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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
20 July 2016 EMA/574895/2016 Procedure Management and Committees Support
List of nationally authorised medicinal products
Active substance: dextromethorphan Procedure No.: PSUSA/00001009/201511
List of nationally authorised medicinal products EMA/574895/2016 Page 2/23
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 1 mg/ml siroop not available BE 171437 CONFORMA NV BE Dextroforme 1mg/ml Sirop not available BE 171437 CONFORMA NV BE Dextroforme, 1 mg/ml, Sirup not available BE 171437 CONFORMA NV BE NEO BOROCILLINA SEDATIVO TOSSE “30 mg/ml Gocce orali, soluzione”
not available 036872024 ALFA WASSERMANN SPA IT
NEO BOROCILLINA SEDATIVO TOSSE “30 mg/10 ml Sciroppo"
not available 036872012 ALFA WASSERMANN SPA IT
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 mit Honig 3 mg/ml Sirup
not available BE228462 TAKEDA BELGIUM SCA/CVA BE
Dexofan, filmovertrukne tabletter not available 12295 TAKEDA PHARMA A/S DK TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 1 mg/ml sirop, TOUX-SAN DEXTROMETHORPHAN avec Miel 3 mg/ml sirop, TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 3 mg/ml sirop
not available 0430/10120906 TAKEDA BELGIUM SCA/CVA LU
TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 3 mg/ml sirop
not available BE269717 TAKEDA BELGIUM SCA/CVA BE
TOUX-SAN DEXTROMETHORPHAN met Honing 3 mg/ml siroop
not available BE228462 TAKEDA BELGIUM SCA/CVA BE
TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 1 mg/ml sirop TOUX-SAN DEXTROMETHORPHAN avec Miel 3 mg/ml sirop TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 3 mg/ml sirop
not available 2010120905 TAKEDA BELGIUM SCA/CVA LU
TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 1 mg/ml sirop
not available 2010120904 TAKEDA BELGIUM SCA/CVA LU
TOUX-SAN DEXTROMETHORPHAN avec Miel 3 mg/ml sirop
not available BE228462 TAKEDA BELGIUM SCA/CVA BE
List of nationally authorised medicinal products EMA/574895/2016 Page 3/23
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 SUIKERVRIJ 3 mg/ml siroop
not available BE269717 TAKEDA BELGIUM SCA/CVA BE
TOUX-SAN DEXTROMETHORPHAN SANS SUCRE 1 mg/ml sirop
not available BE269701 TAKEDA BELGIUM SCA/CVA BE
TOUX-SAN DEXTROMETHORPHAN SUIKERVRIJ 1 mg/ml siroop
not available BE269701 TAKEDA BELGIUM SCA/CVA BE
Dexofan 30 mg apvalkotas tabletes not available 93-0507 TAKEDA PHARMA AS LV cinfatós 2 mg / ml solución oral not available 57.623 LABORATORIOS CINFA, S.A. ES BALSOCLASE DEXTROMETHORPHAN 15 mg / 5 ml, ORAL SOLUTION WITHOUT SUGAR
not available BE275177 PIERRE FABRE MEDICAMENT BE
DEXTUSSIL 30mg/15mL, sirop en récipient unidose
not available 6 888 645 3 PHARMACIE CENTRALE DES ARMEES
FR
DEXTUSSIL 0,2 %, sirop not available 6 795 928 6 PHARMACIE CENTRALE DES ARMEES
FR
Dextrometorfano Farmalider 10 mg solución oral
not available 80341 FARMALIDER, S.A. ES
DEXTROMETHORPHANE ELERTE 1,5 mg/ml, sirop
not available NL 30226-3400936715516
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 30 mg, comprimé pelliculé sécable
not available NL 38185-3400941558054
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 1,5 mg/ml, sirop not available NL 28071-3400936226821
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
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
BALSOCLASE DEXTROMETHORPHAN 15 mg / 5 ml, ORAL SOLUTION WITHOUT SUGAR
not available BE275177 PIERRE FABRE MEDICAMENT BE
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ TUSSIDRILL 15 mg / 5 ml FOR ADULTS not available 61.398 PIERRE FABRE IBERICA / SPAIN ES DRILL TOUX SECHE 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré au maltitol liquide
not available 334 207-2 PIERRE FABRE MEDICAMENT FR
List of nationally authorised medicinal products EMA/574895/2016 Page 4/23
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 SANS SUCRE 5 mg/5 ml ENFANTS, sirop (édulcoré au maltitol liquide)
not available 334 210-3 PIERRE FABRE MEDICAMENT FR
Tussi Drill 5 mg/5 ml, syrop not available 9136 PIERRE FABRE MEDICAMENT PL Drill tosse seca 1 mg/ml xarope not available 3482080 PFDC / PORTUGAL PT TUSSOPRONT 15 mg / 5 ml ORAL SOLUTION FOR ADULTS
not available OGYI/11707-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSOPRONT 5 mg/5 ml, ORAL SOLUTION FOR CHILDREN
not available OGYI/12709-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSIDRILL SUGAR FREE FOR DRY COUGHS 15 MG/5 ML
not available PL 05630/0030 PIERRE FABRE MEDICAMENT UK
