active substance: dextromethorphan procedure no.: psusa ... … · benylin non drowsy dry coughs,...
TRANSCRIPT
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
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© European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged.
14 June 2019 EMA/450475/2019 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: dextromethorphan
Procedure no.: PSUSA/00001009/201811
List of nationally authorised medicinal products EMA/450475/2019 Page 2/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ACODIN not available 4042 SANOFI-AVENTIS SP Z.O.O. PL
ACODIN not available 4042 SANOFI-AVENTIS SP Z.O.O. PL
Actifed New 15 mg/ 5 ml Sirup not available 0260/09020203
GLAXOSMITHKLINE PHARMACEUTICALS SA LU
Actifed New 15 mg/5 ml siroop not available BE227893
GLAXOSMITHKLINE PHARMACEUTICALS SA BE
Actifed New 15 mg/5 ml sirop. not available BE227893
GLAXOSMITHKLINE PHARMACEUTICALS SA BE
Actifed New 15 mg/5 ml sirop. not available 0260/09020203
GLAXOSMITHKLINE PHARMACEUTICALS SA LU
Actifed New Sirup, 15 mg/ 5 ml not available BE227893
GLAXOSMITHKLINE PHARMACEUTICALS SA BE
ARICODILTOSSE 15 mg/ml gocce orali, soluzione not available 011680067
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L. IT
List of nationally authorised medicinal products EMA/450475/2019 Page 3/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ARICODILTOSSE 3 mg/ml sciroppo not available 011680079
A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L. IT
Aritos 2 mg/ml solucion oral not available 71681 ARISTO PHARMA IBERIA, S.L. ES
Asda Strong Dry Tickly Cough Syrup not available PL 03105/0076
BELL SONS & CO (DRUGGISTS) LTD UK
ATUXANE, sirop not available 336 622-7 MERCK MÉDICATION FAMILIALE S.A.S. FR
ATUXANE, sirop not available 349 685-2 MERCK MÉDICATION FAMILIALE S.A.S. FR
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, drank zonder suiker not available BE275177 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, drank zonder suiker not available BE490080 PIERRE FABRE MEDICAMENT BE
List of nationally authorised medicinal products EMA/450475/2019 Page 4/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, drank zonder suiker not available BE275177 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, drank zonder suiker not available BE490080 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, solution buvable sans sucre not available BE275177 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, solution buvable sans sucre not available BE490080 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, solution buvable sans sucre not available BE275177 PIERRE FABRE MEDICAMENT BE
BALSOCLASE DEXTROMETHORPHAN 15 mg/5 ml, solution buvable sans sucre not available BE490080 PIERRE FABRE MEDICAMENT BE
List of nationally authorised medicinal products EMA/450475/2019 Page 5/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
BECHILAR 3 mg/ml sciroppo not available 018130029 MONTEFARMACO OTC S.P.A. IT
Bell's Healthcare Dual Action Dry Cough 10mg per 5ml oral solution not available 03105/0076
BELL SONS & CO (DRUGGISTS) LTD UK
Benflux Tosse Seca, 2 mg/ml, solução oral not available 5702873 LABORATÓRIOS ATRAL, S.A. PT
Benflux Tosse Seca, 2 mg/ml, solução oral not available 5702907 LABORATÓRIOS ATRAL, S.A. PT
Benflux Tosse Seca, 2 mg/ml, solução oral not available 5702873 LABORATÓRIOS ATRAL, S.A. PT
Benflux Tosse Seca, 2 mg/ml, solução oral not available 5702907 LABORATÓRIOS ATRAL, S.A. PT
BENYLIN DRY COUGHS 7.5mg/5ml Syrup not available 15513/0051 MCNEIL PRODUCTS LIMITED UK
BENYLIN DRY COUGHS 7.5mg/5ml Syrup not available 15513/0051 MCNEIL PRODUCTS LIMITED UK
BENYLIN DRY COUGHS 7.5mg/5ml Syrup not available 100/00301 MCNEIL PRODUCTS LIMITED MT
BENYLIN DRY COUGHS 7.5mg/5ml Syrup not available 100/00301 MCNEIL PRODUCTS LIMITED MT
BENYLIN Non Drowsy Dry Coughs, Syrup not available PA 330/25/1
JOHNSON & JOHNSON (IRELAND) LTD. IE
List of nationally authorised medicinal products EMA/450475/2019 Page 6/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
BENYLIN Non Drowsy Dry Coughs, Syrup not available PA 330/25/1
JOHNSON & JOHNSON (IRELAND) LTD. IE
BENYLIN Non Drowsy Dry Coughs, Syrup not available PA 330/25/1
JOHNSON & JOHNSON (IRELAND) LTD. IE
BIOCADEXTRO 1 mg/ml ENFANTS SANS SUCRE, sirop édulcoré à la saccharine sodique et au maltitol liquide not available 34009 348 513 3 9 ZAMBON FRANCE S.A. FR
