Official Journal C 76 of the European Union
Volume 59
English edition Information and Notices 26 February 2016
Contents
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
2016/C 076/01 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) ...... 1
2016/C 076/02 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) ...... 10
EN
26.2.2016 EN Official Journal of the European Union C 76/1
IV
(Notices)
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
EUROPEAN COMMISSION
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1)) (2016/C 076/01)
(1) OJ L 136, 30.4.2004, p. 1. C 76/2
— Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted EN INN (International Number of the entry in ATC code (Anatomi- Date of the Name of the medicinal Date of noti- Non-Proprietary Holder of the marketing authorisation the Community Regis- Pharmaceutical form cal Therapeutic Che- decision product fication Name) ter mical Code)
11.1.2016 Eptifibatide Accord eptifibatide Accord Healthcare Limited EU/1/15/1065 Solution for infusion B01AC16 13.1.2016 Sage House, 319 Pinner Road, North Harrow, Mid- Solution for injec- dlesex, HA1 4HF, United Kingdom tion
14.1.2016 Benepali etanercept Samsung Bioepis UK Limited EU/1/15/1074 Solution for injec- L04AB01 18.1.2016 Off
3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, tion icial United Kingdom Jour nal 14.1.2016 Briviact brivaracetam UCB Pharma S.A. EU/1/15/1073 Film-coated tablet N03AX23 18.1.2016 Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Oral solution of Researchdreef 60, 1070 Brussel, België Solution for injec- the
tion or infusion European
14.1.2016 Episalvan birch bark ex- Birken AG EU/1/15/1069 Gel Pending 18.1.2016 tract Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Uni
Deutschland on
14.1.2016 Lopinavir/Ritonavir lopinavir/ritona- Mylan S.A.S EU/1/15/1067 Film-coated tablet J05AR10 18.1.2016 Mylan vir 117 allée des Parcs, F-69800 Saint Priest, France
14.1.2016 Oncaspar pegaspargase Baxalta Innovations GmbH EU/1/15/1070 Powder and solvent L01XX24 18.1.2016 Industriestrasse 67, A-1221 Vienna, Österreich for solution for in- jection/infusion
14.1.2016 Spectrila asparaginase medac Gesellschaft für klinische Spezialpräparate mbH EU/1/15/1072 Powder for concen- L01XX02 18.1.2016 Theaterstr. 6, D-22880 Wedel, Deutschland trate for solution for
infusion 26.2.2016 26.2.2016
INN (International Number of the entry in ATC code (Anatomi- Date of the Name of the medicinal Date of noti- Non-Proprietary Holder of the marketing authorisation the Community Regis- Pharmaceutical form cal Therapeutic Che- decision product fication Name) ter mical Code)
18.1.2016 Pemetrexed Accord pemetrexed Accord Healthcare Limited EU/1/15/1071 Powder for concen- L01BA04 20.1.2016 EN Sage House, 319 Pinner Road, North Harrow, Mid- trate for solution for dlesex, HA1 4HF, United Kingdom infusion 18.1.2016 Pemetrexed Actavis pemetrexed Actavis Group PTC ehf. EU/1/15/1063 Concentrate for so- L01BA04 21.1.2016 Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland lution for infusion Off icial Jour nal of the European Uni on C 76/3 C 76/4 EN Official Journal of the European Union 26.2.2016
— Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
7.1.2016 Bosulif Pfizer Limited EU/1/13/818 11.1.2016 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
7.1.2016 Kuvan BioMarin International Limited EU/1/08/481 11.1.2016 Shanbally, Ringaskiddy, County Cork, Ireland
7.1.2016 Sildenafil Teva Teva B.V. EU/1/09/584 11.1.2016 Swensweg 5, 2031 GA Haarlem, Nederland
7.1.2016 Sirturo Janssen-Cilag International NV EU/1/13/901 11.1.2016 Turnhoutseweg 30, B-2340 Beerse, België
11.1.2016 Cometriq TMC Pharma Services Ltd EU/1/13/890 13.1.2016 Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom
11.1.2016 Latuda Takeda Pharma A/S EU/1/14/913 13.1.2016 Dybendal Alle 10, 2630 Taastrup, Danmark
11.1.2016 Sivextro Merck Sharp & Dohme Limited EU/1/15/991 13.1.2016 Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
11.1.2016 Yellox PharmaSwiss Česká republika s.r.o. EU/1/11/692 13.1.2016 Jankovcova 1569/2c 17000 Praha 7 Česká republika
11.1.2016 Zinforo AstraZeneca AB EU/1/12/785 13.1.2016 SE-151 85 Södertälje, Sverige
12.1.2016 Atriance Novartis Europharm Limited EU/1/07/403 14.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
12.1.2016 Cervarix GlaxoSmithKline Biologicals S.A. EU/1/07/419 14.1.2016 rue de l’Institut 89, 1330 Rixensart, Belgique
12.1.2016 Gardasil Sanofi Pasteur MSD SNC EU/1/06/357 14.1.2016 162 avenue Jean Jaurès, 69007 Lyon, France
12.1.2016 Gardasil 9 Sanofi Pasteur MSD SNC EU/1/15/1007 14.1.2016 162 avenue Jean Jaurès, 69007 Lyon, France
12.1.2016 Silgard Merck Sharp & Dohme Limited EU/1/06/358 14.1.2016 Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
14.1.2016 Bronchitol Pharmaxis Pharmaceuticals Limited EU/1/12/760 18.1.2016 25 Moorgate, London, EC2R 6AY, United King- dom.
14.1.2016 Caprelsa AstraZeneca AB EU/1/11/749 18.1.2016 SE-151 85 Södertälje, Sverige 26.2.2016 EN Official Journal of the European Union C 76/5
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
14.1.2016 Eliquis Bristol-Myers Squibb/Pfizer EEIG EU/1/11/691 18.1.2016 Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom
14.1.2016 Evoltra Genzyme Europe B.V. EU/1/06/334 18.1.2016 Gooimeer 10, NL-1411 DD Naarden, Nederland
14.1.2016 Glivec Novartis Europharm Limited EU/1/01/198 18.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
14.1.2016 Leganto UCB Manufacturing Ireland Ltd EU/1/11/695 19.1.2016 Shannon Industrial Estate, Co, Clare, Ireland
14.1.2016 Lumigan Allergan Pharmaceuticals Ireland EU/1/02/205 18.1.2016 Castlebar Road, Westport, County Mayo, Ireland
14.1.2016 Pravafenix LABORATOIRES SMB SA EU/1/11/679 18.1.2016 26-28 rue de la Pastorale/26-28 Herderslied- straat, 1080 Brussel/Bruxelles, Belgique/België
14.1.2016 Rotarix GlaxoSmithKline Biologicals S.A. EU/1/05/330 18.1.2016 rue de l’Institut 89, 1330 Rixensart, Belgique
14.1.2016 Torisel Pfizer Limited EU/1/07/424 18.1.2016 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
14.1.2016 Trobalt Glaxo Group Ltd EU/1/11/681 18.1.2016 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
14.1.2016 VELCADE Janssen-Cilag International NV EU/1/04/274 18.1.2016 Turnhoutseweg 30, B-2340 Beerse, België
14.1.2016 Xeloda Roche Registration Limited EU/1/00/163 18.1.2016 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
18.1.2016 Repso Teva B.V. EU/1/11/674 20.1.2016 Swensweg 5, 2031 GA Haarlem, Nederland
18.1.2016 Xagrid Shire Pharmaceutical Contracts Ltd EU/1/04/295 20.1.2016 Hampshire International Business Park, Chine- ham, Basingstoke, Hampshire RG24 8EP, United Kingdom
18.1.2016 Xiapex Swedish Orphan Biovitrum AB (publ) EU/1/11/671 20.1.2016 SE-112 76 Stockholm, Sverige
22.1.2016 Clopidogrel Teva Teva B.V. EU/1/09/561 26.1.2016 Pharma Swensweg 5, 2031 GA Haarlem, Nederland C 76/6 EN Official Journal of the European Union 26.2.2016