Dextromethorphan Hydrobromide 10mg/5ml Oral Solution
not available PL 17907/0314 BRISTOL LABORATORIES LTD (BERKHAMSTED)
UK
Tip pastillas para chupar sabor miel-limón not available 64.727 FARMALIDER, S.A. ES Resilar 3 mg/ml oral lösning not available 9436 ORION OYJ FI Resilar 3 mg/ml oraaliliuos not available 9436 ORION OYJ FI AQUITOS 10 mg pastillas para chupar sabor anís-regaliz
not available 64.002 URIACH AQUILEA OTC S.L. ES
AQUITOS10 mg pastillas para chupar sabor miel-limón
not available 64.003 URIACH AQUILEA OTC S.L. ES
CLARIX TOUX SÈCHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 081 6 0 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
CLARIX TOUX SÈCHE DEXTROMETHORPHANE 15 mg/5 ml ADULTES SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 081 6 0 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
ROMILAR 15 mg Comprimidos not available 24.381 BAYER HISPANIA SL ES ROMILAR 15 mg/ml gotas orales en solución
not available 24.379 BAYER HISPANIA SL ES
ROMILAR 15 mg/5 ml jarabe not available 28.727 BAYER HISPANIA SL ES Actifed New siroop 15 mg/5 ml not available BE227893 GLAXOSMITHKLINE
PHARMACEUTICALS SA BE
List of nationally authorised medicinal products EMA/574895/2016 Page 5/23
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
Actifed New Sirup, 15 mg/ 5 ml not available BE227893 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Actifed New siroop 15 mg/5 ml not available 0260/09 02 0203 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Actifed New Sirup, 15 mg/ 5 ml not available 0260/09 02 0203 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Actifed New sirop 15 mg/5 ml. not available BE227893 GLAXOSMITHKLINE PHARMACEUTICALS SA
BE
Actifed New siroop 15 mg/5 ml not available 0260/09 02 0203 GLAXOSMITHKLINE PHARMACEUTICALS SA
LU
Tussin Forte 20 mg comprimate not available 4754/2012/01 EUROPHARM S.A. RO DEXTROMETHORPHANE UNITHER 15 mg/5ml SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique
not available 34009 279 276 1 4 UNITHER PHARMACEUTICALS FR
Hustenstiller-ratiopharm Dextromethorphan not available 15503.00.00 RATIOPHARM GMBH DE Hustenstiller-ratiopharm® Dextromethorphan Hartkapseln
not available 15503.00.00 RATIOPHARM GMBH DE
Destrometorfano bromidrato Farmakopea 30 mg/10 ml sciroppo
not available 030490015 FARMAKOPEA SPA IT
Destrometorfano bromidrato Farmakopea 15 mg/ml gocce orali, soluzione
not available 030490027 FARMAKOPEA SPA IT
Destrometorfano bromidrato FederFARMA.CO 15 mg/ml gocce orali, soluzione
not available 030261034 FEDERFARMA.CO SPA IT
Destrometorfano bromidrato FederFARMA.CO 30mg/10ml sciroppo
not available 030261010 FEDERFARMA.CO SPA IT
TOUXIUM ANTITUSSIVUM 30 mg Gélules not available BE154734 LABORATOIRES SMB S.A. BE TOUXIUM ANTITUSSIVUM 30 mg Gélules not available 0160/91/11/0189 LABORATOIRES SMB S.A. LU TOUXIUM ANTITUSSIVUM 30 mg Capsules, hard
not available BE154734 LABORATOIRES SMB S.A. BE
TUXIUM 30 mg, capsule not available 331 169-2 LABORATOIRES SMB S.A. FR TOUXIUM ANTITUSSIVUM 30 mg Hartkapseln
not available BE154734 LABORATOIRES SMB S.A. BE
List of nationally authorised medicinal products EMA/574895/2016 Page 6/23
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
TOUXIUM ANTITUSSIVUM 30 mg Hartkapseln
not available 0160/91/11/0189 LABORATOIRES SMB S.A. LU
TUXIUM 30 mg, capsule not available 331 381-1 LABORATOIRES SMB S.A. FR DEXTROMETHORPHANE ELERTE 1,5 mg/ml, sirop
not available NL 30226-3400936715516
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 30 mg, comprimé pelliculé sécable
not available NL 38185-3400941558054
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 1,5 mg/ml, sirop not available NL 28071-3400936226821
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
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
cinfatós infantil 2,5 mg solución oral en sobres
not available 79010 LABORATORIOS CINFA, S.A. ES
Stopex Junior 15 mg tablety not available 36/0332/09-S WALMARK A.S. SK COULDETOS 5MG PASTILLAS PARA CHUPAR not available 67205 LABORATORIOS ALTER, S.A. ES Novag tuss 10 mg/5 ml solución oral not available 67208 FERRER INTERNACIONAL, S.A. ES NeoTussan Hustensaft 111 mg Dextromethorphan pro 100 g Suspension zum Einnehmen
not available 5064.00.00 NOVARTIS CONSUMER HEALTH GMBH
DE
Tusifan sirup 1 mg/ml not available UP/I-530-09/09-02/543
JADRAN-GALENSKI LABORATORIJ D.D.
HR
Tusifan sirup 3 mg/ml not available UP/I-530-09/09-02/544
JADRAN-GALENSKI LABORATORIJ D.D.
