybion Injection Vitamin B Complex POM Solution for

Injection

278/020 Erica Pharma Pvt Ltd, India

2019Ryvakelfin Oral Drops Pyrimthamine 25 + Sulfadoxine

500mg, per 10ml

POM Solution for Oral

Use

278/021 Erica Pharma Pvt Ltd, India

2020 Erither Capsules Artemether 40mg POM Capsule oral 278/022 Erica Pharma Pvt Ltd, India

2021Erixime Injection Cefotaxime 1g POM Powder for

Injection

278/023 Erica Pharma Pvt Ltd, India

2022Oral Rehydration Salt Oral Rehydration Salt GS Powder for Oral

Solution

278/024 Erica Pharma Pvt Ltd, India

2023 Furosemide Tablets Furosemide BP 40mg POM Tablet Uncoated 278/025 Erica Pharma Pvt Ltd, India

2024 Erimet 850 Tablets Metformin Hydrochloride 850mg POM Tablet Uncoated 278/026 Erica Pharma Pvt Ltd, India

2025

Erion K Syrup Ferric Ammonium Citrate USP +

Folic Acid BP + Cynocobalamin

P Syrup 278/027 Erica Pharma Pvt Ltd, India

2026Clauviax 625mg Tablets Amoxicillin USP + Clavulanic

Acid USP

POM Tablet Uncoated 278/028 Erica Pharma Pvt Ltd, India

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2027Chloramphenicol Sodium Succinate

Injection

Chloramphenicol Sodium

Succinate 1g

POM Powder for

Injection

278/032 Erica Pharma Pvt Ltd, India

2028Furosemide Injection Furosemide BP 10mg, per ml POM Solution for

Injection

278/033 Erica Pharma Pvt Ltd, India

2029Gentamycin Sulphate Injection Gentamycin Sulphate 40mg, per

ml

POM Solution for

Injection

278/034 Erica Pharma Pvt Ltd, India

2030Rancip 250 Tablets Ciprofloxacin Hydrochloride

250mg

POM Tablet Uncoated 278/035 Erica Pharma Pvt Ltd, India

2031 Cefax -250 Tablets Cefuroxime Axetil 250mg POM Tablet Uncoated 278/036 Erica Pharma Pvt Ltd, India

2032Erimal Capsules Amodiquine Hydrochloride

300mg + Artesunate 100mg

POM Capsule oral 278/038 Erica Pharma Pvt Ltd, India

2033Erither 40 Injection Artemether 40mg, per ml POM Solution for

Injection

278/041 Erica Pharma Pvt Ltd, India

2034 Vagiclin Suppositories Clindamycin+ Clotrimazole POM Suppository 278/042 Erica Pharma Pvt Ltd, India

2035 Optracip Drops Ciprofloxacin 0.3% POM Eye Drops 278/043 Erica Pharma Pvt Ltd, India

2036 Vagiclo Tablets Clotrimazole 100mg POM Tablet Vaginal 278/044 Erica Pharma Pvt Ltd, India

2037 Erimet Tablets Metformin Hydrochloride 500mg POM Tablet Uncoated 278/045 Erica Pharma Pvt Ltd, India

2038Clauviax -375 Amoxicillin 250mg + Clavulanate

125mg

POM Tablet Uncoated 278/047 Erica Pharma Pvt Ltd, India

2039Clauviax Suspension Amoxicillin 125mg + Clavulanate

31.25mg

POM Suspension 278/048 Erica Pharma Pvt Ltd, India

2040 Psyclocare Tablets Resperidone 2mg POM Tablet Uncoated 278/049 Erica Pharma Pvt Ltd, India

2041Flucolife Infusion Fluconazole 200mg, per 100ml POM Solution for

infusion

307/001 Eurolife Healthcare PVT Ltd, India

2042Mannilfe Infusion Mannitol 20g, per 100ml POM Solution for

infusion

307/002 Eurolife Healthcare PVT Ltd, India

2043Metlife Infusion Metronidazole 500mg, per

100ml

POM Solution for

infusion

307/003 Eurolife Healthcare PVT Ltd, India

2044Sterile Water for Injection Water For Injection POM Solution for

Injection

307/004 Eurolife Healthcare PVT Ltd, India

2045Ciplife Infusion Ciprofloxacin 200mg, per 100ml POM Solution for

infusion

307/005 Eurolife Healthcare PVT Ltd, India

2046 Virecta Tablets Sildenafil Citrate I.H 100mg POM Tablet Uncoated 358/001 Eva Pharma

2047Vendexine Syrup Dexamethasone 0.5mg +

Chlorpheniramine 2mg

P Syrup 358/002 Eva Pharma

2048 Fusiderm Cream Fusidic acid 2% POM Cream Topical 358/003 Eva Pharma

2049

Electral Forte Powder Sodium Chloride,Potassium

Chloride, Sodium Citrate,

Dextrose 24g

GS Powder for Oral

Solution

197/001 FDC Limited, India

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2050Co-trimoxazole Tablets Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 197/002 FDC Limited, India

2051Moisol Eye Drops Hydroxypropylmethyl Cellulose

0.7%w/v

P Eye Drops 197/003 FDC Limited, India

2052 Pilocar Eye Drops Pilocarpine 2%w/v POM Eye Drops 197/004 FDC Limited, India

2053Pyricort Eye/Ear Drops Dexamethasone + Gentamycin

0.1%w/v

POM Ear/Eye Drops 197/005 FDC Limited, India

2054Pyrimon Eye/Ear Drops Dexamethasone +

Chloramphenicol 1.1%w/v

POM Ear/Eye Drops 197/006 FDC Limited, India

2055 Zoxan Eye/Ear Drops Ciprofloxacin 0.3%w/v POM Ear/Eye Drops 197/007 FDC Limited, India

2056 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 197/008 FDC Limited, India

2057 Paracetamol Tablets Paracetamol BP 500mg GS Tablet Uncoated 197/010 FDC Limited, India

2058

Nucleo CMP Forte Capsules Cytidine -5 Disodium

Monophosphate + Uridine

Triphosphate

POM Capsule oral 366/001 Ferrer International S.A

2059

Nucleo Forte C.M.P Forte Injection Cytidine -5-Disodium

Monophosphate (CMP -

Disodium Salt Urid

POM Solution for

Injection

366/002 Ferrer International S.A

2060 Zalain Vaginal Suppository Sertaconazole Nitrate 300mg POM Suppository 366/003 Ferrer International S.A

2061Amoxycillin Oral Suspension Amoxycillin 250mg, per 5ml POM Suspension for

Oral Use

126/001 Flamingo Pharmaceuticals

Limited, India

2062Ampicillin 1000 Injection Ampicillin 1g POM Powder for

Injection

126/002 Flamingo Pharmaceuticals

Limited, India

2063Ampicillin 500 Injection Ampicillin 500mg POM Powder for

Injection

126/003 Flamingo Pharmaceuticals

Limited, India

2064Medampi Capsules Ampicillin 500mg POM Capsule oral 126/004 Flamingo Pharmaceuticals

Limited, India

2065Benzyl Penicillin Injection Benzyl Penicillin 1 Mega POM Powder for

Injection

126/005 Flamingo Pharmaceuticals

Limited, India

2066Tetra 500 Capsules Tetracycline 500mg POM Capsule oral 126/006 Flamingo Pharmaceuticals

Limited, India

2067Kanamycin Injection Kanamycin 1g POM Powder for

Injection

126/007 Flamingo Pharmaceuticals

Limited, India

2068Fortified Procaine Penicillin Injection Procain Penicillin POM Powder for

Injection

126/008 Flamingo Pharmaceuticals

Limited, India

2069Ibuprofen 200mg Tablets Ibuprofen 200mg P Tablet Uncoated 126/009 Flamingo Pharmaceuticals

Limited, India

2070Compound Magnesuim Trisilicate

Tablets

Aluminium Hydroxide 125mg +

Magnesium Trisilicate 250mg

GS Tablet Uncoated 126/010 Flamingo Pharmaceuticals

Limited, India

Page 100 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2071Co-trimoxazole Suspension Sulphamethoxazole +

Trimethoprim 240mg, per 5ml

POM Suspension for

Oral Use

126/011 Flamingo Pharmaceuticals

Limited, India

2072Cephalexin 500 Capsules Cephalexin 500mg POM Capsule oral 126/012 Flamingo Pharmaceuticals

Limited, India

2073Amoxin 500 Capsules Amoxicillin 500mg POM Capsule oral 126/013 Flamingo Pharmaceuticals

Limited, India

2074Indo 25 Capsules Indomethacin 25mg P Capsule oral 126/014 Flamingo Pharmaceuticals

Limited, India

2075Erycin 125 Suspension Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

126/015 Flamingo Pharmaceuticals

Limited, India

2076Quinine Tablets Quinine Sulphate 300mg POM Tablet Uncoated 126/016 Flamingo Pharmaceuticals

Limited, India

2077Metronidazole Suspension Metronidazole 125mg, per 5ml POM Suspension for

Oral Use

126/017 Flamingo Pharmaceuticals

Limited, India

2078Medfulin Tablets Griseofulvin 500mg POM Tablet Uncoated 126/018 Flamingo Pharmaceuticals

Limited, India

2079Metroforce 200 Tablets Metronidazole 200mg POM Tablet Uncoated 126/019 Flamingo Pharmaceuticals

Limited, India

2080Reduced 300 Tablets Ranitidine 300mg POM Tablet Uncoated 126/020 Flamingo Pharmaceuticals

Limited, India

2081Flamodip 10 Tablets Amlodipine 10mg POM Tablet Uncoated 126/021 Flamingo Pharmaceuticals

Limited, India

2082Flamodip 5 Tablets Amlodipine 5mg POM Tablet Uncoated 126/022 Flamingo Pharmaceuticals

Limited, India

2083Reduced 150 Tablets Ranitidine 150mg POM Tablet Uncoated 126/023 Flamingo Pharmaceuticals

Limited, India

2084Ibuprofen 400mg Tablets Ibuprofen 400mg P Tablet Uncoated 126/024 Flamingo Pharmaceuticals

Limited, India

2085Cardipril 2.5 Capsules Ramipril 2.5mg POM Capsule oral 126/025 Flamingo Pharmaceuticals

Limited, India

2086Mefenamic Acid Capsules Mefenamic Acid 500mg P Capsule oral 126/026 Flamingo Pharmaceuticals

Limited, India

2087Neumicin B Injection Benzathine Penicillin 2.5Mega POM Powder for

Injection

126/027 Flamingo Pharmaceuticals

Limited, India

2088Kamox 250 Capsules Amoxycillin 250mg POM Capsule oral 126/028 Flamingo Pharmaceuticals

Limited, India

2089Aziflam 250 Capsules Azithromycin 250mg POM Capsule oral 126/029 Flamingo Pharmaceuticals

Limited, India

Page 101 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2090Sodipen-5 Injection Benzyl Penicillin 5 Mega POM Powder for

Injection

126/030 Flamingo Pharmaceuticals

Limited, India

2091Corin 50 Tablets Atenolol 50mg POM Tablet Uncoated 126/031 Flamingo Pharmaceuticals

Limited, India

2092Metformin Tablets Metformin 850mg POM Tablet Uncoated 126/032 Flamingo Pharmaceuticals

Limited, India

2093Glibetics Tablets Glibenclamide 5mg POM Tablet Uncoated 126/033 Flamingo Pharmaceuticals

Limited, India

2094Medichlor Injection Chloramphenicol 1g POM Powder for

Injection

126/034 Flamingo Pharmaceuticals

Limited, India

2095Aziflam 500 Capsules Azithromycin 500mg POM Capsule oral 126/035 Flamingo Pharmaceuticals

Limited, India

2096Chloramphenicol Suspension Chloramphenicol 125mg, per 5ml POM Suspension for

Oral Use

126/036 Flamingo Pharmaceuticals

Limited, India

2097Acenopril 5 Tablets Enalapril 5mg POM Tablet Uncoated 126/037 Flamingo Pharmaceuticals

Limited, India

2098Quinone G-500 Tablets Nalidixic acid 500mg POM Tablet Uncoated 126/038 Flamingo Pharmaceuticals

Limited, India

2099

Magacid Oral Suspension Aluminium Hydroxide 200mg +

Magnesium Hydroxide 200mg +

Simethicone 135mg, per 5ml

P Suspension for

Oral Use

126/039 Flamingo Pharmaceuticals

Limited, India

2100Acenopril 10 Tablets Enalapril 10mg POM Tablet Uncoated 126/040 Flamingo Pharmaceuticals

Limited, India

2101Corin 100 Tablets Atenolol 100mg POM Tablet Uncoated 126/041 Flamingo Pharmaceuticals

Limited, India

2102

Coughex Syrup Salbutamol 1mg + Bromhexine

2mg + Guaiphenisin 50mg +

Menthol 0.5mg

GS Syrup 126/042 Flamingo Pharmaceuticals

Limited, India

2103Paracetamol BP Tablets Paracetamol 500mg GS Tablet Uncoated 126/043 Flamingo Pharmaceuticals

Limited, India

2104Trixone 1 Injection Cefotaxime 1g POM Powder for

Injection

126/044 Flamingo Pharmaceuticals

Limited, India

2105Trixol 250 Injection Ceftriaxone 250mg POM Powder for

Injection

126/045 Flamingo Pharmaceuticals

Limited, India

2106Lexin 125 Oral Suspension Cephalexin 125mg, per 5ml POM Suspension 126/047 Flamingo Pharmaceuticals

Limited, India

2107Lanocid 30 Capsules Lansoprazole 30mg POM Capsule oral 126/048 Flamingo Pharmaceuticals

Limited, India

Page 102 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2108Healz Tablets Serrapeptase 10mg POM Tablet Uncoated 126/049 Flamingo Pharmaceuticals

Limited, India

2109Profit Syrup Protein Syrup GS Syrup 126/051 Flamingo Pharmaceuticals

Limited, India

2110Hyomide 10 Tablets Hyoscine Butyl Bromide 10mg POM Tablet Uncoated 126/052 Flamingo Pharmaceuticals

Limited, India

2111Cloxacillin Sodium Injection Cloxacillin 500mg, per ml POM Powder for

Injection

126/053 Flamingo Pharmaceuticals

Limited, India

2112Cardilan Injection Hydrocortisone 100mg POM Powder for

Injection

126/054 Flamingo Pharmaceuticals

Limited, India

2113Loperamide Capsules Loperamide 2mg POM Capsule oral 126/055 Flamingo Pharmaceuticals

Limited, India

2114Cefotax Powder for Injection Cefotaxime 1g POM Powder for

Injection

126/056 Flamingo Pharmaceuticals

Limited, India

2115Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric

Coated

126/057 Flamingo Pharmaceuticals

Limited, India

2116Cloxin DS Cloxacillin Sodium 125mg POM Powder for

Suspension

126/058 Flamingo Pharmaceuticals

Limited, India

2117Flamivit Syrup Multivitamins GS Syrup 126/059 Flamingo Pharmaceuticals

Limited, India

2118Kamox 125 Oral Suspension Amoxicillin 25mg, per 5ml POM Suspension for

Oral Use

126/060 Flamingo Pharmaceuticals

Limited, India

2119Erycin Tablets Erythromycin 250mg POM Tablet Uncoated 126/063 Flamingo Pharmaceuticals

Limited, India

2120Angitan 50 Tablet Losartan Potassium 50mg POM Tablet oral 126/064 Flamingo Pharmaceuticals

Limited, India

2121Co-trimoxazole Tablets Trimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 139/046 Flamingo Pharmaceuticals

Limited, India

2122Roxto-25 Tablets Rofecoxib 25mg POM Tablet Uncoated 139/050 Flamingo Pharmaceuticals

Limited, India

2123Forever Kids Chewable Multivitamins

Tablets

Multivitamins P Tablet Uncoated 080/001 Forever Living Products, USA

2124 Forever Nature Min Tablets Minerals P Tablet Uncoated 080/002 Forever Living Products, USA

2125 Forever Absorbent-C Tablets Vitamin C 60mg P Tablet Uncoated 080/003L Forever Living Products, USA

2126Forever Royal Jelly Tablets Royal Jelly powder 250mg P Powder for Oral

Solution

080/004L Forever Living Products, USA

2127 Forever Bee Pollen Capsules Bee Pollen 500mg P Capsule oral 080/005L Forever Living Products, USA

2128 Forever Bee Propolis Tablets Bee Propolis 500mg P Tablet Uncoated 080/006L Forever Living Products, USA

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2129Forever Garlic- Thyme SoftGel

Capsules

Garlic Oil 10mg + Thyme

Powdered 50mg

P Tablet Uncoated 080/007L Forever Living Products, USA

2130

Forever Gin -Chia Tablets Premium Ginseng + 80mg

Oriental Ginseng 40mg +

Siberian Ginseng 20mg

P Tablet Uncoated 080/008L Forever Living Products, USA

2131

Ulgicid Suspension Alginic Acid BP 200 mg +

Magnesium Hydroxide BP 250

mg + Dried Aluminium Hydroxide

BP 250 mg + Magnesium

Trisilicate BP 250 mg + Activated

Dimethicone BP 125 mg/ 15ml

P Suspension 246/006 Fountil Life Sciences, India

2132 Purecal Tablets Vitamin + Mineral Preparation P Tablets 246/007 Fountil Life Sciences, India

2133

Ulgicid Antacid Tablets Alginic Acid BP 200 mg +

Magnesium Hydroxide BP 250

mg + Dried Aluminium Hydroxide

BP 250 mg + Magnesium

Trisilicate BP 250 mg + Activated

Dimethicone BP 125 mg

P Tablets 246/008 Fountil Life Sciences, India

2134

Capisfenac Gel Capsaicin 0.025%w/w +

Diclofenc Diethylalamine

1.160%w/w + Levomenthol

1.00%w/w

P Gel Topical 246/021 Fountil Life Sciences, India

2135Diszinc Dispersible Tablets Zinc Sulfate 20mg POM Tablet

Dispersible

246/022 Fountil Life Sciences, India

2136Aminogard Granules Minerals + Vitamins P Granules for

Oral Use

246/023 Fountil Life Sciences, India

2137 Primox 250 Capsules Amoxicillin 250mg POM Capsule oral 265/003 Fountil Life Sciences, India

2138Pedifen Suspension Ibuprofen 100mg P Suspension for

Oral Use

151/033 Fourrts (India) Laboratories (Pvt)

Limited

2139Omfil 20 Capsules Omeprazole 20mg POM Capsule oral 177/001 Fourrts (India) Laboratories (Pvt)

Limited

2140Ampifil 250 Capsules Ampicillin 250mg POM Capsule oral 177/002 Fourrts (India) Laboratories (Pvt)

Limited

2141Doxefil 100 Capsules Doxycycline 100mg POM Capsule oral 177/003 Fourrts (India) Laboratories (Pvt)

Limited

2142Indoril 25 Capsules Indomethacin 25mg P Capsule oral 177/004 Fourrts (India) Laboratories (Pvt)

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2143Gramofil Suspension Nalidixic Acid 300mg, per 5ml POM Suspension for

Oral Use

177/005 Fourrts (India) Laboratories (Pvt)

Limited

2144Malafil Tablets Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 177/006 Fourrts (India) Laboratories (Pvt)

Limited

2145Griseofil Tablets Griseofulvin 500mg POM Tablet Uncoated 177/007 Fourrts (India) Laboratories (Pvt)

Limited

2146Micofil Cream Miconazole 2%w/w POM Cream Topical 177/008 Fourrts (India) Laboratories (Pvt)

Limited

2147Megatrim Suspension Sulphamethoxazole 200mg +

Trimethoprim 40mg

POM Suspension for

Oral Use

177/009 Fourrts (India) Laboratories (Pvt)

Limited

2148Prednifil Tablets Prednisolone 5mg POM Tablet Uncoated 177/010 Fourrts (India) Laboratories (Pvt)

Limited

2149Combifil 125 Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 177/011 Fourrts (India) Laboratories (Pvt)

Limited

2150Diclofil 50 Tablets Diclofenac 50mg P Tablet Uncoated 177/012 Fourrts (India) Laboratories (Pvt)

Limited

2151Parafil Tablets Paracetamol 500mg GS Tablet Uncoated 177/013 Fourrts (India) Laboratories (Pvt)

Limited

2152Clopen 500 Capsules Cloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 177/014 Fourrts (India) Laboratories (Pvt)

Limited

2153Gelfil Tablets Aluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

GS Tablet Uncoated 177/015 Fourrts (India) Laboratories (Pvt)

Limited

2154Fungifen Cream Clotrimazole 1%w/w POM Cream Topical 177/016 Fourrts (India) Laboratories (Pvt)

Limited

2155Mebfil Suspension Mebendazole 100mg, per 30ml P Suspension for

Oral Use

177/017 Fourrts (India) Laboratories (Pvt)

Limited

2156Felcine Capsules Piroxicam 20mg POM Capsule oral 177/018 Fourrts (India) Laboratories (Pvt)

Limited

2157Filobex Tablets Thiamine 1mg + Riboflavine 1mg

+ Niacinamide 10mg

P Tablet Uncoated 177/019 Fourrts (India) Laboratories (Pvt)

Limited

2158Gliclan M Tablets Metformin 250mg + Gliclazide

80mg

POM Tablet Uncoated 177/020 Fourrts (India) Laboratories (Pvt)

Limited

2159Gramofil Tablets Nalidixic acid 500mg POM Tablet Uncoated 177/021 Fourrts (India) Laboratories (Pvt)

Limited

2160Ibufil Tablets Ibuprofen 200mg P Tablet Uncoated 177/022 Fourrts (India) Laboratories (Pvt)

Limited

2161Mebfil Tablets Mebendazole 100mg P Tablet Uncoated 177/023 Fourrts (India) Laboratories (Pvt)

Limited

Page 105 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2162Megatrim Tablets Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 177/024 Fourrts (India) Laboratories (Pvt)

Limited

2163Metfil 850 Tablets Metformin 850mg POM Tablet Uncoated 177/025 Fourrts (India) Laboratories (Pvt)

Limited

2164Salfil 4 Tablets Salbutamol 4mg POM Tablet Uncoated 177/026 Fourrts (India) Laboratories (Pvt)

Limited

2165Salfil 2 Tablets Salbutamol 2mg POM Tablet Uncoated 177/027 Fourrts (India) Laboratories (Pvt)

Limited

2166Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 177/028 Fourrts (India) Laboratories (Pvt)

Limited

2167Fourts B Tablets Multivitamins + Amino Acids +

Minerals

P Tablet Uncoated 177/029 Fourrts (India) Laboratories (Pvt)

Limited

2168Metfil 500 Tablets Metformin 500mg POM Tablet Uncoated 177/030 Fourrts (India) Laboratories (Pvt)

Limited

2169Salbutamol Oral Solution Salbutamol 2mg POM Solution for Oral

Use

177/031 Fourrts (India) Laboratories (Pvt)

Limited

2170Fogyl Suspension Metronidazole 100mg POM Suspension for

Oral Use

177/032 Fourrts (India) Laboratories (Pvt)

Limited

2171Profil 25 Tablets Promethazine 25mg P Tablet Uncoated 177/033 Fourrts (India) Laboratories (Pvt)

Limited

2172Cloxafil 250 Capsules Cloxacillin 250mg POM Capsule oral 177/035 Fourrts (India) Laboratories (Pvt)

Limited

2173Parafil 120 Oral Solution Paracetamol 120mg GS Solution for oral

use

177/036 Fourrts (India) Laboratories (Pvt)

Limited

2174Betafil-50 Tablets Atenolol 50mg POM Tablet Uncoated 177/037 Fourrts (India) Laboratories (Pvt)

Limited

2175Gliclan 80 Tablets Gliclazide 80mg POM Tablet Uncoated 177/038 Fourrts (India) Laboratories (Pvt)

Limited

2176Fomycetin 250 Capsules Chlorampenicol 250mg POM Capsule oral 177/039 Fourrts (India) Laboratories (Pvt)

Limited

2177Fogyl-S Tablets Metronidazole 200mg POM Tablet Uncoated 177/040 Fourrts (India) Laboratories (Pvt)

Limited

2178Multivitamin Tablets Multivitamin Tablets P tablets 177/041 Fourrts (India) Laboratories (Pvt)

Limited

2179Glifil-M Forte Tablets Glibenclamide 5mg + Metformin

500mg

POM Tablet Uncoated 177/042 Fourrts (India) Laboratories (Pvt)

Limited

2180

Quadrajel Chlorhexidine 1% + Gluconate

Solution 1% + Metronidazole

Benzoate 2%

P Gel Oral 177/043 Fourrts (India) Laboratories (Pvt)

Limited

Page 106 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2181Combifil Suspension Pyrantel Pamoate 250mg, per

5ml

P Suspension for

Oral Use

177/044 Fourrts (India) Laboratories (Pvt)

Limited

2182Kontrac- 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 177/045 Fourrts (India) Laboratories (Pvt)

Limited

2183Tinifil Tablets Tinidazole 500mg POM Tablet Uncoated 177/046 Fourrts (India) Laboratories (Pvt)

Limited

2184

Redin plus Capsules Iron+ Folic Acid 1000mg + Zinc

Sulphate 5mg + Selenium 30mg

+ Histidine 50mg

POM Capsule oral 177/048 Fourrts (India) Laboratories (Pvt)

Limited

2185

Cold Fortinsa Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 2mg +

Caffeine 30mg

P Tablets

Uncoated

177/049 Fourrts (India) Laboratories (Pvt)

Limited

2186Ambcet Syrup Ambroxol Hydrochloride 30mg +

Cetirizine Hydrochloride 5mg

P Syrup 177/050 Fourrts (India) Laboratories (Pvt)

Limited

2187Ambcet Tablets Ambroxol Hydrochloride 60mg +

Cetirizine Hydrochloride 5mg

P Tablet Uncoated 177/051 Fourrts (India) Laboratories (Pvt)

Limited

2188Ibufil Suspension Ibuprofen 100mg, per 5ml P Suspension for

Oral Use

177/052 Fourrts (India) Laboratories (Pvt)

Limited

2189

L-Montus Tablets Levocetirizine Hydrochloride 5mg

+ Montelukast Sodium 10mg

P Tablet Uncoated 177/053 Fourrts (India) Laboratories (Pvt)

Limited

2190Cipfil 500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 3129/05 Fourrts (India) Laboratories (Pvt)

Limited

2191Redin PN liquid Haematenic + Calcium + Protein

+ Minerals

POM Solution for Oral

Use

177/047 Fourrts (India) Laboratories (Pvt)

Limited, india

2192Surfaz® Dusting Powder Clotrimazole 1%w/w P Powder for

Topical use

062/007 Franco-Indian Remedies Pvt Ltd,

India

2193

Diavit Plus Capsules Alpha Lipoic Acid USP.NF 200

mg + Beta Carotene USP

(200mg+3mg+1500mcg+20mg+7

0mcg+50mcg+40mg+2mg+0.5m

g+)

P Capsule oral 222/005 Franco-Indian Remedies Pvt Ltd,

India

2194

Stimuliv Syrup Kalmegh (Andrographis

paniculata) 60mg + Bhringaraj

(Eclipta 100mg+100mg

P Syrup 222/006 Franco-Indian Remedies Pvt Ltd,

India

2195

Omilcal Forte Tablets Tribasic Calcium Phosphate BP

1032mg + Heavy Magnesium

Oxide 66.32mg+26.40mg+6mg

P Tablet Uncoated 222/007 Franco-Indian Remedies Pvt Ltd,

India

Page 107 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2196Glyciphage Tablets Metformin 500mg POM Tablet Uncoated 274/001 Franco-Indian Remedies Pvt Ltd,

India

2197Beneuron Forte Tablets Multivitamin GS Tablet Film

coated

274/002 Franco-Indian Remedies Pvt Ltd,

India

2198Beetrion Tablets Multivitamin & Minerals GS Tablet Film

coated

274/003 Franco-Indian Remedies Pvt Ltd,

India

2199Propofol 1% Infusion Propofol 10mg, per ml POM Solution for

infusion

253/001 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2200Voluven Emulsion Hydroxyethyl 60g, per L POM Emulsion 253/002 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2201CAPD/DPCA 2 Stay safe Solution Peritoneal Dialysis Solution POM Solution for

infusion

254/030 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2202CAPD/DPCA 3 Stay safe Solution Peritoneal Dialysis Solution POM Solution for

infusion

254/031 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2203CAPD/DPCA 4 Stay safe Solution Peritoneal Dialysis Solution POM Solution for

infusion

254/032 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2204Gemita Injection Gemcitabine 1g POM Solution for

Injection

254/033 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2205Gemita 200 mg Injection Gemcitabine 200mg POM Solution for

Injection

254/034 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2206Intaxel Injection Paclitaxel 30mg, per 5ml POM Solution for

Injection

254/035 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2207Irinotel Injection Irinotecan 100mg POM Solution for

Injection

254/036 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2208Kemocarb Injection Carboplatin 150mg POM Solution for

Injection

254/037 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2209Oxitan Injection Oxaliplatin 50mg POM Solution for

Injection

254/038 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2210Trozet Tablets Letrozole 2.5mg POM Tablet Uncoated 254/039 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2211Kabiven Emulsion for Injection Glucose + Amino acids+

Minerals + Lipids

POM Emulsion 254/041 Frenesius Kabi S.A (Pty) Ltd,

South Africa

2212

Vitalipid Novum Adult Retinol palmitate 194.1 mcg + dl-

a-tocopherol 0.91mcg + Ergocalc

0.5mcg

POM Emulsion for

infusion

254/043 Fresenius Kabi S.A (Pty) Ltd,

South Africa

2213paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for

infusion

254/044 Fresenius Kabi S.A (Pty) Ltd,

South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2214

Smofkabiven® 800 SMOFlipid 20% / Aminoven 10%

(with or without electrolytes) /

glucose 42% - 800 kcal

POM Emulsion for

infusion

254/045 Fresenius Kabi S.A (Pty) Ltd,

South Africa

2215

Smofkabiven® 1100 SMOFlipid 20% / Aminoven 10%

(with or without electrolytes) /

glucose 42% - 1100 kcal

POM Emulsion for

infusion

254/046 Fresenius Kabi S.A (Pty) Ltd,

South Africa

2216Paracetamol Fresenius Infusion Paracetamol 1000mg POM Solution for

Infusion

254/044 Fresenius Kabi South Africa

2217Vincristine Sulphate Liquid Injection Vincristine 1mg, per ml POM Solution for

Injection

299/001MT Furen Pharmaceuticals Group Co.

Limited

2218Water for Injection BP Water For Injection BP POM Solution for

Injection

299/002MT Furen Pharmaceuticals Group Co.

Limited

2219MZ – CAL Tablets Calcium

Carbonate1000mg+Minerals

P Tablet Uncoated 372/001 Galaxy Pharmaceuticals Ltd

2220MZ – CAL Suspension Calcium carbonate BP equi. To

Calcium 150mg+Minerals

Pharmacy

Medicine

Suspension for

Oral Use

372/002 Galaxy Pharmaceuticals Ltd

2221Foetasafe Capsuless Omega 3 Fish Oil 600mg

+Vitamins + Minerals

Pharmacy

Medicine

Capsule oral 372/003 Galaxy Pharmaceuticals Ltd

2222Ginesomega Soft Capsuless Ginseng extract BP 50mg + Cod

liver Oil BP 50mg + Omega -3 F

Pharmacy

Medicine

Capsule oral 372/004 Galaxy Pharmaceuticals Ltd

2223

Cardiocare SoftGel Capsuless Alpha Lipoic Acid USP 50mg +

Coenzyme Q10 USP 50mg +

Citrus

Pharmacy

Medicine

Capsule oral 372/005 Galaxy Pharmaceuticals Ltd

2224

Neurocare Plus SoftGel Capsules Methycobalanin 750mcg+ Alpha

Lipoic Acid USP 100mg+ B6 BP

3mg +FA 1.5mg +Pregabalin

7.5mg

Pharmacy

Medicine

Capsule oral 372/006 Galaxy Pharmaceuticals Ltd

2225Vita UVD3 60000 SoftGel Capsuless Vitamin D3 BP 60000 IU Pharmacy

Medicine

Capsule oral 372/007 Galaxy Pharmaceuticals Ltd

2226

Cartilomega SoftGel Capsuless Glucosamine Sulphate USP

500mg + Chondroitin Sulphate

USP 200mg + Sodium H 3mg

Pharmacy

Medicine

Capsule Softgel 372/009L Galaxy Pharmaceuticals Ltd

2227 Fungigen Cream Miconazole 1%w/w POM Cream Topical 218/001 Galentic Pharma Limited, India

2228 Derm Keta Cream Ketoconazole 2.0%w/w POM Cream Topical 218/002 Galentic Pharma Limited, India

2229 Netracort Ointment Hydrocortisone 10mg POM Ointment topical 218/003 Galentic Pharma Limited, India

2230 Sylvadex Cream Silver Sulfadiazine 1.0%w/w P Cream Topical 218/004 Galentic Pharma Limited, India

2231 Kloraxin Eye Ointment Chloramphenicol 1%w/w POM Eye Ointment 218/005 Galentic Pharma Limited, India

2232 Diclofenac Gel Diclofenac 1.0%w/w P Gel Topical 218/006 Galentic Pharma Limited, India

2233 Tetracycline Hydrochloride Ointment Tetracycline 1%w/w POM Ointment topical 218/007 Galentic Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2234 Tetracycline Hydrochloride Ointiment Tetracycline 3%w/w POM Ointment topical 218/008 Galentic Pharma Limited, India

2235 Netracort Skin Ointment Hydrocortisone 1%w/w POM Ointment topical 218/009 Galentic Pharma Limited, India

2236

Pyloocain Ointment Bethametasone 0.5mg +

Phenylephrine 1mg + Lidocaine

25mg

POM Ointment topical 218/010 Galentic Pharma Limited, India

2237Caladine lotion Calamine 5% P Lotion for

Topical Use

218/011 Galentic Pharma Limited, India

2238

Neurocare SoftGel Capsules Methylcobalanin 1500mcg +

Gamma Linolenic Acid 60mg +

Alpha Lipoic Acid USP 100mg

+1.5mg + 3mg + 100mcg + 10mg

P Capsule oral 372/008L Galentic Pharma Limited, India

2239Helmanil Oral Suspension Albendazole 200mg, per 5ml POM Suspension for

Oral Use

200/001 Galpha Laboratories Ltd,India

2240Odicef Injection Ceftriaxone 1gm POM Powder for

Injection

200/002 Galpha Laboratories Ltd,India

2241Aben Oral Suspension Mebendazole 100mg, per 5ml P Suspension for

Oral Use

200/003 Galpha Laboratories Ltd,India

2242 Galmox Capsuless Amoxicillin 250mg POM Capsule oral 200/004 Galpha Laboratories Ltd,India

2243Clanoxy 375 Tablets Amoxicillin 250mg + Clavulanate

Potassium 125mg

POM Tablet Film

coated

200/005 Galpha Laboratories Ltd,India

2244 Galexin 250 Capsuless Cephalexin 250mg POM Capsule oral 200/006 Galpha Laboratories Ltd,India

2245Galmox 125 Oral Suspension Amoxicillin 125mg, per 5ml POM Powder for Oral

Suspension

200/008 Galpha Laboratories Ltd,India

2246Malartem Injection Artemether 80mg, per ml POM Solution for

Injection

200/009 Galpha Laboratories Ltd,India

2247Gallin Oral Suspension Ampicillin 125mg, per 5ml POM Powder for Oral

Suspension

200/010 Galpha Laboratories Ltd,India

2248Potamp 500 Capsuless Cloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 200/011 Galpha Laboratories Ltd,India

2249 Galin Capsuless Ampicillin 250mg POM Capsule oral 200/012 Galpha Laboratories Ltd,India

2250Metrogal Oral Suspension Metronidazole 200mg, per 5ml POM Suspension for

Oral Use

200/014 Galpha Laboratories Ltd,India

2251Clanoxy Dry Syrup Amoxicillin 200mg + Clavulanic

acid 28.5mg , per 5ml

POM Powder for Oral

Suspension

200/015 Galpha Laboratories Ltd,India

2252Galdic SR 100 Tablets Diclofenac 100mg P Tablet Film

coated

200/016 Galpha Laboratories Ltd,India

2253Hydrocortisone Sodium Injection Hydrocortisone 100mg, per 7.5ml POM Powder for

Injection

200/017 Galpha Laboratories Ltd,India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2254 Restum 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 200/018 Galpha Laboratories Ltd,India

2255 Restum 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 200/019 Galpha Laboratories Ltd,India

2256Altax Powder for Injection Cefotaxime 1gm POM Powder for

Injection

200/020 Galpha Laboratories Ltd,India

2257

Galprim-P Suspension Trimethoprim 40mg +

Sulphamethoxazole 200mg, per

5ml

POM Suspension 200/022 Galpha Laboratories Ltd,India

2258Ecocin Suspension Paracetamol 125mg, per 5ml GS Suspension for

Oral Use

200/023 Galpha Laboratories Ltd,India

2259Clanoxy 625 Tablets Amoxycillin 500mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 200/024 Galpha Laboratories Ltd,India

2260Galclox Oral Suspension Cloxacillin 125mg, per 5ml POM Suspension for

Oral Use

200/025 Galpha Laboratories Ltd,India

2261Galthrox 125 Oral Suspension Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

200/026 Galpha Laboratories Ltd,India

2262 Dr-x 50 Tablets Sildenafil 50mg POM Tablet Uncoated 200/027 Galpha Laboratories Ltd,India

2263Galexin 125 Suspension Cefalexin 125mg, per 5ml POM Suspension for

Oral Use

200/028 Galpha Laboratories Ltd,India

2264 Azvit-M Syrup Multivitamins GS Syrup 200/029 Galpha Laboratories Ltd,India

2265Galgin Capsules Dimethicone + Magnesium +

Aluminium Hydroxide

P Suspension 200/030 Galpha Laboratories Ltd,India

2266 Galamine P Syrup Chlorpheniramine 2mg P Syrup 200/031 Galpha Laboratories Ltd,India

2267

Desol Ear Drops Paradichlorobenzene 21.5mg +

Benzocaine 25mg +

Chlorobutanol 55mg +

Turpentine 157mg

P Ear Drops 273/001 Geno Pharmaceuticals Ltd, India

2268 Cypon Syrup Cyproheptadine + Tricholine P Syrup 273/002 Geno Pharmaceuticals Ltd, India

2269Brupal Tablets Ibuprofen 400mg + Paracetamol

325mg

P Tablet Uncoated 273/003 Geno Pharmaceuticals Ltd, India

2270

Peptica Gel Aluminium Hydroxide 225mg +

Magnesium Hydroxide 200mg +

Simethicone U 50mg

P Suspension for

Oral Use

273/004 Geno Pharmaceuticals Ltd, India

2271

Respira Cough Formula Ambroxol Hydrochloride 1.65mg

+ Salbutamol Sulphate 1.3mg +

Guafene 50mg

P Syrup 273/005 Geno Pharmaceuticals Ltd, India

2272

Myloxin - D Gel Oleoresin Capiscum 0.075%w/w

+ Methyl Salicylate 20%w/w +

Menthol 10%w/w + Camph

5%w/w

GS Gel Topical 273/006 Geno Pharmaceuticals Ltd, India

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2273

Respira - D Cough Formula Dextromethophan Hydrobromide

BP 10mg + Chlorpheinramine

Maleate BP 2mg

P Syrup 273/007 Geno Pharmaceuticals Ltd, India

2274Deriphyllin 300 Retard Tablets Theophylline Anhydrous BP +

Etofylline BP 300mg

POM Tablet Film

coated

159/001 Germany Remedies, India

2275Deriphyllin 150 Retard Tablets Theophylline Anhydrous BP +

Etofylline BP 150mg

POM Tablet Film

coated

159/002 Germany Remedies, India

2276Deriphylline Tablets Theophylline Anhydous BP +

Etofylline BP

POM Tablet Uncoated 159/003 Germany Remedies, India

2277Deriphylline Injection Theophylline Anhydrous BP +

Etofylline BP

POM Solution for

Injection

159/004 Germany Remedies, India

2278Deriphylline Syrup Theophylline Anhydrous BP +

Etofylline BP

POM Syrup 159/005 Germany Remedies, India

2279

Kalzana Tablets Ascobic acid 40mg +

Cholecalciferol BP 200iu+

Dibasic Calcium Phosphate BP

100mg

P Tablet Uncoated 159/006 Germany Remedies, India

2280Carbotin Injection Carboplatin 150mg, per 15ml POM Powder for

Injection

302/001 Getwell Pharmaceuticals Limited

2281Doxoruba Injection Doxorubicin 50mg, per 25ml POM Powder for

Injection

302/002 Getwell Pharmaceuticals Limited

2282Pacliwel Injection Paclitaxel 30mg, per 5ml POM Powder for

Injection

302/003 Getwell Pharmaceuticals Limited

2283Platicin Injection Cisplatin 10mg, per 10ml POM Powder for

Injection

302/004 Getwell Pharmaceuticals Limited

2284Taxewell Injection Docetaxel 120mg, per 3ml POM Powder for

Injection

302/005 Getwell Pharmaceuticals Limited

2285Zoldron Injection Zoledronic Acid 4mg, per 4ml POM Powder for

Injection

302/006 Getwell Pharmaceuticals Limited

2286Frusemide Injection Frusemide 10mg, per ml POM Solution for

Injection

403/001 Gland Pharma Ltd. India

2287Hyoscine Butylbromide Injection Hyoscine Butylbromide 20mg POM Solution for

Injection

403/002 Gland Pharma Ltd. India

2288

Actifed Cold Tablets Tripolidine Hydrochloride 1.25mg

+ Pseudoephrine Hydrochloride

3.00mg

P Tablets 025/004 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

2289

Eno Active Fruit Salts Citric Acid 2.16g + Sodium

Bicarbonate 2.29g + Sodium

Carbonate 0.5g

GS Powder for Oral

Solution

025/016 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2290Grandpa Tablets Aspirin 226.8mg + Caffeine

32.4mg + Paracetamol 162.0mg

GS Tablet Uncoated 025/017 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

2291Calpol Paediatric Suspension Paracetamol 120 mg, per 5ml GS Suspension for

Oral Use

025/018 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

2292Grandpa Headache Powder Aspirin 453.6mg + Caffeine

64.5mg + Paracetamol 324mg

GS Powder for Oral

Suspension

025/019 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

2293Med Lemon Sachets Aspirin 800mg + Caffeine 50mg

+ Ascorbic Acid 48mg

GS Powder for Oral

Solution

179/067 GlaxoSmithKline Consumer

Healthcare (Pty) Ltd, South Africa

2294Actifed Compound Linctus Triprolidine + Pseudoephedrine +

Dextromethorphen

P Syrup 025/001 GlaxoSmithKline Consumer

Healthcare SA Limited

2295Actifed Syrup Triprolidine + Pseudoephedrine P Syrup 025/003 GlaxoSmithKline Consumer

Healthcare SA Limited

2296Eltroxin Tablets Thyroxine 100mcg POM Tablet Uncoated 179/052 GlaxoSmithKline Consumer

Healthcare SA Limited

2297Corsodyl Mouthwash - Mint Chlorhexidine Gluconate 2mg,

per ml

GS Solution for Oral

Use

179/061 GlaxoSmithKline Consumer

Healthcare SA Limited

2298

Med-Lemon HM with Vitamin C Powder

for Suspension

Aspirin 800 mg + Caffeine 50 mg

+ Ascorbic Acid 45 mg + Menthol

2.6mg

GS powder for

Suspension

179/067 GlaxoSmithKline Consumer

Healthcare SA Limited

2299Vibrocil Nasal Drops Phenylephrine + Dimethendene P Nasal drops 242/003 GlaxoSmithKline Consumer

Healthcare SA Limited

2300Proctoglyvenol Cream Lidocaine + Tribenocide POM Cream Topical 242/004 GlaxoSmithKline Consumer

Healthcare SA Limited

2301Otrivin Spray Xylometazoline 0.1%w/v POM Spray For Nasal

Use

242/006 GlaxoSmithKline Consumer

Healthcare SA Limited

2302Lamisil Cream Terbinafine 10% POM Cream Topical 242/008 GlaxoSmithKline Consumer

Healthcare SA Limited

2303Eurax Cream Crotamiton 10% POM Cream Topical 242/012 GlaxoSmithKline Consumer

Healthcare SA Limited

2304Otrivin Nasal Drops Xylometazoline Hydrochloride

0.05% w/v

P Nasal drops 242/013 GlaxoSmithKline Consumer

Healthcare SA Limited

2305Otrivin Nasal Drops-Adults Xylometazoline Hydrochloride

0.1% w/v

P Nasal drops 242/014 GlaxoSmithKline Consumer

Healthcare SA Limited

2306

Voltaren Gel Diclofenac Diethylamide

corresponding to 1g Diclofenac

Sodium per 100g

POM Topical gel 242/015 GlaxoSmithKline Consumer

Healthcare SA Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2307

Calcium Forte Effervescent Tablets Calcium Carbonate 0.3g +

Calcium lactate Gluconate 2.94g

equivalent to 500mg elemental

Calcium

P Effervescent

Tablets

242/016 GlaxoSmithKline Consumer

Healthcare SA Limited

2308

Calcium + Vitamin C Tablets Ascorbic Acid 1000mg + Calcium

Lactate Gluconate 1000mg +

Calcium Carbonate 327mg

P Tablets

Uncoated

242/017 GlaxoSmithKline Consumer

Healthcare SA Limited

2309Panado Advance Tablets Paracetamol 500mg GS Tablets

Uncoated

242/019 GlaxoSmithKline Consumer

Healthcare SA Limited

2310Panado Extra Tablets Paracetamol 500mg + Caffeine GS Tablets

Uncoated

242/020 GlaxoSmithKline Consumer

Healthcare SA Limited

2311

Rotarix Vaccine Live attenauted Human

Rotovirus RIX 4414 1000000

CCID 50

POM Oral Suspension 025/034 GlaxoSmithKline SA (Pty) Ltd

2312Clavulin Suspension Amoxicillin + Clavulanic Acid

156mg, per 5ml

POM Suspension for

Oral Use

179/001 GlaxoSmithKline SA (Pty) Ltd

2313 Bactroban Cream Mupirocin 10.5% POM Cream Topical 179/003 GlaxoSmithKline SA (Pty) Ltd

2314 Ziagen Tablets Abacavir 300mg POM Tablet Uncoated 179/004 GlaxoSmithKline SA (Pty) Ltd

2315Combivir Tablets Lamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 179/005 GlaxoSmithKline SA (Pty) Ltd

2316Epivir Oral Solution Lamivudine 10mg, per ml POM Solution for Oral

use

179/006 GlaxoSmithKline SA (Pty) Ltd

2317Epivir Tablets Lamivudine 150mg POM Tablet film

coated

179/007 GlaxoSmithKline SA (Pty) Ltd

2318 Alben 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/008 GlaxoSmithKline SA (Pty) Ltd

2319Augmentin Oral Suspension Amoxicillin + Clavulanic Acid POM Suspension for

Oral Use

179/009 GlaxoSmithKline SA (Pty) Ltd

2320Telzir Suspension Fosamprenavir 50mg, per ml POM Suspension for

Oral Use

179/010 GlaxoSmithKline SA (Pty) Ltd

2321Kivexa Tablets Abacavir 600mg + Lamivudine

300mg

POM Tablet film

coated

179/011 GlaxoSmithKline SA (Pty) Ltd

2322Zinnat Suspension Cefuroxime 125mg, per 5ml POM Suspension for

Oral Use

179/013 GlaxoSmithKline SA (Pty) Ltd

2323

Flixonase Aqueous Nasal Spray

(Micronized fluticasone propionate

0.5% w/w)

Fluticasone Propionate POM Nasal spray 179/014 GlaxoSmithKline SA (Pty) Ltd

2324 Zinnat 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 179/015 GlaxoSmithKline SA (Pty) Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2325Zinacef Injection Cefuroxime 750mg POM Solution for

Injection

179/016 GlaxoSmithKline SA (Pty) Ltd

2326 Zinnat 250 Tablets Cefuroxime 250mg POM Tablet Uncoated 179/017 GlaxoSmithKline SA (Pty) Ltd

2327 Engerix B Paediatric Tablets Hepatitis B 10mcg, per 0.5ml POM Tablet Uncoated 179/018 GlaxoSmithKline SA (Pty) Ltd

2328 Engerix B Adult Injection Hepatitis B 20mcg, per ml POM Tablet Uncoated 179/019 GlaxoSmithKline SA (Pty) Ltd

2329Halfan Suspension Halofantrine 125mg, per 5ml POM Suspension for

Oral Use

179/020 GlaxoSmithKline SA (Pty) Ltd

2330 Halfan Tablets Halofantrine 250mg POM Tablet Uncoated 179/021 GlaxoSmithKline SA (Pty) Ltd

2331 Zentel 400 Tablets Albendazole 400mg POM Tablet Uncoated 179/022 GlaxoSmithKline SA (Pty) Ltd

2332Otosporin Ear Drops Hydrocortisone + Neomycin +

Polymixin B

POM Ear Drops 179/028 GlaxoSmithKline SA (Pty) Ltd

2333Augmentin SF Suspension Amoxicillin 200mg + Potassium

Clavulanate 28.50mg

POM Tablet Uncoated 179/030 GlaxoSmithKline SA (Pty) Ltd

2334Augmentin BD Suspension Amoxicillin + Potassium

Clavulanate 375mg

POM Suspension for

Oral Use

179/032 GlaxoSmithKline SA (Pty) Ltd

2335Zentel Suspension Albendazole 125mg POM Suspension for

Oral Use

179/033 GlaxoSmithKline SA (Pty) Ltd

2336 Flixotide Inhaler Fluticasone 1g POM Capsule oral 179/034 GlaxoSmithKline SA (Pty) Ltd

2337 Flixotide 125 Inhaler Fluticasone 125mcg POM Capsule oral 179/035 GlaxoSmithKline SA (Pty) Ltd

2338Flixotide Inhaler Fluticasone 50mcg POM Solution for

Injection

179/036 GlaxoSmithKline SA (Pty) Ltd

2339Augmentin BD Tablets Amoxicillin + Potassium

Clavulanate 1g

POM Suspension for

Oral Use

179/037 GlaxoSmithKline SA (Pty) Ltd

2340Ventolin cfc Inhaler Salbutamol 100mcg POM Solution for

Inhalation

179/038 GlaxoSmithKline SA (Pty) Ltd

2341Seretide Inhaler Salmeterol 25mg + Fluticasone

100mg

POM Solution for

Inhalation

179/039 GlaxoSmithKline SA (Pty) Ltd

2342Seretide Inhaler Salmeterol 25mg + Fluticasone

125mg

POM Solution for

Inhalation

179/040 GlaxoSmithKline SA (Pty) Ltd

2343Seretide Inhaler Salmeterol 25mg + Fluticasone

250mg

POM Solution for

Inhalation

179/041 GlaxoSmithKline SA (Pty) Ltd

2344Seretide Inhaler Salmeterol 50mg + Fluticasone

100mg

POM Solution for

Inhalation

179/042 GlaxoSmithKline SA (Pty) Ltd

2345Seretide Inhaler Salmeterol 50mg + Fluticasone

250mg

POM Solution for

Inhalation

179/043 GlaxoSmithKline SA (Pty) Ltd

2346Seretide Inhaler Salmeterol 50mg + Fluticasone

500mg

POM Solution for

Inhalation

179/044 GlaxoSmithKline SA (Pty) Ltd

2347Augmentin Suspension Amoxicillin 125mg + Potassium

Clavulanate 31mg

POM Suspension for

Oral Use

179/045 GlaxoSmithKline SA (Pty) Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2348Augmentin BD SF Suspension Amoxicillin 400mg + Potassium

Clavulanate 59.85mg

POM Suspension for

Oral Use

179/046 GlaxoSmithKline SA (Pty) Ltd

2349 Bactroban Ointment Mupirocin 2%w/w POM Cream Topical 179/049 GlaxoSmithKline SA (Pty) Ltd

2350 Eltroxin Tablets Thyroxine 50mcg POM Cream Topical 179/051 GlaxoSmithKline SA (Pty) Ltd

2351Rotarix Liquid Oral Vaccine Live Attenauted Human

Rotovirus RIX 4414

POM Solution for Oral

Use

179/056 GlaxoSmithKline SA (Pty) Ltd

2352

Synflorix Vaccine Pneumococcal polysaccharide

serotype 1, 4, 5, 6B, 7F, 9V, 14,

18C, 19F & 23F

POM Suspension for

Injection

179/057 GlaxoSmithKline SA (Pty) Ltd

2353Ventolin Rotacaps Salbutamol 200mcg POM Capsule for

Inhalation

179/058 GlaxoSmithKline SA (Pty) Ltd

2354Aropax 20 Tablets Paroxetine Hydrochloride

Hemihdrate 20mg

POM Tablet Uncoated 179/059 GlaxoSmithKline SA (Pty) Ltd

2355Augumentin - 600 Suspension Amoxicillin 600mg + Clavulanic

Acid 42.9mg

POM Powder for Oral

Suspension

179/062 GlaxoSmithKline SA (Pty) Ltd

2356Cervarix Human Papilomavirus Vaccine Human Papillomavirus type 16

L1 and 18 L1

POM Suspension for

Injection

179/066 GlaxoSmithKline SA (Pty) Ltd

2357Avamys Nasal Spray Fluticasone Furoate POM Spray For Nasal

Use

179/068 GlaxoSmithKline SA (Pty) Ltd

2358Polio Sabin One and Three (Oral)

Bivalent Oral Poliomyelitis Vaccine T

Oral Poliomyelitis Vaccine POM Suspension for

Oral Use

179/069 GlaxoSmithKline SA (Pty) Ltd

2359

Candid B Cream Clotrimazole 1%w/w +

Beclometasone Dipropionate

0.025 % w/w.

POM Cream Topical 093/001 Glenmark Pharmaceuticals

Limited, India

2360

Candid B lotion Clotrimazole 1% w/v +

Beclomethasone Dipropionate

0.025% w/v

POM Lotion for

Topical Use

093/002 Glenmark Pharmaceuticals

Limited, India

2361Candid Cream Clotrimazole 1% w/w POM Cream Topical 093/003 Glenmark Pharmaceuticals

Limited, India

2362

Candiderm Cream Gentamicin 0.1% w/w +

Beclometasone Dipropionate

0.025% w/w + Clotrimazole 1%

w/w

POM Cream Topical 093/004 Glenmark Pharmaceuticals

Limited, India

2363Candid Dusting Powder Clotrimazole 1% w/w POM Powder for

Topical use

093/005 Glenmark Pharmaceuticals

Limited, India

2364

Candid Ear Drops Clotrimazole 1% w/v +

Lignocaine Hydrochloride 2% w/v

POM Ear Drops 093/006 Glenmark Pharmaceuticals

Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2365Candid lotion Clotrimazole 1% w/v POM Lotion for

Topical Use

093/007 Glenmark Pharmaceuticals

Limited, India

2366Candid Mouth Paint Clotrimazole 1%w/v POM Suspension for

Oral Use

093/008 Glenmark Pharmaceuticals

Limited, India

2367Candid TV Lotion Selenium sulfide 2.5% w/v +

Clotrimazole 1% w/v

POM Lotion for

Topical Use

093/009 Glenmark Pharmaceuticals

Limited, India

2368Candid V Gel Clotrimazole 2% w/w POM Gel Vaginal 093/010 Glenmark Pharmaceuticals

Limited, India

2369CandidV-1 Vaginal Tablets Clotrimazole 500mg POM Tablet Vaginal 093/011 Glenmark Pharmaceuticals

Limited, India

2370CandidV-3 Vaginal Tablets Clotrimazole 200mg POM Tablet Vaginal 093/012 Glenmark Pharmaceuticals

Limited, India

2371Candid V-6 Vaginal Tablets Clotrimazole 100mg POM Tablet Vaginal 093/013 Glenmark Pharmaceuticals

Limited, India

2372Diziron Tablets Cinnarizine 25mg POM Tablet Uncoated 093/014 Glenmark Pharmaceuticals

Limited, India

2373Scaboma Cream Benzocaine 2% w/w + Lindane

2% w/w

P Cream Topical 093/015 Glenmark Pharmaceuticals

Limited, India

2374Scaboma lotion Lindane 1%w/w P Lotion for

Topical Use

093/016 Glenmark Pharmaceuticals

Limited, India

2375Supricort Cream Fluocinolone Acetonide 0.025%

w/w

POM Cream Topical 093/017 Glenmark Pharmaceuticals

Limited, India

2376Supricort N Cream Neomycin Sulphate 0.5% +

Fluocinolone Acetonide 0.025%

POM Cream Topical 093/018 Glenmark Pharmaceuticals

Limited, India

2377Supricort Skin lotion Fluocinolone Acetonide 0.025% POM Lotion for

Topical Use

093/019 Glenmark Pharmaceuticals

Limited, India

2378Syntran DS Tablets Sulphamethoxazole 800mg +

Trimethoprim 160mg

POM Tablet Uncoated 093/020 Glenmark Pharmaceuticals

Limited, India

2379Syntran Paediatric Syrup Sulfamethoxazole 200mg +

Trimethoprim 40mg

POM Syrup 093/021 Glenmark Pharmaceuticals

Limited, India

2380Vorth 10 Tablets Valdecoxib 10mg POM Tablet Uncoated 093/022 Glenmark Pharmaceuticals

Limited, India

2381Vorth 20 Tablets Valdecoxib 20mg POM Tablet Uncoated 093/023 Glenmark Pharmaceuticals

Limited, India

2382Deriva Aqueous Gel Adapalene 0.1%w/v P Gel Topical 093/024 Glenmark Pharmaceuticals

Limited, India

2383Rosicon-2mg Tablets Rosiglitazone 2mg POM Tablet Uncoated 093/025 Glenmark Pharmaceuticals

Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2384Rosicon-4 Tablets Rosiglitazone 4mg POM Tablet Uncoated 093/026 Glenmark Pharmaceuticals

Limited, India

2385Mumfer Syrup Haematinic preparation (Ferric

Hydroxide 50mg, per 5ml)

P Syrup 093/027 Glenmark Pharmaceuticals

Limited, India

2386Mumfer Drops Haematinic preparation (Ferric

Hydroxide 50mg, per ml)

P Solution for Oral

Use

093/028 Glenmark Pharmaceuticals

Limited, India

2387Esoz Tablets Esomeprazole 20mg POM Tablet Uncoated 093/029 Glenmark Pharmaceuticals

Limited, India

2388Esoz-40 Tablets Esomeprazole 40mg POM Tablets oral 093/030 Glenmark Pharmaceuticals

Limited, India

2389Glevo-250 Tablets Levofloxacin 250mg POM Tablet Uncoated 093/031 Glenmark Pharmaceuticals

Limited, India

2390Glevo-500 Tablets Levofloxacin 500mg POM Tablet Uncoated 093/032 Glenmark Pharmaceuticals

Limited, India

2391Glevo 500 Infusion Levofloxacin 500mg POM Solution for

infusion

093/033 Glenmark Pharmaceuticals

Limited, India

2392Powercort Cream Clobetasol Propionate 0.05% POM Cream Topical 093/034 Glenmark Pharmaceuticals

Limited, India

2393

Mumfer Chewable Tablets Haematinic Preparation (Folic

Acid 500 mcg + Iron (II)

Hydroxide Polymaltose Complex

100mg)

P Tablet Chewable 093/035 Glenmark Pharmaceuticals

Limited, India

2394Elovera Cream Tecopherol Acetate 0.5% w/w +

Aloe crude extract 10.0 %w/w

P Cream Topical 093/036 Glenmark Pharmaceuticals

Limited, India

2395

Relcer Gel Suspension Aluminium Hydroxide 6g +

Magnesium Hydroxide 80mg +

Acitvated Dimethicone 100mg +

Deglycyrrhized Liquorice 400

mg/5 mL.

P Suspension for

Oral Use

093/038 Glenmark Pharmaceuticals

Limited, India

2396Glenseng Capsules Ginseng extract 500mg GS Capsule oral 093/039 Glenmark Pharmaceuticals

Limited, India

2397

Ascoril Expectorant Sabutamol Sulphate 2mg +

Bromhexine Hydrochloride 4mg

+ Menthol 1mg + Guaiphenesin

100mg, per 5ml

POM Solution for Oral

Use

093/040 Glenmark Pharmaceuticals

Limited, India

2398Altacef Suspension Cefuroxime Axetil 125mg, per

5ml

POM Powder for Oral

Suspension

093/041 Glenmark Pharmaceuticals

Limited, India

2399Altacef Tablets Cefuroxime Axetil 250mg POM Tablet Film

coated

093/042 Glenmark Pharmaceuticals

Limited, India

Page 118 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2400Altacef Tablets Cefuroxime Axetil 500mg POM Tablet Uncoated 093/043 Glenmark Pharmaceuticals

Limited, India

2401Ciproglen Tablets Ciprofloxacin 500mg POM Tablet Uncoated 093/044 Glenmark Pharmaceuticals

Limited, India

2402Glimulin Tablets Glimepiride 2mg POM Tablet Uncoated 093/045 Glenmark Pharmaceuticals

Limited, India

2403Enamate 10 Tablets Enalapril 10mg POM Tablet Uncoated 093/046 Glenmark Pharmaceuticals

Limited, India

2404Altacef 750 Injection Cefuroxime 750mg POM Powder for

Injection

093/047 Glenmark Pharmaceuticals

Limited, India

2405Altacef 250mg Injection Cefuroxime 250mg POM Powder for

Injection

093/048 Glenmark Pharmaceuticals

Limited, India

2406Glucar Tablets Acarbose 50mg POM Tablet Uncoated 093/049 Glenmark Pharmaceuticals

Limited, India

2407Erythromycin Tablets Erythromycin Stearate250mg POM Tablet Film

coated

093/050 Glenmark Pharmaceuticals

Limited, India

2408Perigard 2 Tablets Perindopril 2mg POM Tablet Uncoated 093/051 Glenmark Pharmaceuticals

Limited, India

2409Perigard 4 Tablets Perindopril 4mg POM Tablet Uncoated 093/052 Glenmark Pharmaceuticals

Limited, India

2410Telma 20 Tablets Telmisartan 20mg POM Tablet Uncoated 093/053 Glenmark Pharmaceuticals

Limited, India

2411Telma 40 Tablets Telmisartan 40mg POM Tablet Uncoated 093/054 Glenmark Pharmaceuticals

Limited, India

2412Telma-H Tablets Hydrochlorothiazide 12.5mg +

Telmisartan 40mg

POM Tablet Uncoated 093/055 Glenmark Pharmaceuticals

Limited, India

2413Valus AP Tablets Paracetamol 500mg +

Aceclofenac 100mg

P Tablet Uncoated 093/056 Glenmark Pharmaceuticals

Limited, India

2414Doxetaxel 80mg Injection Doxetaxel 80mg POM Powder for

Injection

093/057 Glenmark Pharmaceuticals

Limited, India

2415Doxetaxel 20mg Injection Doxetaxel 20mg POM Powder for

Injection

093/058 Glenmark Pharmaceuticals

Limited, India

2416Irinotecan 100mg Servycal Injection Irinotecan Hydrochloride

Trihydrate 100mg

POM Powder for

Injection

093/059 Glenmark Pharmaceuticals

Limited, India

2417Irinotecan 40mg Servycal Injection Irinotecan Hydrochloride

Trihydrate 40mg

POM Powder for

Injection

093/060 Glenmark Pharmaceuticals

Limited, India

2418Oxaliplatino Servycal 100mg Injection Oxaliplatin 100mg POM Powder for

Injection

093/061 Glenmark Pharmaceuticals

Limited, India

Page 119 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2419Oxaliplatino Servycal 50mg Injection Oxaliplatin 50mg POM Powder for

Injection

093/062 Glenmark Pharmaceuticals

Limited, India

2420Doxorubicina 50mg Servycal Injection Doxorubicin Hydrochloride 50mg Vial Vial 093/063 Glenmark Pharmaceuticals

Limited, India

2421Doxorubicina 10mg Servycal Injection Doxorubicin Hydrochloride 10mg POM Powder for

Injection

093/064 Glenmark Pharmaceuticals

Limited, India

2422Carboplastino Servycal 450mg

Injection

Carboplatin 450mg POM Powder for

Injection

093/065 Glenmark Pharmaceuticals

Limited, India

2423Carboplastino Servycal 150mg

Injection

Carboplatin 150mg POM Powder for

Injection

093/066 Glenmark Pharmaceuticals

Limited, India

2424Paclitaxel Servycal 30 mg Injection Paclitaxel 30mg POM Powder for

Injection

093/067 Glenmark Pharmaceuticals

Limited, India

2425Paclitaxel Servycal 100mg Injection Paclitaxel 100mg POM Powder for

Injection

093/068 Glenmark Pharmaceuticals

Limited, India

2426

Leucovorina servycal 50mg Injection Leucovorin Calcica 50mg POM Lyophilised

concentrate for

Injection

093/069 Glenmark Pharmaceuticals

Limited, India

2427Ondansetron Servycal 8mg Injection Ondansetron 8mg, per 4ml POM Solution for

Injection

093/070 Glenmark Pharmaceuticals

Limited, India

2428Supirocin Ointment Mupirocin 2% w/w POM Cream Topical 093/071 Glenmark Pharmaceuticals

Limited, India

2429X-met Tablets Metformin Hydrochloride 500mg POM Tablet extended

release

093/072 Glenmark Pharmaceuticals

Limited, India

2430Ascovent Syrup Acebrophylline 50mg, per 5ml P Syrup 093/073 Glenmark Pharmaceuticals

Limited, India

2431Halovate Ointment Halobetasol Propionate

0.05%w/w

POM Ointment topical 093/074 Glenmark Pharmaceuticals

Limited, India

2432Artiglen+ Tablets Artemether 80mg + Lumefantrine

480mg

POM Tablet Uncoated 093/075 Glenmark Pharmaceuticals

Limited, India

2433Artiglen + Dry Syrup 60mls Artemether180mg +

Lumefantrine 1080mg

POM Powder for Oral

Suspension

093/076 Glenmark Pharmaceuticals

Limited, India

2434Beclometasone Pressurised Inhalation Beclamethasone Dipropionate

Anhydrous 250mcg

POM Solution for

Inhalation

093/077 Glenmark Pharmaceuticals

Limited, India

2435

Relcer Gel Vanilla Flavour Aluminium Hydroxide 365mg +

Magnesium Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized Liquorice 400

mg

POM Suspension for

Oral Use

093/078 Glenmark Pharmaceuticals

Limited, India

Page 120 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2436

Relcer Gel Mango Flavour Aluminium Hydroxide 365mg +

Magnesium Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized Liquorice 400

mg

POM Suspension for

Oral Use

093/079 Glenmark Pharmaceuticals

Limited, India

2437

Relcer Gel Strawberry Flavour Aluminium Hydroxide 365mg +

Magnesium Hydroxide 80mg +

Simethicone 100mg

+Deglycyrrhized Liquorice 400

mg

POM Suspension for

Oral Use

093/080 Glenmark Pharmaceuticals

Limited, India

2438Flexilor 4 Tablets Lornoxicam 4mg P Tablet Uncoated 093/081 Glenmark Pharmaceuticals

Limited, India

2439Flexilor 8 Tablets Lornoxicam 8mg P Tablet Uncoated 093/082 Glenmark Pharmaceuticals

Limited, India

2440Flexilor -SR Tablets Lornoxicam 16mg P Tablet sustained

release

093/083 Glenmark Pharmaceuticals

Limited, India

2441

Ascoril D Syrup Dextromethorphan Hydromide

10.00mg + Triprolidine

Hydrochloride 1.25mg +

Phenylephrine Hydrochloride

30.00mg

P Solution for Oral

Use

093/084 Glenmark Pharmaceuticals

Limited, India

2442Esoz Fast Tablets 20mg Esomeprazole Magnesium 20mg POM Tablet Film

coated

093/085 Glenmark Pharmaceuticals

Limited, India

2443Esoz Fast Tablets 40mg Esomeprazole Magnesium 40mg POM Tablet Film

coated

093/086 Glenmark Pharmaceuticals

Limited, India

2444

Airtec SF 50 Inhaler Salmeterol Xinafoate BP 25mcg

+ Fluticasone Propionate BP

50mcg

POM Solution for

Inhalation

093/087 Glenmark Pharmaceuticals

Limited, India

2445

Airtec SF-125 Inhaler Salmeterol Xinafoate BP 25mcg

+ Fluticasone Propionate BP

125mcg

POM Solution for

Inhalation

093/088 Glenmark Pharmaceuticals

Limited, India

2446

Airtec SF 250 Inhaler Salmeterol Xinafoate BP 25mcg

+ Fluticasone Propionate BP

250mcg

POM Solution for

Inhalation

093/089 Glenmark Pharmaceuticals

Limited, India

2447Dermikelp Topical Cream Ecklonia maxima extract

375mg/g

GS Cream Topical 093/090 Glenmark Pharmaceuticals

Limited, India

2448V Wash Plus Lactic Acid 1.2% w/v GSL Liquid soap 093/091 Glenmark Pharmaceuticals

Limited, India

Page 121 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2449Razel 20 Tablets Rosuvastatin (as calcium) 20mg POM Tablet Uncoated 093/095 Glenmark Pharmaceuticals

Limited, India

2450Razel 10 Tablets Rosuvastatin (as calcium) 10mg POM Tablet Uncoated 093/096 Glenmark Pharmaceuticals

Limited, India

2451Tacroz Forte Ointment Tacrolimus 0.1% w/w POM Ointment topical 093/097 Glenmark Pharmaceuticals

Limited, India

2452Glemont - CT4 Tablets Monteleukast Sodium 4mg POM Tablet Chewable 093/099 Glenmark Pharmaceuticals

Limited, India

2453Glemont- CT5 Tablets Monteleukast Sodium 5mg POM Tablet Chewable 093/100 Glenmark Pharmaceuticals

Limited, India

2454

Demelan 15g Cream Glycolic Acid 100mg + Alpha-

Albutin 50 mg + Kojic Dipalmitate

20mg

GS Cream Topical 093/101 Glenmark Pharmaceuticals

Limited, India

2455Razel 40 Tablets Rosuvastatin (as Calcium) 40mg POM Tablet Uncoated 093/102 Glenmark Pharmaceuticals

Limited, India

2456

Sensur Lotion Wintergreen oil 12 % w/v +

Peppermint oil 1 % w/v + Clove

oil 1 % w/v + Cinnamon oil 1 %

w/v + Camphor 7 % w/v +

Mentha Piperita 7 % w/v +

Eucalyptus oil 7 % w/v.

GS Lotion for

Topical Use

093/103L Glenmark Pharmaceuticals

Limited, India

2457

Sensur Rubefacient Mentha Piperita 14 % w/w +

Eucalyptus Oil 7.5 % w/v +

Camphor 14.7 % w/w + Clove Oil

7.8 % v/v + Cinnamon Oil 2 %

w/v + Peppermint Oil 8 % w/v.

GS Ointment topical 093/104L Glenmark Pharmaceuticals

Limited, India

2458

Sensor Roll Mentha Piperita 14 % w/v +

Wintergreen Oil 40 % v/v +

Camphor 17 % v/v + Eucalyptus

Oil 6.5 % v/v.

