human medicines withdrawn products - hpra · human medicines withdrawn products this list was last...

Human Medicines Withdrawn ProductsThis list was last updated on Sunday, November 22, 2020

Please NoteThe contents of the table are believed to be correct at the time of compilation. The HPRA makes no representations or warranties about and disclaim all liability for the content, accuracy, completeness or suitability of the information contained in the table for any purpose whatsoever and the information is made available to the public for information purposes only.

Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateCreon 40000 Gastro-resistant Capsules

Mylan IRE Healthcare Limited

PA2010/008/003 400 milligram(s) Gastro-resistant capsule - Pancreas powder 16/11/2020

Creon 40000 Gastro-resistant Capsules

Mylan IRE Healthcare Limited

PA2010/008/003 400 milligram(s) Gastro-resistant capsule - Pancreas powder 16/11/2020

Xatral 2.5mg Film-Coated Tablets

LTT Pharma Limited PPA1562/020/002 2.5 milligram(s) Film-coated tablet - ALFUZOSIN HYDROCHLORIDE

06/11/2020


LTT Pharma Limited PPA1562/020/002 2.5 milligram(s) Film-coated tablet - ALFUZOSIN HYDROCHLORIDE

06/11/2020

NovoMix 30 NovoLet Novo Nordisk A/S EU/1/00/142/006 100 unit(s)/millilitre Suspension for injection - Insulin aspart 04/11/2020

NOVOMIX 70 FlexPen Novo Nordisk A/S EU/1/00/142/0020-23 100 U/ml unit(s)/millilitre Suspension for injection - Insulin aspart 04/11/2020

NOVOMIX 70 FlexPen Novo Nordisk A/S EU/1/00/142/0020-23 100 U/ml unit(s)/millilitre Suspension for injection - Insulin aspart 04/11/2020

NovoSeven Novo Nordisk A/S EU/1/96/006/001 0.6 micromole(s) Powder and solvent for solution for injection

- Factor viia human, recombinant

04/11/2020

NovoSeven Novo Nordisk A/S EU/1/96/006/002 2.4 milligram(s) Powder and solvent for solution for injection

- Factor viia human, recombinant

04/11/2020

Primolut N 5 mg Tablets Bayer Limited PA1410/010/001 5 milligram(s) Tablet - Norethisterone 04/11/2020

Primolut N 5 mg Tablets Bayer Limited PA1410/010/001 5 milligram(s) Tablet - Norethisterone 04/11/2020

BRAVELLE 75 IU powder and solvent for solution for injection

Ferring Ireland Ltd PA1009/019/001 75 international unit(s) Powder and solvent for solution for injection

- Urofollitropin 03/11/2020

BRAVELLE 75 IU powder and solvent for solution for injection

Ferring Ireland Ltd PA1009/019/001 75 international unit(s) Powder and solvent for solution for injection

- Urofollitropin 03/11/2020

Flursil Relief Sugar Free 8.75 mg lozenges

Rowex Ltd PA0711/257/001 8.75 milligram(s) Lozenge - Flurbiprofen 03/11/2020

Flursil Relief Sugar Free 8.75 mg lozenges

Rowex Ltd PA0711/257/001 8.75 milligram(s) Lozenge - Flurbiprofen 03/11/2020

Tadalafil Rowex 10 mg Film-coated Tablets

Rowex Ltd PA0711/261/003 10 milligram(s) Film-coated tablet - Tadalafil 03/11/2020



Tadalafil Rowex 2.5 mg Film-coated Tablets

Rowex Ltd PA0711/261/001 2.5 milligram(s) Film-coated tablet - Tadalafil 03/11/2020

Tadalafil Rowex 2.5 mg Film-coated Tablets

Rowex Ltd PA0711/261/001 2.5 milligram(s) Film-coated tablet - Tadalafil 03/11/2020





Fucidin 250mg/5ml Oral Suspension

Leo Laboratories Limited PA0046/004/010 250 mg/5ml Oral suspension - Fusidic acid anhydrous 31/10/2020

Fucidin 250mg/5ml Oral Suspension

Leo Laboratories Limited PA0046/004/010 250 mg/5ml Oral suspension - Fusidic acid anhydrous 31/10/2020

Ivabradine 5 mg Film-coated Tablets

Accord Healthcare Ireland Ltd.

PA2315/224/001 5 milligram(s) Film-coated tablet - Ivabradine 30/10/2020

Ivabradine 5 mg Film-coated Tablets


PA2315/224/001 5 milligram(s) Film-coated tablet - Ivabradine 30/10/2020

Ivabradine 7.5 mg Film-coated Tablets


PA2315/224/002 7.5 milligram(s) Film-coated tablet - Ivabradine 30/10/2020

Ivabradine 7.5 mg Film-coated Tablets


PA2315/224/002 7.5 milligram(s) Film-coated tablet - Ivabradine 30/10/2020

TCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w, Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w

Chefaro Ireland DAC PA1186/005/001 25 %w/w+0.5%w/w+ 0.3 percent weight/weight

Cream - TCP Liquid Antiseptic- Chloroxylenol- Triclosan

30/10/2020

Human Medicines Withdrawn Products Page 1 of 704

Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateTCP First Aid Antiseptic Cream.TCP Liquid Antiseptic 25% w/w, Chloroxylenol 0.5% w/w, Triclosan 0.3% w/w



30/10/2020




30/10/2020




30/10/2020




30/10/2020




30/10/2020

TCP Liquid AntisepticHalogenated Phenols 0.68% w/vPhenol 0.175% w/v

Chefaro Ireland DAC PA1186/005/002 0.68%w/v+0.175 percent weight/volume

Cutaneous solution - Halogenated phenols- Phenol

30/10/2020

TCP Liquid AntisepticHalogenated Phenols 0.68% w/vPhenol 0.175% w/v

Chefaro Ireland DAC PA1186/005/002 0.68%w/v+0.175 percent weight/volume

Cutaneous solution - Halogenated phenols- Phenol

30/10/2020

Ciproxin Bayer Limited PA1410/028/001 100 milligram(s) Tablet - CIPROFLOXACIN HYDROCHLORIDE

29/10/2020

Ciproxin Bayer Limited PA1410/028/001 100 milligram(s) Tablet - CIPROFLOXACIN HYDROCHLORIDE

29/10/2020

Ciproxin Bayer Limited PA1410/028/005 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 29/10/2020Ciproxin Bayer Limited PA1410/028/005 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 29/10/2020Ciproxin IV Flexibag Bayer Limited PA1410/028/010 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 29/10/2020Ciproxin IV Flexibag Bayer Limited PA1410/028/010 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 29/10/2020Ciproxin Oral Suspension 250mg/5ml

Bayer Limited PA1410/028/008 5.0 gram(s) - Ciprofloxacin 29/10/2020

Ciproxin Oral Suspension 250mg/5ml


Ciproxin Oral Suspension Forte 500 mg/5ml


Ciproxin Oral Suspension Forte 500 mg/5ml


Alverine citrate 120mg capsules, hard

Incepta Euro Limited PA22965/001/002 120 milligram(s) Capsule, hard - ALVERINE CITRATE 21/10/2020







Kolbam Retrophin Europe Limited

EU/1/13/895/001 50 milligram(s) Capsule, hard - Cholic acid 21/10/2020







Dostinex 500 microgram Tablets

Lexon (UK) Ltd PPA1097/029/001 0.5 milligram(s) Tablet - Cabergoline 16/10/2020

Dostinex 500 microgram Tablets

Lexon (UK) Ltd PPA1097/029/001 0.5 milligram(s) Tablet - Cabergoline 16/10/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateStelazine 1mg/5ml Syru Amdipharm Limited PA1142/037/003 1 mg/5ml Syrup - Trifluoperazine 16/10/2020