HR
Dextrometorfano Codramol 10 mg pastillas para chupar sabor miel-limón
not available 76770 FARMALIDER, S.A. ES
Dextrometorfano Farmalider 20 mg solución oral
not available 80342 FARMALIDER, S.A. ES
WICK Husten-Sirup gegen Reizhusten mit Honig
DE/H/2733/001/MR 5400.00.00 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
DE
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/574895/2016 Page 7/23
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 ízu szirup DE/H/2733/001 OGYI-T-21731/03 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
HU
MedDex Wick 20mg/15ml méz ízu szirup DE/H/2733/001 OGYI-T-21731/04 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
HU
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
MedDex Vicks pastilky na suchý kašel s medem 7,33 mg pastilky
DE/H/2743/001 36/450/11-C PROCTER & GAMBLE GMBH CZ
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 avec Miel 7,33 mg pastilles
DE/H/2743/001 BE386172 PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A.
BE
VICKS TOUX SECHE DEXTROMETHORPHANE 7,33 mg ADULTES MIEL, pastille
DE/H/2743/001/MR 34009 415 132 2 0 PROCTER & GAMBLE PHARMACEUTICALS FRANCE
FR
WICK Husten-Pastillen gegen Reizhusten mit Honig 7,33 mg Lutschpastille
DE/H/2743/001 6080683.00.00 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
DE
MedDex Wick 7,33 mg méz ízu szopogató tabletta
DE/H/2743/001 OGYI-T-21678/01 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
HU
MedDex Wick 7,33 mg méz ízu szopogató tabletta
DE/H/2743/001 OGYI-T-21678/02 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
HU
Vicks Vapotabs antitussif avec Miel DE/H/2743/001/MR 1653/11090069- 0627539
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A.
LU
Vicks Vapotabs antitussif avec Miel DE/H/2743/001/MR 1653/11090069- 0627542
PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A.
LU
List of nationally authorised medicinal products EMA/574895/2016 Page 8/23
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,7,33 mg, pastylki twarde
DE/H/2743/001 18559 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
PL
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
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
VICKS TOUX SECHE DEXTROMETHORPHANE 7,33 mg ADULTES MIEL, pastille
DE-H-2743-001 34009 415 133 9 8 PROCTER & GAMBLE PHARMACEUTICALS FRANCE
FR
Vicks VapoSyrup Antitussif avec miel, 1,33mg/ml, sirop
not available 2013110427 PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A.
LU
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 VapoSyrup Antitussif avec miel, 1,33mg/ml, sirop
not available BE172952 PROCTER & GAMBLE DISTRIBUTION COMPANY EUROPE B.V.B.A.
BE
List of nationally authorised medicinal products EMA/574895/2016 Page 9/23
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 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
WICK Formel 44 Husten-Pastillen 7,33 mg not available 1-23559 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
AT
FormulaTus 7,33 mg Pastillas para chupar sabor miel
not available 61.392 LABORATORIOS VICKS, S.L. ES
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
Vicks Xarope Antitússico Mel, 1,33 mg/ml, xarope
not available 2772788 LABORATORIOS VICKS, S.L. PT
FormulaTus 1,33 mg/ml jarabe sabor miel not available 60.357 LABORATORIOS VICKS, S.L. ES MedDex Vicks sirup na suchý kašel s medem Sirup
DE/H/2733/001 36/561/11-C PROCTER & GAMBLE GMBH CZ
Drill tosse seca 1 mg/ml xarope not available 3482080 PFDC / PORTUGAL PT 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, Solução oral
not available 5622279 LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
PT
Dexomet 3 mg/ml mixtúra, lausn 853587 853587 ACTAVIS HF. IS Calmarum tosse seca e irritativa 2 mg / ml solução oral
not available 13/H/0042/001 SOCIEDADE FARMACÊUTICA GESTAFARMA, LDA.
PT
MUGOTUSSOL 10 mg/5 ml, sirup UK/H/5042/001 36/337/13-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucotussin, 10 mg/5 ml, syrop UK_H_5042_001_DC
21692 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
Mugotussol 10 mg/5 ml, sirup UK/H/5042/001 36/0234/13-S BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SK
List of nationally authorised medicinal products EMA/574895/2016 Page 10/23
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 2mg/ml ADULTES SANS SUCRE, sirop édulcoré à|la saccharine sodique et au maltitol liquide
not available 34009 348 515 6 8 BOEHRINGER INGELHEIM FRANCE FR
Bisoltussin 2 mg/ml Sirup Erwachsene not available BE266217 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Bisoltussin 2 mg/ml Sirup Erwachsene not available 2013110372 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Bisoltussin 2 mg/ml sirup not available UP/I-530-09/11-01/61 BOEHRINGER INGELHEIM ZAGREB D.O.O.
HR
Dextromethorphan Sirup gegen Reizhusten 10 mg/ 5ml Sirup
not available 71778.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Silomat® DMP Sirup gegen Reizhusten 10 mg/ 5ml Sirup
not available 71777.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15 mg/5 ml SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique
not available 34009 279 277 8 2 BOEHRINGER INGELHEIM FRANCE FR
LAIRANT Sirup 5 mg / 5 ml Lösung zum Einnehmen
not available 6184804.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bisolvon Antitusivo 15 mg solución oral en sobres
not available 71680 BOEHRINGER INGELHEIM ESPANA S.A.
ES
Dextrocap 15 mg Hartkapseln not available 56501.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Silomat® DMP INTENSIV gegen Reizhusten 30 mg / Hartkapsel
not available 56502.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Silomat® DMP gegen Reizhusten 10,5 mg /Lutschpastille
not available 49060.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bisoltussin Tosse Seca, 2 mg/ml, solução oral
not available 3605995 BOEHRINGER INGELHEIM, UNIPESSOAL, LDA.