GS Solution for

Topical Use

093/105L Glenmark Pharmaceuticals

Limited, India

2459Burnstart Dressing Medical grade Aluminosilicate

powder 46.5% w/w

P Paste Topical 027/001L Global Natural Products

2460 G-Vit Tablets with Minerals Tablets Multivitamin + Minerals P Tablet Uncoated 291/001 Global Pharma Healthcare

2461 Rabazole - 20 Tablets Rabeprazole 20mg POM Tablet Uncoated 291/003 Global Pharma Healthcare

2462 D-Lor Tablets Desloratadine 5mg P Tablet Uncoated 291/004 Global Pharma Healthcare

2463 Priloten - 5 Tablets Enalapril 5mg POM Tablet Uncoated 291/005 Global Pharma Healthcare

Page 122 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2464

Feramin Tablets Folic Acid 500mg +

Methylcobalamin 50mg +

Elemental Iron 1mg + Zinc

61.8mg

P Tablet Uncoated 291/002 Global Pharma Healthcare, India

2465TiniTablets- N Tablets Tinidazole 600mg + Norfloxacin

400mg

POM Tablet Uncoated 291/006 Global Pharma Healthcare, India

2466 Anaflam Tablets Ibuprofen 400mg P Tablet Uncoated 291/007 Global Pharma Healthcare, India

2467 Tryzin Tablets Cetirizine Dihydrochloride 10mg P Tablet Uncoated 291/008 Global Pharma Healthcare, India

2468

Polybac -N Ointment Bactricine Zinc 5000units +

Neomycin Sulphate 400units +

Polymixin B Su 3400units

POM Ointment topical 291/009 Global Pharma Healthcare, India

2469 Dolmax Gel Diclofenac Sodium 1%w/w P Gel Topical 291/010 Global Pharma Healthcare, India

2470LA - DS Tablets Artemether 40mg + Lumefantrine

240mg

POM Tablet Uncoated 291/011 Global Pharma Healthcare, India

2471Ferrous Sulphate Tablets Ferrous Sulphate 200mg POM Tablet Uncoated 221/001 Glow Export Trading Pvt Ltd, India

2472

Cetrol ORS Powder Sodium Chloride 3.5g + Sodium

Citrate 2.9g + Potassium

Chloride 1.5g + Anhydrous

Glucose 20g

POM Powder for Oral

Solution

221/002 Glow Export Trading Pvt Ltd, India

2473Artesunate Tablets Artesunate 100mg POM Tablet Uncoated 221/003 Glow Export Trading Pvt Ltd, India

2474G-Prop Tablets Propranolol 40mg POM Tablet Uncoated 221/004 Glow Export Trading Pvt Ltd, India

2475Pharmadar Tablets Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 169/001 Glumex Pharmaceuticals (Pvt)

Ltd, India

2476Eryomycin Syrup Erythromycin 125mg, per 5ml POM Syrup 169/002 Glumex Pharmaceuticals (Pvt)

Ltd, India

2477C.P.Mex Syrup Chlorpheniramine 2mg, per 5ml P Syrup 169/003 Glumex Pharmaceuticals (Pvt)

Ltd, India

2478Glucain Tablets Aluminium Hydrochloride 120mg

+ Magnesium trisilicate 250 mg

GS Tablet Uncoated 169/004 Glumex Pharmaceuticals (Pvt)

Ltd, India

2479Pharmadar Suspension Sulphadoxine 250 mg +

Pyrimethamine 12.50mg

P Suspension for

Oral Use

169/005 Glumex Pharmaceuticals (Pvt)

Ltd, India

2480Biovit-Z-Syrup Multivitamins + Minerals P Syrup 169/006 Glumex Pharmaceuticals (Pvt)

Ltd, India

2481

Cold care Tablets Chlorpheniramine 2mg +

Caffeine 30mg + Paracetamol

500mg

P Tablet Uncoated 169/007 Glumex Pharmaceuticals (Pvt)

Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2482Gluvit Syrup Multivitamins + Minerals GS Syrup 169/008 Glumex Pharmaceuticals (Pvt)

Ltd, India

2483Lopamet Capsules Loperamide 2mg POM Capsule oral 169/010 Glumex Pharmaceuticals (Pvt)

Ltd, India

2484Apectin Tablets Cyproheptadine 4mg P Tablet Uncoated 169/011 Glumex Pharmaceuticals (Pvt)

Ltd, India

2485Clopin Syrup Ampicillin 125mg + Cloxacillin

125mg, per 5ml

POM Powder for Oral

Solution

169/012 Glumex Pharmaceuticals (Pvt)

Ltd, India

2486Cephamex Syrup Cephalexin 125mg, per 5ml POM Powder for Oral

Solution

169/013 Glumex Pharmaceuticals (Pvt)

Ltd, India

2487Flucomex Capsules Fluconazole 200mg POM Capsule oral 169/014 Glumex Pharmaceuticals (Pvt)

Ltd, India

2488Eromycin Tablets Erythromycin 250mg POM Tablet Uncoated 169/015 Glumex Pharmaceuticals (Pvt)

Ltd, India

2489Amizide Tablets Hydrochlorothiazide 50mg +

Amiloride Hydrochloride 5mg

POM Tablet Uncoated 169/017 Glumex Pharmaceuticals (Pvt)

Ltd, India

2490Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 169/018 Glumex Pharmaceuticals (Pvt)

Ltd, India

2491Zovex Tablets Acyclovir 200mg POM Tablet Uncoated 169/019 Glumex Pharmaceuticals (Pvt)

Ltd, India

2492Carbamax Tablets Carbamazepine 200mg POM Tablets 169/020 Glumex Pharmaceuticals (Pvt)

Ltd, India

2493Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 169/021 Glumex Pharmaceuticals (Pvt)

Ltd, India

2494Pyridoxine Tablets Pyridoxine 50mg POM Tablet Uncoated 169/022 Glumex Pharmaceuticals (Pvt)

Ltd, India

2495Nalidiixic Acid Oral Suspension Nalidixic acid 300mg, per 5ml POM Oral Suspension 169/023 Glumex Pharmaceuticals (Pvt)

Ltd, India

2496Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 169/024 Glumex Pharmaceuticals (Pvt)

Ltd, India

2497Glibenclamide Tablets Glibenclamide 5mg POM Tablet Uncoated 169/025 Glumex Pharmaceuticals (Pvt)

Ltd, India

2498Viengray Tablets Sildenafil 50mg POM Tablet Uncoated 169/026 Glumex Pharmaceuticals (Pvt)

Ltd, India

2499Apectine Syrup Cyproheptidine 2mg, per 5ml P Syrup 169/027 Glumex Pharmaceuticals (Pvt)

Ltd, India

2500Ebut Capsules Paracetamol 325mg + Ibuprofen

200mg + Caffeine 40mg

P Capsule oral 169/028 Glumex Pharmaceuticals (Pvt)

Ltd, India

Page 124 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2501Polyinosinic-polycytidylic Acid Injection Polyinosinic-polycytidylic acid

2mg, per 2ml

POM Solution for

Injection

261/001 Guangdong Bang Min

Pharmaceutical Co. Ltd,China

2502

Artescore for Children Tablets Pyrimethamine 25mg +

Artesunate 50mg + Sulfadoxine

500mg

POM Tablet Uncoated 043/001 Guilin Pharmaceuticals Co

Ltd,China

2503Artescore Tablets Artesunate 100 + Sulfadoxine

500 + Pyrimethamine 25mg

POM Tablet Uncoated 043/002 Guilin Pharmaceuticals Co

Ltd,China

2504Artesun 60 Injection Artesunate 60mg POM Solution for

Injection

043/003 Guilin Pharmaceuticals Co

Ltd,China

2505G - Abzole Tablets Albendazole 400mg POM Tablet Uncoated 043/004 Guilin Pharmaceuticals Co

Ltd,China

2506G-ciprox Tablets Ciprofloxacin 500mg POM Tablet Enteric

Coated

043/005 Guilin Pharmaceuticals Co

Ltd,China

2507Sulphamethoxazole 800mg+

Trimethoprim 160mg USP Tablets

Sulfamethoxazole 800mg +

Trimethoprim 160mg

POM Tablet Uncoated 043/006 Guilin Pharmaceuticals Co

Ltd,China

2508Sulphamethoxazole 400mg+

Trimethoprim 80mg USP Tablets

Sulfamethoxazole 400mg +

Trimethoprim 160mg

POM Tablet Uncoated 043/007 Guilin Pharmaceuticals Co

Ltd,China

2509Artesun Injection 30mg Artesunate 30mg POM Solution for

Injection

043/008 Guilin Pharmaceuticals Co

Ltd,China

2510Artesun Injection 120mg Artesunate 120mg POM Solution for

Injection

043/009 Guilin Pharmaceuticals Co

Ltd,China

2511G-Cospe Tablets Sulfadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 043/010 Guilin Pharmaceuticals Co. Ltd,

China

2512G-Ceftria Injection Ceftriaxone Sodium 1.0g POM Powder for

Injection

043/011 Guilin Pharmaceuticals Co. Ltd,

China

2513 D-Artepp Tablets Dihydroartemisinin 40mg +

Piperaquine Phosphate 320mg

POM Tablet Uncoated 043/012 Guilin Pharmaceuticals Co. Ltd,

China

2514

Ferro Booster Capsules Iron 100mg + Vitamin C 75mg +

Zinc 22.5mg + Folic Acid 1.5mg

+ Selenium 60mcg + Vit B12

5mcg + Vit E 15I.U

P Capsule oral 360/001 Hanson canada

2515

Rejuvin Tablets Methylcobalamin 500 mcg

+Vitamin A (as acetate) 5000IU +

Asc

P Tablet Uncoated 360/002 Hanson canada

2516Miracle Detox Tablets Biotin USP 100mcg + Calcium D

Pantothenate BP 10mg + Folic A

P Tablet Uncoated 360/003 Hanson canada

2517 Omega 369 Capsules Flax Seed Oil 500mg P Capsule oral 360/004 Hanson canada

2518 Alatrol Tablets Cetirizine Hydrochloride 10mg P Tablet Uncoated 345/001 Hasafa Health Sciences,Tanzania

2519Anadol 100 Injection Tramadol Hydrochloride 100mg POM Solution for

Injection

345/002 Hasafa Health Sciences,Tanzania

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2520Osmolax Oral Solution Lactulose 3.4mg, per 5ml P Solution for Oral

Use

345/003 Hasafa Health Sciences,Tanzania

2521Trupan 20 Tablets Pantoprazole Sodium 20mg POM Tablet Film

coated

345/004 Hasafa Health Sciences,Tanzania

2522 Zimax 500 Tablets Azithromycin Dihydrate 500mg POM Tablet Uncoated 345/005 Hasafa Health Sciences,Tanzania

2523Hecmetro 200 Tablets Metronidazole 200mg POM Tablet Film

coated

190/002 Healthy Life Pharma (Pvt) Ltd,

India

2524Jantrax Tablets Levamisole 40mg P Tablet Film

coated

190/003 Healthy Life Pharma (Pvt) Ltd,

India

2525Trimoxazole Oral Suspension Trimethoprim 40mg +

Sulphamethoxazole 200mg

POM Suspension for

Oral Use

190/005 Healthy Life Pharma (Pvt) Ltd,

India

2526Chloramphenicol Sodium Injection Chloramphenicol 1g, per 10ml POM Powder for

Injection

190/013 Healthy Life Pharma (Pvt) Ltd,

India

2527Indometacin Capsules Indomethacin 25mg P Capsule oral 190/019 Healthy Life Pharma (Pvt) Ltd,

India

2528Amoxicillin Oral Suspension Amoxicillin 125mg, per 5ml POM Suspension for

Oral Use

190/020 Healthy Life Pharma (Pvt) Ltd,

India

2529Vita+ Iron Tablets Multivitamins + Iron P Tablet Uncoated 190/022 Healthy Life Pharma (Pvt) Ltd,

India

2530Folic Acid 5mg Tablets Folic acid 5mg P Tablet Uncoated 292/001 Hebei Jiheng Pharmaceuticals Co

Limited

2531Paracare 500 Tablets Paracetamol 500mg GS Tablet Uncoated 292/002 Hebei Jiheng Pharmaceuticals Co

Limited

2532Rapid 1-2-3 Hema HIV Whole Format

Test Kit

Diagnostic Test Kits P HDPE Strips 021/001L Hema Diagnostic Systems, USA

2533Rapid 1-2-3 Hema express HIV

(Whole Blood) Kit

Diagnostic Test Kits P HDPE Strips 021/002L Hema Diagnostic Systems, USA

2534Rapid 1-2-3 Hema express HIV

(Serum/Plasma) Strip Format Test Kit

Diagnostic Test Kits P HDPE Strips 021/003L Hema Diagnostic Systems, USA

2535Rapid 1-2-3 Hema express HIV

(Serum/Plasma) Test Kit

Diagnostic Test Kits P HDPE Strips 021/004L Hema Diagnostic Systems, USA

2536Rapid 1-2-3 Hema Syphilis Dipstick

Test Kit

Diagnostic Test Kits P HDPE Strips 021/005L Hema Diagnostic Systems, USA

2537Rapid 1-2-3 Hema express Syphilis

Test

Diagnostic Test Kits P HDPE Strips 021/006L Hema Diagnostic Systems, USA

2538

Rapid 1-2-3 Hema Malaria

Plasmodium Falciparum(pf)Strip

Format Test K

Diagnostic Test Kits P HDPE Strips 021/007L Hema Diagnostic Systems, USA

Page 126 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2539

Rapid 1-2-3 Hema Malaria

Plasmodium Falciparum(pf)Strip

Format Test K

Diagnostic Test Kits P HDPE Strips 021/008L Hema Diagnostic Systems, USA

2540Rapid 1-2-3 Hema Malaria 9pf Dipstick

Test

Diagnostic Test Kits P HDPE Strips 021/009L Hema Diagnostic Systems, USA

2541

Rapid 1-2-3 Hema express Malaria

Plasmodium Falciparum/Plasmodium

Vivax

Diagnostic Test Kits P HDPE Strips 021/010L Hema Diagnostic Systems, USA

2542Rapid 1-2-3 Hema Malaria Dipstick

Test for Multiple Malaria Species

Diagnostic Test Kits P HDPE Strips 021/011L Hema Diagnostic Systems, USA

2543Rapid 1-2-3 Hema express Malaria pfv-

Multiple Test

Diagnostic Test Kits P HDPE Strips 021/012L Hema Diagnostic Systems, USA

2544 Zido-H 300 Tablets Zidovudine 300mg POM Tablet Uncoated 150/001 Hetero Drugs Limited, India

2545 Heptavir 150 Tablets Lamivudine 150mg POM Tablet Uncoated 150/002 Hetero Drugs Limited, India

2546 Indivir -400 Capsules Indinavir 400mg POM Capsule oral 150/003 Hetero Drugs Limited, India

2547 Nevivir 200 Tablets Nevirapine 200mg POM Tablet Uncoated 150/006 Hetero Drugs Limited, India

2548Zidolam Tablets Lamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 150/007 Hetero Drugs Limited, India

2549Nevilast 30 Tablets Lamivudine 150mg + Nevirapine

200mg + Stavudine 30mg

POM Tablet Uncoated 150/008 Hetero Drugs Limited, India

2550Nevilast - 40 Tablets Lamivudine 150mg + Nevirapine

200mg + Stavudine 40mg

POM Tablet Uncoated 150/009 Hetero Drugs Limited, India

2551Zidolam-N Tablets Zidovudine 300mg + Lamivudine

150mg + Nevirapine 200mg

POM Tablet Uncoated 150/010 Hetero Drugs Limited, India

2552 Estiva-600 Tablets Efavirenz 600mg POM Tablet Uncoated 150/011 Hetero Drugs Limited, India

2553 Ciproplus -250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 150/012 Hetero Drugs Limited, India

2554 Ciproplus 500mg Tablets Ciprofloxacin 500mg POM Tablet Uncoated 150/013 Hetero Drugs Limited, India

2555 Clarigen 250mg Tablets Clarithromycin 250mg POM Tablet Uncoated 150/014 Hetero Drugs Limited, India

2556 Clarigen 500mg Tablets Clarithromycin 500mg POM Tablet Uncoated 150/015 Hetero Drugs Limited, India

2557Tenof Tablets Tenofivir disoproxil fumurate

300mg

POM Tablet Uncoated 150/018 Hetero Drugs Limited, India

2558Tenolam Tablets Tenofivir Disoproxil Fumurate

300mg + Lamivudine 300mg

POM Tablet Uncoated 150/022 Hetero Drugs Limited, India

2559

Efavirenz/Emtricitabine/Tenofivir

Tablets

Efavirenz 600mg + Emtricitabine

200mg + Tenofivir Disoproxil

Fumurate 300mg

POM Tablet Film

coated

150/023 Hetero Drugs Limited, India

2560Lopinavir & Ritonavir 200mg/50mg

Tablets

Lopinavir 200mg +

Ritonavir50mg

POM Tablet Film

coated

150/024 Hetero Drugs Limited, India

2561 Amlo - H 10 Tablets Amlodipine Besylate 10mg POM Tablet Uncoated 150/025 Hetero Drugs Limited, India

Page 127 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2562 Amlo - H 5 Tablets Amlodipine Besylate 5mg POM Tablet Uncoated 150/026 Hetero Drugs Limited, India

2563Gemtero 1g Injection Gemcitabine Hydrochloride 1g POM Solution for

Injection

150/027 Hetero Drugs Limited, India

2564Gemtero 200mg Injection Gemcitabine Hydrochloride 200

mg

POM Solution for

Injection

150/028 Hetero Drugs Limited, India

2565Levin 500 Tablets Levofloxacin Hemihydrate 500mg POM Tablet Uncoated 150/029 Hetero Drugs Limited, India

2566Levin 250 Tablets Levofloxacin Hemihydrate 250mg POM Tablet Uncoated 150/030 Hetero Drugs Limited, India

2567Penvir-750 Tablets Famcyclovir 750mg POM Tablet Film

coated

150/031 Hetero Drugs Limited, India

2568Penvir-250 Tablets Famcyclovir 250mg POM Tablet Film

coated

150/033 Hetero Drugs Limited, India

2569 Irbis-H 300 Tablets Irbesartan 300mg POM Tablet Uncoated 150/035 Hetero Drugs Limited, India

2570 Irbis-H 150 Tablets Irbesartan 150mg POM Tablet Uncoated 150/036 Hetero Drugs Limited, India

2571Atazanavir + Ritonavir Tablets Atazanavir Sulphate 300mg +

Ritonivir 100mg

POM Tablet Film

coated

150/038 Hetero Drugs Limited, India

2572Emtricitabine & Tenofivir Disoproxil

Fumarate Tablets

Emtricitabine 200mg + Tenofivir

Disoproxil Fumarate300mg

POM Tablet Film

coated

150/039 Hetero Drugs Limited, India

2573 Acyclovir Tablets Acyclovir 200mg POM Tablet Uncoated 150/040 Hetero Drugs Limited, India

2574 Flugen-150 Tablets Fluconazole 150mg POM Tablet Uncoated 150/041 Hetero Drugs Limited, India

2575 Flugen 200 Tablets Fluconazole 200mg POM Tablet Uncoated 150/042 Hetero Drugs Limited, India

2576 Giagra 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 150/043 Hetero Drugs Limited, India

2577 Giagra 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 150/044 Hetero Drugs Limited, India

2578 Lamivudine Oral Solution Lamivudine 10mg, per ml POM Syrup 150/045 Hetero Drugs Limited, India

2579 Abacavir Sulphate 300mg Tablets Abacavir Sulphate 300mg POM Tablet Uncoated 150/046 Hetero Drugs Limited, India

2580 Anatero Tablets Anastrozole 1mg POM Tablet Uncoated 150/047 Hetero Drugs Limited, India

2581

Efavirenz/Lamivudine/Tenofovir Tablets Efavirenz 600mg + Lamivudine

300mg + Tenofivir Disoproxil

Fumurate 300mg

POM Tablet Uncoated 150/048 Hetero Drugs Limited, India

2582Diclofenac Sodium Delayed Release

Tablets

Diclofernac Sodium 50 mg P Capsule oral 150/049 Hetero Drugs Limited, India

2583 Omegenix 20 Capsules Omeprazole 20mg POM Capsule oral 150/050 Hetero Drugs Limited, India

2584 Ibuprofen Tablets 400mg Ibuprofen 400mg P Tablet oral 150/051 Hetero Drugs Limited, India

2585 Bicatero 50 Tablets Bicalutamide 50mg POM Tablet Uncoated 150/052 Hetero Drugs Limited, India

2586 Binfin 5 Tablets Finastride 5mg POM Tablet oral 150/053 Hetero Drugs Limited, India

2587 Zolid Tablets Linezolid 600mg POM Tablet Uncoated 150/054 Hetero Drugs Limited, India

2588Abacavir Sulphate and Lamivudine

Tablets

Abacavir sulphate 600mg +

Lamivudine 300mg

POM Tablet Film

coated

150/056 Hetero Drugs Limited, India

Page 128 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2589 Paclitero 300 Injection Paclitaxel 300mg POMSolution for

Injection150/057 Hetero Drugs Limited, India

2590Monte H 4 Tablets Montelukast Sodium 4mg POM

Tablet Film

Coated150/059 Hetero Drugs Limited, India

2591 Monte H 5 Tablets Montelukast Sodium 5mg POMTablet Film

Coated150/060 Hetero Drugs Limited, India

2592 Monte H 10 Tablets Montelukast Sodium 10mg POMTablet Film

Coated150/061 Hetero Drugs Limited, India

2593Cycloz Ophthalmic Ointment Acyclovir 5% w/w POM Eye Ointment 157/001 Highnoon Laboratories Ltd,

Pakistan

2594Cycloz Cream Acyclovir 5%w/w POM Cream Topical 157/002 Highnoon Laboratories Ltd,

Pakistan

2595Cycloz Tablets Acyclovir 200mg POM Tablet Uncoated 157/003 Highnoon Laboratories Ltd,

Pakistan

2596Loprin 75 mg Tablets Acetyl Salicylic Acid 75mg P Tablet Uncoated 157/004 Highnoon Laboratories Ltd,

Pakistan

2597Loprin 150mg Tablets Acetyl Salicylic Acid 150mg P Tablet Uncoated 157/005 Highnoon Laboratories Ltd,

Pakistan

2598Loprin 300mg Tablets Acetyl Salicylic Acid 300mg P Tablet Uncoated 157/006 Highnoon Laboratories Ltd,

Pakistan

2599Evacef Suspension Cefadroxil Monohydrate 125mg,

per 5ml

POM Suspension for

Oral Use

157/007 Highnoon Laboratories Ltd,

Pakistan

2600Evacef Suspension Cefadroxil Monohydrate 250mg,

per 5ml

POM Suspension for

Oral Use

157/008 Highnoon Laboratories Ltd,

Pakistan

2601Tramadol Injection Tramadol Hydrochloride 100mg,

per ml

POM Solution for

Injection

157/009 Highnoon Laboratories Ltd,

Pakistan

2602Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 157/010 Highnoon Laboratories Ltd,

Pakistan

2603Ciprofloxacin Tablets Ciprofloxacin Hydrochloride

250mg

POM Tablet Uncoated 157/011 Highnoon Laboratories Ltd,

Pakistan

2604Cyprocin Tablets Ciprofloxacin 500mg POM Tablet Uncoated 157/012 Highnoon Laboratories Ltd,

Pakistan

2605Tamadol Capsules Tramadol Hydrochloride 50mg P Capsule oral 157/013 Highnoon Laboratories Ltd,

Pakistan

2606Tamadol Injection Tramadol Hydrochloride 100mg,

per 2ml

POM Solution for

Injection

157/014 Highnoon Laboratories Ltd,

Pakistan

2607Beprosone Cream Betamethasone Dipropionate

0.064%w/w

POM Cream Topical 146/001 Hoe Pharmaceuticals Sdn Bud,

Malaysia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2608Beprosone Ointment Betamethasone Dipropionate

0.064%w/w

POM Ointment topical 146/002 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2609BeproGel Topical Solution Betamethasone Dipropionate

0.064%w/v

POM Solution for

Topical Use

146/003 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2610

Beprosalic Ointment Salicylic acid 3% +

Betamethasone Dipropionate

0.064%w/w

POM Ointment topical 146/004 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2611Cloderm Cream Clobetasol Propionate

0.0568%w/w

POM Cream Topical 146/005 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2612Cloderm Ointment Clobetasol Propionate

0.0568%w/v

POM Ointment topical 146/006 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2613Cloderm Scalp Application Solution Clobetasol Propionate

0.0568%w/v

POM Solution for

Topical Use

146/007 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2614Candazole Cream Clotrimazole 1%w/v POM Cream Topical 146/008 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2615Candazole lotion Clotrimazole 1%w/v POM Lotion for

Topical Use

146/009 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2616Candacort Cream Hydrocortisone 10mg +

Clotrimazole 10 mg

POM Cream Topical 146/010 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2617Ecocort Cream Triamcinolone Acetonide

0.1%w/w + Econazole 1%w/w

POM Cream Topical 146/011 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2618Dezor Cream Ketoconazole 2.0 %w/w POM Cream Topical 146/012 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2619Dezor Shampoo Ketoconazole 2%w/v POM Shampoo 146/013 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2620Decozol Cream Miconazole Nitrate 2% w/w POM Cream Topical 146/014 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2621Decocort Cream Hydrocortisone 1% w/w +

Miconazole Nitrate 2.0% w/w

POM Cream Topical 146/015 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2622Tolnaderm lotion Tolnaftate 1% w/v POM Lotion for

Topical Use

146/017 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2623Foban Cream Fusidic acid 2% w/w POM Cream Topical 146/018 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2624Foban Ointment Sodium Fusidate 2%w/w POM Ointment topical 146/019 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2625

Fobancort Ointment Betamethasone Dipropionate

0.064% w/w + Sodium

Fusidate2.0% w/w

POM Ointment topical 146/020 Hoe Pharmaceuticals Sdn Bud,

Malaysia

Page 130 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2626Declovir Cream Acyclovir 5% w/w POM Cream Topical 146/021 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2627A-Lices Shampoo Malathion 1.0% w/v POM Solution for

Topical Use

146/022 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2628Gentamicin Cream Gentamicin Sulphate 0.17%w/w POM Cream Topical 146/023 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2629

Beprosalic lotion Betamethasone Dipropionate

0.064% w/v + Salicyclic acid

2%w/v

POM Lotion for

Topical Use

146/024 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2630Poviderm Ointment Povidone Iodine 10%w/w GS Ointment topical 146/027 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2631U-closone Ointment Clobetasone 0.05% POM Ointment topical 146/028 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2632Menzze Cream Methyl salicylate 25%w/w GS Cream Topical 146/029 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2633Zellox-DS Suspension Aluminium Hydroxide +

Simethicone

P Suspension for

Oral Use

146/030 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2634Rhuma Gel Piroxicam 0.5% POM Gel Topical 146/031 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2635C-mycin Gel Clindamycin 1.2% POM Gel Topical 146/032 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2636C-mycin lotion Clindamycin 1.2% POM Lotion for

Topical Use

146/033 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2637H-cort Ointment Hydrocortisone 1% POM Ointment topical 146/034 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2638Beprogent Cream Betamethasone + Gentamycin POM Cream Topical 146/035 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2639Oxy-nase 0.05% Nasal Spray Oxymetazoline 0.05% POM Spray For Nasal

Use

146/036 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2640Oxy-nase Drops Oxymetazoline 0.025% POM Nasal drops 146/037 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2641Oxy-Nase 0.025% Nasal Spray Oxymetazoline 0.025% POM Spray For Nasal

Use

146/038 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2642U-closone Cream Clobetasone Butyrate 0.05%

w/w

POM Cream Topical 146/039 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2643OrrePaste Oral Paste Triamcinolone Acetonide 0.1% POM Oral paste 146/040 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2644Oxy-Nase 0.025% Nasal Drops Oxymetazoline Hydrochloride

0.025%w/v

P Solution for

Topical Use

146/041 Hoe Pharmaceuticals Sdn Bud,

Malaysia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2645

Fobancort Cream Fusidic acid 2% w/w

Dipropionate + Betamethasone

Dipropionate 0.064% w/w

POM Cream Topical 146/042 Hoe Pharmaceuticals Sdn Bud,

Malaysia

2646Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 059/001 Holden Medicals B.V, The

Netherlands

2647Acetyl Salicylic Acid Acetyl Salicylic acid 300mg P Tablet Uncoated 059/002 Holden Medicals B.V, The

Netherlands

2648Folic Acid Tablets Folic acid 5mg P Tablet Uncoated 059/003 Holden Medicals B.V, The

Netherlands

2649Ferrous Sulphate Tablets Ferrous sulphate 200mg P Tablet Film

coated

059/004 Holden Medicals B.V, The

Netherlands

2650

Oral Rehydration Salt Sodium Chloride 3.5g + Sodium

Citrate 2.9g + Potassium

Chloride 1.5g + Anhydrous

Glucose 20g

GS Powder for Oral

Solution

059/005 Holden Medicals B.V, The

Netherlands

2651Albendazole Albendazole 400mg POM Tablet Uncoated 059/006 Holden Medicals B.V, The

Netherlands

2652Tetracycline Eye Ointment Tetracycline 1% w/w POM Eye Ointment 059/007 Holden Medicals B.V, The

Netherlands

2653Paracetamol 100mg Tablets Paracetamol 100mg GS Tablet Uncoated 059/008 Holden Medicals B.V, The

Netherlands

2654Mebendazole 500mg Chewable Tablets Mebendazole 500mg P Tablet Uncoated 059/009 Holden Medicals B.V, The

Netherlands2655 Hope C Tablets Chlorpheniramine 4mg P Tablet Uncoated 087/005 Hope Pharmaceuticals

2656 Hope - C Syrup Chlorpheniramine 2mg, per 5ml P Syrup 087/006 Hope Pharmaceuticals

2657 Hope-O Capsules Omeprazole 20mg POM Capsule oral 087/009 Hope Pharmaceuticals

2658

4CC Syrup Paracetamol 120mg +

Phenylepherine Hydrochloride

2.5mg + Dextromethophan

2.00mg + Chlorpheniramine

0.50mg, per 5ml

P Syrup 087/001 Hope Pharmaceuticals Limited

2659 Blue Strength Tablets Sildenafil 50mg POM Tablet Uncoated 087/002 Hope Pharmaceuticals Limited

2660DIABEST Suspension Metronidazole 100mg +

Furazolidone 30mg

POM Suspension for

Oral Use

087/003 Hope Pharmaceuticals Limited

2661DIAFREE Suspension Metronidazole 100mg +

Norfloxacin 100mg

POM Suspension for

Oral Use

087/004 Hope Pharmaceuticals Limited

2662Hopedom Suspension Domperidone 5mg, per 5ml POM Suspension for

Oral Use

087/007 Hope Pharmaceuticals, India

2663 Hopedom Tablets Domperidone 10mg POM Tablet Uncoated 087/008 Hope Pharmaceuticals, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2664Hopenac Tablets Diclofenac sodium 100mg POM Tablet Film

coated

087/010 Hope Pharmaceuticals, India

2665I-Plus Tablets Ibuprofen 400mg + Paracetamol

500mg

P Tablet Uncoated 087/011 Hope Pharmaceuticals, India

2666Cloveg Tablets Clotrimazole 100mg POM Tablet Uncoated 225/001 Household Pharmaceuticals Ltd,

India

2667Cloveg 1%Cream Clotrimazole 1.0%w/w POM Cream Topical 225/002 Household Pharmaceuticals Ltd,

India

2668

Trioderm Cream Gentamycin 0.1% w/w +

Fluocinolone Acetonide 0.01%

w/w + Miconazole 2% w/w

POM Cream Topical 225/003 Household Pharmaceuticals Ltd,

India

2669Ampigran Granules for Suspension Ampicillin 125mg, per 5ml POM Granules for

Suspension

173/001 Hovid Sdn Bhd, Malaysia

2670 Griseofulvin 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 173/002 Hovid Sdn Bhd, Malaysia

2671 Nutrivit Syrup Multivitamins GS Syrup 173/003 Hovid Sdn Bhd, Malaysia

2672 Hostan 250 Capsules Mefenamic Acid 250mg P Capsule oral 173/004 Hovid Sdn Bhd, Malaysia

2673 Prozotab Tablets Prazosin 1mg POM Tablet Uncoated 173/006 Hovid Sdn Bhd, Malaysia

2674Amoxiclav 625 Tablets Amoxicillin 500mg + Clavulanic

Acid 125mg

POM Tablet Film

coated

173/007 Hovid Sdn Bhd, Malaysia

2675 Nizole Tablets Metronidazole 200mg POM Tablet Uncoated 173/008 Hovid Sdn Bhd, Malaysia

2676 Feloxicam 20 Capsules Piroxicam 20mg POM Capsule oral 173/009 Hovid Sdn Bhd, Malaysia

2677Clofenac SR Tablets Diclofenac 100mg P Tablet Film

coated

173/010 Hovid Sdn Bhd, Malaysia

2678Clofenac 50 SR Tablets Diclofenac 50mg P Tablet sustained

release

173/011 Hovid Sdn Bhd, Malaysia

2679 Amoxicap 250mg Capsules Amoxicillin 250mg POM Capsule oral 173/012 Hovid Sdn Bhd, Malaysia

2680Suprim 480 Tablets Trimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 173/013 Hovid Sdn Bhd, Malaysia

2681Thelmin Tablets Pyrantel Pamoate 125mg P Tablet Film

coated

173/014 Hovid Sdn Bhd, Malaysia

2682 Ternolol Tablets Atenolol 100mg POM Tablet Uncoated 173/015 Hovid Sdn Bhd, Malaysia

2683 Chloramphenicol Eye Drops Chloramphenicol 0.5% w/v POM Eye Drops 173/016 Hovid Sdn Bhd, Malaysia

2684Ternolol 50 Tablets Atenolol 50mg POM Tablet Film

coated

173/017 Hovid Sdn Bhd, Malaysia

2685Dapatab M 250 Tablets Methyldopa 250mg POM Tablet Film

coated

173/018 Hovid Sdn Bhd, Malaysia

2686 Omezole 20 Capsules Omeprazole 20mg POM Capsule oral 173/019 Hovid Sdn Bhd, Malaysia

2687 Horamine Syrup Chlorpheniramine 4mg P Syrup 173/020 Hovid Sdn Bhd, Malaysia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2688Hopranolol Tablets Propranolol 40mg POM Tablet Film

coated

173/021 Hovid Sdn Bhd, Malaysia

2689 Norelut Tablets Norethisterone 5mg POM Tablet Uncoated 173/023 Hovid Sdn Bhd, Malaysia

2690 Ampicap 250 Capsules Ampicillin 250mg POM Capsule oral 173/026 Hovid Sdn Bhd, Malaysia

2691Virest 200mg Tablets Acyclovir 200mg POM Tablet Film

coated

173/027 Hovid Sdn Bhd, Malaysia

2692 Tinazole 2% Cream Miconazole 2%w/w POM Cream Topical 173/028 Hovid Sdn Bhd, Malaysia

2693 Celexin Capsules Cephalexin 250mg POM Capsule oral 173/029 Hovid Sdn Bhd, Malaysia

2694 Doxicap Capsules Doxycycline 100mg POM Capsule oral 173/030 Hovid Sdn Bhd, Malaysia

2695 Tetracap 250mg Capsules Tetracycline 250mg POM Capsule oral 173/031 Hovid Sdn Bhd, Malaysia

2696 Cortisone Cream Hydrocortisone 1%w/w POM Cream Topical 173/032 Hovid Sdn Bhd, Malaysia

2697 Virest Cream Acyclovir 5%w/w POM Cream Topical 173/033 Hovid Sdn Bhd, Malaysia

2698 Betasone Cream Betamethasone 0.1%w/w POM Cream Topical 173/034 Hovid Sdn Bhd, Malaysia

2699 Ventamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 173/035 Hovid Sdn Bhd, Malaysia

2700 Ventamol 4mg Tablets Salbutamol 4mg POM Tablet Uncoated 173/036 Hovid Sdn Bhd, Malaysia

2701 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 173/037 Hovid Sdn Bhd, Malaysia

2702Hostan Paediatric Suspension Mefenamic Acid 125mg, per 5ml P Suspension for

Oral Use

173/038 Hovid Sdn Bhd, Malaysia

2703 Neurovit Tablets B Complex P Tablet Uncoated 173/039 Hovid Sdn Bhd, Malaysia

2704 Colodium Capsules Loperamide 2mg POM Capsule oral 173/040 Hovid Sdn Bhd, Malaysia

2705 Hovid Betaton Capsules Beta Caraotene + Multivitamin P Capsule oral 173/041 Hovid Sdn Bhd, Malaysia

2706Erotab Erythromycin Tablets Erythromycin 250mg POM Tablet Film

coated

173/042 Hovid Sdn Bhd, Malaysia

2707 Cloxamp 250mg Capsules Cloxacillin 250mg POM Capsule oral 173/043 Hovid Sdn Bhd, Malaysia

2708 Ventamol Syrup Salbutamol 2mg, per 5ml POM Syrup 173/044 Hovid Sdn Bhd, Malaysia

2709Diabetmin Tablets Metformin 500mg POM Tablet Film

coated

173/045 Hovid Sdn Bhd, Malaysia

2710Amoxigram Granules Amoxicillin 125mg, per 5ml POM Granules for

Suspension

173/046 Hovid Sdn Bhd, Malaysia

2711Colospan Tablets Hyoscine Butyl Bromide 10mg POM Tablet Film

coated

173/048 Hovid Sdn Bhd, Malaysia

2712 Clamide-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 173/049 Hovid Sdn Bhd, Malaysia

2713 Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 222/001 IDA Foundation, The Netherlands

2714 Aciclovir Eye Ointment Aciclovir 3% w/w POM Eye Ointment 222/001MT IDA Foundation, The Netherlands

2715Ceftriaxone Injection Ceftriaxone 1g POM Powder for

Injection

222/002MT IDA Foundation, The Netherlands

2716Chloramphenicol Sodium succinate

Injection

Chloramphenicol 1g POM Powder for

Injection

222/003MT IDA Foundation, The Netherlands

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2717 Ciprofloxacin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 222/004MT IDA Foundation, The Netherlands

2718 Erythromycin Stearate Tablets Erythromycin 250mg POM Tablet Uncoated 222/005MT IDA Foundation, The Netherlands

2719Co-trimoxazole Tablets Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 222/006MT IDA Foundation, The Netherlands

2720Nystatin 100,000 IU Oral Suspension Nystatin 100,000 IU POM Suspension for

Oral Use

222/008MT IDA Foundation, The Netherlands

2721Cotrimoxazole Tablets Trimethoprim 80mg+

Sulphamethoxazole 400mg

POM Tablet Uncoated 222/009MT IDA Foundation, The Netherlands

2722Co-trimoxazole Tablets Sulphamethoxazole 800mg +

Trimethoprim 160mg

POM Tablet Uncoated 222/010MT IDA Foundation, The Netherlands

2723Cotrimoxazole Tablets Sulphamethoxazole 100mg +

Trimethoprim 20mg

POM Tablet Uncoated 222/011MT IDA Foundation, The Netherlands

2724Artesunate + Amodiaquine Tablets Amodiaquine 50mg + Artesunate

200mg

POM Tablet Uncoated 222/013MT IDA Foundation, The Netherlands

2725Ceftriaxone Injection Ceftriaxone 250mg POM Powder for

Injection

222/014MT IDA Foundation, The Netherlands

2726 Cefixime Tablets Cefixime 200mg POM Tablet Uncoated 222/015MT IDA Foundation, The Netherlands

2727 Fluconazole Capsules Fluconazole 200mg POM Capsule oral 222/016MT IDA Foundation, The Netherlands

2728 Fluconazole Capsules Fluconazole 50mg POM Capsule oral 222/017MT IDA Foundation, The Netherlands

2729 Fluconazole Capsules Fluconazole 150mg POM Capsule oral 222/018MT IDA Foundation, The Netherlands

2730 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 222/019 IDA Foundation, The Netherlands

2731 Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 222/020MT IDA Foundation, The Netherlands

2732

Multivitamin Tablets Vitamin A2500IU + Vitamin B

37.5mg + Vitamin B1 1mg

+Vitamin C 0.15mg +Vitamin B2

0.5mg + Vitamin 300IU

GS Tablet Film

coated

222/021MT IDA Foundation, The Netherlands

2733 Amoxiciliin BP 250mg Capsules Amoxicillin 250mg POM Capsule oral 222/022MT IDA Foundation, The Netherlands

2734 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 222/023 IDA Foundation, The Netherlands

2735 Amoxicillin BP 250mg Tablets Amoxicillin 250mg POM Tablet Uncoated 222/024MT IDA Foundation, The Netherlands

2736Gentamycin Injection Gentamycin 80mg, per 2ml POM Solution for

Injection

222/025MT IDA Foundation, The Netherlands

2737Erythromycin Suspension Erythromycin 125mg, per 5ml POM Powder for Oral

Suspension

222/026MT IDA Foundation, The Netherlands

2738Metronidazole 125mg/5ml Powder for

Oral Suspension

Metronidazole 125mg POM Powder for Oral

Suspension

222/027MT IDA Foundation, The Netherlands

2739 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 222/028MT IDA Foundation, The Netherlands

2740Abhayrab Vaccine Inactivated Rabies Antigen

2.5IU, per 0.5ml

POM Solution for

Injection

088/001 Indian Immunological limited

Page 135 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2741Abay tox IP Vaccine Tetanus Toxoid Vaccine 0.5ml Suspension for

Injection

088/002 Indian Immunological limited

2742 Metaplex Syrup B Complex P Syrup 152/001 Indoco Remedies Limited, India

2743

Flamar Cream Methyl Salicylate 8.0% w/w +

Mephenesin 5.0% w/w + Methyl

Nictinate 1.0% w/w + Methanol

2.05 w/w

P Cream Topical 152/002 Indoco Remedies Limited, India

2744Indo 250 Tablets Erythromycin 250mg POM Tablet Film

coated

152/003 Indoco Remedies Limited, India

2745 Concise 50 Tablets Fluconazole 50mg POM Tablet Uncoated 152/004 Indoco Remedies Limited, India

2746 Ciprind 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 152/005 Indoco Remedies Limited, India

2747 Nimind Tablets Nimesulide 100mg POM Tablet Uncoated 152/006 Indoco Remedies Limited, India

2748 Dexoren Eye/Ear Drops Chlorampenicol 0.5%w/v POM Ear/Eye Drops 152/007 Indoco Remedies Limited, India

2749 Tamigen Eye/Ear Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 152/008 Indoco Remedies Limited, India

2750 Atropen-P Eye Drops Atropine 1%w/v POM Eye Drops 152/009 Indoco Remedies Limited, India

2751 Cyclopam Tablets Paracetamol + Dicyclomine P Tablet Uncoated 152/010 Indoco Remedies Limited, India

2752 Metchek Tablets Metformin Hydrochloride 500mg POM Tablet Uncoated 152/011 Indoco Remedies Limited, India

2753 Triz Tablets Cetirizine 10mg POM Tablet Uncoated 152/012 Indoco Remedies Limited, India

2754

Febrex Plus Tablets Paracetamol 500mg +

Phenylephrine Hydrochloride

10mg + Chlopheniramine 2mg

P Tablet Uncoated 152/013 Indoco Remedies Limited, India

2755

Febrex Plus Syrup Paracetamol 125mg + Sodium

Citrate 60mg +Phenylephrine

Hydrocloride 2.5mg

P Syrup 152/014 Indoco Remedies Limited, India

2756

Otorex Ear Drops Paradichlorobenzene 2.0%w/v +

Benzocaine 2.7%w/v +

Chlorobutanol 5.0%w/v

P Solution for

Topical Use

152/015 Indoco Remedies Limited, India

2757Cital Solution Disodium Hydrogen Citrate 1.37

mg

P Solution for Oral

Use

152/016 Indoco Remedies Limited, India

2758DentoGel Choline Salicylate 8.7%w/w +

Lignocaine Hcl 2.0% w/w

P Gel Topical 152/017 Indoco Remedies Limited, India

2759

Rexidin - M Gel Metronidazole Benzoate 10mg/g

+ Chlorhexidine Gluconate

Solutio 0.25%w/w

P Gel Oral 152/018 Indoco Remedies Limited, India

2760

Cloben G Cream Clotrimazole 1% w/w +

Gentamycin 0.1%w/w +

Beclomethasone Dipropionate

0.025% w/w

POM Cream Topical 152/019 Indoco Remedies Limited, India

2761 Clob Cream Clotrimazole 1.0%w/w POM Cream Topical 152/020 Indoco Remedies Limited, India

Page 136 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2762 Ibuflamar 200 Tablets Ibuprofen 200mg P Tablet Uncoated 152/021 Indoco Remedies Limited, India

2763 Megyl Tablets Metronidazole 200mg POM Tablet Uncoated 152/022 Indoco Remedies Limited, India

2764

Flamar MX Tablets Diclofenac potassium 50mg +

Paracetamol 325mg +

Chlorzoxazone 250mg

P Tablet Uncoated 152/023 Indoco Remedies Limited, India

2765

Cloben Skin Cream Clotrimazole 1% w/w +

Beclomethasone Dipropionate

0.025% w/w

Cream Topical 152/024 Indoco Remedies Limited, India

2766Nosic Tablets Doxylamine Succinate 10 mg +

Pyridoxine Hydrochloride 10 mg

POM Tablets 152/025 Indoco Remedies Limited, India

2767

Viscid Gel Aluminium Hydroxide 400mg +

Magnesium Hydroxide 100mg +

Simethicone 25mg

GS Oral suspension 152/026 Indoco Remedies Limited, India

2768Lignox 2% Injection  Lidocaine 20 mg , per ml POM Solution for

Injection

152/027 Indoco Remedies Limited, India

2769

Karvol Plus Inhalant Capsules Camphor 25mg + Chlorothymol

5mg + Eucalyptol 125mg +

Menthol 55mg +  Terpineol

120mg

GS Liquid capsule

for Inhalation

152/028 Indoco Remedies Limited, India

2770 Clarie-250 Tablets Clarithromycin 250mg POM Tablet Uncoated 260/001 Ind-Swift Limited, India

2771 Netazox 500 Tablets Nitazoxanide 500mg POM Tablet Uncoated 260/002 Ind-Swift Limited, India

2772Netazox Oral Suspension Nitazoxanide 100mg, per 5ml POM Suspension for

Oral Use

260/003 Ind-Swift Limited, India

2773 Candez 4 Tablets Candesartan 4mg POM Tablet Uncoated 260/004 Ind-Swift Limited, India

2774 Atstat 10 Tablets Atorvastatin 10mg POM Tablet Uncoated 260/005 Ind-Swift Limited, India

2775 Atstat 20 Tablets Atorvastatin 20mg POM Tablet Uncoated 260/006 Ind-Swift Limited, India

2776Fexidine 120 Tablets Fexofenadine Hydrocloride

120mg

POM Tablet Uncoated 260/007 Ind-Swift Limited, India

2777Fexidine 180 Tablets Fexofenadine Hydrochloride

180mg

POM Tablet Uncoated 260/008 Ind-Swift Limited, India

2778 Glitter 15 Tablets Pioglitazone 15mg POM Tablet Uncoated 260/009 Ind-Swift Limited, India

2779 Glitter 30 Tablets Pioglitazone 30mg POM Tablet Uncoated 260/010 Ind-Swift Limited, India

2780Lamitar - AM Tablets Lumefantrine 120mg +

Artemether 20mg

POM Tablet Uncoated 260/011 Ind-Swift Limited, India

2781Levoset Levocetrizine Dihydrochloride

5mg

POM Tablet Film

coated

376/001 Innovata Pharmaceuticals (Pty)

Ltd

2782Paratram Tramadol hydrochloride 37.5mg

+ Paracetamol 325mg

P Tablet Film

coated

376/002 Innovata Pharmaceuticals (Pty)

Ltd

Page 137 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2783Citara 250 Tablets Levetiracetam 250mg POM Tablet Film

coated

376/003 Innovata Pharmaceuticals (Pty)

Ltd

2784Citara 500 Tablets Levetiracetam 500mg POM Tablet Film

coated

376/004 Innovata Pharmaceuticals (Pty)

Ltd

2785Citara 750 Tablets Levetiracetam 750mg POM Tablet Film

coated

376/005 Innovata Pharmaceuticals (Pty)

Ltd

2786Citara 1000 Tablets Levetiracetam 1000mg POM Tablet Film

coated

376/006 Innovata Pharmaceuticals (Pty)

Ltd

2787Dicloflame Tablets Diclofenac 50mg P Tablet Enteric

Coated

085/002 Intas International

Pharmaceuticals Co. Ltd, India

2788Presilone Tablets Prednisolone 5mg POM Tablet Uncoated 085/003 Intas International

Pharmaceuticals Co. Ltd, India

2789Methyldopa Tablets Methyldopa 282 mg (as Levo

isomer)

POM Tablet Uncoated 085/004 Intas International

Pharmaceuticals Co. Ltd, India

2790Amoxycillin Tablets Amoxycillin 250mg POM Capsule oral 085/005 Intas International

Pharmaceuticals Co. Ltd, India

2791Intacillin Tablets Ampicillin 250 mg POM Tablet Uncoated 085/006 Intas International

Pharmaceuticals Co. Ltd, India

2792Binimycin Tablets Erythromycin Stearate 440mg POM Tablet Uncoated 085/007 Intas International

Pharmaceuticals Co. Ltd, India

2793Asthamol Tablets Salbutamol Sulphate 4.820mg POM Tablet Uncoated 085/008 Intas International

Pharmaceuticals Co. Ltd, India

2794Intrim 480 Tablets Sulphamethoxazole 400mg+

Trimethoprim 80mg

POM Tablet Uncoated 085/009 Intas International

Pharmaceuticals Co. Ltd, India

2795Piroflame Tablets Piroxicam 10mg POM Tablet Uncoated 085/010 Intas International

Pharmaceuticals Co. Ltd, India

2796Intafen Tablets Ibuprofen 200mg P Tablet Uncoated 085/011 Intas International

Pharmaceuticals Co. Ltd, India

2797Intalol 100mg Tablets Atenolol 100mg POM Tablet Uncoated 085/012 Intas International

Pharmaceuticals Co. Ltd, India

2798Intalol 50 mg Tablets Atenolol 50mg POM Tablet Uncoated 085/015 Intas International

Pharmaceuticals Co. Ltd, India

2799Spasmine Injection Hyoscine Butyl Bromide 20mg POM Solution for

Injection

085/017 Intas International

Pharmaceuticals Co. Ltd, India

2800Ranloc Tablets Ranitidine 150mg POM Tablet Film

coated

085/018 Intas International

Pharmaceuticals Co. Ltd, India

2801Carditas Retard Tablets Nifedipine 20mg POM Tablet Film

coated

085/019 Intas International

Pharmaceuticals Co. Ltd, India

Page 138 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2802Monit-10 Tablets Isosorbide 10mg POM Tablet Uncoated 085/020 Intas International

Pharmaceuticals Co. Ltd, India

2803Monit-20 Tablets Isosorbide 20mg POM Tablet Uncoated 085/021 Intas International

Pharmaceuticals Co. Ltd, India

2804Astem-10 Tablets Astemizole 10mg POM Tablet Uncoated 085/023 Intas International

Pharmaceuticals Co. Ltd, India

2805Enapril - 10mg Tablets Enalapril 10mg POM Tablet Uncoated 085/024 Intas International

Pharmaceuticals Co. Ltd, India

2806Enapril 5mg Tablets Enalapril 5mg POM Tablet Uncoated 085/025 Intas International

Pharmaceuticals Co. Ltd, India

2807FCN Tablets Fluconazole 200mg POM Capsule oral 085/026 Intas International

Pharmaceuticals Co. Ltd, India

2808Kwinil-300 Tablets Quinine 300mg POM Tablet Film

coated

085/027 Intas International

Pharmaceuticals Co. Ltd, India

2809Intagenta Injection Gentamycin 80mg, per 2ml POM Solution for

Injection

085/028 Intas International

Pharmaceuticals Co. Ltd, India

2810Dicloflame Injection Diclofenac 75mg, per 3ml POM Solution for

Injection

085/029 Intas International

Pharmaceuticals Co. Ltd, India

2811Ciflox Tablets Ciprofloxacin 250mg POM Tablet Uncoated 085/030 Intas International

Pharmaceuticals Co. Ltd, India

2812Malostat Tablets Mefloquine 250mg POM Tablet Uncoated 085/031 Intas International

Pharmaceuticals Co. Ltd, India

2813Zen-200 Tablets Carbamazepine 200mg POM Tablet Uncoated 085/032 Intas International

Pharmaceuticals Co. Ltd, India

2814Cimecid Tablets Cimetidine 200mg POM Tablet Uncoated 085/033 Intas International

Pharmaceuticals Co. Ltd, India

2815Doxytas Capsules Doxycycline 100mg POM Capsule oral 085/035 Intas International

Pharmaceuticals Co. Ltd, India

2816Meflostats Tablets Mefloquine 250mg POM Tablet Uncoated 085/038 Intas International

Pharmaceuticals Co. Ltd, India

2817Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 085/039 Intas International

Pharmaceuticals Co. Ltd, India

2818Rifampicin + Isoniazid Tablets Rifampicin 150mg + Isoniazid

100mg

POM Tablet Uncoated 085/040 Intas International

Pharmaceuticals Co. Ltd, India

2819Spasmintas-10 Tablets Hyoscine Butyl Bromide 10mg POM Tablet Enteric

Coated

085/041 Intas International

Pharmaceuticals Co. Ltd, India

2820Intavita Capsules Minerals + Mutivitamin P Tablet Uncoated 085/043 Intas International

Pharmaceuticals Co. Ltd, India

Page 139 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2821Aclotas SR Tablets Aceclofenac 200mg P Tablet Uncoated 085/044 Intas International

Pharmaceuticals Co. Ltd, India

2822Lipitas-20 Atorvastatin 20mg POM Tablet Uncoated 085/045 Intas International

Pharmaceuticals Co. Ltd, India

2823Valtas OD-500 Tablets Valproic acid 500mg POM Tablet Uncoated 085/046 Intas International

Pharmaceuticals Co. Ltd, India

2824Amtas 5 Tablets Amlodipine 5mg POM Tablet Uncoated 085/047 Intas International

Pharmaceuticals Co. Ltd, India

2825Amtas-10 Tablets Amlodipine 10mg POM Tablet Uncoated 085/048 Intas International

Pharmaceuticals Co. Ltd, India

2826Lan-30 Capsules Lansoprazole 30mg POM Capsule oral 085/049 Intas International

Pharmaceuticals Co. Ltd, India

2827Lovastin-10 Tablets Lovastatin 10mg POM Tablet Uncoated 085/050 Intas International

Pharmaceuticals Co. Ltd, India

2828Risdone 1mg Tablets Risperidone 1mg POM Tablet Uncoated 085/051 Intas International

Pharmaceuticals Co. Ltd, India

2829Risdone 2mg Tablets Risperidone 2mg POM Tablet Film

coated

085/052 Intas International

Pharmaceuticals Co. Ltd, India

2830Doverin 80 Tablets Drotaverin Hydrochloride 80mg POM Tablet Uncoated 085/053 Intas International

Pharmaceuticals Co. Ltd, India

2831Mims Co-trimoxazole Tablets Trimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 155/001 International Drug Company

Limited

2832

Mims Pain Rub Ointment Menthol + Camphor + Eucalyptus

+ Pine Oil + Nutmeg + Methyl

Salicylate

GS Ointment topical 155/002 International Drug Company

Limited

2833Mims AntAcid Suspension Aluminium Hydroxide +

Magnesium Trisilicate

GS Suspension for

Oral Use

155/003 International Drug Company

Limited

2834Mims Children Cough Syrup Guaiphenesin + Paracetamol P Syrup 155/004 International Drug Company

Limited

2835Mims metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 155/005 International Drug Company

Limited

2836Mims vitamin B complex Tablets B Complex P Tablet Uncoated 155/006 International Drug Company

Limited

2837Mims Co-trimoxazole Suspension Sulphamethoxazole 200 +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

155/007 International Drug Company

Limited

2838Mims No-Coff Syrup Guaiphenesin + Race Menthol +

Creosate wood oil + Pine

P Syrup 155/008 International Drug Company

Limited

2839Mims Fastamol Syrup Paracetamol 120mg, per 5ml GS Syrup 155/009 International Drug Company

Limited

Page 140 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2840Mims Gripe Water Solution Dill oil + Sodium Bicarbonate +

Sodium Citrate

GS Solution for Oral

Use

155/010 International Drug Company

Limited

2841Mims Pheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 155/011 International Drug Company

Limited

2842Mims Salbutamol Syrup Salbutamol 2.5mg, per 5ml POM Syrup 155/012 International Drug Company

Limited

2843Mims GV Paint Suspension Methylrosanilinium P Suspension 155/013 International Drug Company

Limited

2844Mims Whitefield Ointment Salicylic acid 6%w/w + Benzoic

Acid 3%w/w

P Ointment topical 155/014 International Drug Company

Limited

2845Mims Metronidazole Suspension Metronidazole 30mg, per 5ml POM Suspension for

Oral Use

155/016 International Drug Company

Limited

2846Dextrose 5% Intravenous Fluid Dextrose 5%w/v POM Solution for

infusion

155/017 International Drug Company

Limited

2847Sodium Chloride Intravenous Fluid Sodium Chloride 0.9%w/v POM Solution for

infusion

155/018 International Drug Company

Limited

2848

Darrows Solution for Injection Sodium Chloride 2g + Sodium

Lactate 2.95g + Potassium

Chloride 1.3g, per 500ml

POM Solution for

infusion

155/019 International Drug Company

Limited

2849

Ringer's Lactate Intravenous Fluid Sodium Chloride 6g + Sodium

Lactate 3.1g + Potassium

Chloride 0.3g + Calcium Chloride

0.2g, per L

POM Solution for

infusion

155/020 International Drug Company

Limited

2850Dextrose 10% Intravenous Fluid Dextrose 10%w/v POM Solution for

Injection

155/021 International Drug Company

Limited

2851

Dextrose 2.5%+ Half Strength Darrows

I.V Infusion

Dextrose 2.5% + Sodium

Chloride 2g + Sodium Lactate

2.95g + Potassium Chloride

1.3g, per 1000ml

POM Solution for

Injection

155/022 International Drug Company

Limited

2852Dextrose + Sodium Chloride Infusion Dextrose 5% w/v + Sodium

Chloride 0.9%w/v

POM Solution for

infusion

155/023 International Drug Company

Limited

2853

Mims Idphen Syrup Ammonium Chloride 200mg +

Menthol 2mg + Chlorpheniramine

2mg

P Solution for Oral

Use

155/024 International Drug Company

Limited

2854Mims Mutivitamins Syrup Multivitamins GS Syrup 155/025 International Drug Company

Limited

2855Mims Benzyl Benzoate Application 25%

w/w

Benzyl Benzoate 25 %w/w P Solution for

Topical Use

155/026 International Drug Company

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2856Mims Phenamine Syrup Chlorpheniramine 2mg, per 5ml P Syrup 155/027 International Drug Company

Limited

2857

Fenelyn Expectorant Diphenhydramine Hydrochloride

12.5mg + Ammonium Chloride

125mg + Sodium Citrate 50mg +

Menthol 1mg

P Solution for Oral

Use

155/028 International Drug Company

Limited

2858Mims Promine Elixir Promethazine 5mg, per 5ml P Elixir 155/029 International Drug Company

Limited

2859

Mims Calamine Lotion Calamine 15% w/v + Zinc Oxide

5% w/v + Liquified Phenol 0.4%

w/v

P Lotion for

Topical Use

155/030 International Drug Company

Limited

2860Mims Peppermint Coughs and Cold

Syrup

Peppermint Oil 0.02mg +

Menthol 3.5mg

P Syrup 155/031 International Drug Company

Limited

2861

Mims Zinc &Castor Oil Ointment Arachis Oil 30.50%w/w + Zinc

Oxide 7.50% w/w+ Castor Oil

50% w/w

P Ointment topical 155/032 International Drug Company

Limited

2862

Mims Vapour Rub Ointment Menthol 3% w/w + Camphor 3%

w/w + Eucalyptus oil 1.25% w/w

+ Pine oil 0.5% w/w + Thymol

crystals 0.10% w/w + Nutmeg oil

0.55% w/w + Terpentine oil 5%

w/w

GS Ointment topical 155/033 International Drug Company

Limited

2863Mims Mobilub Capsules Glucosamine 500mg P Capsule oral 155/034 International Drug Company

Limited

2864Mims Rejuva Capsules Multivitamin P Capsule oral 155/037 International Drug Company

Limited

2865Mims Cod liver Oil Capsules Cod Liver Oil 300mg GS Capsule oral 155/035 International Drug Company

Limited, Zambia

2866Mims cod liver oil + vitamin E Capsules Cod Liver Oil 300mg + Vitamin E

400mg

GS Capsule oral 155/036 International Drug Company

Limited, Zambia

2867Bupacin Injection 50mg/ml - 20ml Buparvaquone 50 mg, per ml

(VET)

POM Solution for

Injection

382/001 Intracin Pharmaceuticals Pvt Ltd

2868Bupacin Injection 50mg/ml - 50ml Buparvaquone 50 mg, per ml

(VET)

POM Solution for

Injection

382/002 Intracin Pharmaceuticals Pvt Ltd

2869Butafen-400 Tablets Ibuprofen 400mg P Tablet Enteric

Coated

114/001 IPCA Laboratories Ltd, India

2870 Butafen-200 Tablets Ibuprofen 200mg P Tablet Uncoated 114/002 IPCA Laboratories Ltd, India

2871 Cimet-200 Tablets Cimetidine 200mg POM Tablet Uncoated 114/003 IPCA Laboratories Ltd, India

2872 Cimet-400 Tablets Cimetidine 400mg POM Tablet Uncoated 114/004 IPCA Laboratories Ltd, India

Page 142 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2873 Chloramphenicol Capsules Chloramphenicol 250mg POM Capsule oral 114/005 IPCA Laboratories Ltd, India

2874 Tetracycline 250mg Capsules. Tetracycline 250mg POM Capsule oral 114/006 IPCA Laboratories Ltd, India

2875Giardyl Suspension Metronidazole 200mg, per 5ml POM Suspension for

Oral Use

114/007 IPCA Laboratories Ltd, India

2876Nebagin Injection Dipyron 500mg, per ml POM Solution for

Injection

114/008 IPCA Laboratories Ltd, India

2877 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 114/009 IPCA Laboratories Ltd, India

2878Metoclopromide Solution Metoclopramide 5mg, per 5ml POM Solution for Oral

Use

114/010 IPCA Laboratories Ltd, India

2879Perinan Injection Metoclopramide 5mg, per ml POM Solution for

Injection

114/011 IPCA Laboratories Ltd, India

2880 Nemocid Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 114/012 IPCA Laboratories Ltd, India

2881Pyrantel Pamoate Suspension Pyrantel Pamoate 125mg, per

5ml

P Suspension for

Oral Use

114/013 IPCA Laboratories Ltd, India

2882Erythromycin Suspension Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

114/014 IPCA Laboratories Ltd, India

2883 Pacimol 500mg Tablets Paracetamol 500mg P Tablet Uncoated 114/015 IPCA Laboratories Ltd, India

2884 Pacimol Syrup Paracetamol 125mg, per 5ml GS Syrup 114/016 IPCA Laboratories Ltd, India

2885 Clarbact 250 Tablets Clarithromycin 250mg POM Tablet Uncoated 114/018 IPCA Laboratories Ltd, India

2886 Clarbact 500 Tablets Clarithromycin 500mg POM Tablet Uncoated 114/019 IPCA Laboratories Ltd, India

2887 Normax Tablets Norfloxacin 400mg POM Tablet Uncoated 114/020 IPCA Laboratories Ltd, India

2888Stericef Injection Cefuroxime 1g POM Powder for

Injection

114/021 IPCA Laboratories Ltd, India

2889Larither 40 Injection Artemether 40mg, per ml POM Solution for

Injection

114/022 IPCA Laboratories Ltd, India

2890Cincoma Injection Quinine 300mg, per 1ml POM Solution for

Injection

114/023 IPCA Laboratories Ltd, India

2891 Imox Trihydrate Capsules Amoxicillin Trihydrate 250mg POM Capsule oral 114/024 IPCA Laboratories Ltd, India

2892Imox Dry Syrup Amoxicillin Trihydrate 125mg,

per 5ml

POM Suspension for

Oral Use

114/025 IPCA Laboratories Ltd, India

2893 Ipcacillin Capsules Ampicillin 250mg POM Capsule oral 114/026 IPCA Laboratories Ltd, India

2894 Ipcavite-m Multivitamins GS Syrup 114/027 IPCA Laboratories Ltd, India

2895Laridox Tablets Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 114/028 IPCA Laboratories Ltd, India

2896Larither-80 Injection Artemether 80mg POM Solution for

Injection

114/029 IPCA Laboratories Ltd, India

2897 Procip-250 Capsules Ciprofloxacin 250mg POM Tablet Uncoated 114/030 IPCA Laboratories Ltd, India

2898 Tenolol Tablets Atenolol 100mg POM Tablet Uncoated 114/031 IPCA Laboratories Ltd, India

2899 Tenolol-50 Tablets Atenolol 50mg POM Tablet Uncoated 114/032 IPCA Laboratories Ltd, India

Page 143 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2900 Zerodol Tablets Aceclofenac 100mg P Tablet Uncoated 114/033 IPCA Laboratories Ltd, India

2901Lumerax 20/120 Tablets Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 114/034 IPCA Laboratories Ltd, India

2902 Pari -CR 12.5 Tablets Paroxetine 12.5mg POM Tablet Uncoated 114/035 IPCA Laboratories Ltd, India

2903 Pari-CR 25 Tablets Paroxetine 25mg POM Tablet Uncoated 114/036 IPCA Laboratories Ltd, India

2904 Lisoril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 114/037 IPCA Laboratories Ltd, India

2905 Glyree-1 Tablets Glimepiride 1mg POM Tablet Uncoated 114/038 IPCA Laboratories Ltd, India

2906 Glyree-2 Tablets Glimepiride 2mg POM Tablet Uncoated 114/039 IPCA Laboratories Ltd, India

2907 Glimepiride 3mg Tablets Glimepiride 3mg POM Tablet Uncoated 114/040 IPCA Laboratories Ltd, India

2908 Glimepiride 4mg Tablets Glimepiride 4mg POM Tablet Uncoated 114/041 IPCA Laboratories Ltd, India

2909 Nilitis 750mg Tablets Nabumetone 750mg POM Tablet Uncoated 114/042 IPCA Laboratories Ltd, India

2910 Nilitis 500mg Tablets Nabumetone 500mg POM Tablet Uncoated 114/043 IPCA Laboratories Ltd, India

2911 Azifast-500 Tablets Azithromycin 500mg POM Tablet Uncoated 114/045 IPCA Laboratories Ltd, India

2912 Revelol xl 25 Tablets Metoprolol 25mg POM Tablet Uncoated 114/046 IPCA Laboratories Ltd, India

2913 Revelol xl 50 Tablets Metoprolol 50mg POM Tablet Uncoated 114/047 IPCA Laboratories Ltd, India

2914 Emnorm 500 Tablets Metformin 500mg POM Tablet Uncoated 114/048 IPCA Laboratories Ltd, India

2915 Emnorm 850 Tablets Metformin 850mg POM Tablet Uncoated 114/049 IPCA Laboratories Ltd, India

2916Lisoretic -10 Tablets Hydrochlorothiazide 12.5mg +

Lisinopril 10mg

POM Tablet Uncoated 114/050 IPCA Laboratories Ltd, India

2917Lisoretic -20 Tablets Hydrochlorothiazide 12.5mg +

Lisinopril20mg

POM Tablet Uncoated 114/051 IPCA Laboratories Ltd, India

2918 Piomed-15 Tablets Pioglitazone 15mg POM Tablet Uncoated 114/052 IPCA Laboratories Ltd, India

2919 Piomed-30 Tablets Pioglitazone 30mg POM Tablet Uncoated 114/053 IPCA Laboratories Ltd, India

2920 Presartan-25 Tablets Losartan 25mg POM Tablet Uncoated 114/054 IPCA Laboratories Ltd, India

2921Presartan-50 Tablets Losartan 50mg POM Tablet Film

coated

114/055 IPCA Laboratories Ltd, India

2922 Ramcor-1.25 Tablets Ramipril 1.25mg POM Tablet Uncoated 114/056 IPCA Laboratories Ltd, India

2923 Ramcor-2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 114/057 IPCA Laboratories Ltd, India

2924 Ramcor-5 Tablets Ramipril 5mg POM Tablet Uncoated 114/058 IPCA Laboratories Ltd, India

2925 Ramcor-10 Tablets Ramipril 10mg POM Tablet Uncoated 114/059 IPCA Laboratories Ltd, India

2926Betamotil Injection Beta Arteether 150mg, per 2ml POM Solution for

Injection

114/060 IPCA Laboratories Ltd, India

2927Cinkona Suspension Quinine 150mg, per 5ml POM Suspension for

Oral Use

114/061 IPCA Laboratories Ltd, India

2928Arthemeter + Lumefanterine Tablets Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 114/062 IPCA Laboratories Ltd, India

2929Tenoric 50 Tablets Atenolol 50mg + Chlortalidone

12.50mg

POM Tablet Uncoated 114/063 IPCA Laboratories Ltd, India

Page 144 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2930Tenoric 100 Tablets Atenolol 100mg + Chlortalidone

25mg

POM Tablet Uncoated 114/064 IPCA Laboratories Ltd, India

2931 Olex -7.5 Tablets Olanzepine 7.5mg POM Tablet Uncoated 114/065 IPCA Laboratories Ltd, India

2932 Zerodol-CR Tablets Aceclofenac 200mg POM Tablet Uncoated 114/066 IPCA Laboratories Ltd, India

2933 Glycinorm -80 Tablets Gliclazide 80mg POM Tablet Uncoated 114/067 IPCA Laboratories Ltd, India

2934Presartan - H Tablets Lorsartan 50mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 114/068 IPCA Laboratories Ltd, India

2935Cotrimoxazole BP Tablets Trimethoprim 80mg +

Sulfamethoxazole 400mg

POM Tablet Uncoated 114/069 IPCA Laboratories Ltd, India

2936

Glyree - M 1 Tablets Glimepiride USP 1mg +

Metformin Hydrochloride USP

500mg

POM Tablet Uncoated 114/071 IPCA Laboratories Ltd, India

2937

Glyree - M 2 Tablets Glimepiride USP 2mg +

Metformin Hydrochloride USP

500mg

POM Tablet Uncoated 114/072 IPCA Laboratories Ltd, India

2938Rapiclav 1g Tablets Amoxicillin trihydrate 875 mg +

Clavulanate Potassium 125mg

POM Tablet Uncoated 114/073 IPCA Laboratories Ltd, India

2939

Nutrifiber Resistant Maltodextrin 1.270g +

Partially hydrolyzed Guar Gum

1.110g + Inulin 1.320g +

Mannitol 0.800g

Powder for Oral

Suspension

114/074 IPCA Laboratories Ltd, India

2940Larinate Injection Artesunate BP 60 mg POM Solution for

Injection

114/075 IPCA Laboratories Ltd, India

2941iASAQ Tablets Artesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 114/076 IPCA Laboratories Ltd, India

2942iSAQ 50/135 Tablets Artesunate 50mg + Amodiaquine

135mg

POM Tablet Uncoated 114/077 IPCA Laboratories Ltd, India

2943Pantonex -DR 20 Tablets Pantoprazole Sodium

Sesquihydrate BP 20mg

POM Tablet delayed

Release

114/078 IPCA Laboratories Ltd, India

2944Pantonex -DR 40 Tablets Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Tablet delayed

Release

114/079 IPCA Laboratories Ltd, India

2945Zitram - SR 200 Tablets Tramadol Hydrochloride Ph. Eur

200mg

POM Tablet sustained

release

114/080 IPCA Laboratories Ltd, India

2946Cotrimoxazole Oral Suspension Trimethoprim BP 40mg +

Sulfamethoxazole BP 200mg

POM Suspension for

Oral Use

114/081 IPCA Laboratories Ltd, India

2947 Multicharge Capsules (Men) Combination P Capsule oral 114/082L IPCA Laboratories Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2948

Multicharge Capsules Women Minerals + Natural Extracts +

Methionine 22mg + Glutamic

Acid 20 mg + Lysin 10mg +

Cystein 2.5mg

P Capsule oral 114/083L IPCA Laboratories Ltd, India

2949

Multicharge Eye Capsules Eicosapantaenoic Acid 325mg +

Docosahexaenoic Acid 175mg +

Lutein 5mg + Zeaxanthin 1mg

P Capsule oral 114/084L IPCA Laboratories Ltd, India

2950 Multicharge Daily Capsules Combination P Capsule oral 114/085L IPCA Laboratories Ltd, India

2951Beclasone CFC Free Metered Doses

Inhaler

Beclamethasone 50mcg POM Powder for

Inhalation

004/001 Ivax Pharma Ireland, Ireland

2952Salmol CFC Free Metered Dose Inhaler Salbutamol 100mcg per Metered

Dose

POM Powder for

Inhalation

004/002 Ivax Pharma Ireland, Ireland

2953 Haycrom Aqueous Eye Drops Sodium Cromoglycate 2% POM Eye Drops 004/003 Ivax Pharma Ireland, Ireland

2954 Warfarin Tablets Warfarin Sodium 100mcg POM Tablet Uncoated 004/004 Ivax Pharma Ireland, Ireland

2955 Ivytimol Eye Drops Timolol 5mg, per ml POM Eye Drops 189/001 Ivee Aqua EPZ Limited, Kenya

2956 Ivygentacin Eye/Ear Drops Gentamycin 3mg, per ml POM Ear/Eye Drops 189/002 Ivee Aqua EPZ Limited, Kenya

2957 Ivyphenicol Eye Drops Chloramphenicol 5mg, per ml POM Eye Drops 189/003 Ivee Aqua EPZ Limited, Kenya

2958 Ivyzoxam Eye/Ear Drops Ciprofloxacin 3mg, per ml POM Ear/Eye Drops 189/004 Ivee Aqua EPZ Limited, Kenya

2959 Ivynoraxine Eye/Ear Drops Norfloxacin 3mg, per ml POM Ear/Eye Drops 189/005 Ivee Aqua EPZ Limited, Kenya

2960 Ivydexone Eye Drops Dexamethasone 1mg, per ml POM Eye Drops 189/006 Ivee Aqua EPZ Limited, Kenya

2961 Ivysone Ophthalmic Solution Hydrocortisone 10mg, per ml POM Eye Drops 189/007 Ivee Aqua EPZ Limited, Kenya

2962 Ivysolone Opthlamic Suspension Prednisolone 10mg, per ml POM Eye Suspension 189/008 Ivee Aqua EPZ Limited, Kenya

2963Ivydexnicol Eye Drops Dexamethasone 1mg+

Chloramphenicol 10mg, per ml

POM Eye Drops 189/009 Ivee Aqua EPZ Limited, Kenya

2964Ivydexgent Eye/Ear Drops Gentamycin 4mg +

Dexamethasone 3mg, per ml

POM Ear/Eye Drops 189/010 Ivee Aqua EPZ Limited, Kenya

2965Ivydexneocin Eye/Ear Drops Dexamethasone 3.5mg +

Neomycin 1mg, per ml

POM Ear/Eye Drops 189/011 Ivee Aqua EPZ Limited, Kenya

2966 Ivytimol Eye Drops Timolol 0.5mg, per ml POM Eye Drops 189/012 Ivee Aqua EPZ Limited, Kenya

2967 Ivysine Eye Drops Tetrahydrozoline 0.5mg, per ml POM Eye Drops 189/013 Ivee Aqua EPZ Limited, Kenya

2968 Ivyzinc Eye Drops Zinc Sulphate 2.5mg, per ml POM Eye Drops 189/014 Ivee Aqua EPZ Limited, Kenya

2969 Ivyflur Eye Drops Flurbiprofen 0.3mg, per ml POM Eye Drops 189/015 Ivee Aqua EPZ Limited, Kenya

2970Ivymoicell Eye Drops Hydroxypropylmethyl Cellulose

7mg, per ml

POM Eye Drops 189/016 Ivee Aqua EPZ Limited, Kenya

2971 Ivyfrin Nasal Drops Ephedrine 10mg, per ml POM Nasal drops 189/017 Ivee Aqua EPZ Limited, Kenya

2972 Ivyfrin Nasal Drops Ephedrine 5mg, per ml POM Nasal drops 189/018 Ivee Aqua EPZ Limited, Kenya

2973 Ivynozvin A Nasal Drops Xylometazoline 1mg, per ml POM Nasal drops 189/019 Ivee Aqua EPZ Limited, Kenya

2974 Ivyfrin P Nasal Drops Xylometazoline 0.5mg, per ml POM Nasal drops 189/020 Ivee Aqua EPZ Limited, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2975 Ivyfchlornicol Ear Drops Drops Chloramphenicol 50mg, per ml POM Ear Drops 189/021 Ivee Aqua EPZ Limited, Kenya

2976 Ivybetasone Eye Drops Betamethasone 1mg, per ml POM Eye Drops 189/022 Ivee Aqua EPZ Limited, Kenya

2977Ivybetaneocin Eye/Ear Drops Betamethasone 3.5mg +

Neomycin 1mg, per ml

POM Ear/Eye Drops 189/023 Ivee Aqua EPZ Limited, Kenya

2978 Ivyxolol Eye Drops Betaxolol 5mg, per ml POM Eye Drops 189/024 Ivee Aqua EPZ Limited, Kenya

2979Water for Injection Sterile Water BP POM Solution for

Injection

189/025 Ivee Aqua EPZ Limited, Kenya

2980 Ivycarp Eye Drops Pilocarpine 20mg, per ml POM Eye Drops 189/026 Ivee Aqua EPZ Limited, Kenya

2981Ivycrom Eye Drops Sodium Cromoglycate 20mg, per

ml

POM Eye Drops 189/027 Ivee Aqua EPZ Limited, Kenya

2982

Trimetabol Oral Suspension Cyproheptadine Acefyllinate

0.035mg + DI-Carmitine

Hydrochloride 7.00mg

P Solution for Oral

Use

324/001 J.Uriach Y Company, S.A

2983Lusia - F Tablets Ethinyl Estradiol 0.0306mg +

Norgesterel 0.30mg

POM Tablet Film

coated

211/001 Jai Pharmacueticals Ltd

2984Hyan Tablets Levonorgestrel 0.03mg POM Tablet Film

coated

211/002 Jai Pharmacueticals Ltd

2985Famyrel Tablets Norgestrel 0.075mg POM Tablet Film

coated

211/003 Jai Pharmacueticals Ltd

2986Oralcon Tablets Ethinyl Estradiol 0.03mg +

Levonorgestrel 0.15mg

POM Tablet Film

coated

211/004 Jai Pharmacueticals Ltd

2987 Pregnon Tablets Levonorgestrel 0.75mg POM Tablet Uncoated 211/005 Jai Pharmacueticals Ltd

2988Oralcon-F Tablets Ethinyl Estradiol 0.15mg +

Levonorgestrel 0.03mg

POM Tablet Uncoated 211/006 Jai Pharmacueticals Ltd

2989Depo Progestin Injection Medroxyprogesterone 150mg,

per ml

POM Solution for

Injection

211/007 Jai Pharmacueticals Ltd

2990Daisy Tablets Desogestrel 0.15mg +

EthnylEstradiol 0.03mg

POM Tablet Uncoated 211/008 Jai Pharmacueticals Ltd

2991Cypress Tablets Cyproterone Acetate 2.04 +

EthinylEstradiol 0.03675

POM Tablet Film

coated

211/009 Jai Pharmacueticals Ltd

2992Zinnia Tablets EthinylEstradiol 30mcg +

Levonogestrel 150mcg

POM Tablet Film

coated

211/010 Jai Pharmacueticals Ltd

2993Zinnia P Tablets EthinylEstradiol 30mcg +

Levonogestrel 150 mcg

POM Tablet Uncoated 211/011 Jai Pharmacueticals Ltd

2994Famy Depo Injectable Suspension Medroxyprogesterone Acetate

150mg, per ml

POM Suspension for

Injection

211/012 Jai Pharmacueticals Ltd

2995 Indoplant (Contraceptive Implant) Levonogestrel 75mg POM Implant 211/013 Jai Pharmacueticals Ltd

2996Zinnia-F Tablets Levonorgestrel 150mcg +

EthinylEstradiol 30mcg

POM Tablet Film

coated

211/014 Jai Pharmacueticals Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

2997Revoke -72 Tablets Levonogestrel 0.75mg POM Tablet Film

coated

211/015 Jai Pharmacueticals Ltd

2998Caelyx Injection Doxorubicin Hydrochloride 2mg,

per ml

POM Suspension for

Injection

071/006 Janssen Cilag Pharmaceuticals

Limited

2999Prezista 150 Tablets Darunavir Ethanolate 150mg POM Tablet Film

coated

071/008 Janssen Cilag Pharmaceuticals

Limited

3000Prezista 75 Tablets Darunavir Ethanolate 75mg POM Tablet Film

coated

071/009 Janssen Cilag Pharmaceuticals

Limited

3001Prezista 400 Tablets Darunavir Ethanolate 400 mg POM Tablets oral 071/010 Janssen Cilag Pharmaceuticals

Limited

3002Prezista 100mg, per ml Oral

Suspension

Darunavir Ethanolate 100mg, per

ml

POM Suspension for

Oral Use

071/011 Janssen Cilag Pharmaceuticals

Limited

3003Daktacort Cream 20g Hydrocortisone 2% w/w +

Miconazole 1% w/w

POM Cream Topical 009/007 Janssen-Cilag Pharmaceuticals

Ltd

3004Gyno-Daktarin Vaginal Cream Miconazole 2% w/w POM Cream Vaginal 009/008 Janssen-Cilag Pharmaceuticals

Ltd

3005Daktacort Oral Gel Hydrocortisone 2% w/w +

Miconazole 1% w/w

POM Gel Oral 009/010 Janssen-Cilag Pharmaceuticals

Ltd

3006Daktarin Cream 20g Miconazole 2% w/w POM Cream Topical 009/011 Janssen-Cilag Pharmaceuticals

Ltd

3007Stugeron Tablets 25mg Cinnarizine 25mg POM Tablet Uncoated 009/012 Janssen-Cilag Pharmaceuticals

Ltd

3008Immodium Capsules 2mg Loperamide 2mg POM Tablet Uncoated 009/013 Janssen-Cilag Pharmaceuticals

Ltd

3009Gyno-Daktarin Vaginal Ovules Miconazole 1200mg POM Ovule Vaginal 071/003 Janssen-Cilag Pharmaceuticals

Ltd

3010Daktarin Dusting Powder 2% Miconazole 2% w/w POM Powder Topical 081/001 Janssen-Cilag Pharmaceuticals

Ltd

3011Intelence Tablets Etravirine 25mg POM Tablet Uncoated 364/001 Janssen-Cilag Pharmaceuticals

Ltd3012 Zenglobin Syrup Vitamins + Zinc P Syrup 266/001 Jenburt Pharmaceuticals Limited

3013 Zeglobin Capsules Vitamins + Zinc P Capsule oral 266/002 Jenburt Pharmaceuticals Limited

3014

Cartisafe Forte MSM Tablets Glucosamine Sulphate 750 mg +

Elemental calcium 250 mg +

Vitamin D3 125 IU +

Methylsulfonylmethane 200 mg

P Tablets oral 266/003 Jenburt Pharmaceuticals Limited

3015

Powergesic MR Tablets Chlorzoxazone 500 mg +

Paracetamol 325 mg +

Diclofenac Sodium 50 mg.