BISOLTUSSIN 2 mg/ml siroop volwassenen not available BE266217 SANOFI BELGIUM BE
BISOLTUSSIN 2 mg/ml sirop adultes not available BE266217 SANOFI BELGIUM BE
BISOLTUSSIN 2 mg/ml sirop adultes not available 2013110372 SANOFI BELGIUM LU
Bisoltussin 2 mg/ml Sirup Erwachsene not available 2013110372 SANOFI BELGIUM LU
Bisoltussin 2 mg/ml Sirup Erwachsene Dextromethorphanhydrobromid not available BE266217 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/450475/2019 Page 7/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Bisoltussin Tosse Seca, 2 mg/ml, solução oral not available 3605995
SANOFI - PRODUTOS FARMACEUTICOS LDA PT
Bisoltussin, 10,5 mg, pastilha mole not available 5421375
SANOFI - PRODUTOS FARMACEUTICOS LDA PT
Bisolvon Antitusivo 15 mg solución oral en sobres not available 71.680 SANOFI-AVENTIS, S.A. ES
Bisolvon Antitusivo 2 mg/ ml jarabe not available 57.174 SANOFI-AVENTIS, S.A. ES
Bisolvon tosse sedativo 10,5 mg pastiglie gommose not available 038593024 SANOFI S.P.A IT
Bisolvon tosse sedativo 2 mg/ml sciroppo not available 038593012 SANOFI S.P.A IT
Boots Dry Cough Relief 2.5mg Lozenges not available PL 00014/0357 THE BOOTS COMPANY PLC UK
BRONCHENOLO TOSSE 1,54 mg/ml sciroppo not available 019771043 PERRIGO ITALIA S.R.L. IT
List of nationally authorised medicinal products EMA/450475/2019 Page 8/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Bronchosedal Dextromethorphan 2mg/ml sirop not available 2014100323
JOHNSON & JOHNSON CONSUMER N.V./S.A. LU
Bronchosedal® Dextromethorphan 2 mg/ml Sirup not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
Bronchosedal® Dextromethorphan 2 mg/ml Sirup not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
Bronchosedal® Dextromethorphan 2mg/ml siroop not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
Bronchosedal® Dextromethorphan 2mg/ml siroop not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
Bronchosedal® Dextromethorphan 2mg/ml sirop not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
List of nationally authorised medicinal products EMA/450475/2019 Page 9/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Bronchosedal® Dextromethorphan 2mg/ml sirop not available BE439345
JOHNSON & JOHNSON CONSUMER N.V./S.A. BE
Broncoliber tosse seca 2 mg/ml xarope not available 5704218
TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA PT
Broncoliber tosse seca 2 mg/ml xarope not available 5663224
TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA PT
cinfatós 10 mg pastillas para chupar not available 64.797 LABORATORIOS CINFA, S.A. ES
cinfatós 15 mg solución oral en sobres not available 78.764 LABORATORIOS CINFA, S.A. ES
cinfatós 2 mg / ml solución oral not available 57.623 LABORATORIOS CINFA, S.A. ES
cinfatós infantil 1 mg / ml solución oral not available 67.311 LABORATORIOS CINFA, S.A. ES
List of nationally authorised medicinal products EMA/450475/2019 Page 10/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
CLARIX TOUX SÈCHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 082 2 1
COOPERATION PHARMACEUTIQUE FRANCAISE FR
CODOTUSSYL 20 mg TOUX SÈCHE, capsule molle not available 34009 348 153 7 9 LABORATOIRES GENEVRIER FR
DARO Retard capsules dextromethorfan 29,5 mg, capsules met gereguleerde afgifte not available RVG 13143 REMARK PHARMA NL
Destrometorfano bromidrato Sella 15 mg/ ml gocce orali, soluzione not available 029788027 SELLA IT
Destrometorfano bromidrato Sella 30 mg/10 ml sciroppo not available 029788039 SELLA IT
Destrometorfano bromidrato Sella 7,65 mg compresse masticabili not available 029788015 SELLA IT
List of nationally authorised medicinal products EMA/450475/2019 Page 11/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DESTROMETORFANO BROMIDRATO ZENTIVA 15 mg capsule molli not available 027026018 ZENTIVA ITALIA SRL IT
DESTROMETORFANO BROMIDRATO ZENTIVA 15 mg capsule molli not available 027026018 ZENTIVA ITALIA SRL IT
Destrometorfano Unither Pharmaceuticals 15 mg soluzione orale in bustine ES/H/0388/001 045108014 UNITHER PHARMACEUTICALS IT
Destrometorfano Unither Pharmaceuticals 15 mg soluzione orale in bustine ES/H/0388/001 045108026 UNITHER PHARMACEUTICALS IT
DEXATUSSIN Junior, 1 mg/1 ml, syrop not available 4219 NUTROPHARMA SP. Z O. O. PL
Dexofan, filmovertrukne tabletter not available 12295 TAKEDA PHARMA A/S DK