PT
Bisolvon Antitusivo 2 mg/ ml jarabe not available 57.174 BOEHRINGER INGELHEIM ESPANA S.A.
ES
Bisolvon tosse sedativo 2 mg/ml sciroppo not available 038593012 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
List of nationally authorised medicinal products EMA/574895/2016 Page 11/23
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 2 mg/ml sirop adultes not available BE266217 SCS BOEHRINGER INGELHEIM COMM.V.
BE
BISOLTUSSIN 2 MG/ML SIROOP VOLWASSENEN
not available BE266217 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Dextromethorphan hydrobromide 10mg/5ml syrup
UK/H/5042/001 PL 14598/0098 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
UK
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15mg/5ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 073 3 0 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15mg/5ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 075 6 9 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
SURBRONC TOUX SECHE DEXTROMETHORPHANE 15mg/5ml SANS SUCRE, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 072 7 9 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
Bisoltussin, 10,5 mg, pastilha mole not available 5421375 BOEHRINGER INGELHEIM, UNIPESSOAL, LDA.
PT
Silomat® DMP 10,5 mg /Lutschpastille
not available 49062.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bisolvon tosse sedativo 10,5 mg pastiglie gommose
not available 038593024 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
BISOLTUSSIN 2 MG/ML SIROP ADULTES not available 2013110372 SCS BOEHRINGER INGELHEIM COMM.V.
LU
MEDORPHAN not available 21899 MEDOCHEMIE LTD. CY Tussastopp® 10 mg Husten-Pastillen not available 1-31452 RATIOPHARM ARZNEIMITTEL
VERTRIEBS-GMBH AT
BALSOCLASE DEXTROMETHORPHAN 15 mg / 5 ml, ORAL SOLUTION WITHOUT SUGAR
not available BE275177 PIERRE FABRE MEDICAMENT BE
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ TUSSIDRILL 15 mg / 5 ml FOR ADULTS not available 61.398 PIERRE FABRE IBERICA / SPAIN ES
List of nationally authorised medicinal products EMA/574895/2016 Page 12/23
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 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré au maltitol liquide
not available 334 207-2 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE SANS SUCRE 5 mg/5 ml ENFANTS, sirop (édulcoré au maltitol liquide)
not available 334 210-3 PIERRE FABRE MEDICAMENT FR
Tussi Drill 5 mg/5 ml, syrop not available 9136 PIERRE FABRE MEDICAMENT PL Drill tosse seca 1 mg/ml xarope not available 3482080 PFDC / PORTUGAL PT TUSSOPRONT 15 mg / 5 ml ORAL SOLUTION FOR ADULTS
not available OGYI/11707-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSOPRONT 5 mg/5 ml, ORAL SOLUTION FOR CHILDREN
not available OGYI/12709-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSIDRILL SUGAR FREE FOR DRY COUGHS 15 MG/5 ML
not available PL 05630/0030 PIERRE FABRE MEDICAMENT UK
ERGIX ADULTES TOUX SECHE, sirop not available 328 525-6 MERCK MÉDICATION FAMILIALE S.A.S.
FR
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
ERGIX 20 mg TOUX SECHE, gélule not available 347 958-1 MERCK MÉDICATION FAMILIALE S.A.S.
FR
ERGIX ENFANTS TOUX SECHE, sirop not available 356 224-7 MERCK MÉDICATION FAMILIALE S.A.S.
FR
Stopex na suchý kašel 15 mg tablety not available 36/590/08-C WALMARK A.S. CZ cinfatós 10 mg pastillas para chupar not available 64.797 LABORATORIOS CINFA, S.A. ES DARO Retard capsules dextromethorfan 29,5 mg, capsules met gereguleerde afgifte
not available RVG 13143 REMARK PHARMA NL
DRILL TOUX SECHE SANS SUCRE 5 mg/5 ml ENFANTS, sirop (édulcoré au maltitol liquide)
not available 334 210-3 PIERRE FABRE MEDICAMENT FR
BECHILAR 3 mg/ml sciroppo not available 018130029 MONTEFARMACO OTC S.P.A. IT DEXTROMETHORPHANE ELERTE 1,5 mg/ml, sirop
not available NL 30226-3400936715516
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
List of nationally authorised medicinal products EMA/574895/2016 Page 13/23
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 30 mg, comprimé pelliculé sécable
not available NL 38185-3400941558054
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 1,5 mg/ml, sirop not available NL 28071-3400936226821
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
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
DEXTROMETHORPHANE ELERTE 1,5 mg/ml, sirop
not available NL 30226-3400936715516
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 30 mg, comprimé pelliculé sécable
not available NL 38185-3400941558054
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
TUSSIDANE 1,5 mg/ml, sirop not available NL 28071-3400936226821
LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE
FR
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
DEXIR ADULTE 3mg/ml, sirop not available BE 154637 BRISTOL-MYERS SQUIBB BELGIUM S.A.
BE
DEXIR ENFANT 1.5mg/ml, sirop not available BE 154621 BRISTOL-MYERS SQUIBB BELGIUM S.A.