P Tablets oral 266/004 Jenburt Pharmaceuticals Limited

Page 148 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3016

Piritexyl – BR Tablets Terbutaline Sulphate 1.25 mg +

Ambroxol Hydrochloride 15 mg +

Guaiphenesin 50 mg + Menthol

2.5 mg.

P Tablets oral 266/006 Jenburt Pharmaceuticals Limited

3017Ojen-OZ Tablets Ofloxacin 200mg + Ornidazole

500mg

POM Tablet Uncoated 266/007 Jenburt Pharmaceuticals Limited

3018Luma Tablets Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 266/008 Jenburt Pharmaceuticals Limited

3019

Powergesic Plus Gel Diclofenac 1%w/w + Methyl

Salicylate 5%w/w + Menthol

1.0%w/w

GS Gel Topical 266/009 Jenburt Pharmaceuticals Limited

3020

Nervijen -P Capsules Pregabalin 75mg +

Methylcobalamin 750mcg +

Vitamin B6 1.50mg + Benfothiam

0.75mg

POM Capsule oral 266/010 Jenburt Pharmaceuticals Limited

3021

Trega Cream Econazole 10mg +

Triamcinolone Acetonide 1mg +

Gentamicin 1mg

POM Cream Topical 266/011 Jenburt Pharmaceuticals Limited

3022Spymal Tablets Pyrimethamine 25mg +

Suphadoxine 500mg

P Tablet Uncoated 022/001 JMB Pharmaceuticals Ltd, India

3023 Besix Tablets Pyridoxine 50mg POM Tablet Uncoated 022/002 JMB Pharmaceuticals Ltd, India

3024 Nystem Tablets Nystatin 100,000 IU POM Tablet Uncoated 022/003 JMB Pharmaceuticals Ltd, India

3025 Multi mix Tablets Vitamin A 2500 IU POM Tablet Uncoated 022/004 JMB Pharmaceuticals Ltd, India

3026 Metroz - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 022/005 JMB Pharmaceuticals Ltd, India

3027 Loperid Capsules Loperamide 2mg POM Capsule oral 022/006 JMB Pharmaceuticals Ltd, India

3028Kotrim Tablets Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 022/007 JMB Pharmaceuticals Ltd, India

3029 Frude Tablets Frusemide 40mg POM Tablet Uncoated 022/008 JMB Pharmaceuticals Ltd, India

3030 Flucoz-200 Tablets Fluconazole 200mg POM Tablet Uncoated 022/009 JMB Pharmaceuticals Ltd, India

3031 Fego Tablets Paracetamol 500mg GS Tablet Uncoated 022/010 JMB Pharmaceuticals Ltd, India

3032 DS - 100 Tablets Diclofenac 100mg P Tablet Uncoated 022/011 JMB Pharmaceuticals Ltd, India

3033 Beco Tablets B Complex P Tablet Uncoated 022/012 JMB Pharmaceuticals Ltd, India

3034 Pentra-50 Tablets Sildenafil 50mg POM Tablet Uncoated 022/013 JMB Pharmaceuticals Ltd, India

3035 Vitacy Tablets Ascorbic Acid 100mg GS Tablet Uncoated 022/014 JMB Pharmaceuticals Ltd, India

3036C.M.T Tablets Aluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

GS Tablet Uncoated 022/015 JMB Pharmaceuticals Ltd, India

3037 Ciprroz 500 Ciprofloxacin 500mg POM Tablet Uncoated 022/016 JMB Pharmaceuticals Ltd, India

3038 Indomin-25 Tablets Indomethacin 25mg P Tablet Uncoated 022/017 JMB Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3039

Brumol Capsules Paracetamol 325mg + Ibuprofen

200mg + Caffeine anhydrous

30mg

P Capsule oral 022/018 JMB Pharmaceuticals Ltd, India

3040 Erymin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 022/019 JMB Pharmaceuticals Ltd, India

3041Duomal Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 022/020 JMB Pharmaceuticals Ltd, India

3042

Flugripp Tablets Paracetamol 500mg + Caffeine

30mg + Chlorpheniramine 2mg +

Phenylephrine 5mg

GS Tablet Uncoated 022/021 JMB Pharmaceuticals Ltd, India

3043 Vermox Tablets Mebendazole 100mg P Tablets 009/003 Johnson & Johnson (Pty) Limited

3044 Combantrin Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 048/001 Johnson & Johnson (Pty) Limited

3045Visine Original Eye Drops Tetrahydrozoline Hydrochloride

0.05% w/v

P Eye Drops 050/001 Johnson & Johnson (Pty) Limited

3046Benylin for Colds Tablets Pseudoephedrine 30mg +

Ibuprofen 200mg

P Tablet Film

coated

062/060 Johnson & Johnson (Pty) Limited

3047Oraldine Mouth Wash Hexetidine 0.1g, per 100ml GS Solution for Oral

Use

082/006 Johnson & Johnson (Pty) Limited

3048Chaberlain's Cough Remedy Regular

Syrup

Guaiphenesin 50 mg, per 5 ml P Syrup 082/007 Johnson & Johnson (Pty) Limited

3049Chaberlain's Cough Remedy

PepperMint Syrup

Guainphenesin 50 mg, per 5 ml +

Peppermint

P Syrup 082/008 Johnson & Johnson (Pty) Limited

3050

Anusol Suppositories Bismuth Subgallate 22.5mg +

Bismuth Oxide 8.75mg + Zinc

Oxide 107.5mg

P Suppository 082/026 Johnson & Johnson (Pty) Limited

3051Cool Mint Listerine Mouth Wash Alcohol 95% 4,58 ml + Thymol

12,78 ml

GS Solution for Oral

Use

082/031 Johnson & Johnson (Pty) Limited

3052

Anusol Ointment Bismuth Subgallate22.5mg +

Bismuth Oxide 8.75mg + Zinc

Oxide 107.5mg

P Ointment topical 082/032 Johnson & Johnson (Pty) Limited

3053Listerine Antiseptic MouthWash Thymol 12,781 mg + Alcohol

95% 5 + Peppermint, per 20ml

GS Solution for Oral

Use

082/034 Johnson & Johnson (Pty) Limited

3054 Benylin Wet Cough methol Syrup Guaifenesin 100mg, per 5ml P Syrup 082/039 Johnson & Johnson (Pty) Limited

3055

Benylin DMD Decongestant Syrup Dextromethorphan

HydroBromide 15 mg +

Pseudoephedrine Hydrochloride

30 mg/5ml

P Syrup 082/046 Johnson & Johnson (Pty) Limited

3056Benylin Dry Cough Syrup Dextromethorphan 15mg, per

5ml

P Syrup 082/047 Johnson & Johnson (Pty) Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3057

Benylin 4 Flu Syrup Diphenhydramine Hydrochloride

25mg+ Paracetamol 1000mg +

Pseudoephedrine Hydrochloride

45mg

P Syrup 082/048 Johnson & Johnson (Pty) Limited

3058

Benylin with Codeine Syrup Diphenhydramine Hydrochloride

14mg + Codeine Phosphate

5.7mg + Levomenthol 1.1mg, per

5 ml.

P Syrup 082/049 Johnson & Johnson (Pty) Limited

3059

Benylin Original Cough Syrup Diphenyhydramine Hydrochloride

12.5mg + Ammoniun Chloride

125mg

P Syrup 082/050 Johnson & Johnson (Pty) Limited

3060Benylin Chest Cough Syrup Guaifenesin 100mg +

Levomenthol 1.1 mg

P Syrup 082/051 Johnson & Johnson (Pty) Limited

3061 Benylin Paediatric Diphenhydramine 7mg, per 5ml P Syrup 082/052 Johnson & Johnson (Pty) Limited

3062

Tartar control Listerine Antiseptic

MouthWash

Alcohol 95% 4,54 ml +Thymol

12,78 mg + Zinc Chloride 18,0

mg, per 20ml

GS Solution for Oral

Use

082/053 Johnson & Johnson (Pty) Limited

3063

Fresburst Listerine MouthWash Alcohol 95% 4,540 ml + Thymol

12,780 mg + Menthol +

Eucalyptus, per 20ml

GS Solution for Oral

Use

082/054 Johnson & Johnson (Pty) Limited

3064 Benylin Children Wet Cough Guaifenesin 200 mg, per 5ml P Syrup 082/055 Johnson & Johnson (Pty) Limited

3065Benylin Adult Wet Cough Syrup Guaiphenesin 200mg + Sodium

Benzoate 200mg

P Syrup 082/056 Johnson & Johnson (Pty) Limited

3066

Sinutab Sinus Allergy Congestion and

Pain

Paracetamol 500mg +

Phenylephrine 2mg +

Chlorpheniramine +

Psuedoephedrine 30mg

P Tablet Uncoated 082/057 Johnson & Johnson (Pty) Limited

3067Sinutab Nasal Drop Spray Xylometazoline 1mg +

Benzalkonium chloride 0.02%

POM Nasal drops 082/058 Johnson & Johnson (Pty) Limited

3068

Teeth and Gum Listerine Mouth Wash Thymol 12,780mg + Alcohol

4,540ml + Sodium Flouride

4,420mg

P Solution for Oral

Use

082/059 Johnson & Johnson (Pty) Limited

3069Benylin Daytime Flu Tablets Pseudoephedrine 30mg +

Ibuprofen 200mg

P Tablet 082/060 Johnson & Johnson (Pty) Limited

3070Woods PepperMint Cough Syrup for

Children

Combination GSL Syrup 153/001 Kalbe International Ltd, South

Africa

3071Woods PepperMint Cough Syrup Combination GSL Syrup 153/002 Kalbe International Ltd, South

Africa3072 Karbazole Tablets Carbimazole 5mg POM Tablet Uncoated 098/001 Kamal International Ltd, India

Page 151 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3073 Kamlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 098/002 Kamal International Ltd, India

3074For-flu Tablets Paracetamol + Chlopheniramine

+ Caffeine

P Tablet Uncoated 098/004 Kamal International Ltd, India

3075Kamcold Tablets Paracetamol + Phenylephrine +

Chlorpheniramine + Caffeine

P Tablet Uncoated 098/005 Kamal International Ltd, India

3076 Power-apetite Tablets Cyproheptadine 4mg P Tablet Uncoated 098/006 Kamal International Ltd, India

3077 Kaonil Tablets Glibenclamide 5mg POM Tablet Uncoated 098/007 Kamal International Ltd, India

3078Mixiderm Cream Miconazole + Neomycin +

Beclomethasone

POM Cream Topical 098/008 Kamal International Ltd, India

3079 Spironolactone 50mg Tablets Spironolactone 50mg POM Tablet Uncoated 098/009 Kamal International Ltd, India

3080 Kafen 100 Tablets Diclofenac 100mg P Tablet Uncoated 098/010 Kamal International Ltd, India

3081 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 098/011 Kamal International Ltd, India

3082 Kamtrax Tablets Levamisole 40mg P Tablet Uncoated 098/012 Kamal International Ltd, India

3083

Sure Cream Iodochlorhydroxyqunolone +

Gentamycin + Bethamethasone

+ Tolnafate

POM Cream Topical 098/013 Kamal International Ltd, India

3084 Klopera Tablets Loperamide 2mg POM Tablet Uncoated 098/014 Kamal International Ltd, India

3085 Kamtopril Tablets Captopril 25mg POM Tablet Uncoated 098/015 Kamal International Ltd, India

3086 Kaydigo Tablets Digoxin 0.25mg POM Tablet Uncoated 098/016 Kamal International Ltd, India

3087 Klax Tablets Bisacodyl 5mg POM Tablet Uncoated 098/017 Kamal International Ltd, India

3088Obrocid Suspension Pyrantel Pamoate 250mg, per

5ml

P Suspension for

Oral Use

098/018 Kamal International Ltd, India

3089Ferrous Sulphate & Folic Acid Tablets Ferrous Sulphate 200mg + Folic

Acid 0.25mg

P Tablet Uncoated 098/019 Kamal International Ltd, India

3090 Knor Tablets Norethistrerone 5mg POM Tablet Uncoated 098/020 Kamal International Ltd, India

3091 Kamipramine Tablets Imipramine 25mg POM Tablet Uncoated 098/021 Kamal International Ltd, India

3092 Kantibac Tablets Nitrofurantoin 100mg POM Tablet Uncoated 098/023 Kamal International Ltd, India

3093 Kamvit-6 Tablets Pyridoxine 50mg POM Tablet Uncoated 098/024 Kamal International Ltd, India

3094 Kasipro 25mg Tablets Spironolactone 25mg POM Tablet Uncoated 098/025 Kamal International Ltd, India

3095 Kamfru Tablets Frusemide 40mg POM Tablet Uncoated 098/026 Kamal International Ltd, India

3096

Oral Rehydration Salts Sodium Chloride 3.5g + Sodium

Citrate 1.5g + Potassium

Chloride 2.9g+ Glucose 20g

POM Powder for Oral

Solution

098/027 Kamal International Ltd, India

3097 Kamvir Tablets Aciclovir 200mg POM Tablet Uncoated 098/028 Kamal International Ltd, India

3098 Kampred Tablets Prednisolone 5mg POM Tablet Uncoated 098/029 Kamal International Ltd, India

3099 Kamcard Tablets Propranolol 40mg POM Tablet Uncoated 098/030 Kamal International Ltd, India

3100 Karbapin Tablets Carbamazepine 200mg POM Tablet Uncoated 098/031 Kamal International Ltd, India

3101 7 Hours 50mg Tablets Sildenafil 50mg POM Tablet Uncoated 098/032 Kamal International Ltd, India

Page 152 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3102 7 Hours 50mg Oral Gel Sildenafil 50mg POM Gel Oral 098/033 Kamal International Ltd, India

3103Boro Pearl Cream Herbal Extracts P Cream Topical 219/001 Kamdhenu Agro-Chem

Industrires, India

3104Foot heal Cream Herbal Extracts P Cream Topical 219/002HM Kamdhenu Agro-Chem

Industrires, India

3105Pain off Cream Herbal Extracts P Cream Topical 219/003 Kamdhenu Agro-Chem

Industrires, India

3106Granny's formula Gel Herbal Extracts P Gel Topical 219/004HM Kamdhenu Agro-Chem

Industrires, India

3107Benzyl Penicillin Injection 1MU Benzyl Penicillin 1 MU POM Powder for

Injection

255/001 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3108Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 MU POM Powder for

Injection

255/002 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3109Ampicillin & Cloxacillin Injection Cloxacillin 250mg + Ampicillin

250mg

POM Powder for

Injection

255/003 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3110Cloxacillin Injection Cloxacillin 500mg POM Powder for

Injection

255/004 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3111Ampicillin 500 Injection Ampicillin 500mg POM Powder for

Injection

255/005 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3112Cefotaxime 1g Injection Cefotaxime 1 gram POM Powder for

Injection

255/006 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3113Cefotaxime 500mg Injection Cefotaxime 500mg POM Powder for

Injection

255/007 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3114Cefotaxime 250mg Injection Cefotaxime 250mg, per 5ml POM Powder for

Injection

255/008 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3115Procaine Penicillin Injection Procaine Benzyl Penicillin 3 MU POM Powder for

Injection

255/009 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3116Benzathine Penicillin Injection 5MU Benzathine Penicillin 5 MU POM Powder for

Injection

255/010 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3117Gentamycin Sulphate Injection Gentamycin 40mg, per ml POM Solution for

Injection

255/011 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3118Ampicillin 1000 Injection Ampicillin 1000mg POM Powder for

Injection

255/012 Karnataka Antibiotics

&Pharmaceuticals Ltd, India

3119Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 007/001 Kausikh Therapeutics (P) Ltd,

India

3120Chlorpheniramine Tablets Chlorpheniramine 4mg P Tablet Uncoated 007/002 Kausikh Therapeutics (P) Ltd,

India

3121Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 007/003 Kausikh Therapeutics (P) Ltd,

India

Page 153 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3122Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 007/004 Kausikh Therapeutics (P) Ltd,

India

3123Tetracycline Capsules Tetracycline 250mg POM Capsule oral 007/005 Kausikh Therapeutics (P) Ltd,

India

3124Furosemide Tablets Furosemide 40mg POM Tablet Uncoated 007/006 Kausikh Therapeutics (P) Ltd,

India

3125Methyldopa Tablets Methyldopa 250mg POM Tablet Film

coated

007/007 Kausikh Therapeutics (P) Ltd,

India

3126Nifedipine Tablets Nifedipine 20mg POM Tablet Uncoated 007/008 Kausikh Therapeutics (P) Ltd,

India

3127Ferrous Sulphate + Folic Acid Tablets Ferrous Sulphate + Folic Acid P Tablets oral 007/009 Kausikh Therapeutics (P) Ltd,

India

3128Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 007/010 Kausikh Therapeutics (P) Ltd,

India

3129Ketoconazole Tablets Ketoconazole 200mg POM Tablet Uncoated 007/011 Kausikh Therapeutics (P) Ltd,

India

3130Penicillin V Tablets Phenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 007/012 Kausikh Therapeutics (P) Ltd,

India

3131Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 007/013 Kausikh Therapeutics (P) Ltd,

India

3132Ampicillin Capsules Ampicillin 250mg POM Capsule oral 007/014 Kausikh Therapeutics (P) Ltd,

India

3133Pyridoxine 50mg Tablets Pyridoxine 50mg P Tablet Uncoated 007/015 Kausikh Therapeutics (P) Ltd,

India

3134Omeprazole Capsules Omeprazole 20mg POM Capsule oral 007/016 Kausikh Therapeutics (P) Ltd,

India

3135Ampicillin and Cloxacillin Capsules Cloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 007/017 Kausikh Therapeutics (P) Ltd,

India

3136Hypocare-5 Tablets Amlodipine 5mg POM Tablet Uncoated 007/018 Kausikh Therapeutics (P) Ltd,

India

3137Ayocare Tablets Amlodipine 10mg POM Tablet Uncoated 007/019 Kausikh Therapeutics (P) Ltd,

India

3138Luxopril-20 Tablets Enalapril 20mg POM Tablet Uncoated 007/020 Kausikh Therapeutics (P) Ltd,

India

3139Luxcee 500 Tablets Ascorbic Acid 500mg GS Tablet Uncoated 007/021 Kausikh Therapeutics (P) Ltd,

India

3140Albendazole Tablets Albendazole 400mg POM Tablet Uncoated 007/022 Kausikh Therapeutics (P) Ltd,

India

Page 154 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3141Capril Tablets Captopril 25mg POM Tablet Uncoated 007/023 Kausikh Therapeutics (P) Ltd,

India

3142Domidome Tablets Domperidone 10mg POM Tablet Uncoated 007/024 Kausikh Therapeutics (P) Ltd,

India

3143Erythromycin Tablets Erythromycin 250mg POM Tablet Uncoated 007/025 Kausikh Therapeutics (P) Ltd,

India

3144Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 007/026 Kausikh Therapeutics (P) Ltd,

India

3145Acyclvir Tablets Acyclovir 200mg POM Tablet Uncoated 007/027 Kausikh Therapeutics (P) Ltd,

India

3146Acyclovir Tablets Aciclovir 400mg POM Tablet Uncoated 007/028 Kausikh Therapeutics (P) Ltd,

India

3147Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 007/029 Kausikh Therapeutics (P) Ltd,

India

3148Emthex 50 Injection Methotrexate 25mg, per ml POM Powder for

Injection

267/001 Khandelwal Laboratories Pvt.Ltd,

India

3149Oncomide 500 Injection Cyclophosphamide 500mg POM Powder for

Injection

267/002 Khandelwal Laboratories Pvt.Ltd,

India

3150Platinex 50 Injection Cisplatin 1mg, per ml POM Powder for

Injection

267/003 Khandelwal Laboratories Pvt.Ltd,

India

3151Womastin Injection Carboplatin 150mg, per 15ml POM Powder for

Injection

267/004 Khandelwal Laboratories Pvt.Ltd,

India

3152Urafil 50 Injection Fluorouracil 500mg, per 10ml POM Powder for

Injection

267/005 Khandelwal Laboratories Pvt.Ltd,

India

3153Mamofen 10 Tablets Tamoxifen 10mg POM Tablet Uncoated 267/006 Khandelwal Laboratories Pvt.Ltd,

India

3154Mamofen 20 Tablets Tamoxifen 20mg POM Tablet Uncoated 267/007 Khandelwal Laboratories Pvt.Ltd,

India

3155Zophost Tablets Alendronate 10mg POM Tablet Uncoated 267/008 Khandelwal Laboratories Pvt.Ltd,

India

3156Anafortan Tablets Paracetamol + Camylofin P Tablet Film

coated

267/009 Khandelwal Laboratories Pvt.Ltd,

India

3157Converten 5 Tablets Enalapril 5mg POM Tablet Uncoated 267/010 Khandelwal Laboratories Pvt.Ltd,

India

3158Allerfast 120 Tablets Fexofenadine 120mg POM Tablet Film

coated

267/011 Khandelwal Laboratories Pvt.Ltd,

India

3159Prenoxid 100 Tablets Prednisolone 100mg POM Tablet Film

coated

267/012 Khandelwal Laboratories Pvt.Ltd,

India

Page 155 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3160

ROIVT Multivitamin Effervescent

Tablets

Ascorbic Acid 67.787mg +

Vitamin E 33mg + Nicotinamide

19mg + Calcium D 7mg +

Pantothen 2.533mg

General Sale Tablet

Effervescent

392/001 Kilitch Drugs ( India) Limited

3161ROIVT Vitamin C 1000mg Effervescent

Tablets

Ascorbic Acid BP 1000mg General Sale Tablet

Effervescent

392/002 Kilitch Drugs ( India) Limited

3162

ROIVT Ginseng Plus Effervescent

Tablets

Taurine 250mg + Guarana

extract 30mg + Ginseng root

extract 15mg + Caffeine 15mg

General Sale Tablet

Effervescent

392/003 Kilitch Drugs ( India) Limited

3163 ONECEF SB 1.5gm InjectionCeftriazone Sodium USP 1gm +

Sulbactam Sodium 500mgPOM

Powder for

Injection392/004 Kilitch Drugs ( India) Limited

3164 9-Vit Infusion Multivitamin infusion POMSolution for

Infusion392/005 Kilitch Drugs ( India) Limited

3165Difisal SR Tablets Diclofenac 100mg P Tablet Film

coated

250/001 Kopran Limited, India

3166 Ciproquin Tablets Ciprofloxacin USP 500mg POM Tablet Uncoated 250/002 Kopran Limited, India

3167 Amyn Capsules Amoxicillin 250mg POM Capsule oral 250/003 Kopran Limited, India

3168Ampicloxa Dry Suspension Cloxacillin 250mg + Ampicillin

250mg

POM Suspension for

Oral Use

250/004 Kopran Limited, India

3169 Paralget Tablets Paracetamol 500mg GS Tablet Uncoated 250/005 Kopran Limited, India

3170Eryko Oral Suspension Erythromycin 125mg, per 5ml POM Suspension for

Oral Use

250/006 Kopran Limited, India

3171 Az-1 Capsules Azithromycin 250mg POM Capsule oral 250/007 Kopran Limited, India

3172 Lokit Capsules Omeprazole 20mg POM Capsule oral 250/008 Kopran Limited, India

3173 Difisal Tablets Diclofenac 50mg P Tablet Uncoated 250/009 Kopran Limited, India

3174 Ciproquin 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 250/010 Kopran Limited, India

3175Bren-200 Tablets Ibuprofen 200mg P Tablet Film

coated

250/011 Kopran Limited, India

3176 Kometro 200 Tablets Metronidazole 200mg POM Tablet Uncoated 250/012 Kopran Limited, India

3177 Rintid 150 Tablets Ranitidine 150mg POM Tablet Uncoated 250/013 Kopran Limited, India

3178 Quinolox 400 Tablets Norfloxacin 400mg POM Tablet Uncoated 250/014 Kopran Limited, India

3179Trim 480 Tablets Trimethoprim 80mg +

Sulphamethoxozole 400mg

POM Tablet Uncoated 250/015 Kopran Limited, India

3180 Ampic Dry Syrup Ampicillin 125mg, per 5ml POM Syrup 250/016 Kopran Limited, India

3181 Ampik Capsules Ampicillin 250mg POM Capsule oral 250/017 Kopran Limited, India

3182 Bren-400 Tablets Ibuprofen 400mg P Tablet Uncoated 250/018 Kopran Limited, India

3183Trim Suspension Sulphamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

250/019 Kopran Limited, India

Page 156 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3184Eryko 250 Tablets Erythromycin 250mg POM Tablet Film

coated

250/020 Kopran Limited, India

3185Amyn Syrup Amoxicillin 125mg, per 5ml POM Granules for

Oral Solution

250/021 Kopran Limited, India

3186 Nubend 400 Tablets Albendazole 400mg POM Tablet Uncoated 250/023 Kopran Limited, India

3187 Klodip-5 Tablets Amlodipine 5mg POM Tablet Uncoated 250/024 Kopran Limited, India

3188 Zimat Tablets Cetirizine 10mg POM Tablet Uncoated 250/025 Kopran Limited, India

3189 Felexin 500 Capsules Cephalexin 500mg POM Capsule oral 250/026 Kopran Limited, India

3190Cloxin Oral Solution Cloxacillin Sodium eq. to 125mg,

per 5ml

POM Granules for

Oral Solution

250/027 Kopran Limited, India

3191Pulmin Inhaler Salbutamol BP 100mcg POM Powder for

Inhalation

250/028 Kopran Limited, India

3192AZ-1 500 Tablets Azithromycin Dihydrate 500mg POM Tablet Film

coated

250/029 Kopran Limited, India

3193Mepran - 500 IV Injection Meropenem Trihydrate 500mg POM Powder for

Injection

250/030 Kopran Limited, India

3194Mepran - 1000 IV Injection Meropenem Trihydrate 1000mg POM Powder for

Injection

250/031 Kopran Limited, India

3195Artemeter Injection Artemether 80mg, per ml POM Solution for

Injection

135/001 Kunming Pharmaceutical Corp.

(KPC), China

3196Artemether 40mg Tablets Artemether 40mg POM Tablet Uncoated 135/002 Kunming Pharmaceutical Corp.

(KPC), China

3197Artemether 50mg Tablets Artemether 50mg POM Tablet Uncoated 135/003 Kunming Pharmaceutical Corp.

(KPC), China

3198Gentamedine Injection Gentamycin 80,000iu, per 2ml POM Solution for

Injection

135/004 Kunming Pharmaceutical Corp.

(KPC), China

3199Vitamedine Injection Vitamin K POM Solution for

Injection

135/005 Kunming Pharmaceutical Corp.

(KPC), China

3200Arco Tablets Artemisinine 250mg +

Naphthoquine 100mg

POM Tablet Film

coated

135/006 Kunming Pharmaceutical Corp.

(KPC), China

3201

Skineal Cream 15g (Ketoconazole 10mg +

Clobetasol Propionate 0.25mg +

Neomycin 5000 iu), per 1g

POM Cream Topical 135/007 Kunming Pharmaceutical Corp.

(KPC), China

3202

Rapid Relief Hot Gel Menthol 5.91% + Eucalyptus

1.97% + Methyl Salicylate 12.8%

+ Terpentine oil 1.47%

P Gel Topical 207/001 L`amar Natural Products Pvt

Ltd,India

3203Rapid relief cold Gel 30g Menthol 2% P Gel Topical 207/002 L`amar Natural Products Pvt

Ltd,India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3204Anaesthetic F.D Injection Lignocaine 2 % + Epinephrine

1:100,000

POM Solution for

Injection

026/001 Laboratories ZEYCO S.A

3205 Burnazine Cream 15g Silver Sulphadiazine 1% POM Cream Topical 309/001 Laboratory & Allied Limited, India

3206 Hycorum Cream 15g Hydrocortisone 1%w/w POM Cream Topical 309/002 Laboratory & Allied Limited, India

3207

Neogracin Dusting Powder 10g Neomycin Sulphate 5mg +

Bacitracin2.5mg + Gramicidin D

0.5mg

P Powder for

Topical use

309/003 Laboratory & Allied Limited, India

3208Gono Injection Specitinomycin Hydrochloride

2.0g

POM Powder for

Injection

309/004 Laboratory & Allied Limited, India

3209

Homagon Capsules Chlorpheniramine maleate 4mg +

Paracetamol 350mg + Caffeine

anhydrous 30mg +

Pseudoephedrine 3mg

GS Tablet Uncoated 309/005 Laboratory & Allied Limited, India

3210Lastmol Salbutamol Sulphate 2mg, per

5ml

P Syrup 309/006 Laboratory & Allied Limited, India

3211 Kemoxyl 250 Capsules Amoxicillin Trihydrate 250mg POM Capsule oral 309/007 Laboratory & Allied Limited, India

3212 Phenobarbiton 30 Tablets Phenobarbitone 30mg POM Capsule oral 309/008 Laboratory & Allied Limited, India

3213 Labesten Vaginal Tablets Nystatin 100,000 IU POM Tablet Uncoated 309/009 Laboratory & Allied Limited, India

3214Lecotrim 480 Tablets Trimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 309/010 Laboratory & Allied Limited, India

3215Axylin Capsules Ampicillin 250mg + Cloxacillin

250mg

POM Capsule oral 309/011 Laboratory & Allied Limited, India

3216 Dermikelp shampoo Ecklonia maxima 31.5 mg, per g GS Shampoo 301/001L Lamicare SA (PTY) Limited

3217 Dermikelp topical Cream Ecklonia maxima 375 mg, per g GS Cream Topical 301/002L Lamicare SA (PTY) Limited

3218Moxileb Dry Syrup Amoxycillin 125mg, per 5ml POM Granules for

Oral Use

149/001 Leben Laboratories (Pvt) Limited,

India

3219Cipium Tablets Chlorpheniramine 4mg P Tablet Uncoated 149/002 Leben Laboratories (Pvt) Limited,

India

3220Regurg 10mg Tablets Metoclopramide 10mg POM Tablet Uncoated 149/003 Leben Laboratories (Pvt) Limited,

India

3221Moxileb 250mg Capsules Amoxycillin 250mg POM Capsule oral 149/004 Leben Laboratories (Pvt) Limited,

India

3222Nalidixic Acid Tablets Nalidixic Acid 500mg POM Tablet Uncoated 149/005 Leben Laboratories (Pvt) Limited,

India

3223Trifluoperazine Tablets Trifluoperazine 5mg POM Tablet Film

coated

149/006 Leben Laboratories (Pvt) Limited,

India

3224Amphen Capsules Chloramphenicol 250mg POM Capsule Oral 149/007 Leben Laboratories (Pvt) Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3225Alclox Capsules Cloxacillin 250mg POM Capsule oral 149/008 Leben Laboratories (Pvt) Limited,

India

3226Metroleb - 200 Tablets Metronidazole 200mg POM Tablets Oral 149/009 Leben Laboratories (Pvt) Limited,

India

3227Griseben 125mg Tablets Griseofulvin 125mg POM Tablet Uncoated 149/010 Leben Laboratories (Pvt) Limited,

India

3228Propranolol 40mg Tablets Propranolol 40mg POM Tablet Uncoated 149/011 Leben Laboratories (Pvt) Limited,

India

3229Ateleb 100mg Tablets Atenolol 100mg POM Tablet Uncoated 149/012 Leben Laboratories (Pvt) Limited,

India

3230Ateleb 50mg Tablets Atenolol 50mg POM Tablet Uncoated 149/013 Leben Laboratories (Pvt) Limited,

India

3231Silveleb 1% Cream Silver Suphadiazine 1% P Cream Topical 149/014 Leben Laboratories (Pvt) Limited,

India

3232Scabcur lotion Lindane 1% P Lotion for

Topical Use

149/015 Leben Laboratories (Pvt) Limited,

India

3233Benzyl Benzoate application Benzyl benzoate P Emulsion 149/016 Leben Laboratories (Pvt) Limited,

India

3234Tetret-250mg Capsules Tetracycline 250mg POM Capsule oral 149/017 Leben Laboratories (Pvt) Limited,

India

3235Indul 25mg Capsules Indomethacin 25mg P Capsule oral 149/018 Leben Laboratories (Pvt) Limited,

India

3236Ciproleb 500 Tablets Ciprofloxacin 500mg POM Tablet Film

coated

149/019 Leben Laboratories (Pvt) Limited,

India

3237Ibut 200mg Tablets Ibuprofen 200mg P Tablet Film

coated

149/020 Leben Laboratories (Pvt) Limited,

India

3238Promethazine 25mg Tablets Promethazine 25mg P Tablet Uncoated 149/021 Leben Laboratories (Pvt) Limited,

India

3239Zylo-P Topical Solution Povidone iodine 10%w/w P Solution for

Topical Use

149/022 Leben Laboratories (Pvt) Limited,

India

3240Foliben 5mg Tablets Folic Acid 5mg POM Tablet Uncoated 149/023 Leben Laboratories (Pvt) Limited,

India

3241QSM Suspension Quinine 150mg POM Suspension for

Oral Use

149/024 Leben Laboratories (Pvt) Limited,

India

3242Kelvin 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 149/025 Leben Laboratories (Pvt) Limited,

India

3243Adiflam Tablets Diclofenac 50mg POM Tablets Oral 149/026 Leben Laboratories (Pvt) Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3244L-Trim Tablets Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablets Oral 149/027 Leben Laboratories (Pvt) Limited,

India

3245Lebasma Syrup Salbutamol 2mg, per 5ml POM Syrup 149/028 Leben Laboratories (Pvt) Limited,

India

3246Lebasma-4 Tablets Salbutamol 4mg POM Tablet Uncoated 149/029 Leben Laboratories (Pvt) Limited,

India

3247Promethazine Syrup Promethazine 5mg, per 5ml P Syrup 149/030 Leben Laboratories (Pvt) Limited,

India

3248

Beclomin Ointment Beclomethasone Dipropionate

0.025% + Miconazole Nitrate BP

2% + Neomycin BP 0.55

POM Ointment topical 149/031 Leben Laboratories (Pvt) Limited,

India

3249L-Trim Suspension Sulfamethoxazole 200mg +

Trimethoprim 40mg

POM Suspension for

Oral Use

149/032 Leben Laboratories (Pvt) Limited,

India

3250Chlorpromazine Tablets Chlorpromazine 100mg POM Tablet Film

coated

149/033 Leben Laboratories (Pvt) Limited,

India

3251Doxyleb Capsule Doxycycline 100mg POM Capsule oral 149/034 Leben Laboratories (Pvt) Limited,

India

3252Lampy-250 Capsules Ampicillin 250mg POM Capsule oral 149/035 Leben Laboratories (Pvt) Limited,

India

3253Adiflam Gel Diclofenac 1 % w/w P Gel Topical 149/036 Leben Laboratories (Pvt) Limited,

India

3254Cipium Syrup Chlorpheniramine 2mg, per ml P Syrup 149/037 Leben Laboratories (Pvt) Limited,

India

3255Cebay-Trx-1000 Injection Ceftriaxone 1000mg POM Powder for

Injection

149/038 Leben Laboratories (Pvt) Limited,

India

3256Cefaxil-1000 Injection Cefotaxime 1000mg POM Powder for

Injection

149/039 Leben Laboratories (Pvt) Limited,

India

3257Prohibin Capsules Omeprazole 20mg POM Capsule oral 149/040 Leben Laboratories (Pvt) Limited,

India

3258Kelvin Syrup Paracetamol 120mg, per 5ml GS Syrup 149/041 Leben Laboratories (Pvt) Limited,

India

3259

Antagit-DS Gel Aluminium hydroxide 400mg +

Magnesium Hydroxide 400mg +

Simethicone 50mg/5ml

P Gel Oral 149/042 Leben Laboratories (Pvt) Limited,

India

3260Alclox Suspension Cloxacillin 125mg, per 5ml POM Powder for Oral

Suspension

149/043 Leben Laboratories (Pvt) Limited,

India

3261Adiflam Injection Diclofenac 50mg, per 3ml POM Solution for

Injection

149/044 Leben Laboratories (Pvt) Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3262Cortileb Cream Hydrocortisone 1%w/w POM Cream Topical 149/045 Leben Laboratories (Pvt) Limited,

India

3263

Elcuf Syrup Chlorpheramine 2.5mg +

Ammonium Chloride 125mg +

Sodium Citrate 55mg, per 5ml

P Syrup 149/046 Leben Laboratories (Pvt) Limited,

India

3264Enderm G.M Cream Clobetasol 0.05% + Miconazole

2% + Gentamicin 0.1%

POM Cream Topical 149/047 Leben Laboratories (Pvt) Limited,

India

3265Nystaleb Suspension Nystatin 100,000 iu, per 5ml POM Suspension for

Oral Use

149/048 Leben Laboratories (Pvt) Limited,

India

3266

Libitus Plus Syrup Guanefenesin 50mg +

Bromhexine 4mg + Terbutaline

Sulphate 1.25mg

POM Syrup 149/049 Leben Laboratories (Pvt) Limited,

India

3267Pyraleb Suspension Pyrantel Pamoate 125mg, per

5ml

P Suspension for

Oral Use

149/050 Leben Laboratories (Pvt) Limited,

India

3268Zylo-P Ointment Povidone Iodine 5% P Ointment topical 149/051 Leben Laboratories (Pvt) Limited,

India

3269Pyraleb Tablets Pyrantel Pamoate 125mg P Tablet Uncoated 149/052 Leben Laboratories (Pvt) Limited,

India

3270Cexil 125 Syrup Cefadroxil 125mg/5ml POM Syrup 149/054 Leben Laboratories (Pvt) Limited,

India

3271Hykophos Syrup Multivitamins GS Syrup 149/055 Leben Laboratories (Pvt) Limited,

India

3272Cexil 500mg Tablets Cefadroxil 500mg POM Tablet Uncoated 149/056 Leben Laboratories (Pvt) Limited,

India

3273Chlorpromazine 25mg Tablets Chlorpromazine 25mg POM Tablet Film

coated

149/057 Leben Laboratories (Pvt) Limited,

India

3274Haloperidol Tablets Haloperidol 1.5mg POM Tablet Uncoated 149/058 Leben Laboratories (Pvt) Limited,

India

3275Chelferron Liquid Haematinic preparation P Solution for Oral

Use

149/059 Leben Laboratories (Pvt) Limited,

India

3276Greseben 500 Tablets Griseofulvin 500mg POM Tablets oral 149/060 Leben Laboratories (Pvt) Limited,

India

3277Q.S.M Tablets Quinine 300mg POM Tablet Uncoated 149/061 Leben Laboratories (Pvt) Limited,

India

3278Cebay - Trx 250 Injection Ceftriaxone 250mg POM Powder for

Injection

149/062 Leben Laboratories (Pvt) Limited,

India

3279Lebasma 2 Tablets Salbutamol 2mg POM Tablet Uncoated 149/063 Leben Laboratories (Pvt) Limited,

India

Page 161 of 296

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3280Cebay 100 Dry Powder Cefixime 100mg, per 5ml POM Powder for Oral

Suspension

149/064 Leben Laboratories (Pvt) Limited,

India

3281Praziquantel Tablets Praziquantel 600mg POM Tablet Uncoated 149/065 Leben Laboratories (Pvt) Limited,

India

3282Amileb-25 Tablets Amitriptyline 25mg POM Tablet Uncoated 149/066 Leben Laboratories (Pvt) Limited,

India

3283Betaleb Ointment Betamethasone 0.10% POM Ointment topical 149/067 Leben Laboratories (Pvt) Limited,

India

3284Kelvin-P Syrup Paracetamol 125mg +

Promethazine 6.25mg, per 5ml

P Syrup 149/068 Leben Laboratories (Pvt) Limited,

India

3285Adiflam Compound Tablets Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 149/069 Leben Laboratories (Pvt) Limited,

India

3286Adiflam Plus Tablets Paracetamol 500mg + Ibuprofen

400mg

P Tablet Uncoated 149/070 Leben Laboratories (Pvt) Limited,

India

3287Ciproleb 250 Tablets Ciprofloxacin 250mg POM Tablet Film

coated

149/071 Leben Laboratories (Pvt) Limited,

India

3288Lamizol O Suspension Ofloxacin 50mg + Ornidazole

125mg, per 5ml

POM Suspension for

Oral Use

149/073 Leben Laboratories (Pvt) Limited,

India

3289Lamizol O Tablets Ofloxacin 200mg + Ornidazole

500mg

POM Tablet Uncoated 149/074 Leben Laboratories (Pvt) Limited,

India

3290Ferrous Sulphate Tablets Ferrous Sulphate 200mg P Tablet Enteric

Coated

149/075 Leben Laboratories (Pvt) Limited,

India

3291Multivitamins Tablets Multivitamins GS Tablet Film

coated

149/076 Leben Laboratories (Pvt) Limited,

India

3292

Sinurhon Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 2mg +

Caffeine 30mg

P Tablet Uncoated 149/077 Leben Laboratories (Pvt) Limited,

India

3293Adiflam -SR Tablets Diclofenac Sodium 100mg P Tablet Uncoated 149/078 Leben Laboratories (Pvt) Limited,

India

3294

Fricold Suspension (Paracetamol BP 250mg +

Chlorpheniramine Maleate BP

2.0mg + Phenylephrin 5.0mg),

per 5ml

GS Suspension for

Oral Use

149/079 Leben Laboratories (Pvt) Limited,

India

3295Kaldol Suspension Paracetamol 120mg, per 5ml GS Suspension for

Oral Use

149/080 Leben Laboratories (Pvt) Limited,

India

3296Moxileb CV 228.5 Dry Syrup (Amoxicillin 200mg + Clavulanic

Acid 28.5mg), per 5ml

POM Syrup 149/081 Leben Laboratories (Pvt) Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3297

Libitus Cough Syrup (Dextromethorphan

HydroBromide BP 10.0mg +

Phenylephrine Hydrochloride

5.0mg + Chlorpheniramine

Maleate 2.0mg), per 5ml

POM Syrup 149/082 Leben Laboratories (Pvt) Limited,

India

3298Rihaee Tablets Aceclofenac BP 100mg +

Paracetamol BP 500mg

P Tablet Film

coated

149/083 Leben Laboratories (Pvt) Limited,

India

3299

Colicspam Oral Drops (Dicyclomine Hydrochloride

10mg + Simethicone 40mg), per

5ml

POM Solution for Oral

Use

149/084 Leben Laboratories (Pvt) Limited,

India

3300

Colicspam Oral Suspension (Dicyclomine Hydrochloride

10mg + Simethicone 40mg), per

5ml

POM Suspension for

Oral Use

149/085 Leben Laboratories (Pvt) Limited,

India

3301Adiflam Plus Suspension Ibuprofen BP 100mg +

Paracetamol BP 125mg

P Suspension for

Oral Use

149/086 Leben Laboratories (Pvt) Limited,

India

3302

Libitus LS Syrup Levosalbutamol Sulphate 1 mg +

Ambroxol Hydrochloride BP

30mg + Guafenisin BP 50mg

POM Syrup 149/087 Leben Laboratories (Pvt) Limited,

India

3303Alwo 400 Tablets Albendazole 400mg POM Tablet Chewable 149/088 Leben Laboratories (Pvt) Limited,

India

3304Azileb 200 Suspension Azithromycin 200mg POM Suspension for

Oral Use

149/089 Leben Laboratories (Pvt) Limited,

India

3305Azileb 500 Tablets Azithromycin 500mg POM Tablets Oral 149/090 Leben Laboratories (Pvt) Limited,

India

3306Betaleb Cream Betamethasone Valerate

0.1%w/w

POM Cream Topical 149/091 Leben Laboratories (Pvt) Limited,

India

3307Enderm Cream Clobetasol Propionate USP

0.05%w/w

POM Cream Topical 149/092 Leben Laboratories (Pvt) Limited,

India

3308

Sinurho Suspension Chlorpheniramine 1mg +

Phenylephrine 5mg +

Paracetamol 125mg

POM Suspension for

Oral Use

228/069 Leben Laboratories (Pvt) Limited,

India

3309

Beclomin Lotion Beclomethasone Dipropionate

BP 0.025% + Miconazole Nitrate

BP 2%

POM Lotion for

Topical Use

228/070 Leben Laboratories (Pvt) Limited,

India

3310HCT Tablets Hydrochlorothiazide 25mg POM Tablet Uncoated 228/071 Leben Laboratories (Pvt) Limited,

India

3311IbuPlus Tablets Ibuprofen 400mg + Paracetamol

325mg

P Tablet Uncoated 228/072 Leben Laboratories (Pvt) Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3312Cypine Tablets Cyproheptadine Hydrochloride

BP 4mg

POM Tablet Enteric

Coated

228/073 Leben Laboratories (Pvt) Limited,

India

3313Lib-Mox 250 Capsules Amoxicillin 250mg POM Capsule oral 284/001 Liberal Pharmaceuticals Limited,

India

3314Lib-Mox Suspension Amoxicillin 125mg, per 5ml POM Suspension for

Oral Use

284/002 Liberal Pharmaceuticals Limited,

India

3315Lib-Dox-100 Capsules Doxycycline 100mg POM Capsule oral 284/003 Liberal Pharmaceuticals Limited,

India

3316Lib-Tetra Capsules Tetracycline 250mg POM Capsule oral 284/004 Liberal Pharmaceuticals Limited,

India

3317Lib-Indo-25 Capsules Indomethacin 25mg P Capsule oral 284/005 Liberal Pharmaceuticals Limited,

India

3318

D'Tuss Ginger Lozenges

Pudina (Mentha viridis) 5.75mg +

Karpura (Cinnamomum

camphora Nees ) 0.18mg

(Multiple)

GS Lozenges 409/001L Lifeon Labs Pvt Ltd

3319

D'Tuss Honey & Lemon Lozenges

Pudina (Mentha viridis) 5.75mg +

Karpura (Cinnamomum

camphora Nees ) 0.18mg

(Multiple)

GS Lozenges 409/002L Lifeon Labs Pvt Ltd

3320D’Tuss Menthol Lozenges

Pudina (mentha viridis) 7mg +

Taila Parni (Eucalyptus globus)

3.3mg

GS Lozenges 409/003L Lifeon Labs Pvt Ltd

3321

D'Tuss Orange Lozenges

Pudina (Mentha viridis) 5.75mg +

Karpura (Cinnamomum

camphora Nees ) 0.18mg

(Multiple)

GS Lozenges 409/004L Lifeon Labs Pvt Ltd

3322Chloramphenicol Injection Chloramphehicol 1g POM Powder for

Injection

228/001 Lincoln Pharmaceuticals Ltd, India

3323Lincosone Cream 15g Neomycin 0.5% + Clotrimazole

1% + Beclometasone 0.025%

POM Cream Topical 228/002 Lincoln Pharmaceuticals Ltd, India

3324 Te-De-V Tablets Clotrimazole 100mg POM Tablet Vaginal 228/003 Lincoln Pharmaceuticals Ltd, India

3325

Vivian Gel Diclofenac 1.16% + Linseed Oil

3% + Methy Salicylate 10% +

Menthol 5%

P Gel Topical 228/004 Lincoln Pharmaceuticals Ltd, India

3326 Neovag Ointment 30g Nystatin 100,000iu POM Ointment topical 228/005 Lincoln Pharmaceuticals Ltd, India

3327 Deexa Eye Drops Dexamethasone 0.1% w/v POM Eye Drops 228/006 Lincoln Pharmaceuticals Ltd, India

3328Deexa-N Eye Drops Dexamethasone 0.1 % w/v +

Neomycin 0.5 % w/v

POM Eye Drops 228/007 Lincoln Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3329 Omlink-20 Capsules Omeprazole 20mg POM Capsule oral 228/008 Lincoln Pharmaceuticals Ltd, India

3330 Daolin-5 Tablets Glibenclamide 5mg POM Tablet Uncoated 228/009 Lincoln Pharmaceuticals Ltd, India

3331 Malarid-200 Tablets Amodiaquine 200mg POM Tablet Uncoated 228/010 Lincoln Pharmaceuticals Ltd, India

3332Rifalin Tablets Rifampicin 150mg + Isoniazid

100mg

POM Tablet Uncoated 228/011 Lincoln Pharmaceuticals Ltd, India

3333 Konazol Cream Ketoconazole 2% w/w POM Cream Topical 228/012 Lincoln Pharmaceuticals Ltd, India

3334

Cotrimoxazole Oral Suspension Trimethoprim 40mg +

Sulphamethoxazole 200mg, per

5ml

POM Suspension for

Oral Use

228/013 Lincoln Pharmaceuticals Ltd, India

3335Compound Magnesium Triscilicate

Tablets

Aluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

GS Tablet Uncoated 228/014 Lincoln Pharmaceuticals Ltd, India

3336 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 228/015 Lincoln Pharmaceuticals Ltd, India

3337 Frusemide Tablets Furosemide 40mg POM Tablet Uncoated 228/016 Lincoln Pharmaceuticals Ltd, India

3338Metronidazole Suspension Metronidazole Benzoate 200mg,

per 5mls

POM Suspension for

Oral Use

228/017 Lincoln Pharmaceuticals Ltd, India

3339Ampicillin Sodium Injection Ampicillin Sodium 500mg POM Powder for

Injection

228/018 Lincoln Pharmaceuticals Ltd, India

3340 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 228/019 Lincoln Pharmaceuticals Ltd, India

3341Benzyl Penicillin Injection 5MU Benzyl Penicillin 5 Mega POM Powder for

Injection

228/020 Lincoln Pharmaceuticals Ltd, India

3342 Licambutol Tablets Ethambutol 800mg POM Tablet Uncoated 228/021 Lincoln Pharmaceuticals Ltd, India

3343Perilin Injection Metoclopramide 5mg, per ml POM Solution for

Injection

228/022 Lincoln Pharmaceuticals Ltd, India

3344 Ranilink 150 Tablets Ranitidine 150mg POM Tablet Uncoated 228/023 Lincoln Pharmaceuticals Ltd, India

3345Vitamin B Complex Injection Vitamin B Complex POM Solution for

Injection

228/024 Lincoln Pharmaceuticals Ltd, India

3346 Teterous-250 Capsules Tetracycline 250mg POM Capsule oral 228/025 Lincoln Pharmaceuticals Ltd, India

3347 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 228/026 Lincoln Pharmaceuticals Ltd, India

3348 Penizin Tablets Benzathine Penicillin 2.4MU POM Tablet Uncoated 228/027 Lincoln Pharmaceuticals Ltd, India

3349 Bet Cream 15g Betamethasone Valerate 0.1% POM Cream Topical 228/028 Lincoln Pharmaceuticals Ltd, India

3350Clotrilin MouthWash Clotrimazole 1% POM Solution for Oral

Use

228/029 Lincoln Pharmaceuticals Ltd, India

3351 Dermofulvin Tablets Griseofulvin 125mg POM Tablet Uncoated 228/031 Lincoln Pharmaceuticals Ltd, India

3352Hydrocortisone Sodium Injection Hydrocortisone Sodium

Succinate 100mg

POM Powder for

Injection

228/032 Lincoln Pharmaceuticals Ltd, India

3353Nystatin Oral Suspension Nystatin 100,000 IU, per ml POM Suspension for

Oral Use

228/033 Lincoln Pharmaceuticals Ltd, India

3354 Neovag vaginal Tablets Nystatin 100,000 IU POM Tablet Vaginal 228/034 Lincoln Pharmaceuticals Ltd, India

3355 Perfloxacin Tablets Perfloxacin 400mg POM Tablet Uncoated 228/035 Lincoln Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3356 Povidone iodine Ointment Povidone Iodine 5.0%w/w GS Ointment topical 228/036 Lincoln Pharmaceuticals Ltd, India

3357 Pyrazinamide Tablets Pyrazanamide 500mg POM Tablet Uncoated 228/037 Lincoln Pharmaceuticals Ltd, India

3358

Silvo Cream Silver Sulfadiazine USP 1%w/w

+ Chlorhexadine Gluconate

2%w/w

P Cream Topical 228/038 Lincoln Pharmaceuticals Ltd, India

3359Diclofenac Sodium Injection Diclofenac Sodium 75mg, per

3ml

POM Solution for

Injection

228/039 Lincoln Pharmaceuticals Ltd, India

3360 Micolin Cream 15g Miconazole 2% POM Cream Topical 228/040 Lincoln Pharmaceuticals Ltd, India

3361 L-genta Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 228/041 Lincoln Pharmaceuticals Ltd, India

3362 Allphenicol Eye Drops Chloramphenicol 0.5%w/v POM Ear/Eye Drops 228/042 Lincoln Pharmaceuticals Ltd, India

3363

Bet.N Cream Betamethasone Valeate 0.05%

w/w + Neomycin Sulphate

0.5%w/w

POM Cream Topical 228/043 Lincoln Pharmaceuticals Ltd, India

3364 Doxycycline Capsules Doxycycline 100mg POM Capsule oral 228/044 Lincoln Pharmaceuticals Ltd, India

3365 Clotrimazole Cream Clotrimazole 1%w/w POM Cream Topical 228/045 Lincoln Pharmaceuticals Ltd, India

3366Fortified procaine pencillin Injection

2.4MU

Fortified Procaine Penicillin 4MU POM Powder for

Injection

228/046 Lincoln Pharmaceuticals Ltd, India

3367 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 228/047 Lincoln Pharmaceuticals Ltd, India

3368Lignocaine Injection Lignocaine 2% POM Solution for

Injection

228/048 Lincoln Pharmaceuticals Ltd, India

3369Ibun Tablets Ibuprofen 400mg + Paracetamol

500mg

P Tablet Uncoated 228/049 Lincoln Pharmaceuticals Ltd, India

3370 Aminophylline Tablets Aminophylline 100mg POM Tablet Uncoated 228/050 Lincoln Pharmaceuticals Ltd, India

3371 Losa 50 Tablets Losartan Potassium USP 50mg POM Tablet Uncoated 228/051 Lincoln Pharmaceuticals Ltd, India

3372Strom Injection Tramadol Hydrochloride 100mg,

per 2ml

POM Solution for

Injection

228/052 Lincoln Pharmaceuticals Ltd, India

3373Soludine -M Ointment Povidone Iodine USP 5%w/w +

Metronidazole BP 1%w/w

P Ointment topical 228/053 Lincoln Pharmaceuticals Ltd, India

3374

Dermolin GM Cream Clobetasone Propionate 0.05%

+ Gentamicin Sulphate 2.00% +

Miconazo 0.10%

POM Cream Topical 228/054 Lincoln Pharmaceuticals Ltd, India

3375

Flucomol Anticold Capsules Paracetamol 500mg +

Phenylephrine 10mg +

Dextromethorphan 15mg +

Chlorpheniramine 2mg

POM Capsule oral 228/055 Lincoln Pharmaceuticals Ltd, India

3376

Flucomol Anticold Suspension (Paracetamol 250mg +

Phenylephrine 5mg +

Dextromethorphan 10mg +

Chlorpheniramine 2mg)/5ml

POM Suspension for

Oral Use

228/056 Lincoln Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3377

Glymet -1 Tablets Glimepiride 1mg + (extended

release) Metformin Hydrochloride

500mg

POM Tablet Uncoated 228/057 Lincoln Pharmaceuticals Ltd, India

3378

Glymet -2 Tablets Glimepiride 2mg + (extended

release) Metformin Hydrochloride

500mg

POM Tablet Uncoated 228/058 Lincoln Pharmaceuticals Ltd, India

3379Trioxon-O 200mg Cefixime Trihydrate USP eq.

Cefixime 200mg

POM Tablet Uncoated 228/059 Lincoln Pharmaceuticals Ltd, India

3380Trioxon-O Oral Suspension Cefixime Trihydrate USP eq.

Cefixime 50mg, per 5ml

POM Suspension for

Oral Use

228/060 Lincoln Pharmaceuticals Ltd, India

3381Trioxon-O 100mg Cefixime Trihydrate USP eq.

Cefixime 100mg

POM Tablet Uncoated 228/061 Lincoln Pharmaceuticals Ltd, India

3382 L-Pill Tablets Misoprostal 200mcg POM Tablet Uncoated 228/062 Lincoln Pharmaceuticals Ltd, India

3383Pentalink 40mg Tablets Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Tablet Uncoated 228/063 Lincoln Pharmaceuticals Ltd, India

3384Ofloque -OZ Suspension Ofloxacin BP 50mg + Ornidazole

125mg, per 5ml

POM Suspension for

Oral Use

228/064 Lincoln Pharmaceuticals Ltd, India

3385

PA 12 Tablets Paracetamol BP 300mg (as

immediate release) +

Paracetamol BP 700mg (as

sustained release)

P Tablet Modified

Release

228/065 Lincoln Pharmaceuticals Ltd, India

3386

Ciprovital + Tablets Cyproheptadine Hydrochloride

2mg + Thiamine Hydrochloride

1.2mg + Pyridoxine

Hydrochloride BP 1.2mg +

Nicotinamide Hydrochloride BP

1.2mg

P Tablet Uncoated 228/066 Lincoln Pharmaceuticals Ltd, India

3387

Ciprovital + Syrup (Cyproheptadine Hydrochloride

2mg + Thiamine Hydrochloride

1.2mg + Pyridoxine

Hydrochloride BP 1.2mg +

Nicotinamide Hydrochloride BP

1.2mg), per 5ml

P Syrup 228/067 Lincoln Pharmaceuticals Ltd, India

3388

Losa-H Tablets Losartan Potassium USP 50mg +

Hydrochlorothiazide BP 12.5mg

POM Tablet Uncoated 228/068 Lincoln Pharmaceuticals Ltd, India

3389L-kelfin Tablets Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 228/069 Lincoln Pharmaceuticals Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3390Gluzojoint-F Capsules Glucosamine Hydrochloride

750mg

P Capsule oral 365/001 LOK WAL DEVELOPMENT LTD.

HONG KONG

3391Glugogone Capsules Bitter Melon Extract 496.5mg P Capsule oral 365/002 LOK WAL DEVELOPMENT LTD.

HONG KONG

3392Refined Yunzhi Essence Capsules Yunzhi Essence 300 mg P Capsule oral 365/005L LOK WAL DEVELOPMENT LTD.

HONG KONG

3393Ginseng coffee (4 in 1) Ginseng Extract 0.2mg + Coffee

2mg

P Powder for Oral

Solution

382/003 LOK WAL DEVELOPMENT LTD.

HONG KONG

3394Cerebrain Tablets Gingko leaves Extract 30mg P Tablet Uncoated 382/004 LOK WAL DEVELOPMENT LTD.

HONG KONG

3395Tonac -10mg Tablets Atorvastatin 10mg POM Tablet Film

coated

281/001 Lupin laboratories Limited, India

3396 Ceff pead Tablets Cephalexin 125mg POM Tablet Uncoated 281/002 Lupin laboratories Limited, India

3397 Tonac-20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 281/003 Lupin laboratories Limited, India

3398Ceff Dry Syrup Cefalexin 125mg, per 5ml POM Suspension for

Oral Use

281/004 Lupin laboratories Limited, India

3399Novapime 0.5g Injection Cefepime Hydrochloride USP

500mg

POM Solution for

Injection

281/005 Lupin laboratories Limited, India

3400Novapime 1g Injection Cefepime Hydrochloride USP

1000mg

POM Solution for

Injection

281/006 Lupin laboratories Limited, India

3401Salbair Solution Salbutamol 100mcg POM Solution for

Inhalation

281/012 Lupin laboratories Limited, India

3402Salbair-1 Solution Salbutamol 100mcg +

Ipratropium 20mcg

POM Solution for

Inhalation

281/013 Lupin laboratories Limited, India

3403Salbair-B Salbutamol 100mcg +

Beclomethasone 50mcg

POM Solution for

Inhalation

281/014 Lupin laboratories Limited, India

3404Hepp Forte Syrup Folic Acid 0.5mg + Elemental

Iron 50mg, per 15ml

P Syrup 281/015 Lupin laboratories Limited, India

3405 Cetil -250 Tablets Ceforoxime 250mg POM Tablet Uncoated 281/016 Lupin laboratories Limited, India

3406 Cetil -500 Tablets Ceforoxime 500mg POM Tablet Uncoated 281/017 Lupin laboratories Limited, India

3407Odicef Injection Ceftriaxone 1g POM Powder for

Injection

281/018 Lupin laboratories Limited, India

3408 Ceff-250 Capsules Cephalexin 250mg POM Capsule oral 281/019 Lupin laboratories Limited, India

3409Novapime Injection Cefepime 1000mg POM Solution for

Injection

281/020 Lupin laboratories Limited, India

3410 Ceff 500 Capsules Cephalexin 500mg POM Capsule oral 281/021 Lupin laboratories Limited, India

3411Esiflo 125 Inhaler Salmeterol 25mcg + Fluticasone

125mcg

POM Powder for

Inhalation

281/022 Lupin laboratories Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3412Esiflo 250 Inhaler Salmeterol 25mcg + Fluticasone

250mcg

POM Powder for

Inhalation

281/023 Lupin laboratories Limited, India

3413 Odoxil Tablets Cefadroxil 500mg POM Tablet Uncoated 281/024 Lupin laboratories Limited, India

3414Odoxil Oral Suspension Cefradoxil 125mg/5mg POM Suspension for

Oral Use

281/025 Lupin laboratories Limited, India

3415Akurit-3 Tablets Rifampicin 150mg + Isoniazid

75mg + Ethambutol 275mg

POM Tablet Uncoated 281/028 Lupin laboratories Limited, India

3416Akurit Kids Rifampicin 60mg + Isoniazid

30mg

POM Tablet Uncoated 281/029 Lupin laboratories Limited, India

3417Akurit - Z Kids Tablets Rifampicin 60mg + Isoniazid

30mg + Pyrazinamide 150mg

POM Tablet Uncoated 281/030 Lupin laboratories Limited, India

3418

Akurit-4 Tablets Rifampicin 150mg + Isoniazid

75mg + Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 281/031 Lupin laboratories Limited, India

3419 Ethambutol Tablets Ethambutol 400mg POM Tablet Uncoated 281/032 Lupin laboratories Limited, India

3420 Ethide Tablets Ethionamide 250mg POM Tablet Uncoated 281/033 Lupin laboratories Limited, India

3421Lyforan Injection Cefotaxime 1g POM Powder for

Injection

163/001 Lyka Labs limited, India

3422 Fas-3 Kit Tablets Azithromycin 2.15g POM Tablet Uncoated 163/002 Lyka Labs limited, India

3423 Lyproquin Tablets Ciprofloxacin 250mg POM Tablet Uncoated 163/003 Lyka Labs limited, India

3424Lyramycin Injection Gentamycin 40mg, per ml POM Solution for

Injection

163/004 Lyka Labs limited, India

3425 Imidil Vaginal Tablets Clotrimazole 100mg POM Tablet Uncoated 163/005 Lyka Labs limited, India

3426 Lamoxy Capsules Amoxicillin 250mg POM Capsule oral 163/006 Lyka Labs limited, India

3427Lycortin-s-Injection Hydrocortisone 1000mg POM Powder for

Injection

163/007 Lyka Labs limited, India

3428Basin 500 Capsules Cloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 163/008 Lyka Labs limited, India

3429Anquin 400 Tablets Norfloxacin 400mg POM Tablet Film

coated

163/009 Lyka Labs limited, India

3430Ampicillin Injection Ampicillin 1g POM Powder for

Injection

163/010 Lyka Labs limited, India

3431 Sepexin-250 Capsules Cephalexin BP 250mg POM Capsule oral 163/011 Lyka Labs limited, India

3432Lamoxyl Syrup Amoxicillin Trihydrate BP 125mg,

per 5ml

POM Suspension for

Oral Use

163/012 Lyka Labs limited, India

3433Lamoxy Syrup Amoxicillin Trihydrate BP 250mg POM Powder for Oral

Solution

163/013 Lyka Labs limited, India

3434Lyfaxone Injection Ceftriaxone USP 1g POM Powder for

Injection

163/014 Lyka Labs limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3435Lyseptol Tablets Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 163/015 Lyka Labs limited, India

3436 Lanol 500 Tablets Paracetamol BP 500mg GS Tablet Uncoated 163/016 Lyka Labs limited, India

3437 Imidil Vaginal Tablets Clotrimazole USP 200mg POM Tablet Vaginal 163/017 Lyka Labs limited, India

3438Sulfadar Tablets Sulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 163/018 Lyka Labs limited, India

3439 Klox 250 Capsules Cloxacillin BP 250mg POM Capsule oral 163/019 Lyka Labs limited, India

3440 Lyproquin Tablets Ciprofloxacin USP 500mg POM Tablet Uncoated 163/020 Lyka Labs limited, India

3441 Lydic Tablets Diclofenac Sodium BP 25mg P Tablet Uncoated 163/021 Lyka Labs limited, India

3442Ampicillin 250 Capsules Ampicillin Trihydrate BP 250mg POM Capsule oral 206/001 Maan Pharmaceuticals Limited,

India

3443Amoxicillin 250 Capsules Amoxicillin Trihydrate BP 250mg POM Capsule oral 206/002 Maan Pharmaceuticals Limited,

India

3444Primacort 100 Injection Hydrocortisone 100mg, per 10ml POM Powder for

Injection

192/001 Macleods Pharmaceuticals

Limited, India

3445Kanamac 1000 Injection Kanamycin 1000mg, per 10ml POM Powder for

Injection

192/002 Macleods Pharmaceuticals

Limited, India

3446Macox Plus 100 Tablets Isoniazid 50mg + Rifampicin

250mg

POM Tablet Uncoated 192/003 Macleods Pharmaceuticals

Limited, India

3447Anti-thyrox Tablets Carbimazole 5mg POM Tablet Uncoated 192/004 Macleods Pharmaceuticals

Limited, India

3448Amlodipine Tablets Amlodipine 5mg POM Tablet Uncoated 192/005 Macleods Pharmaceuticals

Limited, India

3449Ecox 400 Tablets Ethambutol 400mg POM Tablet Uncoated 192/006 Macleods Pharmaceuticals

Limited, India

3450Macrozide 500 Tablets Pyrazinamide 500mg POM Tablet Uncoated 192/007 Macleods Pharmaceuticals

Limited, India

3451Azicure 250 Tablets Azithromycin 250mg POM Tablet Uncoated 192/008 Macleods Pharmaceuticals

Limited, India

3452Azicure 500 Tablets Azithromycin 500mg POM Tablet Uncoated 192/009 Macleods Pharmaceuticals

Limited, India

3453Azicure 200/5ml Oral Suspension Azithromycin 200mg, per 5ml POM Suspension for

Oral Use

192/010 Macleods Pharmaceuticals

Limited, India

3454Chloramphenicol Sodium Injection Chlorampehicol 1g POM Powder for

Injection

192/011 Macleods Pharmaceuticals

Limited, India

3455Econex 400 Tablets Ethambutol + Isoniazid POM Tablet Uncoated 192/012 Macleods Pharmaceuticals

Limited, India

3456Forecox-Trac Tablets Rifampicin + Isoniazid +

Pyrazinamide + Ethambutol

POM Tablet Uncoated 192/013 Macleods Pharmaceuticals

Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3457Levomac 500 I.V infusion Levofloxacin 500mg POM Solution for

infusion

192/014 Macleods Pharmaceuticals

Limited, India

3458Levovac 250 Tablets Levofloxacin 250mg POM Tablet Uncoated 192/015 Macleods Pharmaceuticals

Limited, India

3459Levovac 500 Tablets Levofloxacin 500mg POM Tablet Uncoated 192/016 Macleods Pharmaceuticals

Limited, India

3460Kapocin Injection Capreomycin 1g POM Powder for

Injection

192/017 Macleods Pharmaceuticals

Limited, India

3461Coxerin Tablets Cycloserine 250mg POM Tablet Uncoated 192/018 Macleods Pharmaceuticals

Limited, India

3462Macripril – 10 Tablets (Enalapril

maleate USP 10mg)

Enalapril 10mg POM Tablets Oral 192/019 Macleods Pharmaceuticals

Limited, India

3463Tenomac 50 Tablets (Atenolol BP

50mg)

Atenolol 50mg POM Tablets Oral 192/020 Macleods Pharmaceuticals

Limited, India

3464Haloperidol Tablets (Haloperidol BP

5mg)

Haloperidol 5mg POM Tablets Oral 192/021 Macleods Pharmaceuticals

Limited, India

3465Rifampicin and Isoniazid Tablets Isoniazid150mg + Rifampicin

225mg

POM Tablet Film

coated

192/023 Macleods Pharmaceuticals

Limited, India

3466

Forecox Tablets Rifampicin 150mg + Isoniazid

75mg + Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 192/024 Macleods Pharmaceuticals

Limited, India

3467Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 192/025 Macleods Pharmaceuticals

Limited, India

3468Cotrimoxazole Tablets Sulphamethoxazole +

Trimethoprim 480mg

POM Tablet Uncoated 192/026 Macleods Pharmaceuticals

Limited, India

3469Lamivudine Tablets Lamivudine 150mg POM Tablet Film

coated

192/027 Macleods Pharmaceuticals

Limited, India

3470Lamivudine/Zidovudine Tablets Lamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 192/028 Macleods Pharmaceuticals

Limited, India

3471Isoniazid Tablets Isoniazid 100mg POM Tablet Film

coated

192/029 Macleods Pharmaceuticals

Limited, India

3472Isoniazid Tablets Isoniazid 300mg POM Tablet Film

coated

192/030 Macleods Pharmaceuticals

Limited, India

3473Nifedipine BP 10mg Tablets Nifedipine 10mg POM Tablet Uncoated 192/031 Macleods Pharmaceuticals

Limited, India

3474Macrozide Tablets Pyrazinamide 400mg POM Tablet Uncoated 192/032 Macleods Pharmaceuticals

Limited, India

3475Torvast 20mg Tablets Artovastatin 20mg POM Tablet Uncoated 192/033 Macleods Pharmaceuticals

Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3476Cefolac 200 Tablets Cefixime Trihydrate 200mg POM Tablet Uncoated 192/034 Macleods Pharmaceuticals

Limited, India

3477Ziidovudine 300mg Tablets Zidovudine 300mg POM Tablet Uncoated 192/035 Macleods Pharmaceuticals

Limited, India

3478Efavirenz 600mg Tablets Efavirenz 600mg POM Tablet Uncoated 192/036 Macleods Pharmaceuticals

Limited, India

3479Emtricitabine 200mg + Tenofovir DF

300mg Tablets

Emtricitabine 200mg + Tenofovir

DF 300mg Tablets

POM Tablet Film

coated

192/037 Macleods Pharmaceuticals

Limited, India

3480Rifampicin 60mg + Isoniazid 30mg Rifampicin 60mg + Isoniazid

30mg Dispersible tablets

POM Tablet

Dispersible

192/038 Macleods Pharmaceuticals

Limited, India

3481

Rifampicin 60mg + Isoniazid 30mg +

Pyrazinamide 150mg Dispersible tabl

Rifampicin 60mg + Isoniazid

30mg + Pyrazinamide 150mg

Dispersible tablet

POM Tablet

Dispersible

192/039 Macleods Pharmaceuticals

Limited, India

3482Lamivudine 300mg & Tenofovir 300mg

Tablets

Lamivudine 300mg + Tenofovir

300mg tablets

POM Tablet Uncoated 192/040 Macleods Pharmaceuticals

Limited, India

3483

Lamivudine 150mg+Zidovudine 300mg

+ Nevirapine 200mg Tablets

Lamivudine 150mg+ Zidovudine

300mg + Nevirapine 200mg

tablets

POM Tablet Uncoated 192/041 Macleods Pharmaceuticals

Limited, India

3484Tenofovir 300mg Tablets Tenofovir Disoproxil Fumarate

300mg

POM Tablet Uncoated 192/042 Macleods Pharmaceuticals

Limited, India

3485

Emtricitabine 200mg + Tenofovir DF

300mg + Efavirenz 600mg Tablets

Emtricitabine I.H 200mg +

Tenofivir Diisoproxil I.H 300mg +

Efavirenz 600mg

POM Tablet Uncoated 192/043 Macleods Pharmaceuticals

Limited, India

3486Lumitar Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet Uncoated 192/044 Macleods Pharmaceuticals

Limited, India

3487Ethomid 250 Tablets Ethionamide 250mg POM Tablet Film

coated

192/045 Macleods Pharmaceuticals

Limited, India

3488Pas Sodium Granules Para Aminosalicylate Sodium

600mg, per g

POM Powder for Oral

Suspension

192/046 Macleods Pharmaceuticals

Limited, India

3489Moximac Tablets Moxifloxacin Hydrochloride

Tablets 400 mg

POM Tablet Film

coated

192/047 Macleods Pharmaceuticals

Limited, India

3490Maxadol Tablets Paracetamol 500mg GS Tablet Uncoated 167/012 Mac's Pharmaceuticals Limited,

Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3491

Cofrid Tablets Extract Glycyrhh BP 35mg +

Menthol BP 10mg + Aniseed BP

0.001ml + Peppermint oil BP

0.001ml + Tincture of Capsicum

BPC 0.020ml + Pini pumil oil

BPC 0.001ml + Eucalyptus BP

0.02ml

GS Tablet Uncoated 167/013 Mac's Pharmaceuticals Limited,

Kenya

3492Orthoboon Sachets

Collagen Peptides 10g +

Glucosamine Sulphate 1500mg +

Potassium Chloride 35mg

GSPowder for Oral

Solution325/030L Mankind Pharma Limited

3493 Uniortho - 500 TabletsUnivestin (a blend of extracts of

Scutellaria baicalensis) 500mgP Tablet Uncoated 325/031L Mankind Pharma Limited

3494 Uniortho - 250 TabletsUnivestin (a blend of extracts of

Scutellaria baicalensis) 250mgP Tablet Uncoated 325/032L Mankind Pharma Limited

3495Reheptin Tablets

Metadoxine 500mg + Silymarin

140mg + L-Ornithine150mg + L-

Aspartate 3mg + Pyridox 1.5mg

P Tablet Uncoated 325/033L Mankind Pharma Limited

3496 Texakind Injection Tranexamic Acid BP 500mg POMSolution for

Injection325/034 Mankind Pharma Limited

3497 Manforce Condoms Strawberry Flavour Male Latex Condom GSLatex Products

325/035L Mankind Pharma Limited

3498 Manforce Condoms Mango Flavour Male Latex Condom GS Latex Products 325/036L Mankind Pharma Limited

3499Manforce Condoms Black Grapes

FlavourMale Latex Condom GS

Latex Products325/037L Mankind Pharma Limited

3500Manforce Condoms Black Chocolate

FlavourMale Latex Condom GS

Latex Products325/038L Mankind Pharma Limited

3501Pantakind 40 Tablets Pantoprazole Sodium 40mg POM Tablet Film

coated

325/001 Mankind Pharma Ltd, India

3502Manforce 50 Tablets Sildenafil Citrate 50mg POM Tablet Film

coated

325/002 Mankind Pharma Ltd, India

3503Manforce 100 Tablets Sildenafil Citrate 100mg POM Tablet Film

coated

325/003 Mankind Pharma Ltd, India

3504 Losakind-50 Tablets Losartan Potassium 50mg POM Tablet Uncoated 325/004 Mankind Pharma Ltd, India

3505 Losakind 25 Tablets Losartan Potassium 25mg POM Tablet Uncoated 325/005 Mankind Pharma Ltd, India

3506Glimestar 4 Tablets Glimepiride 4mg POM Tablet Film

coated

325/006 Mankind Pharma Ltd, India

3507Glimestar 3 Tablets Glimepiride 3mg POM Tablet Film

coated

325/007 Mankind Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3508Glimestar 2 Tablets Glimepiride 2mg POM Tablet Film

coated

325/008 Mankind Pharma Ltd, India

3509Glimestar 1 Tablets Glimepiride 1mg POM Tablet Film

coated

325/009 Mankind Pharma Ltd, India

3510

Moxikind - CV 625 Tablets Amoxicillin Trihydrate BP 500mg

+ Clavulanate Potassium BP

125mg

POM Tablet Film

coated

325/010 Mankind Pharma Ltd, India

3511

Moxikind - CV Suspension Amoxicillin Trihydrate BP 200mg

+ Potassium Clavulanate BP

28.50mg

POM Suspension for

Oral Use

325/011 Mankind Pharma Ltd, India

3512

Moxikind - CV 375 Tablets Amoxicillin Trihydrate BP 250mg

+ Clavulanate Potassium BP

125mg

POM Tablet Uncoated 325/012 Mankind Pharma Ltd, India

3513 Rabekind -20 tablet Rabeprazole 20mg POM Tablet Uncoated 325/013 Mankind Pharma Ltd, India

3514Vomikind Injection Ondasetron Hydrochloride USP

2mg

POM Solution for

Injection

325/014 Mankind Pharma Ltd, India

3515 Deoregdina Tablets Levonorgestrel 1.5mg POM Tablet Uncoated 325/015 Mankind Pharma Ltd, India

3516 Ominext -20 Capsules Omeprazole BP 20mg POM Capsule oral 325/016 Mankind Pharma Ltd, India

3517

Nuforce G Cream Betamethasone Dipropionate BP

0.643mg + Clotrimazole BP

10mg + Gentamycin 1mg

POM Cream Topical 325/017 Mankind Pharma Ltd, India

3518

Losakind - H Tablets Losartan Potassium USP 50mg +

Hydrochlorothiazide USP 25mg

POM Tablet Uncoated 325/018 Mankind Pharma Ltd, India

3519 Cefakind 500 Tablets Cefuroxime Axetil 500mg POM Tablet Uncoated 325/019 Mankind Pharma Ltd, India

3520 Cefakind 250 Tablets Cefuroxime Axetil 250mg POM Tablet Uncoated 325/020 Mankind Pharma Ltd, India

3521Terbinaforce - 250 Tablets Terbinafine Hydrochloride USP

250mg

POM Tablet Uncoated 325/021 Mankind Pharma Ltd, India

3522Clopikind - 75 Tablets Clopidogrel Bisulphate USP

75mg

POM Tablet Film

coated

325/022 Mankind Pharma Ltd, India

3523Ceftatime SB 1.5 Injection Ceftriaxone USP 1000mg +

Sulbactum Sodium USP 500mg

POM Powder for

Injection

325/023 Mankind Pharma Ltd, India

3524Ceftatime -1000 Injection Ceftriaxone USP 1000mg POM Powder for

Injection

325/024 Mankind Pharma Ltd, India

3525Levostand 500 Tablets Levofloxacin Hemihydrate 500mg POM Tablet Uncoated 325/025 Mankind Pharma Ltd, India