Stelazine 1mg/5ml Syru Amdipharm Limited PA1142/037/003 1 mg/5ml Syrup - Trifluoperazine 16/10/2020

Ponalgic 250mg Hard Capsules

Mercury Pharmaceuticals (Ireland) Ltd

PA0073/097/001 250 milligram(s) Capsule - Mefenamic acid 15/10/2020

Ponalgic 250mg Hard Capsules

Mercury Pharmaceuticals (Ireland) Ltd

PA0073/097/001 250 milligram(s) Capsule - Mefenamic acid 15/10/2020

NeoRecormon Roche Registration Limited

EU/1/97/031/027 . percent volume/volume Solution for injection - Epoetin beta 12/10/2020


EU/1/97/031/028 . percent volume/volume Solution for injection - Epoetin beta 12/10/2020


EU/1/97/031/039 60,000 international unit(s)

Powder and solvent for solution for injection

- Epoetin beta 12/10/2020






EU/1/97/031/001 500 international unit(s) Powder and solvent for solution for injection





































NeoRecormon for Reco-Pen

Roche Registration Limited













NeoRecormon Multidose Roche Registration Limited




NeoRecormon Recopen Roche Registration Limited


Powder for solution for injection


Oxaliplatin Hospira 5 mg/ml Concentrate for Solution for Infusion

Hospira UK Limited PA0437/056/002 5 milligram(s)/millilitre Concentrate for solution for infusion

- Oxaliplatin 12/10/2020

Oxaliplatin Hospira 5 mg/ml Concentrate for Solution for Infusion

Hospira UK Limited PA0437/056/002 5 milligram(s)/millilitre Concentrate for solution for infusion

- Oxaliplatin 12/10/2020

Phenobarbital 60 mg Tablets

Clonmel Healthcare Ltd PA0126/019/003 60 milligram(s) Tablet - PHENOBARBITAL 12/10/2020

Phenobarbital 60 mg Tablets

Clonmel Healthcare Ltd PA0126/019/003 60 milligram(s) Tablet - PHENOBARBITAL 12/10/2020

Zyban 150 mg prolonged release tablets

PCO Manufacturing Ltd. PPA0465/089/002 150 milligram(s) Prolonged-release tablet - Bupropion hydrochloride

12/10/2020

Zyban 150 mg prolonged release tablets

PCO Manufacturing Ltd. PPA0465/089/002 150 milligram(s) Prolonged-release tablet - Bupropion hydrochloride

12/10/2020

Kaletra AbbVie Deutschland GmbH & Co. KG

EU/1/01/172/001 133,3/33,3 milligram(s) Capsule - Lopinavir- Ritonavir

06/10/2020

Kaletra AbbVie Deutschland GmbH & Co. KG

EU/1/01/172/001 133,3/33,3 milligram(s) Capsule - Lopinavir- Ritonavir

06/10/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateINACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for injection in prefilled syringe.Influenza vaccine (split virion, inactivated)

Sanofi Pasteur PA2131/012/001 15/15/15mc percent volume/volume

Suspension for injection - A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)- A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)- B/brisbane/60/2008 - like strain (b/brisbane/60/2008)

05/10/2020

INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP, suspension for injection in prefilled syringe.Influenza vaccine (split virion, inactivated)

Sanofi Pasteur PA2131/012/001 15/15/15mc percent volume/volume

Suspension for injection - A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)- A/hong kong/4801/2014 (h3n2) - like strain (a/hong kong/4801/2014, nymc x-263b)- B/brisbane/60/2008 - like strain (b/brisbane/60/2008)

05/10/2020

Invirase Roche Registration GmbH

EU/1/96/026/001 200 milligram(s) Capsule - Saquinavir 05/10/2020

Invirase Roche Registration GmbH

EU/1/96/026/001 200 milligram(s) Capsule - Saquinavir 05/10/2020

Mircera Roche Registration Limited

EU/1/07/400/001 50/1 microgram(s)/millilitre

Solution for injection - Ro0503821 05/10/2020

Mircera Roche Registration GmbH





































EU/1/07/400/14 400/0.6 microgram(s)/millilitre




















Tamiflu Roche Registration GmbH

EU/1/02/222/002 12 micromole(s) Powder for oral suspension

- Oseltamivir phosphate 05/10/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateMethotrexate 10 mg tablets

Orion Corporation PA1327/009/002

Interchangeable List Code:IC0098-002-002

10 milligram(s) Tablet - Methotrexate 02/10/2020

Methotrexate 10 mg tablets



10 milligram(s) Tablet - Methotrexate 02/10/2020

Methotrexate 2.5mg Tablets



2.5 milligram(s) Tablet - Methotrexate 02/10/2020

Methotrexate 2.5mg Tablets



2.5 milligram(s) Tablet - Methotrexate 02/10/2020

Paracetamol 500 mg film-coated tablets


PA2315/030/001 500 milligram(s) Film-coated tablet - PARACETAMOL 01/10/2020

Paracetamol 500 mg film-coated tablets


PA2315/030/001 500 milligram(s) Film-coated tablet - PARACETAMOL 01/10/2020

Truoxin 250 mg Film-coated Tablets

Fannin Limited PA1457/013/001 250 milligram(s) Film-coated tablet - Ciprofloxacin 30/09/2020







Kaletra AbbVie Ltd EU/1/01/172/002 percent volume/volume Capsule - Ritonavir- Lopinavir

28/09/2020

Kaletra AbbVie Ltd EU/1/01/172/002 percent volume/volume Capsule - Ritonavir- Lopinavir

28/09/2020

Norvir AbbVie Ltd EU/1/96/016/001 80 milligram(s)/millilitre Infus/Pdr/Oral Soln - Ritonavir 28/09/2020Norvir AbbVie Ltd EU/1/96/016/001 80 milligram(s)/millilitre Infus/Pdr/Oral Soln - Ritonavir 28/09/2020Norvir Soft Capsules AbbVie Ltd EU/1/96/016/003 100 milligram(s) Capsule - Ritonavir 28/09/2020Norvir Soft Capsules AbbVie Ltd EU/1/96/016/003 100 milligram(s) Capsule - Ritonavir 28/09/2020Nicochew Fruit 2 mg medicated chewing-gum

Clonmel Healthcare Ltd PA0126/263/001 2 milligram(s) Medicated chewing-gum - Nicotine 24/09/2020

Nicochew Fruit 2 mg medicated chewing-gum






Vepacel Ology Bioservices Ireland LTD

EU/1/12/752/001 7.5 microgram(s)

Suspension for injection - Whole virion non-adjuvanted influenza virus (a/vietnam/1203/2004 (h5n1))

24/09/2020

Vepacel Ology Bioservices Ireland LTD

EU/1/12/752/001 7.5 microgram(s)

Suspension for injection - Whole virion non-adjuvanted influenza virus (a/vietnam/1203/2004 (h5n1))

24/09/2020

TechneScan LyoMAA, Powder for suspension for injection/kit for radiopharmaceutical preparation

Mallinckrodt Medical B.V.

PA0690/012/001 2.0 milligram(s) Powder for suspension for injection

- Human albumin macro aggregated

21/09/2020

TechneScan LyoMAA, Powder for suspension for injection/kit for radiopharmaceutical preparation

Mallinckrodt Medical B.V.