BE
RECOTUSS SEDATIVO 6,5 mg compresse masticabili
not available 025273095 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
RECOTUSS SEDATIVO 2 mg/ml sciroppo not available 025273095 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
Toularynx dextromethorphan forte 3 mg/ml, siroop
not available BE476622 LABORATORIA QUALIPHAR NV SA BE
Toularynx dextromethorphan forte 3 mg/ml, sirop
not available BE476622 LABORATORIA QUALIPHAR NV SA BE
Toularynx dextromethorphan forte 3 mg/ml, Sirup
not available BE476622 LABORATORIA QUALIPHAR NV SA BE
BALSOCLASE DEXTROMETHORPHAN 15 mg / 5 ml, ORAL SOLUTION WITHOUT SUGAR
not available BE275177 PIERRE FABRE MEDICAMENT BE
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ TUSSIDRILL 15 mg / 5 ml FOR ADULTS not available 61.398 PIERRE FABRE IBERICA / SPAIN ES
List of nationally authorised medicinal products EMA/574895/2016 Page 14/23
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 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré au maltitol liquide
not available 334 207-2 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE SANS SUCRE 5 mg/5 ml ENFANTS, sirop (édulcoré au maltitol liquide)
not available 334 210-3 PIERRE FABRE MEDICAMENT FR
Tussi Drill 5 mg/5 ml, syrop not available 9136 PIERRE FABRE MEDICAMENT PL Drill tosse seca 1 mg/ml xarope not available 3482080 PFDC / PORTUGAL PT TUSSOPRONT 15 mg / 5 ml ORAL SOLUTION FOR ADULTS
not available OGYI/11707-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSOPRONT 5 mg/5 ml, ORAL SOLUTION FOR CHILDREN
not available OGYI/12709-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSIDRILL SUGAR FREE FOR DRY COUGHS 15 MG/5 ML
not available PL 05630/0030 PIERRE FABRE MEDICAMENT UK
ARITOS 2 mg/ml solución oral not available 71681 ARISTO PHARMA IBERIA, S.L. ES Dextromethorfan hydrobromide 1,5 mg/ml PCH, drank
not available RVG 28400=19939 PHARMACHEMIE B.V NL
Normotus 2 mg/ml solución oral not available 67155 LABORATORIOS NORMON, S.A. ES Stopex na suchý kašel 30 mg tablety not available 36/591/08-C WALMARK A.S. CZ CODOTUSSYL 20 mg TOUX SÈCHE, capsule molle
not available 34009 348 153 7 9 LABORATOIRES GENEVRIER FR
CLARIX TOUX SECHE DEXTROMETHORPHANE 15 mg/5ml ADULTES SANS SUCRE , solution buvable en flacon édulcorée à la saccharine sodique
not available 34009 279 278 4 3 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
Toularynx Dextromethorphan Eucalyptussmaak 1,5 mg/ml, siroop
not available BE464400 LABORATORIA QUALIPHAR NV SA BE
Toularynx Dextromethorphan Goût d’eucalyptus 1,5 mg/ml, sirop
not available BE464400 LABORATORIA QUALIPHAR NV SA BE
Toularynx Dextromethorphan Eucalyptusgeschmack 1,5 mg/ml, Sirup
not available BE464400 LABORATORIA QUALIPHAR NV SA BE
Dextromethorfan Qualiphar, 1mg/ml, siroop not available BE193584 LABORATORIA QUALIPHAR NV SA BE Dextromethorfan Qualiphar, 1mg/ml, sirop not available BE193584 LABORATORIA QUALIPHAR NV SA BE Dextromethorfan Qualiphar, 1mg/ml, Sirup not available BE193584 LABORATORIA QUALIPHAR NV SA BE
List of nationally authorised medicinal products EMA/574895/2016 Page 15/23
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
Toularynx dextromethorphan 1,5 mg/ml, siroop
not available BE156256 LABORATORIA QUALIPHAR NV SA BE
Toularynx dextromethorphan 1,5 mg/ml, sirop
not available BE156256 LABORATORIA QUALIPHAR NV SA BE
TOULARYNX DEXTROMETHORPHAN 1,5 mg/ml, Sirup
not available BE156256 LABORATORIA QUALIPHAR NV SA BE
Toularynx dextromethorphan 1,5 mg/ml, sirop
not available 1994040165 LABORATORIA QUALIPHAR NV SA LU
Tussipect, drank 1,5 mg/ml not available RVG 19939 LABORATORIA QUALIPHAR NV SA NL Dextromethoform, 1mg/ml, siroop not available BE443782 LABORATORIA QUALIPHAR NV SA BE Dextromethoform, 1mg/ml, sirop not available BE443782 LABORATORIA QUALIPHAR NV SA BE Dextromethoform, 1mg/ml, Sirup not available BE443782 LABORATORIA QUALIPHAR NV SA BE Dextrocalyptus, 1mg/ml, siroop not available BE443773 LABORATORIA QUALIPHAR NV SA BE Dextrocalyptus, 1mg/ml, sirop not available BE443773 LABORATORIA QUALIPHAR NV SA BE Dextrocalyptus, 1mg/ml, Sirup not available BE443773 LABORATORIA QUALIPHAR NV SA BE Tussican, 3 mg/ml, xarope not available 5627658 MEDINFAR CONSUMER HEALTH -
PRODUTOS FARMACÊUTICOS,LDA PT
Tussal Antitussicum, 15 mg, tabletki powlekane
not available 4919 BIOFARM SP. Z O.O. PL
Dextrometorfano FARMALIDER 10 mg pastillas para chupar sabor miel-limón
not available 77424 FARMALIDER, S.A. ES
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ Tussastopp-Lösung zum Einnehmen not available 1-27312 RATIOPHARM ARZNEIMITTEL
VERTRIEBS-GMBH AT
AUROTOS 15 mg solución oral not available 78676 LABORATORIOS AUROBINDO S.L.U.