3526Zadiways - 500 Tablets Azithromycin Dihydrochloride

500mg

POM Tablet Uncoated 325/026 Mankind Pharma Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3527Zadiways - 250 Tablets Azithromycin Dihydrochloride

250mg

POM Tablet Uncoated 325/027 Mankind Pharma Ltd, India

3528Ubinex-LC Tablets L-Carnitine L-Tatrate 735mg +

Ubidecarenone 30mg

Pharmacy

Medicine

Tablet Film

coated

325/028L Mankind Pharma Ltd, India

3529Ovagrace Sachets Myo-inositol 2000mg + Folic

Acid 0.3mg + Vitamin D3 8mg

Pharmacy

Medicine

Powder for Oral

Solution

325/029L Mankind Pharma Ltd, India

3530Candican liquid Infusion Fluconazole 200mg, per 100ml POM Solution for

infusion

186/002 Marck Biosciences Ltd, India

3531Mannitol Intravenous Solution Mannitol 20g, per 100ml POM Solution for

infusion

186/004 Marck Biosciences Ltd, India

3532Sterilised Water BP Sterlised Water POM Solution for

Injection

186/005 Marck Biosciences Ltd, India

3533 Paracetin Eye Drops Chloramphenicol 0.5% POM Eye Drops 186/009 Marck Biosciences Ltd, India

3534Septimar Tablets Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 148/001 Mars Life Sciences Ltd, India

3535Marquinite Tablets Quinine 300mg POM Tablet Film

coated

148/002 Mars Life Sciences Ltd, India

3536 O-mar Capsules Omeprazole 20mg POM Capsule oral 148/003 Mars Life Sciences Ltd, India

3537 Moxmar Capsules Amoxicillin 250mg POM Capsule oral 148/004 Mars Life Sciences Ltd, India

3538 Marthrocin Tablets Erythromycin 250mg POM Tablet Uncoated 148/005 Mars Life Sciences Ltd, India

3539 Candimar Cream Clotrimazole 1% POM Cream Topical 148/006 Mars Life Sciences Ltd, India

3540 Flumar 200 Capsules Fluconazole 200mg POM Capsule oral 148/007 Mars Life Sciences Ltd, India

3541Marzid Injection Certazidine 1g POM Powder for

Injection

148/008 Mars Life Sciences Ltd, India

3542Resflo Granules Saccharomyces Boulardii 250mg POM Powder for Oral

Suspension

148/009 Mars Life Sciences Ltd, India

3543 Instakleen Hand Gel Ethyl Alcohol 96% GS Gel Topical 148/010 Mars Life Sciences Ltd, India

3544

Mardip GC Cream Clotrimazole 10mg + Gentamycin

1mg + Betamethasone 0.65mg

POM Cream Topical 148/011 Mars Life Sciences Ltd, India

3545 Marixime-100 Tablets Cefixime 100mg POM Tablet Uncoated 148/012 Mars Life Sciences Ltd, India

3546 Haemar-z Capsules Haematinic Preparation P Capsule oral 148/013 Mars Life Sciences Ltd, India

3547Marixime-200 Tablets Cefixime Trihydrate USP 200mg POM Tablet Film

coated

148/014 Mars Life Sciences Ltd, India

3548Marvoran-50 Tablets Diclofenac Sodium BP 50mg P Tablet Enteric

Coated

148/015 Mars Life Sciences Ltd, India

3549Miconaz Cream Miconazole 2%w/v POM Cream Topical 277/001 Medical Union Pharmaceuticals

Ltd, Egypt

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3550Miconaz Vaginal Ovules Miconazole 400mg POM Ovule Vaginal 277/003 Medical Union Pharmaceuticals

Ltd, Egypt

3551Miconaz Oral Gel Miconazole 2%w/v POM Gel Oral 277/004 Medical Union Pharmaceuticals

Ltd, Egypt

3552Miconaz-H Emugel Hydrocortisone 10mg +

Miconazole 20mg

POM Gel Topical 277/005 Medical Union Pharmaceuticals

Ltd, Egypt

3553Vagyl Powder Borax 13.75mg + Sodium

Chloride 8mg

P Powder for

Topical use

277/006 Medical Union Pharmaceuticals

Ltd, Egypt

3554Sediproct Cream Hydrocortisone 0.5% +

Cinchocaine 0.5%

POM Cream Topical 277/007 Medical Union Pharmaceuticals

Ltd, Egypt

3555Biovit 12 Depot Injection Folic Acid 1mg + Pyridoxine

20mg + Hydroxocobalamin 1mg

POM Solution for

Injection

277/008 Medical Union Pharmaceuticals

Ltd, Egypt

3556Phytovit MM Injection Phytomenadione 10mg, per ml POM Solution for

Injection

277/009 Medical Union Pharmaceuticals

Ltd, Egypt

3557Zinc Olive Cream Zinc Oxide BP 10% GS Cream Topical 277/011 Medical Union Pharmaceuticals

Ltd, Egypt

3558Fantem Tablets Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 058/001 Medinomics Healthcare Pvt Ltd,

India

3559Nevirapine Tablets Nevirapine 200mg POM Tablet Uncoated 142/001 Meditab Specialities (Pvt) Ltd,

India

3560Indinavir 400 Capsules Indinavir 400mg POM Capsule oral 142/002 Meditab Specialities (Pvt) Ltd,

India

3561Stavudine30 Capsules Stavudine 30mg POM Capsule oral 142/003 Meditab Specialities (Pvt) Ltd,

India

3562Stavudine 40 Capsules Stavudine 40mg POM Capsule oral 142/004 Meditab Specialities (Pvt) Ltd,

India

3563Medivir- L Tablets Lamivudine 300mg + Zidovudine

150mg

POM Tablet Film

coated

142/005 Meditab Specialities (Pvt) Ltd,

India

3564Zidovudine Capsules Zidovudine 100mg POM Capsule oral 142/006 Meditab Specialities (Pvt) Ltd,

India

3565Efavirenz Capsules Efavirenz 200mg POM Capsule oral 142/007 Meditab Specialities (Pvt) Ltd,

India

3566LSN-30 Tablets Lamivudine 150mg + Stavudine

30mg + Nevirapine 200mg

POM Tablet Uncoated 142/008 Meditab Specialities (Pvt) Ltd,

India

3567Medilam S 30 Tablets Lamivudine 150mg + Stavudine

30mg

POM Tablet Uncoated 142/009 Meditab Specialities (Pvt) Ltd,

India

3568Medivir LN Tablets Lamivudine 150mg + Nevirapine

200mg

POM Tablet Uncoated 142/010 Meditab Specialities (Pvt) Ltd,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3569Medilan S-40 Tablets Lamivudine 150mg + Stavudine

40mg

POM Tablet Uncoated 142/011 Meditab Specialities (Pvt) Ltd,

India

3570LSN- 40 Tablets Lamivudine 150mg + Nevirapine

200mg + Stavudine 40mg

POM Tablet Uncoated 142/012 Meditab Specialities (Pvt) Ltd,

India

3571Zidovudine Tablets Zidovudine 300mg POM Tablet Film

coated

142/013 Meditab Specialities (Pvt) Ltd,

India3572 Codeine Phosphate Tablets Codeine 30mg POM Tablet Uncoated 048/002 Mediwin Pharmaceuticals , India

3573Ciprogun TZ Tablets Ciprofloxacin 600mg +

Tindazole 500mg

POM Tablet Uncoated 048/003 Mediwin Pharmaceuticals , India

3574

Medizox Tablets Paracetamol 325mg + Diclofenac

50mg + Chlorzoxane 250mg

P Tablet Uncoated 048/004 Mediwin Pharmaceuticals , India

3575 Celexin 250mg Capsules Cefalexin 250mg POM Tablet Uncoated 048/005 Mediwin Pharmaceuticals , India

3576Lomexel Tablets Lomefloxacin 400mg POM Tablet Uncoated 106/001 Medley Pharmaceuticals Limited,

India

3577Helmintol Tablets Mebendazole 100mg P Tablet Uncoated 106/002 Medley Pharmaceuticals Limited,

India

3578

Axane Gel Methyl Salicylate 50mg +

Camphors 25mg + Menthol

25mg + Capsaicin 0.25mg, per

1g

GS Gel Topical 106/003 Medley Pharmaceuticals Limited,

India

3579

R B tone Capsules Ferrous Gluconate 259mg +

Folic Acid 5mg + Dibasic

Calcium Ohosph. 100mg + Zinc

Sulp. 33mg + Vit B12 2.5mcg

POM Capsule oral 106/004 Medley Pharmaceuticals Limited,

India

3580Prosup Syrup B Complex + Protein + Vitamin POM Syrup 106/005 Medley Pharmaceuticals Limited,

India

3581Encardil 2.5 Tablets Enalapril 2.5mg POM Tablet Uncoated 106/006 Medley Pharmaceuticals Limited,

India

3582Encardil 5 Tablets Enalapril 5mg POM Tablet Uncoated 106/007 Medley Pharmaceuticals Limited,

India

3583Encardil 10 Tablets Enalapril 10mg POM Tablet Uncoated 106/008 Medley Pharmaceuticals Limited,

India

3584Encardil 20 Tablets Enalapril 20mg POM Tablet Uncoated 106/009 Medley Pharmaceuticals Limited,

India

3585Astem Tablets Astemizole 10mg POM Tablet Uncoated 106/010 Medley Pharmaceuticals Limited,

India

3586Gromin Syrup Minerals + Multivitamins P Syrup 106/011 Medley Pharmaceuticals Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3587Xymex Syrup Riboflavin + Thiamine + Fungal +

Pepsin

P Syrup 106/012 Medley Pharmaceuticals Limited,

India

3588Geramed Injection Gentamicin 80mg, per 2ml POM Solution for

Injection

106/015 Medley Pharmaceuticals Limited,

India

3589Deximed Injection Dexamethasone 4mg POM Powder for

Injection

106/016 Medley Pharmaceuticals Limited,

India

3590Moxmed-250 Capsules Amoxicillin 250mg POM Capsule oral 106/018 Medley Pharmaceuticals Limited,

India

3591Ultigra-180 Tablets Fexofenadine 180mg POM Tablet Uncoated 106/019 Medley Pharmaceuticals Limited,

India

3592Oncet 10 Tablets Cetirizine 10mg POM Tablet Uncoated 106/020 Medley Pharmaceuticals Limited,

India

3593Helmintol Suspension Mebendazole 100mg, per 5ml P Suspension for

Oral Use

106/021 Medley Pharmaceuticals Limited,

India

3594Zoxil 500 Tablets Cefadroxil 500mg POM Tablet Uncoated 106/022 Medley Pharmaceuticals Limited,

India

3595Zoxil dt Tablets Cefadroxil 250mg POM Tablet Uncoated 106/023 Medley Pharmaceuticals Limited,

India

3596Spocelin 250 Capsules Cephalexin 250mg POM Capsule oral 106/024 Medley Pharmaceuticals Limited,

India

3597Ofoxin 200 Tablets Ofloxacin 200mg POM Tablet Uncoated 106/025 Medley Pharmaceuticals Limited,

India

3598Primodil 5 Tablets Amlodipine 5mg POM Tablet Uncoated 106/026 Medley Pharmaceuticals Limited,

India

3599Lansoprazole Capsules Lansoprazole 30mg POM Capsule oral 106/027 Medley Pharmaceuticals Limited,

India

3600Rofexib 25 Tablets Rofecoxib 25mg POM Tablet Uncoated 106/028 Medley Pharmaceuticals Limited,

India

3601Cefo L-200 Tablets Cefixime 200mg POM Tablet Uncoated 106/029 Medley Pharmaceuticals Limited,

India

3602Cefo L-100 Tablets Cefixime 100mg POM Tablet Uncoated 106/030 Medley Pharmaceuticals Limited,

India

3603Pantaz Tablets Pantoprazole 40mg POM Tablet Uncoated 106/031 Medley Pharmaceuticals Limited,

India

3604Ceftriaxone Injection Ceftriaxone 1g POM Powder for

Injection

106/032 Medley Pharmaceuticals Limited,

India

3605Primodil 10 Tablets Amlodipine 10mg POM Tablet Uncoated 106/033 Medley Pharmaceuticals Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3606Ofloxin 400 Tablets Ofloxacin 400mg POM Tablet Uncoated 106/034 Medley Pharmaceuticals Limited,

India

3607Ultigra 120 Tablets Fexofenadine 120mg POM Tablet Uncoated 106/035 Medley Pharmaceuticals Limited,

India

3608Ecoflox -500 Tablets Ciprofloxacin 500mg POM Tablet Uncoated 106/036 Medley Pharmaceuticals Limited,

India

3609Ecoflox-250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 106/037 Medley Pharmaceuticals Limited,

India

3610Decifen SR Tablets Diclofenac 100mg P Tablet Film

coated

106/038 Medley Pharmaceuticals Limited,

India

3611Floxilet 300 Tablets Norfloxacin 400mg POM Tablet Uncoated 106/039 Medley Pharmaceuticals Limited,

India

3612Spocelin 500 Capsules Cephalexin 500mg POM Capsule oral 106/040 Medley Pharmaceuticals Limited,

India

3613Rofexib 12.5 Tablets Rofecoxib 12.5mg POM Tablet Uncoated 106/041 Medley Pharmaceuticals Limited,

India

3614Vasortan-50 Tablets Losartan 50mg POM Tablet Uncoated 106/042 Medley Pharmaceuticals Limited,

India

3615Glucozid Tablets Gliclazide 80mg POM Tablet Uncoated 106/043 Medley Pharmaceuticals Limited,

India

3616Zoxil 125 Rediuse Suspension Cefadroxil 125mg, per 5ml POM Suspension for

Oral Use

106/044 Medley Pharmaceuticals Limited,

India

3617GTN Spray Glyceryltrinitrate 0.4mg, per

Metered Dose

POM Solution for

Inhalation

106/045 Medley Pharmaceuticals Limited,

India

3618Spasmonorm Tablets Paracetamol + Dicyclomine P Tablet Uncoated 106/046 Medley Pharmaceuticals Limited,

India

3619Gromin Drops Minerals + Multivitamins P Solution for Oral

Use

106/047 Medley Pharmaceuticals Limited,

India

3620Motinorm Syrup Domperidone 5mg, per 5ml POM Syrup 106/048 Medley Pharmaceuticals Limited,

India

3621Motinorm Tablets Domperidone 10mg POM Tablet Uncoated 106/049 Medley Pharmaceuticals Limited,

India

3622Motinorm Drops Domperidone 10mg, per 5ml POM Solution for Oral

Use

106/050 Medley Pharmaceuticals Limited,

India

3623Trisoliv Syrup Kalmegh + Citric Acid +

Tricholine Citrate 500mg

P Syrup 106/051 Medley Pharmaceuticals Limited,

India

3624Poraz-20 Capsules Omeprazole 20mg POM Capsule oral 106/052 Medley Pharmaceuticals Limited,

India

Page 179 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3625Atorin 10 Tablets Atorvastatin 10mg POM Tablet Film

coated

106/053 Medley Pharmaceuticals Limited,

India

3626BP Norm 50 Tablets Atenolol 50mg POM Tablet Uncoated 106/054 Medley Pharmaceuticals Limited,

India

3627

New Tuxiril Syrup Dextromethorphan 10mg +

Phenylephrine 5mg + Menthol

5mg

P Syrup 106/055 Medley Pharmaceuticals Limited,

India

3628R.B.Tone Syrup Haematinic Preparation P Syrup 106/056 Medley Pharmaceuticals Limited,

India

3629

Coldrid Day and Night Tablets Paracetamol 500mg+

Chlorpheniramine 2mg+

Phenylephrine 5mg+ Caffeine

15mg

P Tablet Uncoated 106/057 Medley Pharmaceuticals Limited,

India

3630Atorin 50 Tablets Atorvastatin 50mg POM Tablet Uncoated 106/058 Medley Pharmaceuticals Limited,

India

3631Glucozid m Tablets Metformin 500mg + Gliclazide

80mg

POM Tablet Uncoated 106/059 Medley Pharmaceuticals Limited,

India

3632Primodil AT Tablets Amlodipine 7.11mg + Atenolol

50mg

POM Tablet Uncoated 106/060 Medley Pharmaceuticals Limited,

India

3633Acenac-P Tablets Paracetamol 325mg +

Aceclofenac 100mg

P Tablet Uncoated 106/061 Medley Pharmaceuticals Limited,

India

3634Ceurox 500 Tablets Cefuroxime 500mg POM Tablet Uncoated 106/062 Medley Pharmaceuticals Limited,

India

3635

Xymex Drops Pepsin 10mg + Papain 6mg +

Sodium Citrate 40mg + Weak

Ginger Tincture 0.024ml + Citric

8mg

P Solution for Oral

Use

106/063 Medley Pharmaceuticals Limited,

India

3636

Cefo-L Dry Syrup Cefixime Trihydrate 50mg +

Lactic Acid Bacillus 6000 million

spore/g

POM Suspension for

Oral Use

106/064 Medley Pharmaceuticals Limited,

India

3637Vazortan-H Tablets Losartan Potassium 50mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 106/065 Medley Pharmaceuticals Limited,

India

3638Dompan- OD Tablets Domperidone 30mg +

Pantoprazole 47.360mg

POM Tablet Uncoated 106/066 Medley Pharmaceuticals Limited,

India

3639

Coldrid Syrup Cetirizine Dihydrochloride 2.5mg

+ Phenylephrine Hydrochloride

5mg + Paracetamol 125mg

P Syrup 106/067 Medley Pharmaceuticals Limited,

India

3640Supiclox Injection Ampicillin + Cloxacillin POM Powder for

Injection

106/095 Medley Pharmaceuticals Limited,

India

Page 180 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3641SunDe Choleclaciferol 60,000IU P Granules for

Oral Use

106/096L Medley Pharmaceuticals Limited,

India3642 Emcycline 250 Capsules Tetracycline Capsules BP 250 POM Capsule oral 272/001 Medopharm,India

3643 Doxicon Capsules 100mg Doxycycline 100mg POM Capsule oral 272/002 Medopharm,India

3644Sulphadoxine + Pyrimethamine USP

Tablets

Sulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 272/003 Medopharm,India

3645 M-Dopa Tablets Methyldopa Tablets BP 250mg POM Tablets oral 272/004 Medopharm,India

3646 Nalidixic acid Nalidixic Acid 500mg POM Tablet Uncoated 272/007 Medopharm,India

3647 Amitriptyline Tablets Amitriptyline 25mg POM Tablet Uncoated 272/008 Medopharm,India

3648 Amoxicillin BP Capsules Amoxicillin 250mg POM Capsule oral 272/009 Medopharm,India

3649 Cimetidine Tablets Cimetidine 200mg POM Tablet Uncoated 272/010 Medopharm,India

3650Co-trimoxazole Tablets Trimethoprim 80 +

Sulfamethoxazole 400mg

POM Tablet Uncoated 272/011 Medopharm,India

3651 Cyproheptadine Tablets Cyproheptadine 4mg P Tablet Uncoated 272/012 Medopharm,India

3652 Diclofenac Tablets Diclofenac 100mg P Tablet Uncoated 272/013 Medopharm,India

3653 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 272/014 Medopharm,India

3654 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 272/015 Medopharm,India

3655 Norfloxacin Tablets Norfloxacin 400mg POM Tablet Uncoated 272/016 Medopharm,India

3656 Nitrofurantoin Tablets Nitrofurantoin 100mg POM Tablet Uncoated 272/017 Medopharm,India

3657 Ranitidine Tablets Ranitidine 150mg POM Tablet Uncoated 272/018 Medopharm,India

3658Amoxicillin Suspension Amoxicillin 125mg, per 5ml POM Suspension for

Oral Use

272/019 Medopharm,India

3659 Ethionamide Tablets Ethionamide 250mg POM Tablet Uncoated 272/020 Medopharm,India

3660 Ofloxacin Tablets Ofloxacin 200mg POM Tablet Uncoated 272/021 Medopharm,India

3661 Medomol Tablets Paracetamol 500mg GS Tablet Uncoated 272/022 Medopharm,India

3662Cedomox 228.5 Suspension Clavulanate 28.5mg + Amoxicillin

200mg

POM Suspension for

Oral Use

272/023 Medopharm,India

3663Cledomox 375 Tablets Clavulanate 250mg + Amoxicillin

125mg

POM Tablet Uncoated 272/024 Medopharm,India

3664 Nat B Capsules Multivitamins & Minerals P Capsule oral 355/001 Mega Lifescience PLC

3665

Osteomin Tablets Glucosamine Sulphate 2Kcl USP

667mg eq to Glucosamine

Sulphate 500mg + Chondroitin

Sulphate USP 400mg

P Tablets

uncoated

355/002 Mega Lifescience PLC

3666 Enat 400 SoftGel Capsules Vitamin E 400 I.U P Capsule oral 385/001 Mega Lifescience PLC

3667Zeman SX Capsules Magnesium 83.52mg+ Zinc

5.58mg + Vitamin B6 1.935mg

P Capsule oral 385/002 Mega Lifescience PLC

3668 Gogaz Capsules Simethicone 200mg P Capsule oral 385/003 Mega Lifescience PLC

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3669 Livolin Forte Capsules Vitamins & Minerals P Capsule oral 385/004L Mega Lifescience PLC

3670 Calcivita Supplement for Children Calcium Supplement + Vitamins P Capsule oral 385/005L Mega Lifescience PLC

3671Ginsomin Capsules Ginseng Extract 50mg+

Multivitamins & Minerals

P Capsule oral 385/006L Mega Lifescience PLC

3672

Maxcal Tablets CaCO3 600mg + Vit D3 200 IU+

Culpric Gluconate 40mg + Mg

O2m 7.5mg+ MnO2 1mg +

NaTetraborate 1.8mg + Z

0.25mg

P Tablets

uncoated

385/009L Mega Lifescience PLC

3673

Ginsomin Eve Capsules Evening Primrose Oil 50mg +

Ginseng Extract 50mg+

Multivitamins

P Capsule oral 385/010L Mega Lifescience PLC

3674 Vitacap Softgel Capsules Multivitamin & Minerals P Capsule oral 385/011L Mega Lifescience PLC

3675Prenatal Softgel Capsules Multivitamin & Minerals Pharmacy

Medicine

Capsule oral 385/012L Mega Lifescience PLC

3676 GOFEN 400 Capsules Ibuprofen USP 400mg P Capsule oral 385/013 Mega Lifescience PLC

3677Meldol Tablets 500mg Paracetamol 500mg GS Tablet Uncoated 008/001 Melcome Pharmaceuticals Limited

Zambia

3678Meldol Syrup (Paracetamol 120mg, per

5ml)

Paracetamol 120mg, per 5ml GS Solution for Oral

Use

008/003 Melcome Pharmaceuticals Limited

Zambia

3679Melcotrim Suspension Oral

Suspension.

Sulphamethoxazole 100mg +

Trimethoprim 20mg

POM Suspension for

Oral Use

008/004 Melcome Pharmaceuticals Limited

Zambia

3680Painrid Capsules Paracetamol BP 50mg +

Caffiene 30mg

GS Capsule Oral 008/002 Melcome Pharmaceuticals Ltd,

Zambia3681 Euthyrox 25 Levothyroxine Sodium 25mcg POM Tablet Uncoated 363/007 Merck (Pty) Ltd

3682 Euthyrox 50 Levothyroxine Sodium 50mcg POM Tablet Uncoated 363/008 Merck (Pty) Ltd

3683 Euthyrox 100 Levothyroxine Sodium 100mcg POM Tablet Uncoated 363/009 Merck (Pty) Ltd

3684Betanil GM Cream Gentamycin 0.1% + Miconazole

2% + Betamethasone 0.05%

POM Cream Topical 181/001 Merck Limited, India

3685 Betanil Cream Betamethasone 0.05%w/w POM Cream Topical 181/002 Merck Limited, India

3686Betanil N Cream Betamethasone 0.05% +

Neomycin Sulphate 0.5%

POM Cream Topical 181/003 Merck Limited, India

3687 Diclofenac Diethylamine Cream Diclofenac 1% P Gel Topical 181/004 Merck Limited, India

3688 Nasivion Adult Nasal Drops Oxymetazoline 0.05% P Nasal drops 181/005 Merck Limited, India

3689 Navison Paediatric Nasal Drops Oxymetazoline 0.025% P Nasal drops 181/006 Merck Limited, India

3690 Evion 200 Capsules D-Alpha-Tocopherol 200mg POM Capsule oral 181/007 Merck Limited, India

3691 Evion 400 Capsules D-Alpha-Tocopherol 400mg POM Capsule oral 181/008 Merck Limited, India

3692 Evion Cream Vitamin E 1.0%w/w POM Cream Topical 181/009 Merck Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3693

Neurobion Forte Tablets Thiamine Mononitrate 10 mg +

Riboflavin 10 mg + Pyridoxine

Hydrochloride 3 mg +

Cyanocobalamin 15 mcg +

Nicotinamide 45 mg + Calcium

Pantothenate 50 mg

P Tablet Uncoated 181/010 Merck Limited, India

3694

Neurobion Forte Injection Mecobalamin 1000 mcg +

Pyridoxine Hydrochloride 100 mg

+ Niacinamide 100 mg, per 2 ml

P Solution for

Injection

181/011 Merck Limited, India

3695 Polybion Syrup Vit B Complex and Minerals P Syrup 181/012 Merck Limited, India

3696 Polybion Tablets Vit B Complex and Minerals P Tablet Uncoated 181/013 Merck Limited, India

3697Glucophage 1000 Tablets Metformin Hydrochloride BP

1000mg

POM Tablet Film

coated

363/001 Merck Limited, India

3698Glucophage 850 Tablets Metformin Hydrochloride BP

850mg

POM Tablet Film

coated

363/002 Merck Limited, India

3699Glucophage 500 Tablets Metformin Hydrochloride BP

500mg

POM Tablet Film

coated

363/003 Merck Limited, India

3700Ziak 2.5/6.25 Tablets Bisoprolol Fumarate 2.5mg +

Hydrochlorothiazide 6.25mg

POM Tablet Uncoated 363/004 Merck Limited, India

3701Ziak 5/6.25 Tablets Bisoprolol Fumarate 5mg +

Hydrochlorothiazide 6.25mg

POM Tablet Uncoated 363/005 Merck Limited, India

3702Ziak 10/6.25 Tablets Bisoprolol Fumarate 2.5mg +

Hydrochlorothiazide 6.25mg

POM Tablet Uncoated 363/006 Merck Limited, India

3703 Crixivan 400mg Capsules Indinavir 400mg POM Capsule oral 105/002 Merck Sharp and Dohme

3704 Stocrin 200mg Tablets Ritonavir 200mg POM Tablet Uncoated 105/003 Merck Sharp and Dohme

3705 Stocrin 600mg Tablets Ritonavir 600mg POM Tablet Uncoated 105/004 Merck Sharp and Dohme

3706 Stocrin 50mg Tablets Ritonavir 50mg POM Tablet Uncoated 105/005 Merck Sharp and Dohme

3707Atripla Tablets Efavirenz 600mg + Emtricitabine

200mg + Tenofovir 300mg

POM Tablet Uncoated 105/007 Merck Sharpe & Dohme (Pty)

Ltd,France

3708Gardasil Vaccine Human Papillomavirus 9-valent

Vaccine, Recombinant

POM Suspension for

Injection

105/008 Merck Sharpe & Dohme (Pty)

Ltd,France

3709Isentress Tablets Raltegravir 400mg POM Tablet Film

coated

105/009 Merck Sharpe & Dohme (Pty)

Ltd,France

3710Implanon Implant Etonogestrel 68mg, per Implant POM Implant 105/019 Merck Sharpe & Dohme (Pty)

Ltd,France

3711Janumet 50/850 Tablets Sitagliptin 50mg + Metformin

Hydrochloride 850mg

POM Tablet Enteric

Coated

105/020 Merck Sharpe & Dohme (Pty)

Ltd,France

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3712Janumet 50/1000 Tablets Sitagliptin 50mg + Metformin

Hdrochloride 1000mg

POM Tablet Enteric

Coated

105/021 Merck Sharpe & Dohme (Pty)

Ltd,France

3713Implanon NXT Implant Etonogestrel 68mg POM Implant 105/022 Merck Sharpe & Dohme (Pty)

Ltd,France

3714Januvia 25mg Tablets Sitagliptin 25mg POM Tablet Film

coated

105/023 Merck Sharpe & Dohme (Pty)

Ltd,France

3715Januvia 50mg Tablets Sitagliptin 50mg POM Tablet Film

coated

105/024 Merck Sharpe & Dohme (Pty)

Ltd,France

3716Januvia 100mg Tablets Sitagliptin 100mg POM Tablet Film

coated

105/025 Merck Sharpe & Dohme (Pty)

Ltd,France

3717

Rol Cold Tablets Paracetamol 500mg +

Phenylepherine 5mg + Caffeine

15mg + Chlorpheniramine 2mg

P Tablet Uncoated 294/001 Merit Organics Limited

3718

Congestyl Tablets Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 4mg

P Tablet Uncoated 019/001 Meyer Organics Pvt Ltd, India

3719Fiberex Powder Ispaghula Husk 3.75 gm, per

4.8g

GS Powder for Oral

Suspension

019/002 Meyer Organics Pvt Ltd, India

3720Gericare Capsules Magnesium Hydroxide 40mg +

Vitamins + Minerals)

P Capsule oral 019/003 Meyer Organics Pvt Ltd, India

3721Kidcare Plus Syrup Multivitamins + Lysine 40mg +

Minerals

GS Syrup 019/004 Meyer Organics Pvt Ltd, India

3722Lactulin liquid Concentrate Lactulose 10g + Riboflavin

0.6mg

P Solution for Oral

Use

019/005 Meyer Organics Pvt Ltd, India

3723Mim Capsules Magnesium Hydroxide 72mg +

Vitamins + Minerals

GS Capsule oral 019/006 Meyer Organics Pvt Ltd, India

3724Mim Organic Tonic Minerals + Multivitamins P Solution for Oral

Use

019/007 Meyer Organics Pvt Ltd, India

3725 Motionil Capsules Loperamide 2mg POM Capsule oral 019/008 Meyer Organics Pvt Ltd, India

3726 Wingora Tablets Sildenafil 50mg POM Tablet Uncoated 019/009 Meyer Organics Pvt Ltd, India

3727 Lomez Capsules Omeprazole 20mg POM Capsule oral 019/010 Meyer Organics Pvt Ltd, India

3728Aloesilk Cream Vitamin A 1000IU + Aloe Vera

Extracts

P Cream Topical 019/011 Meyer Organics Pvt Ltd, India

3729Babygesic Drops Paracetamol 100mg, per ml GS Solution for Oral

Use

019/012 Meyer Organics Pvt Ltd, India

3730Candifem Vaginal Tablets Miconazole 100mg + Ornidazole

500mg

POM Tablet Vaginal 019/013 Meyer Organics Pvt Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3731

Congestyl Syrup Paracetamol 125mg +

Phenylephrine 2.5mg +

Chlorpheniramine 1.5mg +

Menthol 1mg, per 5ml

P Syrup 019/014 Meyer Organics Pvt Ltd, India

3732 Ugesic Tablets Piroxicam 20mg POM Capsule oral 019/015 Meyer Organics Pvt Ltd, India

3733

Colicaid Drops Simethicone 40mg + Dill Oil

0.005ml + Fennel Oil 0.0007ml,

per ml

P Solution for Oral

Use

019/016 Meyer Organics Pvt Ltd, India

3734Fevril Suspension Paracetamol 125 mg +

Promethazine 2.5mg, per 5ml

P Suspension for

Oral Use

019/017 Meyer Organics Pvt Ltd, India

3735Fairyl Cream (Vitamin E 1% + Vitamin A

1000IU + Zinc oxide 4%), per g

P Cream Topical 019/018 Meyer Organics Pvt Ltd, India

3736

Zedcal Tablets Calcium Carbonate 250mg +

Zinc Sulphate 7.5mg + Calciferol

0.25mg

P Tablet Uncoated 019/019 Meyer Organics Pvt Ltd, India

3737 Coldcare Tablets Multivitamins + Minerals GS Tablet Uncoated 019/020 Meyer Organics Pvt Ltd, India

3738

Gastracid liquid Calcium Carbonate 400mg +

Magnesium Hydroxide 120mg +

Magnesium Trisilicate 50mg +

Simethicone 83mg

P Suspension for

Oral Use

019/021 Meyer Organics Pvt Ltd, India

3739 Oligocare Capsules Multivitamins GS Capsule oral 019/022 Meyer Organics Pvt Ltd, India

3740 Ovacare Capsules Multivitamins GS Capsule oral 019/023 Meyer Organics Pvt Ltd, India

3741 Ultimale Capsules Herbal Extracts P Capsule oral 019/024 Meyer Organics Pvt Ltd, India

3742 Zithrocare-250 Tablets Azithromycin Dihydrate 250mg POM Tablet Uncoated 019/025 Meyer Organics PVT LTd, India

3743 Zithrocare-500 Tablets Azithromycin Dihydrate 500mg POM Tablet Uncoated 019/026 Meyer Organics PVT LTd, India

3744Uvex- 500 Tablets Levofloxacin Hemihydrate 500mg POM Tablet Uncoated 019/027 Meyer Organics PVT LTd, India

3745Uvex- 750 Tablets Levofloxacin Hemihydrate 750mg POM Tablet Uncoated 019/028 Meyer Organics PVT LTd, India

3746Cofaid Liquid Solution Herbal Extracts POM Solution for Oral

Use

019/HM001 Meyer Organics Pvt Ltd, India

3747Ornilox Tablets Ornidazole 500mg + Ofloxacin

200mg

POM Tablet Uncoated 315/001 Micro labs Limited, India

3748Levobact 750 Tablets Levofloxacin Hemihydrate 750mg POM Tablet Uncoated 315/003 Micro labs Limited, India

3749 Clariwin 500 Tablets Clarithromycin USP 500mg POM Tablet Uncoated 315/004 Micro labs Limited, India

3750Bactoclave 562.5 Tablets Amoxicillin Trihydrate BP 500mg

+ Potassium Clavulanate 62.5mg

POM Tablet Uncoated 315/005 Micro labs Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3751Bactoclave 112.5 Dry Syrup Amoxicillin Trihydrate BP 100mg

+ Potassium Clavulanate 12.5mg

POM Powder for Oral

Suspension

315/006 Micro labs Limited, India

3752Bactoclave 1000 Tablets Amoxicillin Trihydrate 875mg +

Clavulanate Potassium 125mg

POM Tablet Film

coated

315/007 Micro labs Limited, India

3753 Arbitel 80 Tablets Telmisartan USP 80mg POM Tablet Uncoated 315/008 Micro labs Limited, India

3754 Nebilong Tablets Nebivolol Hydrochloride 5mg POM Tablet Uncoated 315/009 Micro labs Limited, India

3755Nebilong - H Tablets Nebivolol Hydrochloride 5mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 315/010 Micro labs Limited, India

3756 Alendro Tablets Alendronate Sodium USP 70mg POM Tablet Uncoated 315/011 Micro labs Limited, India

3757Micropime Injection Cefeprime Hydrochloride USP 1g POM Powder for

Injection

315/012 Micro labs Limited, India

3758 Prednisolone Tablets Prednisolone 5mg POM Tablet Uncoated 315/013 Micro labs Limited, India

3759Cotrimoxazole Tablets Trimethoprim BP 80mg +

Sulphamethoxazole BP 400mg

POM Tablet Uncoated 315/014 Micro labs Limited, India

3760Nebilong -AM Tablets Nebivolol Hydrochloride 5mg +

Amlodipine Besylate 5mg

POM Tablet Uncoated 315/015 Micro labs Limited, India

3761Amlozaar Tablets losartan Potassium 50mg +

Amilodipine Besilate 5mg

POM Tablet Uncoated 315/016 Micro labs Limited, India

3762

Amlozaar -H Tablets losartan Potassium 50mg +

Amilodipine Besilate 5mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 315/017 Micro labs Limited, India

3763 Doxycycline Hyclate USP Tablets Doxcycline Hyclate USP 100mg POM Tablet Uncoated 315/018 Micro labs Limited, India

3764 Doxycycline Capsules BP Doxcycline Hyclate BP 100mg POM Capsule oral 315/019 Micro labs Limited, India

3765Nugrel A Plus Tablets Clopidogrel Bisulfate USP 75mg

+ Aspirin BP 100mg

POM Tablet Film

coated

315/020 Micro labs Limited, India

3766 Mebux 80 Tablets Febuxostat 80mg POM Tablet Uncoated 315/021 Micro labs Limited, India

3767 Mebux 40 Tablets Febuxostat 40mg POM Tablet Uncoated 315/022 Micro labs Limited, India

3768Gramocef-O-100 Dry Syrup Cefixime Trihydrate USP 100mg,

per 5ml

POM Powder for Oral

Suspension

315/023 Micro labs Limited, India

3769 Gramocef-O-200 Capsules Cefixime Trihydrate USP 200mg POM Capsule oral 315/024 Micro labs Limited, India

3770

Dolosip-Z Tablets Paracetamol BP 500mg +

Phenylephrine HCl BP 5 mg +

Caffeine BP 25mg

P Tablet Film

coated

315/025 Micro labs Limited, India

3771Clariwin ER Tablets Clarithromycin USP 500mg POM Tablet Film

coated

315/026 Micro labs Limited, India

3772Arbitel-AV Tablets Telmisartan 40 mg + Atorvastatin

10mg Tablets

POM Tablet Uncoated 315/027 Micro labs Limited, India

3773 Arbitel Tablets Telmisartan USP 40mg POM Tablet Uncoated 315/028 Micro labs Limited, India

3774 Ethionamide 250 Tablets Ethionamide USP 250mg POM Tablet Uncoated 315/029 Micro labs Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3775Bonair HFA Inhaler Salbutamol 100mcg POM Powder for

Inhalation

297/001 Midas- Care Pharmaceuticals Pvt

Limited

3776X-Cite Spray (Lidocaine USP) Lidocaine Hydrochloride 1.5mg POM Spray for Topical

Use

279/009 Midas- Care Pharmaceuticals Pvt

Limited, India

3777Besone 250 HFA Inhaler Beclomethasone Dipropionate

250mcg

POM Solution for

Inhalation

297/002 Midas- Care Pharmaceuticals Pvt

Limited, India

3778Mistdress Spray Lidocaine Hydrochloride

1.0%w/w + Cetrimide 1.0%w/w

POM Spray for Topical

Use

297/003 Midas- Care Pharmaceuticals Pvt

Limited, India

3779Flusal 50 HFA Inhaler Salmeterol Xinafoate 25mcg +

Fluticasone Propionate 50mcg

POM Solution for

Inhalation

297/004 Midas- Care Pharmaceuticals Pvt

Limited, India

3780Flusal 125 HFA Inhaler Salmeterol Xinafoate 25mcg +

Fluticasone Propionate 125mcg

POM Solution for

Inhalation

297/005 Midas- Care Pharmaceuticals Pvt

Limited, India

3781Flusal 250 HFA Inhaler Salmeterol Xinafoate 25mcg +

Fluticasone Propionate 250mcg

POM Solution for

Inhalation

297/006 Midas- Care Pharmaceuticals Pvt

Limited, India

3782

Coolex Spray Lidocaine Hydrochloride 3.0%w/v

+ Benzethonium Chloride

0.2%w/v

POM Spray for Topical

Use

297/007 Midas- Care Pharmaceuticals Pvt

Limited, India

3783Vinodine Spray Povidone Iodine 5.0%w/v P Solution for

Topical Use

297/008 Midas- Care Pharmaceuticals Pvt

Limited, India

3784Relispray -Ayurvedic Pain Relief Spray Herbal Preparation GS Spray for Topical

Use

297/010 Midas- Care Pharmaceuticals Pvt

Limited, India

3785Antim Tablets Pyrimthamine25mg +

Sulfadoxine 500mg

POM Tablet Uncoated 170/001 Mihika Pharmaceuticalds Ltd,

India

3786Effecip-500 Tablets Ciprofloxacin USP 500mg POM Tablet Uncoated 170/002 Mihika Pharmaceuticalds Ltd,

India

3787Acyclex 200mg Tablets Acyclovir 200mg POM Tablet Uncoated 170/003 Mihika Pharmaceuticalds Ltd,

India

3788Dermiral 200 Tablets Ketoconazole 200mg POM Tablet Uncoated 170/004 Mihika Pharmaceuticalds Ltd,

India

3789Zolmed 150 Tablets Fluconazole 150mg POM Tablet Uncoated 170/005 Mihika Pharmaceuticalds Ltd,

India

3790Actiflam 200 Tablets Ibuprofen BP 200mg P Tablet Uncoated 170/006 Mihika Pharmaceuticalds Ltd,

India

3791Endorm-100 Tablets Mebendazole USP 100mg P Tablet Uncoated 170/007 Mihika Pharmaceuticalds Ltd,

India

3792Mihizole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 170/008 Mihika Pharmaceuticalds Ltd,

India

3793Cloxasafe 250 Capsules Cloxacillin Sodium BP 250mg POM Capsule oral 170/009 Mihika Pharmaceuticalds Ltd,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3794Novoxi Oral Suspension Amoxicillin 125mg, per 5ml POM Suspension for

Oral Use

170/010 Mihika Pharmaceuticalds Ltd,

India

3795Ompalen 20mg Capsules Omeprazole 20mg POM Capsule oral 170/012 Mihika Pharmaceuticalds Ltd,

India

3796Spasmorid-10mg Tablets Hyoscine Butylbromide 10mg P Tablet Film

coated

170/013 Mihika Pharmaceuticalds Ltd,

India

3797Voltika 50 Tablets Diclofenac Sodium 50mg P Tablet Enteric

Coated

170/014 Mihika Pharmaceuticalds Ltd,

India

3798Histergan 25 Tablets Promethazine 25mg P Tablet Film

coated

170/016 Mihika Pharmaceuticalds Ltd,

India

3799Mihizole Oral Suspension Metronidazole Benzoate BP

125mg, per 5ml

POM Suspension for

Oral Use

170/017 Mihika Pharmaceuticalds Ltd,

India

3800Mahitrim Suspension Sulfamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

170/018 Mihika Pharmaceuticalds Ltd,

India

3801Betrim Tablets Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 280/004 Milan Laboratories Pvt Ltd, India

3802 Milzor Tablets Paracetamol 500mg GS Tablet Uncoated 280/005 Milan Laboratories Pvt Ltd, India

3803ML-Cotri Suspension Sulfamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

280/006 Milan Laboratories Pvt Ltd, India

3804ML-Metro Suspension Metronidazole 125mg, per 5ml POM Suspension for

Oral Use

280/007 Milan Laboratories Pvt Ltd, India

3805 Streptol Cough lozenges Menthol + Eucalyptus Oil GS Lozenges 280/008 Milan Laboratories Pvt Ltd, India

3806 Milmaleate Tablets Chlorpheniramine 4mg P Tablet Uncoated 280/009 Milan Laboratories Pvt Ltd, India

3807 Furosimide Tablets Furosemide 40mg POM Tablet Uncoated 280/010 Milan Laboratories Pvt Ltd, India

3808 Clonex Cream Clotrimazole 1%w/w POM Cream Topical 280/011 Milan Laboratories Pvt Ltd, India

3809Miloxy Oral Suspension Amoxicillin 125mg, per 5ml POM Powder for Oral

Suspension

280/012 Milan Laboratories Pvt Ltd, India

3810 Milpol Syrup Paracetamol 120mg, per 5ml GS Syrup 280/013 Milan Laboratories Pvt Ltd, India

3811 ML - Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 280/014 Milan Laboratories Pvt Ltd, India

3812Phenoxymethyl Penicillin Oral

Suspension

Phenoxymethyl Penicillin

Potassium 125mg, per 5ml

POM Powder for Oral

Suspension

280/015 Milan Laboratories Pvt Ltd, India

3813 Diclofenac Sodium Tablets Diclofenac 50mg P Tablet Uncoated 280/016 Milan Laboratories Pvt Ltd, India

3814 Diclofenac Gel Diclofenac 1%w/w P Gel Topical 280/017 Milan Laboratories Pvt Ltd, India

3815Milclox Capsules Ampicillin 250mg + Cloxacillin

250mg

POM Capsule oral 280/018 Milan Laboratories Pvt Ltd, India

3816Phenoxymethyl Penicillin Potassium

Tablets

Phenoxymethyl Penicillin 250mg POM Tablet Uncoated 280/019 Milan Laboratories Pvt Ltd, India

3817 Heptovit Softgel Capsules Herbal Phytomedicine GS Capsule oral 373/001 Millenium Herbal Care Ltd

Page 188 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3818Amoxicillin Oral Suspension Amoxiclllin 125mg, per 5ml POM Suspension for

Oral Use

144/045 Mission Pharma A/S, Denmark

3819 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 144/046 Mission Pharma A/S, Denmark

3820

Oral Rehydration Salts Sodium Chloride 2.6g +

Potassium Chloride 1.5g +

Sodium Citrate 2.9g + Anhydrous

Glucose 13.5g

GS Powder for Oral

Solution

144/047 Mission Pharma A/S, Denmark

3821 Nystatin Pessaries BP 100,000IU Nystatin 100,000IU POM Tablet Vaginal 144/048 Mission Pharma A/S, Denmark

3822 Paracetamol Tablets BP 500mg Paracetamol 500mg P Tablet Uncoated 144/049 Mission Pharma A/S, Denmark

3823 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/050 Mission Pharma A/S, Denmark

3824 Salbutamol Tablets BP 4mg Salbutamol 4mg POM Tablet Uncoated 144/051 Mission Pharma A/S, Denmark

3825 Amoxicillin Tablets USP 250mg Amoxicillin 250mg POM Tablet Uncoated 144/052 Mission Pharma A/S, Denmark

3826Triclovera Injection Medroxyprogesterone 150mg,

per ml (1ml)

POM Solution for

Injection

144/053 Mission Pharma A/S, Denmark

3827 Nystatin Vaginal Inserts Nystatin USP 100,000IU POM Tablet Vaginal 144/055 Mission Pharma A/S, Denmark

3828Dextrose 50 Injection Dextrose USP 50% POM Solution for

Injection

144/056 Mission Pharma A/S, Denmark

3829Benzylpenicilline 1M Benzyl penicillin 1MIU POM Powder for

Injection

144/057 Mission Pharma A/S, Denmark

3830Sterilised Water For Injection Water for Injections 5ml POM Solution for

Injection

144/058 Mission Pharma A/S, Denmark

3831Sterilised Water For Injection Water for Injections 10ml POM Solution for

Injection

144/059 Mission Pharma A/S, Denmark

3832Nystatin Oral Suspension Nystatin 100 000 IU POM Suspension for

Oral Use

144/063 Mission Pharma A/S, Denmark

3833 Metronidazole 200 Tablets Metronidazole 200mg POM Tablet Uncoated 144/064 Mission Pharma A/S, Denmark

3834 Salbutamol 4 Tablets Salbutamol Sulfate BP 4mg POM Tablet Uncoated 144/065 Mission Pharma A/S, Denmark

3835Metronidazole Tablets Metronidazole BP 200mg POM

Tablet Film

coated144/066 Mission Pharma A/S, Denmark

3836 Male Latex Condoms Male Latex Condoms GS Latex Products 144/066L Mission Pharma A/S, Denmark

3837 Chlopheniramine Tablets Chlopheniramine Maleate 4 mg P Tablet Uncoated 144/067 Mission Pharma A/S, Denmark

3838 Male Latex Condoms Male Latex Condoms GS Latex Products 144/067L Mission Pharma A/S, Denmark

3839 Quinine 300mg Quinine Sulphate BP 300mg POMTablet Film

coated144/068 Mission Pharma A/S, Denmark

3840 Salbutamol Tablets BP 4 mg Salbutamol Tablets BP 4 mg POM Tablet Uncoated 144/069 Mission Pharma A/S, Denmark

3841Erythromycin Stearate Tablets

Erythromycin Stearate BP 250

mgPOM

Tablet Film

coated144/070 Mission Pharma A/S, Denmark

3842Tetracycline Hydrochloride Ophthalmic

Ointment

Tetracycline Hydrochloride USP

1%POM Ointment topical 144/071 Mission Pharma A/S, Denmark

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3843 Phenoxymethylpenicillin Tablets BPPhenoxymethylpenicillin BP

250mgPOM Tablet Uncoated 144/072 Mission Pharma A/S, Denmark

3844Quinine Sulphate Tablets BP 300mg Quinine Sulphate BP 300mg POM

Tablet Film

coated144/073 Mission Pharma A/S, Denmark

3845 Ceftriaxone Powder For Injection Ceftriaxone Sodium 250mg POMPowder for

Injection144/074 Mission Pharma A/S, Denmark

3846 Sterilised Water for InjectionWater for Injection

POMSolution for

infusion144/075 Mission Pharma A/S, Denmark

3847Co-trimoxazole Oral Suspension Sulphamethoxazole 200mg +

Trimethoprim 40mg

POM Suspension for

Oral Use

144/002 Missionpharma A/S, Denmark

3848Co-trimoxazole Tablets Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 144/003 Missionpharma A/S, Denmark

3849Ampicillin Oral Suspension Ampicillin 250mg, per 5ml POM Powder for Oral

Suspension

144/004 Missionpharma A/S, Denmark

3850Amoxicillin Oral Suspension Amoxicillin 250mg, per 5ml POM Powder for Oral

Suspension

144/005 Missionpharma A/S, Denmark

3851 Metronidazole Tablets Metronidazole 250mg POM Tablet Uncoated 144/006 Missionpharma A/S, Denmark

3852 Paracetamol Tablets 1000's Paracetamol 500mg GS Tablet Uncoated 144/007 Missionpharma A/S, Denmark

3853 Ibuprofen Tablets Ibuprofen 200mg P Tablet Uncoated 144/008 Missionpharma A/S, Denmark

3854 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 144/009 Missionpharma A/S, Denmark

3855Sulfadoxine + Pyrimethamine Tablets Sulfadoxine 400mg +

Pyrimethamine 25mg

P Tablet Uncoated 144/010 Missionpharma A/S, Denmark

3856Nystatin Oral Suspension Nystatin 100,000IU POM Suspension for

Oral Use

144/011 Missionpharma A/S, Denmark

3857 Aspirin Tablets Acetyl Salicylic Acid 300mg P Tablet Uncoated 144/012 Missionpharma A/S, Denmark

3858 Amoxicillin Capsules Amoxicillin 250mg POM Tablet Uncoated 144/013 Missionpharma A/S, Denmark

3859Benzathine Benzylpenicillin Injection

2.4MU

Benzathine Benzylpenicillin

2.4MU

POM Solution for

Injection

144/014 Missionpharma A/S, Denmark

3860Benzylpenicillin Injection 1MU Benzyl penicillin 1MU POM Solution for

Injection

144/015 Missionpharma A/S, Denmark

3861Benzylpenicillin Injection 5MU Benzyl penicillin 5MU POM Solution for

Injection

144/016 Missionpharma A/S, Denmark

3862Diazepam Injection 5m, per ml Diazepam 5mg, per ml POM Solution for

Injection

144/017 Missionpharma A/S, Denmark

3863Lidocaine Hydrochloride Injection Lidocaine 100mg, per ml POM Solution for

Injection

144/018 Missionpharma A/S, Denmark

3864 Mebendazole 100mg Tablets Mebendazole 100mg P Tablet Uncoated 144/019 Missionpharma A/S, Denmark

3865Methyllergonovine Injection 0.2mg, per

ml

Methylergonovine 0.2mg, per ml POM Solution for

Injection

144/020 Missionpharma A/S, Denmark

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3866 Nitrofurantoin 50mg Tablets Nitrofurantoin 50mg P Tablet Uncoated 144/021 Missionpharma A/S, Denmark

3867 Paracetamol 500mg Tablets Paracetamol 500mg GS Tablet Uncoated 144/022 Missionpharma A/S, Denmark

3868 Chlorpheniramine 4mg Tablets Chlorpheniramine 4mg P Tablet Uncoated 144/023 Missionpharma A/S, Denmark

3869 Clotrimazole 1% Cream Clotrimazole 1%w/w POM Tablet Uncoated 144/024 Missionpharma A/S, Denmark

3870 Erythromycin Stearate 250mg Tablets Erythromycin 250mg POM Tablet Uncoated 144/025 Missionpharma A/S, Denmark

3871 Ferrous Sulphate 50mg Tablets Ferrous Sulphate 50mg P Tablet Uncoated 144/026 Missionpharma A/S, Denmark

3872 Folic Acid 5mg Tablets Folic Acid 5mg P Tablet Uncoated 144/027 Missionpharma A/S, Denmark

3873 Hydrocortisone Acetate Ointment 1% Hydrocortisone 1% POM Ointment topical 144/028 Missionpharma A/S, Denmark

3874

Compound Magnesium Trisilicate

Tablets

Dried Aluminium Hydroxide

120mg + Magnesium Trisilicate

250mg

GS Tablet Uncoated 144/029 Missionpharma A/S, Denmark

3875 Salbutamol 2mg Tablets Salbutamol 2mg POM Tablet Uncoated 144/030 Missionpharma A/S, Denmark

3876Procain Penicillin Injection Procain Penicillin 3MU POM Solution for

Injection

144/031 Missionpharma A/S, Denmark

3877 Salbutamol Tablets Salbutamol 4mg POM Tablet Uncoated 144/032 Missionpharma A/S, Denmark

3878Phenoxymethylpenicillin Tablets Phenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 144/033 Missionpharma A/S, Denmark

3879Nystatin Oral Suspension Nystatin 100 IU, per 5ml POM Suspension for

Oral Use

144/034 Missionpharma A/S, Denmark

3880 Doxycycline Tablets Doxycycline 100mg POM Tablet Uncoated 144/035 Missionpharma A/S, Denmark

3881 Multivitamin Tablets Multivitamins GS Tablet Uncoated 144/036 Missionpharma A/S, Denmark

3882Water for Injections Sterile Water for Injections 10ml POM Solution for

Injection

144/037 Missionpharma A/S, Denmark

3883 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 144/038 Missionpharma A/S, Denmark

3884 Aciclovir Tablets Aciclovir BP 400mg POM Tablet Uncoated 144/039 Missionpharma A/S, Denmark

3885Benzylpenicillin Injection Benzyl Penicillin Sodium BP

5MIU

POM Powder for

Injection

144/040 Missionpharma A/S, Denmark

3886Erythromycin Tablets Erythromycin Stearate BP 250mg POM Tablet Uncoated 144/041 Missionpharma A/S, Denmark

3887Erythromycin Suspension Erythromycin Ethyl Succinate

USP 125mg, per 5ml

POM Suspension for

Oral Use

144/042 Missionpharma A/S, Denmark

3888 Fluconazole Tablets Fluconazole USP 200mg POM Tablet Uncoated 144/043 Missionpharma A/S, Denmark

3889Gentamicin Injection Gentamicin BP 40ml, per 2ml POM Solution for

Injection

144/044 Missionpharma A/S, Denmark

3890Multivitamin Tablets Multivitamin P Tablet Film

coated

144/054 Missionpharma A/S, Denmark

3891 Lofin 500 Tablets Metformin 500mg POM Tablet Uncoated 062/001 MJ Biopharm Pvt Limited

3892Biosulin N Injection Insulin Isophane 100IU, per

10ml

POM Solution for

Injection

062/002 MJ Biopharm Pvt Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3893Biosulin R Injection Insulin Soluble 100IU, per 10ml POM Solution for

Injection

062/003 MJ Biopharm Pvt Limited

3894Biosulin 30/70 Injection Insulin Solube EP 30% + Insulin

Isophane EP 70%

POM Solution for

Injection

062/004 MJ Biopharm Pvt Limited

3895 Glibex 5 Tablets Glibenclamide 5mg POM Tablet Uncoated 062/005 MJ Biopharm Pvt Limited

3896 Indomethacin 25 Capsules Indomethacin 25mg P Capsule oral 062/006 MJ Biopharm Pvt Limited

3897 Allerdin Syrup Loratadine 5mg P Syrup 310/001 MMC Healthcare Limited, India

3898

Cofsy Syrup Ambroxol BP 15mg + Salbutamol

Sulphate BP 1mg +

Guiaphenesin BP + 50mg +

Menth 1mg

P Syrup 310/002 MMC Healthcare Limited, India

3899 Glimetab -2 Tablets Glimepiride USP 2mg POM Tablet Uncoated 310/003 MMC Healthcare Limited, India

3900 Glimetab -1 Tablets Glimepiride USP 1mg POM Tablet Uncoated 310/004 MMC Healthcare Limited, India

3901 Amlowin -10 Tablets Amlodipine Besylate USP 10mg POM Tablet Uncoated 310/005 MMC Healthcare Limited, India

3902Easoril -40 Capsules Esomeprazole Magnesium USP

40mg

POM Capsule oral 310/006 MMC Healthcare Limited, India

3903Moringa Miracle Capsules Moringa Oleifera 300mg P Capsule oral 352/001L Moringa Initialtive Limited, Zambia

3904 Atorem 10 Tablets Artovastatin Calcium 10mg POM Tablet Uncoated 311/001 MSN Laboratories Ltd, India

3905 Atorem 20 Tablets Artovastatin Calcium 20mg POM Tablet Uncoated 311/002 MSN Laboratories Ltd, India

3906 LDNIL 10 Tablets Rosuvastatin Calcium 10mg POM Tablet Uncoated 311/003 MSN Laboratories Ltd, India

3907 LDNIL 20 Tablets Rosuvastatin Calcium 20mg POM Tablet Uncoated 311/004 MSN Laboratories Ltd, India

3908 Breathezy CW 5 Tablets Montelukast Sodium 5mg POM Tablet Uncoated 311/005 MSN Laboratories Ltd, India

3909Plasep Tablets Clopidogrel 75mg POM Tablet Film

coated

311/006 MSN Laboratories Ltd, India

3910 Esem 5 Tablets S-Amlodipine Besylate 5mg POM Tablet Uncoated 311/007 MSN Laboratories Ltd, India

3911 Esem 2.5mg Tablets S-Amlodipine Besilate 2.5mg POM Tablet Uncoated 311/008 MSN Laboratories Ltd, India

3912Safelevo 750 Tablets Levofloxacin Hemihydrate 750mg POM Tablet Film

coated

311/009 MSN Laboratories Ltd, India

3913Safetelmi 40 Tablets Telmisartan 40mg POM Tablet Film

Coated

311/010 MSN Laboratories Ltd, India

3914Safetelmi 80 Tablets Telmisartan 80mg POM Tablet Film

coated

311/011 MSN Laboratories Ltd, India

3915 Silmet 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 311/012 MSN Laboratories Ltd, India

3916 Silmet 100 Tablets Sildenafil Citrate 100mg POM Tablet Uncoated 311/013 MSN Laboratories Ltd, India

3917 Breatheay 4 Tablets Montelukast Sodium 4mg POM Tablet Uncoated 311/014 MSN Laboratories Ltd, India

3918 Silotrif 8 Capsules Silodosin 8mg POM Capsule oral 311/015 MSN Laboratories Ltd, India

3919 Cosamide 50 Tablets Lacosamide I.H 50mg POM Tablet Uncoated 311/016 MSN Laboratories Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3920 Cosamide 100 Tablets Lacosamide I.H 100mg POM Tablet Uncoated 311/017 MSN Laboratories Ltd, India

3921 Cosamide 150 Tablets Lacosamide I.H 150mg POM Tablet Uncoated 311/018 MSN Laboratories Ltd, India

3922 Cosamide 200 Tablets Lacosamide I.H 200mg POM Tablet Uncoated 311/019 MSN Laboratories Ltd, India

3923Safelevo 500 Tablets Levofloxacin Hemihydrate 500mg POM Tablet Uncoated 311/020 MSN Laboratories Ltd, India

3924 Nebiem 2.5 Tablets Nebivolol 2.5mg POM Tablet Uncoated 311/021 MSN Laboratories Ltd, India

3925 Nebiem 5 Tablets Nebivolol 5mg POM Tablet Uncoated 311/022 MSN Laboratories Ltd, India

3926 Nebiem 10 Tablets Nebivolol 10mg POM Tablet Uncoated 311/023 MSN Laboratories Ltd, India

3927 Nebiem 20 Tablets Nebivolol 20mg POM Tablet Uncoated 311/024 MSN Laboratories Ltd, India

3928ILET B2 Extended Release Tablets

Glimepiride 2mg + Metformin

Hydrochloride 500mgPOM

Caplet

Sustained

Release

311/025 MSN Laboratories Ltd, India

3929 ILET B1 Extended Release TabletsGlimepiride 1mg + Metformin

Hydrochloride 500mgPOM

Tablet Extended

Release311/026 MSN Laboratories Ltd, India

3930 Febuday 80 Tablets Febuxostat 80mg POMTablet sustained

release311/027 MSN Laboratories Ltd, India

3931 Febuday 40 Tablets Febuxostat 40mg POM Tablet Uncoated 311/028 MSN Laboratories Ltd, India3932 Breatheazy 10 Tablets Montelukast 10mg POM Tablet Uncoated 311/029 MSN Laboratories Ltd, India

3933Lopinavir and Ritonivir Tablets Ritonavir 200mg + Lopinavir

50mg

POM Tablet Uncoated 014/001 Mylan Laboratories Ltd, India

3934Tenofivir Disoproxil Fumurate /

Lamivudine Tablets

Tenofovir 300mg + Lamivudine

300mg

POM Tablet Uncoated 014/002 Mylan Laboratories Ltd, India

3935 Tenofovir Disoproxil Fumurate Tablets Tenofovir 300mg POM Tablet Uncoated 014/003 Mylan Laboratories Ltd, India

3936 Abacavir Sulphate Tablets Abacavir 300mg POM Tablet Uncoated 014/004 Mylan Laboratories Ltd, India

3937Tenofovir Disoproxil Fumurate +

Emtricitabine Tablets

Tenofovir 300mg + Emtricitabine

200mg

POM Tablet Uncoated 014/005 Mylan Laboratories Ltd, India

3938 Lamivudine Tablets Lamivudine 150mg POM Tablet Uncoated 014/006 Mylan Laboratories Ltd, India

3939 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 014/007 Mylan Laboratories Ltd, India

3940Lamivudine + Nevirapine + Zidovudine

Tablets

Lamivudine 150mg + Nevirapine

200mg + Zidovudine 300mg

POM Tablet Uncoated 014/019 Mylan Laboratories Ltd, India

3941Lamivudine + Zidovudine Tablets Lamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 014/021 Mylan Laboratories Ltd, India

3942 Nevirapine 200mg Tablets Nevirapine 200mg POM Tablet Uncoated 014/022 Mylan Laboratories Ltd, India

3943 Nevirapine 300mg Tablets Nevirapine 300mg POM Tablet Uncoated 014/023 Mylan Laboratories Ltd, India

3944

Tenofovir disoproxil fumerate/

Efavirenz/ Emitricitabine FDC Tablets

Tenofovir Disoproxil Fumarate

300mg + Emtricitabine 200mg +

Efavirenz 600mg

POM Tablet Uncoated 014/024 Mylan Laboratories Ltd, India

3945Abacavir sulphate/ Lamivudine/

Zidovudine Tablets

Abacavir 60mg + Lamivudine

30mg + Zidovudine 60mg

POM Tablet Film

coated

014/025 Mylan Laboratories Ltd, India

Page 193 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3946Abacavir Tablets Abacavir 60mg POM Tablet Film

coated

014/026 Mylan Laboratories Ltd, India

3947Lamivudine/ Zidovudine Tablets Lamivudine 30mg+ Zidovudine

60mg

POM Tablet Film

coated

014/027 Mylan Laboratories Ltd, India

3948Lopinavir/ Ritonavir Tablets Lopinavir 100 + Ritonavir 25mg POM Tablet Film

coated

014/028 Mylan Laboratories Ltd, India

3949Lamivudine/ Nevirapine/ Zidovudine

Tablets

Lamivudine 30mg + Nevirapine

50mg + Zidovudine 60mg

POM Tablet Uncoated 014/029 Mylan Laboratories Ltd, India

3950

Tenofovir disoproxil fumarate/

Lamivudine/ Efavirenz Tablets

Tenofovir Disproxil Fumarate

300mg + Lamivudine 300mg +

Efavirenz 600mg

POM Tablet Uncoated 014/030 Mylan Laboratories Ltd, India

3951Efavirenz Tablets Efavirenz 100mg POM Tablet Film

coated

014/031 Mylan Laboratories Ltd, India

3952Efavirenz Tablets Efavirenz 200mg POM Tablet Film

coated

014/032 Mylan Laboratories Ltd, India

3953Abacavir Sulphate/Lamivudine Tablets Abacavir 60mg + Lamivudine

30mg

POM Tablet Film

coated

014/033 Mylan Laboratories Ltd, India

3954Ritonivir Tablets Ritonavir 100mg POM Tablet Film

coated

014/034 Mylan Laboratories Ltd, India

3955 Atazanavir Sulphate Tablets Atazanavir 300mg POM Capsule oral 014/035 Mylan Laboratories Ltd, India

3956Anzavir-R Tablets Atazanavir 300mg + Ritonivir

100mg

POM Tablet Film

coated

014/036 Mylan Laboratories Ltd, India

3957 Oseltamivir Phosphate Capsules USP Oseltamivir 30mg POM Capsule oral 014/037 Mylan Laboratories Ltd, India

3958 Oseltamivir Phosphate Capsules USP Oseltamivir 45mg POM Capsule oral 014/038 Mylan Laboratories Ltd, India

3959 Oseltamivir Phosphate Capsules USP Oseltamivir 75mg POM Capsule oral 014/039 Mylan Laboratories Ltd, India

3960Komefan 280 Tablet Artemether 40mg + Lumefantrine

240mg

POM Tablet Uncoated 014/040 Mylan Laboratories Ltd, India

3961Komefan 140 Tablet Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 014/041 Mylan Laboratories Ltd, India

3962Lamivudine 30 + Zidovudine 60 Tablets Lamivudine 30mg + Zidovudine

60mg

POM Tablet Film

coated

014/042 Mylan Laboratories Ltd, India

3963Kefloxa 500 Tablets Cefuroxime Axetil USP 500mg POM Tablet Film

coated

014/043 Mylan Laboratories Ltd, India

3964Kefloxa 250 Tablets Cefuroxime Axetil USP 250mg POM Tablet Film

coated

014/044 Mylan Laboratories Ltd, India

3965 Te4lkast 4 Tablets Montelukast Sodium BP 4mg POM Tablet Uncoated 014/045 Mylan Laboratories Ltd, India

3966 Te4lkast 5 Tablets Montelukast Sodium BP 5mg POM Tablet Uncoated 014/046 Mylan Laboratories Ltd, India

3967 Telkast 10 Tablets Montelukast Sodium BP 10mg POM Tablet Uncoated 014/047 Mylan Laboratories Ltd, India

3968 Zomacid 20 Omeprazole 20mg POM Capsule oral 014/052 Mylan Laboratories Ltd, India

Page 194 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3969 Zomacid 40 Capsules Omeprazole 40mg POM Capsule oral 014/053 Mylan Laboratories Ltd, India

3970Hertraz 150 Infusion Trastuzumab 150mg POM Solution for

infusion

014/054 Mylan Laboratories Ltd, India

3971Hertraz 440 Infusion Trastuzumab 440mg POM Solution for

infusion

014/055 Mylan Laboratories Ltd, India

3972Vancomycin Hydrochloride 500

Injection

Vancomycin Hydrochloride

500mg

POM Solution for

Injection

014/056 Mylan Laboratories Ltd, India

3973

Avonza Tablets Tenofovir Disoproxil Fumarate

300mg + Lamivudine 300mg +

Efavirenz 400mg

POM Tablet Film

coated

014/057 Mylan Laboratories Ltd, India

3974 Vaclovir 500 Film Coated Tablets Valacyclovir 500mg POM Tablet Uncoated 014/058 Mylan Laboratories Ltd, India

3975 Protionamide Tablets 250mg Protionamide 250mg POM Tablet Film

coated

014/059 Mylan Laboratories Ltd, India

3976Carboplatin Mylan Injection Carboplatin 10mg, per ml, 45ml POM Solution for

Injection

014/060 Mylan Laboratories Ltd, India

3977Carboplatin Mylan Injection Carboplatin 10mg, per ml, 15ml POM Solution for

Injection

014/061 Mylan Laboratories Ltd, India

3978Azithromycin Injection Azithromycin Monohydrate USP

500mg

Prescription

Only Medicine

Powder for

Injection

406/001 Mylan Laboratories Ltd, India

3979Glandin E2 Vaginal Gel Dinoprostone 2mg POM Gel Vaginal 070/001 Nabiqasim Industries Ltd,

Pakistan

3980Glandin E2 Vaginal Tablets Dinoprostone 2mg POM Tablet Vaginal 070/002 Nabiqasim Industries Ltd,

Pakistan

3981Kleen Enama Sodium Biphosphate 19.2g +

Sodium Phosphate 7.2g

POM Solution for

infusion

070/003 Nabiqasim Industries Ltd,

Pakistan

3982

Colospas Fibro Sachets Mebeverine Hydrochloride

135mg + Ispaghula Husks

3.5mg

GS Granules for

Oral Use

070/004 Nabiqasim Industries Ltd,

Pakistan

3983Detoxicol Syrup Lactulose + Lactose + Galactose P Syrup 070/005 Nabiqasim Industries Ltd,

Pakistan

3984Irpo FA Tablets Hydroxide Polymaltose Complex

0.35mg + Folic Acid 0.403mg

P Tablet Uncoated 070/006 Nabiqasim Industries Ltd,

Pakistan

3985Acefyl Cough Syrup Acefilline Pipetazine 45mg +

Diphenhydramine 8mg

P Syrup 070/007 Nabiqasim Industries Ltd,

Pakistan

3986Irpo FA Syrup Hydroxide Polymaltose Complex

50mg + Folic Acid 0.35mg

P Syrup 070/008 Nabiqasim Industries Ltd,

Pakistan

3987Clarithro Tablets Clarithromycin USP 500mg POM Tablet Film

coated

070/009 Nabiqasim Industries Ltd,

Pakistan

Page 195 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

3988Capro 6.25 Tablets Carvedilol BP 6.25mg POM Tablet Uncoated 070/010 Nabiqasim Industries Ltd,

Pakistan

3989Capro 25mg Tablets Carvedilol BP 25mg POM Tablets oral 070/011 Nabiqasim Industries Ltd,

Pakistan

3990Capro 12.5 Tablets Carvedilol BP 12.5mg POM Tablet Uncoated 070/012 Nabiqasim Industries Ltd,

Pakistan

3991Zynq Syrup Zinc Sulphate 20mg, per 5ml GSL Solution for Oral

Use

070/013 Nabiqasim Industries Ltd,

Pakistan

3992Multical plus Sachets 10's Calcium Pantothenate BP 15mg P Powder for Oral

Solution

070/014L Nabiqasim Industries Ltd,

Pakistan

3993Multical 1000 Sachets 10's Calcium Lactate Gluconate BP

1000mg

P Powder for Oral

Suspension

070/015L Nabiqasim Industries Ltd,

Pakistan

3994Cefabact 500 Capsules 20's Cefacroxil 500mg USP POM Capsule oral 070/016 Nabiqasim Industries Ltd,

Pakistan

3995Cefabact 125 /5ml Syrup 60ml Cefadroxil 125mg, per 5ml POM Suspension for

Oral Use

070/017 Nabiqasim Industries Ltd,

Pakistan

3996Ciprodex Tablets Ciprofloxacin Hydrochloride

500mg

POM Tablet Film

coated

210/001 Nabros Pharma Limited, India

3997 Nifedipine Capsules Nifedipine 20mg POM Capsule oral 210/002 Nabros Pharma Limited, India

3998

Flucoldex Tablets Chlorpheniramine Maleate 2mg +

Phenylephrine HCl 5mg +

Paracetamol 500mg

P Tablet Uncoated 210/003 Nabros Pharma Limited, India

3999Carboplatin Injection Carboplatin 150mg, per 15ml POM Solution for

Injection

086/001MT Naprod Life Sciences Pvt Limited,

India

4000Daunorubicin Hcl Injection Daunorubicin 20mg POM Solution for

Injection

086/002MT Naprod Life Sciences Pvt Limited,

India

4001Doxorubicin Hcl Injection Doxorubicin 50mg POM Powder for

Injection

086/003MT Naprod Life Sciences Pvt Limited,

India

4002Etoposide Injection Etoposide 100mg, per 5ml POM Powder for

Injection

086/004MT Naprod Life Sciences Pvt Limited,

India

4003Ifosfamide for Injection Ifosfamide 1g POM Powder for

Injection

086/005MT Naprod Life Sciences Pvt Limited,

India

4004Leucovorin Calcium Injection Leucovorin 50mg, per 5ml POM Solution for

Injection

086/006MT Naprod Life Sciences Pvt Limited,

India

4005Vinorelbine Injection Vinorelbine 5mg, per 5ml POM Solution for

Injection

086/007 Naprod Life Sciences Pvt Limited,

India

4006Dactinomycin for Injection Dactinomycin 0.5mg POM Solution for

Injection

086/008MT Naprod Life Sciences Pvt Limited,

India

Page 196 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4007 Capacetabine USP 500mg Tablets Capacetabine 500mgPOM Tablet Film

coated

086/009MT Naprod Life Sciences Pvt Limited,

India

4008Fluouracil BP Injection Fluorouracil 500mg

POM Powder for

Injection

086/010MT Naprod Life Sciences Pvt Limited,

India

4009 Cisplatin BP 50mg/5ml Cisplatin 50mg, per 5mlPOM Solution for

Injection

086/011MT Naprod Life Sciences Pvt Limited,

India

4010 Dacarbazine for Injection USP Dacarbazine 200mgPOM Solution for

Injection

086/012MT Naprod Life Sciences Pvt Limited,

India

4011 Bleomycin for Injection USP 15Units Bleomycin 15UnitsPOM Powder for

Injection

086/013 Naprod Life Sciences Pvt Limited,

India

4012 Necpime- 1G Injection Cefepime 1gPOM Powder for

Injection

306/001 Nectar Lifesciences Limited

4013 Nectram- 1G Injection Ceftriaxone 1gPOM Powder for

Injection

306/002 Nectar Lifesciences Limited

4014 Cefuaxit Dry SyrupCefuroxime Axetil USP 125mg,

per 5ml

POM Powder for Oral

Suspension

306/003 Nectar Lifesciences Limited

4015 Cefuaxit 250 Tablets Cefuroxime Axetil USP 250mg POM Tablet Uncoated 306/004 Nectar Lifesciences Limited

4016 Fixinect 200 TabletsCefixime Trihydrate USP Eq

Anhydrous Cefixime 200mg

POM Tablet Uncoated 306/005 Nectar Lifesciences Limited

4017 Mycol Injection Amphotericin B USP 50mgPOM Solution for

Injection

182/001 Neon Antibiotics Pvt Ltd, India

4018

Alpha Lipid Lifeline Powder

Dextrose 42.22%w/w + Skim Milk

Powder 25.59%w/w + Calcium

Phosphate 10.5%w/w +

Colostrum Powder

GS Powder for Oral

Solution

344/001L New Image International Ltd,

New zealand

4019 Fluconazole Capsules Fluconazole 200mg POM Jar 226/001 Nibin Pharmaceuticals Ltd, India

4020 Sterile Polygeline Solution Polygeline 25gPOM Solution for

infusion

103/001 Nicholas Piramal India Limited

4021 Halothane Calibrated Solution Halothane 250mgPOM Solution for

Inhalation

103/002 Nicholas Piramal India Limited

4022Metronidazole Injection Metronidazole 500mg, per 100ml

POM Solution for

Injection

103/003 Nicholas Piramal India Limited

4023Ciprofloxacin Injection Ciprofloxacin 200mg, per 100ml

POM Solution for

Injection

103/004 Nicholas Piramal India Limited

4024 Glucose IV Infusion 500ml Dextrose 5%POM Solution for

infusion

036/001 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4025Glucose IV Infusion 1000ml Dextrose 5%

POM Solution for

infusion

036/002 Nirlife Healthcare (Former Core

Healthcare Ltd), India

Page 197 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4026 Glucose IV Infusion 10D 1000ml Dextrose 10%POM Solution for

infusion

036/003 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4027Glucose IV Infusion 10D 500ml Dextrose 10%

POM Solution for

infusion

036/004 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4028 Sodium Chloride & Glucose DNS 500mlDextrose 5% + Sodium Chloride

0.9%

POM Solution for

infusion

036/005 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4029Sodium Chloride & Glucose DNS