PA0690/012/001 2.0 milligram(s) Powder for suspension for injection

- Human albumin macro aggregated

21/09/2020

Prapexin 0.26 mg prolonged release tablets

Rowex Ltd PA0711/242/001 0.26 milligram(s) Prolonged-release tablet - Pramipexole 17/09/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DatePrapexin 0.26 mg prolonged release tablets


















Quedute 0.5 mg soft capsules

Rowex Ltd PA0711/276/001 0.5 milligram(s) Capsule, soft - Dutasteride 16/09/2020

Quedute 0.5 mg soft capsules

Rowex Ltd PA0711/276/001 0.5 milligram(s) Capsule, soft - Dutasteride 16/09/2020

Mannitol Intravenous Infusion BP 20% w/v Solution for Infusion

Baxter Healthcare Limited

PA0167/037/009 20 percent weight/volume

Solution for infusion - Mannitol 13/09/2020

Mannitol Intravenous Infusion BP 20% w/v Solution for Infusion

Baxter Healthcare Limited

PA0167/037/009 20 percent weight/volume

Solution for infusion - Mannitol 13/09/2020

Sodium Chloride (Normal Saline) 0.9% w/v Eye Drops Solution

Martindale Pharmaceuticals Ltd

PA0361/012/001 0.9 percent weight/volume

Eye drops, solution - Sodium chloride 11/09/2020

Glycerol 2g Suppositories

Ethypharm PA0549/028/002 2 gram(s) Suppository - Glycerol 10/09/2020

Glycerol 2g Suppositories

Ethypharm PA0549/028/002 2 gram(s) Suppository - Glycerol 10/09/2020

Hyoscine Injection BP 400 micrograms/ml, Solution for Injection

Ethypharm PA0549/031/001 400 microgram(s)/millilitre

Solution for injection - Hyoscine Hydrobromide

10/09/2020

Treosulfan Powder for Solution for Injection or Infusion 5 g

medac Gesellschaft für klinische Spezialpräparate mbH

PA0623/001/002 5 gram(s) Powder for solution for injection/infusion

- Treosulfan 10/09/2020

Treosulfan Powder for Solution for Injection or Infusion 5 g

medac Gesellschaft für klinische Spezialpräparate mbH

PA0623/001/002 5 gram(s) Powder for solution for injection/infusion

- Treosulfan 10/09/2020

Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets

Clonmel Healthcare Ltd PA0126/284/001 600/300 milligram(s) Film-coated tablet - Abacavir- Lamivudine

09/09/2020

Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets

Clonmel Healthcare Ltd PA0126/284/001 600/300 milligram(s) Film-coated tablet - Abacavir- Lamivudine

09/09/2020

CosmoFer 50mg/ml solution for infusion and injection

Lexon (UK) Ltd PPA1097/034/001 50 milligram(s)/millilitre Solution for injection/infusion

- Iron 09/09/2020

Selectol Tablets 200 mg Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/126/001 200 milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE

08/09/2020

Selectol Tablets 200 mg Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/126/001 200 milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE

08/09/2020

Selectol Tablets 400mg Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/126/002 400
milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE

08/09/2020

Selectol Tablets 400mg Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/126/002 400
milligram(s) Tablet - CELIPROLOL HYDROCHLORIDE

08/09/2020

Advantan 0.1% w/w Fatty Ointment

LEO Pharma A/S PA1025/013/003 0.1
percent weight/weight

Ointment - Methylprednisolone aceponate

04/09/2020

Advantan 0.1% w/w Ointment

LEO Pharma A/S PA1025/013/002 0.1

Ointment - Methylprednisolone aceponate

04/09/2020

Advantan cream 0.1% w/w

LEO Pharma A/S PA1025/013/001 0.1

Cream - Methylprednisolone aceponate

04/09/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateDalacin T Topical 10 mg/ml Cutaneous Solution

Pfizer Healthcare Ireland PA0822/121/002 10 milligram(s)/millilitre Cutaneous solution - CLINDAMYCIN PHOSPHATE

03/09/2020

Dalacin T Topical 10 mg/ml Cutaneous Solution

Pfizer Healthcare Ireland PA0822/121/002 10 milligram(s)/millilitre Cutaneous solution - CLINDAMYCIN PHOSPHATE

03/09/2020

Telfast 180mg film-coated tablets

Lexon (UK) Ltd PPA1097/057/001 180 milligram(s) Film-coated tablet - Fexofenadine hydrochloride

03/09/2020

Telfast 180mg film-coated tablets

Lexon (UK) Ltd PPA1097/057/001 180 milligram(s) Film-coated tablet - Fexofenadine hydrochloride

03/09/2020

Asasantin Retard 200mg/25mg Modified Release Hard Capsules

Imbat Limited PPA1151/128/001 200/25 milligram(s) Capsules Modified Release

- Aspirin- Dipyridamole

01/09/2020

Asasantin Retard 200mg/25mg Modified Release Hard Capsules

Imbat Limited PPA1151/128/001 200/25 milligram(s) Capsules Modified Release

- Aspirin- Dipyridamole

01/09/2020

Atacand 16mg tablets Imbat Limited PPA1151/109/001


16 milligram(s) Tablet - Candesartan cilexetil 01/09/2020

Atacand 16mg tablets Imbat Limited PPA1151/109/001



Atacand 4 mg tablets Imbat Limited PPA1151/109/002












Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution

Imbat Limited PPA1151/204/002 50 microgram(s) Pressurised inhalation, solution

- Beclometasone dipropionate

01/09/2020

Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution

Imbat Limited PPA1151/204/002 50 microgram(s) Pressurised inhalation, solution

- Beclometasone dipropionate

01/09/2020

Benylin Day & Night Tablets

Imbat Limited PPA1151/264/001 500/60 & 25 milligram(s) Tablet - Diphenhydramine hydrochloride- PSEUDOEPHEDRINE HYDROCHLORIDE- Paracetamol

01/09/2020

Benylin Day & Night Tablets

Imbat Limited PPA1151/264/001 500/60 & 25 milligram(s) Tablet - Diphenhydramine hydrochloride- PSEUDOEPHEDRINE HYDROCHLORIDE- Paracetamol

01/09/2020

Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg

Imbat Limited PPA1151/130/001 500 12.5 22.5 milligram(s)

Film-coated tablet - Diphenhydramine- Pseudoephedrine- Paracetamol

01/09/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateBenylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg

Imbat Limited PPA1151/130/001 500 12.5 22.5 milligram(s)

Film-coated tablet - Diphenhydramine- Pseudoephedrine- Paracetamol

01/09/2020

Coversyl Arginine Plus 10mg/2.5mg film-coated tablets

LTT Pharma Limited PPA1562/063/002 10/2.5 milligram(s) Film-coated tablet - Indapamide- Perindopril arginine

28/08/2020

Coversyl Arginine Plus 10mg/2.5mg film-coated tablets

LTT Pharma Limited PPA1562/063/002 10/2.5 milligram(s) Film-coated tablet - Indapamide- Perindopril arginine

28/08/2020

Provigil 200 mg Tablets Lexon (UK) Ltd PPA1097/024/001 200 milligram(s) Tablet - Modafinil 28/08/2020Provigil 200 mg Tablets Lexon (UK) Ltd PPA1097/024/001 200 milligram(s) Tablet - Modafinil 28/08/2020Ibuprofen/Phenylephrine Clonmel 400 mg/10 mg film-coated tablets

Clonmel Healthcare Ltd PA0126/296/001 400/10 milligram(s) Film-coated tablet - Ibuprofen- Phenylephrine hydrochloride