ES
Robitussin Dry Cough 7.5 mg / 5ml Oral Solution
not available PA 822/172/1 PFIZER HEALTHCARE IRELAND IE
Robitussin Antitussicum szirup not available OGYI-T-8102/02 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
HU
Robitussin Antitussicum 7,5 mg/5 ml soluţie orală
not available 7841/2006/01 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
RO
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/574895/2016 Page 16/23
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 Dry Cough Medicine not available PL 00165/0100 PFIZER CONSUMER HEALTHCARE LTD.
UK
Robitussin Dry Cough Medicine not available MA111/00402 PFIZER LIMITED MT Robitussin Antitussicum not available 36/0288/00-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 not available 36/0287/00-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
Robitussin Antitussicum, 7,5 mg/5 ml, syrop
not available 8215 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
PL
Robitussin Junior; 3,75 mg/5 ml, syrop not available 8465 PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H.
PL
Стопекс 30 мг таблетки not available 2012564 WALMARK A.S. BG cinfatós 10 mg comprimidos not available 57.177 LABORATORIOS CINFA, S.A. ES Stopex na suchý kašeľ not available 36/0333/09-S WALMARK A.S. SK Stopex 15 mg tabletki not available 21864 WALMARK A.S. PL Stopex 30 mg tabletki not available 21865 WALMARK A.S. PL Stopex for dry cough not available AA1073/00101 WALMARK A.S. MT Stopropharm 30 mg tabletta not available OGYI-T-22268/02 WALMARK A.S. HU Stopropharm 15 mg tabletta not available OGYI-T-22268/01 WALMARK A.S. HU Rhinathiol DextromethorfanHBrmonohydraat stroop 1 mg/ml
not available RVG NR 15850 SANOFI-AVENTIS NETHERLANDS B.V.
NL
Rhinathiol DextromethorfanHBrmonohydraat stroop 1,33 mg/ml
not available RVG NR 15851 SANOFI-AVENTIS NETHERLANDS B.V.
NL
List of nationally authorised medicinal products EMA/574895/2016 Page 17/23
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 DextromethorfanHBrmonohydraat zuigtabletten 10 mg
not available RVG 15852 SANOFI-AVENTIS NETHERLANDS B.V.
NL
LISOMUCIL TOSSE SEDATIVO not available 019396023 SANOFI SPA IT DESTROMETORFANO BROMIDRATO ZENTIVA 15 mg capsule molli
not available 027026018 ZENTIVA ITALIA SRL IT
LISOMUCIL TOSSE SEDATIVO (PASTIGLIE) not available 019396050 SANOFI SPA IT Tussoral 1,33 mg/ml Xarope not available 4974986 SANOFI - PRODUTOS
FARMACEUTICOS LDA PT
TUSSO RHINATHIOL PASTILLES A SUCER not available BE164814 SANOFI BELGIUM BE TUSSO RHINATHIOL PASTILLES A SUCER not available BE164814 SANOFI BELGIUM BE TUSSO RHINATHIOL 1,33 mg/ml sirop not available BE153377 SANOFI BELGIUM BE TUSSO RHINATHIOL PASTILLES A SUCER not available BE164814 SANOFI BELGIUM BE TUSSO RHINATHIOL 1 mg/ml sirop not available BE153361 SANOFI BELGIUM BE TUSSO RHINATHIOL PASTILLES A SUCER not available BE164814 SANOFI BELGIUM BE TUSSO RHINATHIOL 10 mg comprimés à sucer
not available 0006/02/02/7015 SANOFI BELGIUM LU
TUSSO RHINATHIOL 1,33 mg/ml sirop not available 0006/02/02/7017 SANOFI BELGIUM LU TUSSO RHINATHIOL 10 mg comprimés à sucer
not available 0006/02/02/7015 SANOFI BELGIUM LU
TUSSO RHINATHIOL 10 mg comprimés à sucer
not available 0006/02/02/7015 SANOFI BELGIUM LU
ACODIN, 15 mg, tabletki not available 4042 SANOFI-AVENTIS SP Z.O.O. PL RHINATHIOL 1,33 MG/ML KOHOGESCSILLAPITO SZIRUP FELNOTTEKNEK
not available OGYI-T-9257/02 SANOFI-AVENTIS PRIVATE CO LTD HU
RHINATHIOL 1 MG/ML KOHOGESCSILLAPITO SZIRUP GYERMEKEKNEK
not available OGYI-T-9257/01 SANOFI-AVENTIS PRIVATE CO LTD HU
TUSSO RHINATHIOL 0,1 % SIROP ENFANT not available 0006/02/02/7016 SANOFI-AVENTIS BELGIUM LU 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/574895/2016 Page 18/23
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
BIOCADEXTRO 1 mg/ml ENFANTS SANS SUCRE, sirop édulcoré à la saccharine sodique et au maltitol
not available 3400934851339 ZAMBON FRANCE S.A. FR
TUSSIDRILL 15 mg / 5 ml FOR ADULTS not available 61.398 PIERRE FABRE IBERICA / SPAIN ES NOVAG TUSS 15 mg comprimidos not available 75141 FERRER INTERNACIONAL, S.A. ES Destrometorfano bromidrato Zeta 15 mg/ml gocce orali, soluzione
not available 031317011 ZETA FARMACEUTICI S.P.A. IT
Destrometorfano bromidrato Zeta 30 mg/10 ml sciroppo
not available 031317023 ZETA FARMACEUTICI S.P.A. IT
TUSSIN 6,5mg/5 ml sirop not available 7876/2015/01 ROPHARMA S.A RO DRILL TOUX SECHE 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré au maltitol liquide
not available • 334 207-2 PIERRE FABRE MEDICAMENT FR
Nirolex Tosse Secca 30 mg/10 ml sciroppo not available 029741030 BOOTS PHARMACEUTICALS S.R.L. IT Rometor ratiopharm 2 mg/ml oraaliliuos not available 21625 RATIOPHARM OY FI DEXTROCIDINE ADULTES 0,3 POUR CENT, sirop