DEXTROCIDINE 0,3%, sirop not available 34009 341 855 6 4
THERABEL LUCIEN PHARMA S.A. FR
Dextroforme 1mg/ml Siroop not available BE 171437 CONFORMA NV BE
List of nationally authorised medicinal products EMA/450475/2019 Page 12/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dextroforme 1mg/ml Siroop not available BE 171437 CONFORMA NV BE
Dextroforme 1mg/ml Siroop not available BE 171437 CONFORMA NV BE
Dextromethorfan Fagron 1 mg/ml, sirop not available BE191231 FAGRON BELGIUM NV BE
Dextromethorfan hydrobromide Teva 1,5 mg/ml, drank not available RVG 28400=19939 TEVA NEDERLAND B.V. NL
Dextromethorfanhydrobromide Unither Pharmaceuticals 15 mg, drank in sachet ES/H/0388/001 RVG 118744 UNITHER PHARMACEUTICALS NL
Dextromethorphan Teva 1,5 mg/ml drank not available BE211635
TEVA PHARMA BELGIUM N.V./S.A BE
Dextromethorphan Unither Pharmaceuticals 15 mg solution buvable en sachet ES/H/0388/001/DC BE505653 UNITHER PHARMACEUTICALS BE
List of nationally authorised medicinal products EMA/450475/2019 Page 13/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DEXTROMETHORPHANE BIOGARAN 1,5 mg/ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 3400930138342 BIOGARAN FR
DEXTROMETHORPHANE BIOGARAN 1,5 mg/ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 3400930138373 BIOGARAN FR
DEXTROMETHORPHANE BIOGARAN 1,5 mg/ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 3400930138359 BIOGARAN FR
DEXTROMETHORPHANE BIOGARAN 1,5 mg/ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 3400930138380 BIOGARAN FR
List of nationally authorised medicinal products EMA/450475/2019 Page 14/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dextrométhorphane Unither Pharmaceuticals 15 mg solution buvable en sachet ES/H/0388/001 2018010007/0846762 UNITHER PHARMACEUTICALS LU
Dextrométhorphane Unither Pharmaceuticals 15 mg solution buvable en sachet ES/H/0388/001 2018010007/0846776 UNITHER PHARMACEUTICALS LU
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5663620
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5663638
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5363646
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
List of nationally authorised medicinal products EMA/450475/2019 Page 15/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5663653
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5663661
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Azevedos, 2 mg/ml, Solução oral not available 5663679
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano CODRAMOL 10 mg pastillas para chupar sabor miel-limón not available 76770 FARMALIDER, S.A. ES
Dextrometorfano Farmalider 10 mg solución oral not available 80341 FARMALIDER, S.A. ES
Dextrometorfano Farmalider 20 mg solución oral not available 80342 FARMALIDER, S.A. ES
List of nationally authorised medicinal products EMA/450475/2019 Page 16/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dextrometorfano Geiser 10 mg pastillas para chupar not available 66.632 GEISER PHARMA, S.L ES
Dextrometorfano Hidrobromuro Farmalider 15 mg cápsulas blandas not available 66.543 FARMALIDER, S.A. ES
Dextrometorfano Tussilene 2 mg/ml Solução Oral not available 5939194
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Tussilene 2 mg/ml Solução Oral not available 5939293
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Tussilene, 2 mg/ml, Oral solution not available AA685/00401
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. MT
List of nationally authorised medicinal products EMA/450475/2019 Page 17/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dextrometorfano Tussilene, 2 mg/ml, Solução oral not available 5622279
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. PT
Dextrometorfano Unither Pharmaceuticals 15 mg solución oral en sobre. ES/H/0388/001 83295 UNITHER PHARMACEUTICALS ES
Dextux, 2 mg/ml, Solução oral not available 5731443 CUIDAFARMA, LDA. PT
Dextux, 2 mg/ml, Solução oral not available 5731450 CUIDAFARMA, LDA. PT
DIACOL not available 2008290 BIAL - PORTELA & Cª , SA PT
DIACOL, 27 mg/15 ml, syrup not available 19560 BIAL - PORTELA & Cª , SA CY
Dinarex 1,5 mg/ml siirup EE/H/0206/001 941117 MEDOCHEMIE LTD. EE
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/01 MEDOCHEMIE ROMANIA S.R.L. RO
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/02 MEDOCHEMIE ROMANIA S.R.L. RO