27/08/2020

Arcoxia 30 mg film-coated tablets

Imbat Limited PPA1151/137/001


30 milligram(s) Film-coated tablet - Etoricoxib 25/08/2020





Aromasin 25 mg coated tablets

Imbat Limited PPA1151/178/001 25 milligram(s) Coated tablet - Exemestane 25/08/2020

Aromasin 25 mg coated tablets

Imbat Limited PPA1151/178/001 25 milligram(s) Coated tablet - Exemestane 25/08/2020

Arthrotec 50 modified-release tablets



50/0.2 milligram(s) Modified-release tablet - DICLOFENAC SODIUM- Misoprostol

25/08/2020




50/0.2 milligram(s) Modified-release tablet - DICLOFENAC SODIUM- Misoprostol

25/08/2020




75/0.2 milligram(s) Modified-release tablet - Misoprostol- DICLOFENAC SODIUM

25/08/2020




75/0.2 milligram(s) Modified-release tablet - Misoprostol- DICLOFENAC SODIUM

25/08/2020

Asacolon 400 mg Gastro-resistant Tablets

Imbat Limited PPA1151/107/001 400 milligram(s) Gastro-resistant tablet - Mesalazine 25/08/2020

Asacolon 400 mg Gastro-resistant Tablets


Asacolon 800mg Gastro-resistant Tablets


Asacolon 800mg Gastro-resistant Tablets


By-Vertin 8 mg Tablets Fannin Limited PA1457/011/001


8 milligram(s) Tablet - Betahistine dihydrochloride

25/08/2020




25/08/2020

Eslicarbazepine acetate Mylan 800 mg Tablets

McDermott Laboratories Ltd., T/A Gerard Laboratories

PA0577/231/001 800 milligram(s) Tablet - Eslicarbazepine acetate

25/08/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateEslicarbazepine acetate Mylan 800 mg Tablets

McDermott Laboratories Ltd., T/A Gerard Laboratories

PA0577/231/001 800 milligram(s) Tablet - Eslicarbazepine acetate

25/08/2020

Amaryl 2mg Tablets Imbat Limited PPA1151/063/002 2 milligram(s) Tablet - Glimepiride 24/08/2020Amaryl 2mg Tablets Imbat Limited PPA1151/063/002 2 milligram(s) Tablet - Glimepiride 24/08/2020Amaryl 4mg Tablets Imbat Limited PPA1151/063/003 4 milligram(s) Tablet - Glimepiride 24/08/2020Amaryl 4mg Tablets Imbat Limited PPA1151/063/003 4 milligram(s) Tablet - Glimepiride 24/08/2020Arcoxia 120 mg film-coated tablets
























Arimidex 1 mg film-coated tablets



1 milligram(s) Film-coated tablet - Anastrozole 24/08/2020

Arimidex 1 mg film-coated tablets




Omeprazole Teva Pharma 10 mg Gastro-resistant capsules, hard

Teva Pharma B.V. PA0749/092/001


10 milligram(s) Gastro-resistant capsule - Omeprazole 20/08/2020
















40 milligram(s) Gastro-resistant capsule, hard

- Omeprazole 20/08/2020




40 milligram(s) Gastro-resistant capsule, hard

- Omeprazole 20/08/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateActifed 60mg/2.5mg tablets

Imbat Limited PPA1151/210/001 60/2.5 milligram(s) Tablet - TRIPROLIDINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE

19/08/2020

Actifed 60mg/2.5mg tablets

Imbat Limited PPA1151/210/001 60/2.5 milligram(s) Tablet - TRIPROLIDINE HYDROCHLORIDE- PSEUDOEPHEDRINE HYDROCHLORIDE

19/08/2020

Acular 0.5% w/v eye drops, solution

Imbat Limited PPA1151/142/001 0.5 percent weight/volume

Eye drops, solution - Ketorolac trometamol 19/08/2020

Acular 0.5% w/v eye drops, solution

Imbat Limited PPA1151/142/001 0.5 percent weight/volume

Eye drops, solution - Ketorolac trometamol 19/08/2020

Adalat LA 30mg Prolonged-Release Tablet

Imbat Limited PPA1151/047/002 30 milligram(s) Prolonged-release tablet - Nifedipine 19/08/2020

Adalat LA 30mg Prolonged-Release Tablet


Adalat Retard 20 mg Prolonged-Release Tablets


Adalat Retard 20 mg Prolonged-Release Tablets


Aldactone 25mg Film-coated Tablets

Imbat Limited PPA1151/197/001 25 milligram(s) Film-coated tablet - Spironolactone 19/08/2020

Aldactone 25mg Film-coated Tablets

Imbat Limited PPA1151/197/001 25 milligram(s) Film-coated tablet - Spironolactone 19/08/2020

Amaryl 1mg Tablets Imbat Limited PPA1151/063/001 1 milligram(s) Tablet - Glimepiride 19/08/2020Amaryl 1mg Tablets Imbat Limited PPA1151/063/001 1 milligram(s) Tablet - Glimepiride 19/08/2020Dilzem XL 120mg Prolonged-release hard capsules

Teva B.V. PA1986/089/004 120 milligram(s) Prolonged-release capsule

- Diltiazem hydrochloride 17/08/2020

Dilzem XL 120mg Prolonged-release hard capsules



Dilzem XL 180mg Prolonged-release Hard Capsules












Glucobay 100 mg Tablets

Bayer Limited PA1410/029/002 100 milligram(s) Tablet - Acarbose 17/08/2020

Glucobay 100 mg Tablets

Bayer Limited PA1410/029/002 100 milligram(s) Tablet - Acarbose 17/08/2020

Glucobay 50 mg Tablets Bayer Limited PA1410/029/001 50 milligram(s) Tablet - Acarbose 17/08/2020

Glucobay 50 mg Tablets Bayer Limited PA1410/029/001 50 milligram(s) Tablet - Acarbose 17/08/2020




15/08/2020




15/08/2020

Qtrilmet AstraZeneca AB EU/1/19/1401/001-014 850/2.5/5 milligram(s) Modified-release tablet - Saxagliptin- METFORMIN HYDROCHLORIDE- Dapagliflozin

14/08/2020

Tadalafil Clonmel 10 mg Film-coated Tablets

Clonmel Healthcare Ltd PA0126/283/003 10 milligram(s) Film-coated tablet - Tadalafil 14/08/2020




Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateTadalafil Clonmel 2.5 mg Film-coated Tablets

Clonmel Healthcare Ltd PA0126/283/001 2.5 milligram(s) Film-coated tablet - Tadalafil 14/08/2020

Tadalafil Clonmel 2.5 mg Film-coated Tablets

Clonmel Healthcare Ltd PA0126/283/001 2.5 milligram(s) Film-coated tablet - Tadalafil 14/08/2020









Grisol 1% w/w Cutaneous Spray solution

Transdermal Limited PA0991/001/001 1 percent weight/weight Cutaneous spray, solution

- Griseofulvin 12/08/2020

MONTELUKAST Paediatric 4mg Chewable Tablets

Aurobindo Pharma (Malta) Limited

PA1445/015/002


4 milligram(s) Chewable tablet - Montelukast sodium 11/08/2020

MONTELUKAST Paediatric 4mg Chewable Tablets

Aurobindo Pharma (Malta) Limited

PA1445/015/002


4 milligram(s) Chewable tablet - Montelukast sodium 11/08/2020

Zileze 7.5 mg Film-Coated Tablets

Chiesi Limited PA0743/007/003


7.5 milligram(s) Film-coated tablet - Zopiclone 11/08/2020

Zileze 7.5 mg Film-Coated Tablets

Chiesi Limited PA0743/007/003


7.5 milligram(s) Film-coated tablet - Zopiclone 11/08/2020

Lidotec 700 mg medicated plaster

Grunenthal Pharma Ltd PA2242/009/001 5 percent Medicated plaster - Lidocaine 10/08/2020