not available 34009 341 855 6 4 THERABEL LUCIEN PHARMA S.A. FR
Notús Antitusivo 10 mg pastillas para chupar
not available 66.632 TEVA PHARMA S.L.U ES
Notus 10 mg pastillas para chupar not available 66632 LABORATORIOS RIMAFAR S.L ES BALSOCLASE DEXTROMETHORPHAN 15 mg / 5 ml, ORAL SOLUTION WITHOUT SUGAR
not available BE275177 PIERRE FABRE MEDICAMENT BE
TUSSIDRILL sirup bez cukru 15 mg/5 ml not available 36/645/07-C PIERRE FABRE MEDICAMENT CZ TUSSIDRILL 15 mg / 5 ml FOR ADULTS not available 61.398 PIERRE FABRE IBERICA / SPAIN ES
List of nationally authorised medicinal products EMA/574895/2016 Page 19/23
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 15 mg/5 ml ADULTES SANS SUCRE, sirop édulcoré au maltitol liquide
not available • 334 207-2 PIERRE FABRE MEDICAMENT FR
DRILL TOUX SECHE SANS SUCRE 5 mg/5 ml ENFANTS, sirop (édulcoré au maltitol liquide)
not available 334 210-3 PIERRE FABRE MEDICAMENT FR
Tussi Drill 5 mg/5 ml, syrop not available 9136 PIERRE FABRE MEDICAMENT PL Drill tosse seca 1 mg/ml xarope not available 3482080 PFDC / PORTUGAL PT TUSSOPRONT 15 mg / 5 ml ORAL SOLUTION FOR ADULTS
not available OGYI/11707-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSOPRONT 5 mg/5 ml, ORAL SOLUTION FOR CHILDREN
not available OGYI/12709-1/2014 PIERRE FABRE MEDICAMENT HU
TUSSIDRILL SUGAR FREE FOR DRY COUGHS 15 MG/5 ML
not available PL 05630/0030 PIERRE FABRE MEDICAMENT UK
DEXATUSSIN Junior, 1 mg/1 ml, syrop not available 4219 CHEMICZNO-FARMACEUTYCZNA SPÓŁDZIELNIA PRACY ESPEFA
PL
ARICODILTOSSE 3 mg/ml sciroppo not available 011680079 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
ARICODILTOSSE not available 011680067 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
cinfatós infantil 1 mg / ml solución oral not available 67.311 LABORATORIOS CINFA, S.A. ES Toceliv 2 mg/ml xarope not available 5624721 LABORATÓRIOS BASI – INDÚSTRIA
FARMACÊUTICA, S.A. PT
Dextrometorfano Hidrobromuro Farmalider 15 mg cápsulas blandas
not available 66.543 FARMALIDER, S.A. ES
Boots Dry Cough Relief 2.5mg Lozenges not available 00014/0357 THE BOOTS COMPANY PLC UK EUPHONYLL TOUX SECHE DEXTROMETHORPHANE 15mg/5ml ADULTES SANS SUCRE, sirop edulcoré à la saccharine sodique et au sorbitol
not available 34009 335 334 8 9 LABORATOIRES MAYOLY SPINDLER FR
Nortussine Mono, 10 mg/5 ml, Sirup not available BE218477 NORGINE NV/SA BE Nortussine Mono, 10 mg/5 ml, siroop not available 502IS25F8 NORGINE NV/SA BE Nortussine Mono, 10 mg/5 ml, sirop not available 502IS25F8 NORGINE NV/SA BE NORTUSSINE Mono, 10 mg/5 ml, sirop not available 122/01/12/0029 NORGINE NV/SA LU
List of nationally authorised medicinal products EMA/574895/2016 Page 20/23
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
Notús Antitusivo 2 mg/ml solución oral not available 66417 TEVA PHARMA S.L.U ES Стопекс Джуниьр 15 мг таблетки not available 2012563 WALMARK A.S. BG Демефан 3,42 mg/ml сироп not available 20030049 ACTAVIS EAD BG 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
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
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE, sirop
not available 327 784.8 LABORATOIRES URGO FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5ml, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 834 4 0 LABORATOIRES URGO FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5ml, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 076 2 0 LABORATOIRES URGO FR
HUMEX ADUL TES TOUX SECHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5 ml, solution buvable en sachet edulcoree a Ia saccharine sodique
not available 34009 267 077 9 8 LABORATOIRES URGO FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5ml, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 078 5 9 LABORATOIRES URGO FR
List of nationally authorised medicinal products EMA/574895/2016 Page 21/23
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 SECHE DEXTROMETHORPHANE SANS SUCRE 15 mg/5ml, solution buvable en sachet édulcorée à la saccharine sodique
not available 34009 267 833 8 9 LABORATOIRES URGO FR
HUMEX ENFANTS TOUX SECHE DEXTROMETHORPHANE, sirop
not available 356 740.5 LABORATOIRES URGO FR
HUMEX ADULTES TOUX SECHE DEXTROMETHORPHANE, sirop
not available 356 305.7 LABORATOIRES URGO FR
HUMEX PRO DETI SIRUP NA SUCHY KASEL not available 36/267/01-C LABORATOIRES URGO CZ HUMISEC Pentru Adulti 20 mg/15 ml sirop not available 3733/2003/01 LABORATOIRES URGO RO Humisec pentru copii 5 mg/5 ml sirop not available 3734/2003/01 LABORATOIRES URGO RO HUMEXDRY Adults, syrup not available 20040402 LABORATOIRES URGO BG HUMEXDRY Children, syrup not available 20040401 LABORATOIRES URGO BG Unituss not available 033204013 AZIENDE CHIMICHE RIUNITE
ANGELINI FRANCESCO - A.C.R.A.F. S.P.A.