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/03 MEDOCHEMIE ROMANIA S.R.L. RO
List of nationally authorised medicinal products EMA/450475/2019 Page 18/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/04 MEDOCHEMIE ROMANIA S.R.L. RO
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/05 MEDOCHEMIE ROMANIA S.R.L. RO
Dinarex 1,5 mg/ml sirop EE/H/0206/001 10258/2017/06 MEDOCHEMIE ROMANIA S.R.L. RO
Dinarex 1,5 mg/ml sirup EE/H/0206/001 36/459/14-C MEDOPHARM S.R.O. CZ
Dinarex 1,5 mg/ml sirup EE/H/0206/001 36/0149/17-S MEDOCHEMIE LTD. SK
Drill Tosse Seca 1 mg/ml xarope not available 3482080
PIERRE FABRE DERMO-COSMÉTIQUE PORTUGAL, LDA. PT
DRILL TOUX SECHE DEXTROMETHORPHANE ADULTES 15mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 334 207 2 7 PIERRE FABRE MEDICAMENT FR
List of nationally authorised medicinal products EMA/450475/2019 Page 19/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DRILL TOUX SECHE DEXTROMETHORPHANE ADULTES 15mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 343 343 2 0 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE DEXTROMETHORPHANE ADULTES 15mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 359 761 3 0 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE DEXTROMETHORPHANE ADULTES 15mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 359 763 6 9 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE DEXTROMETHORPHANE ENFANTS 5mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 334 210 3 8 PIERRE FABRE MEDICAMENT FR
List of nationally authorised medicinal products EMA/450475/2019 Page 20/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
DRILL TOUX SECHE DEXTROMETHORPHANE ENFANTS 5mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 336 033 1 1 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE DEXTROMETHORPHANE ENFANTS 5mg/5ml SANS SUCRE, sirop édulcoré au maltitol liquide not available 34009 343 344 9 8 PIERRE FABRE MEDICAMENT FR
Dry Cough Syrup not available PL 12063/0024 WRAFTON LABORATORIES LIMITED UK
easybronchial STOP FORTE 3 mg/ml Sirup not available 136708 EASYPHARM OTC GMBH AT
easybronchial STOP JUNIOR 1,5 mg/ml Sirup not available 136709 EASYPHARM OTC GMBH AT
ERGIX 20 mg TOUX SECHE, gélule not available 347 958-1
MERCK MÉDICATION FAMILIALE S.A.S. FR
List of nationally authorised medicinal products EMA/450475/2019 Page 21/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ERGIX ADULTES TOUX SECHE, sirop not available 328 525-6
MERCK MÉDICATION FAMILIALE S.A.S. FR
ERGIX ENFANTS TOUX SECHE, sirop not available 356 224-7
MERCK MÉDICATION FAMILIALE S.A.S. FR
EUPHONYLL TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré à la saccharine sodique et au sorbitol. not available 34009 335 334 8 9
LABORATOIRES MAYOLY SPINDLER FR
FLUIMUCIL TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 3400926706159 ZAMBON FRANCE S.A. FR
List of nationally authorised medicinal products EMA/450475/2019 Page 22/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
FLUIMUCIL TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 3400926706210 ZAMBON FRANCE S.A. FR
FLUIMUCIL TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 3400926706449 ZAMBON FRANCE S.A. FR
FormulaTus 1,33 mg/ml jarabe sabor miel not available 60.357 LABORATORIOS VICKS, S.L. ES
FormulaTus 7,33 mg Pastillas para chupar sabor miel not available 61.392 LABORATORIOS VICKS, S.L. ES
Golasept sedativo tosse 15 mg/ml gocce orali, soluzione not available 031317011 ZETA FARMACEUTICI S.P.A. IT
Golasept sedativo tosse 30 mg/10 ml sciroppo not available 031317023 ZETA FARMACEUTICI S.P.A. IT
List of nationally authorised medicinal products EMA/450475/2019 Page 23/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Holsec 2 mg/ml xarope not available 5704226 HOLON S.A. PT
Holsec 2 mg/ml xarope not available 5684550 HOLON S.A. PT
HUMEX ADULTES TOUX SÈCHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 833 8 9
LABORATOIRES URGO HEALTHCARE FR
HUMEX ADULTES TOUX SÈCHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 834 4 0
LABORATOIRES URGO HEALTHCARE FR
HUMEX ADULTES TOUX SÈCHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 076 2 0
LABORATOIRES URGO HEALTHCARE FR
List of nationally authorised medicinal products EMA/450475/2019 Page 24/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
HUMEX ADULTES TOUX SÈCHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 077 9 8