Lidotec 700 mg medicated plaster

Grunenthal Pharma Ltd PA2242/009/001 5 percent Medicated plaster - Lidocaine 10/08/2020

Salmeterol Neolab 25 micrograms per metered dose pressurised inhalation suspension

Fannin Limited PA1457/024/001 25 microgram(s) Pressurised inhalation, suspension

- Salmeterol 07/08/2020

Salmeterol Neolab 25 micrograms per metered dose pressurised inhalation suspension

Fannin Limited PA1457/024/001 25 microgram(s) Pressurised inhalation, suspension

- Salmeterol 07/08/2020

Suprecur 150 micrograms/ metered dose Nasal Spray, solution

Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/073/002 150 microgram(s) Nasal spray, solution - Buserelin 02/08/2020

Suprecur 150 micrograms/ metered dose Nasal Spray, solution


PA0540/073/002 150 microgram(s) Nasal spray, solution - Buserelin 02/08/2020

Suprefact 1 mg/ml Solution for Injection


PA0540/074/001 1 milligram(s)/millilitre Solution for injection - Buserelin 02/08/2020

Suprefact 1 mg/ml Solution for Injection


PA0540/074/001 1 milligram(s)/millilitre Solution for injection - Buserelin 02/08/2020

Duzallo Grünenthal GmbH EU/1/18/1300/001-002 200/200 milligram(s) Film-coated tablet - Lesinurad- Allopurinol

31/07/2020

Duzallo Grünenthal GmbH EU/1/18/1300/003-004 300/200 milligram(s) Film-coated tablet - Allopurinol- Lesinurad

31/07/2020

Pilocarpine 2% w/v Eye Drops, Solution


PA0361/010/001 2 percent weight/volume Eye drops, solution - Pilocarpine hydrochloride

31/07/2020

Pilocarpine 2% w/v Eye Drops, Solution


PA0361/010/001 2 percent weight/volume Eye drops, solution - Pilocarpine hydrochloride

31/07/2020

Rythmodan Retard 250 mg Prolonged-release Tablets


PA0540/069/004 250 milligram(s) Prolonged-release tablet - Disopyramide 31/07/2020

Rythmodan Retard 250 mg Prolonged-release Tablets


PA0540/069/004 250 milligram(s) Prolonged-release tablet - Disopyramide 31/07/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateTarivid IV 2 mg/ml Solution for Infusion


PA0540/076/002 2 milligram(s)/millilitre Solution for infusion - Ofloxacin 31/07/2020

Tarivid IV 2 mg/ml Solution for Infusion


PA0540/076/002 2 milligram(s)/millilitre Solution for infusion - Ofloxacin 31/07/2020

Aripiprazole Accord Healthcare 10 mg tablet


PA2315/026/002


10 milligram(s) Tablet - Aripiprazole 30/07/2020

Aripiprazole Accord Healthcare 10 mg tablet


PA2315/026/002


10 milligram(s) Tablet - Aripiprazole 30/07/2020

Zemplar 5 micrograms/ml Solution for Injection, glass vial

AbbVie Limited PA1824/005/005 5 microgram(s)/millilitre Solution for injection - Paricalcitol 29/07/2020

Zemplar 5 micrograms/ml Solution for Injection, glass vial

AbbVie Limited PA1824/005/005 5 microgram(s)/millilitre Solution for injection - Paricalcitol 29/07/2020

Cardioplegia Concentrate for Solution for Infusion (163mg/60mg/14mg per ml)


PA0361/014/001 163mg/ml + 60mg/ml+14 milligram(s)/millilitre

Concentrate for solution for infusion

- Potassium chloride- Procaine hydrochloride- Magnesium chloride

27/07/2020

Chloramphenicol 0.5% w/v Eye Drops



Eye drops, solution - Chloramphenicol 27/07/2020

Chloramphenicol 0.5% w/v Eye Drops



Eye drops, solution - Chloramphenicol 27/07/2020

Chloramphenicol 1% w/w Eye Ointment

Ethypharm PA0549/025/002 1 percent weight/weight Eye ointment - Chloramphenicol 27/07/2020

Chloramphenicol 1% w/w Eye Ointment

Ethypharm PA0549/025/002 1 percent weight/weight Eye ointment - Chloramphenicol 27/07/2020

Clarithromycin Martindale Pharma 500 mg Powder for Concentrate for Solution for Infusion


PA0361/025/001 500 milligram(s) Pdr/Conc/Soln for Infus - Clarithromycin 27/07/2020

Clarithromycin Martindale Pharma 500 mg Powder for Concentrate for Solution for Infusion


PA0361/025/001 500 milligram(s) Pdr/Conc/Soln for Infus - Clarithromycin 27/07/2020

Cyclizine Lactate 50 mg/ml Solution for Injection

Ethypharm PA0549/033/001 50 milligram(s)/millilitre Solution for injection - Cyclizine 27/07/2020

Cyclizine Lactate 50 mg/ml Solution for Injection

Ethypharm PA0549/033/001 50 milligram(s)/millilitre Solution for injection - Cyclizine 27/07/2020

Granisetron Martindale Pharma 1mg/1ml Concentrate for Solution for Injection/Infusion


PA0361/029/001 1 milligram(s)/millilitre Concentrate for solution for injection

- Granisetron hydrochloride

27/07/2020



PA0361/029/002 3mg/3ml Concentrate for solution for injection


27/07/2020



PA0361/029/002 3mg/3ml Concentrate for solution for injection


27/07/2020

Midazolam 5 mg/ml Solution for injection or infusion


PA0361/021/001 5 milligram(s)/millilitre Solution for injection/infusion

- MIDAZOLAM HYDROCHLORIDE

27/07/2020

Midazolam 5 mg/ml Solution for injection or infusion


PA0361/021/001 5 milligram(s)/millilitre Solution for injection/infusion

- MIDAZOLAM HYDROCHLORIDE

27/07/2020

Pethidine Injection BP 100mg/2ml


PA0361/008/003 100/2 milligram(s)/millilitre

Solution for injection - PETHIDINE HYDROCHLORIDE

27/07/2020

Pethidine Injection BP 100mg/2ml


PA0361/008/003 100/2 milligram(s)/millilitre

Solution for injection - PETHIDINE HYDROCHLORIDE

27/07/2020

Pethidine Injection BP 50mg/ml


PA0361/008/002 50 milligram(s)/millilitre Solution for injection - PETHIDINE HYDROCHLORIDE

27/07/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DatePethidine Injection BP 50mg/ml


PA0361/008/002 50 milligram(s)/millilitre Solution for injection - PETHIDINE HYDROCHLORIDE

27/07/2020

Pethidine Tablets BP 50 mg


PA0361/008/001 50 milligram(s) Tablet - PETHIDINE HYDROCHLORIDE

27/07/2020

Pethidine Tablets BP 50 mg


PA0361/008/001 50 milligram(s) Tablet - PETHIDINE HYDROCHLORIDE

27/07/2020

Phenobarbital Sodium 15mg/ml Solution for Injection


PA0361/005/001 15 milligram(s)/millilitre Solution for injection - Phenobarbital sodium 27/07/2020
