IT
CINFATOS 15 mg SOLUCIÓN ORAL EN SOBRES
not available 78764 LABORATORIOS CINFA, S.A. ES
DIACOL not available AA004/00301 BIAL - PORTELA & Cª , SA MT DIACOL not available 2008290 BIAL - PORTELA & Cª , SA PT DIACOL, 27 mg/15 ml, syrup not available 19560 BIAL - PORTELA & Cª , SA CY KAUMATUSS 7,5 mg Compresse orosolubili not available 034009011 G.R. FARMA SRL IT KAUMATUSS 7,5 mg Compresse orosolubili not available 034009011 G.R. FARMA SRL IT Dextromethorphan Teva 1,5 mg/ml solution buvable
not available BE211635 TEVA PHARMA BELGIUM N.V./S.A BE
Dextromethorphan Teva 1,5 mg/ml drank not available BE211635 TEVA PHARMA BELGIUM N.V./S.A BE BRONCHENOLO TOSSE 1,54 mg/ml sciroppo
not available 019771043 VERELIBRON S.R.L. IT
BRONCHETAB 7,5 mg compresse not available 038591018 VERELIBRON S.R.L. IT Dextromethorfanhydrobromidehydraat 1,5 mg/ml drank Samenwerkende Apothekers
not available RVG 25116 SAMENWERKENDE APOTHEKERS NEDERLAND B.V.
NL
Zirorphan 1,5 mg/ml siroop BE329131 IDPhar bvba BE Bronchosedal Dextromethorphan BE439345 Johnson & Johnson
Consumer N.V./S.A. BE
List of nationally authorised medicinal products EMA/574895/2016 Page 22/23
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 BE169617 Johnson & Johnson Consumer N.V./S.A.
BE
Bronchosedal Dextromethorphan 2014100323 Johnson & Johnson Consumer N.V./S.A.
LU
Bronchosedal Dextromethorphan 1996040059 Johnson & Johnson Consumer N.V./S.A.
LU
Benylin PA 823/29/1 McNeil Healthcare (Ireland) Limited
IE
Benylin 100/00301 McNeil Products Limited
MT
Benylin 15513/0051 McNeil Products Limited
UK
Iniston Antitusivo 58.91 Johnson & Johnson S.A.
ES
SOLMUCOL 029667021 DYNACREN Laboratorio Farmaceutico
IT
SOLMUCOL 029667033 DYNACREN Laboratorio Farmaceutico
IT
DESTROMETORFANO BROMIDRATO AFOM 029902020 AEFFE FARMACEUTICI S.r.l. IT DESTROMETORFANO BROMIDRATO AFOM 029902032 AEFFE FARMACEUTICI S.r.l. IT DESTROMETORFANO BROMIDRATO FARMAKOPEA 15 MG/ML ORAL DROPS, SOLUTION
030490 027 Farmakopea S.p.A. IT
DESTROMETORFANO BROMIDRATO FARMAKOPEA 30 MG/10 ML SYRUP
030490015 Farmakopea S.p.A. IT
DESTROMETORFANO BROMIDRATO FEDERFARMA.CO 15 MG/ML ORAL DROPS, SOLUTION
030261034 FederFARMA.CO S.p.A. IT
List of nationally authorised medicinal products EMA/574895/2016 Page 23/23
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 FEDERFARMA.CO 30 MG/10 ML SYRUP
030261010 FederFARMA.CO S.p.A. IT
FLUDITEC 04-0363 LABORATOIRE INNOTECH INTERNATIONAL
LV
FLUDITEC 3400934056543 LABORATOIRE INNOTECH INTERNATIONAL
FR
Nirolex Tosse Secca 029741030 Boots Pharmaceuticals S.r.l IT Bicasan 67.400 Pharminicio, S.L. ES DRY COUGH SYRUP PL 12063/0024 Wrafton
Laboratories Limited
UK
Tussabron Syrup PL 03105/0076 Bell, Sons & Company (Druggists) Ltd
UK
Destrometorfano bromidrato Sella 029788027 Laboratorio Chimico Farmaceutico A.Sella srl
IT
Destrometorfano bromidrato Sella 029788039 Laboratorio Chimico Farmaceutico A.Sella srl
IT
Destrometorfano bromidrato Sella 029788015 Laboratorio Chimico Farmaceutico A.Sella srl
IT
LAITOS 70997 LAINCO, S.A. ES