LABORATOIRES URGO HEALTHCARE FR
HUMEX ADULTES TOUX SÈCHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 078 5 9
LABORATOIRES URGO HEALTHCARE FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE, sirop not available 34009 327 784 8 5
LABORATOIRES URGO HEALTHCARE FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE, sirop not available 34009 356 305 7 5
LABORATOIRES URGO HEALTHCARE FR
HUMEX ENFANTS TOUX SECHE DEXTROMETHORPHANE, sirop not available 34009 356 740 5 0
LABORATOIRES URGO HEALTHCARE FR
List of nationally authorised medicinal products EMA/450475/2019 Page 25/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Hustenstiller-ratiopharm® Dextromethorphan Hartkapseln not available 15503.00.00 RATIOPHARM GMBH DE
Iniston ANTITUSIVO 1,5mg/ml JARABE not available 58.910 JOHNSON & JOHNSON S.A. ES
Iniston ANTITUSIVO 1,5mg/ml JARABE not available 58.910 JOHNSON & JOHNSON S.A. ES
KAUMATUSS 7,5 mg Compresse orosolubili not available 034009011 G.R. FARMA SRL IT
LAITOS 3 mg/ml Jarabe not available 70.997 LAINCO, S.A. ES
LemoCalm® Dry Cough 10mg/5ml oral solution not available PL 17907/0314
BRISTOL LABORATORIES LTD (BERKHAMSTED) UK
MedDex Vicks sirup na suchý kašel s medem Sirup DE/H/2733/001 36/561/11-C PROCTER & GAMBLE GMBH CZ
MedDex Wick 20mg/15ml méz ízű szirup DE/H/2733/001 OGYI-T-21731/01
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
List of nationally authorised medicinal products EMA/450475/2019 Page 26/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
MedDex Wick 20mg/15ml méz ízű szirup DE/H/2733/001 OGYI-T-21731/02
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
MedDex Wick 20mg/15ml méz ízű szirup DE/H/2733/001 OGYI-T-21731/03
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
MedDex Wick 20mg/15ml méz ízű szirup DE/H/2733/001 OGYI-T-21731/04
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
MedDex Wick 7,33 mg méz ízű szopogató tabletta DE/H/2743/001 OGYI-T-21678/01
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
MedDex Wick 7,33 mg méz ízű szopogató tabletta DE/H/2743/001 OGYI-T-21678/02
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH HU
MEDORPHAN 7.5mg/5ml oral solution not available 21899 MEDOCHEMIE LTD. CY
MUGOTUSSOL 10 mg/5 ml, sirup UK/H/5042/001 36/337/13-C SANOFI-AVENTIS SRO CZ
List of nationally authorised medicinal products EMA/450475/2019 Page 27/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Mugotussol 10 mg/5 ml, sirup UK/H/5042/001 36/0234/13-S
SANOFI-AVENTIS SLOVAKIA SRO SK
NEO BOROCILLINA SEDATIVO TOSSE “30 mg/10 ml Sciroppo” not available 036872012 ALFASIGMA S.P.A. IT
NEO BOROCILLINA SEDATIVO TOSSE “30 mg/ml Gocce orali, soluzione” not available 036872024 ALFASIGMA S.P.A. IT
Nirolex Tosse Secca 30 mg/10 ml sciroppo not available 029741030 ALMUS S.R.L IT
NODEX ADULTES, sirop en sachet-dose not available 34009 497 305 3 7 LABORATOIRES BROTHIER SA FR
Normotus 2 mg/ml solución oral not available 67155 LABORATORIOS NORMON, S.A. ES
Nortussine Mono, 10 mg/5 ml, siroop not available BE218477 NORGINE NV/SA BE
Nortussine Mono, 10 mg/5 ml, sirop not available BE218477 NORGINE NV/SA BE
Nortussine Mono, 10 mg/5 ml, sirop not available 2001120029 NORGINE NV/SA LU
Nortussine® Mono, 10 mg/5 ml, Sirup not available BE218477 NORGINE NV/SA BE
List of nationally authorised medicinal products EMA/450475/2019 Page 28/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Notus Antitusivo 10 mg pastillas para chupar sabor miel-limón not available 77.424 TEVA PHARMA S.L.U., ES
Notús Antitusivo 2 mg/ml solución oral not available 66417 TEVA PHARMA S.L.U. ES
Novag tuss 10 mg/5 ml solución oral not available 67208 FERRER INTERNACIONAL, S.A. ES
NOVAG TUSS 15 mg comprimidos not available 75141 FERRER INTERNACIONAL, S.A. ES
Numark Adult Dry Cough Linctus not available AA187/00901
BELL SONS & CO (DRUGGISTS) LTD MT
Numark Adult Dry Cough Linctus not available PL 03105/0076
BELL SONS & CO (DRUGGISTS) LTD UK
Parlatos 2 mg/ml solución oral not available 63640
PHARMEX ADVANCED LABORATORIES, S.L. ES
PULMODEXANE 30 mg, comprimé pelliculé not available 34009 378 288 8 8 LABORATOIRE BAILLY-CREAT FR
List of nationally authorised medicinal products EMA/450475/2019 Page 29/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
PULMODEXANE 300 mg/100 ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 34009 355 090 7 9 LABORATOIRE BAILLY-CREAT FR