Drytec 2.5-100 GBq radionuclide generator

GE Healthcare B.V. PA22734/002/001 2.5-100 gigabecquerel(s Radionuclide generator - Sodium Molybdate.99 Mo

24/07/2020

Flexove 625 mg tablets Laboratoires Expanscience

PA1616/001/001 625 milligram(s) Tablet - Glucosamine 22/07/2020

Flexove 625 mg tablets Laboratoires Expanscience

PA1616/001/001 625 milligram(s) Tablet - Glucosamine 22/07/2020

Ariclaim Eli Lilly Nederland B.V. EU/1/04/283/1-6 40 milligram(s) Gastro-resistant capsule - Duloxetine hydrochloride

16/07/2020

Ariclaim Eli Lilly Nederland B.V. EU/1/04/283/1-6 40 milligram(s) Gastro-resistant capsule - Duloxetine hydrochloride

16/07/2020

Zurampic Grünenthal GmbH EU/1/15/1080/001-005 200 milligram(s) Film-coated tablet - Lesinurad 16/07/2020Gastrolief 20 mg gastro-resistant tablets

Clonmel Healthcare Ltd PA0126/220/001 20 milligram(s) Gastro-resistant tablet - Pantoprazole 15/07/2020

Gastrolief 20 mg gastro-resistant tablets

Clonmel Healthcare Ltd PA0126/220/001 20 milligram(s) Gastro-resistant tablet - Pantoprazole 15/07/2020

Anafranil 10mg Capsules

Novartis Pharmaceuticals UK Ltd

PA0013/084/002 10 milligram(s) Capsule - Clomipramine hydrochloride

10/07/2020




10/07/2020




10/07/2020




10/07/2020




10/07/2020




10/07/2020

Captor 25 mg Tablets Rowex Ltd PA0711/002/002 25 milligram(s) Tablet - Captopril 10/07/2020Captor 25 mg Tablets Rowex Ltd PA0711/002/002 25 milligram(s) Tablet - Captopril 10/07/2020Ranitic 150 mg Film-coated tablets

Rowex Ltd PA0711/024/001


150 milligram(s) Film-coated tablet - RANITIDINE HYDROCHLORIDE

07/07/2020

Ranitic 150 mg Film-coated tablets




07/07/2020





07/07/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateRanitic 300 mg Film-coated tablets




07/07/2020


Rowex Ltd PA0711/024/004 75 milligram(s) Film-coated tablet - RANITIDINE HYDROCHLORIDE

07/07/2020


Rowex Ltd PA0711/024/004 75 milligram(s) Film-coated tablet - RANITIDINE HYDROCHLORIDE

07/07/2020

Paramax 500mg/5mg Tablets


PA0540/154/001 500mg/5 milligram(s) Tablet - Paracetamol- Metoclopramide hydrochloride

02/07/2020

Paramax 500mg/5mg Tablets


PA0540/154/001 500mg/5 milligram(s) Tablet - Paracetamol- Metoclopramide hydrochloride

02/07/2020

Captor 12.5mg Tablets Rowex Ltd PA0711/002/001 12.5 milligram(s) Tablet - Captopril 01/07/2020Captor 12.5mg Tablets Rowex Ltd PA0711/002/001 12.5 milligram(s) Tablet - Captopril 01/07/2020Captor 50mg Tablets Rowex Ltd PA0711/002/003 50 milligram(s) Tablet - Captopril 01/07/2020Captor 50mg Tablets Rowex Ltd PA0711/002/003 50 milligram(s) Tablet - Captopril 01/07/2020Captor-HCT 25 mg/12.5 mg Tablets

Rowex Ltd PA0711/025/001 25/12.5 mg milligram(s) Tablet - Captopril- Hydrochlorothiazide

01/07/2020

Captor-HCT 25 mg/12.5 mg Tablets

Rowex Ltd PA0711/025/001 25/12.5 mg milligram(s) Tablet - Captopril- Hydrochlorothiazide

01/07/2020

Captor-HCT 50mg/25mg Tablets

Rowex Ltd PA0711/025/003 50/25mg milligram(s) Tablet - Captopril- Hydrochlorothiazide

01/07/2020

Captor-HCT 50mg/25mg Tablets

Rowex Ltd PA0711/025/003 50/25mg milligram(s) Tablet - Captopril- Hydrochlorothiazide

01/07/2020

Isotrexin 20 mg/g + 0.5 mg/g Gel

GlaxoSmithKline (Ireland) Limited

PA1077/123/001 20+0.5 milligram(s)/gra Gel - Isotretinoin- Erythromycin

01/07/2020

Dutasteride 0.5 mg soft capsules

Cipla Europe NV PA1963/005/001 0.5 milligram(s) Capsule, soft - Dutasteride (dmf) 30/06/2020

Dutasteride 0.5 mg soft capsules

Cipla Europe NV PA1963/005/001 0.5 milligram(s) Capsule, soft - Dutasteride (dmf) 30/06/2020

Stugeron 25 mg Tablets Johnson & Johnson (Ireland) Limited

PA0330/044/002 25 milligram(s) Tablet - Cinnarizine 30/06/2020

Stugeron 25 mg Tablets Johnson & Johnson (Ireland) Limited

PA0330/044/002 25 milligram(s) Tablet - Cinnarizine 30/06/2020

Tyrozets Lozenges Johnson & Johnson (Ireland) Limited

PA0330/043/001 1/5 milligram(s) Lozenge - Benzocaine- Tyrothricin

30/06/2020

Tyrozets Lozenges Johnson & Johnson (Ireland) Limited

PA0330/043/001 1/5 milligram(s) Lozenge - Benzocaine- Tyrothricin

30/06/2020

Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/3 mg film-coated tablets

Laboratorios Leon Farma, S.A.

PA1474/006/001 0.02/3 milligram(s) Film-coated tablet - Drospirenone- Ethinylestradiol

29/06/2020



PA1474/006/001 0.02/3 milligram(s) Film-coated tablet - Drospirenone- Ethinylestradiol

29/06/2020



PA1474/006/002 0.03/3 milligram(s) Film-coated tablet - Ethinylestradiol- Drospirenone

29/06/2020



PA1474/006/002 0.03/3 milligram(s) Film-coated tablet - Ethinylestradiol- Drospirenone

29/06/2020

Caspofungin 50 mg powder for concentrate for solution for infusion

Ethypharm PA0549/022/001 50.00 milligram(s) Powder for concentrate for solution for infusion

- Caspofungin 25/06/2020










Picato Leo Laboratories Limited EU/1/12/796/001 150 Micrograms/g Gel - Ingenol mebutate 25/06/2020

Picato Leo Laboratories Limited EU/1/12/796/001 150 Micrograms/g Gel - Ingenol mebutate 25/06/2020

Accolate 20 mg film-coated tablets

AstraZeneca UK Limited PA0970/001/001 20 milligram(s) Tablet - Zafirlukast 23/06/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateAccolate 20 mg film-coated tablets

AstraZeneca UK Limited PA0970/001/001 20 milligram(s) Tablet - Zafirlukast 23/06/2020

Forane 99.9% w/w, Inhalation Vapour, Liquid

AbbVie Limited PA1824/001/001 99.9 percent weight/weight

Inhalation Gas - Isoflurane 23/06/2020

Forane 99.9% w/w, Inhalation Vapour, Liquid

AbbVie Limited PA1824/001/001 99.9 percent weight/weight

Inhalation Gas - Isoflurane 23/06/2020

Vascace 0.5 mg Film-coated Tablets

Roche Products Limited PA0050/083/001 0.5 milligram(s) Film-coated tablet - Cilazapril 22/06/2020