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
22.1.2016 Kadcyla Roche Registration Limited EU/1/13/885 26.1.2016 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
22.1.2016 Levitra Bayer Pharma AG EU/1/03/248 26.1.2016 D-13342 Berlin, Deutschland
22.1.2016 Levodopa/Carbido- Orion Corporation EU/1/11/706 26.1.2016 pa/Entacapone Or- Orionintie 1, FI-02200 Espoo, Suomi ion
22.1.2016 Neupro UCB Manufacturing Ireland Ltd EU/1/05/331 26.1.2016 Shannon Industrial Estate, Co, Clare, Ireland
22.1.2016 Nplate Amgen Europe B.V. EU/1/08/497 26.1.2016 Minervum 7061, NL-4817 ZK Breda, Nederland
22.1.2016 Ofev Boehringer Ingelheim International GmbH EU/1/14/979 26.1.2016 Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
22.1.2016 Optaflu Novartis Influenza Vaccines Marburg GmbH EU/1/07/394 26.1.2016 Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland
22.1.2016 Topotecan Actavis Actavis Group PTC ehf. EU/1/09/536 27.1.2016 Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland
22.1.2016 Ulunar Breezhaler Novartis Europharm Limited EU/1/14/917 26.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
22.1.2016 Viagra Pfizer Limited EU/1/98/077 26.1.2016 Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
22.1.2016 Vivanza Bayer Pharma AG EU/1/03/249 26.1.2016 D-13342 Berlin, Deutschland
25.1.2016 Corlentor Les Laboratoires Servier EU/1/05/317 27.1.2016 50 rue Carnot, F-92284 Suresnes Cedex, France
25.1.2016 Cyramza Eli Lilly Nederland B.V. EU/1/14/957 27.1.2016 Grootslag 1-5, NL-3991 RA Houten, Nederland
25.1.2016 Entacapone Orion Orion Corporation EU/1/11/708 27.1.2016 Orionintie 1, FI-02200 Espoo, Suomi
25.1.2016 Exviera AbbVie Ltd EU/1/14/983 27.1.2016 Maidenhead, SL6 4UB, United Kingdom
25.1.2016 GILENYA Novartis Europharm Limited EU/1/11/677 27.1.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom 26.2.2016 EN Official Journal of the European Union C 76/7
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
25.1.2016 NovoRapid Novo Nordisk A/S EU/1/99/119 27.1.2016 Novo Allé, DK-2880 Bagsvaerd, Danmark
25.1.2016 Procoralan Les Laboratoires Servier EU/1/05/316 27.1.2016 50 rue Carnot, F-92284 Suresnes Cedex, France
25.1.2016 SANCUSO ProStrakan Limited EU/1/12/766 27.1.2016 Galabank Business Park, Galashiels TD1 1QH, United Kingdom
25.1.2016 Sildenafil Actavis Actavis Group PTC ehf. EU/1/09/595 27.1.2016 Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland
25.1.2016 Sildenafil ratio- ratiopharm GmbH EU/1/09/603 28.1.2016 pharm Graf-Arco-Straße 3, D-89079 Ulm, Deutschland
25.1.2016 Stalevo Orion Corporation EU/1/03/260 27.1.2016 Orionintie 1, FI-02200 Espoo, Suomi
25.1.2016 Tarceva Roche Registration Limited EU/1/05/311 27.1.2016 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
25.1.2016 Travatan Alcon Laboratories (UK) Ltd EU/1/01/199 27.1.2016 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom
25.1.2016 VELCADE Janssen-Cilag International NV EU/1/04/274 27.1.2016 Turnhoutseweg 30, B-2340 Beerse, België
25.1.2016 Viekirax AbbVie Ltd EU/1/14/982 27.1.2016 Maidenhead, SL6 4UB, United Kingdom
28.1.2016 Bexsero GlaxoSmithKline Vaccines S.r.l. EU/1/12/812 1.2.2016 Via Fiorentina, 1, 53100 Siena, Italia
28.1.2016 Clopidogrel Acino Acino AG EU/1/09/532 1.2.2016 Am Windfeld 35, 83714 D-Miesbach, Deutsch- land
28.1.2016 Comtess Orion Corporation EU/1/98/082 1.2.2016 Orionintie 1, FI-02200 Espoo, Suomi
28.1.2016 Daklinza Bristol-Myers Squibb Pharma EEIG EU/1/14/939 1.2.2016 Uxbridge Business Park, Sanderson Road, Ux- bridge UB8 1DH, United Kingdom
28.1.2016 Defitelio Gentium S.p.A. EU/1/13/878 1.2.2016 Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia
28.1.2016 Nonafact Sanquin Plasma Products B.V. EU/1/01/186 1.2.2016 Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland C 76/8 EN Official Journal of the European Union 26.2.2016
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
28.1.2016 Relistor PharmaSwiss Česká republika s.r.o. EU/1/08/463 1.2.2016 Jankovcova 1569/2c 17000 Praha 7 Česká republika
28.1.2016 Revolade Novartis Europharm Limited EU/1/10/612 1.2.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
28.1.2016 Sovaldi Gilead Sciences International Limited EU/1/13/894 1.2.2016 Cambridge CB21 6GT, United Kingdom
28.1.2016 Ultibro Breezhaler Novartis Europharm Limited EU/1/13/862 1.2.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
28.1.2016 Voriconazole Hos- Hospira UK Limited EU/1/15/1004 1.2.2016 pira Queensway, Royal Leamington Spa, Warwick- shire CV31 3RW, United Kingdom
28.1.2016 Xoterna Breezhaler Novartis Europharm Limited EU/1/13/863 1.2.2016 Frimley Business Park, Camberley GU16 7SR, United Kingdom
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
7.1.2016 Activyl Intervet International B.V. EU/2/10/118 11.1.2016 Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland
7.1.2016 CaniLeish VIRBAC S.A. EU/2/11/121 11.1.2016 1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France
7.1.2016 Cimalgex Vétoquinol SA EU/2/10/119 11.1.2016 Magny-Vernois, F-70200 Lure, France
7.1.2016 Comfortis Eli Lilly and Company Ltd, Elanco Animal Health EU/2/10/115 11.1.2016 Lilly House Priestley Road, Basingstoke, Hamp- shire, RG24 9NL, United Kingdom
7.1.2016 Melosus CP-Pharma Handelsgesellschaft mbH EU/2/10/116 11.1.2016 Ostlandring 13, D-31303 Burgdorf, Deutschland
7.1.2016 Neocolipor Merial EU/2/98/008 11.1.2016 29 avenue Tony Garnier, F-69007 Lyon, France 26.2.2016 EN Official Journal of the European Union C 76/9
Date of the Name of the medic- Number of the entry in Date of noti- Holder of the marketing authorisation decision inal product the Community Register fication
7.1.2016 Veraflox Bayer Animal Health GmbH EU/2/10/107 11.1.2016 D-51368 Leverkusen, Deutschland 7.1.2016 Zulvac 1 + 8 Ovis Zoetis Belgium S.A. EU/2/11/120 11.1.2016 Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique 14.1.2016 Procox Bayer Animal Health GmbH EU/2/11/123 18.1.2016 D-51368 Leverkusen, Deutschland 22.1.2016 ERYSENG PARVO Laboratorios Hipra, S.A. EU/2/14/167 26.1.2016 Avda. La Selva, 135, E-17170 Amer (Girona), España 22.1.2016 Purevax RCPCh Merial EU/2/04/047 26.1.2016 FeLV 29 avenue Tony Garnier, F-69007 Lyon, France
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact: European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom C 76/10 EN Official Journal of the European Union 26.2.2016
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2)) (2016/C 076/02)
— Issuing, maintenance or modification of a national marketing authorisation
Date of the Name(s) of the medicinal INN (International Non- Holder(s) of the mar- Member State con- Date of noti- decision product Proprietary Name) keting authorisation cerned fication
7.1.2016 Solamocta See Annex I See Annex I See Annex I 8.1.2016 14.1.2016 Ambroxol or Bromhex- See Annex II See Annex II See Annex II 15.1.2016 ine 18.1.2016 Bimatoprost Bimatoprost Not applicable Not applicable 19.1.2016
See Annex. These Decisions are addressed to the Member States.