PULMODEXANE 300 mg/100 ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available 34009 355 091 3 0 LABORATOIRE BAILLY-CREAT FR
RECOTUSS SEDATIVO 2 mg/ml sciroppo not available 025273095
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT
RECOTUSS SEDATIVO 6,5 mg compresse masticabili not available 025273095
RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. IT
Resilar 3 mg/ml oraaliliuos not available 9436 ORION OYJ FI
Resilar 3 mg/ml oral lösning not available 9436 ORION OYJ FI
List of nationally authorised medicinal products EMA/450475/2019 Page 30/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
RHINATHIOL 1 MG/ML KOHOGESCSILLAPITO SZIRUP GYERMEKEKNEK not available OGYI-T-9257/01 SANOFI-AVENTIS ZRT HU
RHINATHIOL 1,33 MG/ML KOHOGESCSILLAPITO SZIRUP FELNOTTEKNEK not available OGYI-T-9257/02 SANOFI-AVENTIS ZRT HU
Robitussin Antitussicum 7,5 mg/5 ml soluţie orală not available 7841/2006/01
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. RO
Robitussin Antitussicum 7,5 mg/5 ml, sirup not available 36/0288/00-S
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. SK
ROBITUSSIN ANTITUSSICUM na suchý dráždivý kašel 7,50 mg/5 ml, sirup not available 36/138/02-C
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. CZ
List of nationally authorised medicinal products EMA/450475/2019 Page 31/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Robitussin Antitussicum szirup not available OGYI-T-8102/02
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. HU
Robitussin Antitussicum, 7,5 mg/5 ml, syrop not available 8215
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PL
Robitussin Dry Cough 7.5 mg / 5ml Oral Solution not available PA 822/172/1 PFIZER HEALTHCARE IRELAND IE
Robitussin Dry Cough Medicine not available MA111/00402
PFIZER CONSUMER HEALTHCARE LTD. MT
Robitussin Dry Cough Medicine not available PL 00165/0100
PFIZER CONSUMER HEALTHCARE LTD. UK
Robitussin Junior 3,75 mg/5 ml soluţie orală pentru tuse uscată not available 7842/2006/01
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. RO
List of nationally authorised medicinal products EMA/450475/2019 Page 32/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Robitussin Junior 3,75 mg/5 ml, sirup not available 36/0287/00-S
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. SK
ROBITUSSIN JUNIOR na suchý dráždivý kašel 3,75 mg/ 5 ml, sirup not available 36/137/02-C
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. CZ
Robitussin Junior szirup not available OGYI-T-8103/02
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. HU
Robitussin Junior, 3,75 mg/5 ml, syrop not available 8465
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PL
Rometor ratiopharm 2 mg/ml oraaliliuos not available 21625 RATIOPHARM OY FI
ROMILAR 15 mg Comprimidos not available 24.381 BAYER HISPANIA SL ES
List of nationally authorised medicinal products EMA/450475/2019 Page 33/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
ROMILAR 15 mg/5 ml jarabe not available 28.727 BAYER HISPANIA SL ES
ROMILAR 15 mg/ml gotas orales en solución not available 24.379 BAYER HISPANIA SL ES
Stopex 30 mg tablets not available AA1073/00102 WALMARK A.S. MT
Stopex na suchý kašel CZ/H/0509/001 36/160/16-C WALMARK A.S. CZ
Stopex na suchý kašeľ 10 mg/5 ml perorálny roztok CZ/H/0509/001 36/0077/16-S WALMARK A.S. SK
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 058 4 8 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/450475/2019 Page 34/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 060 9 8 SANOFI-AVENTIS FRANCE FR
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique not available 34009 267 056 1 9 SANOFI-AVENTIS FRANCE FR
Tesco Dry Cough Linctus not available PL 03105/0076 BELL SONS & CO (DRUGGISTS) LTD UK
Tip pastillas para chupar sabor miel-limón not available 64.727 FARMALIDER, S.A. ES
Toceliv 2 mg/ml xarope not available 5624721
LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. PT
List of nationally authorised medicinal products EMA/450475/2019 Page 35/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Toceliv 2 mg/ml xarope not available 5704234
LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. PT
TOUX-SAN DEXTROMETHORPHAN avec Miel 3 mg/ml sirop not available 2010120905 TAKEDA BELGIUM SCA/CVA LU
Toux-San Dextromethorphan mit Honig 3 mg/ml Sirup not available BE228462 TAKEDA BELGIUM SCA/CVA BE