Vascace 0.5 mg Film-coated Tablets

Roche Products Limited PA0050/083/001 0.5 milligram(s) Film-coated tablet - Cilazapril 22/06/2020

Zerit Bristol Myers Squibb Pharma EEIG

EU/1/96/009/001 15 milligram(s) Capsule - Stavudine 22/06/2020
































EU/1/96/009/009 1 milligram(s)/millilitre Powder for oral solution - Stavudine 22/06/2020


EU/1/96/009/009 1 milligram(s)/millilitre Powder for oral solution - Stavudine 22/06/2020

Anastrozole 1 mg film-coated tablets


PA2315/011/001





PA2315/011/001



Lotriderm Merck Sharp & Dohme Ireland (Human Health) Limited

PA1286/031/001 0.064/1.0 Cream - Clotrimazole- BETAMETHASONE DIPROPIONATE

18/06/2020

Lotriderm Merck Sharp & Dohme Ireland (Human Health) Limited

PA1286/031/001 0.064/1.0 Cream - Clotrimazole- BETAMETHASONE DIPROPIONATE

18/06/2020

Profal 5 mg film-coated tablets


PA2315/045/001 5 milligram(s) Film-coated tablet - Finasteride 18/06/2020

Profal 5 mg film-coated tablets


PA2315/045/001 5 milligram(s) Film-coated tablet - Finasteride 18/06/2020

Etoricoxib 120 mg film-coated tablets


PA2315/043/004




Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateEtoricoxib 120 mg film-coated tablets


PA2315/043/004





PA2315/043/001





PA2315/043/001





PA2315/043/002





PA2315/043/002





PA2315/043/003





PA2315/043/003



sdfgsdfgsdfg IMB Test Pharmaceutical Company

PA1836/001/063 Infus/Pdr/Oral Soln - C.perfringens type b & c toxoid

10/06/2020

TEST product Test MAH PA22671/001/001 . - Ibuprofen 10/06/2020Inderal 10mg Film-coated Tablets

AstraZeneca AB PA1019/010/001 10 milligram(s) Film-coated tablet - PROPRANOLOL HYDROCHLORIDE

08/06/2020

Inderal 10mg Film-coated Tablets

AstraZeneca AB PA1019/010/001 10 milligram(s) Film-coated tablet - PROPRANOLOL HYDROCHLORIDE

08/06/2020

Tenoret 50mg/12.5mg Film-coated Tablets

AstraZeneca AB PA1019/021/001 50 mg/12.5 milligram(s) Film-coated tablet - Atenolol- Chlorthalidone

08/06/2020

Tenoret 50mg/12.5mg Film-coated Tablets

AstraZeneca AB PA1019/021/001 50 mg/12.5 milligram(s) Film-coated tablet - Atenolol- Chlorthalidone

08/06/2020

Tenoretic 100mg/25mg Film-coated Tablets

AstraZeneca AB PA1019/022/001 100 mg/25 milligram(s) Film-coated tablet - Atenolol- Chlorthalidone

08/06/2020

Tenoretic 100mg/25mg Film-coated Tablets

AstraZeneca AB PA1019/022/001 100 mg/25 milligram(s) Film-coated tablet - Atenolol- Chlorthalidone

08/06/2020

Remifentanil 1mg powder for concentrate for solution for injection/infusion

Actavis Group PTC ehf PA1380/112/001 1 milligram(s) Powder for concentrate for solution for injection/infusion

- Remifentanil 02/06/2020

















Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateFetanex 12.5 microgram/hour Transdermal patch

Rowex Ltd PA0711/137/001 12.5 Microgram per hour Transdermal patch - Fentanyl 26/05/2020

Fetanex 12.5 microgram/hour Transdermal patch






TOPAMAX 200mg Film-coated Tablets

Lexon (UK) Ltd PPA1097/002/002 200 milligram(s) Film-coated tablet - Topiramate 14/05/2020







Pipexus 0.26 mg prolonged-release tablets

Macarthys Laboratories Limited

PA0274/003/001 0.26 milligram(s) Prolonged-release tablet - Pramipexole dihydrochloride monohydrate

12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020




12/05/2020


Fresenius Kabi Deutschland GmbH

PA2059/027/001





PA2059/027/001



Bicalutamide 150 mg film-coated tablets


PA2059/030/002 150 milligram(s) Film-coated tablet - Bicalutamide 11/05/2020

Bicalutamide 150 mg film-coated tablets




Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateBicalutamide 50mg Film-coated tablets



Bicalutamide 50mg Film-coated tablets



Letrozole 2.5mg film-coated tablets


PA2059/047/001 2.5 milligram(s) Film-coated tablet - Letrozole 11/05/2020

Letrozole 2.5mg film-coated tablets


PA2059/047/001 2.5 milligram(s) Film-coated tablet - Letrozole 11/05/2020

Zalmoxis MolMed EU/1/16/1121/001 20 Milligram Suspension for Infusion - Allogeneic t cells mm-tk ds

07/05/2020

Panadol 500 mg Film Coated Tablets

Lexon (UK) Ltd PPA1097/016/001 500 milligram(s) Film-coated tablet - PARACETAMOL 04/05/2020

Panadol 500 mg Film Coated Tablets

Lexon (UK) Ltd PPA1097/016/001 500 milligram(s) Film-coated tablet - PARACETAMOL 04/05/2020

Ciprofloxacin 2mg/ml, Solution for Infusion

Baxter Holding B.V. PA2299/034/001 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 01/05/2020

Ciprofloxacin 2mg/ml, Solution for Infusion

Baxter Holding B.V. PA2299/034/001 2 milligram(s)/millilitre Solution for infusion - Ciprofloxacin lactate 01/05/2020

Prasugrel Rowex 10 mg Film-coated tablets

Rowex Ltd PA0711/282/002 10 milligram(s) Film-coated tablet - Prasugrel 01/05/2020


Rowex Ltd PA0711/282/002 10 milligram(s) Film-coated tablet - Prasugrel 01/05/2020


Rowex Ltd PA0711/282/001 5 milligram(s) Film-coated tablet - PRASUGREL BESILATE

01/05/2020


Rowex Ltd PA0711/282/001 5 milligram(s) Film-coated tablet - PRASUGREL BESILATE

01/05/2020

DDAVP/Desmopressin 0.1mg Tablets

Ferring Ireland Ltd PA1009/001/003 0.1 milligram(s) Tablet - DESMOPRESSIN ACETATE

30/04/2020

DDAVP/Desmopressin 0.1mg Tablets


30/04/2020

Desmotabs 0.2mg Tablets


30/04/2020

Desmotabs 0.2mg Tablets


30/04/2020

Octostim 1.5 mg/ml Nasal Spray

Ferring Ireland Ltd PA1009/014/002 1.5 milligram(s)/millilitre Nasal spray, solution - DESMOPRESSIN ACETATE

30/04/2020

Octostim 1.5 mg/ml Nasal Spray

Ferring Ireland Ltd PA1009/014/002 1.5 milligram(s)/millilitre Nasal spray, solution - DESMOPRESSIN ACETATE

30/04/2020

Octostim 15 micrograms/ml Solution for injection

Ferring Ireland Ltd PA1009/014/001 15 microgram(s)/millilitre Solution for injection - DESMOPRESSIN ACETATE