1000ml

Dextrose 5% + Sodium Chloride

0.9%

POM Solution for

infusion

036/006 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4030 Sodium Chloride Infusion 500ml Sodium Chloride 0.9%POM Solution for

infusion

036/007 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4031 Sodium Chloride Infusion 1000ml Sodium Chloride 0.9%POM Solution for

infusion

036/008 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4032 Ciprofloxacin Injection Ciprofloxacin 0.2%POM Solution for

infusion

036/009 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4033 Water For Injection 5ml Water For Inj. USPPOM Solution for

infusion

036/010 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4034 Water For Injection 10ml Water For Inj. USPPOM Solution for

infusion

036/011 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4035Mannitol IV Infusion 100ml Mannitol 20%

POM Solution for

infusion

036/012 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4036 Mannitol IV Infusion 250ml Mannitol 20%POM Solution for

Injection

036/013 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4037

Compound Sodium Lactate 500ml

Sodium Chloride 6.0g, per L+

Sodium Lactate 3.20g, per L +

Potassium Chloride 0.40g, per L

+ Calcium Chloride 0.27g, per L

POM Solution for

Injection

036/014 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4038

Compound Sodium Lactate 1000ml

Sodium Chloride 6.0g, per L +

Sodium Lactate 3.20g, per L+

Potassium Chloride 0.4g, per L +

Calcium Chloride 0.27g, per L

POM Solution for

Injection

036/015 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4039 Metronidazole Injection Metronidazole 200mgPOM Solution for

Injection

036/016 Nirlife Healthcare (Former Core

Healthcare Ltd), India

4040 Benzylpenicillin Injection 5MU Benzyl Penicillin 5Mega I.U.POM Powder for

Injection

033/001 North China Pharmaceutical

Group International Corporation,

4041 Benzylpenicillin Injection 1MU Benzyl Penicillin 1Mega I.UPOM Powder for

Injection

033/002 North China Pharmaceutical

Group International Corporation,

4042Amoxicillin Capsules Amoxicillin Trihydrate 250mg

POM Capsule oral 033/003 North China Pharmaceutical

Group International Corporation,

Page 198 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4043 Paracetamol Tablets Paracetamol 500mgGS Tablet Uncoated 033/004 North China Pharmaceutical

Group International Corporation,

4044Co-trimoxazole Tablets

Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 033/005 North China Pharmaceutical

Group International Corporation,

4045 Prednisolone Tablets Prednisolone 5mgPOM Tablet Uncoated 033/006 North China Pharmaceutical

Group International Corporation,

4046 Captotril Tablets Captopril 25mgPOM Tablet Uncoated 033/007 North China Pharmaceutical

Group International Corporation,

4047 Carbocisteine Syrup Carbocisteine 250mg, per 5mlPOM Syrup 033/008 North China Pharmaceutical

Group International Corporation,

4048 NCPC Carbocisterine Syrup Carbocisteine 100mg, per 5mlPOM Syrup 033/009 North China Pharmaceutical

Group International Corporation,

4049

Multi-Cal-Vita

Calciumgluconate 100mg +

Calcium 60mg + Hydrogen 20mg

Phosphate 100mg+ Calcium

Glycero 30mg

P Tablet Uncoated 033/010 North China Pharmaceutical

Group International Corporation,

4050 Ibuprofen Tablets Ibuprofen 200mgP Tablet Uncoated 033/011 North China Pharmaceutical

Group International Corporation,

4051 Ceftriaxone Injection Ceftriaxone 1gPOM Powder for

Injection

033/012 North China Pharmaceutical

Group International Corporation,

4052 Diclofenac Tablets Diclofenac 50mgP Tablet Uncoated 033/013 North China Pharmaceutical

Group International Corporation,

4053 Diclofenac Injection Diclofenac 75mg, per 3mlPOM Solution for

Injection

033/014 North China Pharmaceutical

Group International Corporation,

4054 Streptomycin Injection Streptomycin 1gPOM Powder for

Injection

033/015 North China Pharmaceutical

Group International Corporation,

4055 Tetracycline Capsules Tetracycline 250mgPOM Capsule oral 033/016 North China Pharmaceutical

Group International Corporation,

4056Vitamin C Tablets Ascorbic Acid 250mg

GS Tablet Uncoated 033/017 North China Pharmaceutical

Group International Corporation,

4057 Gentamicin Injection Gentamicin 80mg, per 2mlPOM Solution for

Injection

033/018 North China Pharmaceutical

Group International Corporation,

4058Chlorpheniramine Tablets Chlorpheniramine 4mg

P Tablet Uncoated 033/019 North China Pharmaceutical

Group International Corporation,

4059 Metronidazole Tablets Metronidazole 250mgPOM Tablet Uncoated 033/020 North China Pharmaceutical

Group International Corporation,

4060Ibupamol Capsules

Paracetamol 200mg + Ibuprofen

325mg

P Capsule oral 033/021 North China Pharmaceutical

Group International Corporation,

Page 199 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4061 Cefalexin For Oral Suspension Cefalexin 125mg, per 5mlPOM Powder for Oral

Suspension

033/022 North China Pharmaceutical

Group International Corporation,

4062Cephalexin BP 500mg Capsules Cephalexin 500mg

POM Capsule oral 033/023 North China Pharmaceutical

Group International Corporation,

4063 Cefuroxime Axetil For Oral Suspension Cefuroxime 125mg, per 5mlPOM Powder for Oral

Suspension

033/024 North China Pharmaceutical

Group International Corporation,

4064 Cefuroxime Axetil 250mg Tablets Cefuroxime 250mgPOM Tablet Uncoated 033/025 North China Pharmaceutical

Group International Corporation,

4065Benzathine Benzlypenicillin For

Injection

Benzathine Benzlypenicillin

2.4Mega

POM Powder for

Injection

033/026 North China Pharmaceutical

Group International Corporation,

4066 Aminophylline 250mg Injection Aminophylline 250mg, per 10mlPOM Solution for

Injection

033/027 North China Pharmaceutical

Group International Corporation,

4067 Fluconazole Injection Fluconazole 2mg, per mlPOM Solution for

Injection

033/029 North China Pharmaceutical

Group International Corporation,

4068 Salbutamol Tablets Sabultamol 2mgPOM Tablet Uncoated 033/030 North China Pharmaceutical

Group International Corporation,

4069 Chloramphenicol Capsules Chloramphehicol 250mgPOM Capsule oral 033/031 North China Pharmaceutical

Group International Corporation,

4070Furosemide Injection BP Furosemide 20mg, per 2ml

POM Solution for

Injection

033/032 North China Pharmaceutical

Group International Corporation,

4071 Cefotaxime Sodium BP 1gram Injection Cefotaxime 1gramPOM Powder for

Injection

033/033 North China Pharmaceutical

Group International Corporation,

4072Hyocine Butylbromide 20mg BP

InjectionHyocine Butylbromide 20mg

POM Solution for

Injection

033/034 North China Pharmaceutical

Group International Corporation,

4073 Kanamycin Sulphate Injection BP Kanamycin 1.0gPOM Powder for

Injection

033/035 North China Pharmaceutical

Group International Corporation,

4074 Carbamezapine Tablets 200mg BP Carbamezapine 200mgPOM Tablet Uncoated 033/036 North China Pharmaceutical

Group International Corporation,

4075 Trihexyphenidyl Tablets BP 5mg Trihexyphenidyl 5mgPOM Tablet Uncoated 033/037 North China Pharmaceutical

Group International Corporation,

4076 Methyldopa Tablets BP 250mg Methyldopa 250mgPOM Tablet Uncoated 033/038 North China Pharmaceutical

Group International Corporation,

4077 Sterile Water for Injection BP 10mls Sterile Water for InjectionsPOM Solution for

infusion

033/039 North China Pharmaceutical

Group International Corporation,

4078 Vitamin B Complex Injection Vitamin B POM Solution for

Injection

033/040 North China Pharmaceutical

Group International Corporation,

4079Aciclovir Tablets Aciclovir 400mg

POM Tablet Uncoated 033/041 North China Pharmaceutical

Group International Corporation,

Page 200 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4080Hydrocortisone Sodium Succinate for

InjectionHydrocortisone 100mg

POM Powder for

Injection

033/042 North China Pharmaceutical

Group International Corporation,

4081Magnesium Sulphate Injection

Magnesium Sulphate 500mg, per

ml

POM Solution for

Injection

033/043 North China Pharmaceutical

Group International Corporation,

4082 Amoxicillin Oral SuspensionAmoxicilin Trihydrate 125mg, per

5ml

POM Suspension for

Oral Use

033/044 North China Pharmaceutical

Group International Corporation,

4083Chloramphenical Powder for Oral

Suspension

Chloramphenicol Palmitate

125mg/5ml

POM Powder for Oral

Suspension

033/045 North China Pharmaceutical

Group International Corporation,

4084Phenoxymethylpenicillin Powder For

Oral Suspension 125mg/5ml

Phenoxymethyl Penicillin

Potassium 125mg, per 5ml

POM Powder for Oral

Suspension

033/046 North China Pharmaceutical

Group International Corporation,

4085 Aminophylline Tablets Aminophylline 100mgPOM Tablet Uncoated 033/047 North China Pharmaceutical

Group International Corporation,

4086 Aspirin Tablets Aspirin 300mgP Tablet Uncoated 033/048 North China Pharmaceutical

Group International Corporation,

4087 Ciprofloxacin TabletsCiprofloxacin Hydrochloride

500mg

POM Tablet Uncoated 033/049 North China Pharmaceutical

Group International Corporation,

4088 Pyridoxine Tablets Pyridoxine Hydrochloride 50mgPOM Tablet Uncoated 033/050 North China Pharmaceutical

Group International Corporation,

4089Phenoxymethylpenicillin Tablets

Phenoxymethyl Penicillin

Potassium 250mg

POM Tablet Uncoated 033/051 North China Pharmaceutical

Group International Corporation,

4090 Ranitidine tablets Ranitidine 150mgPOM Tablet Uncoated 033/052 North China Pharmaceutical

Group International Corporation,

4091 Water for injection Water for Injection POM Solution for

Injection

033/053 North China Pharmaceutical

Group International Corporation,

4092 Fortified Procaine Penicillin injection Procaine Penicillin 4MUPOM Powder for

Injection

033/054 North China Pharmaceutical

Group International Corporation,

4093 Co-trimoxazole Oral SuspensionSulfamethoxazole 200mg +

Trimethoprim 40mg , per 5ml

POM Suspension for

Oral Use

033/055 North China Pharmaceutical

Group International Corporation,

4094

Vitamin B Complex Tablets

Vitamin B1+ Vitamin B2 +

Vitamin B6 + Nicotinamide 5 +

Calcium D-Pantothenate BP +

Vitamin B 12 + Folic Acid BP

P Tablet Uncoated 033/056 North China Pharmaceutical

Group International Corporation,

4095Oxytocin 10IU Injection Oxytocin 10 IU

POM Solution for

Injection

033/057 North China Pharmaceutical

Group International Corporation,

4096 Chloramphenicol Eye Drops Chloramphehicol 1%POM Eye Drops 033/058 North China Pharmaceutical

Group International Corporation,

4097Cloxacillin Capsules Cloxacillin 250mg

POM Capsule oral 033/059 North China Pharmaceutical

Group International Corporation,

Page 201 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4098 Diclofenac Tablets Diclofenac Sodium 100mgP Tablet Uncoated 033/060 North China Pharmaceutical

Group International Corporation,

4099Indomethacin Capsule Indomethacin 25mg

P Capsule oral 033/061 North China Pharmaceutical

Group International Corporation,

4100 Nystatin Oral Suspension Nystatin 100,000IU, per mlPOM Suspension for

Oral Use

033/062 North China Pharmaceutical

Group International Corporation,

4101 Piroxicam Capsules Piroxicam 20mgP Capsule oral 033/063 North China Pharmaceutical

Group International Corporation,

4102Actifed Expectorant Syrup

Triprolidine 1.25mg+

Pseudoephedrine 30mg +

Guaiphenesin 100mg

P Syrup 025/002 Norvatis Consumer Health

International, Switzerland

4103Antigesic Tablets

Paracetamol + Propylptenazone

+ Caffeine

P Tablet Uncoated 025/005 Norvatis Consumer Health

International, Switzerland

4104 Linctifed Expectorant Forte SyrupTripolidine + Pseudoephedrine +

Guaiphenisin + Codeine

P Syrup 025/015 Norvatis Consumer Health

International, Switzerland

4105Calpol Suspension Paracetamol 120mg, per 5ml

GS Suspension for

Oral Use

025/018 Norvatis Consumer Health

International, Switzerland

4106 Sudafed Syrup Pseudoephedrine 30mg, per 5mlP Syrup 025/031 Norvatis Consumer Health

International, Switzerland

4107 Sudagesic TabletsTriprolidine + Pseudoephedrine +

Paracetamol

P Tablet Uncoated 025/033 Norvatis Consumer Health

International, Switzerland

4108 Galvus Met 50 Tablets Vildagliptin 50mgPOM Tablet Film

coated

121/041 Norvatis Consumer Health

International, Switzerland

4109 Coartem 80/480 TabletArtemether 80mg + Lumefantrine

480mg

POM Tablet Uncoated 121/047 Norvatis Consumer Health

International, Switzerland

4110 Otrivin Gel Xylometazoline 1%w/wP Gel Topical 242/001 Norvatis Consumer Health

International, Switzerland

4111 Fenistil Drops Dimethendene 1mg, per mlP Syrup 242/002 Norvatis Consumer Health

International, Switzerland

4112Slow Iron & Folic Acid Tablets

Ferrous Sulphate 160mg + Folic

Acid 0.4mg

P Tablet Film

coated

242/005 Norvatis Consumer Health

International, Switzerland

4113Pulmex Baby Ointment

Rosemary Oil 5% + Eucalyptus

Oil 5% + Synthetic Perivian

Balisam 6%

P Ointment topical 242/007 Norvatis Consumer Health

International, Switzerland

4114 Travegyl Ampoules Clemastine 1.0mg, per mlPOM Solution for

Injection

242/009 Norvatis Consumer Health

International, Switzerland

4115Travegyl Syrup Clemastine 0.1mg, per ml

POM Syrup 242/010 Norvatis Consumer Health

International, Switzerland

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4116 Travegyl 1mg Syrup Clemastine 1mgPOM Syrup 242/011 Norvatis Consumer Health

International, Switzerland

4117Voltaren Emulgel Diclofenac 1%

P Gel Topical 242/015 Norvatis Consumer Health

International, Switzerland

4118 Calcium Sandoz Tablets Calcium 500mgP Tablet Uncoated 242/016 Norvatis Consumer Health

International, Switzerland

4119 Calcium Sandoz + Vitamin C TabletsCalcium 260mg + Ascorbic Acid

1000mg

P Tablet Uncoated 242/017 Norvatis Consumer Health

International, Switzerland

4120 Co-Diovan TabletsValsartan 160mg +

Hydrochlorothiazide 25mg

POM Tablet Film

coated

242/018 Norvatis Consumer Health

International, Switzerland

4121 Voltaren 75mg Tablets Diclofenac 75mgp Tablet Uncoated 0359/05 Novartis Pharma Services Inc,

Kenya

4122 Exforge TabletsValsartan 160mg + Amlodpine

5mg

POM Tablet Film

coated

120/041 Novartis Pharma Services Inc,

Kenya

4123 Exforge TabletsValsartan 80mg + Amlodipine

5mg

POM Tablet Film

coated

120/042 Novartis Pharma Services Inc,

Kenya

4124 Exforge TabletsValsartan 160mg + Amlodipine

10mg

POM Tablet Film

coated

120/043 Novartis Pharma Services Inc,

Kenya

4125Sebivo Tablets Telbivudine 600mg

POM Tablet Film

coated

120/045 Novartis Pharma Services Inc,

Kenya

4126 Sirdakud Tablets Tizinidine 4mgPOM Tablet Uncoated 120/046 Novartis Pharma Services Inc,

Kenya

4127 Coartem TabletsArtemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 121/001 Novartis Pharma Services Inc,

Kenya

4128 Voltaren D 50mg Tablets Diclofenac 50mgP Tablet Uncoated 121/002 Novartis Pharma Services Inc,

Kenya

4129 Cataflam Drops Diclofenac 15mg, per mlP Oral drops 121/003 Novartis Pharma Services Inc,

Kenya

4130 Elidel Cream Pimecrolimus 1%w/wPOM Cream Topical 121/004 Novartis Pharma Services Inc,

Kenya

4131 Voltaren SR 75mg Tablets Diclofenac 75mgP Tablet Uncoated 121/005 Novartis Pharma Services Inc,

Kenya

4132 Lescol XL Tablets Fluvastatin 80mgPOM Tablet Uncoated 121/006 Novartis Pharma Services Inc,

Kenya

4133 Co-Diovan 80/12.5mg TabletsHydrochlorothiazide 12.5mg +

Valsartan 80mg

POM Tablet Uncoated 121/007 Novartis Pharma Services Inc,

Kenya

4134Cataflam 50mg Tablets Diclofenac 50mg

P Tablet Film

coated

121/008 Novartis Pharma Services Inc,

Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4135 Lamisil Tablets Terbinafine 250mgPOM Tablet Uncoated 121/009 Novartis Pharma Services Inc,

Kenya

4136Tegretol Syrup Carbamazepine 2%w/w

POM Syrup 121/010 Novartis Pharma Services Inc,

Kenya

4137 Tofranil Tablets Imipramine 25mgPOM Tablet Uncoated 121/011 Novartis Pharma Services Inc,

Kenya

4138 Voltaren 50 Suppositories Diclofenac 50mgP Suppository 121/012 Novartis Pharma Services Inc,

Kenya

4139 Voltaren 100 Suppositories Diclofenac 100mgP Suppository 121/013 Novartis Pharma Services Inc,

Kenya

4140 Voltaren Injection Diclofenac 75mg, per 3mlPOM Solution for

Injection

121/014 Novartis Pharma Services Inc,

Kenya

4141 Anafranil Tablets Clomipramine 25mgPOM Tablet Uncoated 121/015 Novartis Pharma Services Inc,

Kenya

4142 Diovan 80mg Tablets Valsartan 80mgPOM Tablet Uncoated 121/016 Novartis Pharma Services Inc,

Kenya

4143 Diovan 160mg Tablets Valsartan 160mgPOM Tablet Uncoated 121/017 Novartis Pharma Services Inc,

Kenya

4144Co-Diovan 160/12.5mg Tablets

Hydrochlorothiazide 12.5mg +

Valsartan 160mg

POM Tablet Uncoated 121/018 Novartis Pharma Services Inc,

Kenya

4145 Voltfast 50mg Tablets Diclofenac 50mg P Tablet Uncoated 121/019 Novartis Pharma Services Inc,

Kenya

4146 Voltaren 12.5 Suppositories Diclofenac 12.5mgP Suppository 121/020 Novartis Pharma Services Inc,

Kenya

4147 Tegretol CR Tablets Carbamazepine 400mgPOM Tablet Uncoated 121/021 Novartis Pharma Services Inc,

Kenya

4148 Tegretol Tablets Carbamazepine 200mgPOM Tablet Uncoated 121/022 Novartis Pharma Services Inc,

Kenya

4149 Slow K Tablets Potassium Chloride 600mgPOM Tablet Film

coated

121/023 Novartis Pharma Services Inc,

Kenya

4150 Sandomigran Coated Tablet 0.5mg Pizotifen Malate 0.5mgPOM Tablet film

coated

121/025 Novartis Pharma Services Inc,

Kenya

4151 Viskaldix Tablet 5/10mg Pindolol 10 Mg + Clopamide 5mgPOM Tablet uncoated 121/026 Novartis Pharma Services Inc,

Kenya

4152 Zaditen Tablet 1mgKetotifen Hydrogen Fumarate

1mg

POM Tablet uncoated 121/028 Novartis Pharma Services Inc,

Kenya

4153Zaditen Syrup 1mg/5ml

Ketotifen Hydrogen Fumarate 1

Mg, per 5ml

POM Syrup 121/029 Novartis Pharma Services Inc,

Kenya

Page 204 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4154Syntocinon Solution For Injection

5IU/mlOxtocin 5IU

POM Solution for

Injection

121/031 Novartis Pharma Services Inc,

Kenya

4155Parlodel Tablet 2.5mg Bromocriptine 2.5mg

POM Tablet uncoated 121/032 Novartis Pharma Services Inc,

Kenya

4156Syntocinon Solution For Injection

10IU/mlOxtocin 10IU

POM Solution for

Injection

121/035 Novartis Pharma Services Inc,

Kenya

4157 Coartem Dispersible Tablets Artemether 20mg +

Lumefantrine 120mg

POM Tablet

Dispersible

121/036 Novartis Pharma Services Inc,

Kenya

4158 Co-Diovan 320/12.5mg TabletsHydrochlorothiazide 12.5mg +

Valsartan 320mg

POM Tablet Uncoated 121/037 Novartis Pharma Services Inc,

Kenya

4159 Rasilez 150mg Tablets Aliskren 150mgPOM Tablet Film

coated

121/038 Novartis Pharma Services Inc,

Kenya

4160 Rasilez 300mg Tablets Aliskiren 300mgPOM Tablet Film

coated

121/039 Novartis Pharma Services Inc,

Kenya

4161 Flotac Capsules Diclofenac 75mgP Capsule oral 121/040 Novartis Pharma Services Inc,

Kenya

4162Voltaren Modified Release Tablet

100mgDiclofenac Sodium 100mg

P modified release

tablet

121/044 Novartis Pharma Services Inc,

Kenya

4163Sirdalud 4 Tablets Tizanidine Hydrochloride 4mg

POM Tablet Film

coated

121/046 Novartis Pharma Services Inc,

Kenya

4164 Insulin Actrapid HM Injection Insulin 100 IU, per mlPOM Suspension for

Injection

040/009 Novo Nordisk (Pty) Ltd, South

Africa

4165 Insulin Actrapid Penfil Injection Insulin 100 IU, per mlPOM Suspension for

Injection

040/010 Novo Nordisk (Pty) Ltd, South

Africa

4166 Insulin Protaphane Injection Insulin 100 IU, per mlPOM Suspension for

Injection

040/011 Novo Nordisk (Pty) Ltd, South

Africa

4167 Insulin Protaphane HM Penfil Injection Insulin 100 IU, per mlPOM Suspension for

Injection

040/012 Novo Nordisk (Pty) Ltd, South

Africa

4168 Insulin Actraphane HM injection Insulin 100 IU, per mlPOM Suspension for

Injection

040/013 Novo Nordisk (Pty) Ltd, South

Africa

4169 Insulin Actraphane HM Penfil Insulin 100 IU, per mlPOM Suspension for

Injection

040/014 Novo Nordisk (Pty) Ltd, South

Africa

4170 Insulin Monotard HM Injection Insulin Zinc 40IU, per mlPOM Suspension for

Injection

040/015 Novo Nordisk (Pty) Ltd, South

Africa

4171 Novo Rapid Injection Insulin Aspart 100IU, per mlPOM Solution for

Injection

040/016 Novo Nordisk (Pty) Ltd, South

Africa

4172Levemir Injection Insulin Detemir 100IU, per ml

POM Solution for

Injection

040/017 Novo Nordisk (Pty) Ltd, South

Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4173Novo Mix 30 Injection

30% Soluble Insulin Aspart And

70% Insulin Aspart Crystallised

with Protamine

POM Solution for

Injection

040/018 Novo Nordisk (Pty) Ltd, South

Africa

4174 Eryfast 250 Tablets Erythromycin Stearate BP 250mgPOM Tablet oral 390/010 NRB Pharma Zambia Limited

4175Viprox® Powder

GSH COMPLEX®: Whey

Protein Isolate + Triozyme®:

Sprouted

P Powder for Oral

Solution

377/001L Nutraxis International

4176Nutrilite Sachets Multivitamins + Minerals

P Granules for

Oral Suspension

375/001L Nutrilite Access Business Group

4177 Acfree Gel Adapalene 0.1%w/w P Gel Topical 287/001 Ochoa Laboratories Ltd, India

4178 Ultican 50 Tablets Fluconazole 50mg POM Tablet Uncoated 287/002 Ochoa Laboratories Ltd, India

4179 Ultican 150 Tablets Fluconazole 150mg POM Tablet Uncoated 287/003 Ochoa Laboratories Ltd, India

4180 Ultican 200 Tablets Fluconazole 200mg POM Tablet Uncoated 287/004 Ochoa Laboratories Ltd, India

4181 Terbofin CreamTerbinafine Hydrochloride

1%w/w

POM Cream Topical 287/005 Ochoa Laboratories Ltd, India

4182 Terbofin Tablets Terbinafine Hydrochloride 250mgPOM Tablet Uncoated 287/006 Ochoa Laboratories Ltd, India

4183Exevate G Cream

Betamethasone Dipropionate BP

0.05% + Gentamycin Sulphate

0.1%

POM Cream Topical 287/007 Ochoa Laboratories Ltd, India

4184Xtraderm Cream

Betamethasone 0.05% +

Gentamycin sulphate 0.1%+

Clotrimazole 1.0%

POM Cream Topical 287/008 Ochoa Laboratories Ltd, India

4185 Topibact Ointment Mupirocin 2% POM Ointment topical 287/009 Ochoa Laboratories Ltd, India

4186Doloact Injection Diclofenac Sodium 25mg, per ml

POM Solution for

Injection

287/011 Ochoa Laboratories Ltd, India

4187 Bivir 300/150mg TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Film

coated

141/001 Okasa Pharma Limited, India

4188 Maxivir 30 TabletsLamivudine 150mg + Nevirapine

200mg + Stavudine 30mg

POM Tablet Uncoated 141/002 Okasa Pharma Limited, India

4189 Maxivir 40 TabletsLamivudine 150 + Nevirapine

200mg + Stavudine 40mg

POM Tablet Uncoated 141/003 Okasa Pharma Limited, India

4190 Okavir Oral Solution Lamivudine 50mg, per 5mlPOM Solution for Oral

Use

141/005 Okasa Pharma Limited, India

4191 Okamune Tablets Nevirapine 200mg POM Tablet Uncoated 141/006 Okasa Pharma Limited, India

4192Oka-Ceftriaxone Injection Ceftriaxone 1g

POM Powder for

Injection

141/007 Okasa Pharma Limited, India

4193 Efiva 200 Capsules Efavirenz 200mg POM Capsule oral 141/008 Okasa Pharma Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4194 Oka-Vincristine Injection Vincristine 1mg, per mlPOM Powder for

Injection

141/009 Okasa Pharma Limited, India

4195 Efiva 600 Tablets Efavirenz 600mg POM Tablet Uncoated 141/010 Okasa Pharma Limited, India

4196 Cefurox 500 Tablets Cefuroxime 500mgPOM Tablet Enteric

Coated

141/012 Okasa Pharma Limited, India

4197 Oka-Azithromycin Tablets Azithromycin 250mg POM Tablet Uncoated 141/013 Okasa Pharma Limited, India

4198 Okavir S 30 Tablets Stavudine 30mg POM Tablet Uncoated 141/014 Okasa Pharma Limited, India

4199 Artheleria Oral Suspension Artemether 15mg, per 5mlPOM Suspension for

Oral Use

141/016 Okasa Pharma Limited, India

4200 Ibuprofen Tablets Ibuprofen 200mgP Tablet Film

coated

141/017 Okasa Pharma Limited, India

4201Viscodril Expectorant Syrup

Ammonium Chloride BP 138mg

+ Diphenylhydramine

Hydrochloride BP 14mg

P Syrup 258/001 Oman Pharmaceutical Products

Co. LLC, Oman

4202 Opizole Cream Clotrmazole USP 1%w/wPOM Cream Topical 258/002 Oman Pharmaceutical Products

Co. LLC, Oman

4203 Clofast GelDiclofenac Diethylamine BP

1%w/w

P Gel Topical 258/003 Oman Pharmaceutical Products

Co. LLC, Oman

4204 Dimet 650 TabletsMetformin Hydrochloride BP

650mg

POM Tablet Uncoated 258/004 Oman Pharmaceutical Products

Co. LLC, Oman

4205 Dimet 500 TabletsMetformin Hydrochloride BP

500mg

POM Tablet Uncoated 258/005 Oman Pharmaceutical Products

Co. LLC, Oman

4206Medicoril-E Syrup

Sodium Citrate 55mg +

Chlorpheniramine 2.5mg +

Ammonium Chloride 125mg

P Syrup 258/006 Oman Pharmaceutical Products

Co. LLC, Oman

4207 Atormin 50 Tablets Atenolol BP 50mgPOM Tablet Uncoated 258/007 Oman Pharmaceutical Products

Co. LLC, Oman

4208 Atormin 100 Tablets Atenolol BP 100mgPOM Tablet Uncoated 258/008 Oman Pharmaceutical Products

Co. LLC, Oman

4209 Pmol Syrup Paracetamol BP 120mg, per 5mlGS Syrup 258/009 Oman Pharmaceutical Products

Co. LLC, Oman

4210Pmol Caplets Paracetamol BP 500mg

GS Capsule oral 258/010 Oman Pharmaceutical Products

Co. LLC, Oman4211 OraQuick - HIV Self-Test Kit HIV Self-Test Kit P HDPE Strips 412/001 OraSure Technologies

4212 Cefacure Capsules Cephalexin USP 250mg POM Capsule oral 185/001 Orchid Healthcare Limited, India

4213 Cefacure Capsules Cephalexin USP 500mg POM Capsule oral 185/002 Orchid Healthcare Limited, India

4214Cefogram Injection Ceftriaxone Sodium 250mg

POM Powder for

Injection

185/003 Orchid Healthcare Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4215 Cefogram Injection Ceftriaxone Sodium 1000mgPOM Powder for

Injection

185/004 Orchid Healthcare Limited, India

4216Orzid Injection Ceftazidine 500mg

POM Powder for

Injection

185/005 Orchid Healthcare Limited, India

4217 Orzid Injection Ceftazidine 1000mgPOM Powder for

Injection

185/006 Orchid Healthcare Limited, India

4218 Tax-O -BID Injection Cefotaxime Sodium 1000mgPOM Powder for

Injection

185/007 Orchid Healthcare Limited, India

4219 Tax-O-BID Injection Cefotaxime Sodium 500mgPOM Powder for

Injection

185/008 Orchid Healthcare Limited, India

4220 Tax-O-BID Injection Cefotaxime Sodium 250mgPOM Powder for

Injection

185/009 Orchid Healthcare Limited, India

4221 Spizef 250 Tablets Cefuroxime Axetil I.H. 250mg POM Tablet Uncoated 185/010 Orchid Healthcare Limited, India

4222 Spizef 500 Tablets Cefuroxime Axetil I.H. 500mg POM Tablet Uncoated 185/011 Orchid Healthcare Limited, India

4223 Ulti-Mate 50 Sildenafil Tablets Sildenafil Citrate I. 50mg POM Tablet Uncoated 185/012 Orchid Healthcare Limited, India

4224 Ulti-Mate 100 Sildenafil Tablets Sildenafil Citrate I. 100mg POM Tablet Uncoated 185/013 Orchid Healthcare Limited, India

4225 Orpime Injection Cefepime Hydrochloride 1gPOM Powder for

Injection

185/014 Orchid Healthcare Limited, India

4226 Orfix Capsules Cefixime Soduim 200mg POM Capsule oral 185/015 Orchid Healthcare Limited, India

4227 Manorest Tablets Alprazolam 0.5mg POM Tablet Uncoated 185/016 Orchid Healthcare Limited, India

4228 Cepotil 200 TabletsCefpodoxime Proxetil USP

200mg

POM Tablet Uncoated 185/017 Orchid Healthcare Limited, India

4229Cepotil 100 Tablets

Cefpodoxime Proxetil USP

100mg

POM Tablet Uncoated 185/018 Orchid Healthcare Limited, India

4230 E-Pril -10 Tablets Enalapril Maleate USP 10mg POM Tablet Uncoated 185/019 Orchid Healthcare Limited, India

4231 Epril 5 Tablets Enalapril Maleate USP 5mg POM Tablet Uncoated 185/020 Orchid Healthcare Limited, India

4232 Monorest Tablets Alprazolam USP 0.25mg POM Tablet Uncoated 185/021 Orchid Healthcare Limited, India

4233 Ciprox InjectionCiprofloxacin USP 200mg, per

100ml

POM Solution for

Injection

194/009 Otsuka Pharmaceuticals India Pvt

Ltd

4234 Metris Injection Metronidazole USP 5mg, per mlPOM Solution for

Injection

194/013 Otsuka Pharmaceuticals India Pvt

Ltd

4235Dextrose Intravenous Infusion Glucose 50g/L

POM Solution for

infusion

194/015 Otsuka Pharmaceuticals India Pvt

Ltd

4236 Sodium Chloride And GlucoseSodium Chloride 0.9w/v +

Glucose 5%w/v

POM Solution for

infusion

194/016 Otsuka Pharmaceuticals India Pvt

Ltd

4237Sodium Chloride Injection Sodium Chloride 0.9%

POM Solution for

infusion

194/017 Otsuka Pharmaceuticals India Pvt

Ltd

4238Compound Sodium Lactate Ringer's Lactate

POM Solution for

infusion

194/018 Otsuka Pharmaceuticals India Pvt

Ltd

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4239 Gentamycin Sulphate Injection Gentamycin 80mg, per 2mlPOM Solution for

Injection

213/001 Ouyi Pharma Co.Ltd, China

4240 Palsar Tablets Losartan Potassium USP 50mg POM Tablet Uncoated 138/001 Palash Pharma

4241 Diflucan 200mg Tablets Fluconazole 200mgPOM Tablet Uncoated 120/001 Pfizer Global Pharmaceuticals

Ltd, South Africa

4242 Zithromax Tablets Azithromycin 500mgPOM Tablet Uncoated 120/002 Pfizer Global Pharmaceuticals

Ltd, South Africa

4243 Viagra Tablets Sildenafil 50mgPOM Tablet Uncoated 120/003 Pfizer Global Pharmaceuticals

Ltd, South Africa

4244 Viagra Tablets Sildenafil 25mgPOM Tablet Uncoated 120/004 Pfizer Global Pharmaceuticals

Ltd, South Africa

4245Liptor Tablets Atorvastatin 10mg

POM Tablet Uncoated 120/005 Pfizer Global Pharmaceuticals

Ltd, South Africa

4246 Liptor Tablets Atorvastatin 20mgPOM Tablet Uncoated 120/006 Pfizer Global Pharmaceuticals

Ltd, South Africa

4247 Diflucan 150mg Tablets Fluconazole 150mgPOM Tablet Uncoated 120/007 Pfizer Global Pharmaceuticals

Ltd, South Africa

4248 Feldene Tablets Piroxcam 20mgPOM Tablet Uncoated 120/008 Pfizer Global Pharmaceuticals

Ltd, South Africa

4249 Diflucan 50mg Tablets Fluconazole 50mgPOM Tablet Uncoated 120/009 Pfizer Global Pharmaceuticals

Ltd, South Africa

4250 Fasigyn Tablets Tinidazole 150mgPOM Tablet Uncoated 120/010 Pfizer Global Pharmaceuticals

Ltd, South Africa

4251 Xalatan Eye Drops Latanoprost 0.005%POM Eye Drops 120/011 Pfizer Global Pharmaceuticals

Ltd, South Africa

4252 Depo Provera InjectionMedroxyprogesterone Acetate

150mg, per ml

POM Suspension for

Injection

120/012 Pfizer Global Pharmaceuticals

Ltd, South Africa

4253Norvasc Tablets Amlodipine 5mg

POM Tablet Uncoated 120/013 Pfizer Global Pharmaceuticals

Ltd, South Africa

4254

Terra-Cotril Eye/Ear Drops

10 Mg Oxytetracycline+ 5 Mg

Hydrocortisone Acetate +10000

Units Polymyxin B Sulphate, per

ml

POM Ear/Eye Drops 120/014 Pfizer Global Pharmaceuticals

Ltd, South Africa

4255 Feldene Injection Piroxcam 20mg, per mlPOM Solution for

Injection

120/015 Pfizer Global Pharmaceuticals

Ltd, South Africa

4256 Prostine E 2 Vaginal Tablets Dinoprostone HSE 3mgPOM Tablet Uncoated 120/017 Pfizer Global Pharmaceuticals

Ltd, South Africa

4257Feldene Capsules Piroxcam 10mg

POM Capsule oral 120/018 Pfizer Global Pharmaceuticals

Ltd, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4258 Trobicin Injection Specitinomycin 3mgPOM Solution for

Injection

120/021 Pfizer Global Pharmaceuticals

Ltd, South Africa

4259Depo Medrol Injection Methylprednisolone 40mg, per ml

POM Solution for

Injection

120/022 Pfizer Global Pharmaceuticals

Ltd, South Africa

4260 Dalacin C 150mg Capsules Clindamycin 150mgPOM Capsule oral 120/023 Pfizer Global Pharmaceuticals

Ltd, South Africa

4261 Accupril Tablets Quinapril 5mgPOM Tablet Uncoated 120/024 Pfizer Global Pharmaceuticals

Ltd, South Africa

4262 Accupril Tablets Quinapril 10mgPOM Tablet Uncoated 120/025 Pfizer Global Pharmaceuticals

Ltd, South Africa

4263 Accupretic TabletsHydrochlothiazide 12.5mg +

Quinapril 10mg

POM Tablet Uncoated 120/026 Pfizer Global Pharmaceuticals

Ltd, South Africa

4264 Ponstan Capsules Mefenamic Acid 250mgP Capsule oral 120/027 Pfizer Global Pharmaceuticals

Ltd, South Africa

4265 Ponstan Suspension Mefenamic Acid 50mg, per 5ml P Suspension for

Oral Use

120/028 Pfizer Global Pharmaceuticals

Ltd, South Africa

4266 Feldene Topical Gel Piroxcam 0.5%POM Gel Topical 120/029 Pfizer Global Pharmaceuticals

Ltd, South Africa

4267Zithromax Suspension Azithromycin 200mg, per 5ml

POM Suspension for

Oral Use

120/030 Pfizer Global Pharmaceuticals

Ltd, South Africa

4268 Sayana InjectionMedroxyprogesterone 104mg,

per 0.65ml

POM Solution for

Injection

120/031 Pfizer Global Pharmaceuticals

Ltd, South Africa

4269 Mycobutin Capsules Rifabutin 150mgPOM Capsule oral 120/032 Pfizer Global Pharmaceuticals

Ltd, South Africa

4270 Dalacin C Capsules Clindamycin 150mgPOM Capsule oral 198/008 Pfizer Global Pharmaceuticals

Ltd, South Africa

4271 Cytotec Tablets Misoprostol 200mcgPOM Tablet Uncoated 120/037 Pfizer Global Pharmaceuticals

Ltd,Nigeria

4272 ASPAVOR 10 TabletsAtorvastalin Calcium Trihydrate

10mg

POM Tablet Uncoated 357/001 Pfizer Global Pharmaceuticals

Ltd,Nigeria

4273 ASPAVOR 20 TabletsAtorvastalin Calcium Trihydrate

20mg

POM Tablet Uncoated 357/002 Pfizer Global Pharmaceuticals

Ltd,Nigeria

4274 ASPAVOR 40 TabletsAtorvastalin Calcium Trihydrate

40mg

POM Tablet Uncoated 357/003 Pfizer Global Pharmaceuticals

Ltd,Nigeria

4275Sayana Press® Pre-Filled Single-Use

Suspension For Injection System

Medroxyprogesterone Acetate

104mg, per 0.65ml

Prescription

Only Medicine

Suspension for

Injection

120/038 Pfizer Laboratories Limited, Kenya

4276 Tetracycline Capsules Tetracycline 250mg POM Capsule oral 131/008 Pharco Limited,Zambia

4277Normavir Tablets

Lamivudine 150mg + Stavudine

30mg + Nevirapine 300mg

POM Tablet Uncoated 132/002 Pharco Limited,Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4278 Cimetidine Tablets Cimetidine 100mg POM Tablet Uncoated 132/003 Pharco Limited,Zambia

4279 Chlorpheniramine Tablets Chlorpheniramine Maleate 4mg P Tablet Uncoated 132/004 Pharco Limited,Zambia

4280Co-Trimoxazole Tablets

Sulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 132/005 Pharco Limited,Zambia

4281 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 132/006 Pharco Limited,Zambia

4282 Folic Acid Tablets Folic Acid 5mg P Tablet Uncoated 132/007 Pharco Limited,Zambia

4283 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 132/009 Pharco Limited,Zambia

4284 Paracetamol Tablets Paracetamol 100mg GS Tablet Uncoated 132/010 Pharco Limited,Zambia

4285 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 132/011 Pharco Limited,Zambia

4286 Sulphadoxine/Pyrimethamine TabletsPyrimethamine 25mg +

Sulphadoxine 500mg

POM Tablet Uncoated 132/012 Pharco Limited,Zambia

4287 Carbamazepine Tablets Carbamazepine 200mg POM Tablet Uncoated 132/013 Pharco Limited,Zambia

4288 Metoclopramide Tablets Metoclopramide BP 10mg POM Tablet Uncoated 132/014 Pharco Limited,Zambia

4289 Quinine Sulphate Tablets Quinine Sulphate 300mg POM Tablet Uncoated 132/015 Pharco Limited,Zambia

4290 Zarin Sino II Implant Levenorgestrel 75mgPOM Transdermal

Rod

081/001 Pharm Access Africa Ltd, Kenya

4291 Dynafloc 500 Tablets Ciprofloxacin 500mgPOM Tablet Uncoated 051/001 Pharma Dynamics (Pty) Limited,

South Africa

4292 Efferflu C Effervesent TabletsParacetamol 500mg + Vitamin C

250mg + Chlorpheniramine 2mg

P Tablet

Dispersible

051/002 Pharma Dynamics (Pty) Limited,

South Africa

4293 Pollentymes S Syrup Loratadine 5mg, per 5mlsP Syrup 051/003 Pharma Dynamics (Pty) Limited,

South Africa

4294 Texa Syrup Cetirizine 1mg, per mlP Syrup 051/004 Pharma Dynamics (Pty) Limited,

South Africa

4295 Texa 10mg Tablets Cetirizine 10mgP Tablet Uncoated 051/005 Pharma Dynamics (Pty) Limited,

South Africa

4296Enap 5mg Tablets Enalapril 5mg

POM Tablet Film

coated

051/006 Pharma Dynamics (Pty) Limited,

South Africa

4297 Enap 10 Tablets Enalapril 10mgPOM Tablet Film

coated

051/007 Pharma Dynamics (Pty) Limited,

South Africa

4298 Enap 20 Tablets Enalapril 20mgPOM Tablet Film

coated

051/008 Pharma Dynamics (Pty) Limited,

South Africa

4299 Pollentyme Tablets Loratadine 10mgP Tablet Film

coated

051/009 Pharma Dynamics (Pty) Limited,

South Africa

4300 Oradoc Gargle & Mouth WashTea Tree Oil 200mg + Eucalyptol

18mg + Thymol 13mg

GS Solution for Oral

Use

051/010 Pharma Dynamics (Pty) Limited,

South Africa

4301Enap - Co Tablets

Enalapril 20mg +

Hydrochlorothiazide 12.5mg

POM Tablet Film

coated

051/011 Pharma Dynamics (Pty) Limited,

South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4302 Pearinda 4 Tablets Perindopril 4mgPOM Tablet Uncoated 051/012 Pharma Dynamics (Pty) Limited,

South Africa

4303Pearinda 8 Tablets Perindopril 8mg

POM Tablet Uncoated 051/013 Pharma Dynamics (Pty) Limited,

South Africa

4304 Carvetrend 6.25mg Tablets Carvedilol 6.25mgPOM Tablet Uncoated 051/014 Pharma Dynamics (Pty) Limited,

South Africa

4305 Carvetrend 12.5mg Tablets Carvedilol 12.5mgPOM Tablet Uncoated 051/015 Pharma Dynamics (Pty)

Limited,South Africa

4306Efferflu C IB

Vitamin C 1000.0mg +

Echinacea Purpurea 50mg +

Zinc Lactate Trihydrate 22.71mg

POM Tablet uncoated 051/016 Pharma Dynamics (Pty)

Limited,South Africa

4307Depogest Injection Medroxyprogesteron USP 150mg

POM Solution for

Injection

247/001 Pharmacarechem International

Ltd, England

4308 Cloxacillin Dry Syrup Cloxacillin 125mg, per 5mlPOM Syrup 247/002 Pharmacarechem International

Ltd, England

4309Amoxicillin Dry Syrup Amoxicillin 125mg, per 5ml

POM Suspension for

Oral Use

247/003 Pharmacarechem International

Ltd, England

4310 Erythromycin Oral Suspension Erythromycin BP 125mg, per 5mlPOM Suspension for

Oral Use

247/004 Pharmacarechem International

Ltd, England

4311 Ampicillin Dry Syrup Ampicillin 125mg, per 5mlPOM Syrup 247/005 Pharmacarechem International

Ltd, England

4312 Phenoxymethyl Penicillin SuspensionPhenoxymethyl Penicillin USP

125mg, per 5ml

POM Suspension for

Oral Use

247/006 Pharmacarechem International

Ltd, England

4313 Solu Medrol Injection Methylprednisolone 40mgPOM Solution for

Injection

198/001 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4314 Medrol Tablets Methylprednisolone 4mgPOM Tablet Uncoated 198/002 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4315 Halcion Tablets Triazolam 0.25mgPOM Tablet Uncoated 198/003 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4316Xalatan Eye Drops Latanoprost 50mg

POM Eye Drops 198/005 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4317 Provera Tablets Medroxyprogesterone 5mgPOM Tablet Uncoated 198/006 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4318 Dalacin C Injection Clindamycin 150mgPOM Solution for

Injection

198/007 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4319 Dalacin C Syrup Clindamycin 75mg, per 5mlPOM Solution for Oral

Use

198/009 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4320Caverject Powder for Injection Alprostadil 20mcg

POM Powder for

Injection

198/010 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4321

Neo Medrol Acne Lotion

Sulfur 50mg +

Methyprednisolone 2.5mg +

Neomycin 2.5mg + Aluminium

Chlorohydrate 100mg

POM Lotion for

Topical Use

198/011 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4322 Solu Cortef InjectionHydrocortisone Sodium

Succinate 100mg

POM Powder for

Injection

198/012 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4323 Unicarp M Capsules MultivitaminsP Capsules Oral 198/013 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4324 Togamycin Injection Specitinomycin 2gPOM Powder for

Injection

198/015 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A

4325 Depo Provera Injection Medroxyprogesterone 150mgPOM Suspension for

Injection

198/016 Pharmacia & Upjohn Worldwide,

Kalamazoo, U.S.A4326 Lomanor 10 Tablets Amlodipine Besylate 10mg POM Tablet Uncoated 357/004 Pharmacia South Africa (Pty) Ltd

4327 Lomanor 5 Tablets Amlodipine Besylate 5mg POM Tablet Uncoated 357/005 Pharmacia South Africa (Pty) Ltd

4328 Accumax 10mg Tablets Quinapril Hydrochloride 10mgPOM Tablet Enteric

Coated

357/006 Pharmacia South Africa (Pty) Ltd

4329Accumax 20mg Tablets Quinapril Hydrochloride 20mg

POM Tablet Film

coated

357/007 Pharmacia South Africa (Pty) Ltd

4330 Accumax Co 10/12.5mg TabletsQuinapril Hydrochloride 10mg +

Hydrochlorothiazide 12.5mg

POM Tablet Film

coated

357/008 Pharmacia South Africa (Pty) Ltd

4331 Accumax Co 20/12.5mg TabletsQuinapril Hydrochloride 20mg +

Hydrochlorothiazide 12.5mg

Prescription

Only Medicine

Tablet Film

coated

370/013L Pharmacia South Africa (Pty) Ltd

4332 Closcript Vaginal Cream Clotrimazole 1% POM Cream Topical 017/001 Pharmanova (Pty) Ltd, Zimbabwe

4333 Closcript Topical Cream Clotrimazole 1% POM Cream Topical 017/002 Pharmanova (Pty) Ltd, Zimbabwe

4334 Goldgesic SyrupParacetamol + Codeine +

Meprobamate

P Syrup 017/003 Pharmanova (Pty) Ltd, Zimbabwe

4335 Grays Eye Drops Tetrahydrozoline 0.05% POM Eye Drops 017/004 Pharmanova (Pty) Ltd, Zimbabwe

4336 Goldgesic TabletsParacetamol + Codeine +

Meprobamate

P Tablet Uncoated 017/005 Pharmanova (Pty) Ltd, Zimbabwe

4337 Pain-Eeze Tabs Aspirin + Caffeine P Tablets oral 017/006 Pharmanova (Pty) Ltd, Zimbabwe

4338 Grays Cough SyrupGrays Pine Tar & Honey Cough

Syrup

P Syrup 017/007 Pharmanova (Pty) Ltd, Zimbabwe

4339 Novadol Tablets Paracetamol 500mg GS Tablet Uncoated 017/009 Pharmanova (Pty) Ltd, Zimbabwe

4340 Novadol Syrup Paracetamol 120mg GS Syrup 017/010 Pharmanova (Pty) Ltd, Zimbabwe

4341 Novatrim SuspensionSulphamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

017/011 Pharmanova (Z) Ltd, Lusaka,

Zambia

4342Adult Cafemol Tablets Aspirin 500mg + Caffeine 15mg

GS Tablet Uncoated 077/001 Pharmanova (Z) Ltd, Lusaka,

Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4343 Child Cafemol Tablets Aspirin 80mgGS Tablet Uncoated 077/002 Pharmanova (Z) Ltd, Lusaka,

Zambia

4344Panado Tablets Paracetamol 500mg

GS Tablet Uncoated 077/003 Pharmanova (Z) Ltd, Lusaka,

Zambia

4345 Novaderm Dusting Powder Clotrimazole 1%w/wP Powder for

Topical use

077/006 Pharmanova (Z) Ltd, Lusaka,

Zambia

4346

Phipps Gripe Water

Sodium Bicarbonate 50mg,

Sodium Citrate 2.5mg, Sucrose

120mg, Spearmint Oil 0.14mg,

0.1mg/50ml

GS Solution for Oral

Use

077/007 Pharmanova (Z) Ltd, Lusaka,

Zambia

4347 Novatrim TabletsTrimethoprim 80mg +

Sulphadoxine 400mg

POM Tablet Uncoated 077/008 Pharmanova (Z) Ltd, Lusaka,

Zambia

4348Novidar Tablets

Pyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 077/009 Pharmanova (Z) Ltd, Lusaka,

Zambia

4349 Panado Syrup Paracetamol 125mg, per 5mlP Syrup 077/010 Pharmanova (Z) Ltd, Lusaka,

Zambia

4350 Drews Liver SaltMagnesium + Sodium

Bicarbonate 3.165gm

GS Powder for Oral

Solution

077/011 Pharmanova (Z) Ltd, Lusaka,

Zambia

4351 Padax 1.65g (Piperazine Citrate) Piperazine Citrate 1.65gPOM Powder 077/012 Pharmanova (Z) Ltd, Lusaka,

Zambia

4352 Metronidazole 200mg Tabs Metronidazole 200mgPOM Tablets oral 077/013 Pharmanova (Z) Ltd, Lusaka,

Zambia

4353 Co-trimoxazole TabletsTrimethoprim 80mg +

Sulphadoxine 400mg

POM Tablet Uncoated 077/014 Pharmanova (Z) Ltd, Lusaka,

Zambia

4354 Novafen 200mg Capsules Ibuprofen 200mgP Capsules oral 077/015 Pharmanova (Z) Ltd, Lusaka,

Zambia

4355 Tetracycline 250mg Caps Tetracyline 250mg POM Capsules oral 077/016 Pharmanova (Z) Ltd, Lusaka,

Zambia

4356

Novalyn Cough Syrup

Diphenyhydramine Hydrochloride

14mg + Ammonium Chloride

138mg + Sodium Citrate 57.3mg

+ Menthol 2g, per 5ml

P Syrup 077/017 Pharmanova (Z) Ltd, Lusaka,

Zambia

4357 Aspirin Tablets Acetyl Salicylic Acid 300mgP Tablet Uncoated 077/018 Pharmanova (Z) Ltd, Lusaka,

Zambia

4358

Novalyte ORS

Sodium Chloride 2.6g + Sodium

Citrate2.9g + Potassium

Chloride1.5g + Anhydrous

Glucose 13.5g

GS Powder for Oral

Solution

077/019 Pharmanova (Z) Ltd, Lusaka,

Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4359Novidar Plus Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 077/020 Pharmanova (Z) Ltd, Lusaka,

Zambia

4360 Novachlor Syrup Chlorpheniramine 2mg, per 5mlP Syrup 077/021 Pharmanova (Z) Ltd, Lusaka,

Zambia

4361Nocold Capsules

Paracetamol 400mg + Caffeine

30mg + Chlorpheniramine 4mg +

Pseudoephedrine 30mg

P Capsules oral 077/022 Pharmanova (Z) Ltd, Lusaka,

Zambia

4362Child Panado Tablets Paracetamol 100mg

GS Tablet Uncoated 077/023 Pharmanova (Z) Ltd, Lusaka,

Zambia

4363 Panado Plus TabletsIbuprofen 200mg +

Paracetamol325mg

P Tablet Uncoated 077/024 Pharmanova (Z) Ltd, Lusaka,

Zambia

4364 Novazinc Tablets Zinc Sulfate 20mgGS Tablet Uncoated 077/025 Pharmanova (Z) Ltd, Lusaka,

Zambia

4365 Kit Yamoyo the Flexi Pack Kit ORS + Zinc Sulphate 200mg + 1

Hand Soap

GS Kit 077/026 Pharmanova (Z) Ltd, Lusaka,

Zambia

4366 Yamoyo Screw Top KitORS + Zinc Sulphate 200mg + 1

Hand Soap

GS kit 077/027 Pharmanova (Z) Ltd, Lusaka,

Zambia

4367 Yamoyo GRZ Co-Pack ORS + Zinc Sulphate 200mgGS Kit 077/028 Pharmanova (Z) Ltd, Lusaka,

Zambia4368 Aspirin Tablets 300mg Aspirin 300mg P Tablet Uncoated 257/001 Pharmanova Limited, Malawi

4369 Phipps Milk Of MagnesiaMagnesium Hydroxide 400mg,

per 5ml

GS Suspension for

Oral Use

257/002 Pharmanova Limited, Malawi

4370 Panadol Tablets For Children Paracetamol 100mg GS Tablet Uncoated 257/003 Pharmanova Limited, Malawi

4371

Stearns Pine Tar

Salicylic Acid 0.014% +

Ammonium Chloride 1.15% +

Hexysuranal 0.1% + Alcohol

1.6%

GS Syrup 257/019 Pharmanova Limited, Malawi

4372 Micro Betamethasone Injection Betamethasone 4mg, per mlPOM Solution for

Injection

034/001 Pharma-Q Holdings (Pty) Ltd,

South Africa

4373Micro Bupivacaine Spinal with Dextrose

Injection

Bupivacaine + Dextrose 20mg,

per 4ml

POM Solution for

Injection

034/002 Pharma-Q Holdings (Pty) Ltd,

South Africa

4374 Micro Dopamine InjectionDopamine Hydrochloride 200mg,

per 5ml

POM Solution for

Injection

034/003 Pharma-Q Holdings (Pty) Ltd,

South Africa

4375Pharma Q Bupivacaine Injection

50mg/10ml Injection

Bupivacaine Hydrochloride

50mg, per 10ml

POM Solution for

Injection

034/004 Pharma-Q Holdings (Pty) Ltd,

South Africa

4376Pharma -Q Gentamicin 80mg/2ml

Injection

Gentamycin Sulphate 80mg, per

2ml

POM Solution for

Injection

034/005 Pharma-Q Holdings (Pty) Ltd,

South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4377 Pharma-Q Metoclopramide InjectionMetoclopramide Hydrochloride

10mg

POM Solution for

Injection

034/006 Pharma-Q Holdings (Pty) Ltd,

South Africa

4378Pharma-Q Hyocine Butylbromide

Injection 20mg/2mlHyocine Butylbromide 20mg

POM Solution for

Injection

034/007 Pharma-Q Holdings (Pty) Ltd,

South Africa

4379Pharma-Q Clindamycin Injection

600mg/4ml

Clindamycin Phosphate 600mg,

per 4ml

POM Solution for

Injection

034/008 Pharma-Q Holdings (Pty) Ltd,

South Africa

4380 Pharma-Q Adrenalin Injection Adrenaline Hydrochloride 1mgPOM Solution for

Injection

034/009 Pharma-Q Holdings (Pty) Ltd,

South Africa

4381 Pharma-Q Pethidine Injection Pethidine Hydrochloride 100mgPOM Solution for

Injection

034/010 Pharma-Q Holdings (Pty) Ltd,

South Africa

4382 Pharma-Q Diclofenac InjectionDiclofenac Sodium 75mg, per

3ml

POM Solution for

Injection

034/011 Pharma-Q Holdings (Pty) Ltd,

South Africa

4383Pharma-Q Dexamethasone Phosphate

Injection

Dexamethasone Sodium

Phosphate 4.0mg

POM Solution for

Injection

034/012 Pharma-Q Holdings (Pty) Ltd,

South Africa

4384 Larvin Tablets Clopidogrel 75mgPOM Tablet Film

coated

320/001 Pharmex SA

4385 Butafusin CreamFusidic Acid 2%w/w +

Betamethasone Valerate 0.1%

POM Cream Topical 320/002 Pharmex SA

4386 Cipocal Cream Calcipotriol 0.005% POM Cream Topical 320/003 Pharmex SA

4387 Phardinol Eye Drop SolutionDorzalamide Hydrochloride 2.0%

+ Timolol Maleate 0.5%

POM Eye Drops 320/004 Pharmex SA

4388 Cipocal Ointment Calcipotriol (Anhydrous), 0.005% GS Ointment topical 320/005 Pharmex SA

4389 Qina Drops Herbal ExtractsP Solution for Oral

Use

078/001HM Phend Pharmaceuticals Pty Ltd,

China

4390 Propovan Injection, 20ml Ampoule Propofol 1%POM Suspension for

Injection

103/005 Piramal Healthcare Limited, India

4391 Actifresh Lozenges - RegularMentha Piperata 1.89mg +

Eucalyptus Globules 0.65mg

GS Lozenges 037/001 Plethico Pharmaceuticals Limited,

India

4392Travisil Cold Rub

Camphor + Turpentine + Menthol

+ Eucalyptus Oil + Thymol +

Nutmeg

GS Ointment topical 037/002 Plethico Pharmaceuticals Limited,

India

4393Therasil Sore Throat Formula

Lozenges

Amylmetacresol 0.6mg + 2,4

Dichlorobenzyl Alcohol 1.2mg

GS Lozenges 037/003 Plethico Pharmaceuticals Limited,

India

4394Artemal M Injection Artemether 80mg, per ml

POM Solution for

Injection

037/004 Plethico Pharmaceuticals Limited,

India

4395 Falquin 600 Injection Quinine 600mg, per 2mlPOM Solution for

Injection

037/005 Plethico Pharmaceuticals Limited,

India

4396Timizol Tablets

Trimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 037/006 Plethico Pharmaceuticals Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4397 Taxocef -O 200 Tablets Cefixime 200mgPOM Tablet Uncoated 037/007 Plethico Pharmaceuticals Limited,

India

4398Travisil Herbal Cough Lemon Flavoured

LozengesHerbal Extract

GS Lozenges 037/008 Plethico Pharmaceuticals Limited,

India

4399Travisil Herbal Cough Mint Flavour

LozengesHerbal Extract

GS Lozenges 037/009 Plethico Pharmaceuticals Limited,

India

4400 Travisil Herbal Cough Syrup Herbal ExtractGS Syrup 037/010 Plethico Pharmaceuticals Limited,

India

4401

Fastorik Tablets

Paracetamol 500mg +

Phenylephrine 5mg +

Chlorpheniramine 4mg +

Caffeine 30mg

P Tablet Uncoated 037/011 Plethico Pharmaceuticals Limited,

India

4402Cloptaz Tablets Clopidogrel 75mg

POM Tablet Film

coated

037/012 Plethico Pharmaceuticals Limited,

India

4403

Coolz Suspension

Aluminium Hydroxide 300mg +

Magnesium Trisilicate 50mg +

Magnesium Hydroxide 25mg +

Simethicone 25mg

POM Suspension for

Oral Use

037/013 Plethico Pharmaceuticals Limited,

India

4404 Forcepime 1g Injection Cefepime Hydrochloride 1gPOM Powder for

Injection

037/014 Plethico Pharmaceuticals Limited,

India

4405 Maxi 75 InjectionDiclofenac Sodium 75mg, per

3ml

POM Solution for

Injection

037/015 Plethico Pharmaceuticals Limited,

India

4406Terbact Cream

Terbinafine Hydrochloride

1%w/w

POM Cream Topical 037/016 Plethico Pharmaceuticals Limited,

India

4407Q-Med Adrenaline Injection Adrenaline

POM Solution for

Injection

183/001 Preterius Patents CC, South

Africa4408 Alphacillin 250 Capsules Ampicillin 250mg POM Capsule oral 265/001 Prime Pharmaceuticals Ltd, India

4409 Acyzon Tablets Acyclovir 200mg POM Tablet Uncoated 265/002 Prime Pharmaceuticals Ltd, India

4410 Ketoniz Tablets Ketaconazole USP 200mg POM Tablet Uncoated 265/004 Prime Pharmaceuticals Ltd, India

4411 Clotflush Injection Heparin 100IUPOM Solution for

Injection

246/001 Prisma Pharmaceuticals Ltd, UK

4412Priskacin 250 Injection Amikacin 250mg

POM Powder for

Injection

246/002 Prisma Pharmaceuticals Ltd, UK

4413 Purecal Tablets Calcium 1250mg POM Tablet Uncoated 246/003 Prisma Pharmaceuticals Ltd, UK

4414 Priskacin 500 Injection Amikacin 500mgPOM Powder for

Injection

246/004 Prisma Pharmaceuticals Ltd, UK

4415Synolube Injection Sodium Hyaluronate 20mg

POM Solution for

Injection

246/005 Prisma Pharmaceuticals Ltd, UK

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4416 Odicef 1000 Injection Ceftriaxone 1000mgPOM Powder for

Injection

246/009 Prisma Pharmaceuticals Ltd, UK

4417Odicef 50 Injection Ceftriaxone 50mg

POM Powder for

Injection

246/010 Prisma Pharmaceuticals Ltd, UK

4418 Odicef 250 Injection Ceftriaxone 250mgPOM Powder for

Injection

246/011 Prisma Pharmaceuticals Ltd, UK

4419 Clavex InjectionAmoxicillin 1000mg +

Clavulanate Potassium 200mg

POM Powder for

Injection

246/014 Prisma Pharmaceuticals Ltd, UK

4420 LMW Enox Injection Enoxaparin 80mg, per 0.8mlPOM Solution for

Injection

246/016 Prisma Pharmaceuticals Ltd, UK

4421 LMW Enox Injection Enoxaparin 40mg, per 0.4mlPOM Solution for

Injection

246/017 Prisma Pharmaceuticals Ltd, UK

4422 LMW Enox Injection Enoxaparin 60mg, per 0.6mlPOM Solution for

Injection

246/018 Prisma Pharmaceuticals Ltd, UK

4423 Kefurox 250 Mg Tablets Cefuroxime 250mgPOM Tablet Film

coated

246/019 Prisma Pharmaceuticals Ltd, UK

4424 Kefurox 500mg Tablets Cefuroxime 500mgPOM Tablet Film

coated

246/020 Prisma Pharmaceuticals Ltd, UK

4425Amoxsan® 250 DT Amoxicillin Trihydrate

POM Tablet

Dispersible

631/001 PT CAPRIFARMINDO

LABORATORIES

4426 Co-Trimoxazole TabletsSulphamethoxazole BP 400mg +

Trimethoprim BP 80mg

POM Tablet Uncoated 162/001 Pure pharma Limited, India

4427 Feefen Tablet Ibuprofen BP 200mg P Tablet Uncoated 162/002 Pure pharma Limited, India

4428Sulphadoxine + Pyrimethamine Tablets

Sulfadoxine 500mg +

Pyrimethamine 25mg +

Artesunate 100mg

POM Tablet Uncoated 162/004 Pure pharma Limited, India

4429 Praziquantel Tablets Praziquantel BP 600mg POM Tablet Uncoated 162/006 Pure pharma Limited, India

4430 Peevaran Tablets Diclofenac Sodium 50mg P Tablet Uncoated 162/008 Pure pharma Limited, India

4431 Peemox Capsules Amoxicillin 250mg POM Capsule oral 162/009 Pure pharma Limited, India

4432 Indomethacin Capsules Indomethacin 25mg P Capsule oral 162/010 Pure pharma Limited, India

4433 Cloxacillin Capsules Cloxacillin 250mg POM Capsule oral 162/011 Pure pharma Limited, India

4434 Betamethasone Dipropionate Cream Betamethasone 0.05%w/w POM Cream Topical 064/001 R K Sharma, India

4435 Acyclovir Tablets 200mg BP Acyclovir 200mg POM Tablet Uncoated 064/002 R K Sharma, India

4436 Ketoconazole Cream 2% Ketoconazole 2%w/w POM Cream Topical 064/004 R K Sharma, India

4437 Miconazole Cream 2% Miconazole 2%w/w POM Cream Topical 064/005 R K Sharma, India

4438 Acyclovir Cream 5% BP Acyclovir 5%w/w POM Cream Topical 064/006 R K Sharma, India

4439Adosine Dr 250 Capsules

Didanosine Delayed Release

USP 250mg

POM Capsule

Delayed

Release

112/133 Ranbaxy Laboratories Ltd, India

Page 218 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4440Adosine Dr 400 Capsules

Didanosine Delayed Release

USP 400mg

POM Capsule

Delayed

Release

112/134 Ranbaxy Laboratories Ltd, India

4441 Cefpi 1000 Injection Cefpirome Sulphate 1000mgPOM Powder for

Injection

112/135 Ranbaxy Laboratories Ltd, India

4442 Cefpi 500 Injection Cefpirome Sulphate 500mgPOM Powder for

Injection

112/136 Ranbaxy Laboratories Ltd, India

4443 Vesizen 5 Tablets Solifenacin Succinate 5mgPOM Tablet Film

coated

112/137 Ranbaxy Laboratories Ltd, India

4444 Vesizen 10 Tablets Solifenacin Succinate 10mgPOM Tablet Film

coated

112/138 Ranbaxy Laboratories Ltd, India

4445Staxom Tablets

Moxifloxacin Hydrochloride

400mg

POM Tablet Film

coated

112/139 Ranbaxy Laboratories Ltd, India

4446

Zytee Mouth Wash

Clove Oil 1% + Mentha Arvensis

1% + Menthol 1% + Chamomile

Oil 0.15% + Sodium Benzoate

2% + Alcohol 95%

POM Solution for Oral

Use

029/001 Raptakos -Brett Company Ltd,

India

4447 Igol Granules Ispaghula Husk 0.66gGS Powder for Oral

Suspension

029/002 Raptakos -Brett Company Ltd,

India

4448 Subsyde CR100mg Capsules Diclofenac 100mgPOM Tablet Uncoated 029/003 Raptakos -Brett Company Ltd,

India

4449Sucon RB Capsules Vitamins + Minerals

GS Capsule oral 029/004 Raptakos -Brett Company Ltd,

India

4450 Sucon RB Suspension Vitamins + MineralsGS Suspension for

Oral Use

029/005 Raptakos -Brett Company Ltd,

India

4451Duralyn-CR Tablets Theophylline 200mg

POM Tablet Uncoated 029/006 Raptakos -Brett Company Ltd,

India

4452 Duralyn - CR 400 Capsules Theophylline 400mgPOM Capsule oral 029/007 Raptakos -Brett Company Ltd,

India

4453 Neogadine Elixir Vitamins + MineralsGS Elixir 029/008 Raptakos -Brett Company Ltd,

India

4454Zytee RB Gel

Choline Salicylate 9%w/v +

Benzokonium Chloride

0.002%w/v

GS Gel Topical 029/009 Raptakos -Brett Company Ltd,

India

Page 219 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4455

Catoxymag-N Suspension

Dried Aluminium Hydroxide

200mg + Magnesium Trisilicate

200mg + Magnesium Hydroxide

100mg + Sodium Alginate 100mg

+ Simethicone 25mg, per 5ml

P Suspension for

Oral Use

029/010 Raptakos -Brett Company Ltd,

India

4456 Durasal 4mg Tablets Salbutamol 4mgPOM Tablet Uncoated 029/011 Raptakos -Brett Company Ltd,

India

4457

Norash Cream

Dimethicone 20%w/w + Zinc

Oxide 7.5%w/w + Calamine

1.5%w/w + Cetrimide +

1.125%w/w

GS Cream Topical 029/012 Raptakos -Brett Company Ltd,

India

4458Takol CR 100mg Capsules Tramadol Hydrochloride 100mg

POM Capsule

Sustained

Release

029/013 Raptakos -Brett Company Ltd,

India

4459 Neopeptine CapsulesAlpha Amylase 100mg + Papain

100mg + Simethicone 30mg

P Capsule oral 029/014 Raptakos -Brett Company Ltd,

India

4460 Neopeptine LiquidAlpha Amylase 100mg + Papain

50mg

P Solution for Oral

Use

029/015 Raptakos -Brett Company Ltd,

India

4461 Neopeptine DropsAlpha Amylase 20mg + Papain

10mg

P Solution for Oral

Use

029/016 Raptakos -Brett Company Ltd,

India

4462 Zevac SyrupZinc Acetate USP as Dihydrate

eq. to Elemental Zinc 20mg

POM Syrup 029/017 Raptakos -Brett Company Ltd,

India

4463 Dettol Antiseptic Liquid Chloroxylenol 4.8g, per 100mlGS Solution for

sterilisation

133/008 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4464Strepsils Eucalyptus Menthol Lozenges

Amylmetacresol 0.6mg + 2,4

Dichlorobenzyl Alcohol 1.2 Mg +

Lignocaine 10.0mg

GS Lozenges 133/009 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4465

Strepsils Orange With Vitamin C

Lozenges

Amylmetacresol 0.6mg + 2.4

Dichlorobenzyl Alcohol 1.2mg +

Vitamin C 100mg

GS Lozenges 133/010 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4466Strepsils Original Lozenges

Amylmetacresol 0.6mg + 2,4

Dichlorobenzyl Alcohol 1.2mg,

GS Lozenges 133/011 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4467Strepsils Cool Mint Lozenges

Amylmetacresol 0.6mg + 2,4

Dichlorobenzyl Alcohol 1.2mg

GS Lozenges 133/012 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4468 Nurofen Cold & Flu TabletsIbuprofen 200mg +

Pseudoephedrine 30mg

P Tablet Uncoated 133/013 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4469Nurofen Tablets Ibuprofen 200mg

P Tablet Uncoated 133/014 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

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4470 Mycota Cream 25gZinc Undecenoate 5.0g +

Undecenoic Acid 1.25g

GS Cream Topical 133/015 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4471Transact 12 Hour Patches Flurbiprofen 40mg

P Transdermal

patch

133/016 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4472 Senokot Tablets Sennoside B 7.5mgP Tablet Film

coated

133/017 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4473Strepsils Plus, Anaesthetic lozenges

Amylmetacresol 0.6mg + 2.4

Dichlorobenzyl 1.2mg +

Lignocaine 10.0mg

P Lozenges 133/018 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4474Strepsils Intensive lozenges (Honey &

Lemon)Flurbiprofen 8.75mg

P Lozenges 133/019 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4475Strepsils Intensive Lozenges Flurbiprofen Sodium 8.75mg

P Lozenges 133/020 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4476Nurofen For Children Strawberry

Suspension

Ibuprofen 2% w/v (100mg, per

5ml)

P Solution for Oral

Use

133/021 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4477Nurofen For Children Sugar Free Syrup Ibuprofen 100mg, per 5ml

P Syrup 133/022 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4478 Nurofen 400 Period Pain Tablets Ibuprofen 400mgP Tablet Film

coated

133/023 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4479Gaviscon Double Action Liquid

Sodium Alginate 500mg +

Sodium Bicarbonate 213mg +

Calcium Carbonate 325mg

GS Suspension for

Oral Use

133/024 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4480Gaviscon Double Action Tablet

Sodium Alginate 250mg +

Sodium Bicarbonate 106.05mg

+ Calcium Carbonate 187.50mg

GS Tablet Uncoated 133/025 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4481Nurofen Maximum Strength 684

CapletsIbuprofen Lysin 684mg

P Tablet Film

coated

133/026 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4482Nurofen Tension Headache 342

CapletsIbuprofen Lysin 342mg

P Tablet Film

coated

133/027 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4483 Nurofen Express 400 Liquid Capsules Ibuprofen 400mgP Capsule, Soft 133/028 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4484Gaviscon Double Action Liquid Sachets

Sodium Alginate 500mg +

Sodium Bicarbonate 213mg +

Calcium Carbonate 325mg

GS Suspension for

Oral Use

133/029 Reckitt Benckiser Pharmaceutical

(Pty) Ltd, SA

4485 Disprin 300mg Tablets Aspirin 300mgGS Tablets

Uncoated

133/001 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4486Disprin 500mg Tablets Aspirin 500mg

GS Tablets

Uncoated

133/002 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

Page 221 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4487 Mycota Powder Zinc Undecenoate 20% w/wGS Powder Topical 133/003 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4488Gaviscon Tablets

Alginic Acid 500 + Sodium

Bicarbonate 213mg + Calcium

Carbonate 325.0mg

GS Suspension for

Oral Use

133/004 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4489Gaviscon Original Aniceed

Sodium Algnite 500mg + Sodium

Hydrogen Carbonate 213mg +

Calcium Carbonate 325mg

GS Suspension for

Oral Use

133/005 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4490Gaviscon Peppermint Liquid

Sodium Algnite 500mg + Sodium

Hydrogen Carbonate 213mg +

Calcium Carbonate 325mg

GS Suspension for

Oral Use

133/006 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4491Bonjela Clear Gel

Centalkonium Chloride 0.010%

w/w + Choline Salicylate 8.714 %

w/w

GS Gel Topical 133/007 Reckitt Benkiser Pharmaceuticals

S.A.(Pty) Ltd, South Africa

4492

Delased Chesty Syrup

Diphenhydramine Hydrochloride

BP 14mg + Ammonium Chloride

BP 135mg + Sodium Citrate BP

57mg + Menthol 1.1mg, per 5ml.

P Syrup 205/001 Regal Pharmaceuticals

Limited,Kenya

4493Delased Dry Syrup

Menthol 2mg + Sodium Citrate

57mg + Dextrometherphan

6.5mg + Diphenhydramine 14mg

P Syrup 205/002 Regal Pharmaceuticals

Limited,Kenya

4494

Coldcap Syrup

Chlorpheniramine Maleate BP

2mg + Pseudoephedrine

Hydrochloride BP 10mg +

Paracetamol BP 120mg, per 5ml.

P Syrup 205/003 Regal Pharmaceuticals

Limited,Kenya

4495

Delased Peadiatric Syrup

Diphenhydramine Hydrochloride

BP 7mg + Sodium Citrate BP

28.5mg + Menthol BP 0.55mg,

per 5ml.