(1) OJ L 311, 28.11.01, p. 67. (2) OJ L 311, 28.11.01, p. 1. 26.2.2016
ANNEX I
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States EN
Member State EU/ Route of adminis- Applicant Name INN Strength Pharmaceutical form Animal species EEA tration
Austria Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur-
The Netherlands keys Off icial Jour Belgium Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks nal
NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- of
The Netherlands keys the European
Czech Republic Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- Uni The Netherlands keys on
Denmark Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys
France Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys C 76/11 C 76/12
Member State EU/ Route of adminis- Applicant Name INN Strength Pharmaceutical form Animal species EEA tration
Germany Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral EN Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys
Greece Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur-
The Netherlands keys Off icial Jour Hungary Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks nal
NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- of
The Netherlands keys the European
Ireland Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral
Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks Uni NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys on
Italy Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys
Luxembourg Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys 26.2.2016 26.2.2016
Member State EU/ Route of adminis- Applicant Name INN Strength Pharmaceutical form Animal species EEA tration
Poland Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral
Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks EN NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys Portugal Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys Slovakia Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks
NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- Off
The Netherlands keys icial Spain Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks Jour
NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- nal
The Netherlands keys of
The Netherlands Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral the
Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks European NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- The Netherlands keys United Kingdom Eurovet Animal Health BV Solamocta 697 mg/g Powder Amoxicillin trihy- 800 mg/g Powder for use in Chickens (broilers, pull- Oral Handelsweg 25 for Use in Drinking Water for drate drinking water ets, breeders), ducks Uni
NL-5531 AE Bladel Chickens, Ducks and Turkeys (broilers, breeders), tur- on The Netherlands keys C 76/13 C 76/14
ANNEX II
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States EN
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Boehringer Ingelheim RCV GmbH & Co Bromhexidine hydro- Bisolvon Hustenlöser — Saft 4 mg/5 ml oral liquid oral use KG chloride Dr. Boehringergasse 5-11
Vienna Off
1121 icial Austria Jour nal
Austria Boehringer Ingelheim RCV GmbH & Co Bromhexidine hydro- Bisolvon — Lösung 8 mg/4 ml oral solution oral use of
KG chloride the
Dr. Boehringergasse 5-11 European Vienna 1121 Austria Uni on
Austria ratiopharm Arzneimittel Vertriebs-GmbH Ambroxole hydrochlor- Ambrobene retard 75 mg — Kapseln 75 mg prolonged-re- oral use Albert Schweitzergasse 3 ide lease capsule, Vienna hard 1140 Austria
Austria ratiopharm Arzneimittel Vertriebs-GmbH Ambroxole hydrochlor- Ambrobene 15 mg/5 ml — Saft 15 mg/5 ml oral liquid oral use Albert Schweitzergasse 3 ide Vienna 1140 Austria 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Aponova-Pharma Handels GmbH Ambroxole hydrochlor- Ambroxol ‘Aponova’ 60 mg — Brauseta- 60 mg effervescent ta- oral use EN Mitterweg 4 Hart ide bletten blet 6265 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucoangin Johannisbeere 20 mg — 20 mg lozenge oral use KG ide Lutschtabletten Dr. Boehringergasse 5-11
Vienna Off
1121 icial Austria Jour nal
Austria ratiopharm Arzneimittel Vertriebs-GmbH Ambroxole hydrochlor- Ambrobene 30 mg — Tabletten 30 mg tablet oral use of
Albert Schweitzergasse 3 ide the Vienna 1140 European Austria Uni
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucoangin Zitrone 20 mg Lutschtable- 20 mg lozenge oral use on KG ide tten Dr. Boehringergasse 5-11 Vienna 1121 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucospas — Tabletten 30 mg, tablet oral use KG ide, 0,02 mg Dr. Boehringergasse 5-11 clenbuterol Vienna 1121 Austria C 76/15 C 76/16
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucospas — Saft 7,5 mg/5 ml, oral liquid oral use EN KG ide, 0,0001 g Dr. Boehringergasse 5-11 clenbuterol Vienna 1121 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosolvan 7,5 mg/1 ml — Lösung 7,5 mg/ml oral solution oral use KG ide
Dr. Boehringergasse 5-11 Off Vienna icial 1121
Austria Jour nal
Austria ratiopharm Arzneimittel Vertriebs-GmbH Ambroxole hydrochlor- Ambrobene 15 mg — Ampullen 15 mg solution for in- intravenous use, of
Albert Schweitzergasse 3 ide jection intramuscular the Vienna use, subcutaneous 1140 use European Austria Uni Austria Genericon Pharma GmbH Ambroxole hydrochlor- Ambroxol Genericon 30 mg Tabletten 30 mg tablet oral use Hafnerstrasse 211 ide on Graz 8054 Austria
Austria Genericon Pharma GmbH Ambroxole hydrochlor- Ambroxol Genericon Lösung 7,5 mg/ml oral solution oral use Hafnerstrasse 211 ide Graz 8054 Austria
Austria Genericon Pharma GmbH Ambroxole hydrochlor- Ambroxol Genericon Saft 15 mg/5 ml oral liquid oral use Hafnerstrasse 211 ide Graz 8054
Austria 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosolvan 15 mg — Lutschpastillen 15 mg lozenge oral use KG ide EN Dr. Boehringergasse 5-11 Vienna 1121 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosan 15 mg — Ampullen 15 mg solution for in- intravenous use KG ide jection Dr. Boehringergasse 5-11
Vienna Off 1121 icial Austria Jour
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosolvan retard 75 mg — Kapseln 75 mg prolonged-re- oral use nal KG ide lease capsule, Dr. Boehringergasse 5-11 hard of Vienna the
1121 European Austria
Austria 1A Pharma GmbH Ambroxole hydrochlor- Ambroxol 1A Pharma 7,5 mg/ml — 7,5 mg/ml oral solution oral use Stella-Klein-Löw-Weg 17 ide Lösung Uni
Vienna on 1020 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucoangin Mint 20 mg — Lutschtable- 20 mg lozenge oral use KG ide tten Dr. Boehringergasse 5-11 Vienna 1121 Austria
Austria +pharma arzneimittel gmbh Ambroxole hydrochlor- Ambroxol + pharma 60 mg lösliche 60 mg tablet oral use Hafnerstrasse 211 ide Tabletten Graz 8054 Austria C 76/17 C 76/18
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Genericon Pharma GmbH Ambroxole hydrochlor- Ambroxol Genericon 60 mg lösliche 60 mg effervescent ta- oral use EN Hafnerstrasse 211 ide Tabletten blet Graz 8054 Austria
Austria ratiopharm Arzneimittel Vertriebs-GmbH Ambroxole hydrochlor- Ambrobene 7,5 mg/ml — Lösung 7,5 mg/ml oral solution oral use Albert Schweitzergasse 3 ide Vienna 1140
Austria Off icial
Austria Hexal Pharma GmbH Ambroxole hydrochlor- Ambrohexal 30 mg — lösbare Tabletten 30 mg effervescent ta- oral use Jour Stella-Klein-Löw-Weg 17 ide blet Vienna nal
1020 of
Austria the European Austria Hexal Pharma GmbH Ambroxole hydrochlor- Ambrohexal 7,5 mg/ml — Lösung 7,5 mg/ml oral solution oral use Stella-Klein-Löw-Weg 17 ide
Vienna Uni 1020 Austria on
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucoangin 17,86 mg/ml Spray zur 17,86 mg/ml oromucosal oral use KG ide Anwendung in der Mundhöhle spray Dr. Boehringergasse 5-11 Vienna 1121 Austria
Austria G.L. Pharma GmbH Ambroxole hydrochlor- Ambrolan 30 mg — Tabletten 30 mg tablet oral use Schlossplatz 1 Lannach ide 8502
Austria 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosolvan 30 mg/5 ml — Saft 30 mg/ml oral liquid oral use KG ide EN Dr. Boehringergasse 5-11 Vienna 1121 Austria
Austria Boehringer Ingelheim RCV GmbH & Co Ambroxole hydrochlor- Mucosolvan 15 mg/5 ml — Saft für 15 mg/5 ml oral liquid oral use KG ide Kinder Dr. Boehringergasse 5-11
Vienna Off
1121 icial Austria Jour
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Ambroxine 2,5 mg/ml oromucosal inhalation use nal
S.C.S.-Comm. V. ide spray of
Avenue Ariane 16 the 1200 Brussels Belgium European
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Ambroxine 20 mg pastille oropharyngeal
S.C.S.-Comm. V. ide use Uni