30/04/2020

Octostim 15 micrograms/ml Solution for injection

Ferring Ireland Ltd PA1009/014/001 15 microgram(s)/millilitre Solution for injection - DESMOPRESSIN ACETATE

30/04/2020

Cystrin 3mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/143/001 3 milligram(s) Tablet - OXYBUTYNIN HYDROCHLORIDE

24/04/2020



24/04/2020



24/04/2020



24/04/2020

Ditropan 2.5mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/146/002 2.5 milligram(s) Tablet - OXYBUTYNIN HYDROCHLORIDE

24/04/2020

Ditropan 2.5mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI

PA0540/146/002 2.5 milligram(s) Tablet - OXYBUTYNIN HYDROCHLORIDE

24/04/2020

Ditropan 5mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI


24/04/2020

Ditropan 5mg Tablets Sanofi-Aventis Ireland Limited T/A SANOFI


24/04/2020

Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution


PA2315/024/001


50 mcg/ml + 5 milligram(s)/millilitre

Eye drops, solution - Latanoprost- Timolol

24/04/2020

Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution


PA2315/024/001


50 mcg/ml + 5 milligram(s)/millilitre

Eye drops, solution - Latanoprost- Timolol

24/04/2020

Sotacor 80 mg Tablets Bristol-Myers Squibb Pharmaceuticals uc

PA2255/003/001 80 milligram(s) Tablet - SOTALOL HYDROCHLORIDE

24/04/2020

Sotacor 80 mg Tablets Bristol-Myers Squibb Pharmaceuticals uc

PA2255/003/001 80 milligram(s) Tablet - SOTALOL HYDROCHLORIDE

24/04/2020

Varuby TESARO Bio Netherlands B.V.

EU/1/17/1180/001 90 milligram(s) Film-coated tablet - Rolapitant 24/04/2020


Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateVaruby TESARO Bio

Netherlands B.V.EU/1/17/1180/001 90 milligram(s) Film-coated tablet - Rolapitant 24/04/2020



PA0540/162/001 2.5 milligram(s) Film-coated tablet - ALFUZOSIN HYDROCHLORIDE

24/04/2020



PA0540/162/001 2.5 milligram(s) Film-coated tablet - ALFUZOSIN HYDROCHLORIDE

24/04/2020

Dassan 700 mg Medicated Plaster

Grunenthal Pharma Ltd PA2242/002/001 700 milligram(s) Medicated plaster - Lidocaine 22/04/2020

Dassan 700 mg Medicated Plaster


Lonqtiv 700 mg Medicated Plaster


Lonqtiv 700 mg Medicated Plaster


Topamax 100mg film-coated tablets

IMED Healthcare Ltd. PPA1463/106/002 100 milligram(s) Film-coated tablet - Topiramate 16/04/2020

Topamax 100mg film-coated tablets

IMED Healthcare Ltd. PPA1463/106/002 100 milligram(s) Film-coated tablet - Topiramate 16/04/2020

Vesitirim 10mg Film-coated Tablets

IMED Healthcare Ltd. PPA1463/046/002 10 milligram(s) Film-coated tablet - Solifenacin succinate 16/04/2020

Vesitirim 10mg Film-coated Tablets


Vesitirim 5 mg Film-coated Tablets


Vesitirim 5 mg Film-coated Tablets


Zovirax 200mg Dispersible Tablets

IMED Healthcare Ltd. PPA1463/132/002 200 milligram(s) Dispersible tablet - ACICLOVIR 16/04/2020

Zovirax 200mg Dispersible Tablets

IMED Healthcare Ltd. PPA1463/132/002 200 milligram(s) Dispersible tablet - ACICLOVIR 16/04/2020

OSSEOR Les Laboratoires Servier EU/1/04/287/001 2 g percent volume/volume

Granules for oral suspension

- Strontium ranelate 14/04/2020

OSSEOR Les Laboratoires Servier EU/1/04/287/001 2 g percent volume/volume



PROTELOS Les Laboratoires Servier EU/1/04/288/1-6 2g percent volume/volume



PROTELOS Les Laboratoires Servier EU/1/04/288/1-6 2g percent volume/volume



Seroxat 20 mg film-coated tablets

Lexon (UK) Ltd PPA1097/040/001


20 milligram(s) Film-coated tablet - Paroxetine hydrochloride hemihydrate

14/04/2020


Lexon (UK) Ltd PPA1097/040/001



14/04/2020


LTT Pharma Limited PPA1562/030/004



14/04/2020


LTT Pharma Limited PPA1562/030/004



14/04/2020

Ambrisentan betapharm 10 mg film-coated tablets.

Betapharm Arzneimittel GmbH

PA22717/001/002 10 milligram(s) Film-coated tablet - Ambrisentan 07/04/2020










Ibuprofen Chanelle Medical 200 mg capsules, soft

Chanelle Medical PA0688/053/001 200 milligram(s) Capsule, soft - Ibuprofen lysine 07/04/2020




Trade Name Licence Holder Licence Number Strength Dosage Form Active Ingredients Withdrawal DateIbuprofen Chanelle Medical 400 mg capsules, soft




Lemsip Cold & Flu 500 mg tablets

Reckitt Benckiser Ireland Ltd

PA0979/051/001 500 milligram(s) Tablet - Paracetamol 07/04/2020

Lemsip Cold & Flu 500 mg tablets


PA0979/051/001 500 milligram(s) Tablet - Paracetamol 07/04/2020

Lemsip Decongestant & Flu Lemon Tablets Paracetamol 500 mg Phenylephrine Hydrochloride 6.1 mg


PA0979/050/001 500 mg/6.1 milligram(s) Tablet - Paracetamol- Phenylephrine hydrochloride

07/04/2020

Lemsip Decongestant & Flu Lemon Tablets Paracetamol 500 mg Phenylephrine Hydrochloride 6.1 mg


PA0979/050/001 500 mg/6.1 milligram(s) Tablet - Paracetamol- Phenylephrine hydrochloride

07/04/2020

Lemsip Decongestant and Flu Blackcurrant tablets Paracetamol 500mg Phenylephrine hydrochloride 6.1mg


PA0979/050/002 500 mg / 6.1 milligram(s) Tablet - Paracetamol- Phenylephrine hydrochloride

07/04/2020

Lemsip Decongestant and Flu Blackcurrant tablets Paracetamol 500mg Phenylephrine hydrochloride 6.1mg


PA0979/050/002 500 mg / 6.1 milligram(s) Tablet - Paracetamol- Phenylephrine hydrochloride

07/04/2020

Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml

Bristol-Myers Squibb Pharmaceuticals uc

PA0002/018/002 10 milligram(s)/millilitre Suspension for injection - Triamcinolone acetonide

01/04/2020

Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml

Bristol-Myers Squibb Pharmaceuticals uc

PA0002/018/002 10 milligram(s)/millilitre Suspension for injection - Triamcinolone acetonide

01/04/2020

Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension

Merck Sharp & Dohme Ireland (Human Health) Limited

PA1286/004/004 2.5 milligram(s)/millilitre Powder for oral suspension

- Losartan potassium 01/04/2020

Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension

Merck Sharp & Dohme Ireland (Human Health) Limited

PA1286/004/004 2.5 milligram(s)/millilitre Powder for oral suspension

- Losartan potassium 01/04/2020

Delmosart PR 18 mg prolonged-release tablets


PA2315/147/001 18 milligram(s) Prolonged-release tablet - Methylphenidate hydrochloride

01/04/2020

Delmosart PR 18 mg prolonged-release tablets


PA2315/147/001 18 m

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