P Syrup 205/004 Regal Pharmaceuticals

Limited,Kenya

4496Coldcap Capsules

Phenylephrine 30mg + Caffeine

30mg + Paracetamol 100mg +

Chlorpheniramine 4mg

P Capsule oral 205/005 Regal Pharmaceuticals

Limited,Kenya

4497Whitfield Ointment

Salicylic Acid 30mg + Benzoic

Acid 60mg

P Ointment topical 205/006 Regal Pharmaceuticals

Limited,Kenya

4498 Rinavit Syrup MultivitaminsGS Syrup 205/007 Regal Pharmaceuticals

Limited,Kenya

4499Ibumex Suspension Ibuprofen 100mg, per 5ml

P Suspension for

Oral Use

205/008 Regal Pharmaceuticals

Limited,Kenya

Page 222 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4500 Rinalin Syrup Chlorpheniramine 2mg/5mlP Syrup 205/009 Regal Pharmaceuticals

Limited,Kenya

4501Megayl - 200 Tablets Metronidazole 200mg

POM Tablet Uncoated 205/010 Regal Pharmaceuticals

Limited,Kenya

4502 Cetamol Syrup Paracetamol 120mg, per 5mlGS Syrup 205/011 Regal Pharmaceuticals

Limited,Kenya

4503 Salbutamol Syrup Salbutamol 2mg, per 5mlPOM Syrup 205/012 Regal Pharmaceuticals

Limited,Kenya

4504 Compound Magnesium TabletsAluminium Hydrochloride 125mg

+ Magnesium Trisilicate 250mg

GS Tablet Uncoated 205/013 Regal Pharmaceuticals

Limited,Kenya

4505 Ruben CreamWhite Soft Paraffin + Methyl

Salicylate + Capsicum Oleoresin

P Cream Topical 205/014 Regal Pharmaceuticals

Limited,Kenya

4506 Cetanol Tablets Paracetamol 500mgGS Tablet Uncoated 205/015 Regal Pharmaceuticals

Limited,Kenya

4507 Trimex Mucolytic SyrupSalbutamol 2mg + Bromhexine

4mg + Guanfenesin 100mg

P Syrup 205/016 Regal Pharmaceuticals

Limited,Kenya

4508 Ibumex Tablets Ibuprofen 200mgP Tablet Uncoated 205/017 Regal Pharmaceuticals

Limited,Kenya

4509Intamine Cream Mepyramine 20mg

P Cream Topical 205/018 Regal Pharmaceuticals

Limited,Kenya

4510 Magnomint SuspensionAluminium Hydrochloride 250mg

+ Magnesium Trisilicate 250mg

GS Suspension for

Oral Use

205/019 Regal Pharmaceuticals

Limited,Kenya

4511Intaplex Tablets

Nicotinamide 15mg + Riboflavin

1mg + Thiamine Hydrochloride

1mg

P Tablet Film

coated

205/020 Regal Pharmaceuticals

Limited,Kenya

4512 Unixil Oral SuspensionAmoxicilin Trihydrate Bp 125mg,

per 5ml

POM Powder for Oral

Suspension

205/021 Regal Pharmaceuticals

Limited,Kenya

4513 Cilox Tablets Ofloxacin 200mgPOM Tablet Film

coated

209/001 Remedica Ltd, Cyprus

4514 Alfoxan 250 Capsules Mefenamic Acid 250mg P Capsule oral 209/002 Remedica Ltd, Cyprus

4515 Cyclovax 200 Tablets Acylovir 200mgPOM Tablet Film

coated

209/003 Remedica Ltd, Cyprus

4516 Ibuprofen Tablets Ibuprofen 200mgP Tablet Film

coated

209/004 Remedica Ltd, Cyprus

4517 Korandil 10 Tablets Enalapril 10mg POM Tablet Uncoated 209/005 Remedica Ltd, Cyprus

4518 Nifelat Sr Tablets Nifedipine 20mgPOM Tablet Film

coated

209/006 Remedica Ltd, Cyprus

4519Nifelat 10 Tablets Nifedipine 10mg

POM Tablet Film

coated

209/007 Remedica Ltd, Cyprus

Page 223 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4520 Ova-Mit 50 Tablets Clomifene 50mgPOM Tablet Film

coated

209/008 Remedica Ltd, Cyprus

4521Remethan 25 Tablets Diclofenac 25mg

P Tablet Film

coated

209/009 Remedica Ltd, Cyprus

4522 Roxitan 10 Capsules Piroxicam 10mg POM Capsule oral 209/010 Remedica Ltd, Cyprus

4523 Zindolin 250 Tablets Ciprofloxacin 250mgPOM Tablet Film

coated

209/011 Remedica Ltd, Cyprus

4524 Calcium + Vitamin D TabletsCalcium 1200mg + Vitamin D

3600IU

Pharmacy

Medicine

Tablet Uncoated 367/001L Robinson Pharma, INC

4525 Garlic Oil Soft Gels Garlic Oil 5000mgPharmacy

Medicine

Capsule oral 367/002L Robinson Pharma, INC

4526Multi-Enzyme Complete Tablets

Calcium 110mg + Multi-Enzyme

Blend 430mg

Pharmacy

Medicine

Tablet Uncoated 367/003L Robinson Pharma, INC

4527 Co-Enzyme Q10 Softgels Co-Enzyme Q10 50mgPharmacy

Medicine

Capsule oral 367/004L Robinson Pharma, INC

4528 Women Once A Day Tablets Multivitamins & MineralsPharmacy

Medicine

Tablet Uncoated 367/005L Robinson Pharma, INC

4529Acetyl L - Carnitine Tablets

Calcium Carbinate 150mg +

Alpha Lipoic Acid 200mg +

Acetyl L Carnitine 500mg

Pharmacy

Medicine

Tablet Uncoated 367/006L Robinson Pharma, INC

4530Green Tea Extract Softgels Green Tea Extract 320mg

Pharmacy

Medicine

Capsule oral 367/007L Robinson Pharma, INC

4531 Liquid Absorbable Calcium SoftgelsVitamin D 200iu + Calcium

Carbonate 1000mg

Pharmacy

Medicine

Capsule oral 367/008L Robinson Pharma, INC

4532Beta Carotene Softgels Vitamin A 25000IU

Pharmacy

Medicine

Capsule oral 367/009L Robinson Pharma, INC

4533 Men Daily Tablets Multivitamins & MineralsPharmacy

Medicine

Tablet Uncoated 367/010L Robinson Pharma, INC

4534 Saw Palmetto 450 Capsules Saw Palmetto 450mgPharmacy

Medicine

Capsule oral 367/011L Robinson Pharma, INC

4535 Super B Complex Capsules Vitamin B ComplexPharmacy

Medicine

Capsule oral 367/012L Robinson Pharma, INC

4536 Aloe Vera 25 Softgels Aloe Vera 25mgPharmacy

Medicine

Capsule oral 367/013L Robinson Pharma, INC

4537 Glucosamine Sulphate 1000 Capsules Glucosamine Sulphate 1000mgPharmacy

Medicine

Capsule oral 367/014L Robinson Pharma, INC

4538Melatonin 5 Tablets Melatonin 5mg

Pharmacy

Medicine

Tablet Uncoated 367/015L Robinson Pharma, INC

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4539 Vitamin D 2000IU Softgel Vitamin D 2000IUPharmacy

Medicine

Capsule oral 367/016L Robinson Pharma, INC

4540Resveratrol Complex Capsules Resveratrol Complex 260mg

Pharmacy

Medicine

Capsule oral 367/017L Robinson Pharma, INC

4541 Rubuphine 10 Injection Nelbuphine Hydrochloride 10mgPOM Solution for

Injection

359/001 RUSAN PHARMA LIMITED

4542 Rubuphine 20 Injection Nelbuphine Hydrochloride 20mgPOM Solution for

Injection

359/002 RUSAN PHARMA LIMITED

4543 BP -Care TabletsTelmisartan 20mg + Amlodipine

2.5mg

POM Tablet Uncoated 354/001 S3K Private Limited, India

4544 BP-Care TabletsTelmisartan 40mg + Amlodipine

5mg

POM Tablet Uncoated 354/002 S3K Private Limited, India

4545 GM - Pride TabletsGlimepiride 2mg + Metformin

Hydrochloride 500mg

POM Tablet Film

coated

354/003 S3K Private Limited, India

4546 Safecoat Aspirin 75mg Tablets Aspirin 75mgPOM Tablet Enteric

Coated

354/004 S3K Private Limited, India

4547 Moxypen Capsules Amoxicillin BP 250mgPOM Capsule oral 032/001 SADM Pharmaceuticals Ltd,

Malawi

4548Puromylon Tablets Nalidixic Acid 500mg

POM Tablet Uncoated 032/002 SADM Pharmaceuticals Ltd,

Malawi

4549 Trichozole Tablets Metronidazole 200mgPOM Tablet Uncoated 032/003 SADM Pharmaceuticals Ltd,

Malawi

4550 Len VK TabletsPhenoxymethyl Penicillin BP

250mg

POM Tablet Uncoated 032/004 SADM Pharmaceuticals Ltd,

Malawi

4551 Doxycline CapsulesDoxycycline Hydrochloride BP

100mg

POM Capsule oral 032/005 SADM Pharmaceuticals Ltd,

Malawi

4552 Quinine Tablets Quinine Sulphate 300mgPOM Tablet Enteric

Coated

032/006 SADM Pharmaceuticals Ltd,

Malawi

4553 Pertecillin Capsules Ampicillin 250mgPOM Tablet Uncoated 032/007 SADM Pharmaceuticals Ltd,

Malawi

4554 Trimaprim TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 249/001 Saga Laboratories, India

4555 Flamcid Capsules Indomethacin BP 25mg P Capsule oral 249/002 Saga Laboratories, India

4556 Safexin 500mg CapsulesCephalexin Anhydrous BP

500mg

POM Capsule oral 249/003 Saga Laboratories, India

4557 Q-Bact Tablets Ciprofloxacin USP 500mg POM Tablet Uncoated 249/004 Saga Laboratories, India

4558 Rufen 200 Tablets Ibuprofen 200mg P Tablet Uncoated 249/005 Saga Laboratories, India

4559Rythrocine Tablets Erythromycin Estolate BP 250mg

POM Tablet Uncoated 249/006 Saga Laboratories, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4560 Omecid Capsules Omeprazole 20mg POM Capsule oral 249/007 Saga Laboratories, India

4561 Finapril Tablets Enalapril Maleate 20mg POM Tablet Uncoated 249/008 Saga Laboratories, India

4562 Finapril Tablets Enalapril 10mg POM Tablet Uncoated 249/009 Saga Laboratories, India

4563 Finapril Tablets Enalapril 5mg POM Tablet Uncoated 249/010 Saga Laboratories, India

4564 Hexantel Tablets Pyrantel Pamoate 125mg POM Tablet Uncoated 249/011 Saga Laboratories, India

4565 Eze DT Tablets Cetirizine 10mg POM Tablet Uncoated 249/012 Saga Laboratories, India

4566 Antipress 100 Tablets Atenolol 100mg POM Tablet Uncoated 249/013 Saga Laboratories, India

4567 Antipress 50 Tablets Atenolol 50mg POM Tablet Uncoated 249/014 Saga Laboratories, India

4568 Nifetab 10 Tablets Nifedipine 10mg POM Tablet Uncoated 249/015 Saga Laboratories, India

4569 Nifetab 20 Tablets Nifedipine 20mgPOM Tablet extended

release

249/016 Saga Laboratories, India

4570 Vitarich Tablets Multivitamins + Minerals POM Tablet Uncoated 249/017 Saga Laboratories, India

4571 Allerban Tablets Loratadine 10mg POM Tablet Uncoated 249/018 Saga Laboratories, India

4572 Pyranim Tablets Nimesulide 100mg POM Tablet Uncoated 249/019 Saga Laboratories, India

4573 Piroximicam Tablets Piroxicam 20mg POM Tablet Uncoated 249/020 Saga Laboratories, India

4574 Diarid SuspensionMetronidazole 100mg +

Norfloxacin 100mg, per 5ml

POM Suspension for

Oral Use

249/021 Saga Laboratories, India

4575 ACE Selenium Tablets Vitamin A,C,E With Selenium P Tablet Uncoated 249/022 Saga Laboratories, India

4576 Diarest SuspensionMetronidazole 100mg +

Furazolidone 30mg, per 5ml

POM Suspension for

Oral Use

249/023 Saga Laboratories, India

4577Airmax -Plus Syrup

Ambroxol 15mg + Salbutamol

Sulphate 1mg + Guaphenesin

50mg + Menthol 1mg

POM Syrup 249/024 Saga Laboratories, India

4578 Abvit Drops MultivitaminsGS Solution for Oral

Use

249/025 Saga Laboratories, India

4579

Lamoryl Suspension

Paracetamol 125mg +

Phenylephrine 2.5mg +

Chlopheniramine Maleate 1mg,

per 5ml

P Suspension for

Oral Use

249/026 Saga Laboratories, India

4580 Iburex CapsulesCaffeine 30mg + Paracetamol

325mg + Ibuprofen 200mg

P Capsule oral 249/027 Saga Laboratories, India

4581Hexantel Suspension Pyrantel Pamoate 250mg

POM Suspension for

Oral Use

249/028 Saga Laboratories, India

4582 Lotenz Tablets Lorsartan Potassium 50mg POM Tablet Uncoated 249/029 Saga Laboratories, India

4583 Lotenz-HLorsartan Potassium 50mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 249/030 Saga Laboratories, India

4584Sefixi Injection Ceftriaxone 1g

POM Powder for

Injection

401/001 Sakar Health Care Pvt India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4585 Samero Meropenem 1gPOM Powder for

Injection

401/002 Sakar Health Care Pvt India

4586Silpen -1000 Injection

Impenem 500mg + Cilastatin

500mg

POM Powder for

Injection

401/003 Sakar Health Care Pvt India

4587 Malacur TabletsDihydroartemisinin 40mg +

Piperaquine Phosphate 320mg

POM Tablet Uncoated 350/001 Salvat, SA

4588Malacur Powder For Oral Suspension

Dihydroartemisinin 90mg +

Piperaquine Phosphate 720mg,

per 60ml

POM Powder for Oral

Suspension

350/002 Salvat, SA

4589 Clindahexal 150 CapsulesClindamycin Hydrochloride

150mg

POM Capsule oral 039/033 Sandoz (SA) Limited

4590Rifampicin BP150mg / Isoniazid BP

75mg

Rifampicin 150mg + Isoniazid

75mg

POM Tablet Uncoated 308/001 Sandoz Private Limited,India

4591Rimstar -4-FDC Tablets

Rifampicin + Isoniazide +

Pyrazinamide + Ethambutol

Hydrochloride

POM Tablet Uncoated 308/002 Sandoz Private Limited,India

4592 ACC 200 Effevescent Tablets n- Acetylcysteine 200mgp Tablet

Effervescent

039/001 Sandoz Pvt Limited, S.A

4593 ACC 600 Effervescent Tablets n- Acetylcysteine 600mgP Tablet

Effervescent

039/002 Sandoz Pvt Limited, S.A

4594 Clatax 0.5g Injection Cefotaxime 0.5gPOM Powder for

Injection

039/003 Sandoz Pvt Limited, S.A

4595Clatax 1.0g Injection Cefotaxime 1.0g

POM Powder for

Injection

039/004 Sandoz Pvt Limited, S.A

4596Kefzol 500 Powder for Injection Cefazolin 500mg

POM Powder for

Injection

039/005 Sandoz Pvt Limited, S.A

4597 Kefzol 1g Powder for Injection Cefazolin 1gPOM Powder for

Injection

039/006 Sandoz Pvt Limited, S.A

4598 Lopedium Effevescent Tablets Loperamide 2mgPOM Tablet

Effervescent

039/007 Sandoz Pvt Limited, S.A

4599Sandoz Co Amoxyclav 0.6g /20ml

Injection

Amoxycillin 500mg + Clavulanate

100mg

POM Powder for

Injection

039/008 Sandoz Pvt Limited, S.A

4600Sandoz Co Amoxyclav 1.2g/20ml

Injection

Amoxycillin 1000mg +

Clavulanate 200mg

POM Powder for

Injection

039/009 Sandoz Pvt Limited, S.A

4601 Sandoz Co Amoxyclav 625mg TabletsAmoxicillin 500mg + Clavulanate

125mg

POM Tablet Film

coated

039/011 Sandoz Pvt Limited, S.A

4602Sandoz Co Amoxuclav 1000 Tablets

Amoxycillin 875mg + Clavulanate

125mg

POM Tablet Film

coated

039/012 Sandoz Pvt Limited, S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4603 Sandoz Co Amoxyclav BD SuspensionAmoxycillin 400mg + Clavulanate

57mg

POM Powder for Oral

Suspension

039/013 Sandoz Pvt Limited, S.A

4604Sandoz Co Amoxyclav S Suspension

Amoxycillin 125mg + Clavulanate

31.25mg

POM Powder for Oral

Suspension

039/014 Sandoz Pvt Limited, S.A

4605 Sandoz Co- Amoxyclav SF SuspensionAmoxycillin 250mg + Clavulanate

62.5mg, per 5ml

POM Powder for Oral

Suspension

039/015 Sandoz Pvt Limited, S.A

4606Sandoz Carbamezapine CR 200

TabletsCarbamezapine 200mg

POM Tablet delayed

Release

039/016 Sandoz Pvt Limited, S.A

4607Sandoz Carbamezapine CR 400mg

TabletsCarbamezapine 400mg

POM Tablet delayed

Release

039/017 Sandoz Pvt Limited, S.A

4608 Tramhexal Capsules Tramadol 50mg POM Capsule oral 039/018 Sandoz Pvt Limited, S.A

4609Tramhexal 100mg/2ml Injections Tramadol 100mg per 2ml

POM Solution for

Injection

039/019 Sandoz Pvt Limited, S.A

4610 Sandoz Atorvastatin 10 Tablets Atorvastalin 10mg POM Tablet Uncoated 039/020 Sandoz Pvt Limited, S.A

4611 Sandoz Atorvastatin 20 Tablets Atorvastalin 20mg POM Tablet Uncoated 039/021 Sandoz Pvt Limited, S.A

4612 Sandoz Atorvastatin 40 Tablets Atorvastalin 40mg POM Tablet Uncoated 039/022 Sandoz Pvt Limited, S.A

4613 Sandoz Atorvastatin 80 Tablets Atorvastalin 80mg POM Tablet Uncoated 039/023 Sandoz Pvt Limited, S.A

4614 Hexal - MPA 10 Tablets Medroxyprogesterone 10mg POM Tablet Uncoated 039/026 Sandoz Pvt Limited, S.A

4615 Hexal - MPA 5 Tablets Medroxyprogesterone 5mg POM Tablet Uncoated 039/027 Sandoz Pvt Limited, S.A

4616 Terbane 250mg Tablets Terbinafine 250mg POM Tablet Uncoated 039/028 Sandoz Pvt Limited, S.A

4617 Terbane 10mg Cream Terbinafine 10mg POM Cream Topical 039/029 Sandoz Pvt Limited, S.A

4618 Los -Arb Comp 100 TabletsLorsartan Potassium 100mg +

Hydrochlorothiazide 25mg

POM Tablet Uncoated 039/031 Sandoz Pvt Limited, S.A

4619Los -Arb Comp 50 Tablets

Lorsartan Potassium 50mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 039/032 Sandoz Pvt Limited, S.A

4620Capectabine Sandoz 500 Film Coated

TabletsCapacetabine 500mg

POM Tablet Film

coated

039/034 Sandoz Pvt Limited, S.A

4621Capectabine Sandoz 150 Film Coated

TabletsCapacetabine 150mg

POM Tablet Film

coated

039/035 Sandoz Pvt Limited, S.A

4622 Epipro 300 CR Tablets Sodium Valproate 300mgPOM Tablet Modified

Release

039/036 Sandoz Pvt Limited, S.A

4623Epipro 500 CR Tablets Sodium Valproate 500mg

POM Tablet Modified

Release

039/037 Sandoz Pvt Limited, S.A

4624 Gentamycin 80mg per 2ml InjectionGentamycin Suliphate 80mg per

2ml

POM Solution for

Injection

039/038 Sandoz Pvt Limited, S.A

4625 Hexal - Lisinopril 5 Tablets Lisinopril Dihydrate 5mg POM Tablet Uncoated 039/039 Sandoz Pvt Limited, S.A

4626 Hexal - Lisinopril 10 Tabletrs Lisinopril Dihydrate 10mg POM Tablet Uncoated 039/040 Sandoz Pvt Limited, S.A

4627 Hexal - Lisinopril 20 Tablets Lisinopril Dihydrate 20mg POM Tablet Uncoated 039/041 Sandoz Pvt Limited, S.A

4628 HR-Enalapril Maleate 5 Tablets Enalapril Maleate 5mg POM Tablet Uncoated 039/042 Sandoz Pvt Limited, S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4629 HR-Enalapril Maleate 10 Tablets Enalapril Maleate 10mg POM Tablet Uncoated 039/043 Sandoz Pvt Limited, S.A

4630 HR-Enalapril Maleate 20 Tablets Enalapril Maleate 20mg POM Tablet Uncoated 039/044 Sandoz Pvt Limited, S.A

4631 Pixicam 20 Tablets Piroxicam 20mg P Tablet Uncoated 039/045 Sandoz Pvt Limited, S.A

4632 Vancocin CP 1g Injection Vancomycin Hydrochloride 1gPOM Powder for

Injection

039/046 Sandoz Pvt Limited, S.A

4633 Vancocin CP 500 InjectionVancomycin Hydrochloride

500mg

POM Powder for

Injection

039/047 Sandoz Pvt Limited, S.A

4634 Zomevak 80 Tablets Valsartan 80mg POM Tablet Uncoated 039/048 Sandoz Pvt Limited, S.A

4635 Zomevak 160 Tablets Valsartan 160mg POM Tablet Uncoated 039/049 Sandoz Pvt Limited, S.A

4636 Sandoz Levofloxacin 500 Tablets Levofloxacin Hemihydrate 500mgPOM Tablet Film

coated

039/050 Sandoz Pvt Limited, S.A

4637 Sandoz Isosorbide Dinitrate 30 Tablets Isorsorbide Dinitrate 30mg POM Tablet Uncoated 039/051 Sandoz Pvt Limited, S.A

4638 Cetirizine HEXAL -1 SyrupCetirizine Dihydrochloride 10mg

per 5ml

P Solution for Oral

Use

039/052 Sandoz Pvt Limited, S.A

4639 Cetirizine Hexal 10 Tablets Cetirizine Hydrochloride 10mgP Solution for Oral

Use

039/053 Sandoz Pvt Limited, S.A

4640 Dantron 4mg Injection Ondansetron Hydrochloride 4mgPOM Solution for

Injection

039/054 Sandoz Pvt Limited, S.A

4641 Dantron 8mg InjectionOndansetron Hydrochloride

Dihydrate 8mg

POM Solution for

infusion

039/055 Sandoz Pvt Limited, S.A

4642 Dantron 4mg TabletsOndansetron Hydrochloride

Dihydrate 4mg

POM Tablet Uncoated 039/056 Sandoz Pvt Limited, S.A

4643Doxorubicin Hexal 10mg/5ml Infusion

Doxorubicin Hydrochloride 10mg,

per 5ml

POM Solution for

infusion

039/057 Sandoz Pvt Limited, S.A

4644Sandoz Isorsobide Dinitrate 5

Sublingual TabletIsorsobide Dinitrate 5 Mg

POM Tablet

Sublingual

039/058 Sandoz Pvt Limited, S.A

4645 Sandoz Isorsobide Dinitrate 30 Tablet Isorsobide Dinitrate 30 Mg POM Tablet Uncoated 039/059 Sandoz Pvt Limited, S.A

4646Doxorubicin Hexal 50mg, per 25ml

Infusion

Doxorubicin Hydrochloride 50mg,

per 25ml

POM Solution for

infusion

039/060 Sandoz Pvt Limited, S.A

4647 Lorano Tablets Loratadine 10mg P Tablet Uncoated 039/061 Sandoz Pvt Limited, S.A

4648 Clenil AQ Nasal SprayBeclomethasone Dipropionate

50mcg

POM Solution for

Inhalation

039/062 Sandoz Pvt Limited, S.A

4649 Clomihexal Tablets Clomiphene Citrate 50mg POM Tablet Uncoated 039/063 Sandoz Pvt Limited, S.A

4650 Oxiceb 100 Mg Capsules Celecoxib 100mg POM Capsules oral 039/084 Sandoz Pvt Limited, S.A

4651 Oxiceb 200 Mg Capsules Celecoxib 200mg POM Capsules oral 039/085 Sandoz Pvt Limited, S.A

4652Airflusal Forspiro

Salmeterol Xinafoate 50µg +

Fluticasone Propionate 250µg

POM Inhaler 039/086 Sandoz Pvt Limited, S.A

4653Airflusal Forspiro

Salmeterol Xinafoate 50mcg +

Fluticasone Propionate 500mcg

POM Inhaler 039/087 Sandoz Pvt Limited, S.A

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4654Salbutamol Sandoz 100 µg, per Dose

Pressurised InhalationSalbutamol 100 µg, per Dose

POM Inhaler 039/088 Sandoz Pvt Limited, S.A

4655Mometasone Sandoz 50

Mometasone Furoate

Monohydrate 50mg, per 1 Dose

POM Inhaler 039/089 Sandoz Pvt Limited, S.A

4656 Metformin 1000 Film Coated Tablets Metformin Hydrochloride 1000mgPOM Tablet Film

coated

039/090 Sandoz Pvt Limited, S.A

4657 Metformin 500 Film Coated Tablets Metformin Hydrochloride 500mgPOM Tablet Film

coated

039/091 Sandoz Pvt Limited, S.A

4658 Anastrozole Sandoz 1mg Tablets Anastrozole 1mgPOM Tablet Film

coated

039/092 Sandoz Pvt Limited, S.A

4659 Fenahex 20 mg Tamoxifen Citrate 20 mg POM Tablet Uncoated 039/093 Sandoz Pvt Limited, S.A

4660Simvastatin 20 mg Simvastatin 20 mg

POM Tablet Film

coated

039/094 Sandoz Pvt Limited, S.A

4661 Simvastatin 40 mg Simvastatin 40 mgPOM Tablet Film

coated

039/095 Sandoz Pvt Limited, S.A

4662 Ospamox 1000 Tablets Amoxicillin Trihydrate 1000mg POM Tablet Uncoated 039/096 Sandoz Pvt Limited, S.A

4663 Ospamox 500 Tablets Amoxicillin 500mg POM Tablet Uncoated 039/097 Sandoz Pvt Limited, S.A

4664 Voriconazole Sandoz 50 Tablets Voriconazole 50mg POM Tablet Uncoated 039/098 Sandoz Pvt Limited, S.A

4665 Nexmezol 20 Esomeprazole 20mg POM Tablet Uncoated 039/099 Sandoz Pvt Limited, S.A

4666 Nexmezol 40 Esomeprazole 40mg POM Tablet Uncoated 039/100 Sandoz Pvt Limited, S.A

4667 Deslatyne 5 Tablets Desloratidine 5mg POM Tablet Uncoated 039/101 Sandoz Pvt Limited, S.A

4668 Furose 40 Tablets Frusemide 40mg POM Tabet Uncoated 039/102 Sandoz Pvt Limited, S.A

4669Topraflux 40 IVI Injection

Pantoprazole Sodium

Sesquihydrate BP 40mg

POM Solution for

Injection

039/103 Sandoz Pvt Limited, S.A

4670 Amlodipine 5 mg Amlodipine 5 mg POM Tablet Uncoated 039/104 Sandoz Pvt Limited, S.A

4671 Amlodipine 10 mg Amlodipine 10 mg POM Tablet Uncoated 039/105 Sandoz Pvt Limited, S.A

4672 Sandaz Azithromycin 500 Tablets Azithromycin 500mg POM Tablet Uncoated 039/106 Sandoz Pvt Limited, S.A

4673 Azithromycin 200 Sandoz Syrup Azithromycin 200mgPOM Solution for Oral

Use039/107 Sandoz Pvt Limited, S.A

4674 Voriconazole Sandoz 200 Tablets Voriconazole 200mgPOM Tablet Film

Coated039/108 Sandoz Pvt Limited, S.A

4675 Sandoz Co Amoxyclav 375 TabletsAmoxycillin 250mg +

Clavulanate 125mg

POM Tablet Film

coated

039/010 Sandoz Pvt Limited, South Africa

4676 Bisohexal 10 Tablets Bisoprolol 10mg POM Tablet Uncoated 039/024 Sandoz Pvt Limited, South Africa

4677 Bisohexal 5 Tablets Bisoprolol 5mg POM Tablet Uncoated 039/025 Sandoz Pvt Limited, South Africa

4678 Sintrine 5 Chewable Tablets Montelukast Sodium BP 5mg POM Tablet Chewable 039/064 Sandoz Pvt Limited, South Africa

4679 Sintrine 10 Chewable Tablets Montelukast Sodium BP 10mg POM Tablet Chewable 039/065 Sandoz Pvt Limited, South Africa

4680Dantron 8 Tablets

Ondansetron Hydrochloride

Dihydrate 8mg

POM Tablet Uncoated 039/066 Sandoz Pvt Limited, South Africa

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4681 Hexaide 25mg Tablets Hydrochlorothiazide 25mgPOM Tablet Film

coated

039/067 Sandoz Pvt Limited, South Africa

4682 Coughspan Dried Ivy Leaves 0.9g P Syrup 039/068 Sandoz Pvt Limited, South Africa

4683 Curitaz 4,5 Infusion PowderPiperacilline 4g + Tozobactam

0.5g

POM Powder for

Injection

039/069 Sandoz Pvt Limited, South Africa

4684 Linex CapsulesBifidobacterium Animalis Sub

Spp. 280mg

P Capsule oral 039/070 Sandoz Pvt Limited, South Africa

4685 Linex Baby SachetsBifidobacterium Animalis Sub

Spp. 100mg

P Granules for

Suspension

039/071 Sandoz Pvt Limited, South Africa

4686 Gemcitabine Ebewe InjectionGemcitabine Hydrochloride

10mg, per ml

POM Solution for

Injection

039/076 Sandoz Pvt Limited, South Africa

4687 Probitor 40 Capsules Omeprazole 40mg POM Capsule oral 039/077 Sandoz Pvt Limited, South Africa

4688Sandoz - Isosorbide Dinitrate 5

Sublingual TabletsIsorsorbide Dinitrate 5mg

POM Tablet

Sublingual

039/078 Sandoz Pvt Limited, South Africa

4689 Sandoz Isosorbide dinitrate 10 tablets Isorsorbide Dinitrate 10mg POM Tablet Uncoated 039/079 Sandoz Pvt Limited, South Africa

4690Sandoz Levofloxacin 250 tablets Levofloxacin Hemihydrate 250mg

POM Tablet Film

coated

039/080 Sandoz Pvt Limited, South Africa

4691 Bromaze 6 tablets Bromazepam 6mg POM Tablet Uncoated 039/081 Sandoz Pvt Limited, South Africa

4692 Bacitracin Zinc + Neomycin SulphateBacitracin Zinc 5000IU +

Neomycin Sulphate 250mg

POM Powder for

Topical use

039/082 Sandoz Pvt Limited, South Africa

4693Dozalgic C Sachets

Paracetamol 500mg + Ascorbic

Acid 300mg

P Powder for Oral

Solution

039/083 Sandoz Pvt Limited, South Africa

4694 Phenergan 10mg Tablets Promethazine 10mgPharmacy

Medicine

Tablets 175/001 Sanofi Aventis Pharma Limited

4695Phenergan 25 Tablets Promethazine 25mg

P Tablet Film

coated

175/002 Sanofi Aventis Pharma Limited

4696 Phenergan Elixir Promethazine 5mg, per 5ml P Elixir 175/003 Sanofi Aventis Pharma Limited

4697 Tritace 5 Tablets Ramipril 5mg POM Tablet Uncoated 175/004 Sanofi Aventis Pharma Limited

4698 Tritace 2.5 Tablets Ramipril 2.5mg POM Tablet Uncoated 175/005 Sanofi Aventis Pharma Limited

4699 Largactil 100mg Tablets Chlorpromazine 100mg POM Tablet Uncoated 175/006 Sanofi Aventis Pharma Limited

4700 Largactil Injection Chlorpromazine 50mg, per 2mlPOM Solution for

Injection

175/007 Sanofi Aventis Pharma Limited

4701 Largactil 25 Tablets Chlorpromazine 25mgPOM Tablet Film

coated

175/008 Sanofi Aventis Pharma Limited

4702 Stemetil InjectionProchlorperazine Mesylate

12.5mg, per ml

POM Solution for

Injection

175/009 Sanofi Aventis Pharma Limited

4703Stemitil 5 Tablets

Prochloperazine Mesylate BP

5mg

POM Tablet Uncoated 175/010 Sanofi Aventis Pharma Limited

4704 Flagyl Suppository Metronidazole 1g POM Suppository 175/011 Sanofi Aventis Pharma Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4705 Flagyl 400 Tablets Metronidazole 400mg POM Tablet Uncoated 175/012 Sanofi Aventis Pharma Limited

4706 Flagyl 200 Tablets Metronidazole 200mg POM Tablet Uncoated 175/013 Sanofi Aventis Pharma Limited

4707 Amaryl 4 Tablets Glimepiride 4mg POM Tablet Uncoated 175/014 Sanofi Aventis Pharma Limited

4708 Amaryl 2 Tablets Glimepiride 2mg POM Tablet Uncoated 175/015 Sanofi Aventis Pharma Limited

4709 Amaryl 1 Tablets Glimepiride 1mg POM Tablet Uncoated 175/016 Sanofi Aventis Pharma Limited

4710 Flagyl Injection Metronidazole 500mg, per 100mlPOM Solution for

Injection

175/017 Sanofi Aventis Pharma Limited

4711 Clexane 20 Injection Enoxaparin 20mg, per 0.2mlPOM Solution for

Injection

175/018 Sanofi Aventis Pharma Limited

4712 Clexane 60 Injection Enoxaparin 60mg, per 0.6mlPOM Solution for

Injection

175/019 Sanofi Aventis Pharma Limited

4713 Clexane 40 Injection Enoxaparin 40mg, per 0.4mlPOM Solution for

Injection

175/020 Sanofi Aventis Pharma Limited

4714Clexane 80 Injection Enoxaparin 80mg, per 0.8ml

POM Solution for

Injection

175/021 Sanofi Aventis Pharma Limited

4715Amaryl-M 1mg/250mg Tablets

Glimepiride 1mg + Metformin

Hydrochloride 250mg

POM Tablet Uncoated 175/022 Sanofi Aventis Pharma Limited

4716 Amaryl-M 2mg/500mg TabletsGlimepiride 2mg + Metformin

Hydrochloride 500mg

POM Tablet Uncoated 175/023 Sanofi Aventis Pharma Limited

4717 Xatral 10mg Tablets Alfuzosin 10mg POM Tablet Uncoated 175/024 Sanofi Aventis Pharma Limited

4718 Xatral 2.5mg Tablets Alfuzosin 2.5mg POM Tablet Uncoated 175/025 Sanofi Aventis Pharma Limited

4719 Daonil Tablets Glibenclamide 5mg POM Tablet Uncoated 175/026 Sanofi Aventis Pharma Limited

4720Artesunate 25mg/Amodiaquine 67.5mg

Tablets

Artesunate 25mg + Amodiaquine

67.5mg

POM Tablet Uncoated 175/027 Sanofi Aventis Pharma Limited

4721 Coarsucam 25mg/67.5mg TabletsArtesunate 25mg + Amodiaquine

67.5mg

POM Tablet Uncoated 175/028 Sanofi Aventis Pharma Limited

4722Artesunate 50mg/Amodiaquine135mg

Tablets

Artesunate 50mg + Amodiaquine

135mg

POM Tablet Uncoated 175/029 Sanofi Aventis Pharma Limited

4723 Coarsucam 50mg/135mg TabletsArtesunate 50mg + Amodiaquine

135mg

POM Tablet Uncoated 175/030 Sanofi Aventis Pharma Limited

4724 Coarsucam 100mg/270 Mg TabletsArtesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 175/031 Sanofi Aventis Pharma Limited

4725Artesunate 100/270 Amodiaquine

Tablets

Artesunate 100mg +

Amodiaquine 270mg

POM Tablet Uncoated 175/032 Sanofi Aventis Pharma Limited

4726 Tritace 10mg Capsules Ramipril 10mg POM Tablet Uncoated 175/033 Sanofi Aventis Pharma Limited

4727Epilim CR 500 Tablets Sodium Valproate 500mg

POM Tablet Modified

Release

175/034 Sanofi Aventis Pharma Limited

4728Epilim CR 300 Tablets Sodium Valproate 300mg

POM Tablet Modified

Release

175/035 Sanofi Aventis Pharma Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4729

Imovax Polio Vaccine

In Activated Polio Virus Type 1 (

Mahoney) 40 Units + Type 2(Mef-

1) 8 Units + Type 3 (Saukett) 32

Units

POM Suspension for

Injection

175/036 Sanofi Aventis Pharma Limited

4730 Shancol VaccineVibrio Cholerae Straines (Oral

Cholera Vaccine)

POM Powder for

Injection

175/037 Sanofi Aventis Pharma Limited

4731 Fluconazole 150 Tablets Fluconazole 150mg POM Tablets 175/038 Sanofi Aventis Pharma Limited

4732Taxotere Injection Docetaxel BP 20mg, per ml

POM Powder for

Injection

175/039 Sanofi Aventis Pharma Limited

4733 Taxotere RTU 80mg/4ml Injection Docetaxel 80mg, per 4mlPOM Solution for

infusion

175/040 Sanofi Aventis Pharma Limited

4734Allstar Reusable Insulin Delivery

DeviceMedical Device P Medical Device 175/041L Sanofi Aventis Pharma Limited

4735 Calbio 200 Nasal Spray Calcitonin 200IU POM Spray , Eye Use 313/001 SAVA Medica Limited, India

4736 Azi Bio 500 Tablets Azithromycin Dihydrate 500mg POM Tablet Uncoated 313/002 SAVA Medica Limited, India

4737Azi Bio Suspension Azithromycin 200mg, per 5ml

POM Suspension for

Oral Use

313/003 SAVA Medica Limited, India

4738Biomist NS 0.1 Nasal Spray

Xylometazoline Hydrochloride

0.1%

POM Spray For Nasal

Use

313/004 SAVA Medica Limited, India

4739 Biomist NS 0.05 Nasal SprayXylometazoline Hydrochloride

0.05%

POM Spray For Nasal

Use

313/005 SAVA Medica Limited, India

4740 Flutiair 0.05 Nasal Spray Fluticasone Propionate 0.05%POM Spray For Nasal

Use

313/006 SAVA Medica Limited, India

4741 Flutiair -S 250 Powder for InhalationSalmeterol 50mcg +

Fluticasone250mcg

POM Powder for

Inhalation

313/007 SAVA Medica Limited, India

4742 Rozatin - 10 Tablets Rosuvastatin 10mg POM Tablet Uncoated 313/008 SAVA Medica Limited, India

4743 Rozatin -20 Tablets Rosuvastatin 20mg POM Tablet Uncoated 313/009 SAVA Medica Limited, India

4744 Esaktive 40 Tablets Esomeprazole 40mg POM Tablet Uncoated 313/010 SAVA Medica Limited, India

4745Momenap Ns 0.05 Nasal Spray Mometasone Furoate 0.05%

POM Spray For Nasal

Use

313/011 SAVA Medica Limited, India

4746 Nystanova Pessaries Nystatin 100,000 I.U. POM Tablet Vaginal 035/003 Scanpharm A/S, Denmark

4747 Viminova Drops Multivitamin Mineral Drops GS Solution for Oral

Use

035/013 Scanpharm A/S, Denmark

4748 Spasmonova Injection Hyoscine Butyl BromidePOM Solution for

Injection

035/021 Scanpharm A/S, Denmark

4749 Ergonova Injection Ergometrine InjectionPOM Solution for

Injection

035/028 Scanpharm A/S, Denmark

4750Oxy Ergonova Injection Ergotocin Maleate

POM Solution for

Injection

035/029 Scanpharm A/S, Denmark

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4751 Mezonova Suspension Trichozol SyrupPOM Suspension for

Oral Use

035/033 Scanpharm A/S, Denmark

4752 Neo-Polynova Ear/Eye Drops Combination POM Ear/Eye Drops 035/034 Scanpharm A/S, Denmark

4753 Gyno-Nova Pesseries Clotrimazole 100mg POM Tablet Vaginal 035/043 Scanpharm A/S, Denmark

4754 Pregnatal TabletsVitamins + Minerals + Amino

Acids

POM Tablet Uncoated 035/042 Scanpharm A/S, Denmark

4755 Dexanova InjectionDexamethasone Sodium

Phosphate 5mg, per ml

POM Solution for

Injection

035/044 Scanpharm A/S, Denmark

4756 Oxytocin Injection Oxytocin 10mgPOM Solution for

Injection

035/045 Scanpharm A/S, Denmark

4757 Cloronova Ear Drops Chlororamphenical 1% POM Ear Drops 035/047 Scanpharm A/S, Denmark

4758 Cloronova Eye Drops Chlororamphenical 1% POM Eye Drops 035/048 Scanpharm A/S, Denmark

4759 Viminova Tablets Multivitamins GS Tablet Uncoated 035/049 Scanpharm A/S, Denmark

4760 Viminova Syrup Multivitamins P Syrup 035/051 Scanpharm A/S, Denmark

4761 Vitalinova Tonic Multivitamins P Syrup 035/052 Scanpharm A/S, Denmark

4762 Claritine Tablets Loratidine 10mgPOM Tablet Uncoated 042/002 Schering-Plough Labo N.V,

Belgium

4763Elocom Cream Mometasone 0.1%

POM Cream Topical 042/003 Schering-Plough Labo N.V,

Belgium

4764 Elocom Lotion Mometasone 0.1%POM Lotion for

Topical Use

042/004 Schering-Plough Labo N.V,

Belgium

4765 Elocom Ointment Mometasone 0.1%POM Ointment topical 042/005 Schering-Plough Labo N.V,

Belgium

4766Peg-Intron 50mcg Injection Peg-Inteferon Alfa-2b 50mcg

POM Suspension for

Injection

042/006 Schering-Plough Labo N.V,

Belgium

4767 Peg-Intron 80mcg Injection Peg-Inteferon Alfa-2b 80mcgPOM Suspension for

Injection

042/007 Schering-Plough Labo N.V,

Belgium

4768 Peg-Intron 100mcg Injection Peg-Inteferon Alfa-2b 100mcgPOM Suspension for

Injection

042/008 Schering-Plough Labo N.V,

Belgium

4769 Peg-Intron 120mcg Injection Peg-Inteferon Alfa-2b 120mcgPOM Suspension for

Injection

042/009 Schering-Plough Labo N.V,

Belgium

4770Peg-Intron 150mcg Injection Peg-Inteferon Alfa-2b 150mcg

POM Suspension for

Injection

042/010 Schering-Plough Labo N.V,

Belgium

4771Ramicade Injection Infliximab 100mg

POM Powder for

Injection

042/011 Schering-Plough Labo N.V,

Belgium

4772 Intron A Solution 18 IU Interferon Alfa 2b 18M.I.UPOM Solution for

Injection

042/012 Schering-Plough Labo N.V,

Belgium

4773Intron A Solution 25 IU Interferon Alfa 2b 25M.I.U

POM Solution for

Injection

042/013 Schering-Plough Labo N.V,

Belgium

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4774 Caelyx Injection Doxorubicin 2mg, per mlPOM Suspension for

Injection

042/015 Schering-Plough Labo N.V,

Belgium

4775Nasonex Aqueous Nasal Spray Mometasone

POM Spray For Nasal

Use

042/016 Schering-Plough Labo N.V,

Belgium

4776 Temodal 5mg Capsules Temozolomide 5mgPOM Capsule oral 042/017 Schering-Plough Labo N.V,

Belgium

4777 Temodal 20mg Capsules Temozolomide 20mgPOM Capsule oral 042/018 Schering-Plough Labo N.V,

Belgium

4778 Temodal100mg Capsules Temozolomide 100mgPOM Capsule oral 042/019 Schering-Plough Labo N.V,

Belgium

4779 Temodal 250 Mg Capsules Temozolomide 250mgPOM Capsule oral 042/020 Schering-Plough Labo N.V,

Belgium

4780 Aerius Syrup Des-Loratadine 0.5mg, per mlPOM Syrup 042/021 Schering-Plough Labo N.V,

Belgium

4781 Aerius Tablets Des-Loratadine 5mgPOM Tablet Uncoated 042/022 Schering-Plough Labo N.V,

Belgium

4782Diprofos Injection

Betamethasone Dipropionate

5mg+Betamethasone Sodium

Sulphate 2.5mg

POM Injection 042/023 Schering-Plough Labo N.V,

Belgium

4783 Celestamine TabletsBetamethasone 0.25mg +

Dexchlorpheniramine 2mg

POM Tablet Uncoated 042/024 Schering-Plough Labo N.V,

Belgium

4784 Esmeron Injection Rocuronium 10mg, per mlPOM Solution for

Injection

042/025 Schering-Plough Labo N.V,

Belgium

4785Octenisept Solution

Ocetinidine Dihydrochloride

0.1%w/v + Phenoxy Ethanol

2.0%w/v

P Solution for Oral

Use

321/001L Schulke & Mayr GBMH, Germany

4786 Lignospan Special InjectionLidocaine Hydrochloride 2% +

1:80,000 Adrenaline Tartrate

POM Solution for

Injection

319/001 Septodont, France

4787SII Polyvalent Anti -Snake Venom

InjectionPolyvalent Anti Snake Serum

POM Solution for

Injection

035/002 Serum Institute of India

4788 Sicriptin Tablets Bromocriptine Mesylate 2.5mg POM Tablet Uncoated 053/001 Serum Institute of India

4789Hepatitis B Vaccine (rDNA) Injection Hepatitis B Vaccine

POM Suspension for

Injection

053/003 Serum Institute of India

4790S11 Rabivax- Liquid (Rabies Vaccine

USP)

Rabies Vaccine, Human I.P.

(Liquid)

POM Suspension for

Injection

053/004 Serum Institute of India

4791Measles Vaccine, Live, Attenuated

(Freeze Dried) Injection

1000 CCID50 Of Live Measles

Virus Particles, per 0.5ml

POM Suspension for

Injection

053/005 Serum Institute of India

Page 235 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4792

Rubella Vaccine/Mumps

Vaccine/Measles Vaccine,

Live,Atten.(Freeze Dried

Rubella Vaccine 1000 Ccid50 +

Mumps 5000 Ccid50 + Measles

1000 Ccid50, Per 0.5ml

POM Suspension for

Injection

053/006 Serum Institute of India

4793Vincristine Sulphate BP (Lyophilised)

InjectionVincristine 1mg, per Vial

POM Powder for

Injection

053/007 Serum Institute of India

4794 Cisplatin BP Injection Cisplatin 1mg, per mlPOM Powder for

Injection

053/008 Serum Institute of India

4795 Tetanus Antitoxin BP Injection Tetanus AntitoxinPOM Suspension for

Injection

053/009 Serum Institute of India

4796Tetanus Toxoid Vaccine adsorbed

InjectionTetanus Toxoid 1500IU

POM Suspension for

Injection

053/010 Serum Institute of India

4797Diptheria-Tetanus-Pertusis Vaccine

adsorbed Injection

Diptheria 30IU + Tetanus 40IU +

Pertusis 4IU

POM Suspension for

Injection

053/011 Serum Institute of India

4798Measles and Rubella Vacine Live

Measles And Rubella Vaccine

Live

POM Lyophilised

Powder for

Injection

053/012 Serum Institute of India

4799Seven Seas Orange Syrup + Cod Liver

OilCod Liver Oil + Vitamins

GS Syrup 154/001 Seven Seas Ltd, England

4800Seven Seas One A Day Pure Cod Liver

Oil + Vitamin CapsulesCod Liver Oil + Vitamins

GS Capsule oral 154/003 Seven Seas Ltd, England

4801Seven Seas Cherry Flavoured Cod

Liver LiquidCod Liver Oil + Vitamins

GS Syrup 154/004 Seven Seas Ltd, England

4802Seven Seas One A Day Cod Liver Oil +

Evening Primrose Capsules

Cod Liver Oil + Evening

Primerose

GS Capsule oral 154/007 Seven Seas Ltd, England

4803Seven Seas One A Day Odourless

Garlic Pearls Capsules Garlic Oil 6mg

GS Capsule oral 154/008 Seven Seas Ltd, England

4804Seven Seas One A Day Cod Liver Oil +

Glusamine Capsules

Cod Liver Oil + Glusamine

1500mg

GS Capsule oral 154/011 Seven Seas Ltd, England

4805Seven Seas Multivitamins + Minerals

CapsulesMinerals + Multivitamins

P Capsule oral 154/013 Seven Seas Ltd, England

4806 Minadex Tonic Vitamins + Minerals GS Syrup 154/019 Seven Seas Ltd, England

4807 Diproson Cream Betamethasone 0.05% POM Cream Topical 057/034 Shalina Healthcare Limited, UAE

4808Alcozyme Xp Syrup

Cetirizine 5mg + Bromhexine

4mg + Ammonium Chloride

125mg

P Syrup 075/001 Shalina Healthcare Limited, UAE

4809Shaltoux Syrup

Salbutamol 2mg + Bromhexine

4mg + Guaiphenesin 100mg +

Menthol 1mg

POM Syrup 075/002 Shalina Healthcare Limited, UAE

4810 Ketazol Shampoo Ketoconazole 2%w/w POM Shampoo 075/003 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4811Polygel Suspension

Dimethicone 50mg + Magnesium

Hydroxide 250mg + Dried

Aluminium Hydroxide 250mg

P Suspension for

Oral Use

075/004 Shalina Healthcare Limited, UAE

4812Polygel Mango Suspension

Dimethicone 50mg + Magnesium

Hydroxide 250mg + Dried

Aluminium Hydroxide 250mg

P Syrup 075/005 Shalina Healthcare Limited, UAE

4813Polygel Mint Suspension

Dimethicone 50mg + Magnesium

Hydroxide 250mg + Dried

Aluminium Hydroxide 250mg

P Suspension for

Oral Use

075/006 Shalina Healthcare Limited, UAE

4814 Floxan 250mg Tablets Ofloxacin 250mg POM Tablet Uncoated 075/007 Shalina Healthcare Limited, UAE

4815 Floxan 500mg Tablets Ofloxacin 500mg POM Tablet Uncoated 075/008 Shalina Healthcare Limited, UAE

4816 Shaltrim SuspensionSulphamethoxazole 40mg +

Trimethoprim 200mg

POM Suspension for

Oral Use

075/009 Shalina Healthcare Limited, UAE

4817 Leopard BaumeMethyl Salicylate 7%w/w +

Menthol 7%w/w

GS Ointment topical 075/010 Shalina Healthcare Limited, UAE

4818 Gogynax Cream Clotrimazole 2% POM Cream Topical 075/011 Shalina Healthcare Limited, UAE

4819 Zanzicap CapsulesAspirin 300mg + Paracetamol

300mg + Caffeine 30mg

GS Capsule oral 075/012 Shalina Healthcare Limited, UAE

4820 Monalisa CreamAllantoin 1.0% + Hydroquinone

2% + Vitamin E 0.3%w/w

P Cream Topical 075/013 Shalina Healthcare Limited, UAE

4821 Flazine Cream Silver Sulphadiazine 1.0% P Cream Topical 075/014 Shalina Healthcare Limited, UAE

4822 Metazol Suspension Metronidazole 125mg, per 5mlPOM Suspension for

Oral Use

075/015 Shalina Healthcare Limited, UAE

4823Rufenac-50 Tablets Diclofenac 50mg

P Tablet Film

coated

075/016 Shalina Healthcare Limited, UAE

4824 Shalvit Syrup Multivitamin GS Syrup 075/017 Shalina Healthcare Limited, UAE

4825 Rufedol TabletsParacetamol 500mg + Diclofenac

50mg

P Tablet Uncoated 075/018 Shalina Healthcare Limited, UAE

4826Germol Solution

Chloroxylenol 4.8% Terpineol +

9% Ethanol 13.1%

GS Solution for

Topical Use

075/019 Shalina Healthcare Limited, UAE

4827 Rufenac Gel Diclofenac 1.16% P Gel Topical 075/020 Shalina Healthcare Limited, UAE

4828 Magnavit Capsules Minerals + Multivitamins P Capsule oral 075/021 Shalina Healthcare Limited, UAE

4829 Amlox-5 Tablets Amlodipine 5mg POM Tablet Uncoated 075/022 Shalina Healthcare Limited, UAE

4830 Amlox-10 Tablets Amlodipine 10mg POM Tablet Uncoated 075/023 Shalina Healthcare Limited, UAE

4831 Ketazol Cream Ketoconazole 2%w/w POM Cream Topical 075/024 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4832

Epiderm Cream

Betamethasone 0.643mg +

Gentamycin 1mg + Tolnaftate

10mg +

Iodochlorohydroxyquinolone

10mg

POM Cream Topical 075/025 Shalina Healthcare Limited, UAE

4833Marfol Syrup

Ferric Ammonium 250mg + Folic

Acid 0.5mg + Cyanocobalamin

5mcg, per 5ml

P Syrup 075/026 Shalina Healthcare Limited, UAE

4834 Efishal 200 Capsules Alpha Tocopherol 200mg P Capsule oral 075/027 Shalina Healthcare Limited, UAE

4835

Epiderm Lotion

Betamethasone 0.643mg +

Gentamycin 1mg + Tolnaftate

10mg +

Iodochlorohydroxyquinolone

10mg

POM Lotion for

Topical Use

075/028 Shalina Healthcare Limited, UAE

4836 Betasol Cream Clobetasol 0.05%w/w POM Cream Topical 075/029 Shalina Healthcare Limited, UAE

4837 Gliben M TabletsGlibenclamide 5mg + Metformin

500mg

POM Tablet Uncoated 075/030 Shalina Healthcare Limited, UAE

4838 Ibucap TabletsIbuprofen 200mg + Paracetamol

325mg + Caffeine 30mg

P Tablet Uncoated 075/032 Shalina Healthcare Limited, UAE

4839Betasol Solution Clobetasol 0.05%w/v

POM Solution for

Topical Use

075/033 Shalina Healthcare Limited, UAE

4840Neocin Ointment

Polymyxin B 5000 IU +

Bacitracin Zinc 400 IU +

Neomycin 3400 IU/g

POM Ointment topical 075/035 Shalina Healthcare Limited, UAE

4841

Hemoforce Syrup

Haemoglobin 2.095gm + Ferric

Ammonium Nitrate 125mg +

Cynanocobalamin 7.5mg + Folic

Acid 0.51gm

P Syrup 075/036 Shalina Healthcare Limited, UAE

4842 Germol SoapTriclosan 1.0% + Triclocarban

0.40% + Glycerine 0.5%

GS Solid Soap 075/037 Shalina Healthcare Limited, UAE

4843 Sulfatrim Forte TabletsTrimethoprim 160mg +

Sulphamethoxazole 800mg

POM Tablet Uncoated 075/038 Shalina Healthcare Limited, UAE

4844 Cal - D TabletsCalcium 500mg + Vitamin D3

250mg

P Tablet Uncoated 075/040 Shalina Healthcare Limited, UAE

4845 Kifaru 50 Tablets Sildenafil Citrate 50mg POM Tablet Uncoated 075/041 Shalina Healthcare Limited, UAE

4846Polygel Tablets

Aluminium Hydroxide 300mg +

Magnesium Hydroxide 25mg +

Simethicone 25mg

P Tablet Uncoated 075/042 Shalina Healthcare Limited, UAE

4847 Loprade Tablets Loperamide 2mg P Tablet Uncoated 075/043 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4848 Clarinez Nasal Drops (Paed) Xylometazoline 0.05%w/v POM Nasal drops 075/044 Shalina Healthcare Limited, UAE

4849 Clarinez Nasal Drops (Adult) Xylometazoline 0.1%w/v POM Nasal drops 075/045 Shalina Healthcare Limited, UAE

4850 Tanzol Tablets Albendazole 400mg POM Tablet Uncoated 075/046 Shalina Healthcare Limited, UAE

4851 Sulfatrim TabletsSulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 075/047 Shalina Healthcare Limited, UAE

4852 Wormex -100 Tablets Mebendazole 100mg POM Tablet Uncoated 075/048 Shalina Healthcare Limited, UAE

4853 Super Apeti Tablets Cyproheptadine 4mg POM Tablet Uncoated 075/049 Shalina Healthcare Limited, UAE

4854 Shalcip Tablets Ciprofloxacin 500mg POM Tablet Uncoated 075/050 Shalina Healthcare Limited, UAE

4855 Tinizol 500 Tablets Tinidazole 500mg POM Tablet Uncoated 075/051 Shalina Healthcare Limited, UAE

4856 Amidol Syrup Paracetamol 120mg, per 5mlsGS Solution for Oral

Use

075/052 Shalina Healthcare Limited, UAE

4857

Shaltoux XPS Syrup

Diphenhydramine

Hydrochlorothiazide BP 14.00mg

+ Ammonium Chloride BP

135.0mg

P Syrup 075/053 Shalina Healthcare Limited, UAE

4858 Amidol Tablets Paracetamol 500mg POM Tablet Uncoated 075/054 Shalina Healthcare Limited, UAE

4859

Leopard Vapour Rub

Menthol 2.82% + Camphor

5.25% + Thymol 0.1% +

Turpentine 5.57% + Eucalypt

1.49% + 0.54%

GS Ointment topical 075/055 Shalina Healthcare Limited, UAE

4860 Shalcip Injection Ciprofloxacin 0.2%POM Solution for

infusion

075/056 Shalina Healthcare Limited, UAE

4861 Cevite TabletsAscorbic Acid 200mg + Sodium

Ascorbate 300mg

P Tablet Chewable 075/057 Shalina Healthcare Limited, UAE

4862 Omeshal -D CapsulesOmeprazole 20mg +

Domperidone 10mg

POM Capsule

sublingual

075/058 Shalina Healthcare Limited, UAE

4863 Omeshal Capsules Omeprazole 20mg POM Capsule oral 075/059 Shalina Healthcare Limited, UAE

4864

Amido Cold & Flu Tablets

Chlorpheniramine 2mg +

Paracetamol 500mg +

Phenylephrine 5mg + Caffeine

30mg

GS Tablet Uncoated 075/060 Shalina Healthcare Limited, UAE

4865Amidol Cold And Flu Syrup

Chlorpheniramine1mg +

Paracetamol 125mg +

Phenylephrine 2.5mg

GS Syrup 075/061 Shalina Healthcare Limited, UAE

4866 Cevite Effervescent Tablets Ascorbic Acid 1000mgGS Tablet

Effervescent

075/062 Shalina Healthcare Limited, UAE

4867Hemoforce Plus Syrup

Ferric Ammonium Citrate 160mg

+ Folic Acid 0.5mg +

Cynocobalamin 7.5mg

P Suspension for

Injection

075/063 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4868 Leopard Nasal InhalerMentha Piperata 42.5% +

Cinnamon 40.0%

GS Nasal Inhaler 075/064 Shalina Healthcare Limited, UAE

4869Super Apeti Plus Syrup

Cyproheptadine Hydrochloride

2mg + Multivitamins

P Syrup 075/065 Shalina Healthcare Limited, UAE

4870 Wormex Suspension Mebendazole 100mgP Suspension for

Oral Use

075/066 Shalina Healthcare Limited, UAE

4871 Ibucap Forte CapsulesIbuprofen 400mg + Paracetamol

325mg + Cafeine 30mg

P Capsule oral 075/067 Shalina Healthcare Limited, UAE

4872 Zanitin Duo 1.2g Powder For InjectionAmoxycillin Trihydrate 1000mg +

Clavulanate Potassium 200mg

POM Powder for

Injection

075/068 Shalina Healthcare Limited, UAE

4873 Shalcip TZ TabletsCiprofloxacin 500mg + Tindazole

600mg

POM Tablet Uncoated 075/069 Shalina Healthcare Limited, UAE

4874 Metazol Infusion 100mls Metronidazole 0.5w/vPOM Solution for

infusion

075/070 Shalina Healthcare Limited, UAE

4875 Cevite Syrup Ascorbic Acid 50mg, per 5ml P Syrup 075/071 Shalina Healthcare Limited, UAE

4876Rufezone Plus Tablets

Diclofenac Potassium 50mg +

Paracetamol 500mg +

Chlorzoxazone 250mg

P Tablet Uncoated 075/072 Shalina Healthcare Limited, UAE

4877Germol Cream

Chloroxylenol 0.3%w/v +

Triclosan 0.3%w/v + Edetic acid

(as Potassium) 0.2%w/v

GS Cream Topical 075/073 Shalina Healthcare Limited, UAE

4878 Maladox TabletsSulphadoxine 500mg +

Pyrimethamine 25mg

POM Tablet Uncoated 075/074 Shalina Healthcare Limited, UAE

4879 Gogynax Clotrimazole Vaginal Inserts Clotrimazole 100mg POM Tablet Uncoated 075/075 Shalina Healthcare Limited, UAE

4880Shaltoux Natural Cough Lozenges

Glycyrrhiza glabra 20mg +

Terminalia belerica 5mg +

Zingibar Officinalis 5mg

GS Lozenges 075/076 Shalina Healthcare Limited, UAE

4881 Tanzol Suspension Albendazole 400mg, per 10mlP Suspension for

Oral Use

075/077 Shalina Healthcare Limited, UAE

4882 Shal' Artem Dry SyrupArtemether 180mg +

Lumefantrine 1080mg

POM Powder for Oral

Suspension

075/078 Shalina Healthcare Limited, UAE

4883 Canderm Powder Clotrimazole USP 1%w/wPOM Powder for

Topical use

075/079 Shalina Healthcare Limited, UAE

4884 ZANITIN DUO 1000 TabletsAmoxycillin 875mg + Clavulanate

Potassium 125mg

POM Tablet Film

coated

075/080 Shalina Healthcare Limited, UAE

4885ZANITIN DUO 562.5 Tablets

Amoxycillin 500mg + Clavulanate

Potassium 62.5mg

POM Tablet Film

coated

075/081 Shalina Healthcare Limited, UAE

4886ZANITIN DUO 457 Oral Suspension

Amoxycillin 400mg + Clavulanate

Potassium 57mg

POM Powder for Oral

Suspension

075/082 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4887 Ceftriaxone Injection Ceftriaxone 1gPOM Powder for

Injection

075/083 Shalina Healthcare Limited, UAE

4888 Magnavit Tonic Syrup Multivitamins & Minerals P Syrup 075/084 Shalina Healthcare Limited, UAE

4889 Shalzin TabletsAzithromycin Dihydrate USP

500mg

POM Tablet Uncoated 075/085 Shalina Healthcare Limited, UAE

4890 Shalzin SuspensionAzithromycin Dihydrate USP

100mg, per 5ml

POM Suspension for

Oral Use

075/086 Shalina Healthcare Limited, UAE

4891 Kifaru 100 Tablets Sildenafil Citrate 100mgPOM Tablet Film

coated

075/087 Shalina Healthcare Limited, UAE

4892 Gentamycin Ear/Eye Drops Gentamycin 0.3%w/v POM Ear/Eye Drops 075/088 Shalina Healthcare Limited, UAE

4893Seloral Oral Rehydration Salt

Sodium Chloride + Potassium

Chloride + Sodium Citrate +

Dextrose

GS Powder for Oral

Suspension

075/089 Shalina Healthcare Limited, UAE

4894Polyfast Granules

Citric Acid 2.18g + Sodium

Bicarbonate 2.32g

P Granules for

Oral Use

075/090 Shalina Healthcare Limited, UAE

4895Epiderm Light Cream

Vitamin B3 I.H 9.31mg + Vitamin

C I.H 23.28mg + Vitamin E I.H

2.33mg

GS Cream Topical 075/091L Shalina Healthcare Limited, UAE

4896Epiderm Light Lotion

Vitamin B3 I.H 9.25mg + Vitamin

C I.H 23.14mg + Vitamin E I.H

2.31mg

GS Lotion for

Topical Use

075/092L Shalina Healthcare Limited, UAE

4897 Shal Artem TabletsArtemether 80mg + Lumefantrine

480mg

POM Tablet Uncoated 075/093 Shalina Healthcare Limited, UAE

4898Shal Artem Tablets

Artemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 075/094 Shalina Healthcare Limited, UAE

4899 Amoxy 500 Capsules Amoxicillin Trihydrate 500mg POM Tablet Uncoated 075/095 Shalina Healthcare Limited, UAE

4900 Amoxy 250 Capsules Amoxicillin Trihydrate 250mg POM Tablet Uncoated 075/096 Shalina Healthcare Limited, UAE

4901 Ampicillin 1000 Injection Ampicillin Sodium BP 1gPOM Powder for

Injection

075/097 Shalina Healthcare Limited, UAE

4902 Ampicillin 500 Injection Ampicillin Sodium BP 500mgPOM Powder for

Injection

075/098 Shalina Healthcare Limited, UAE

4903 Fortified Benzylpenicillin InjectionProcaine Benzyl Penicillin BP

4M.I.U

POM Powder for

Injection

075/099 Shalina Healthcare Limited, UAE

4904 Benzathine Benzylpenicllin 2.4 InjectionBenzathine Benzyl Penicillin

2,400,000 IU

POM Powder for

Injection

075/100 Shalina Healthcare Limited, UAE

4905 Benzylpenillin 5 Injection Benzyl Penicillin 5,000,000 IUPOM Powder for

Injection

075/101 Shalina Healthcare Limited, UAE

4906Phenoxymethyl Penicillin 250 Tablets

Phenoxymethyl Penicillin

Potassium 250mg

POM Tablet Uncoated 075/102 Shalina Healthcare Limited, UAE

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4907 Gentamycin 40 Injection Gentamycin 40mg, per mlPOM Solution for

Injection

075/103 Shalina Healthcare Limited, UAE

4908

Hemoforce Plus Syrup

Sodium Feredetate 11mg + Folic

Acid 0.5mg + Cyanocobalamin

5mcg + Zinc Sulphate 3.33mg +

20mg

P Syrup 075/104 Shalina Healthcare Limited, UAE

4909 Aloe Soft Gel Capsules Aloe Vera 500mgP Capsule oral 323/001L Shanghai Eternal Biotechnology

Co. Limited, China

4910Broken Ganoderma Lucidium Spore

Softgel CapsulesGanoderma Lucidium 500mg

P Capsule oral 323/002L Shanghai Eternal Biotechnology

Co. Limited, China

4911 Fish Oils Softgel Capsules Fish Oil 1000mgP Capsule oral 323/003L Shanghai Eternal Biotechnology

Co. Limited, China

4912Lecithin Soft Capsules Soyabean Lecithin 22.3%

P Capsule oral 323/004L Shanghai Eternal Biotechnology

Co. Limited, China

4913 Natural Vitamin E Soft Gel Capsules Vitamin E 500mgP Capsule oral 323/005L Shanghai Eternal Biotechnology

Co. Limited, China

4914 Propolis Softgel Capsules Propolis Extracts 55%P Capsule oral 323/006L Shanghai Eternal Biotechnology

Co. Limited, China

4915 Soy Isoflavones Capsules Soy Bean Extracts 67.06%P Capsule oral 323/007L Shanghai Eternal Biotechnology

Co. Limited, China

4916 Spirulina Soft Gel Capsules Spirulina 150mgP Capsule oral 323/008L Shanghai Eternal Biotechnology

Co. Limited, China

4917 Kanamycin Injection Kanamycin 1000mgPOM Powder for

Injection

269/001 Shanghai Pharmateq Company

Ltd, China

4918 Calcium Gluconate Injection Calcium Gluconate 10%w/vPOM Solution for

Injection

269/002 Shanghai Pharmateq Company

Ltd, China

4919 Promethazine Injection Promethazine 50mg, per 2mlPOM Solution for

Injection

269/003 Shanghai Pharmateq Company

Ltd, China

4920Diclofenac Sodium Injection Diclofenac 75mg, per 3ml

POM Solution for

Injection

269/004 Shanghai Pharmateq Company

Ltd, China

4921 Atropine Injection Atropine 0.6mg, per mlPOM Solution for

Injection

269/005 Shanghai Pharmateq Company

Ltd, China

4922Furosemide Injection Furosemide 20mg, per 2ml

POM Solution for

Injection

269/006 Shanghai Pharmateq Company

Ltd, China

4923 Dexamethasone Sodium Injection Dexamethasone 4mg, per mlPOM Solution for

Injection

269/007 Shanghai Pharmateq Company

Ltd, China

4924Adrenaline Injection Adrenaline 1mg, per ml

POM Solution for

Injection

269/008 Shanghai Pharmateq Company

Ltd, China

Page 242 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4925 Oxytocin Injection Oxytocin 10IU/MlPOM Solution for

Injection

269/010 Shanghai Pharmateq Company

Ltd, China

4926Menadione Injection Phytomenadione 10mg, per ml

POM Solution for

Injection

269/011 Shanghai Pharmateq Company

Ltd, China

4927 Quinine Dihydrochloride Injection Quinine 600mg, per 2mlPOM Solution for

Injection

269/012 Shanghai Pharmateq Company

Ltd, China

4928 Hydrocortisone Injection Hydrocortisone 100mgPOM Powder for

Injection

269/013 Shanghai Pharmateq Company

Ltd, China

4929 Zwagra Tablets Sildenafil 50mgPOM Tablet Uncoated 066/001 Shaphaco Pharmaceutical

Industries , Yemen

4930 Saheal Tablets Tadalafil 20mgPOM Tablet Uncoated 066/002 Shaphaco Pharmaceutical

Industries , Yemen

4931 Koflyn Syrup Herbal ExtractsP Syrup 134/001 Shelys Pharmaceuticals Limited,

Tanzania

4932 Diclofenac Sodium Tablets Diclofenac 50mgP Tablet Uncoated 134/003 Shelys Pharmaceuticals Limited,

Tanzania

4933 Chloramphenicol Suspension Chloramphenicol 125mg, per 5mlPOM Suspension for

Oral Use

134/004 Shelys Pharmaceuticals Limited,

Tanzania

4934Shelys Gripe Water Bicarbonate

GS Solution for Oral

Use

134/005 Shelys Pharmaceuticals Limited,

Tanzania

4935 Ibuprofen 200 Tablets Ibuprofen 200mgP Tablet Uncoated 134/006 Shelys Pharmaceuticals Limited,

Tanzania

4936 Amolin Suspension Amoxicillin 125mg, per 5mlPOM Granules for

Oral Suspension

134/007 Shelys Pharmaceuticals Limited,

Tanzania

4937 Sheladol Suspension Paracetamol 120mg, per 5mlGS Suspension for

Oral Use

134/008 Shelys Pharmaceuticals Limited,

Tanzania

4938 Ampishel Capsules Ampicillin 250mgPOM Capsule oral 134/009 Shelys Pharmaceuticals Limited,

Tanzania

4939 Hemovit Capsules Haematic Preparation P Capsule oral 134/010 Shelys Pharmaceuticals Limited,

Tanzania

4940 Hemovit Syrup Haematic Preparation P Syrup 134/011 Shelys Pharmaceuticals Limited,

Tanzania

4941 Aspirin Tablets Acetyl Salicylic Acid 300mgP Tablet Uncoated 134/012 Shelys Pharmaceuticals Limited,

Tanzania

4942 Histin Tablets Chlorpheniramine 4mgP Tablet Uncoated 134/013 Shelys Pharmaceuticals Limited,

Tanzania

4943Shetrim Tablets

Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 134/015 Shelys Pharmaceuticals Limited,

Tanzania

Page 243 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4944 Mebendazole Tablets Mebendazole 200mgP Tablet Uncoated 134/016 Shelys Pharmaceuticals Limited,

Tanzania

4945Alben Suspension Albendazole 200mg, per 10ml

POM Suspension 134/017 Shelys Pharmaceuticals Limited,

Tanzania

4946 Shelgyl 200 Tablets Metronidazole 200mgPOM Tablet Uncoated 134/018 Shelys Pharmaceuticals Limited,

Tanzania

4947 Chloramphenicol Capsules Chloramphenicol 250mgPOM Capsule oral 134/020 Shelys Pharmaceuticals Limited,

Tanzania

4948 Ascorbic Acid Tablets Ascorbic Acid 100mgGS Tablet Uncoated 134/021 Shelys Pharmaceuticals Limited,

Tanzania

4949 Bactol Solution Chloroxylenol 4.8%w/wGS Solution for

Topical Use

134/022 Shelys Pharmaceuticals Limited,

Tanzania

4950 Folic Acid Tablets Folic Acid 5mgP Tablet Uncoated 134/023 Shelys Pharmaceuticals Limited,

Tanzania

4951 Sulphadar TabletsPyrimethamine 500mg +

Sulphadoxine 25mg

P Tablet Uncoated 134/024 Shelys Pharmaceuticals Limited,

Tanzania

4952 Erythromycin Tablets Erythromycin 250mgPOM Tablet Uncoated 134/025 Shelys Pharmaceuticals Limited,

Tanzania

4953Mucolyn Asthalin Syrup

Salbutamol 2mg + Bromhexine

4mg, per 5ml

POM Syrup 134/026 Shelys Pharmaceuticals Limited,

Tanzania

4954 Asthalin Syrup Salbutamol 2mg, per 5mlPOM Syrup 134/028 Shelys Pharmaceuticals Limited,

Tanzania

4955 Shetrim Per 5mlSulfamethoxazole BP 200mg +

Trimethoprim BP 40mg

POM Syrup 134/029 Shelys Pharmaceuticals Limited,

Tanzania

4956 Cloxashel Capsules Cloxacillin 250mgPOM Capsule oral 134/030 Shelys Pharmaceuticals Limited,

Tanzania

4957 Vitamin B Complex Tablets Vitamin B ComplexP Tablet Uncoated 134/031 Shelys Pharmaceuticals Limited,

Tanzania

4958 Amolin Capsules Amoxicillin 250mgPOM Capsule oral 134/032 Shelys Pharmaceuticals Limited,

Tanzania

4959 Cloxam Dry SyrupCloxacillin 125mg + Ampicillin

125mg, per 5ml

POM Suspension for

Oral Use

134/034 Shelys Pharmaceuticals Limited,

Tanzania

4960 Megavit Syrup MultivitaminsGS Syrup 134/035 Shelys Pharmaceuticals Limited,

Tanzania

4961 Hyosine Butyl Bromide Tablets Hyoscine Butyl Bromide 10mgPOM Tablet Uncoated 134/036 Shelys Pharmaceuticals Limited,

Tanzania

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4962

Mucolyn Paediatric Syrup

Ammonium Chloride BP 50mg +

Pseudoephedrine Hydrochloride

10mg + Chlorpheniramine

Maleate BP 2mg +

Dextromethorphan Hydrobromide

BP 5mg, per 5ml

P Syrup 134/037 Shelys Pharmaceuticals Limited,

Tanzania

4963 Feritone Syrup Haematic Preparation P Syrup 134/038 Shelys Pharmaceuticals Limited,

Tanzania

4964Praziquantel 600mg Tablets Praziquantel 600mg

POM Tablet Film

coated

134/039 Shelys Pharmaceuticals Limited,

Tanzania

4965 Bromoxil CapsulesBromhexine 8mg + Amoxicillin

250mg

POM Capsule oral 134/040 Shelys Pharmaceuticals Limited,

Tanzania

4966 Bromoxil Syrup 100mlBromhexine 4mg + Amoxicillin

125mg

POM Syrup 134/041 Shelys Pharmaceuticals Limited,

Tanzania

4967 Sulphadar TabletsPyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 134/042 Shelys Pharmaceuticals Limited,

Tanzania

4968 Sheladol Tablets Paracetamol 500mgGS Tablet Uncoated 134/044 Shelys Pharmaceuticals Limited,

Tanzania

4969 Shelgyl Oral Suspension Metronidazole 200mg, per 5mlPOM Suspension for

Oral Use

134/045 Shelys Pharmaceuticals Limited,

Tanzania

4970Mucolyn Syrup

Ammonium Chloride 50mg +

Bromhexine 4mg +

Chlorpheniramine 2mg.