Avenue Ariane 16 on 1200 Brussels Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Ambroxine 20 mg lozenge oropharyngeal S.C.S.-Comm. V. ide use Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Bisolangin 20 mg pastille oromucosal use S.C.S.-Comm. V. ide Avenue Ariane 16 1200 Brussels Belgium C 76/19 C 76/20
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Mucoangin 2,5 mg/ml oromucosal oromucosal use EN S.C.S.-Comm. V. ide spray Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Mucoangin Cassis 20 mg pastille oral use S.C.S.-Comm. V. ide Avenue Ariane 16 1200 Brussels Off Belgium icial
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Mucoangin Citron 20 mg lozenge oral use Jour
S.C.S.-Comm. V. ide nal Avenue Ariane 16 1200 Brussels of Belgium the European
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Mucoangin Menthe 20 mg pastille oropharyngeal S.C.S.-Comm. V. ide use Avenue Ariane 16 Uni
1200 Brussels on Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Mucoangin Menthe 20 mg lozenge oropharyngeal S.C.S.-Comm. V. ide use Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Rexambro 20 mg lozenge oropharyngeal S.C.S.-Comm. V. ide use Avenue Ariane 16 1200 Brussels
Belgium 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Surbronc 30 mg/5 ml syrup oral use EN S.C.S.-Comm. V. ide Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Surbronc 60 mg tablet oral use S.C.S.-Comm. V. ide Avenue Ariane 16 1200 Brussels Off Belgium icial
Belgium Boehringer Ingelheim Ambroxol Hydrochlor- Surbronc 60 mg granules for oral oral use Jour
S.C.S.-Comm. V. ide solution nal Avenue Ariane 16 1200 Brussels of Belgium the European
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon 2 % nebuliser solu- inhalation use S.C.S.-Comm. V. chloride tion Avenue Ariane 16 Uni
1200 Brussels on Belgium
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon 2 mg/ml oral drops, solu- oral use S.C.S.-Comm. V. chloride tion Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon 8 mg tablet oral use S.C.S.-Comm. V. chloride Avenue Ariane 16 1200 Brussels Belgium C 76/21 C 76/22
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon 8 mg/5 ml syrup oral use EN S.C.S.-Comm. V. chloride Avenue Ariane 16 1200 Brussels Belgium
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon Citrus 8 mg tablet oral use S.C.S.-Comm. V. chloride Avenue Ariane 16
1200 Brussels Off
Belgium icial Jour
Belgium Boehringer Ingelheim Bromhexine Hydro- Bisolvon Instant 8 mg tablet oral use nal S.C.S.-Comm. V. chloride Avenue Ariane 16 of 1200 Brussels the
Belgium European
Belgium E.G. S.A.-N.V. Bromhexine Hydro- Bromhexine 8 mg tablet oral use Heizel Esplanade b22 chloride Uni
1020 Brussels on Belgium
Belgium D.J. Van Tintelen Beheer Bromhexine Hydro- Bronchi-Mereprine 8 mg tablet oral use B.V. chloride Stijntjesduinstraat 41 Noordwijk The Netherlands
Belgium Laboratoria Qualiphar N.V/S.A Bromhexine Hydro- Toularynx Bromhexine 5 mg/5 ml syrup oral use Rijksweg 9 chloride 2880 Bornem
Belgium 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Bulgaria Sopharma AD Ambroxol hydrochloride Ambixol 15 mg/5 ml syrup oral use EN 16, Iliensko shosse str. Sofia 1220 Bulgaria
Bulgaria Nobel Pharma OOD Ambroxol hydrochloride Ambrex 15 mg/5 ml syrup oral use 24 Simeonovsko shose bulvd. 1700 Sofia Bulgaria Off
Bulgaria Nobel Pharma OOD Ambroxol hydrochloride Ambrex 30 mg/5 ml syrup oral use icial 24 Simeonovsko shose bulvd. 1700 Sofia, Jour
Bulgaria nal of
Bulgaria Tchaikapharma Highquality Medicines Ambroxol hydrochloride Ambrin 30 mg effervescent ta- oral use the
1 G. M. Dimitrov Blvd blet European Sofia, 1172 Bulgaria Uni
Bulgaria Hexal AG Ambroxol hydrochloride Ambro 3 mg/ml oral solution oral use on Industriestrasse 25, D-83607 Holzkirchen, Germany
Bulgaria Hexal AG Ambroxol hydrochloride Ambro 30 mg tablet oral use Industriestrasse 25, D-83607 Holzkirchen, Germany
Bulgaria Aliud Pharma GmbH Ambroxol hydrochloride Ambrolex R 75 mg prolonged-re- oral use 19 Gottlieb-Daimler-Str. lease capsule, 89150 Laichingen, hard Germany C 76/23 C 76/24
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Bulgaria Adipharm EAD Ambroxol hydrochloride Ambroxol Adipharm 15 mg/5 ml syrup oral use EN 130 Simeonovsko Shosse blvd 1700 Sofia Bulgaria
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed 60 mg effervescent ta- oral use Glienicker Weg 125 — 127 blet 12489 Berlin Germany Off
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed 15 mg/5 ml oral solution oral use icial Glienicker Weg 125 — 127 12489 Berlin Jour
Germany nal of
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed Cough Tablets 30 mg tablet oral use the
Glienicker Weg 125 — 127 European 12489 Berlin Germany Uni
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed for children 15 mg/5 ml oral solution oral use on Glienicker Weg 125 — 127 12489 Berlin Germany
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed forte 30 mg/5 ml oral solution oral use Glienicker Weg 125 — 127 12489 Berlin Germany
Bulgaria Berlin-Chemie AG Ambroxol hydrochloride Flavamed max 30 mg/5 ml oral solution oral use Glienicker Weg 125 — 127 12489 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Bulgaria Cyathus Exquirere Pharmaforschungs Ambroxol hydrochloride Gogolox 5 % oral solution oral use EN GmbH Rudolfsplatz 2/1/8 1010 Wienna Austria
Bulgaria Aliud Pharma GmbH Ambroxol hydrochloride Grippostad Ambro 30 mg tablet oral use 19 Gottlieb-Daimler-Str. 89150 Laichingen, Germany Off icial Jour Bulgaria Boehringer Ingelheim International Ambroxol hydrochloride Mucoangin 20 mg lozenge oral use GmbH nal
Binger Strasse 173 of
55216 Ingelheim am Rhein the Germany European
Bulgaria Actavis EAD Ambroxol hydrochloride Mucolisin 30 mg/5 ml syrup oral use
29 Atanas Dukov str. Uni 1407 Sofia on Bulgaria
Bulgaria Zentiva, a.s. Ambroxol hydrochloride Mucosin Zentiva 30 mg tablet oral use Einsteinova 24 851 01, Bratislava Slovak Republic
Bulgaria Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 15 mg/5 ml syrup oral use GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany C 76/25 C 76/26
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Bulgaria Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 15 mg pastille oral use EN GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Bulgaria Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 75 mg prolonged-re- oral use GmbH lease capsule, Binger Strasse 173 hard 55216 Ingelheim am Rhein Off
Germany icial Jour
Bulgaria Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use nal
GmbH of
Binger Strasse 173 the 55216 Ingelheim am Rhein Germany European
Bulgaria Divapharma GmbH Ambroxol hydrochloride Neo-bronchol 15 mg lozenge oral use Uni Motzener Straße 41 on 12277 Berlin Germany
Bulgaria KRKA, d.d. Ambroxol hydrochloride Solvolan 15 mg/5 ml syrup oral use Smarjeska cesta 6 Novo mesto, 8501 Slovenia
Bulgaria KRKA, d.d. Ambroxol hydrochloride Solvolan 30 mg tablet oral use Smarjeska cesta 6 Novo mesto, 8501
Slovenia 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Bulgaria Actavis EAD Bromhexine hydrochlor- Bromhexin Actavis 4 mg coated tablet oral use EN 29 Atanas Dukov str. ide 1407 Sofia Bulgaria
Bulgaria Actavis EAD Bromhexine hydrochlor- Bromhexin Actavis 8 mg coated tablet oral use 29 Atanas Dukov str. ide 1407 Sofia Bulgaria Off
Bulgaria Sopharma AD Bromhexine hydrochlor- Bromhexine Sopharma 2 mg/ml solution for in- intramuscular icial 16, Iliensko shosse str. ide jection use, intravenous Sofia, 1220 use Jour
Bulgaria nal of
Bulgaria Sopharma AD Bromhexine hydrochlor- Bromhexine Sopharma 8 mg tablet oral use the
16, Iliensko shosse str. ide European Sofia, 1220 Bulgaria Uni
Croatia Medis Adria d.o.o. ambroxolum Ambrospray 10 mg/potisku spreja, oralna 50 mg/ml oral solution oral use on Kolarova 7, Zagreb otopina 10000 Croatia
Croatia Boehringer Ingelheim Zagreb d.o.o. ambroxolum Mucosolvan 75 mg kapsule s produljenim 75 mg prolonged-re- oral use Radnička 40-5, Zagreb oslobađanjem lease capsule 10000 Croatia
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. ambroxolum Flavamed 15 mg/5 ml oralna otopina 15 mg/5 ml oral solution oral use Horvatova 80a, Zagreb 10000 Croatia C 76/27 C 76/28
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. ambroxolum Flavamed forte 30 mg/5 ml oralna 30 mg/5 ml oral solution oral use EN Horvatova 80a, Zagreb otopina 10000 Croatia
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. ambroxolum Flavamed 30 mg tablete 30 mg tablet oral use Horvatova 80a, Zagreb 10000 Croatia Off
Croatia Berlin-Chemie Menarini Hrvatska d.o.o. ambroxolum Flavamed forte 60 mg šumeće tablete 60 mg effervescent ta- oral use icial Horvatova 80a, Zagreb blet 10000 Jour
Croatia nal of