Toux-San Dextromethorphan Ohne Zucker 1 mg/ml Sirup not available BE269701 TAKEDA BELGIUM SCA/CVA BE
Toux-San Dextromethorphan Ohne Zucker 3 mg/ml Sirup not available BE269717 TAKEDA BELGIUM SCA/CVA BE
TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 1 mg/ml sirop not available 2010120904 TAKEDA BELGIUM SCA/CVA LU
List of nationally authorised medicinal products EMA/450475/2019 Page 36/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Toux-San Dextromethorphan Sans Sucre 3 mg/ml sirop not available 2010120906 TAKEDA BELGIUM SCA/CVA LU
Tussabron for Dry Coughs not available PL 03105/0076
BELL SONS & CO (DRUGGISTS) LTD UK
Tussabron Syrup not available 03105/0076 BELL SONS & CO (DRUGGISTS) LTD UK
Tussal Antitussicum, 15 mg, tabletki powlekane not available 4919 BIOFARM SP. Z O.O. PL
Tussastopp-Lösung zum Einnehmen not available 1-27312 TEVA B.V AT
Tussi Drill 5 mg/5 ml, syrop not available 9136 PIERRE FABRE MEDICAMENT PL
Tussican, 3 mg/ml, xarope not available 5627658
MEDINFAR CONSUMER HEALTH - PRODUTOS FARMACÊUTICOS,LDA PT
List of nationally authorised medicinal products EMA/450475/2019 Page 37/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
TUSSIDANE 1,5 mg/ml SANS SUCRE, solution buvable édulcorée au maltitol liquide et à la saccharine sodique not available NL 33766-3400937985994
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE FR
TUSSIDANE 1,5 mg/ml, sirop not available NL 28071-3400936226821
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE FR
TUSSIDANE 30 mg, comprimé pelliculé sécable not available NL 38185-3400941558054
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE FR
TUSSIDEX mite, 15 mg, kapsu ﾅＬi mi ﾄ冖 kie not available 15685 HASCO-LEK PL
TUSSIDEX, 30 mg, kapsułki miękkie not available 9551 HASCO-LEK PL
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ
List of nationally authorised medicinal products EMA/450475/2019 Page 38/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Tussimono 10 mg siroop BE/H/0255/01/DC BE499786 KELA PHARMA NV BE
Tussimono 10 mg sirop BE/H/0255/01/DC BE499786 KELA PHARMA NV BE
Tussimono 10 mg sirop BE/H/0255/001 2017040146 KELA PHARMA NV LU
Tussimono 10 mg Sirup BE/H/0255/01/DC BE499786 KELA PHARMA NV BE
Tussimono 20 mg siroop BE/H/0255/002 BE499795 KELA PHARMA NV BE
Tussimono 20 mg sirop BE/H/0255/002 201704147 KELA PHARMA NV LU
Tussimono 20 mg sirop BE/H/0255/002 BE499795 KELA PHARMA NV BE
Tussimono 20 mg Sirup BE/H/0255/002 BE499795 KELA PHARMA NV BE
TUSSIN 6,5mg/5 ml sirop not available 7876/2015/01 ROPHARMA S.A RO
TUSSIN 6,5mg/5 ml sirop not available 7876/2015/01 ROPHARMA S.A RO
Tussin Forte 20 mg comprimate not available 4754/2012/01
GLAXOSMITHKLINE (GSK) S.R.L. RO
TUSSO RHINATHIOL 0,1 % SIROP ENFANT not available 0314307 SANOFI BELGIUM LU
TUSSO RHINATHIOL 1 mg/ml siroop not available BE153361 SANOFI BELGIUM BE
TUSSO RHINATHIOL 1 mg/ml sirop not available BE153361 SANOFI BELGIUM BE
TUSSO RHINATHIOL 10 mg comprimés à sucer not available BE164814 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/450475/2019 Page 39/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
TUSSO RHINATHIOL 10 mg comprimés à sucer not available BE164814 SANOFI BELGIUM BE
TUSSO RHINATHIOL 10 mg comprimés à sucer not available 0314324 SANOFI BELGIUM LU
TUSSO RHINATHIOL 10 mg comprimés à sucer not available 0450584 SANOFI BELGIUM LU
TUSSO RHINATHIOL 10 mg comprimés à sucer not available 0314311 SANOFI BELGIUM LU
TUSSO RHINATHIOL 10 mg comprimés à sucer not available BE164814 SANOFI BELGIUM BE
TUSSO RHINATHIOL 10 mg zuigtabletten not available BE164814 SANOFI BELGIUM BE
TUSSO RHINATHIOL 10 mg zuigtabletten not available BE164814 SANOFI BELGIUM BE
TUSSO RHINATHIOL 10 mg zuigtabletten not available BE164814 SANOFI BELGIUM BE
Tussopront 15 mg/5 ml belsőleges oldat felnőtteknek not available OGYI-T-6635/01 PIERRE FABRE MEDICAMENT HU
Tussopront 5 mg/5 ml belsőleges oldat gyermekeknek not available OGYI-T-6636/01 PIERRE FABRE MEDICAMENT HU
List of nationally authorised medicinal products EMA/450475/2019 Page 40/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Tussoral 1,33 mg/ml Xarope not available 4974986
SANOFI - PRODUTOS FARMACEUTICOS LDA PT
UNITUSS 133 mg/100 ml sciroppo not available 033204013
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. IT