P Syrup 134/046 Shelys Pharmaceuticals Limited,

Tanzania

4971 Ampishel Syrup Ampicillin 125mgPOM Syrup 134/048 Shelys Pharmaceuticals Limited,

Tanzania

4972 Erthromycin Dry Syrup Erythromycin 125mgPOM Powder for Oral

Suspension

134/049 Shelys Pharmaceuticals Limited,

Tanzania

4973 Diclopar 550mg TabletsParacetamol 500mg + Diclofenac

50mg

P Tablet Uncoated 134/050 Shelys Pharmaceuticals Limited,

Tanzania

4974 Amodar Suspension Amodiaquine 50mg, per 5mlPOM Suspension 134/051 Shelys Pharmaceuticals Limited,

Tanzania

4975Cipron Tablets Ciprofloxacin 500mg

POM Tablet oral 134/052 Shelys Pharmaceuticals Limited,

Tanzania

4976Coldril Syrup

Chlorpheniramine 1mg +

Paracetamol 120mg +

Pseudoephedrine 10mg

P Syrup 134/053 Shelys Pharmaceuticals Limited,

Tanzania

4977Malafin Tablets

Pyrimethamine 25mg +

Sulphamethoxypyrazine 500mg

P Tablet Uncoated 134/054 Shelys Pharmaceuticals Limited,

Tanzania

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4978 Malather Tablets Artesunate BP 100mgPOM Tablet Uncoated 134/055 Shelys Pharmaceuticals Limited,

Tanzania

4979

Coldril Capsules

Paracetamol BP 500mg +

Pseudoephedrine Hydrochloride

BP 30mg + Chlorpheniramine

Maleate BP 2mg

POM Capsule oral 134/056 Shelys Pharmaceuticals Limited,

Tanzania

4980 Amodar Tablets Amodiaquine 260mgPOM Tablet Uncoated 134/057 Shelys Pharmaceuticals Limited,

Tanzania

4981Gastocid Suspension

Simethicone 25mg + Aluminium

Hydroxide 220mg + Magnesium

Hydroxide 195mg

P Suspension for

Oral Use

134/058 Shelys Pharmaceuticals Limited,

Tanzania

4982 Gastrocid Chewable TabletsDried Aluminium Hydroxide +

Magnesium Trisilicate 395mg

GS Tablet Chewable 134/059 Shelys Pharmaceuticals Limited,

Tanzania

4983 Flucozal 150 Tablets Fluconazole 150mgPOM Tablet Uncoated 134/060 Shelys Pharmaceuticals Limited,

Tanzania

4984Flucozal 200 Tablets Fluconazole 200mg

POM Tablet Uncoated 134/062 Shelys Pharmaceuticals Limited,

Tanzania

4985 Maladar Adult Kit TabletsAmodiaquine 200mg +

Artesunate 50mg

POM Tablet Uncoated 134/063 Shelys Pharmaceuticals Limited,

Tanzania

4986 Maladar Pead Kit TabletsAmodiaquine 100mg +

Artesunate 50mg

POM Tablet Uncoated 134/064 Shelys Pharmaceuticals Limited,

Tanzania

4987Save Oral Rehydration Salt

Sodium Chloride + Sodium

Citrate + Potassium Chloride +

Glucose

GS Powder for Oral

Solution

134/065 Shelys Pharmaceuticals Limited,

Tanzania

4988 Ped Zinc Tablets Zinc Sulphate 20mgGS Tablet Uncoated 134/066 Shelys Pharmaceuticals Limited,

Tanzania

4989 Acefen Tablets Aceclofenac 100mgP Tablet Uncoated 134/067 Shelys Pharmaceuticals Limited,

Tanzania

4990 Levoz Tablets Levofloxacin 500mgPOM Tablet Uncoated 134/068 Shelys Pharmaceuticals Limited,

Tanzania

4991 Njoi Tablets Sildenafil 50mgPOM Tablet Uncoated 134/069 Shelys Pharmaceuticals Limited,

Tanzania

4992 Quinalin Syrup Quinine 100g/5mlPOM Syrup 134/070 Shelys Pharmaceuticals Limited,

Tanzania

4993Diclopar-Ultra Tablets

Paracetamol 500mg +

Diclofenac 50mg

P Tablet Uncoated 134/071 Shelys Pharmaceuticals Limited,

Tanzania

4994Azuma - 250 Tablets Azithromycin 250mg

POM Tablet Uncoated 134/072 Shelys Pharmaceuticals Limited,

Tanzania

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

4995 Azuma - 500 Tablets Azithromycin 500mgPOM Tablet Film

coated

134/073 Shelys Pharmaceuticals Limited,

Tanzania

4996Azuma Suspension Azithromycin 200mg

POM Suspension for

Oral Use

134/074 Shelys Pharmaceuticals Limited,

Tanzania

4997 Sheltrizine Tablets Cetrizine 10mgP Tablet Uncoated 134/075 Shelys Pharmaceuticals Limited,

Tanzania

4998 Burnox CreamSilver Sulfadiazine 1.0%w/w +

Chlorhexidine 0.2%w/w

P Cream Topical 134/076 Shelys Pharmaceuticals Limited,

Tanzania

4999Dermacin Cream

Clobetasone 0.05%w/w +

Gentamicin Sulphate 0.1%w/w

+ Miconazole 10.0%w/w

POM Cream Topical 134/077 Shelys Pharmaceuticals Limited,

Tanzania

5000Orazinc Kit ORS + Zinc Sulphate 20mg

P Powder for oral

solution

134/078 Shelys Pharmaceuticals Limited,

Tanzania

5001

Diclopar Activa Gel

Diclofenac Diethylalamine

1.16%w/w + Methyl Salycilate

10.00%w/w + Racementhol

5.00%w/w

P Gel Topical 134/079 Shelys Pharmaceuticals Limited,

Tanzania

5002 Micosil Cream Miconazole Nitrate BP 1%w/wPOM Cream Topical 134/080 Shelys Pharmaceuticals Limited,

Tanzania

5003Benzathine Penicillin 2.4MU Injection Benzathine Penicillin 2.4g

POM Powder for

Injection

212/001 Shijiazhvang Pharma Group,

Zhonghuo Pharmaceutical Co.,

Ltd,

5004Ampicillin Sodium Injection Ampicillin 1.0g

POM Powder for

Injection

212/002 Shijiazhvang Pharma Group,

Zhonghuo Pharmaceutical Co.,

Ltd,

5005

Ceftriaxone Sodium Injection Cefriaxone 1.0g POM Powder for

Injection

212/003 Shijiazhvang Pharma Group,

Zhonghuo Pharmaceutical Co.,

Ltd,

5006Benzathine Penicillin 2.4MU Injection Benzathine Penicillin 2.4MU

POM Powder for

Injection

212/006 Shijiazhvang Pharma Group,

Zhonghuo Pharmaceutical Co.,

Ltd,

5007Cefotaxime Sodium 1g For Injection Cefotaxime Sodium 1g

POM Powder for

Injection

212/007 Shijiazhvang Pharma Group,

Zhonghuo Pharmaceutical Co.,

Ltd,

5008 Cichlor Eye Drops Chloramphenicol 0.5%w/vPOM Eye Drops 143/003 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5009Vitamin B Complex Injection Vitamin B Complex

POM Solution for

Injection

143/004 Shreechem Pharmaceuticals (Pvt)

Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5010 Sangel TabletsAluminium Hydroxide +

Magnesium Trisilicate

P Tablet Uncoated 143/005 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5011Multivitamins Tablets Multivitamins

GS Tablet Uncoated 143/006 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5012 Maxinfen TabletsSulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 143/007 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5013 Ciphenicol 250 Capsules Chloramphenicol 250mgPOM Capsule oral 143/008 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5014 Apetito Tablets Cyproheptadine 4mgP Tablet Uncoated 143/009 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5015 Bumol CapsulesParacetamol 325mg + Ibuprofen

200mg + Caffeine 25mg

P Capsule oral 143/010 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5016 Deworm Tablets Mebendazole 100mgP Tablet Uncoated 143/011 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5017 Lignocaine Injection Lignocaine 2%w/wPOM Solution for

Injection

143/012 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5018 Cimol Tablets Paracetamol 500mgGS Tablet Uncoated 143/013 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5019Chaptone Extra Tablets Multivitamins

GS Tablet Uncoated 143/014 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5020 Ceagra Tablets Sildenafil 50mgPOM Tablet Uncoated 143/015 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5021 Chapsulf Ointment Precipitated Sulphur 10%P Ointment topical 143/016 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5022 Cindo-25 Capsules Indomethacin 25mgP Capsule oral 143/017 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5023 Cibufen-200 Tablets Ibuprofen 200mgP Tablet Uncoated 143/018 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5024 Chapvit Tablets MultivitaminsGS Tablet Uncoated 143/019 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5025Clearcold Tablets

Chlorpheniramine BP 2mg +

Paracetamol BP 500mg +

Caffeine (Anhydrous) BP 30mg

P Tablet Uncoated 143/020 Shreechem Pharmaceuticals (Pvt)

Ltd, India

5026 Misotac Tablets Misoprostol 0.2mgPOM Tablet Uncoated 107/001 Sigma Pharmaceuticals Ltd,

Egypt

5027Eurartesim 320/40 Tablets

Piperaquine Tetraphosphate

320mg + Dihydroartemesinin

40mg

POM Tablet Film

coated

351/001 SIGMA-TAU INDUSTRIE

FARMACEUTICHE RIUNITE

S.P.A

Page 248 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5028Eurartesim 160/20 Tablets

Piperaquine Tetraphosphate

160mg + Dihydroartemesinin

20mg

POM Tablet Film

coated

351/002 SIGMA-TAU INDUSTRIE

FARMACEUTICHE RIUNITE

S.P.A

5029 Frusemide Tablets Frusemide 40mg POM Tablet Uncoated 151/051 SK Age Exports, India

5030 Amoxykant 250 Capsules Amoxicillin 250mg POM Capsule oral 162/005 SK Age Exports, India

5031 Metronol Tablets Metronidazole 200mg POM Tablet Uncoated 162/007 SK Age Exports, India

5032 Melquin 250 Tablets Erythromycin 250mg POM Tablet Uncoated 161/003 SKant Healthcare Ltd, India

5033 Malacure TabletsPyrimethamine 25mg +

Sulphadoxine 500mg

P Tablet Uncoated 161/004 SKant Healthcare Ltd, India

5034 Amoxykant Capsules Amoxycillin 250mg POM Capsule oral 161/005 SKant Healthcare Ltd, India

5035 Promethazine Hydrochloride Injection Promethazine 25mg, per 2mlPOM Solution for

Injection

161/006 SKant Healthcare Ltd, India

5036 Gentamycin Injection Gentamycin 40mg, per mlPOM Solution for

Injection

161/007 SKant Healthcare Ltd, India

5037 Metronikant Suspension Metronidazole 125mg, per 5mlPOM Suspension for

Oral Use

161/009 SKant Healthcare Ltd, India

5038 Cotrikant Oral SuspensionSulphamethoxazole 200mg +

Trimethoprim 40mg

POM Suspension for

Oral Use

161/010 SKant Healthcare Ltd, India

5039 Paracetamol Tablets Paracetamol 500mg GS Tablet Uncoated 161/011 SKant Healthcare Ltd, India

5040 Salbukant 4 Tablets Salbutamol 4mg POM Tablet Uncoated 161/013 SKant Healthcare Ltd, India

5041 Cotrikant TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 161/014 SKant Healthcare Ltd, India

5042 Ampikant Capsules Ampicillin 250mg POM Capsule oral 161/015 SKant Healthcare Ltd, India

5043 Ibukant Tablets Ibuprofen 200mg BP P Tablet Uncoated 161/016 SKant Healthcare Ltd, India

5044 Erythrokant Suspension Erythromycin 125mg, per 5ml POM Suspension 161/017 SKant Healthcare Ltd, India

5045 Doxykant Capsules Doxycycline 250mg POM Capsule oral 161/018 SKant Healthcare Ltd, India

5046 Phenoxymethyl Penicillin TabletsPhenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 161/019 SKant Healthcare Ltd, India

5047 Cloxikant Capsules Cloxacillin 250mg POM Capsule oral 161/020 SKant Healthcare Ltd, India

5048 Tetrakant CapsulesTetracycline Hydrochloride BP

250mg

POM Capsule oral 161/021 SKant Healthcare Ltd, India

5049 Apicloxkant CapsulesCloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 161/022 SKant Healthcare Ltd, India

5050 Aspikant Tablets Acetyl Salicylic Acid 300mg P Tablet Uncoated 161/023 SKant Healthcare Ltd, India

5051 Metrokant Tablets Metronidazole 200mg POM Tablet Uncoated 161/024 SKant Healthcare Ltd, India

5052 Magtrikant TabletsAluminium Hydrochloride +

Magnesium Trisilicate

GS Tablet Uncoated 161/025 SKant Healthcare Ltd, India

5053 CPkant Tablets Chlorpheniramine 2mg P Tablet Uncoated 161/026 SKant Healthcare Ltd, India

5054 Salbukant Syrup Salbutamol 2mg, per 5ml POM Syrup 161/027 SKant Healthcare Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5055 Parakant Syrup Paracetamol 120mg, per 5ml GS Syrup 161/028 SKant Healthcare Ltd, India

5056 Amoxykant Syrup Amoxicillin 125mg, per 5ml POM Syrup 161/029 SKant Healthcare Ltd, India

5057Procaine Penicillin Injection Procain Penicillin 4MU

POM Powder for

Injection

161/030 SKant Healthcare Ltd, India

5058 Diclokant Tablets Diclofenac 100mg P Tablet Uncoated 161/031 SKant Healthcare Ltd, India

5059 Cimetidine 200 Tablets Cimetidine 200mg POM Tablet Uncoated 161/032 SKant Healthcare Ltd, India

5060 Cimetidine 400 Tablets Cimetidine 400mg POM Tablet Uncoated 161/033 SKant Healthcare Ltd, India

5061Oral Rehydration Salts

Sodium Chloride + Sodium

Citrate + Potassium Chloride +

Glucose

GS Powder for Oral

Solution

161/034 SKant Healthcare Ltd, India

5062 Apiclockant CapsulesCloxacillin 250mg + Ampicillin

250mg

POM Capsule oral 161/036 SKant Healthcare Ltd, India

5063 Ferrous+ Folic Acid Tablets Ferrous Sulphate + Folic Acid P Tablet Uncoated 161/037 SKant Healthcare Ltd, India

5064 Nalikant Tablets Nalidixic Acid 500mg POM Tablet Uncoated 161/038 SKant Healthcare Ltd, India

5065 Aminophyline Tablets Aminophylline 100mg POM Tablet Uncoated 161/039 SKant Healthcare Ltd, India

5066 Prazikant Tablets Praziquantel 600mg POM Tablet Uncoated 161/040 SKant Healthcare Ltd, India

5067 Mebekant Tablets Mebendazole 100mg P Tablet Uncoated 161/041 SKant Healthcare Ltd, India

5068 Ampicillin Injection Ampicillin 1000mgPOM Powder for

Injection

161/042 SKant Healthcare Ltd, India

5069 Ciprokant 250 Tablets Ciprofloxacin 250mg POM Tablet Uncoated 161/043 SKant Healthcare Ltd, India

5070 Meldol Tablets Paracetamol 500mg GS Tablet Uncoated 161/044 SKant Healthcare Ltd, India

5071 Painrid Capsules Paracetamol + Caffeine GS Capsule oral 161/045 SKant Healthcare Ltd, India

5072 Coldnil TabletsParacetamol + Caffeine +

Chlorpheniramine

P Tablet Uncoated 161/046 SKant Healthcare Ltd, India

5073 Melcid TabletsDried Aluminium Hydroxide +

Magnesium Trisilicate

GS Tablet Uncoated 161/047 SKant Healthcare Ltd, India

5074 Melkoff Tablets Combination P Tablet Uncoated 161/048 SKant Healthcare Ltd, India

5075 Metronidazole Tablets Metronidazole 200mg POM Tablet Uncoated 161/049 SKant Healthcare Ltd, India

5076

Hematonic

Ferric Ammonium Citrate 204mg

+ Cyanocobalamine 0.100mg +

Pyridoxine Hydrochloride

0.600mg + Folic Acid 1.800mg +

Zinc Sulphate Monohydrate

1.455mg, per 5ml

P Syrup 161/050 SKant Healthcare Ltd, India

5077 Good Night Syrup Combination P Syrup 161/052 SKant Healthcare Ltd, India

5078 Propranolol Tablets Propranolol 40mg POM Tablet Uncoated 161/053 SKant Healthcare Ltd, India

5079 Methyldopa Tablets Methyldopa 250mg POM Tablet Uncoated 161/054 SKant Healthcare Ltd, India

5080 Pyrazinamide Tablets Pyrazinamide 500mg POM Tablet Uncoated 161/055 SKant Healthcare Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5081 Erythrokant Tablets Erythromycin 250mg POM Tablet Uncoated 161/056 SKant Healthcare Ltd, India

5082 Folicant 5 Tablets Folic Acid 5mg P Tablet Uncoated 161/057 SKant Healthcare Ltd, India

5083 Tetrakant 250 Capsules Tetracycline 250mg POM Capsule oral 161/058 SKant Healthcare Ltd, India

5084 Ibuprofen Tablets Ibuprofen 200mgP Tablet Film

coated

161/059 SKant Healthcare Ltd, India

5085 Quinine Sulphate Tablets BP Quinine Sulphate 300mgPOM Tablet Film

coated

161/060 SKant Healthcare Ltd, India

5086 Arthemether + Lumefantrine TabletsArtemether 20mg + Lumefantrine

120mg

POM Tablet Uncoated 161/061 SKant Healthcare Ltd, India

5087 Nystatin Vaginal Insert USP 1000IU Nystatin USP 100 000IU POM Tablet Vaginal 161/062 SKant Healthcare Ltd, India

5088 Silverkant Cream Silver Sulfadiazine USP 1%w/w POM Cream topical 161/063 SKant Healthcare Ltd, India

5089

Hematonic Syrup

Ferric Ammonium Citrate 204mg

+ Cyanocobalamine 0.100mg +

Pyridoxine Hcl 0.600mg + Folic

Acid 1.800mg + Zinc Sulphate

Monohydrate 1.455mg, per 5ml

POM Syrup 161/064 SKant Healthcare Ltd, India

5090

Go Gel

Diclofenac Dimethylamine 1.16%

w/w + Oleum Lini 1%w/w +

Menthol BP 5%w/w + Mathyl

Salicylate 10% + Capsaicin USP

0.025%w/w

P Gel Topical 161/065 SKant Healthcare Ltd, India

5091Safe Plan Family Planning Pills

Ethinylestradiol 0.03mg +

Levonorgestrel 0.15mg + Ferrous

Fumurate 75mg

POM Tablet Uncoated 125/001 Soceity For Family Health Ltd,

Zambia

5092 My Choice InjectionMedroxyprogesterone 150mg,

per ml

POM Solution for

Injection

125/002 Society for Family Health Ltd,

Zambia

5093Mychoice Microgynon Ed Fe Tablets

Ethinyl Estradiol 0.03mg +

Levonorgestrel 0.15mg + Ferrous

Fumurate 75mg

POM Tablet Uncoated 125/003 Society for Family Health Ltd,

Zambia

5094Mychoice Intra Uterine Contraceptive

DeviceCopper-T Cu 380 A

N/A Intra Uterine 125/004 Society for Family Health Ltd,

Zambia

5095 Mychoice Woman Condom Latex ProductsGS Latex Products 125/005L Society for Family Health Ltd,

Zambia

5096 Mychoice Diaphragm Latex ProductsGS Latex Products 125/006L Society for Family Health Ltd,

Zambia

5097 Mychoice Lubricant LubricantGS Gel Topical 125/007L Society for Family Health Ltd,

Zambia

5098Trust Studed Condom Male Latex Condom

GS Latex Products 125/008L Society for Family Health Ltd,

Zambia

Page 251 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5099 Trust Smooth Condom Male Latex CondomGS Latex Products 125/009L Society for Family Health Ltd,

Zambia5100 Cloxispa Capsules Cloxacillin 250mg POM Capsule oral 231/001 Sparsh Biotech Pvt Ltd, India

5101 Spamcil Capsules Ampicillin 250mg POM Capsule oral 231/002 Sparsh Biotech Pvt Ltd, India

5102 Spmox Capsules Amoxicillin 250mg POM Capsule oral 231/003 Sparsh Biotech Pvt Ltd, India

5103 Speniv TabletsPhenoxymethyl Penicillin V

250mg

POM Tablet Uncoated 231/004 Sparsh Biotech Pvt Ltd, India

5104 Speniv Oral SuspensionPhenoxymethyl Penicillin V

125mg, per 5ml

POM Powder for Oral

Suspension

231/005 Sparsh Biotech Pvt Ltd, India

5105 Spamox CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 231/006 Sparsh Biotech Pvt Ltd, India

5106Spamox Dispersible Tablets Amoxicillin 250mg

POM Tablet

Dispersible

231/007 Sparsh Biotech Pvt Ltd, India

5107 Hibiscrub Topical Solution Chlorhexidine 4.0%w/v GS Solution Topical 023/005 SSL International, England

5108 Hibitane 5% Concentrate Chlorhexidine 5% GS Solution Topical 023/006 SSL International, England

5109 Hibiscet Hospital Concentration Chlorhexidine 40% GS Solution Topical 023/016 SSL International, England

5110 Esoz 40 Tablets Esomeprazole 40mgPOM Tablet Uncoated 039/030 Stada Vietnam Joint Venture Co.

Ltd, Vietnam

5111 Stalclox CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 016/001 Stallion Laboratories Limited,

India

5112 Cedril-250 Tablets Cefadroxil 250mgPOM Tablet Uncoated 016/002 Stallion Laboratories Limited,

India

5113Endulax Powder Ispaghula Husk 3.5g 100% w/w

P Powder for Oral

Suspension

016/003 Stallion Laboratories Limited,

India

5114Ole-400 Tablets Ofloxacin 400mg

POM Tablet Uncoated 016/004 Stallion Laboratories Limited,

India

5115 Ciptid-500 Tablets Ciprofloxacin 500mgPOM Tablet Uncoated 016/005 Stallion Laboratories Limited,

India

5116 Stalfin TabletsSulphadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 016/006 Stallion Laboratories Limited,

India

5117P-Cam 20 Caspules Piroxicam 20mg

POM Capsule

Sustained

Release

016/007 Stallion Laboratories Limited,

India

5118 Endulx Garlic Tablets Ispaghula Husk 300mgP Tablet Uncoated 016/008 Stallion Laboratories Limited,

India

5119Quinlin-300 Tablets Quinine 300mg

POM Tablet Uncoated 016/009 Stallion Laboratories Limited,

India

5120Endulax Karela Capsules Ispaghula Husk 400mg

P Capsule oral 016/010 Stallion Laboratories Limited,

India

Page 252 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5121 Alvenax Drench 1000ml Albendazole 23mg, per mlP Suspension for

Oral Use

122/711 Star Laboratories Pvt Ltd,

Pakistan

5122Teragen Aerosol Spray

Oxytetracycline 40mg + Gentian

Violet 4mg

P Spray for Topical

Use

122/712 Star Laboratories Pvt Ltd,

Pakistan

5123 Tylomac Injection 100ml Tylosin 200mg, per mlPOM Solution for

Injection

122/713 Star Laboratories Pvt Ltd,

Pakistan

5124 Amino Vital Injection 100mls MultivitaminPOM Solution for

Injection

122/714 Star Laboratories Pvt Ltd,

Pakistan

5125 Drez OintmentPovidone Iodine 5.0%w/w +

Metronidazole 1.0%w/w

P Ointment topical 208/002 Stedman Pharmaceuticals (Pvt)

Litd, India

5126 Drez PowderPovidone Iodine 5.0%w/w +

Metronidazole 1.0%w/w

P Powder for

Topical Solution

208/003 Stedman Pharmaceuticals (Pvt)

Litd, India

5127 Drez SolutionPovidone Iodine 5.0%w/w +

Metronidazole 1.0%w/w

P Solution for

Topical Use

208/004 Stedman Pharmaceuticals (Pvt)

Litd, India

5128Contus Plus Paediatric Suspension

Chlorpheniramine 1mg +

Phenylephrine 5mg +

Paracetamol 160mg

P Suspension for

Oral Use

208/005 Stedman Pharmaceuticals (Pvt)

Litd, India

5129Contus Paediatric linctus

Chlorpheniramine 1mg +

Phenylephrine 5mg +

Dextromethophen 10mg

P Solution for Oral

Use

208/006 Stedman Pharmaceuticals (Pvt)

Litd, India

5130 Drez-V GelMiconazole 1%w/w +

Metronidazole 100mg

POM Gel Vaginal 208/007 Stedman Pharmaceuticals (Pvt)

Litd, India

5131Contus-650 Tablets

Chlorpheniramine 2mg +

Paracetamol 650mg +

Phenylephrine 5mg

P Tablet Uncoated 208/008 Stedman Pharmaceuticals (Pvt)

Litd, India

5132 STEDNAC Tablets Aceclofenac 100mgP Tablet Uncoated 208/009 Stedman Pharmaceuticals (Pvt)

Litd, India

5133 DREZ Gargle Iodinated Povidone 2%w/vP Solution for Oral

Use

208/010 Stedman Pharmaceuticals (Pvt)

Litd, India

5134 Lamivudine + Zidovudine TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 090/001 Strides Shasun

5135 Stavudine Capsules Stavudine 30mg POM Capsule oral 090/002 Strides Shasun

5136 Efavirenz Tablets Efavirenz 600mg POM Tablet Uncoated 090/003 Strides Shasun

5137Stavudine + Lamivudine + Nevirapine

Tablets

Stavudine 30mg + Lamivudine

150mg + Nevirapine 200mg

POM Tablet Uncoated 090/004 Strides Shasun

5138Stavudine + Lamivudine Tablets

Stavudine 30mg + Lamivudine

150mg

POM Tablet Uncoated 090/005 Strides Shasun

5139 Abacavir Sulphate Tablets Abacavir Sulphate 300mg POM Tablet Uncoated 090/006 Strides Shasun

5140 Lamivudine Tablets Lamivudine USP 300mg POM Tablet Uncoated 090/007 Strides Shasun

Page 253 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5141 Pyrazinamide Tablets Pyrazinamide 400mg POM Tablet Uncoated 090/008 Strides Shasun

5142 Rifampicin & Isoniazid TabletsRifampicin 60mg + Isoniazid

30mg

POM Tablet

Dispersible

090/009 Strides Shasun

5143 Simclox -500 CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 090/010 Strides Shasun

5144 Hyosim Tablets Hyoscine Butylbromide 10mgPOM Tablet Film

coated

090/013 Strides Shasun

5145 Griseosim - 500 Tablets Griseofulvin 500mg POM Tablet Uncoated 090/014 Strides Shasun

5146 Mebrone -100 Tablets Mebendazole 100mg P Tablet Uncoated 090/015 Strides Shasun

5147 Nalidixic Acid Tablets Nalidixic Acid 500mg P Tablet Uncoated 090/016 Strides Shasun

5148 Cefalexin - 500 Capsules Cefalexin 500mg POM Capsule oral 090/017 Strides Shasun

5149 Celltriaxone Injection Ceftriaxone Sodium USP 1gPOM Powder for

Injection

090/018 Strides Shasun

5150

Vitafer Forte Syrup

Ferric Ammonium Citrate USP

200mg (Equivalent To Elemental

Iron 41mg) Folic Acid BP 1.5mg

+ Vitamin B12 BP 50mcg, per

5ml)

P Syrup 090/019 Strides Shasun

5151 Lorhist Tablets Loratadine USP 10mg POM Tablet Uncoated 090/020 Strides Shasun

5152 Melonax 15 Tablets Meloxicam 15mg BPPOM Tablet Film

coated

090/021 Strides Shasun

5153 Camvit -Plus Capsules Multivitamins & Minerals P Capsule oral 090/022 Strides Shasun

5154 Efavirenz Tablets Efavirenz 200mg POM Tablet Uncoated 090/023 Strides Shasun

5155Amoxicillin Dry Powder For Syrup

125mg/5mlAmoxicillin 125mg

POM powder for syrup 286/001 Strides Shasun

5156 Indomethacin Capsules 25mg Indomethacin 25mg P Capsule oral 286/004 Strides Shasun

5157 Apirone 250mg Capsules Ampicillin 250mg POM Capsule oral 286/005 Strides Shasun

5158 Cloxacillin 250mg Capsules Cloxacillin 250mg POM Capsule oral 286/006 Strides Shasun

5159 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 286/008 Strides Shasun

5160 Vitamin C Tablets Ascorbic Acid P Tablet 286/009 Strides Shasun

5161Cloxacillin Dry Powder For Syrup

125mg/5mlCloxacillin 125mg

POM powder for syrup 286/010 Strides Shasun

5162Co-trimoxazole Dry Powder For Syrup

240mg/5ml

Sulfamethoxazole 200mg +

Trimethoprim 40mg

POM powder for syrup 286/013 Strides Shasun

5163 Medabon TabletsMifepristone 200mg +

Misoprostol 200mcg

POM Tablet Uncoated 083/001 Sun Pharmaceticals Limited

5164Sporidex 500 Capsules Cephalexin 500mg

POM Capsule oral 112/001 Sun Pharmaceutical Industries

Limited

Page 254 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5165 Sporidex Capsules Cephalexin 250mgPOM Capsule oral 112/002 Sun Pharmaceutical Industries

Limited

5166Simvor 10 Tablets Simvastatin 10mg

POM Tablet Film

coated

112/003 Sun Pharmaceutical Industries

Limited

5167 Simvor 20 Tablets Simvastatin 20mgPOM Tablet Film

coated

112/004 Sun Pharmaceutical Industries

Limited

5168 Effical Tablets Vitamin B3 + Calcium Carbonate P Tablet Film

coated

112/005 Sun Pharmaceutical Industries

Limited

5169 Enhancin InjectionAmoxicillin 1000mg +

Clavulanate Potassium 200mg

POM Solution for

Injection

112/007 Sun Pharmaceutical Industries

Limited

5170 Canova-50 Tablets Sildenafil 50mgPOM Tablet Uncoated 112/009 Sun Pharmaceutical Industries

Limited

5171 Fluroric 50 Capsules Fluconazole 50mgPOM Capsule oral 112/012 Sun Pharmaceutical Industries

Limited

5172 Fluroric 150 Capsules Fluconazole 150mgPOM Capsule oral 112/013 Sun Pharmaceutical Industries

Limited

5173 Silverex CreamChlorhexidine + Silver

Sulfadiazine

P Cream Topical 112/016 Sun Pharmaceutical Industries

Limited

5174Volini Gel

Race Menthol + Methyl Salicylate

+ Diclofenac + Linse

P Gel Topical 112/018 Sun Pharmaceutical Industries

Limited

5175 Storvas 20mg Tablets Atorvastatin 20mgPOM Tablet Film

coated

112/023 Sun Pharmaceutical Industries

Limited

5176 Storvas 10mg Tablets Atorvastatin 10mgPOM Tablet Film

coated

112/024 Sun Pharmaceutical Industries

Limited

5177 Ranophage 500mg Tablets Metformin 500mgPOM Tablet Uncoated 112/025 Sun Pharmaceutical Industries

Limited

5178 Enhancin 1000 TabletsAmoxicillin 875mg + Clavulanate

Potassium 125mg

POM Tablet Film

coated

112/026 Sun Pharmaceutical Industries

Limited

5179 Amlovas Tablets Amlodipine 10mgPOM Tablet Uncoated 112/027 Sun Pharmaceutical Industries

Limited

5180 Ceroxim 125mg/5ml Suspension Cefuroxime 125mg, per 5mlPOM Suspension for

Oral Use

112/028 Sun Pharmaceutical Industries

Limited

5181 Ceroxim 250mg/5ml Suspension Cefuroxime 250mg, per 5mlPOM Suspension for

Oral Use

112/029 Sun Pharmaceutical Industries

Limited

5182 Flucoric 100mg Capsules Fluconazole 100mgPOM Capsule oral 112/030 Sun Pharmaceutical Industries

Limited

5183Klabax Tablets Clarithromycin 250mg

POM Tablet Film

coated

112/031 Sun Pharmaceutical Industries

Limited

Page 255 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5184 Klabax 500 Tablets Clarithromycin 500mgPOM Tablet Film

coated

112/032 Sun Pharmaceutical Industries

Limited

5185Flucoric Capsules Fluconazole 200mg

POM Capsule oral 112/033 Sun Pharmaceutical Industries

Limited

5186 Ranmoxy 125 Suspension 125mg Amoxicillin 125mgPOM Suspension for

Oral Use

112/035 Sun Pharmaceutical Industries

Limited

5187 Cifran OD Tablets Ciprofloxacin 1gPOM Tablet Uncoated 112/036 Sun Pharmaceutical Industries

Limited

5188 Cifran OD Tablets Ciprofloxacin 500mgPOM Tablet Uncoated 112/037 Sun Pharmaceutical Industries

Limited

5189 Oframax 250 Injection Ceftriaxone 250mgPOM Powder for

Injection

112/040 Sun Pharmaceutical Industries

Limited

5190 Oframax Injection Ceftriaxone 1000mgPOM Powder for

Injection

112/041 Sun Pharmaceutical Industries

Limited

5191

Ranferon - 12 Capsules

Ferrous Fumarate 305mg +

Ascorbic Acid 75mg +

Cyanocobalamine 5mcg + Foilc

Acid 0.75mg

P Capsule oral 112/042 Sun Pharmaceutical Industries

Limited

5192 Loxof Infusion Levofloxacin 5mg, per mlPOM Solution for

infusion

112/046 Sun Pharmaceutical Industries

Limited

5193 Avostav 30 Capsules Stavudine 30mgPOM Capsule oral 112/047 Sun Pharmaceutical Industries

Limited

5194 Loxf-250 Tablets Levofloxacin 250mgPOM Tablet Film

coated

112/049 Sun Pharmaceutical Industries

Limited

5195 Loxof 500 Tablets Levofloxacin 500mgPOM Tablet Film

coated

112/050 Sun Pharmaceutical Industries

Limited

5196 Rancotrim SuspensionSulphamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

112/051 Sun Pharmaceutical Industries

Limited

5197Copril Capsules Ramipril 5mg

POM Capsule oral 112/054 Sun Pharmaceutical Industries

Limited

5198 Amlovas Tablets Amlodipine 5mgPOM Tablet Uncoated 112/055 Sun Pharmaceutical Industries

Limited

5199Bacqure 50 Injection

Cilastatin 500mg + Imipenem

500mg

POM Solution for

Injection

112/056 Sun Pharmaceutical Industries

Limited

5200 Contiflo 0.4 Capsules Tamsulosin 0.4mgPOM Capsule oral 112/057 Sun Pharmaceutical Industries

Limited

5201Avolam Tablets Lamivudine 150mg

POM Tablet Uncoated 112/058 Sun Pharmaceutical Industries

Limited

Page 256 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5202 Avocomb TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Uncoated 112/059 Sun Pharmaceutical Industries

Limited

5203Avocomb-N Tablets

Lamivudine 150mg + Nevirapine

200mg + Zidovudine 300mg

POM Tablet Uncoated 112/060 Sun Pharmaceutical Industries

Limited

5204 Abac 300 Tablets Abacavir 300mgPOM Tablet Uncoated 112/061 Sun Pharmaceutical Industries

Limited

5205 Aviro-Z Tablets Zidovudine 300mgPOM Tablet Uncoated 112/062 Sun Pharmaceutical Industries

Limited

5206 Nevipan Tablets Nevirapine 200mgPOM Tablet Uncoated 112/063 Sun Pharmaceutical Industries

Limited

5207 Histac EVT 150 Tablets Ranitidine 150mgPOM Tablet Uncoated 112/068 Sun Pharmaceutical Industries

Limited

5208 Enhancin 375 TabletsAmoxicillin 250mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 112/069 Sun Pharmaceutical Industries

Limited

5209 Enhancin 625 TabletsAmoxicillin 500mg + Clavulanate

Potassium 125mg

POM Tablet Uncoated 112/070 Sun Pharmaceutical Industries

Limited

5210 Sporidex Suspension Cephalexin 125mg, per 5mlPOM Suspension for

Oral Use

112/071 Sun Pharmaceutical Industries

Limited

5211Triviro 30 --LNS Tablets

Stavudine 30mg + Nevirapine

200mg + Lamivudine 150mg

POM Tablet Uncoated 112/073 Sun Pharmaceutical Industries

Limited

5212 Triviro 40 -LNS TabletsStavudine 40mg + Nevirapine

200mg + Lamivudine 150mg

POM Tablet Uncoated 112/074 Sun Pharmaceutical Industries

Limited

5213 Coviro-LS 30 Compliance Pack TabletsLamivudine 150mg + Stavudine

30mg

POM Tablet Uncoated 112/075 Sun Pharmaceutical Industries

Limited

5214 Coviro-LS 40 Compliance Pack TabletsLamivudine 150mg + Stavudine

40mg

POM Tablet Uncoated 112/076 Sun Pharmaceutical Industries

Limited

5215 Abac-LZ TabletsAbacavir 300mg + Lamivudine

150mg + Zidovudine 300mg

POM Tablet Uncoated 112/077 Sun Pharmaceutical Industries

Limited

5216 Avirodin Capsules Indinavir 400mgPOM Capsule oral 112/078 Sun Pharmaceutical Industries

Limited

5217 Aviranz 600 Tablets Efavirenz 600mgPOM Tablet Uncoated 112/079 Sun Pharmaceutical Industries

Limited

5218 Aviranz 200 Tablets Efavirenz 200mgPOM Tablet Uncoated 112/080 Sun Pharmaceutical Industries

Limited

5219Chericoff Syrup

Chlorpheniramine 2mg +

Dextrometherphan 10mg +

Phenylephrine 5mg, per 5ml

P Syrup 112/081 Sun Pharmaceutical Industries

Limited

5220Cifran C.T Tablets

Ciprofloxacin 500mg + Tinidazole

600mg

POM Tablet Uncoated 112/082 Sun Pharmaceutical Industries

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5221 Riconia Liquid MultivitaminsGS Syrup 112/083 Sun Pharmaceutical Industries

Limited

5222Sebifin Tablets Terbinafine 250mg

POM Tablet Uncoated 112/084 Sun Pharmaceutical Industries

Limited

5223 Riconia Tablets MultivitaminsGS Tablet Uncoated 112/085 Sun Pharmaceutical Industries

Limited

5224 Monsin Ointment Mupirocin 2.0%w/wPOM Ointment topical 112/086 Sun Pharmaceutical Industries

Limited

5225 Cepodem Suspension Cefpodoxime 40mg, per 5mlPOM Suspension for

Oral Use

112/087 Sun Pharmaceutical Industries

Limited

5226 Cepodem 200mg Tablets Cefpodoxime 200mgPOM Tablet Uncoated 112/088 Sun Pharmaceutical Industries

Limited

5227 Ranophage 1000mg Tablets Metformin 1000mgPOM Tablet Uncoated 112/089 Sun Pharmaceutical Industries

Limited

5228 Cepodem 100mg Tablets Cefpodoxime 100mgPOM Tablet Uncoated 112/090 Sun Pharmaceutical Industries

Limited

5229 Brustan TabletsParacetamol 375mg + Ibuprofen

200mg

P Tablet Film

coated

112/091 Sun Pharmaceutical Industries

Limited

5230Brustan Suspension

Paracetamol 125mg + Ibuprofen

100mg

P Suspension for

Oral Use

112/092 Sun Pharmaceutical Industries

Limited

5231 Corpril 2.5 Tablets Ramipril 2.5mgPOM Tablet Uncoated 112/093 Sun Pharmaceutical Industries

Limited

5232 Corpril 10 Tablets Ramipril 10mgPOM Tablet Uncoated 112/094 Sun Pharmaceutical Industries

Limited

5233 Avocomb-E Compliance Pack TabletsLamivudine 150mg + Zidovudine

300mg + Efavirenz 600mg

POM Tablet Uncoated 112/095 Sun Pharmaceutical Industries

Limited

5234 Coviro-E 30 Compliance Pack TabletsStavudine 30mg + Lamivudine

150mg + Efavirenz 600mg

POM Tablet Uncoated 112/096 Sun Pharmaceutical Industries

Limited

5235 Triviro LNS Kid Dispersible TabletsStavudine 10mg + Lamivudine

40mg + Nevirapine 70mg

POM Tablet

Dispersible

112/098 Sun Pharmaceutical Industries

Limited

5236 Triviro LNS Kid Dispersible TabletsStavudine 5mg + Lamivudine

20mg + Nevirapine 35mg

POM Tablet

Dispersible

112/099 Sun Pharmaceutical Industries

Limited

5237 Ranferon-12 Syrup Haematinic PreparationP Syrup 112/100 Sun Pharmaceutical Industries

Limited

5238 Enhancin SuspensionAmoxicillin 125mg + Clavulanic

Acid 31.25mg, per 5ml

POM Suspension for

Oral Use

112/101 Sun Pharmaceutical Industries

Limited

5239Lovir Cream Acyclovir 5%

POM Cream Topical 112/102 Sun Pharmaceutical Industries

Limited

Page 258 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5240 Klabax Suspension -12 Clarithromycin 125mgPOM Suspension 112/103 Sun Pharmaceutical Industries

Limited

5241Revital Capsules Ginseng + Multivitamin + Mineral

GS Capsule 112/104 Sun Pharmaceutical Industries

Limited

5242 Mucasone OintmentFluticasone 0.05mg + Mupirocin

20mg

POM Ointment topical 112/105 Sun Pharmaceutical Industries

Limited

5243 Relenost Tablets Alendronate 70mgPOM Tablet Uncoated 112/106 Sun Pharmaceutical Industries

Limited

5244 Raciper Tablets Esomeprazole 20mgPOM Tablet Uncoated 112/107 Sun Pharmaceutical Industries

Limited

5245 Amosec Tablets Secnidazole 1000mgPOM Tablet Uncoated 112/108 Sun Pharmaceutical Industries

Limited

5246 Rodera Tablets Desloratadine 5mgPOM Tablet Uncoated 112/109 Sun Pharmaceutical Industries

Limited

5247 Staval 80 Tablets Valsartan 80mgPOM Tablet Uncoated 112/110 Sun Pharmaceutical Industries

Limited

5248 Starval 16 Tablets Valsartan 160mgPOM Tablet Uncoated 112/111 Sun Pharmaceutical Industries

Limited

5249Starval HCT 80 + 12.5 Tablets

Valsartan 80mg +

Hydrochlorothiazide 12.5mg

POM Tablet Uncoated 112/112 Sun Pharmaceutical Industries

Limited

5250 Starval HCT 160/25 TabletsValsartan 160mg +

Hydrochlorothiazide 25mg

POM Tablet Uncoated 112/113 Sun Pharmaceutical Industries

Limited

5251 Raciper 40 Tablets Esomeprazole 40mgPOM Tablet Uncoated 112/114 Sun Pharmaceutical Industries

Limited

5252 Romilast 10 Tablets Montelukast 10mgPOM Tablet Uncoated 112/115 Sun Pharmaceutical Industries

Limited

5253 Ceruvin Tablets Clopidogrel 75mgPOM Tablet Uncoated 112/116 Sun Pharmaceutical Industries

Limited

5254 Brustan Gel Ibuprofen 5% + Levomenthol 3%P Gel Topical 112/117 Sun Pharmaceutical Industries

Limited

5255 Rosuvas 10 Tablets Rosuvastatin 10mgPOM Tablet Uncoated 112/118 Sun Pharmaceutical Industries

Limited

5256 Rosuvas 20 Tablets Rosuvastatin 20mgPOM Tablet Uncoated 112/119 Sun Pharmaceutical Industries

Limited

5257 Alyvir Tablets Valacyclovir 500mgPOM Tablet Uncoated 112/120 Sun Pharmaceutical Industries

Limited

5258Ranophage G1 Tablets

Glimepiride 1mg + Metformin

500mg

POM Tablet Film

coated

112/121 Sun Pharmaceutical Industries

Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5259 Ranophage G2 TabletsGlimepiride 2mg + Metformin

500mg

POM Tablet Film

coated

112/122 Sun Pharmaceutical Industries

Limited

5260Bestinem 1000mg Injection Meropenem 1000mg

POM Powder for

Injection

112/123 Sun Pharmaceutical Industries

Limited

5261 Cilentra Tablets Escitalopram Oxalate 10mgPOM Tablet Uncoated 112/124 Sun Pharmaceutical Industries

Limited

5262 Cilentra Tablets Escitalopram Oxalate 20mgPOM Tablet Uncoated 112/125 Sun Pharmaceutical Industries

Limited

5263 Adosine 100 Tablets Didanosine 100mgPOM Tablet

Dispersible

112/126 Sun Pharmaceutical Industries

Limited

5264 Adosine 50 Tablets Didanosine 50mgPOM Tablet

Dispersible

112/127 Sun Pharmaceutical Industries

Limited

5265 Adosine 25 Tablets Didanosine 25mgPOM Tablet

Dispersible

112/128 Sun Pharmaceutical Industries

Limited

5266 Olvance 20 Tablets Olmesartan Medoxomil 20mgPOM Tablet Film

coated

112/129 Sun Pharmaceutical Industries

Limited

5267 Olvance 40 Tablets Olmesartan Medoxomil 40mgPOM Tablet Film

coated

112/130 Sun Pharmaceutical Industries

Limited

5268Olvance HCT 20 Tablets

Olmesartan Medoxomil 20mg +

Hydrochlorothiazide 12.5mg

POM Tablet Film

coated

112/131 Sun Pharmaceutical Industries

Limited

5269 Olvance HCT 40 TabletsOlmesartan Medoxomil 40mg +

Hydrochlorothiazide 12.5mg

POM Tablet Film

coated

112/132 Sun Pharmaceutical Industries

Limited

5270 Sterile Water For Injection Water For InjectionPOM Solution for

Injection

262/001 Sunny Impex Private Ltd, India

5271Oral Rehydrate Salts

Sodium Chloride + Sodium

Citrate + Potassium Chloride +

Dextrose

GS Powder for Oral

Solution

262/002 Sunny Impex Private Ltd, India

5272 Water For Injection Water For InjectionPOM Solution for

Injection

056/001 Svizera Europe BV, The

Netherlands

5273

Rifampicin + Isoniazid + Pyrazinamide

+ Ethambutol FDC Tablets

Rifampicin 150mg + Isoniazid

75mg + Pyrazinamide 400mg +

Ethambutol 275mg

POM Tablet Uncoated 056/002 Svizera Europe BV, The

Netherlands

5274Streptomycin Sulphate Powder For

InjectionStreptomycin 1.0 Grams

POM Powder for

Injection

056/003 Svizera Europe BV, The

Netherlands

5275 Synerpen InjectionSulbactam 125mg + Ampicillin

250mg

POM Solution for

Injection

131/002 T3A Pharma Group, Egypt

5276Synerpen T3A Injection

Sulbactam 250mg + Ampicillin

500mg

POM Solution for

Injection

131/003 T3A Pharma Group, Egypt

Page 260 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5277 Synerpen T3A InjectionSulbactam 500mg + Ampicillin

1000mg

POM Solution for

Injection

131/004 T3A Pharma Group, Egypt

5278Cefotax T3A Injection Cefotaxime 250mg

POM Solution for

Injection

131/005 T3A Pharma Group, Egypt

5279 Bacticid Injection Gentamicin 80mg, per 2mlPOM Solution for

Injection

238/001 Tablets (India) Ltd, India

5280 Ambrolite Syrup Ambroxol 30mg, per 5ml POM Syrup 238/002 Tablets (India) Ltd, India

5281 Omnicort InjectionDexamethasone Sodium

Phosphate 4mg, per ml

POM Solution for

Injection

238/003 Tablets (India) Ltd, India

5282

Ferup Syrup

Ferrous Glycine Sulphate 220mg

+ Thiamine Hydrochloride BP

0.25mg + Cynocobalamin BP +

Folic Acid 0.5mg

P Syrup 238/004 Tablets (India) Ltd, India

5283 Tilprome Injection Promethazine 25mgPOM Solution for

Injection

238/005 Tablets (India) Ltd, India

5284 Ednisol Tablets Prednisolone 5mg POM Tablet Uncoated 238/006 Tablets (India) Ltd, India

5285 Tocosules 400 Capsules Vitamin E 400mg POM Capsule 238/007 Tablets (India) Ltd, India

5286 Astymin-3-200 Ml Injection Amino AcidsP Powder for

Injection

238/008 Tablets (India) Ltd, India

5287 Tilzole Tablets Mebendazole 100mg P Tablet Uncoated 238/009 Tablets (India) Ltd, India

5288 Neutrosec Syrup Vitamins + Minerals P Syrup 238/010 Tablets (India) Ltd, India

5289 Cifrotil Injection Ciprofloxacin 200mg, per 100mlPOM Solution for

infusion

238/011 Tablets (India) Ltd, India

5290 Statasmin-4 Tablets Salbutamol 4mg POM Tablet Uncoated 238/012 Tablets (India) Ltd, India

5291 Fevastin Tablets Paracetamol 500mg GS Tablet Uncoated 238/013 Tablets (India) Ltd, India

5292 Astymin Syrup Amino Acids And Vitamins P Syrup 238/014 Tablets (India) Ltd, India

5293 Tilstigmin Injection Neostigmine 0.5mg, per mlP Solution for

injection

238/015 Tablets (India) Ltd, India

5294 Astymin Forte Capsules Amino Acids + Minerals P Capsule oral 238/017 Tablets (India) Ltd, India

5295 Tilprome Tablets Promethazine 25mg P Tablet Uncoated 238/018 Tablets (India) Ltd, India

5296 Tilvit Syrup Multivitamins GS Syrup 238/019 Tablets (India) Ltd, India

5297 Astyfer Liquid Haematic Preparation P Solution for Oral

Use

238/020 Tablets (India) Ltd, India

5298 Antoxyl Forte Capsules Vitamins + Minerals P Capsule oral 238/021 Tablets (India) Ltd, India

5299 Movactive CapsulesGlucosamine 500mg +

Magnesium 2mg

P Capsule oral 238/022 Tablets (India) Ltd, India

5300 Profundin Tablets Ibuprofen 200mg P Tablet Uncoated 238/023 Tablets (India) Ltd, India

5301 Amedosix Tablets Furosemide 40mg POM Tablet Uncoated 238/024 Tablets (India) Ltd, India

5302 Trichogyl - 200 Tablets Metronidazole 200mg POM Tablet Uncoated 238/025 Tablets (India) Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5303 Estyplex-5 Injection Vitamin B ComplexPOM Solution for

Injection

238/026 Tablets (India) Ltd, India

5304 Promethazine Tablets Promethazine 10mg P Tablet Uncoated 238/027 Tablets (India) Ltd, India

5305 Trichogyl I.V. Injection Metronidazole 500mgPOM Solution for

infusion

238/028 Tablets (India) Ltd, India

5306 Amedosix -10 Injection Furosemide 10mgPOM Solution for

Injection

238/029 Tablets (India) Ltd, India

5307 Astyfer Capsules Folic Acid + Iron + Vit B

Complex + Amino Acids

P Capsule oral 238/030 Tablets (India) Ltd, India

5308 Cifrotil Tablets Ciprofloxacin 500mg POM Tablet Uncoated 238/031 Tablets (India) Ltd, India

5309 Tilvitone Tablets Vitamin B Complex P Tablet Uncoated 238/032 Tablets (India) Ltd, India

5310Zoleshot Fluconazole 200mg, per ml

POM Solution for

infusion

238/033 Tablets (India) Ltd, India

5311 Omega 3 Capsules Minerals + Vitamins GS Capsules Oral 008/000HM Tasly(S.A) Pty Ltd, South Africa

5312 Tasly Nano Iron + Vitamin C TabletsIron 11mg + Ascorbic Acid

100mg

GS Tablets 008/001 Tasly(S.A) Pty Ltd, South Africa

5313Miss Bee Propolis & Glossy

Ganordema Capsules

Propolis Beeglue CP 125mg +

Spora Gonaderma CP 125mg

GS Capsules oral 008/001HM Tasly(S.A) Pty Ltd, South Africa

5314 Tasly Sea Oil Capsules Cold Liver Oil 313mg GS Capsule oral 008/002HM Tasly(S.A) Pty Ltd, South Africa

5315 Kasly Cordyceps Capsules Quinese Cordceps Powder GSL capsules 008/003HM Tasly(S.A) Pty Ltd, South Africa

5316 Tasly Phyto Soy TabletsWhite Peony Root Extract, Soy

Isoflavones

GSL Tablets 008/004HM Tasly(S.A) Pty Ltd, South Africa

5317 Ginseng RH Capsules Radix Ginseng Powder GSL capsules 008/005 HM Tasly(S.A) Pty Ltd, South Africa

5318Tasly Danshen Tea Herbal Extracts 1500mg

GS Granules for

Oral Use

008/006HM Tasly(S.A) Pty Ltd, South Africa

5319 Tasly Miss Bee Royal Jelly Capsules Royal Jelly 500mg GS Capsule oral 008/007HM Tasly(S.A) Pty Ltd, South Africa

5320 Tasly Miss Bee Propolis Soft Gel Bee Propolis 400mg GS Capsule oral 008/008HM Tasly(S.A) Pty Ltd, South Africa

5321 Tasly Miss Bee Camellia BeeCamellia Pollen 500mg + Green

Tea 100mg

GS Capsule oral 008/009HM Tasly(S.A) Pty Ltd, South Africa

5322 Tasly AL Capsules Herbal Extracts 400mg GS Capsule oral 008/010HM Tasly(S.A) Pty Ltd, South Africa

5323 Tasly Propolis Syrup Bee Propolis GS Syrup 008/011HM Tasly(S.A) Pty Ltd, South Africa

5324Tasly Miss Bee Propolis + Water Pollen

CapsuleBee Propolis 500mg

GS Capsule oral 008/012HM Tasly(S.A) Pty Ltd, South Africa

5325 Tasly Kings Capsules Herbal Extracts 300mg GS Capsule oral 008/013HM Tasly(S.A) Pty Ltd, South Africa

5326 Tasly Bitter Melon Powder Capsules Bitter Melon Extract 500mg GS Capsule oral 008/014HM Tasly(S.A) Pty Ltd, South Africa

5327 Tasly Amical Capsules Amino Acids P Capsule oral 008/015 Tasly(S.A) Pty Ltd, South Africa

5328 Tasly Glucare Capsules Herbal Extracts 500mg GS Capsule oral 008/015HM Tasly(S.A) Pty Ltd, South Africa

5329 Tasly Milk Calcium Tablets Milk Calcium + Vitamins P Tablet Uncoated 008/016 Tasly(S.A) Pty Ltd, South Africa

Page 262 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5330 Tasly Nano Tammy Relief Powder Herbal ExtractsGS Powder for Oral

Use

008/016HM Tasly(S.A) Pty Ltd, South Africa

5331 Tasly Colim Forte Tablets B Complex P Tablet Uncoated 008/017 Tasly(S.A) Pty Ltd, South Africa

5332 Tasly Cerebralcare Granules Herbal ExtractsGS Granules for

Oral Use

008/017HM Tasly(S.A) Pty Ltd, South Africa

5333 Tasly Cen Forte Tablets Vitamins + Minerals P Tablet Uncoated 008/018 Tasly(S.A) Pty Ltd, South Africa

5334 Tasly Citrus Sour Tablets Herbal Extracts GS Tablet Uncoated 008/019 Tasly(S.A) Pty Ltd, South Africa

5335 Tasly I- Cleansing Capsules Herbal Extracts GS Capsule oral 008/019HM Tasly(S.A) Pty Ltd, South Africa

5336 Tasly Red Yeast Tablets Red Yeast Rice Extract GS Tablet Uncoated 008/020 Tasly(S.A) Pty Ltd, South Africa

5337 Adrenalline Injection Adrenalline 1mg, per mlPOM Solution for

Injection

147/001 Tejay Pharmaceuticals Limited

5338 Atropine Injection Atropine 0.6mg, per mlPOM Solution for

Injection

147/002 Tejay Pharmaceuticals Limited

5339Amonophylline Injection Amonophylline 25mg, per ml

POM Solution for

Injection

147/003 Tejay Pharmaceuticals Limited

5340Chlorpromazine Injection Chlorpromazine 25mg, per ml

POM Solution for

Injection

147/004 Tejay Pharmaceuticals Limited

5341 Diazepam Injection Diazepam 5mg, per mlPOM Solution for

Injection

147/005 Tejay Pharmaceuticals Limited

5342 Furosemide Injection Furosemide 10mg, per mlPOM Solution for

Injection

147/006 Tejay Pharmaceuticals Limited

5343 Gentamycin Injection Gentamycin InjectionPOM Solution for

Injection

147/007 Tejay Pharmaceuticals Limited

5344Pethidine Injection Pethidine 40mg, per ml

POM Solution for

Injection

147/008 Tejay Pharmaceuticals Limited

5345 Quinine Injection Quinine 300mg, per mlPOM Solution for

Injection

147/009 Tejay Pharmaceuticals Limited

5346 Chloramphenicol Drops Chlorampehicol BP 0.5% POM Eye Drops 147/010 Tejay Pharmaceuticals Limited

5347 Betamethasone Drops Betamethasone 0.1% POM Eye Drops 147/011 Tejay Pharmaceuticals Limited

5348 Betamethasone Plus DropsNeomycin + Betamethasone

0.45%

POM Eye Drops 147/012 Tejay Pharmaceuticals Limited

5349 Ciprofloxacin Eye/Ear Drops Ciprofloxacin 0.3% POM Eye Drops 147/013 Tejay Pharmaceuticals Limited

5350 Analgin Injection Analgin I.P 500mg, per mlPOM Solution for

Injection

147/014 Tejay Pharmaceuticals Limited

5351Dexamethasone+ Neoomycin Eye/Ear

Drops

Neomycin Sulphate +

Dexamethasone Phosphate

POM Ear/Eye Drops 147/015 Tejay Pharmaceuticals Limited

5352Promethazine Injection

Promethazine Hydrochloride

25mg, per ml

POM Solution for

Injection

147/016 Tejay Pharmaceuticals Limited

5353 Gentamycin Eye/Ear Drops Gentamycin Sulphate 0.3% POM Ear/Eye Drops 147/018 Tejay Pharmaceuticals Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5354 Lignocaine 2% Injection Lignocaine Dihydrochloride 2.0%POM Solution for

Injection

147/020 Tejay Pharmaceuticals Limited

5355Hydralazine Injection Hydralazine 20mg, per ml

POM Solution for

Injection

147/021 Tejay Pharmaceuticals Limited

5356 Dexamethasone InjectionDexamethasone Phosphate

0.1%w/v

POM Solution for

Injection

147/022 Tejay Pharmaceuticals Limited

5357 Diclofenac Sodium Injection Diclofenac Sodium 25mgPOM Solution for

Injection

147/023 Tejay Pharmaceuticals Limited

5358 Metoclopromide InjectionMetoclopromide Hydrochloride

USP 5mg, per ml

POM Solution for

Injection

147/024 Tejay Pharmaceuticals Limited

5359 Hyoscine Butylbromide InjectionHyocine Butylbromide 20mg, per

ml

POM Solution for

Injection

147/025 Tejay Pharmaceuticals Limited

5360 Potassium Chloride InjectionPotassium Chloride Injection

150mg, per ml

POM Solution for

Injection

147/026 Tejay Pharmaceuticals Limited

5361 Calcium Gluconate Injection Calcium Gluconate 15mgPOM Solution for

Injection

147/027 Tejay Pharmaceuticals Limited

5362 Pilocarpine Nitrate Eye Drops Pilocarpine Nitrate 15mg POM Eye Drops 147/028 Tejay Pharmaceuticals Limited

5363 Sodium Cromoglycate Eye Drops Sodium Cromoglycate 2% P Eye Drops 147/029 Tejay Pharmaceuticals Limited

5364 Xylomethazoline Nasal Drops Xylomethazoline 0.1% P Nasal drops 147/030 Tejay Pharmaceuticals Limited

5365 Timolol Eye Drops Timolol 0.5% POM Eye Drops 147/031 Tejay Pharmaceuticals Limited

5366Sodium Bicarbonate Injection Sodium Bicarbonate 8.4%

POM Solution for

Injection

147/032 Tejay Pharmaceuticals Limited

5367 Magnesium Sulphate Injection Magnesium SulphatePOM Solution for

Injection

147/033 Tejay Pharmaceuticals Limited

5368 Atropin Sulphate Eye Drops Atropin Sulphate 1% POM Eye Drops 147/034 Tejay Pharmaceuticals Limited

5369 Morphine Sulphate Injection Morphine SulphatePOM Solution for

Injection

147/035 Tejay Pharmaceuticals Limited

5370

Asmarid Syrup

Adhatoda vasica 0.68gm + Piper

longum 0.14gm + Vitis vinifera

0.14gm + Terminalia chebula

73.24mg + Woodfordia fruti-

cosa 1.14gm + Glycyrhiza glabra

6.78mg + Ficas infectoria

6.78mg + Acorns calamus

6.78mg + Trikatu ( Piper longum

+ Piper nigrum +

Zingiber officinalis

P Syrup 147/036 Tejay Pharmaceuticals Limited

5371Histinil Syrup

Chlopheniramine Maleate BP

2mg, per 5ml

P Syrup 147/037 Tejay Pharmaceuticals Limited

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5372 Panridol Syrup P Syrup 147/038 Tejay Pharmaceuticals Limited

5373 Promethazine Syrup Promethazine 5mg, per 5ml P Syrup 147/039 Tejay Pharmaceuticals Limited

5374Guaiphen Cough Syrup

Paracetamol + Chlopheniramine

+ Guaiphenesin

P Syrup 147/040 Tejay Pharmaceuticals Limited

5375 Co-Trimoxazole SuspensionSulphamethoxazole +

Trimethoprim 240mg, per 5ml

POM Suspension for

Oral Use

147/041 Tejay Pharmaceuticals Limited

5376 Diclofenac Eye Drops Diclofenac 1.1% POM Eye Drops 147/042 Tejay Pharmaceuticals Limited

5377 Arti Tear Hydroxypropyl Methyl Cellulose P Eye Drops 147/043 Tejay Pharmaceuticals Limited

5378 Betagenta Eye/Ear DropsBetamethasone 0.1% +

Gentamycin 0.3%

POM Eye Drops 147/044 Tejay Pharmaceuticals Limited

5379 Dexagenta Eye/Ear DropsBetamethasone 0.1% +

Gentamycin 0.3%

POM Ear/Eye Drops 147/045 Tejay Pharmaceuticals Limited

5380 Chlordex Eye/Ear DropsDexamethasone 0.1%+

Chloramphenicol 0.5%

POM Ear/Eye Drops 147/046 Tejay Pharmaceuticals Limited

5381 Tvision Eye Drops Lignocaine 0.02% POM Eye Drops 147/047 Tejay Pharmaceuticals Limited

5382Menadione Bisufite Injection Phytomenadione 10mg, per ml

POM Solution for

Injection

147/048 Tejay Pharmaceuticals Limited

5383

Histinil with Codiene

Diphenylhydramine

Hydrochloride 10mg + Codeine

Phosphate 10mg + Ammonium

Chloride 125mg

P Syrup 147/049 Tejay Pharmaceuticals Limited

5384 Mentholatum Deep RubTerpentine + Eucalyptus +

Menthol + Methyl Salicylate

P Cream Topical 003/004 The Mentholatum company Ltd,

UK

5385Mentholatum Balm

Camphor + Menthol + Methyl

Salicylate

GS Ointment topical 003/006 The Mentholatum company Ltd,

UK5386 Sepgard Gel Centbucridine + Feracrylum 1% P Gel Topical 171/001 Themis Medicare Ltd, India

5387 Simvastol 10mg Tablets Simvastatin 10mg POM Tablet Uncoated 171/002 Themis Medicare Ltd, India

5388 Simvastol 20mg Tablets Simvastatin 20mg POM Tablet Uncoated 171/003 Themis Medicare Ltd, India

5389 Hemolok Solution Feracrylum 1%w/vP Solution for

Topical Use

171/004 Themis Medicare Ltd, India

5390 E Mal Injection Artemether 150mg, per 2mlPOM Solution for

Injection

171/005 Themis Medicare Ltd, India

5391 7-Forces Capsules Herbal Extracts 115mgGS Capsule oral 069/001 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5392 Casper Capsules Herbal ExtractsGS Capsule oral 069/002 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5393Mega-Mind 1120mg Capsules Herbal Extracts 1120mg

GS Capsule oral 069/003 Tianjin Tianshi Biological

Engineering Co. Ltd, China

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5394 Vega Power 710mg Capsules Herbal Extracts 710mgGS Capsule oral 069/004 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5395CZF-Iron 55.3mg Capsules

Ferrous Sulphate 16.33mg +

Zinc Sulfate 15mg + Vitamin C

24mg

P Capsule oral 069/005 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5396 Dia Gins Soft Gel Capsules Ginseng Extract 100mgP Capsule oral 069/006 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5397 Toma Soft Gelatin CapsulesGarlic Oil 0.66mg + Biloba

Extract 120mg

GS Capsule oral 069/007 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5398 King Royal 600mg CapsulesRoyal Jelly 600mg + Puama

Extract 30mg

GS Capsule oral 069/008 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5399Ever Youth Capsules

Royal Jelly 200mg + Damiana

Extract 200mg + Evening

Primrose Extract 250mg

P Capsule oral 069/009 Tianjin Tianshi Biological

Engineering Co. Ltd, China

5400 Antidep Tablets Imipramine 25mgPOM Tablet Uncoated 089/061 Torrent Pharmaceuticals Limited,

India

5401 Nexpro -40 TabletsEsomeprazole Magnesium

Trihydrate 40mg

POM Tablet Enteric

Coated

089/062 Torrent Pharmaceuticals Limited,

India

5402 Nexpro -20 TabletsEsomeprazole Magnesium

Trihydrate 20mg

POM Tablet Enteric

Coated

089/063 Torrent Pharmaceuticals Limited,

India5403 Listril-10 Tablets Lisinopril 10mg POM Tablet Uncoated 082/022 Torrent Exports Limited, India

5404 Rantin-150 Tablets Ranitidine 150mg POM Tablet Uncoated 089/003 Torrent Exports Limited, India

5405Quintor-500 Tablets Ciprofloxacin 500mg

POM Tablet Film

coated

089/007 Torrent Exports Limited, India

5406 Herpex-200 Tablets Acyclovir 200mg POM Tablet Uncoated 089/008 Torrent Exports Limited, India

5407 Herpex Cream Aciclovir 5%w/w POM Cream Topical 089/009 Torrent Exports Limited, India

5408Calcigard Retard Tablets Nifedipine 20mg

POM Tablet extended

release

089/010 Torrent Exports Limited, India

5409 Tozaar - 50 Tablets Losartan 50mgPOM Tablet Film

coated

089/011 Torrent Exports Limited, India

5410 Domstal Tablets Domperidone 10mg POM Tablet Uncoated 089/012 Torrent Exports Limited, India

5411 Domstal Suspension Domperidone 1mg, per mlPOM Suspension for

Oral Use

089/013 Torrent Exports Limited, India

5412 Ranitin Injection Ranitidine 25mgPOM Solution for

Injection

089/014 Torrent Exports Limited, India

5413 Toroxx -MT-50 Tablets Rofecoxib 50mg POM Tablet Uncoated 089/016 Torrent Exports Limited, India

5414Deplatt Tablets Mannitol USP + Clopidogrel I.H

POM Tablet Film

coated

089/017 Torrent Exports Limited, India

5415 Uroflox -400 Tablets Norfloxacin 400mg POM Tablet Uncoated 089/018 Torrent Exports Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5416 Betacard-100 Tablets Atenolol 100mg POM Tablet Uncoated 089/019 Torrent Exports Limited, India

5417 Syscan-100 Caspules Fluconazole 100mg POM Capsule oral 089/020 Torrent Exports Limited, India

5418 Omizac Capsules Omeprazole 20mg POM Capsule oral 089/021 Torrent Exports Limited, India

5419 Syscan- 200 Capsules Fluconazole 200mg POM Capsule oral 089/023 Torrent Exports Limited, India

5420 Tocofer-200 Soft Gelatin Capsules Vitamin E 200mg POM Capsule oral 089/024 Torrent Exports Limited, India

5421 Tocofer-400 Capsules Vitamin E 400mg POM Capsule oral 089/025 Torrent Exports Limited, India

5422 Batacard-50 Tablets Atenolol 50mg POM Tablet Uncoated 089/026 Torrent Exports Limited, India

5423 Syscan-150 Capsules Fluconazole 150mg POM Capsule oral 089/027 Torrent Exports Limited, India

5424 Calcigard-10 Capsules Nifedipine 10mg POM Capsule oral 089/028 Torrent Exports Limited, India

5425 Lopamide Tablets Loperamide 2mg POM Tablet Uncoated 089/029 Torrent Exports Limited, India

5426Ive Metro Injection Metronidazole 5mg, per ml

POM Solution for

Infusion

089/030 Torrent Exports Limited, India

5427 Tormoxine 250 Capsules Amoxicillin 250mg POM Capsule oral 089/031 Torrent Exports Limited, India

5428 Listril-5 Tablets Lisinopril 5mg POM Tablet Uncoated 089/032 Torrent Exports Limited, India

5429 Fegem 100 Tablets Ferric Hydroxide 450mg P Tablet Uncoated 089/033 Torrent Exports Limited, India

5430 Herpex 800 DT Tablets Acyclovir 800mg POM Tablet Uncoated 089/035 Torrent Exports Limited, India

5431 Modlip 10 Tablets Atorvastatin 10mgPOM Tablet Film

coated

089/036 Torrent Exports Limited, India

5432 Domstal O CapsulesOmeprazole 10mg +

Domperidone 10mg

POM Capsule oral 089/037 Torrent Exports Limited, India

5433 Modlip 20 Tablets Atorvastatin 20mgPOM Tablet Film

coated

089/038 Torrent Exports Limited, India

5434 Lamitor 100 Tablets Lamotrigine 100mg POM Tablet Uncoated 089/039 Torrent Exports Limited, India

5435 Nebicard -5 Tablets Nebivolol 5mg POM Tablet Uncoated 089/040 Torrent Exports Limited, India

5436 Velos-20 Tablets Rabeprazole 20mg POM Tablet Uncoated 089/041 Torrent Exports Limited, India

5437 Velos-Tablets Rabeprazole 10mg POM Tablet Uncoated 089/042 Torrent Exports Limited, India

5438 Valparin 200 Tablets Sodium Valproate 200mg POM Tablet Uncoated 089/043 Torrent Exports Limited, India

5439 Tide-10 Tablets Torasemide 10mg POM Tablet Uncoated 089/044 Torrent Exports Limited, India

5440 Lefra 20 Tablets Leflunomide 20mg POM Tablet Uncoated 089/045 Torrent Exports Limited, India

5441 Karvil-6.25 Tablets Carvedilol 6.25mg POM Tablet Uncoated 089/046 Torrent Exports Limited, India

5442 Esam-2.5 Tablets Amlodipine 2.5mg POM Tablet Uncoated 089/047 Torrent Exports Limited, India

5443 Azulix 2 Tablets Glimepiride 2mg POM Tablet Uncoated 089/048 Torrent Exports Limited, India

5444 Topril Capsules Ramipril 5mg POM Capsule oral 089/049 Torrent Exports Limited, India

5445 Serenata-50 Tablets Sertraline 50mg POM Tablet Uncoated 089/050 Torrent Exports Limited, India

5446 Valzaar 80 Tablets Valsartan 80mg POM Tablet Uncoated 089/051 Torrent Exports Limited, India

5447 Valzaar 160 Tablets Valsartan 160mg POM Tablet Uncoated 089/052 Torrent Exports Limited, India

5448Tozaar-H 62.5mg Tablets

Hydrochlorothiazide 12.5mg +

Losartan 50mg

POM Tablet Uncoated 089/053 Torrent Exports Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5449 Tozaar-100mg Tablets Losartan 125mg POM Tablet Uncoated 089/054 Torrent Exports Limited, India

5450 Nexpro IV Injection Esomeprazole 40mgPOM Powder for

Injection

089/055 Torrent Exports Limited, India

5451 Tozaar-Plus DS 125mg TabletsHydrochlorothiazide 25mg +

Losartan 100mg

POM Tablet Uncoated 089/056 Torrent Exports Limited, India

5452 Torocef - 1 Injection Ceftriaxone 1000mgPOM Powder for

Injection

089/057 Torrent Exports Limited, India

5453 Quintor Infusion Ciprofloxacin 200mgPOM Solution for

infusion

089/058 Torrent Exports Limited, India

5454 Syscan -100ml I.V Infusion Fluconazole 200mgPOM Solution for

infusion

089/059 Torrent Exports Limited, India

5455 Funginoc Cream Ketoconazole 2%w/w POM Cream Topical 089/060 Torrent Exports Limited, India

5456 Asthator 5 Tablets Montelukast Sodium IH 5mg POM Tablet Uncoated 089/064 Torrent Exports Limited, India

5457 Asthator 10 Tablets Montelukast Sodium IH 10mg POM Tablet Uncoated 089/065 Torrent Exports Limited, India

5458 Asthator 4 Tablets Montelukast Sodium BP 4mg POM Tablet Uncoated 089/066 Torrent Exports Limited, India

5459Olmecor Tablets

Olmesartan Medoxomil

Hydrochloride 40mg

POM Tablet Uncoated 089/068 Torrent Exports Limited, India

5460 Alfutor ER TabletsAlfuzosine Hydrochloride USP

10mg

POM Tablet Uncoated 089/069 Torrent Exports Limited, India

5461 Acetyl Salicylic Acid 300mg Tablets Acetycylsalicylic Acid BP 300mg GS Tablet Uncoated 110/002 Troge Medical GMBH, Germany

5462 Amoxicillin 250 Capsules Amoxicilin 250mg POM Capsule oral 110/003 Troge Medical GMBH, Germany

5463 Trio-Vital Tablets Multivitamin GS Tablet Uncoated 110/003 Troge Medical GMBH, Germany

5464Amoxicillin Suspension Amoxicilin 125mg, per 5ml

POM Powder for Oral

Suspension

110/004 Troge Medical GMBH, Germany

5465 Tetracycline 250mg Capsules Tetracycline 250mg POM Capsule oral 110/005 Troge Medical GMBH, Germany

5466 Tetracycline Ophthalmic OintmentTetracycline Hydrochloride

1%w/v

POM Eye Ointment 110/006 Troge Medical GMBH, Germany

5467 Ampicillin Injection Ampicillin 500mgPOM Powder for

Injection

110/008 Troge Medical GMBH, Germany

5468 Ampicillin Oral Suspension Ampicillin 125mg, per mlPOM Suspension for

Oral Use

110/009 Troge Medical GMBH, Germany

5469Streptomycin Injection Streptomycin Sulphate 1g

POM Powder for

Injection

110/010 Troge Medical GMBH, Germany

5470 Vitamin B Complex Injection Vitamin B ComplexPOM Solution for

Injection

110/011 Troge Medical GMBH, Germany

5471Crystalline Benzylpenicillin Injection Benzyl Penicillin 1Mega

POM Solution for

Injection

110/012 Troge Medical GMBH, Germany

5472 Indomethacin 25mg Capsules Indomethacin 25mg POM Capsule oral 110/015 Troge Medical GMBH, Germany

5473 Metronidazole 200mg Tablets Metronidazole 200mg POM Tablet Uncoated 110/016 Troge Medical GMBH, Germany

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5474 Phenoxymethyl Penicillin 250 Tablets Phenoxymethyl Penicillin 250mg POM Tablet Uncoated 110/018 Troge Medical GMBH, Germany

5475 Crystalline Benzyl Penicillin Injection Benzyl Penicillin 5megaPOM Solution for

Injection

110/019 Troge Medical GMBH, Germany

5476 Chloramphenicol Eye Ointment Chlorampenicol 1%w/w POM Eye Ointment 110/021 Troge Medical GMBH, Germany

5477 Fortified Procaine Penicillin Injection Procain Penicillin 4MegaPOM Powder for

Injection

110/022 Troge Medical GMBH, Germany

5478 Gentamycin Injection Gentamycin 80mg, per 2mlPOM Solution for

Injection

110/023 Troge Medical GMBH, Germany

5479 Griseofulvin Tablets Griseofulvin 500mg POM Tablet Uncoated 110/024 Troge Medical GMBH, Germany

5480 Chloramphenicol InjectionChlorampenicol Sodium

Succinate Injection BP 1g

POM Powder for

Injection

110/025 Troge Medical GMBH, Germany

5481Co-trimoxazole Tablets

Trimethoprim 80mg +

Sulphamethoxazole 400mg

POM Tablet Uncoated 110/026 Troge Medical GMBH, Germany

5482 Ampicillin/Cloxacillin CapsulesAmpicillin 250mg + Cloxacillin

250mg

POM Capsule oral 110/027 Troge Medical GMBH, Germany

5483Erythromycin Tablets Erythromycin Stearate BP 250mg

POM Tablet Uncoated 110/029 Troge Medical GMBH, Germany

5484 Dynapar AQ 3ml Injection Diclofenac 25mg, per mlPOM Solution for

Injection

196/001 Troikaa Pharmaceuticals Limited,

India

5485Hydrocortisone Sodium Succinate

InjectionHydrocortisone 100mg

POM Powder for

Injection

196/002 Troikaa Pharmaceuticals Limited,

India

5486 Gentamicin Sulphate Injection Gentamicin 80mg, per 2mlPOM Solution for

Injection

196/004 Troikaa Pharmaceuticals Limited,

India

5487Dynapar tablets

Diclofenac 50mg + Paracetamol

500mg

P Tablets

Uncoated

196/005 Troikaa Pharmaceuticals Limited,

India

5488 Ketamax-50 InjectionKetamine Hydrochloride 50mg,

per ml

POM Solution for

Injection

196/006 Troikaa Pharmaceuticals Limited,

India

5489 Dynapar SR 100 Tablets Diclofenac 100mgPOM Tablet Uncoated 196/007 Troikaa Pharmaceuticals Ltd,

India

5490Dynapar AQ 1ml Injection Diclofenac 75mg

POM Solution for

Injection

196/008 Troikaa Pharmaceuticals Ltd,

India

5491 Isotroy 100 Liquid Isoflurane 1mg, per mlPOM Solution for

Inhalation

196/009 Troikaa Pharmaceuticals Ltd,

India

5492 Troypofol Injection Propofol 10mg, per mlPOM Powder for

Injection

196/010 Troikaa Pharmaceuticals Ltd,

India

5493 Troycurium Injection Atracurium Besylate 10mg/mlPOM Solution for

Injection

196/011 Troikaa Pharmaceuticals Ltd,

India

5494Xykaa Extend Tablets Paracetamol 650mg

GS Tablet extended

release

196/012 Troikaa Pharmaceuticals Ltd,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5495 Lesstrol -10 Tablets Atorvastatin Calcium 10mgPOM Tablet Uncoated 196/013 Troikaa Pharmaceuticals Ltd,

India

5496Telmikaa - 40 Tablets Telmisartan 40mg

POM Tablet Uncoated 196/014 Troikaa Pharmaceuticals Ltd,

India

5497 Telmikka - 80 Tablets Telmisartan 80mgPOM Tablet Uncoated 196/015 Troikaa Pharmaceuticals Ltd,

India

5498 Feno TG Tablets Fenofibrate 160mgPOM Tablet Uncoated 196/016 Troikaa Pharmaceuticals Ltd,

India

5499 Telmikaa -H TabletsTelmisartan 40mg +

Hydrochlorothiazide 12.50mg

POM Tablet Uncoated 196/017 Troikaa Pharmaceuticals Ltd,

India

5500 Zyltan 50 Tablets Losartan Potassium 50mgPOM Tablet Uncoated 196/018 Troikaa Pharmaceuticals Ltd,

India

5501 Xykaa Rapid Tablets Paracetamol 500mgGS Tablet Uncoated 196/019 Troikaa Pharmaceuticals Ltd,

India

5502 Bupitroy 0.5% InjectionBupivacaine Hydrochloride

0.5mg USP

POM Solution for

Injection

196/020 Troikaa Pharmaceuticals Ltd,

India

5503 Dynapar QPS Topical SolutionDiclofenac Diethyl Amine

46.40mg

P Solution for

Topical Use

196/021 Troikaa Pharmaceuticals Ltd,

India

5504Dynapar QPS Plus Topical Soution

Diclofenac Diethyl Amine

23.20mg + Methyl Salicylate

100.00mg + Menthol 50mg

P Solution for

Topical Use

196/022 Troikaa Pharmaceuticals Ltd,

India

5505 Diltigesic Gel Diltiazem Hydrochloride 2% w/w POM Gel Topical 196/023Troikaa Pharmaceuticals Ltd,

India

5506 Ucetamol-500 Tablets Paracetamol 500mgGS Tablet Uncoated 193/001 Umedica Laboratories (Pvt Ltd,

India

5507 Erythromycin 250mg Tablets Erythromycin 250mgPOM Tablet Uncoated 193/002 Umedica Laboratories (Pvt Ltd,

India

5508 Nifedipine Retard-20 Tablets Nifedipine 20mgPOM Tablet Uncoated 193/003 Umedica Laboratories (Pvt Ltd,

India

5509Ucetaxime-1000 Injection Cetaxime 1000mg

POM Powder for

Injection

193/004 Umedica Laboratories (Pvt Ltd,

India

5510 Co-Trimoxazole 480mg TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 193/005 Umedica Laboratories (Pvt Ltd,

India

5511 Umoxil-250mg Capsules Amoxicillin 250mgPOM Capsule Oral 193/006 Umedica Laboratories (Pvt Ltd,

India

5512 Benzyl Penicillin 5 M.U Injection Benzyl Penicillin 5M.UPOM Powder for

Injection

193/007 Umedica Laboratories (Pvt Ltd,

India

5513Co-Trimoxazole 240mg/5ml Oral

Suspension

Sulphamethoxazole 200mg +

Trimethoprim 80mg

POM Suspension for

Oral Use

193/008 Umedica Laboratories (Pvt Ltd,

India

Page 270 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5514Umoxil-125mg/5ml Powder For Oral