Croatia Boehringer Ingelheim Zagreb d.o.o. ambroxolum Mucosolvan 30 mg tablete 30 mg tablet oral use the
Radnička 40-5, Zagreb European 10000 Croatia Uni
Croatia Divapharma GmbH ambroxolum neo-bronchol 15 mg pastile 15 mg pastille oral use on Motzener Str. 41, Berlin 12277 Germany
Croatia Pliva Hrvatska d.o.o. bromhexinum Bisolex 2 mg/ml otopina 2 mg/ml oral drops, solu- oral use Prilaz baruna Filipovića 25, Zagreb tion 10000 Croatia
Croatia Pliva Hrvatska d.o.o. bromhexinum Bisolex 4 mg/5 ml sirup 4 mg/5 ml syrup oral use Prilaz baruna Filipovića 25, Zagreb 10000
Croatia 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Croatia Pliva Hrvatska d.o.o. bromhexinum Bisolex 8 mg tablete 8 mg tablet oral use Prilaz baruna Filipovića 25, Zagreb EN 10000 Croatia
Croatia Pliva Hrvatska d.o.o. bromhexinum Bisolex F 16 mg tablete 16 mg tablet oral use Prilaz baruna Filipovića 25, Zagreb 10000 Croatia Off Croatia Boehringer Ingelheim Zagreb d.o.o. bromhexinum Bisolvon 2 mg/ml otopina 2 mg/ml solution for oral oral use Radnička 40-5, Zagreb use icial
10000 Jour Croatia nal
Croatia Boehringer Ingelheim Zagreb d.o.o. bromhexinum Bisolvon 4 mg/5 ml sirup 4 mg/5 ml syrup oral use of Radnička 40-5, Zagreb the
10000 European Croatia
Croatia Boehringer Ingelheim Zagreb d.o.o. bromhexinum Bisolvon 8 mg tablete 8 mg tablet oral use Uni Radnička 40-5, Zagreb 10000 on Croatia
Cyprus The Star Medicines Importers & Co Ltd ambroxol hydrochloride Anavix 15 mg/5 ml syrup oral use 9A Loukis Akritas Street Lemesos 3601 Cyprus
Cyprus Varnavas Hadjipanayis Ltd ambroxol hydrochloride Fluibron 15 mg/5 ml syrup oral use Yiannou Kranidioti Avenue 226 Latsia/Lefkosia 2234 Cyprus C 76/29 C 76/30
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Cyprus CDL Pharmaceutical Products Ltd ambroxol hydrochloride Hyvotex 30 mg/5 ml syrup oral use 12 Agiou Spiridonos Street EN Aradippou/Larnaca 7102 Cyprus
Cyprus Medochemie Ltd ambroxol hydrochloride Medovent 30 mg tablet oral use 1-10 Constantinoupoleos Street P.O. BOX 51409 3505 Lemesos Cyprus Off icial
Cyprus Medochemie Ltd ambroxol hydrochloride Medovent elixir 15 mg/5 ml syrup oral use Jour 1-10 Constantinoupoleos Street P.O. BOX 51409 nal
3505 Lemesos of
Cyprus the European Cyprus Mundipharma Pharmaceuticals Ltd ambroxol hydrochloride Mucobroxol 15 mg/5 ml syrup oral use 13 Othellos Street Dhali Industrial Zone Uni 1685 Lefkosia on Cyprus
Cyprus Boehringer Ingelheim Ellas AE ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use Ellinikou 2 Street 16777 Athens Greece
Cyprus Boehringer Ingelheim Ellas AE Ellinikou 2 ambroxol hydrochloride Mucosolvan oral Gum 15 mg oral gum oral use Street 16777 Athens
Greece 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Cyprus Boehringer Ingelheim Ellas AE Ellinikou 2 ambroxol hydrochloride Mucosolvan 30 mg tablet oral use Street EN 16777 Athens Greece
Cyprus Boehringer Ingelheim Ellas AE ambroxol hydrochloride Mucosolvan 15 mg/5 ml syrup oral use Ellinikou 2 Street 16777 Athens Greece Off icial
Cyprus Boehringer Ingelheim Ellas AE ambroxol hydrochloride Mucosolvan 75 mg prolonged-re- oral use Jour Ellinikou 2 Street lease tablet 16777 nal
Athens of
Greece the European Cyprus Boehringer Ingelheim Ellas AE ambroxol hydrochloride Mucosolvan 7,5 mg/ml solution for in- intramuscular Ellinikou 2 Street jection use, intravenous 16777 use Uni Athens Greece on
Cyprus Boehringer Ingelheim Ellas AE ambroxol hydrochloride Lysopadol 20 mg lozenge oral use Ellinikou 2 Street 16777 Athens Greece
Cyprus REMEDICA LTD bromhexine hydrochlor- Flecoxin Elixir 4 mg syrup oral use Aharnon street ide P.O. Box 51706 3508 Lemesos Cyprus C 76/31 C 76/32
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Cyprus REMEDICA LTD bromhexine hydrochlor- Flecoxin 4 mg tablet oral use EN Aharnon street ide P.O. Box 51706 3508 Lemesos Cyprus
Cyprus REMEDICA LTD bromhexine hydrochlor- Flecoxin 8 mg tablet oral use Aharnon street ide
P.O. Box 51706 Off
3508 icial Lemesos
Cyprus Jour nal
Czech Republic WALMARK, a.s. ambroxol hydrochloride Ambex 60 mg effervescent ta- oral use of Oldřichovice 44 blet the
739 61 Třinec European Czech Republic
Czech Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 7,5 mg/ml solution for in- intravenous use, Uni
Graf Arco Strasse 3 jection intramuscular on 89079 Ulm use, subcutaneous Germany use
Czech Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 15 mg/5 ml 3 mg/ml syrup oral use Graf Arco Strasse 3 89079 Ulm Germany
Czech Republic Teva Pharmaceuticals CR, s.r.o. ambroxol hydrochloride Ambrobene 3 mg/ml 3 mg/ml oral solution oral use Radlická 3185/1c 150 00 Prague 5
Czech Republic 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 30 mg 30 mg tablet oral use EN Graf Arco Strasse 3 89079 Ulm Germany
Czech Republic Teva Pharmaceuticals CR, s.r.o. ambroxol hydrochloride Ambrobene 6 mg/ml 6 mg/ml oral solution oral use Radlická 3185/1c 150 00 Prague 5 Czech Republic Off
Czech Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 7,5 mg/ml 7,5 mg/ml oral solution oral use icial Graf Arco Strasse 3 89079 Ulm Jour
Germany nal of
Czech Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 75 mg 75 mg prolonged-re- oral use the
Graf Arco Strasse 3 lease capsule, European 89079 Ulm hard Germany Uni
Czech Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan 15 mg 15 mg tablet oral use on Telčská 1 140 00 Prague 4 Czech Republic
Czech Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan 15 mg/5 ml Sirup 3 mg/ml syrup oral use Telčská 1 140 00 Prague 4 Czech Republic
Czech Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan 30 mg 30 mg tablet oral use Telčská 1 140 00 Prague 4 Czech Republic C 76/33 C 76/34
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan 60 mg 60 mg tablet oral use Telčská 1 EN 140 00 Prague 4 Czech Republic
Czech Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan kapky 7,5 mg/ml oral drops, solu- oral use Telčská 1 tion 140 00 Prague 4 Czech Republic Off
Czech Republic CYATHUS Exquirere Pharmaforschungs ambroxol hydrochloride Ambrospray 5 % 50 mg/ml oromucosal oromucosal use icial GmbH spray Rudolfsplatz 2/8 Jour 1010 Wien nal Austria of the Czech Republic Aliud Pharma GmbH ambroxol hydrochloride Ambroxol Al 30 30 mg tablet oral use Gottlieb-Daimler-Strasse 19 European 89150 Laichingen Germany Uni
Czech Republic Aliud Pharma GmbH ambroxol hydrochloride Ambroxol Al 75 Retard 75 mg prolonged-re- oral use on Gottlieb-Daimler-Strasse 19 lease capsule, 89150 Laichingen hard Germany
Czech Republic Aliud Pharma GmbH ambroxol hydrochloride Ambroxol Al kapky 7,5 mg/ml oral drops, solu- oral use Gottlieb-Daimler-Strasse 19 tion 89150 Laichingen Germany
Czech Republic BERLIN-CHEMIE AG ambroxol hydrochloride Ambroxol Berlin-Chemie 30 mg/5 ml 6 mg/ml oral solution oral use Glienicker Weg 125 perorální roztok 12489 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 15 mg/5 ml perorální roztok 3 mg/ml oral solution oral use Glienicker Weg 125 EN 12489 Berlin Germany
Czech Republic BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed effervescent tablet 60 mg 60 mg effervescent ta- oral use Glienicker Weg 125 blet 12489 Berlin Germany Off Czech Republic BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed Forte 30 mg/5 ml 6 mg/ml oral solution oral use Glienicker Weg 125 icial
12489 Berlin Jour Germany nal
Czech Republic BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed tablety 30 mg tablet oral use of Glienicker Weg 125 the
12489 Berlin European Germany
Czech Republic Egis Pharmaceuticals PLC ambroxol hydrochloride Halixol 30 mg 30 mg tablet oral use Uni Keresztúri út. 30-38 1106 Budapest on Hungary
Czech Republic Zentiva, k.s. ambroxol hydrochloride Mucosin s medem sir 3 mg/ml syrup oral use U kabelovny 130 Dolni Mėcholupy 102 37 Prague 10 Czech Republic
Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan 7,5 mg/ml oral drops, solu- oral use, GmbH tion inhalation use Binger Strasse 173 /inhalation solu- 55216 Ingelheim am Rhein tion Germany C 76/35 C 76/36
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan 30 mg tablet oral use EN GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan 15 mg pastille oromucosal use GmbH Binger Strasse 173
55216 Ingelheim am Rhein Off Germany icial Jour Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan Junior 3 mg/ml syrup oral use GmbH nal
Binger Strasse 173 of
55216 Ingelheim am Rhein the Germany European
Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan Long Effect 75 mg prolonged-re- oral use
GmbH lease capsule, Uni Binger Strasse 173 hard 55216 Ingelheim am Rhein on Germany