UTATUS 10 mg pastillas para chupar sabor miel-limón not available 64.003 URIACH AQUILEA OTC S.L. ES
VICKS 0,133 % ADULTES TOUX SECHE MIEL, sirop not available 378 528-9
PROCTER & GAMBLE PHARMACEUTICALS FRANCE FR
VICKS 0,133 % ADULTES TOUX SECHE MIEL, sirop not available 378 529-5
PROCTER & GAMBLE PHARMACEUTICALS FRANCE FR
VICKS 0,133 % ADULTES TOUX SECHE MIEL, sirop not available 378 530-3
PROCTER & GAMBLE PHARMACEUTICALS FRANCE FR
List of nationally authorised medicinal products EMA/450475/2019 Page 41/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Vicks MedDex o smaku miodu na kaszel suchy, 20 mg/15 ml, syrop DE/H/2733/001 18051
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH PL
VICKS TOSSE not available 031107016 PROCTER & GAMBLE S.R.L IT
VICKS TOSSE not available 031107028 PROCTER & GAMBLE S.R.L IT
VICKS TOSSE SEDATIVO sciroppo sedativo della tosse not available 028688012 PROCTER & GAMBLE S.R.L IT
VICKS TOSSE SEDATIVO sciroppo sedativo della tosse not available 028688024 PROCTER & GAMBLE S.R.L IT
VICKS TOSSE SEDATIVO sciroppo sedativo della tosse not available 028688036 PROCTER & GAMBLE S.R.L IT
VICKS TOUX SECHE DEXTROMETHORPHANE 7,33 mg ADULTES MIEL, pastille DE/H/2743/001 34009 415 132 2 0
PROCTER & GAMBLE PHARMACEUTICALS FRANCE FR
VICKS TOUX SECHE DEXTROMETHORPHANE 7,33 mg ADULTES MIEL, pastille DE/H/2743/001 34009 415 133 9 8
PROCTER & GAMBLE PHARMACEUTICALS FRANCE FR
List of nationally authorised medicinal products EMA/450475/2019 Page 42/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Vicks VapoSyrup Antitussif avec miel, 1,33mg/ml, sirop not available 2013110427
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. LU
Vicks VapoSyrup Antitussif avec miel, 1,33mg/ml, sirop not available BE172952
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks VapoSyrup Antitussif met honing, 1,33mg/ml, siroop not available BE172952
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks VapoSyrup Antitussif mit Honig, 1,33mg/ml, Sirup not available BE172952
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks Vapotabs antitussif avec Miel DE/H/2743/001 1653/11090069- 0627539
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. LU
List of nationally authorised medicinal products EMA/450475/2019 Page 43/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Vicks Vapotabs antitussif avec Miel DE/H/2743/001 1653/11090069- 0627542
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. LU
Vicks Vapotabs antitussif avec Miel 7,33 mg pastilles Dextrométhorphane DE/H/2743/001 BE386172
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks Vapotabs antitussif met Honing 7,33 mg zuigtabletten DE/H/2743/001 BE386172
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks Vapotabs Antitussif mit Honig 7,33 mg Lutschtabletten DE/H/2743/001/MR BE386172
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A. BE
Vicks Xarope Antitússico Mel, 1,33 mg/ml, xarope not available 2772887 LABORATORIOS VICKS, S.L. PT
Vicks Xarope Antitússico Mel, 1,33 mg/ml, xarope not available 2772986 LABORATORIOS VICKS, S.L. PT
List of nationally authorised medicinal products EMA/450475/2019 Page 44/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Vicks Xarope Antitússico Mel, 1,33 mg/ml, xarope not available 2772788 LABORATORIOS VICKS, S.L. PT
WICK Formel 44 Husten-Pastillen mit Honig 7,33 mg not available 1-23560
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH AT
WICK Formel 44 Hustenstiller-Sirup 20 mg / 15 ml not available 1-20403
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH AT
WICK Formel 44 Hustenstiller-Sirup mit Honig 20 mg / 15 ml not available 1-27061
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH AT
WICK Husten-Pastillen gegen Reizhusten mit Honig 7,33 mg Lutschpastille Dextromethorphan DE/H/2743/001 6080683.00.00
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH DE
WICK Husten-Sirup gegen Reizhusten mit Honig DE/H/2733/001 5400.00.00
WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH DE
List of nationally authorised medicinal products EMA/450475/2019 Page 45/45
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number MAH of product in the member state
Member State where product is authorised
Демефан 3,42 mg/ml сироп not available 20030049 ACTAVIS EAD BG
ДИНАРЕКС 1,5 mg/ml сироп EE/H/0206/001 20170220 MEDOCHEMIE LTD. BG
Стопекс 30 мг таблетки not available 20120564 WALMARK A.S. BG