SuspensionAmoxicillin 125mg, per 5ml

POM Powder for Oral

Suspension

193/009 Umedica Laboratories (Pvt Ltd,

India

5515Umeran 50 (Diclofenac 50mg Tablets Diclofenac 50mg

P Tablet Oral 193/010 Umedica Laboratories (Pvt Ltd,

India

5516 Kojex Tablets Liquorice 180mgGS Tablet Uncoated 193/013 Umedica Laboratories (Pvt Ltd,

India

5517 Umedica Blood Tonic Haematic Preparation P Solution for Oral

Use

193/014 Umedica Laboratories (Pvt Ltd,

India

5518 Uroxime 250 Tablets Cefuroxime 250mgPOM Tablet Uncoated 193/015 Umedica Laboratories (Pvt Ltd,

India

5519 Uroxime 500 Tablets Cefuroxime 500mgPOM Tablet Uncoated 193/016 Umedica Laboratories (Pvt Ltd,

India

5520 Fast Releif TabletsParacetamol 100mg +

Aceclofenac 500mg

P Tablet Uncoated 193/017 Umedica Laboratories (Pvt Ltd,

India

5521 Malidar TabletsSulfadoxine 500mg +

Pyrimethamine 25mg

P Tablet Uncoated 193/018 Umedica Laboratories (Pvt Ltd,

India

5522 Fixdep -180 Tablets Fexofenadine 180mgPOM Tablet Uncoated 193/019 Umedica Laboratories (Pvt Ltd,

India

5523Unimezol Tablets Metronidazole 200mg

POM Tablet Uncoated 268/001 Unichem Laboratories Limited,

India

5524 Zyncet Tablets Cetirizine 10mgPOM Tablet Uncoated 268/002 Unichem Laboratories Limited,

India

5525 Zyncet Syrup Cetirizine 5mg, per 5mlPOM Syrup 268/003 Unichem Laboratories Limited,

India

5526 Evaflox Tablets Ofloxacin 200mgPOM Tablet Uncoated 268/004 Unichem Laboratories Limited,

India

5527 Evaflox 400 Tablets Ofloxacin 400mgPOM Tablet Uncoated 268/005 Unichem Laboratories Limited,

India

5528 M-Cam 15 Tablets Meloxicam 15mgPOM Tablet Uncoated 268/006 Unichem Laboratories Limited,

India

5529 M-Cam 7.5 Tablets Meloxicam 7.5mgPOM Tablet Uncoated 268/007 Unichem Laboratories Limited,

India

5530 Corvadil-A Tablets Atenolol 50mg + Amlodipine 5mgPOM Tablet Uncoated 268/008 Unichem Laboratories Limited,

India

5531 Tagera Forte Tablets Secnidazole 1gPOM Tablet Uncoated 268/009 Unichem Laboratories Limited,

India

5532Sulbacin Injection

Ampicillin 500mg + Sulbactam

250mg

POM Powder for

Injection

268/010 Unichem Laboratories Limited,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5533 Sulbacin 375 TabletsAmpicillin 500mg + Sulbactam

250mg

POM Tablet Uncoated 268/011 Unichem Laboratories Limited,

India

5534Domadol Capsules Tramadol 50mg

POM Capsule oral 268/012 Unichem Laboratories Limited,

India

5535 Domadol Injection Tramadol 50mgPOM Solution for

Injection

268/013 Unichem Laboratories Limited,

India

5536 Tg Tor Tablets Atorvastatin 10mgPOM Tablet Uncoated 268/014 Unichem Laboratories Limited,

India

5537 Corvadil 5 Tablets Amlodipine 5mgPOM Tablet Uncoated 268/015 Unichem Laboratories Limited,

India

5538 Losar-50 Tablets Losartan 50mgPOM Tablet Uncoated 268/016 Unichem Laboratories Limited,

India

5539 Myclav 625 TabletsAmoxicillin 500mg + Clavulanate

125mg

POM Tablet Uncoated 268/018 Unichem Laboratories Limited,

India

5540 Domadol 100mg Injection Tramadol 100mgPOM Solution for

Injection

268/019 Unichem Laboratories Limited,

India

5541Unienzyme Cmps Tablet

Fungal Distate (1:8000) 20mg +

Papain 30mg + Simethicone

30mg + Act 75mg

P Tablet Chewable 268/020 Unichem Laboratories Limited,

India

5542 Corbis - 10 Tablets Bisoprolol Fumerate 10mgPOM Tablet Uncoated 268/021 Unichem Laboratories Limited,

India

5543 Corbis-5 Tablets Bisoprolol Fumerate 5mgPOM Tablet Uncoated 268/022 Unichem Laboratories Limited,

India

5544 Aroff Tablets Aceclofenac 100mgP Tablet Film

coated

268/023 Unichem Laboratories Limited,

India

5545 Myclav Powder 228.5 SuspensionAmoxicillin Trihydrate 200mg +

Potassium Clavulanate 28.5mg

POM Suspension 268/024 Unichem Laboratories Limited,

India

5546 Myclav Powder 156.25 SuspensionAmoxicillin Trihydrate 125mg +

Potassium Clavulanate 28.5mg

POM Suspension 268/025 Unichem Laboratories Limited,

India

5547Myclav 375 Tablets

Amoxicillin 250mg + Clavulanate

125mg

POM Tablet Uncoated 286/017 Unichem Laboratories Limited,

India

5548Domadol Plus Tablets

Acetaminophen 325mg +

Tramadol Hydrocholoride 37.5mg

POM Tablet Film

coated

288/026 Unichem Laboratories Limited,

India

5549 Quetia 25 Tablets Quentiapine 25mgPOM Tablet Uncoated 288/027 Unichem Laboratories Limited,

India

5550Quetia 100 Tablets Quentiapine 100mg

POM Tablet Uncoated 288/028 Unichem Laboratories Limited,

India

Page 272 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5551 Quetia 200 Tablets Quentiapine 200mgPOM Tablet Uncoated 288/029 Unichem Laboratories Limited,

India

5552Quetia 300 Tablets Quentiapine 300mg

POM Tablet Uncoated 288/030 Unichem Laboratories Limited,

India

5553 Lenor 72 Tablets Levonorgestrel 0.75mgPOM Tablet Uncoated 223/001 Unicure Remedies (Pvt) Limited,

India

5554 Mepen 250 Tablets Mefenamic Acid 250mgP Tablet Uncoated 223/002 Unicure Remedies (Pvt) Limited,

India

5555 NC Norm-P Tablets Norethisterone 5mgPOM Tablet Uncoated 223/003 Unicure Remedies (Pvt) Limited,

India

5556 Eros 10 Tablets Tadalafil 10mgPOM Tablet Uncoated 223/004 Unicure Remedies (Pvt) Limited,

India

5557 Lactone 25 Tablets Spironolactone 25mgPOM Tablet Uncoated 223/005 Unicure Remedies (Pvt) Limited,

India

5558 Flagon 50 Tablets Diclofenac 50mgP Tablet Uncoated 223/006 Unicure Remedies (Pvt) Limited,

India

5559 Blue Diamond Tablets Sildenafil 50mgPOM Tablet Uncoated 223/007 Unicure Remedies (Pvt) Limited,

India

5560Florina -28 Tablets

Ethinylestradiol 0.03mg +

Levonorgestrel 0.15mg

POM Tablet Film

coated

223/008 Unicure Remedies (Pvt) Limited,

India

5561 Eros 20 Tablets Tadalafil 20mgPOM Tablet Uncoated 223/010 Unicure Remedies (Pvt) Limited,

India

5562 Goldman Tablets Dapoxetine Hydrochloride 60mgPOM Tablet Uncoated 223/011 Unicure Remedies (Pvt) Limited,

India

5563 Vital-Z PowderAnhydrous Glucose + Sucrose +

Ascorbic Acid + Zinc

P Powder for Oral

Solution

223/07 Unicure Remedies (Pvt) Limited,

India5564 Love condoms Male Latex Condoms GS Latex Products 410/001L Unidus Corporation

5565Lifebuoy Deofresh Bar Soap

EHDP/ADPA/Etidronic Acid

0.04% + Tetrasodium EDTA

0.02%

GS Solid Soap 012/001 Unilever SEA Zambia Limited,

Zambia

5566 Lifebuoy Total Red Bar SoapEHDP + ADPA + Etidronic Acid +

Tetrasodium EDTA

GS Solid Soap 012/002 Unilever SEA Zambia Limited,

Zambia

5567Geisha Germigaurd Soap (Neem &

Soothing Basil)Extrapone 5 Plant 0.0003%w/w

GS Solid Soap 012/002HM Unilever SEA Zambia Limited,

Zambia

5568Lifebuoy Herbal Bar Soap

EHDP/ADPA/Etidronic Acid

0.04% + Tetrasodium EDTA

0.02%

GS Solid Soap 012/003 Unilever SEA Zambia Limited,

Zambia

5569Geisha Germigaurd Soap (Mint &

Green Tea)Extrapone 5 Plant 0.0003%w/w

GS Solid Soap 012/003HM Unilever SEA Zambia Limited,

Zambia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5570Lifebuoy Care Bar Soap

EHDP/ADPA/Etidronic Acid

0.04% + Tetrasodium EDTA

0.02%

GS Solid Soap 012/004 Unilever SEA Zambia Limited,

Zambia

5571

Lifebouy Antibacterial Handwash - Care

Trichlorocarbanilide 0.02% +

DTPA-Na 0.125% + Glyceryl

Mono Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/004L Unilever SEA Zambia Limited,

Zambia

5572

Lifebouy Antibacterial Handwash -

Classic

Trichlorocarbanilide 0.02% +

DTPA -Na 0.125% + Glyceryl

Mono Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/005L Unilever SEA Zambia Limited,

Zambia

5573

Lifebouy Antibacterial Handwash -

Fresh

Trichlorocarbanilide 0.02% +

DTPA -Na 0.125% + Glyceryl

Mono Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/006L Unilever SEA Zambia Limited,

Zambia

5574

Lifebouy Antibacterial Handwash-

Nature

Trichlorocarbanilide 0.02% +

DTPA -Na 0.125% + Glyceryl

Mono Laurate 0.05% + Tur

0.05%

GS Liquid soap 012/007L Unilever SEA Zambia Limited,

Zambia

5575 Lifebouy Herbal Antibacterial SoapTrichlorocarbanilide 0.04% +

Trichlorosan 0.02%

GS Solid soap 012/001HM Uniliver SEA Zambia Limited,

Zambia

5576IC2 500 Injection Imipenem 500mg

POM Powder for

Injection

356/001 Unimark Ramedies Limited, India

5577 Vencer 250 Injection Meropenem Trihydrate 250mgPOM Powder for

Injection

356/002 Unimark Ramedies Limited, India

5578 Vencer 1000 Injection Meropenem Trihydrate 1000mgPOM Powder for

Injection

356/003 Unimark Ramedies Limited, India

5579 Pedvite Forte Capsules MultivitaminsGS Capsule oral 072/011 Unique Pharmaceyticals

Laboratories, India

5580 Epirubitec 50 Injection Epirubicin Hcl 50mg, per 50mlPOM Powder for

Injection

314/001MT United Biotec (P) Ltd, India

5581 Oplatin 100 Injection Oxaliplatin 100mg, per 50mlPOM Solution for

Injection

314/002MT United Biotec (P) Ltd, India

5582 Oncosid 100 Injection Etopside 100mg, per 5mlPOM Solution for

Injection

314/003MT United Biotec (P) Ltd, India

5583 Uniblastin InjectionVinblastine Sulphate 10mg, per

10ml

POM Solution for

Injection

314/004MT United Biotec (P) Ltd, India

5584Uniplatin 50 Injection Cisplatin 50mg, per 50ml

POM Solution for

Injection

314/005MT United Biotec (P) Ltd, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5585 Unifolin 15 Tablets Leucovorin Calcium 15mg POM Tablet Uncoated 314/006MT United Biotec (P) Ltd, India

5586 Citabin 500 Tablets Capacetabine 500mgPOM Tablet Film

coated

314/007MT United Biotec (P) Ltd, India

5587 O-SET - 4mg Injection Ondasetron Hydrochloride USP

4mg

POM Solution for

Injection

314/008MT United Biotec (P) Ltd, India

5588 O-SET - 8mg InjectionOndasetron Hydrochloride USP

8mg

POM Solution for

Injection

314/009MT United Biotec (P) Ltd, India

5589 UNICARB 150 Injection Dacarbazine 150mg USPPOM Powder for

Injection

314/010MT United Biotec (P) Ltd, India

5590 DACMED 150 Injection Darcabazine 150mg, per 15mlPOM Solution for

Injection

314/011MT United Biotec (P) Ltd, India

5591Clotrine B Cream

Clotrimazole 1%w/w +

Betamethasone 0.05%w/w

POM Cream Topical 283/001 Universal Corporation Ltd, Kenya

5592 Univir Cream Acyclovir 5%w/v POM Cream Topical 283/002 Universal Corporation Ltd, Kenya

5593 Univir 400 Tablets Aciclovir 400mg POM Tablet Uncoated 283/003 Universal Corporation Ltd, Kenya

5594 Strox Tablets Ciprofloxacin 500mg POM Tablet Uncoated 283/004 Universal Corporation Ltd, Kenya

5595Unilyte Oral Powder

Sodium Chloride 3.5g + Sodium

Citrate 1.5g + Potassium

Chloride 2.5g + Glucose 20g

P Powder for Oral

Solution

283/005 Universal Corporation Ltd, Kenya

5596 Nelzole Suspension Metronidazole 200mgPOM Suspension for

Oral Use

283/007 Universal Corporation Ltd, Kenya

5597 Universal Gripe WaterSodium Bicarbonate 50mg + Dill

Oil 2.15mg, per 5ml

GS Solution for Oral

Use

283/008 Universal Corporation Ltd, Kenya

5598Sulfran Paediatric Suspension

Sulphamethoxazole 200mg +

Trimethoprim 40mg, per 5ml

POM Suspension for

Oral Use

283/009 Universal Corporation Ltd, Kenya

5599 Unified OintmentBenzoic Acid 80mg + Salicylic

Acid 30mg

P Ointment topical 283/010 Universal Corporation Ltd, Kenya

5600 Dinac Tablets Diclofenac 50mg P Tablet Uncoated 283/011 Universal Corporation Ltd, Kenya

5601 Sulfran TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 283/012 Universal Corporation Ltd, Kenya

5602 Ulzol Capsules Omeprazole 20mg POM Capsule oral 283/013 Universal Corporation Ltd, Kenya

5603 Acnesol Cream Tretinoin 0.05%w/v P Cream Topical 283/014 Universal Corporation Ltd, Kenya

5604 Dinac Gel Diclofenac 1%w/v P Gel Topical 283/015 Universal Corporation Ltd, Kenya

5605 Clobit Cream Clobetasol 0.05%w/v P Cream Topical 283/016 Universal Corporation Ltd, Kenya

5606 Clotrine Pessaries Clotrimazole 100mg P Tablet Vaginal 283/017 Universal Corporation Ltd, Kenya

5607 Clotrine Cream Clotrimazole 1%w/v P Cream Topical 283/018 Universal Corporation Ltd, Kenya

5608 Flutrox Capsules Fluconazole 200mg POM Capsule oral 283/019 Universal Corporation Ltd, Kenya

5609 Lockit Tablets Domperidone 10mg POM Tablet Uncoated 283/020 Universal Corporation Ltd, Kenya

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5610 Nelstat Oral Drops Nystatin 100000IUP Solution for Oral

Use

283/021 Universal Corporation Ltd, Kenya

5611Unibazole Suspension Albendazole 400mg, per 100ml

P Suspension for

Oral Use

283/022 Universal Corporation Ltd, Kenya

5612 Unibazole Tablets Albendazole 400mg P Tablet Uncoated 283/023 Universal Corporation Ltd, Kenya

5613 Unibet Cream Betamethasone 0.1%w/v P Cream Topical 283/024 Universal Corporation Ltd, Kenya

5614 Univir 200 Tablets Aciclovir 200mg POM Tablet Uncoated 283/025 Universal Corporation Ltd, Kenya

5615 Neladol Extra CapletsParacetamol 500mg + Caffeine

65mg

GS Caplets oral

Uncoated

283/026 Universal Corporation Ltd, Kenya

5616 Co-Max TabletsArtemether 120mg +

Lumefantrine 20mg

P Tablet Uncoated 283/027 Universal Corporation Ltd, Kenya

5617Actcid Tablets

Aluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

P Tablet Uncoated 283/029 Universal Corporation Ltd, Kenya

5618 Unigentyl Tablets Secnidazole 500mg POM Tablet Uncoated 283/030 Universal Corporation Ltd, Kenya

5619 Rexedine Mouthwash Povidone Iodine 1%GS Solution for Oral

Use

283/031 Universal Corporation Ltd, Kenya

5620 K-Nac 50 Tablets Diclofenac 50mgP Tablet Film

coated

283/032 Universal Corporation Ltd, Kenya

5621 Sulfran DS CapletsSulfamethoxazole 800mg +

Trimethoprim 160mg

POM Caplets oral

Uncoated

283/033 Universal Corporation Ltd, Kenya

5622 Erythro 250 Tablets Erythromycin 250mg POM Tablet Uncoated 283/034 Universal Corporation Ltd, Kenya

5623 Neladol Suspension Paracetamol 120mg, per 5mlGS Suspension for

Oral Use

283/035 Universal Corporation Ltd, Kenya

5624 Lolip 20mg Tablets Atorvastatin 20mg POM Tablet Uncoated 283/036 Universal Corporation Ltd, Kenya

5625 Lolip 10mg Tablets Atorvastatin 10mg POM Tablet Uncoated 283/037 Universal Corporation Ltd, Kenya

5626 K-Nac 75 Tablets Diclofenac 75mg P Tablet Uncoated 283/038 Universal Corporation Ltd, Kenya

5627 Unibrol Oral Syrup Aminosidine 125mg, per 5ml POM Syrup 283/039 Universal Corporation Ltd, Kenya

5628 Unibrol Tablets Aminosidine 250mg POM Tablet Uncoated 283/040 Universal Corporation Ltd, Kenya

5629 Altrine Syrup Cetirizine 5mg, per 5ml P Syrup 283/041 Universal Corporation Ltd, Kenya

5630 Altrine Tablets Cetirizine 10mg P Tablet Uncoated 283/042 Universal Corporation Ltd, Kenya

5631 Throza 500 tablets Azithromycin 500mg POM Tablet Uncoated 283/043 Universal Corporation Ltd, Kenya

5632Zeenk 20 tablets Zinc sulphate 20mg

General Sale Tablet

Dispersible

283/044 Universal Corporation Ltd, Kenya

5633Zeerol Co-Pack for Diarrhoea

Treatment

Oral Rehydration Salts Int. Ph

20.56g + Zinc sulphate USP 20

General Sale Powder for Oral

Solution

283/045 Universal Corporation Ltd, Kenya

5634 HB Glow Capsules Haematic Preparation P Capsule oral 054/001 Universal Pharmaceuticals Ltd,

India

5635HB Glow Liquid Haematic Preparation

P Solution for Oral

Use

054/002 Universal Pharmaceuticals Ltd,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5636 Unimin Liquid Minerals + MultivitaminsP Solution for Oral

Use

054/003 Universal Pharmaceuticals Ltd,

India

5637Unimin Capsules Minerals + Multivitamins

P Capsule oral 054/004 Universal Pharmaceuticals Ltd,

India

5638 Mestil Liquid Salbutamol 1mg/5mlPOM Solution for Oral

Use

054/005 Universal Pharmaceuticals Ltd,

India

5639 Mestil-S LiquidAmbroxol 15mg + Salbutamol

1mg + Guaiphenesin 50mg

P Solution for Oral

Use

054/006 Universal Pharmaceuticals Ltd,

India

5640 Unimin G Liquid Minerals + MultivitaminsP Solution for Oral

Use

054/007 Universal Pharmaceuticals Ltd,

India

5641 Mucorol-S LiquidAmbroxol 30mg + Salbutamol

1mg + Guiaphenesin 50mg

P Solution for Oral

Use

054/008 Universal Pharmaceuticals Ltd,

India

5642 Apitup-P Liquid Cyproheptadine 2mg, per 5mlP Solution for Oral

Use

054/009 Universal Pharmaceuticals Ltd,

India

5643 Fradex CapsulesFerrous Fumarate +

Multivitamins + Minerals

P Capsule oral 054/010 Universal Pharmaceuticals Ltd,

India

5644 Softvit-E Capsules Vitamin E 200mgPOM Capsule oral 054/011 Universal Pharmaceuticals Ltd,

India

5645Softvit-E Capsules Vitamin E 400mg

POM Capsule oral 054/012 Universal Pharmaceuticals Ltd,

India

5646

Trilac Capsules

Probiotic (Streptococcus

Faecalis + Clostridium Butyricum

+ Bacillus Mesentericus + Lactic

Acid Bacillus (Lactobacillus

Sporogenes))

POM Capsule oral 054/013 Universal Pharmaceuticals Ltd,

India

5647

Trilac Sachets

Probiotic (Streptococcus

Faecalis + Clostridium Butyricum

+ Bacillus Mesentericus + Lactic

Acid Bacillus(Lactobacillus

Sporogenes))

POM Granules for

Oral Use

054/014 Universal Pharmaceuticals Ltd,

India

5648 Vovenil Injection Diclofenac Sodium 25mgPOM Solution for

Injection

374/001 Unosource Pharma Ltd. India

5649 Akurose Injection Elemental Iron 20mg, per 2mlPOM Solution for

Injection

374/002 Unosource Pharma Ltd. India

5650 Corfex 250 Capsules Cephalexin 250mg POM Capsule 374/003 Unosource Pharma Ltd. India

5651 Corfex 500 Capsules Cephalexin 500mg POM Capsule 374/004 Unosource Pharma Ltd. India

5652Prostar 100 Injection Progesterone 100mg, per 2ml

POM Solution for

Injection

374/005 Unosource Pharma Ltd. India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5653 Prostar 200 Injection Progesterone 200mg, per 2mlPOM Solution for

Injection

374/006 Unosource Pharma Ltd. India

5654Thermodol Infusion Paracetamol 1%w/v

POM Solution for

infusion

374/007 Unosource Pharma Ltd. India

5655 Unotation Injection Tranexamic Acid 100mg BPPOM Solution for

Injection

374/008 Unosource Pharma Ltd. India

5656 Welquine Infusion Levofloxacin 0.5%w/vPOM Solution for

infusion

374/009 Unosource Pharma Ltd. India

5657 Akumero 1000 Injection Meropenem 1000mgPOM Powder for

injection

374/010 Unosource Pharma Ltd. India

5658 Ceftrisone 1000 Injection Ceftriaxone Sodium 1000mgPOM Solution for

Injection

374/011 Unosource Pharma Ltd. India

5659 Damphos Vaginal SuppositoriesClindamycin Phosphate 100mg

USP + Clotrimazole 100mg

POM Vaginal

Suppostory

374/012 Unosource Pharma Ltd. India

5660 Tradmin Injection Tramadol Hydrochloride 50mgPOM Solution for

Injection

374/013 Unosource Pharma Ltd. India

5661

Tumbeno

Sodium bicarbonate - Sarjikshara

(Suddha) 2.6g + Citrus Medica

(Citric Acid) – Nimbu Satva

(Nimbukamlam) 1.90g

GSPowder for Oral

Solution374/014 Unosource Pharma Ltd. India

5662 Oflotech Infusion Ofloxacin USP 200mgPOM Solution for

Infusion374/015 Unosource Pharma Ltd. India

5663 Glynase XL-5 Tablets Glipizide 5mg POM Tablet Uncoated 282/001 USV Ltd, India

5664 Grovit Drops Multivitamin P Syrup 282/002 USV Ltd, India

5665 Pioz-15 Tablets Pioglitazone Hydrochloride 15mgPOM Tablet Uncoated 282/003 USV Ltd, India

5666 Ecorin-75 Tablets Acetylsalicyclic Acid 75mg POM Tablet Uncoated 282/004 USV Ltd, India

5667 Lipicard Capsules Fenofibrate 200mg POM Capsule oral 282/005 USV Ltd, India

5668 Amoxen Suspension Amoxicillin 125mg, per 5mlPOM Suspension for

Oral Use

230/002 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5669Amoxen Capsule Amoxicillin 250mg

POM Capsule oral 230/003 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5670Cotrizole Tablets

Sulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 230/004 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5671 Cloxacillin Capsules Cloxacillin 250mgPOM Capsule oral 230/005 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5672Varipan Tablets Paracetamol 500mg

GS Tablet Uncoated 230/006 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5673 Varivar TabletsLamivudine 150mg + Zidovudine

300mg

POM Tablet Film

coated

230/007 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5674STALANEV 30 Tablets

Stavudine 30mg + Lamivudine

150mg + Nevirapine 200mg

POM Tablet Uncoated 230/008 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5675

Hydrasalts Oral Rehydration Salts

Glucose Anhydrous Ph. Int

13.5g,+Glucose 75.0mmol/L +

Sodium Chloride Ph.Int 2.6g +

Sodium 75.0mmol/ L + Trisodium

Citrate Dihydrate Ph.Int 2.9g+

Citrate 10.0mmol/L + Potassium

Chloride Ph.Int 1.5g + Potassium

20.0mmol/L + Chloride

65.0mmol/L

P Powder for Oral

Solution

230/009 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5676 Micort CreamMiconazole Nitrate 20mg +

Hydrocortisone Acetate 10mg

POM Cream Topical 230/010 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5677Neutracid Tablets

Aluminium Hydrochloride 120mg

+ Magnesium Trisilicate 250mg

GS Tablet Uncoated 230/011 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe

5678Ibuprofen Oral Suspension Ibuprofen 100mg

GS Suspension for

Oral Use

230/012 Varichem Pharmaceuticals (Pvt)

Ltd, Zimbabwe5679 Erythromycin Tablets Erythromycin Stearate 250mg POM Tablet Uncoated 214/001 Venkant Pharma Limited, India

5680 Cephalexin Capsules Cephalexin 500mg POM Capsule oral 214/002 Venkant Pharma Limited, India

5681 Ibuprofen Tablets Ibuprofen 400mgP Tablet Film

coated

214/003 Venkant Pharma Limited, India

5682 Diclofenac Tablets Diclofenac 50mg P Tablet Uncoated 214/004 Venkant Pharma Limited, India

5683 Amoxicillin Capsules Amoxicillin 250mg POM Capsule oral 214/005 Venkant Pharma Limited, India

5684 Omeprazole Capsules Omeprazole 20mg POM Capsule oral 214/006 Venkant Pharma Limited, India

5685 Indomethacin Capsules Indomethacin 25mg P Capsule oral 214/007 Venkant Pharma Limited, India

5686 Ampicillin Capsules Ampicillin 250mg POM Capsule oral 214/008 Venkant Pharma Limited, India

5687 Mtx-vhb Injection Methotrexate 50mg, per mlPOM Powder for

Injection

084/001 VHB Medi Sciences

5688T- Bactum Injection

Cefoperazone USP 0.5g +

Sulbactam 0.5g

POM Powder for

Injection

084/002 VHB Medi Sciences

5689Zonactam Injection

Ceftriazone USP 1g +

Tazobactam 125mg

POM Powder for

Injection

084/003 VHB Medi Sciences

5690 Ce - Fine 1g Injection Cefepime Hydrochloride 1gPOM Powder for

Injection

084/004 VHB Medi Sciences

5691Domaxin Rd 10mg Injection Doxorubicin Hydrochloride 10mg

POM Solution for

Injection

084/005 VHB Medi Sciences

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5692 Peractam 4.5 G InjectionPiperacillin Sodium 4g +

Tazobactam Sodium 0.5g

POM Powder for

Injection

084/006 VHB Medi Sciences

5693Tetra 250 Capsules Tetracycline 250mg

POM Capsule oral 160/001 Vigor Laboratories 586-A Mody

Estates, India

5694 Vardhmans Silver Cream Silver Sulfadiazine 1%P Cream Topical 160/002 Vigor Laboratories 586-A Mody

Estates, India

5695 Vardex CreamBeclomethasone + Gentamycin +

Econazole

POM Cream Topical 160/003 Vigor Laboratories 586-A Mody

Estates, India

5696 Betavard Cream Betamethasone 1%POM Cream Topical 160/004 Vigor Laboratories 586-A Mody

Estates, India

5697 Tetraskin Ointment Tetracycline 1%POM Ointment topical 160/005 Vigor Laboratories 586-A Mody

Estates, India

5698Vardman Strong Cream

Camphor + Eucalyptus Oil +

Turpentine Oil + Methol + Methyl

Salicylate

GS Cream Topical 160/006 Vigor Laboratories 586-A Mody

Estates, India

5699Pen-V Oral Solution Suspension

Phenoxymethyl Penicillin V

125mg, per 5ml

POM Suspension for

Oral Use

160/007 Vigor Laboratories 586-A Mody

Estates, India

5700 Blimketas Tablets Levamisole 40mgPOM Tablet Uncoated 160/008 Vigor Laboratories 586-A Mody

Estates, India

5701 Conjex Tablets Liquorice GS Tablet Uncoated 160/009 Vigor Laboratories 586-A Mody

Estates, India

5702 Cotrim 480 TabletsSulphamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 160/010 Vigor Laboratories 586-A Mody

Estates, India

5703 Doloprin Tablets AspirinPOM Tablet Uncoated 160/011 Vigor Laboratories 586-A Mody

Estates, India

5704 Go-Cough Tablets Liquorice 189.98mgGS Tablet Uncoated 160/012 Vigor Laboratories 586-A Mody

Estates, India

5705 Indo-25 Caspules Indomethacin 25mgP Capsule oral 160/013 Vigor Laboratories 586-A Mody

Estates, India

5706Jeri Stop Cold Tablets

Chlorpheniramine 2mg +

Caffeine 30mg + Paracetamol

500mg

P Tablet Uncoated 160/014 Vigor Laboratories 586-A Mody

Estates, India

5707 Mebenda-100 Tablets Mebendazole 100mgP Tablet Uncoated 160/015 Vigor Laboratories 586-A Mody

Estates, India

5708 Mekalfin TabletsSulfadoxine + Pyrimethamine

525mg

P Tablet Uncoated 160/016 Vigor Laboratories 586-A Mody

Estates, India

5709Metro-200 Tablets Metronidazole 200mg

POM Tablet Uncoated 160/017 Vigor Laboratories 586-A Mody

Estates, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5710 MCT Tablets Magnesium Trisilicate 200mgP Tablet Uncoated 160/018 Vigor Laboratories 586-A Mody

Estates, India

5711Parapain Capsules

Pseudoephedrine +

Chlorpheniramine + Paracetamol

550mg

P Capsule oral 160/019 Vigor Laboratories 586-A Mody

Estates, India

5712 Salbuta 2 Tablets Salbutamol 2mgPOM Tablet Uncoated 160/020 Vigor Laboratories 586-A Mody

Estates, India

5713 Symaclox 500 Capsules Cloxacillin Sodium 500mgPOM Capsule oral 160/021 Vigor Laboratories 586-A Mody

Estates, India

5714 Analgin Tablets Dipyrone 500mgPOM Tablet Uncoated 160/022 Vigor Laboratories 586-A Mody

Estates, India

5715Pyramoate Suspension Pyrantel Pamoate 125mg, per ml

P Suspension for

Oral Use

160/023 Vigor Laboratories 586-A Mody

Estates, India

5716 Jonacan Cream Clotrimazole 1%w/vPOM Cream Topical 160/024 Vigor Laboratories 586-A Mody

Estates, India

5717Pyrantrin Tablets Pyrantel Pamoate 125mg

P Tablets 160/025 Vigor Laboratories 586-A Mody

Estates, India

5718 Ibu-200 Tablets Ibuprofen 200mgP Tablet Uncoated 160/027 Vigor Laboratories 586-A Mody

Estates, India

5719 Lopamide Capsules Loperamide Hydrochloride2mgPOM Capsule oral 160/028 Vigor Laboratories 586-A Mody

Estates, India

5720 Nystatin Vaginal Tablets Nystatin 100,000I.U.POM Tablet Vaginal 160/029 Vigor Laboratories 586-A Mody

Estates, India

5721 Stamache TabletsMagnesium Carbonate +

Magnesium Hydroxide

GS Tablet Uncoated 160/030 Vigor Laboratories 586-A Mody

Estates, India

5722 Kezoral Cream Ketoconazole 2%POM Cream Topical 160/031 Vigor Laboratories 586-A Mody

Estates, India

5723 Vardacort Cream Hydrocortisone 1%w/wPOM Cream Topical 160/032 Vigor Laboratories 586-A Mody

Estates, India

5724Vardacort Ointment Hydrocortisone 1%w/w

POM Ointment topical 160/033 Vigor Laboratories 586-A Mody

Estates, India

5725 Vardamin Tablets Metformin Hydrochloride 500mgPOM Tablet Uncoated 160/034 Vigor Laboratories 586-A Mody

Estates, India

5726 Vardaplex Super Tablets B ComplexP Tablet Uncoated 160/035 Vigor Laboratories 586-A Mody

Estates, India

5727 Vardaplex Forte Tablets B ComplexP Tablet Uncoated 160/036 Vigor Laboratories 586-A Mody

Estates, India

5728Diclofenac Gel Diclofenac 1%w/w

P Gel Topical 160/037 Vigor Laboratories 586-A Mody

Estates, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5729 Isoniazid Tablets Isoniazid 300mgPOM Tablet Uncoated 160/038 Vigor Laboratories 586-A Mody

Estates, India

5730Vard Blood Tonic Haematic Preparation

P Solution for Oral

Use

160/039 Vigor Laboratories 586-A Mody

Estates, India

5731 Kofsil Lozenges Eucalyptus + MentholGS Lozenges 160/040 Vigor Laboratories 586-A Mody

Estates, India

5732

Safiphen Syrup

Chlorpheniramine USP 2mg +

Ammonium Chloride BP 100mg

+ Guaifenesin BP 80mg +

Sodium Citrate BP 44mg +

Terpine Hydrate 4mg + Tolu

Balsam 6mg, per 5ml

P Syrup 160/041 Vigor Laboratories 586-A Mody

Estates, India

5733 Vardavit Syrup MultivitaminsGS Syrup 160/042 Vigor Laboratories 586-A Mody

Estates, India

5734 Benzathine Penicillin 2.4MU Injection Benzathine Penicillin 2.4MUPOM Powder for

Injection

160/043 Vigor Laboratories 586-A Mody

Estates, India

5735 Dexamycin Eye/Ear DropsDexamethasone 5mg +

Neomycin 1mg, per ml

POM Ear/Eye Drops 160/044 Vigor Laboratories 586-A Mody

Estates, India

5736 Mr. Power 500 Tablets Aspirin 500 + Caffeine 30mgGS Tablet Uncoated 160/045 Vigor Laboratories 586-A Mody

Estates, India

5737 Benzyl Peniciliin 5MU Injection Benzyl Penicillin 5MUPOM Powder for

Injection

160/046 Vigor Laboratories 586-A Mody

Estates, India

5738Quinine Injection Quinine 300mg

POM Solution for

Injection

160/047 Vigor Laboratories 586-A Mody

Estates, India

5739Anti-Diar Suspension Light Kaolin + Pectin

GS Suspension for

Oral Use

160/048 Vigor Laboratories 586-A Mody

Estates, India

5740 Ciprofin 250 Tablets Ciprofloxacin 250mgPOM Tablet Uncoated 160/049 Vigor Laboratories 586-A Mody

Estates, India

5741 Ciprofin 500 Tablets Ciprofloxacin 500mgPOM Tablet Uncoated 160/050 Vigor Laboratories 586-A Mody

Estates, India

5742 Syamoxil 500 Capsules Amoxicillin 500mgPOM Capsule oral 160/051 Vigor Laboratories 586-A Mody

Estates, India

5743 Cimedine 200 Tablets Cimetidine 200mgPOM Tablet Uncoated 160/052 Vigor Laboratories 586-A Mody

Estates, India

5744 Rifa 300 Capsules Rifampicin 300mgPOM Capsule oral 160/053 Vigor Laboratories 586-A Mody

Estates, India

5745Paladol Tablets Paracetamol 500mg

GS Tablet Uncoated 160/054 Vigor Laboratories 586-A Mody

Estates, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5746 Chlorphen Eye/Ear Drops Chloramphenicol 0.5%w/vPOM Ear/Eye Drops 160/056 Vigor Laboratories 586-A Mody

Estates, India

5747Chlorpheniramine Suspension Chlorpheniramine 2mg, per 5ml

P Suspension 160/057 Vigor Laboratories 586-A Mody

Estates, India

5748 Tetracycline Eye Drops Tetracycline 1%w/vPOM Eye Drops 160/058 Vigor Laboratories 586-A Mody

Estates, India

5749 Betnovate Cream Betamethasone 1.0%w/vP Cream Topical 160/059 Vigor Laboratories 586-A Mody

Estates, India

5750 Diarstop TabletsMetronidazole BP 200mg +

Furazolidone BP 100mg

POM Tablet Uncoated 160/060 Vigor Laboratories 586-A Mody

Estates, India

5751 Cimedine 400 Tablets Cimetidine 400mgPOM Tablet Uncoated 160/061 Vigor Laboratories 586-A Mody

Estates, India

5752 Wintogram 500 Tablets Nalidixic Acid 500mgPOM Tablet Uncoated 160/062 Vigor Laboratories 586-A Mody

Estates, India

5753 Ferenol 500 Tablets Paracetamol 500mgGS Tablet Uncoated 160/063 Vigor Laboratories 586-A Mody

Estates, India

5754 Dawanol 500 Tablets Paracetamol BP 500mgGS Tablet Uncoated 160/064 Vigor Laboratories 586-A Mody

Estates, India

5755Nystatin Oral Suspension Nystatin 100,000 IU, per ml

POM Suspension for

Oral Use

160/065 Vigor Laboratories 586-A Mody

Estates, India

5756 Salbuta 4 Tablets Salbutamol 4mgPOM Tablet Uncoated 160/066 Vigor Laboratories 586-A Mody

Estates, India

5757 Go Coff Cough syrupGo Coff Cough Syrup 315.5mg,

per 100ml

P Syrup 160/067 Vigor Laboratories 586-A Mody

Estates, India

5758

Vardhaman ORS Powder

Sodium Chloride BP 2.9g +

Potassium Chloride BP 1.5g +

Glucose Anhydrous BP 20g +

Orange Flavour 0.05g

GS Powder for Oral

Solution

160/068 Vigor Laboratories 586-A Mody

Estates, India

5759Get-On Capsules Herbal Extracts

P Capsule oral 160/069 Vigor Laboratories 586-A Mody

Estates, India

5760 Jeritone E Capsules Minerals + MultivitaminsP Capsule oral 160/070 Vigor Laboratories 586-A Mody

Estates, India

5761Powerfil 50 Tablets Sildenafil 50mg

POM Tablet Uncoated 160/071 Vigor Laboratories 586-A Mody

Estates, India

5762 Vardavit Plus Tablets MultivitaminsGS Tablet Uncoated 160/072 Vigor Laboratories 586-A Mody

Estates, India

5763Supertone Syrup Multivitamin

GS Syrup 160/073 Vigor Laboratories 586-A Mody

Estates, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5764 Instaclenz Hand GelEthyl Alcohol 66.5%w/v +

Isopropyl Alcohol 3.5%v/v

GS Gel Topical 068/001 Virchow Healthcare Ltd, India

5765Vife-Z

Cabonyl Iron 50mg + Zinc

Sulphate Monohydrate 61.8mg +

Folic Acid 0.5mg

P Capsule oral 068/002 Virchow Healthcare Ltd, India

5766 Viprax 200 Tablets Cefixime Tables 200mg POM Tablet Uncoated 068/003 Virchow Healthcare Ltd, India

5767 Viprax-Dt 100 Cefixime Tablets 100mg POM Tablet Uncoated 068/004 Virchow Healthcare Ltd, India

5768 Osteocare Tablets Minerals + Vitamins P Tablet Uncoated 236/001 Vitabiotics Limited, England

5769 Immunace Capsules Multivitamins GS Capsule oral 236/002 Vitabiotics Limited, England

5770 Perfectil Capsules Minerals + Vitamins P Capsule oral 236/003 Vitabiotics Limited, England

5771 Ferroglobin B12 SyrupFerroglobin B12 Syrup

717.45mg

P Syrup 236/004 Vitabiotics Limited, England

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5772

Omega H3 Capsules

Soya Bean Oil (from Soya),

Wheat-Germ Oil, Vitamin C

(Ascorbic Acid), Methionine,

Magnesium Oxide, L-Lysine HCl,

Cod Liver Oil (from Fish), Omega-

3 Fish Oil (from Fish), Ferrous

Fumarate, Zinc Sulphate,

Lecithin (contains Soya Bean Oil)

(from Soya), Hard Vegetable

Prep., Vitamin E (as DL-Alpha

Tocopheryl Acetate Prep.),

Inositol, Para-Aminobenzoic

Acid, Thiamin (Vitamin B1

Mononitrate), Niacin (as

Nicotinamide), Garlic

Concentrate (Grapeseed Oil),

Natural Mixed Carotenoids

(Betacarotene, Alpha-Carotene,

Cryptoxanthin, Zeaxanthin,

Lutein, [Carrier; Olive Oil]),

Pantothenic Acid (as Calcium

Salt), Vitamin B12 (as

Cyanocobalamin, Trisodium

Citrate, Citric Acid, Maltodextrin),

Vitamin B6 (as Pyridoxine HCl),

Rutin, Beeswax, Manganese

Sulphate, Riboflavin (Vitamin

B2), Copper Sulphate, Ginseng

5;1 Conc. Extract (Potato

Dextrins), Vitamin A Palmitate

P Capsule oral 236/005 Vitabiotics Limited, England

5773 Wellwoman Capsules Minerals + Vitamins P Capsule oral 236/006 Vitabiotics Limited, England

5774 Wellman Capsules Minerals + Vitamins P Capsule oral 236/007 Vitabiotics Limited, England

5775 Visionace Capsules Minerals + Vitamins P Capsule oral 236/008 Vitabiotics Limited, England

5776 Cardioace Capsules Minerals + Vitamins P Capsule oral 236/009 Vitabiotics Limited, England

5777 Jointace Capsules Minerals + Vitamins P Capsule oral 236/010 Vitabiotics Limited, England

5778 Diabetone Capsules Minerals + Vitamins P Capsule oral 236/011 Vitabiotics Limited, England

5779 Feroglobin B12 Capsules Minerals + Vitamins P Capsule oral 236/012 Vitabiotics Limited, England

5780 Neurozan Capsules Minerals + Vitamins P Capsule oral 236/013 Vitabiotics Limited, England

5781 Jointace Omega -3 Capsules Multivitamins GS Capsule oral 236/014 Vitabiotics Limited, England

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5782 Liveril CapsulesVitamins + Minerals + Amino

Acids

P Capsule oral 236/015 Vitabiotics Limited, England

5783Vital Multime Capsules Multivitamins

GS Capsule oral 191/001 Vital Health Foods (Pvt) Ltd,

South Africa

5784 Vital Dolomite 200's Tablets Vitamin D3 + DolomiteP Tablet Film

coated

191/002 Vital Health Foods (Pvt) Ltd,

South Africa

5785 Multitime Potency Capsules MultivitaminsGS Capsule oral 191/003 Vital Health Foods (Pvt) Ltd,

South Africa

5786Vitane's Nature Evening Primrose Oil

Softgels 1000mgPrimrose Oil 1000mg

GS Capsule oral 300/001 Vitane Pharmaceuticals Pvt Ltd,

India

5787 Probiotane Capsules Lactobacilli Culture 36mgP Capsule oral 300/002 Vitane Pharmaceuticals Pvt Ltd,

India

5788 Vitane's Nature Kids Plus Tablets MultivitaminsGS Tablet Chewable 300/003 Vitane Pharmaceuticals Pvt Ltd,

India

5789Vitane's Nature Vitamin E 400iu

SoftgelsAlpha Tocopheryl 400IU

POM Capsule oral 300/004 Vitane Pharmaceuticals Pvt Ltd,

India

5790 Omegavyte Liquicaps Omega-3 Fish Oil 600mgGS Capsule oral 300/005 Vitane Pharmaceuticals Pvt Ltd,

India

5791Igra 100 Oral Jelly Sildenafil Citrate100mg

POM Tablet Film

coated

395/001 VV Labs Pvt. Ltd

5792 Vivamox SuspensionAmoxicillin Trihydrate 125mg,

per 5ml

POM Powder for Oral

Suspension

243/001 VVS Pharmaceuticals and

Chemicals (P) Ltd,India

5793 Vivamox Capsules Amoxicillin Trihydrate 250mgPOM Capsule oral 243/002 VVS Pharmaceuticals and

Chemicals (P) Ltd,India

5794 Vigrex D5 Tablets Sildenafil Citrate 100mgPOM Tablet Film

coated

243/003 VVS Pharmaceuticals and

Chemicals (P) Ltd,India

5795 Vecostatin Injection Nystatin 500000 IU, per 5mlPOM Solution for

Injection

243/004 VVS Pharmaceuticals and

Chemicals (P) Ltd,India

5796 Inal Gel Diclofenac Sodium 1mgPOM Gel Topical 243/005 VVS Pharmaceuticals and

Chemicals (P) Ltd,India

5797 Salbutamol Syrup Salbutamol 2mg, per 5mlPOM Syrup 104/001 VYKing Pharmaceuticals Ltd,

Lusaka

5798 Kotrim SuspensionTrimethoprim 200mg +

Sulphamethoxazole 40mg

POM Suspension for

Oral Use

104/005 VYKing Pharmaceuticals Ltd,

Lusaka

5799

Magnesium Trisilicate Mixture

Sodium Bicarbonate 500mg, per

5ml + Magnesium Trisilicate

500mg, per 5ml + Light

Magnesium Oxide 500mg, per

5ml

GS Suspension for

Oral Use

104/006 VYKing Pharmaceuticals Ltd,

Lusaka

Page 286 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5800 Whitefield’s OintmentSalicylic Acid 3% + Benzoic Acid

6%

P Ointment topical 104/012 VYKing Pharmaceuticals Ltd,

Lusaka

5801Antacid Tablets

Peppermint Oil 0.003ml + Dried

Aluminium Hydroxide 120mg +

Magnesium Trisilicate 250mg

GS Tablet Uncoated 104/018 VYKing Pharmaceuticals Ltd,

Lusaka

5802 Kotrim TabletsTrimethoprim 400mg +

Sulphamethoxazole 80mg

POM Tablet Uncoated 104/020 VYKing Pharmaceuticals Ltd,

Lusaka

5803 Aspirin Tablets Acetyl Salicylic Acid 300mgP Tablet Uncoated 104/030 VYKing Pharmaceuticals Ltd,

Lusaka

5804 Metronidazole Tablets Metronidazole 200mgPOM Tablet Uncoated 104/031 VYKing Pharmaceuticals Ltd,

Lusaka

5805Mebendazole Tablets Mebendazole 100mg

P Tablet Uncoated 104/032 VYKing Pharmaceuticals Ltd,

Lusaka

5806Triphen 4 Flu Syrup

Diphenhydramine 12.5mg +

Paracetamol 500mg +

Pseudoephedrine 22.5mg

P Syrup 104/034 VYKing Pharmaceuticals Ltd,

Lusaka

5807 Pharmadol Tablets Paracetamol 100mgGS Tablet Uncoated 104/035 VYKing Pharmaceuticals Ltd,

Lusaka

5808

Grilinctus Syrup

Dextromethophan Hydrochloride

5mg, per 5ml +

Chlorpheinramine Maleate BP

2.5mg, per 5ml + Guainephensin

BP 50mg, per 5ml + Ammonium

Chloride BP 6mg, per 5ml

P Syrup 220/001 Wardex Pharmaceuticals Pvt Ltd,

India

5809 Grilintus BM SyrupBrohexine Hydrochloride 8mg +

Terbutaline Sulphate 2.5mg

P Syrup 220/002 Wardex Pharmaceuticals Pvt Ltd,

India

5810 Grilinctus BM Pediatric SyrupBromhexine Hydrochloride 4mg

+ Terbutaline Sulphate 1.5mg

P Syrup 220/003 Wardex Pharmaceuticals Pvt Ltd,

India

5811Dexorange Syrup

Ferric Ammonium Citrate

160mg/15ml + Cyanocobalamin

7.5mg

P Syrup 220/004 Wardex Pharmaceuticals Pvt Ltd,

India

5812

Forache Toothache Solution

Solvent Ether 1.5%v/v + Menthol

1.25w/v + Cajuput Oil 2.5%v/v+

Clove Oil 3.12%v/v + Tolu

Balsum 1.25%

POM Solution for Oral

Use

011/035 West-Coast Pharmaceutical

Works, India

5813

Waxnil Ear Drops

Paradichlorobenzene 2%w/v +

Benzocaine 2.7% w/v +

Chlorobutol 5.0% w/v +

Turpentine 2% w/v

P Solution for

Topical Use

011/037 West-Coast Pharmaceutical

Works, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5814 Pedicol DropsDicyclomine 10mg +

Dimethicone 133.32mg

P Solution for Oral

Use

011/039 West-Coast Pharmaceutical

Works, India

5815Wescovita Tablets Multivitamin

P Tablet Uncoated 011/044 West-Coast Pharmaceutical

Works, India

5816 Wescotone Syrup MultivitaminGS Syrup 011/045 West-Coast Pharmaceutical

Works, India

5817 Demson Tablets Dexamethasone 0.5mgPOM Tablet Uncoated 011/050 West-Coast Pharmaceutical

Works, India

5818 Folfes Plus TabletsFerrous Sulphate 200mg + Folic

Acid 0.5mg

P Tablet Uncoated 011/059 West-Coast Pharmaceutical

Works, India

5819 Levazid SuspensionLevamisole 15mg +

Oxyclozanide 30mg

P Suspension 011/062 West-Coast Pharmaceutical

Works, India

5820 Mebenda Tablets Mebendazole 100mgP Tablet Uncoated 011/063 West-Coast Pharmaceutical

Works, India

5821 Leva-Vet Solution Levamisole 15mgP Solution for Oral

Use

011/701 West-Coast Pharmaceutical

Works, India

5822 Welden-10 Tablet Piroxicam 10mgPOM Tablet Uncoated 011/001 West-Coast Pharmaceutical

Works, India, Lusaka

5823Welden-20 Tablets Piroxicam 20mg

POM Tablet Uncoated 011/002 West-Coast Pharmaceutical

Works, India, Lusaka

5824 Profen 200 Tablets Ibuprofen 200mgP Tablet Uncoated 011/003 West-Coast Pharmaceutical

Works, India, Lusaka

5825 Profen 400 Tablets Ibuprofen 400mgP Tablet Uncoated 011/004 West-Coast Pharmaceutical

Works, India, Lusaka

5826 Samaol-2 Tablets Salbutamol 2mgPOM Tablet Uncoated 011/005 West-Coast Pharmaceutical

Works, India, Lusaka

5827 Samaol-4 Tablets Salbutamol 4mgPOM Tablet Uncoated 011/006 West-Coast Pharmaceutical

Works, India, Lusaka

5828 Ulcidin-200 Tablets Cimetidine 20mgPOM Tablet Uncoated 011/007 West-Coast Pharmaceutical

Works, India, Lusaka

5829 Metamide Tablets Metoclopramide POM Tablet Uncoated 011/008 West-Coast Pharmaceutical

Works, India, Lusaka

5830 Tenil Tablets Atenolol 50mgPOM Tablet Uncoated 011/009 West-Coast Pharmaceutical

Works, India, Lusaka

5831 Tenil 100 Tablets Atenolol 100mgPOM Tablet Uncoated 011/010 West-Coast Pharmaceutical

Works, India, Lusaka

5832Clofen 25 Tablets Diclofenac 25mg

P Tablet Uncoated 011/011 West-Coast Pharmaceutical

Works, India, Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5833 Clofen 50 Tablets Diclofenac 50mgP Tablet Uncoated 011/012 West-Coast Pharmaceutical

Works, India, Lusaka

5834Hexin Tablets

Bromhexine Hydrochloride IP

8mg

P Tablet Uncoated 011/013 West-Coast Pharmaceutical

Works, India, Lusaka

5835 Wescolax Tablets Bisacodyl 5mgP Tablet Uncoated 011/014 West-Coast Pharmaceutical

Works, India, Lusaka

5836 Prodin Tablets Cyproheptadine 4mgP Tablet Uncoated 011/015 West-Coast Pharmaceutical

Works, India, Lusaka

5837 Nefed-5 Tablets Nifedipine 5mgPOM Tablet Uncoated 011/016 West-Coast Pharmaceutical

Works, India, Lusaka

5838 Nefed-10 Tablets Nifedipine 10mgPOM Tablet Uncoated 011/017 West-Coast Pharmaceutical

Works, India, Lusaka

5839 Clomzol Tablets Clotrimazole 10mgPOM Lozenges 011/018 West-Coast Pharmaceutical

Works, India, Lusaka

5840 Zepine Tablets Chlorpromazine 200mgPOM Tablet Uncoated 011/019 West-Coast Pharmaceutical

Works, India, Lusaka

5841 Tizole 150 Tablets Tinidazole 150mgPOM Tablet Uncoated 011/020 West-Coast Pharmaceutical

Works, India, Lusaka

5842Tizole 300 Tablets Tinidazole 300mg

POM Tablet Uncoated 011/021 West-Coast Pharmaceutical

Works, India, Lusaka

5843 Tizole 500 Tablets Tinidazole 500mgPOM Tablet Uncoated 011/022 West-Coast Pharmaceutical

Works, India, Lusaka

5844 Glemide 2.5 Tablets Glibenclamide 2.5mgPOM Tablet Uncoated 011/023 West-Coast Pharmaceutical

Works, India, Lusaka

5845 Glemide 5 Tablets Glibenclamide 5mgPOM Tablet Uncoated 011/024 West-Coast Pharmaceutical

Works, India, Lusaka

5846 Dawacid SuspensionAluminium Hydrochloride 625mg

+ Magnesium Trisilicate 312mg

GS Suspension for

Oral Use

011/025 West-Coast Pharmaceutical

Works, India, Lusaka

5847 Wescogyl Oral Suspension Metronidazole 200mg, per 5mlPOM Suspension for

Oral Use

011/026 West-Coast Pharmaceutical

Works, India, Lusaka

5848 Nytin Pessaries Nystatin 100,000IUPOM Tablet Vaginal 011/027 West-Coast Pharmaceutical

Works, India, Lusaka

5849 Allucid TabletsAluminium Hydrochloride 250mg

+ Magnesium Trisilicate 120mg

GS Tablet Uncoated 011/028 West-Coast Pharmaceutical

Works, India, Lusaka

5850 Wamargan Syrup Promethazine 5mg, per 5mlP Syrup 011/029 West-Coast Pharmaceutical

Works, India, Lusaka

5851Loptil Capsules Loperamide Hydrocholride 2mg

POM Capsule oral 011/030 West-Coast Pharmaceutical

Works, India, Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5852Oralyt Powder

ORS (Sodium Chloride + Sodium

Citrate + Potassium Chloride +

Glucose)

POM Powder for Oral

Solution

011/031 West-Coast Pharmaceutical

Works, India, Lusaka

5853 B-Covit TabletsB Complex (Vit B1 1mg + B2

1mg + Niacinamide 10mg)

P Tablet Uncoated 011/032 West-Coast Pharmaceutical

Works, India, Lusaka

5854 Samol Syrup Salbutamol 2mg, per 5mlPOM Syrup 011/033 West-Coast Pharmaceutical

Works, India, Lusaka

5855 Bacrizole 480 TabletsSulfamethoxazole 400mg +

Trimethoprim 80mg

POM Tablet Uncoated 011/034 West-Coast Pharmaceutical

Works, India, Lusaka

5856 Kezol Cream Ketoconazole 2%w/wPOM Cream Topical 011/036 West-Coast Pharmaceutical

Works, India, Lusaka

5857OTO-4 Ear Drops

Chloramphenicol 5%w/v +

Beclomethasone Dipropionate

0.025%w/v + Clotrim 1%w/v

POM Ear Drops 011/038 West-Coast Pharmaceutical

Works, India, Lusaka

5858 Phenamine Tablets Chlopheniramine 4mgP Tablet Uncoated 011/040 West-Coast Pharmaceutical

Works, India, Lusaka

5859 Spasminal Tablets Hyoscine Butylbromide 10mgPOM Tablet Uncoated 011/041 West-Coast Pharmaceutical

Works, India, Lusaka

5860 Xylone Nasal Drops (Paed) Xylometazoline 0.05%w/vP Nasal drops 011/042 West-Coast Pharmaceutical

Works, India, Lusaka

5861 Xylone Nasal Drops (Adult) Xylometazoline 0.1%w/vP Nasal drops 011/043 West-Coast Pharmaceutical

Works, India, Lusaka

5862Asbic-100 Tablets Ascorbic Acid 100mg

P Tablet Uncoated 011/046 West-Coast Pharmaceutical

Works, India, Lusaka

5863ASP-300 Tablets Acetylsalicylic Acid 300mg

P Tablet Uncoated 011/047 West-Coast Pharmaceutical

Works, India, Lusaka

5864 Etoin -100 Tablets Phenytoin 100mgPOM Tablet Uncoated 011/048 West-Coast Pharmaceutical

Works, India, Lusaka

5865 Eril-10 Tablets Enalapril 10mgPOM Tablets oral 011/049 West-Coast Pharmaceutical

Works, India, Lusaka

5866 CT-SuspensionCiprofloxacin 250mg +

Tinidazole 300mg

POM Suspension for

Oral Use

011/051 West-Coast Pharmaceutical

Works, India, Lusaka

5867Cofnil Syrup

Chlorpheniramine 2.5mg +

Ammonium Chloride 125mg +

Soduim Citrate +125mg

P Syrup 011/052 West-Coast Pharmaceutical

Works, India, Lusaka

5868Cetri-10 Tablets Cetirizine 10mg

P Tablet Uncoated 011/053 West-Coast Pharmaceutical

Works, India, Lusaka

5869Bactrizole Suspension

Trimethoprim 40mg +

Sulphamethoxazole 200mg

POM Suspension for

Oral Use

011/054 West-Coast Pharmaceutical

Works, India, Lusaka

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5870 B-Folcin TabletsNiacinamide 50mg + Riboflavin

10mg + Folic Acid 1.5mg

P Tablet Uncoated 011/055 West-Coast Pharmaceutical

Works, India, Lusaka

5871Azolevet Suspension Albendazole 25mg/Ml

P Suspension for

Oral Use

011/056 West-Coast Pharmaceutical

Works, India, Lusaka

5872 Forache TabletsAcetaminophen 250mg +

Caffeine 30mg + Aspirin 300mg

GS Tablet Uncoated 011/058 West-Coast Pharmaceutical

Works, India, Lusaka

5873 Fesate Tablets Ferrous Sulphate 200mgP Tablet Uncoated 011/060 West-Coast Pharmaceutical

Works, India, Lusaka

5874 Ferolax Syrup HaematinicP Syrup 011/061 West-Coast Pharmaceutical

Works, India, Lusaka

5875 Glucose Intravenous InfusionGlucose Intravenous Infusion

B.P 5%w/v

POM Solution for

infusion

124/001 Wockhardt Limited, India

5876 Glucose Intravenous InfusionGlucose Intravenous Infusion

B.P 10%w/v

POM Solution for

infusion

124/002 Wockhardt Limited, India

5877

Compound Sodium Lactate Injection

Sodium Chloride 0.6%w/v +

Calcium Chloride 0.027g w/v +

Potassium Chloride 0.04%w/v +

Sodium Lactate 0.24%w/v

POM Solution for

infusion

124/003 Wockhardt Limited, India

5878 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/004 Wockhardt Limited, India

5879 Metronidazole Injection Metronidazole 5mg, per mlPOM Solution for

infusion

124/005 Wockhardt Limited, India

5880Wokadine Germicide Gargles Povidone Iodine 1%

GS Solution for Oral

Use

124/006 Wockhardt Limited, India

5881 Wokadine Vaginal Pesseries Povidone Iodine 200mg POM Tablet Vaginal 124/007 Wockhardt Limited, India

5882

Zedex Cough Syrup

Bromhexine 4mg +

Dextromethorphan 5mg +

Ammonium Chloride 50mg +

Menthol 2.5mg, per 100ml

POM Syrup 124/008 Wockhardt Limited, India

5883 Soduim Chloride Injection Sodium Chloride 0.9%POM Solution for

infusion

124/009 Wockhardt Limited, India

5884 Aziwork USP Capsules Azithromycin 250mg POM Capsule oral 124/010 Wockhardt Limited, India

5885Bro-Zedex Cough Syrup

Terbutaline 1.25mg +

Bromhexine 4mg + Guaifenesin

50mg + Menthol 2.5mg, per 5ml

POM Syrup 124/011 Wockhardt Limited, India

5886 Aziwork Suspension Azithromycin 100mg, per 5mlPOM Suspension for

Oral Use

124/012 Wockhardt Limited, India

5887Proxyvon Capsules

Dextropropoxyphen 65mg +

Paracetamol 400mg

POM Capsule oral 124/013 Wockhardt Limited, India

5888 Pelox-400 Tablets Perfloxacin 400mg POM Tablet Uncoated 124/014 Wockhardt Limited, India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5889 Wokadine 10%w/w Ointment Povidone Iodine 10%w/w GS Ointment topical 124/015 Wockhardt Limited, India

5890 Powercef 125mg Injection Ceftriaxone 125mgPOM Powder for

Injection

124/016 Wockhardt Limited, India

5891 Powercef 250 Injection Ceftriaxone 250mgPOM Powder for

Injection

124/017 Wockhardt Limited, India

5892 Powercef 500mg Injection Ceftriaxone 500mgPOM Powder for

Injection

124/018 Wockhardt Limited, India

5893 Powercef 1000mg Injection Ceftriaxone 1000mgPOM Powder for

Injection

124/019 Wockhardt Limited, India

5894 Sparx-200 Tablets Sparfloxacin 200mg POM Tablet Uncoated 124/020 Wockhardt Limited, India

5895 Wepox 2000 InjectionRecombinant Human

Erythropoietin 2000 IU, per ml

POM Solution for

Injection

124/021 Wockhardt Limited, India

5896 Nadoxin Cream Nadifloxacin 1%w/v POM Cream Topical 124/022 Wockhardt Limited, India

5897 Wosulin-R Injection Insulin EP 100 IU, per mlPOM Solution for

Injection

124/023 Wockhardt Limited, India

5898Wosulin 30/70 Injection

Recombinant (R-DNA) Human

Insulin Biphasic 30%

Regular/70% Isophane

POM Solution for

Injection

124/024 Wockhardt Limited, India

5899 Wosulin N Injection 30%Recombinant (R-DNA) Human

Insulin NPH - Intermediate Acting

POM Solution for

Injection

124/025 Wockhardt Limited, India

5900 Promethazine Injection Promethazine 50mg, per 2mlPOM Solution for

Injection

028/001MT Wuhan Grand Pharmaceutical

Group Co. Ltd

5901Chlorpromazine Injection Chlorpromazine 25mg, per ml

POM Solution for

Injection

028/002MT Wuhan Grand Pharmaceutical

Group Co. Ltd

5902Metoclopromide Injection Metoclopramide 10mg, per 2ml

POM Solution for

Injection

028/003MT Wuhan Grand Pharmaceutical

Group Co. Ltd

5903 Oxytocin Injection Oxytocin 10 IUPOM Solution for

Injection

033/027 Wuhan Grand Pharmaceutical

Group Co. Ltd

5904

Oral Rehydration Salts

Sodium Chloride 3.5g +

Potassium Chloride 1.5g +

Sodium Citrate 2.9g + Anhydrous

Glucose 20g

GS Powder for Oral

Solution

033/028 Wuhan Grand Pharmaceutical

Group Co. Ltd

5905

Shangring Male Circumcision Device

With Removal Tool & Band Aid

Shangring Male Circumcision

Device with Removal Tool &

Band

P Medical Device 386/001L Wuhu Snnda Medical Treatment

Appliance

5906 Premarin Tablets Oestrogen 0.3mgPOM Tablet Uncoated 116/005 Wyeth Laboratories (Pty) Limited,

SA

Page 292 of 296

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5907Advil CS Tablets

Ibuprofen 200mg +

Pseudoephedrine Hydrochloride

30mg

P Tablet Uncoated 120/033 Wyeth Laboratories (Pty) Limited,

SA

5908 Anadin TabletsAspirin 400mg + Caffeine

22.7mg

GS Tablet Uncoated 120/034 Wyeth Laboratories (Pty) Limited,

SA

5909 Preparation H OintmentYeast Cell Extract + 3g Shark

Liver Oil + 1g Alcohol, per 100g

P Ointment topical 120/035 Wyeth Laboratories (Pty) Limited,

SA

5910

Preparation H Suppositories

Petrolatum71.9% + Mineral Oil

14% + Shark Liver Oil 3% +

Phenylephedrine Hydrochloride

0.25%

P Suppository 120/036 Wyeth Laboratories (Pty) Limited,

SA

5911 Valizgy Eczema Cream Betamethasone 1% POM Cream Topical 216/001 Yash Pharmaceuticals Ltd

5912 Herpizyg Cream Acyclovir 5 % POM Cream Topical 216/002 Yash Pharmaceuticals Ltd

5913 Butate Antifungal CreamClotrimazole 1%w/w + Benzyl

Alcohol 1%w/w

POM Cream Topical 216/003 Yash Pharmaceuticals Ltd

5914 Dipvite Cream Betamethasone 0.643mg/g POM Cream Topical 216/004 Yash Pharmaceuticals Ltd

5915 Naftol Topical Solution Tolnaftate 10mgPOM Solution for

Topical Use

216/005 Yash Pharmaceuticals Ltd

5916Clodip Cream

Clotrimazole 10mg +

Betamethasone 0.643mg, per g

POM Cream Topical 216/006 Yash Pharmaceuticals Ltd

5917

Fosure Cream

Betamethasone Dipropionate

0.64mg + Clotrimazole 10mg +

Gentamicin Base 1 mg +

Tolnaftate 10 Mg +

Iodochlorhydroxyquinoline 10mg

POM Cream Topical 216/007 Yash Pharmaceuticals Ltd

5918 Epiklin OintmentSalicylic Acid 30mg +

Betamethasone 0.64mg

POM Ointment topical 216/009 Yash Pharmaceuticals Ltd

5919Naftatin Cream

Nystatin 100,000 I.U + Tolnaftate

10mg

POM Cream Topical 216/010 Yash Pharmaceuticals Ltd

5920 Yashiprostol - 200 Tablets Misoprostol 200mcg POM Tablet Uncoated 349/001 Yashika Pharmaceuticals Pvt Ltd

5921 Oxytocin Injection USP 10 IU/Ml Oxytocin USP 10IU, per mlPOM Solution for

Injection

349/002 Yashika Pharmaceuticals Pvt Ltd

5922 Gummi King Vitamin C Gummi Ascorbic Acid 30mg P Gel Oral 411/001LZanon USA Inc. d.b.a. Vitamec

USA Inc

5923Gummi King Multivitamin & Mineral

GummiMultivitamins & Minerals P Gel Oral 411/002L

Zanon USA Inc. d.b.a. Vitamec

USA Inc

5924Gummi King Calcium Plus +Vitamin D

Gummi

Calcium 50mg + Vitamin D

0.00006mgP Gel Oral 411/003L

Zanon USA Inc. d.b.a. Vitamec

USA Inc

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5925Gummi King Echinacea Plus Vitamin C

& Zinc Gummi

Echinacea 25mg + Ascorbic Acid

15mg + Zinc 2.5mgP Gel Oral 411/004L

Zanon USA Inc. d.b.a. Vitamec

USA Inc

5926Gummi King Vitamin D Gummi. Vitamin D 0.01mg P Gel Oral 411/005L

Zanon USA Inc. d.b.a. Vitamec

USA Inc

5927 Siesta TabletsValeriana Officinalis Root Extract

2g

GS Tablet Uncoated 052/001 Zifam Pinnacle Pty Ltd, Australia

5928 Pinch TabletsChromium Picolinate 50mcg +

Sucralose 8mg

GS Tablet Uncoated 052/001L Zifam Pinnacle Pty Ltd, Australia

5929 Eposoft Gelatin Capsules Gamma Linolenic Acid 100mg GS Capsule oral 052/002 Zifam Pinnacle Pty Ltd, Australia

5930 Supravit Tablets Minerals + Multivitamins P Tablet Uncoated 052/003 Zifam Pinnacle Pty Ltd, Australia

5931 Lobese CapsulesPhaseolus Vulgaris Extract

500mg

P Capsule oral 052/004 Zifam Pinnacle Pty Ltd, Australia

5932 Vitacee Tablets Ascorbic Acid 500mg GS Tablet Uncoated 052/005 Zifam Pinnacle Pty Ltd, Australia

5933 Vibran Tablets D-Alpha-Tocopherol 82.6mg POM Tablet Uncoated 052/006 Zifam Pinnacle Pty Ltd, Australia

5934 Protec Caplets MultivitaminsGS Caplets oral

Uncoated

052/007 Zifam Pinnacle Pty Ltd, Australia

5935 Mega 3 Fish Oil Concentrate CapsulesEicosapentaenoic Acid 180mg +

Ocosahexaenoic Acid 120mg

P Capsule oral 052/008 Zifam Pinnacle Pty Ltd, Australia

5936 Vitakid Tablets Minerals + Multivitamins P Tablet Chewable 052/009 Zifam Pinnacle Pty Ltd, Australia

5937 Ozical TabletsMilk Calcium 600mg + Vitamin

D3 0.5mg

P Tablet Uncoated 052/010 Zifam Pinnacle Pty Ltd, Australia

5938Immunor Capsules

Colostrum Powder Bovine75mg+

Lactoferrin Bovin 100mg

P Capsule oral 052/011 Zifam Pinnacle Pty Ltd, Australia

5939 Zifam St Johns Wort Tablets Hypericum Perforatum 1800mg P Tablet Uncoated 052/012 Zifam Pinnacle Pty Ltd, Australia

5940 Amino-XL TabletsAmino Acids + Vitamins &

Minerals

P Tablet Uncoated 052/013 Zifam Pinnacle Pty Ltd, Australia

5941 Vitrum Tablets Minerals + MultivitaminsP Caplets oral

Uncoated

052/014 Zifam Pinnacle Pty Ltd, Australia

5942G-Trim Powder (Lime & Lemon

Flavour)Herbal Preparation

P Powder for Oral

Solution

052/015L Zifam Pinnacle Pty Ltd, Australia

5943Mega 3 Chewable Softgels

Fish Oil Natural (Eq. To

Docosahexaenoic Acid )750mg

P Capsule oral 052/016L Zifam Pinnacle Pty Ltd, Australia

5944 Natocare Softgels Fish Oil Natural 800mg P Capsule oral 052/017L Zifam Pinnacle Pty Ltd, Australia

5945Tribull Tablets

Tribulus Terrestris 250mg +

Avena Sativa Extract 10mg +

Zinc Sulphate 40mg

P Tablet Uncoated 052/018L Zifam Pinnacle Pty Ltd, Australia

5946 Cee Lime N Lemon Chewable Tablets Vitamin C 500mg GS Tablet Chewable 052/019L Zifam Pinnacle Pty Ltd, Australia

5947 Cee Orange Chewable Tablets Vitamin C 500mg GS Tablet Chewable 052/020L Zifam Pinnacle Pty Ltd, Australia

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5948 Menofem CapsulesBlack Cohosh 200mg + Red

Clover 1g

P Capsule Hard

Gelatin

052/021L Zifam Pinnacle Pty Ltd, Australia

5949 Emuflam Cream Herbal Extracts GS Cream Topical 052/022L Zifam Pinnacle Pty Ltd, Australia

5950 Nuflam CapsulesGlucosamine Sulphate 667mg +

Chondroitin 278mg

GS Capsule Hard

Gelatin

052/023L Zifam Pinnacle Pty Ltd, Australia

5951 Cee Pineapple Tablets Vitamin C 500mg General Sale Tablet Chewable 052/024L Zifam Pinnacle Pty Ltd, Australia

5952 Cee Strawberry Tablets Vitamin C 500mg General Sale Tablet Chewable 052/025L Zifam Pinnacle Pty Ltd, Australia

5953 Gaseze Softgels Combination P Capsule, soft 052/026L Zifam Pinnacle Pty Ltd, Australia

5954 Infant Coleze Softgels Combination P Capsule, soft 052/027L Zifam Pinnacle Pty Ltd, Australia

5955 Urisol Sachets Vaccinum Macrocarpon 360mg P Powder for oral 052/028L Zifam Pinnacle Pty Ltd, Australia

5956Ferosorb Capsules

Iron 24mg + Vitamin C 100mg +

Vitamin B12 500mcg + Folic

Acid 500mcg

P Capsule, Hard

gelatin

052/029L Zifam Pinnacle Pty Ltd, Australia

5957 Deltaprim TabletsPyrimethamine 3.125mg +

Dapsone 25mg

P Tablet Uncoated 091/001 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5958 Betaco SyrupDextromethorphan Hydrobromide

15mg/5ml

P Syrup 091/002 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5959Betafed Syrup

Dextromethorphan 15mg, per

5ml + Pseudoephedrine 30mg,

per 5ml

P Syrup 091/003 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5960 Betamint Cough Syrup Guaiphenesin 100mg, per 5mlP Syrup 091/004 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5961 Betamol Syrup Paracetamol 120mg, per 5mlGS Syrup 091/005 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5962 Betapro SyrupTriprolidine 1.375mg, per 5ml +

Pseudoephedrine 30mg, per 5ml

P Syrup 091/006 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5963 Deltaprim Paediatric SyrupDapsone 25mg + Pyrimethamine

3.125mg

POM Syrup 091/007 Zimbabwe Pharmaceuticals (Pvt)

Limited, Zimbabwe

5964R-Loc 150 Tablets Ranitidine Hydrochloride 150mg

POM Tablet Uncoated 139/001 Zydus Cadila Healthcare Ltd,

India

5965 Tiniba 500 Tablets Tinidazole 500mgPOM Tablet Uncoated 139/002 Zydus Cadila Healthcare Ltd,

India

5966 Betanese 5 Tablets Glibenclamide 5mgPOM Tablet Uncoated 139/003 Zydus Cadila Healthcare Ltd,

India

5967 Amlodac-5 Tablets Amilodipine 5mgPOM Tablet Uncoated 139/004 Zydus Cadila Healthcare Ltd,

India

5968Amilodac 10 Tablets Amilodipine 10mg

POM Tablet Uncoated 139/005 Zydus Cadila Healthcare Ltd,

India

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ZAMBIA MEDICINES REGULATORY AUTHORITYREGISTER OF MARKETING AUTHORISATIONS - 2018

5969 Piricam 10 Capsules Piroxicam 10mgPOM Tablet Uncoated 139/006 Zydus Cadila Healthcare Ltd,

India

5970Piricam 20 Capsules Piroxicam 20mg

POM Capsule oral 139/007 Zydus Cadila Healthcare Ltd,

India

5971 Odace 5 Tablets Lisinopril Dihydrate 5mgPOM Capsule oral 139/008 Zydus Cadila Healthcare Ltd,

India

5972 Nilfast Suspension Nimesulide 50mg, per mlPOM Tablet Uncoated 139/009 Zydus Cadila Healthcare Ltd,

India

5973 Cefotim 1000 Injection Cefotaxime 1000mgPOM Suspension for

Oral Use

139/010 Zydus Cadila Healthcare Ltd,

India

5974 Hipen Capsules Amoxicillin 250mgPOM Powder for

Injection

139/011 Zydus Cadila Healthcare Ltd,

India

5975 Loridin Rapitas Tablets Loratadine 10mgPOM Capsule oral 139/012 Zydus Cadila Healthcare Ltd,

India

5976 Loridin Suspension Loratadine 5mg, per 5mlPOM Tablet Uncoated 139/013 Zydus Cadila Healthcare Ltd,

India

5977 Norswell Tablets Ibuprofen 200mgP Suspension for

Oral Use

139/014 Zydus Cadila Healthcare Ltd,

India

5978Tramazac Injection

Tramadol Hydrochloride 50mg,

per ml

POM Solution for

Injection

139/015 Zydus Cadila Healthcare Ltd,

India

5979 Tramazac Capsules Tramadol Hydrochloride 50mgP Tablet Uncoated 139/016 Zydus Cadila Healthcare Ltd,

India

5980 Odace-10 Tablets Lisinopril 10mgPOM Tablets

Uncoated

139/017 Zydus Cadila Healthcare Ltd,

India

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