Czech Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan pro dospělé 6 mg/ml syrup oral use GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Czech Republic Divapharma GmbH ambroxol hydrochloride Neo-Bronchol 15 mg lozenge oromucosal use Motzener Str. 41 12277 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic Krka, d.d., Novo mesto ambroxol hydrochloride Solvolan 3 mg/ml syrup oral use EN Šmarješka cesta 6 8501 Novo mesto Slovenia
Czech Republic BERLIN-CHEMIE AG bromhexine hydrochlor- Bromhexin 12 BC 12 mg/ml oral drops, solu- oral use Glienicker Weg 125 ide tion 12489 Berlin Germany Off
Czech Republic Krewel Meuselbach GmbH bromhexine hydrochlor- Bromhexin 12 KM-kapky 12 mg/ml oral drops, solu- oral use icial Krewelstrasse 2 ide tion 53783 Eitorf Jour
Germany nal of
Czech Republic BERLIN-CHEMIE AG bromhexine hydrochlor- Bromhexin 8 Berlin-Chemie 8 mg coated tablet oral use the
Glienicker Weg 125 ide European 12489 Berlin Germany Uni
Czech Republic Krewel Meuselbach GmbH bromhexine hydrochlor- Bromhexin 8 KM kapky 8 mg/ml oral drops, solu- oral use on Krewelstrasse 2 ide tion 53783 Eitorf Germany
Czech Republic Krewel Meuselbach GmbH bromhexine hydrochlor- Bromhexin 8-sirup KM 0,8 mg/ml syrup oral use Krewelstrasse 2 ide 53783 Eitorf Germany
Czech Republic GALMED a.s. bromhexine hydrochlor- Bromhexin Galmed 12 12 mg/ml oral drops, solu- oral use Těšínská 1349/296 ide tion 716 00 Ostrava — Radvanice Czech Republic C 76/37 C 76/38
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Czech Republic GALMED a.s. bromhexine hydrochlor- Bromhexin Galmed 8 8 mg/ml oral drops, solu- oral use EN Těšínská 1349/296 ide tion 716 00 Ostrava — Radvanice Czech Republic
Czech Republic Egis Pharmaceuticals PLC bromhexine hydrochlor- Bromhexin-Egis 2 mg/ml oral solution oral use Keresztúri út. 30-38 ide 1106 Budapest Hungary Off
Czech Republic Egis Pharmaceuticals PLC bromhexine hydrochlor- Paxirasol 2 mg/ml solution for in- intravenous use, icial Keresztúri út. 30-38 ide jection intramuscular 1106 Budapest use, subcutaneous Jour
Hungary use nal of
Denmark Berlin-Chemie AG ambroxol hydrochloride Flavamed 60 mg effervescent ta- oral use the
Glienicker Weg 125 blet European 12489 Berlin Germany Uni
Denmark Berlin-Chemie AG ambroxol hydrochloride Flavamed 6 mg/ml oral solution oral use on Glienicker Weg 125 12489 Berlin Germany
Denmark Boehringer Ingelheim Int. GmbH ambroxol hydrochloride Mucoangin 20 mg compressed lo- oral use Binger Strasse 173 zenge 55216 Ingelheim am Rhein Germany
Denmark Boehringer Ingelheim Int. GmbH ambroxol hydrochloride Mucoangin 2,5 mg/dose oromucosal oral use Binger Strasse 173 spray, solution 55216 Ingelheim am Rhein
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Denmark Boehringer Ingelheim Int. GmbH ambroxol hydrochloride Mucoangin Citron 20 mg compressed lo- oral use EN Binger Strasse 173 zenge 55216 Ingelheim am Rhein Germany
Denmark Boehringer Ingelheim Int. GmbH ambroxol hydrochloride Mucoangin Cassis 20 mg compressed lo- oral use Binger Strasse 173 zenge 55216 Ingelheim am Rhein Germany Off
Denmark Boehringer Ingelheim Int. GmbH bromhexine hydrochlor- Bisolvon 0,8 mg/ml oral solution oral use icial Binger Strasse 173 ide 55216 Ingelheim am Rhein Jour
Germany nal of
Denmark Boehringer Ingelheim Int. GmbH bromhexine hydrochlor- Bisolvon 8 mg tablet oral use the
Binger Strasse 173 ide European 55216 Ingelheim am Rhein Germany Uni
Denmark Boehringer Ingelheim Int. GmbH bromhexine hydrochlor- Bisolvon 8 mg soluble tablet oral use on Binger Strasse 173 ide 55216 Ingelheim am Rhein Germany
Denmark Takeda Pharma A/S bromhexine hydrochlor- Bromhexin ‘DAK’ 0,8 mg/ml oral solution oral use Dybendal Aile 10 ide 2630 Taastrup Denmark
Denmark Takeda Pharma A/S bromhexine hydrochlor- Bromhexin ‘DAK’ 8 mg tablet oral use Dybendal Aile 10 ide 2630 Taastrup Denmark C 76/39 C 76/40
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Estonia AS Grindeks Bromhexine Bromhexine-Grindeks 0,8 mg/ml syrup oral use Krustpils 53 EN 1057 Riga Latvia
Estonia AS Grindeks Bromhexine Bromhexine-Grindeks 8 mg tablet oral use Krustpils 53 1057 Riga Latvia Off
Estonia G.L. Pharma GmbH Ambroxol Ambrolan 30 mg tablet oral use icial Schlossplatz 1 8502 Lannach Jour Austria nal of
Estonia Sandoz d.d. Ambroxol Ambroxol Sandoz 15 mg/5 ml 3 mg/ml syrup oral use the Verovskova 57 1000 Ljubljana European Slovenia
Estonia Sandoz d.d. Ambroxol Ambroxol Sandoz 30 mg 30 mg tablet oral use Uni Verovskova 57 on 1000 Ljubljana Slovenia
Estonia PRO. MED. CS. PRAHA a.s Ambroxol Pro-Ambrosan 30 mg tablet oral use Telcska 1 14000 Praha 4 Czech Republic
Estonia BOEHRINGER INGELHEIM INTER- Ambroxol Lasolvan 3 mg/ml syrup oral use NATIONAL GmbH — Binger Strasse 173 Ingelheim/Rhein 55216
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Estonia ratiopharm GmbH Ambroxol Brontex Lahus 7,5 mg/ml oral solution oral use Graf-Arco-Strasse 3 EN 89079 Ulm Germany
Estonia ratiopharm GmbH Ambroxol Brontex Tabletid 30 mg tablet oral use Graf-Arco-Strasse 3 89079 Ulm Germany
Estonia ratiopharm GmbH Ambroxol Brontex Siirup 3 mg/ml syrup oral use Off Graf-Arco-Strasse 3 icial 89079 Ulm Germany Jour nal
Estonia DIVAPHARMA GmbH Ambroxol Neo-Bronchol 15 mg pastille oral use of
Motzener Str. 41 the 12277 Berliin Germany European
Estonia Berlin-Chemie AG Ambroxol Flavamed 30 Mg 30 mg tablet oral use (Menarini Group) Uni
Glienicker Weg 125 on 12489 Berlin Germany
Estonia Berlin-Chemie AG Ambroxol Flavamed 60 mg 60 mg effervescent ta- oral use (Menarini Group) blet Glienicker Weg 125 12489 Berlin Germany
Estonia Berlin-Chemie AG Ambroxol Flavamed Forte 6 mg/ml oral solution oral use (Menarini Group) Glienicker Weg 125 12489 Berlin Germany C 76/41 C 76/42
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Estonia Berlin-Chemie AG Ambroxol Flavamed Vaarikas 3 mg/ml oral solution oral use (Menarini Group) EN Glienicker Weg 125 12489 Berlin Germany
Finland Berlin-Chemie AG Ambroxol hydrochloride FLAVAMED 30 mg tablet oral use Glienicker Weg 125 12489 BERLIN Germany Off
Finland Berlin-Chemie AG Ambroxol hydrochloride FLAVAMED 60 mg effervescent ta- oral use icial Glienicker Weg 125 blet 12489 BERLIN Jour
Germany nal of
Finland Berlin-Chemie AG Ambroxol hydrochloride FLAVAMED 6 mg/ml oral solution oral use the Glienicker Weg 125 12489 BERLIN European Germany
Finland Berlin-Chemie AG Ambroxol hydrochloride FLAVAMED 3 mg/ml oral solution oral use Uni
Glienicker Weg 125 on 12489 BERLIN Germany
Finland Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON 0,8 mg/ml oral solution oral use GmbH ide Binger Strasse 173 P.O. BOX 200 55216 Ingelheim Am Rhein Germany
Finland Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON 8 mg tablet oral use GmbH ide Binger Strasse 173 P.O. BOX 200 55216 Ingelheim Am Rhein Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Finland Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON 8 mg soluble tablet oral use EN GmbH ide Binger Strasse 173 P.O. BOX 200 55216 Ingelheim Am Rhein Germany
Finland Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON 8 mg oral solution, sa- oral use GmbH ide chet Binger Strasse 173 P.O. BOX 200 Off 55216 Ingelheim Am Rhein Germany icial
Finland Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON STRONG 1,6 mg/ml oral solution oral use Jour
GmbH ide nal Binger Strasse 173 P.O. BOX 200 of 55216 Ingelheim Am Rhein Germany the European
Finland Orion Oyj bromhexine hydrochlor- MEDIPEKT 0,8 mg/ml oral solution oral use Orionintie 1 ide PL 65 Uni
02101 ESPOO on Finland
Finland Orion Oyj bromhexine hydrochlor- MEDIPEKT 8 mg tablet oral use Orionintie 1 ide PL 65 02101 ESPOO Finland
Finland Oy Leiras Takeda bromhexine hydrochlor- MUCOVIN 0,8 mg/ml oral solution oral use Paciuksenkatu 21 ide PL 1406 00101 HELSINKI Finland C 76/43 C 76/44
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
France Laboratoires de l'AEROCID ambroxol (chlorhydrate AMBROXOL AEROCID 0,6 %, solution 0,6 g per 100 ml of oral solution oral use EN 248 bis, rue Gabriel Péri d') buvable solution B.P. 126 94232 Cachan Cedex France
France ARROW GENERIQUES ambroxol (chlorhydrate AMBROXOL ARROW 0,6 %, solution 0,6 g per 100 ml of oral solution oral use 26, avenue Tony Garnier d') buvable solution 69007 Lyon Off France icial Jour France ARROW GENERIQUES ambroxol (chlorhydrate AMBROXOL ARROW 30 mg, comprimé 30 mg tablet oral use nal 26, avenue Tony Garnier d') 69007 Lyon of France the European
France BIOGARAN ambroxol (chlorhydrate AMBROXOL BIOGARAN CONSEIL 0,6 % 0,6 g per 100 ml of oral solution oral use 15, boulevard Charles de Gaulle d') SANS SUCRE, solution buvable édulcorée solution 92700 Colombes au sorbitol Uni France on
France BIOGARAN ambroxol (chlorhydrate AMBROXOL BIOGARAN CONSEIL 30 mg tablet oral use 15, boulevard Charles de Gaulle d') 30 mg, comprimé sécable 92700 Colombes France
France EG LABO — Laboratoires EuroGenerics ambroxol (chlorhydrate AMBROXOL EG 0,3 POUR CENT SANS 0,3 g per 100 ml of oral solution oral use ‘Le Quintet’ — bâtiment A d') SUCRE, solution buvable édulcorée au solution 12, rue Danjou cyclamate de sodium et au sorbitol 92517 Boulogne Billancourt Cedex
France 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
France EG LABO — Laboratoires EuroGenerics ambroxol (chlorhydrate AMBROXOL EG 0,6 %, solution buvable 0,6 g per 100 ml of oral solution oral use EN ‘Le Quintet’ — bâtiment A d') solution 12, rue Danjou 92517 Boulogne Billancourt Cedex France
France EG LABO — Laboratoires EuroGenerics ambroxol (chlorhydrate AMBROXOL EG 30 mg, comprimé séc- 30 mg tablet oral use ‘Le Quintet’ — bâtiment A d') able 12, rue Danjou Off 92517 Boulogne Billancourt Cedex France icial Jour nal France MYLAN SAS ambroxol (chlorhydrate AMBROXOL MYLAN 0,6 %, solution 0,6 g per 100 ml of oral solution oral use 117, allée des Parcs d') buvable solution of 69800 Saint-Priest the
France European
France MYLAN SAS ambroxol (chlorhydrate AMBROXOL MYLAN 30 mg, comprimé 30 mg tablet oral use 117, allée des Parcs d') Uni 69800 Saint-Priest on France
France SANDOZ ambroxol (chlorhydrate AMBROXOL SANDOZ CONSEIL 0,6 % 0,6 g per 100 ml of oral solution oral use 49, avenue Georges Pompidou d') SANS SUCRE, solution buvable édulcorée solution 92300 Levallois-Perret à la saccharine sodique France
France TEVA SANTE ambroxol (chlorhydrate AMBROXOL TEVA CONSEIL 0,3 %, solu- 0,3 g per 100 ml of oral solution oral use 110, Esplanade du Général de Gaulle d') tion buvable solution 92931 Paris La Défense Cedex France C 76/45 C 76/46
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
France TEVA SANTE ambroxol (chlorhydrate AMBROXOL TEVA CONSEIL 0,6 %, solu- 0,6 g per 100 ml of oral solution oral use EN 110, Esplanade du Général de Gaulle d') tion buvable solution 92931 Paris La Défense Cedex France
France TEVA SANTE ambroxol (chlorhydrate AMBROXOL TEVA CONSEIL 30 mg, 30 mg tablet oral use 110, Esplanade du Général de Gaulle d') comprimé 92931 Paris La Défense Cedex
France Off icial Jour France TEVA SANTE ambroxol (chlorhydrate VICKS EXPECTORANT AMBROXOL 0,6 g per 100 ml of oral solution oral use 110, Esplanade du Général de Gaulle d') 0,6 %, solution buvable solution nal
92931 Paris La Défense Cedex of
France the European
France TEVA SANTE ambroxol (chlorhydrate VICKS EXPECTORANT AMBROXOL 30 mg tablet oral use
110, Esplanade du Général de Gaulle d') 30 mg, comprimé sécable Uni 92931 Paris La Défense Cedex France on
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate LYSOPAÏNE MAUX DE GORGE AM- 20 mg lozenge oromucosal use 14, rue Jean Antoine de Baïf d') BROXOL CASSIS 20 mg SANS SUCRE, 75013 Paris pastille édulcorée au sorbitol et au France sucralose
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate LYSOPAÏNE MAUX DE GORGE AM- 20 mg lozenge oromucosal use 14, rue Jean Antoine de Baïf d') BROXOL CITRON 20 mg SANS SUCRE, 75013 Paris pastille édulcorée au sorbitol et au France sucralose 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate LYSOPAÏNE MAUX DE GORGE AM- 20 mg lozenge oromucosal use EN 14, rue Jean Antoine de Baïf d') BROXOL MENTHE 20 mg SANS SUCRE, 75013 Paris pastille édulcorée au sorbitol et au France sucralose
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate SURBRONC 60 mg, comprimé enrobé 60 mg tablet oral use 14, rue Jean Antoine de Baïf d') sécable 75013 Paris France Off
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate SURBRONC 60 mg, granulés pour solu- 60 mg granules for oral oral use icial 14, rue Jean Antoine de Baïf d') tion buvable en sachet solution 75013 Paris Jour
France nal of
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate SURBRONC EXPECTORANT AMBROX- 30 mg tablet oral use the
14, rue Jean Antoine de Baïf d') OL 30 mg, comprimé sécable European 75013 Paris France Uni
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate SURBRONC EXPECTORANT AMBROX- 0,600 g per 100 ml oral solution oral use on 14, rue Jean Antoine de Baïf d') OL SANS SUCRE, solution buvable édul- of solution 75013 Paris corée à l'acésulfame potassique et au France sorbitol
France BOEHRINGER INGELHEIM FRANCE ambroxol (chlorhydrate SURBRONC L.P. 75 mg, gélule à libéra- 75 mg hard capsule, oral use 14, rue Jean Antoine de Baïf d') tion prolongée prolonged relase 75013 Paris France
France BIOCODEX ambroxol (chlorhydrate MUXOL 30 mg, comprimé 30 mg tablet oral use 7, avenue Gallieni d') 94250 Gentilly France C 76/47 C 76/48
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
France BIOCODEX ambroxol (chlorhydrate MUXOL, solution buvable 0,3 g per 100 ml of oral solution oral use EN 7, avenue Gallieni d') solution 94250 Gentilly France
France CHRIS PHARMAZEUTISCHE HANDELS- ambroxol (chlorhydrate MUXOL 60 mg, comprimé effervescent 60 mg effervescent ta- oral use GESELLSCHAFT mbH d') blet Weg im Esterholz 6 82064 Strasslach Off Germany icial Jour France RECKITT BENCKISER HEALTHCARE ambroxol (chlorhydrate STREPSILS EXPECTORANT 30 mg/5 ml 30 mg per 5 ml of syrup oral use nal France d') ADULTES, sirop syrup 15, rue Ampère of 91748 Massy Cedex the
France European
France BOEHRINGER INGELHEIM FRANCE bromhexine (chlorhy- BISOLVON 0,2 POUR CENT, solution 200 mg per 100 ml oral solution oral use 14, rue Jean Antoine de Baïf drate de) buvable of solution Uni 75013 Paris on France
France BOEHRINGER INGELHEIM FRANCE bromhexine (chlorhy- BISOLVON 8 mg, comprimé 8 mg per tablet tablet oral use 14, rue Jean Antoine de Baïf drate de) 75013 Paris France
France BOEHRINGER INGELHEIM FRANCE bromhexine (chlorhy- BISOLVOMYCINE, comprimé enrobé 4 mg per tablet tablet oral use 14, rue Jean Antoine de Baïf drate de); tétracycline 75013 Paris (chlorhydrate de)
France 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany 1 A Pharma Ambroxol hydrochloride Ambroxol 15 Saft — 1A Pharma 0,3 g oral solution oral use EN Keltenring 1 + 3 82041 Oberhaching Germany
Germany 1 A Pharma Ambroxol hydrochloride Ambroxol 30 Saft — 1A Pharma 6 mg oral solution oral use Keltenring 1 + 3 82041 Oberhaching Germany Off
Germany 1 A Pharma Ambroxol hydrochloride Ambroxol 30 Tab — 1A Pharma 30 mg tablet oral use icial Keltenring 1 + 3 82041 Oberhaching Jour
Germany nal of
Germany 1 A Pharma Ambroxol hydrochloride Ambroxol 30 Tropfen — 1A Pharma 15 mg oral drops, solu- oral use the
Keltenring 1 + 3 tion European 82041 Oberhaching Germany Uni
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambro-AbZ 3 mg/ml Lösung zum Ein- 3 mg oral solution oral use on Graf-Arco-Str. 3 nehmen 89079 Ulm Germany
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambroxol AbZ Hustensaft 15 mg/5 ml 15 mg/5 ml oral solution oral use Graf-Arco-Str. 3 Lösung zum Einnehmen 89079 Ulm Germany
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambroxol-CT Tropfen 7,5 mg oral drops, solu- oral use Graf-Arco-Str. 3 tion 89079 Ulm Germany C 76/49 C 76/50
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany AbZ Pharma GmbH Ambroxol hydrochlor- Doxy comp.-CT 100 mg/75 mg Retard- 75 mg, 115,4 mg prolonged-re- oral use EN Graf-Arco-Str. 3 ide, Doxycycline hyca- kapseln lease capsule, 89079 Ulm late hard Germany
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambro-AbZ 6 mg/ml Lösung zum Ein- 6 mg/ml oral solution oral use Graf-Arco-Str. 3 nehmen 89079 Ulm Germany Off
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambro-CT 3 mg/ml Lösung zum Ein- 3 mg/ml oral solution oral use icial Graf-Arco-Str. 3 nehmen 89079 Ulm Jour
Germany nal of
Germany AbZ Pharma GmbH Ambroxol hydrochloride Ambroxol AbZ 75 mg Retardkapseln 75 mg prolonged-re- oral use the
Graf-Arco-Str. 3 lease capsule, European 89079 Ulm hard Germany Uni
Germany acis Arzneimittel GmbH Ambroxol hydrochloride Ambroxol acis Tropfen 7,5 mg oral solution oral use on Lil-Dagover-Ring 7 82031 Grünwald Germany
Germany acis Arzneimittel GmbH Ambroxol hydrochloride Ambroxol acis 60 mg Brausetabletten 60 mg effervescent ta- oral use Lil-Dagover-Ring 7 blet 82031 Grünwald Germany
Germany acis Arzneimittel GmbH Ambroxol hydrochloride Ambroxol acis Saft 15 mg oral solution oral use Lil-Dagover-Ring 7 82031 Grünwald
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany acis Arzneimittel GmbH Ambroxol hydrochloride Ambroxol acis 30 mg Trinktabletten 30 mg soluble tablet oral use EN Lil-Dagover-Ring 7 82031 Grünwald Germany
Germany Aliud Pharma GmbH Ambroxol hydrochloride Ambroxol AL 30 30 mg tablet oral use Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Off
Germany Aliud Pharma GmbH Ambroxol hydrochlor- Ambroxol AL comp 75 mg, 115,4 mg prolonged-re- oral use icial Gottlieb-Daimler-Str. 19 ide, Doxycycline hyca- lease capsule, 89150 Laichingen late hard Jour
Germany nal of
Germany Aliud Pharma GmbH Ambroxol hydrochloride Ambroxol AL Saft 15 mg oral solution oral use the
Gottlieb-Daimler-Str. 19 European 89150 Laichingen Germany Uni
Germany Aliud Pharma GmbH Ambroxol hydrochloride Ambroxol AL 75 retard 75 mg prolonged-re- oral use on Gottlieb-Daimler-Str. 19 lease capsule, 89150 Laichingen hard Germany
Germany Aliud Pharma GmbH Ambroxol hydrochloride Ambroxol AL Tropfen 7,5 mg oral drops, solu- oral use Gottlieb-Daimler-Str. 19 tion 89150 Laichingen Germany
Germany Aliud Pharma GmbH Ambroxol hydrochloride Ambroxol AL 60 mg Brausetabletten 60 mg effervescent ta- oral use Gottlieb-Daimler-Str. 19 blet 89150 Laichingen Germany C 76/51 C 76/52
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Aristo Pharma GmbH Ambroxol hydrochloride Ambroxol Aristo Hustentropfen 15 mg/ 15 mg oral solution oral use EN Wallenroder Str. 8-10 ml 13435 Berlin Germany
Germany Aristo Pharma GmbH Ambroxol hydrochloride Ambroxol Aristo Hustentropfen für Kin- 7,5 mg oral solution oral use Wallenroder Str. 8-10 der 7,5 mg/ml 13435 Berlin Germany Off
Germany Aristo Pharma GmbH Ambroxol hydrochlor- Doxam 100 mg/75 mg Hartkapsel re- 75 mg, 115,4 mg prolonged-re- oral use icial Wallenroder Str. 8-10 ide, Doxycycline hyca- tardiert lease capsule, 13435 Berlin late hard Jour
Germany nal of
Germany Aristo Pharma GmbH Ambroxol hydrochloride Ambroxol Aristo Hustensaft 30 mg/5 ml 30 mg/5 ml oral solution oral use the
Wallenroder Str. 8-10 European 13435 Berlin Germany Uni
Germany axcount Generika GmbH Ambroxol hydrochloride Ambroxol axcount Saft 15 mg oral solution oral use on Max-Planck. Str. 36 b 61381 Friedrichsdorf Germany
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed Hustensaft 30 mg/5 ml Lösung 30 mg/5 ml oral solution oral use Glienicker Weg 125 zum Einnehmen 12489 Berlin Germany
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed Hustenlöser 30 mg/5 ml Lö- 30 mg/5 ml oral solution oral use Glienicker Weg 125 sung zum Einnehmen 12489 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Berlin-Chemie AG Bromhexine hydrochlor- BROMHEXIN 12 BC 12 mg oral drops, solu- oral use EN Glienicker Weg 125 ide tion 12489 Berlin Germany
Germany Berlin-Chemie AG Bromhexine hydrochlor- BROMHEXIN 4 BC 4 mg oral solution oral use Glienicker Weg 125 ide 12489 Berlin Germany Off
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed Hustensaft 15 mg oral solution oral use icial Glienicker Weg 125 12489 Berlin Jour
Germany nal of
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed Hustentabletten 30 mg tablet oral use the
Glienicker Weg 125 European 12489 Berlin Germany Uni
Germany Berlin-Chemie AG Bromhexine hydrochlor- BROMHEXIN 8 Berlin-Chemie 8 mg coated tablet oral use on Glienicker Weg 125 ide 12489 Berlin Germany
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed Hustensaft 15 mg/5 ml Lösung 15 mg oral solution oral use Glienicker Weg 125 zum Einnehmen 12489 Berlin Germany
Germany Berlin-Chemie AG Ambroxol hydrochloride Flavamed 60 mg Brausetabletten 60 mg effervescent ta- oral use Glienicker Weg 125 blet 12489 Berlin Germany C 76/53 C 76/54
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany betapharm Arzneimittel GmbH Ambroxol hydrochloride Ambrobeta 30 30 mg effervescent ta- oral use EN Kobelweg 95 blet 86156 Augsburg Germany
Germany betapharm Arzneimittel GmbH Ambroxol hydrochloride Ambrobeta Saft 3 mg oral solution oral use Kobelweg 95 86156 Augsburg Germany Off icial Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Filmtabletten 60 mg 60 mg film-coated ta- oral use Co. KG blet Jour
Binger Str. 173 nal 55216 Ingelheim Germany of the European Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Retardkapseln 75 mg 75 mg prolonged-re- oral use Co. KG lease capsule, Binger Str. 173 hard 55216 Ingelheim Uni
Germany on
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochlor- Spasmo-Mucosolvan Saft 7,5 mg, 0,005 mg oral solution oral use Co. KG ide, Clenbuterol hydro- Binger Str. 173 chloride 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucoangin gegen Halsschmerzen 20 mg 20 mg pastille oromucosal use Co. KG Pastillen Binger Str. 173 55216 Ingelheim
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucoangin gegen Halsschmerzen Zitrone 20 mg lozenge oromucosal use EN Co. KG 20 mg Lutschtabletten Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucoangin gegen Halsschmerzen Minze 20 mg lozenge oromucosal use Co. KG Off Binger Str. 173 55216 Ingelheim icial
Germany Jour nal of
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Hustensaft 30 mg/5 ml 30 mg/5 ml oral solution oral use the Co. KG Binger Str. 173 European 55216 Ingelheim Germany Uni on
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Inhalationslösung 15 mg/ 15 mg/2 ml nebuliser solu- inhalation use Co. KG 2 ml tion Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Tabletten 30 mg 30 mg tablet oral use Co. KG Binger Str. 173 55216 Ingelheim Germany C 76/55 C 76/56
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Infusionslösungskonzentrat 1 mg concentrate for intravenous use EN Co. KG solution for in- Binger Str. 173 fusion 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Brausetabletten 60 mg 60 mg effervescent ta- oral use Co. KG blet Off Binger Str. 173 55216 Ingelheim icial
Germany Jour nal of
Germany Boehringer Ingelheim Pharma GmbH & Bromhexine hydrochlor- Bisolvon Hustentropfen 2 mg oral drops, solu- oral use the Co. KG ide tion Binger Str. 173 European 55216 Ingelheim Germany Uni on
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Kindersaft 30 mg/5 ml 30 mg/5 ml oral solution oral use Co. KG Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Tropfen 30 mg/2 ml 30 mg/2 ml oral drops, solu- oral use Co. KG tion Binger Str. 173 55216 Ingelheim Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Tropfen 30 mg/2 ml 30 mg/2 ml oral drops, solu- oral use EN Co. KG tion Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Injektionslösung 15 mg solution for in- intravenous use, Co. KG jection intramuscular Off Binger Str. 173 use, subcutaneous 55216 Ingelheim use icial
Germany Jour nal of
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucoangin gegen Halsschmerzen Wald- 20 mg lozenge oromucosal use the Co. KG beere Binger Str. 173 European 55216 Ingelheim Germany Uni on
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Lutschpastillen 15 mg 15 mg pastille oromucosal use Co. KG Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Ambroxol 60 mg 60 mg granules for oral oral use Co. KG solution Binger Str. 173 55216 Ingelheim Germany C 76/57 C 76/58
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Boehringer Ingelheim Pharma GmbH & Bromhexine hydrochlor- Bisolvon-Linctus Hustensaft 0,08 g/100 ml oral solution oral use EN Co. KG ide Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Bromhexine hydrochlor- Bisolvon Hustentabletten 8 mg tablet oral use Co. KG ide Off Binger Str. 173 55216 Ingelheim icial
Germany Jour nal of
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Kindersaft 15 mg/5 ml 15 mg oral solution oral use the Co. KG Binger Str. 173 European 55216 Ingelheim Germany Uni on
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan Portionsbeutel 30 mg/5 ml 30 mg oral solution oral use Co. KG Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Ambroxol Portionsbeutel 30 mg/5 mg 30 mg oral solution oral use Co. KG Binger Str. 173 55216 Ingelheim Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Mucosolvan 60 mg 60 mg granules for oral oral use EN Co. KG solution Binger Str. 173 55216 Ingelheim Germany
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochloride Bisolaryn gegen Halzschmerzen 20 mg 20 mg pastille oromucosal use Co. KG Pastillen Off Binger Str. 173 55216 Ingelheim icial
Germany Jour nal of
Germany Boehringer Ingelheim Pharma GmbH & Ambroxol hydrochlor- Spasmo-Mucosolvan 30 mg, 0,02 mg tablet oral use the Co. KG ide, Clenbuterol hydro- Binger Str. 173 chloride European 55216 Ingelheim Germany Uni on
Germany Boehringer Ingelheim Pharma GmbH & Bromhexine hydrochlor- Bisolvon Hustensaft 8 mg oral solution oral use Co. KG ide Binger Str. 173 55216 Ingelheim Germany
Germany Cyathus Exquirere Pharma- Ambroxol hydrochloride Ambroxolhydrochloride Cyathus 10 mg/ 10 mg oral solution oral use forschungsGmbH Sprühstoß Lösung zum Einnehmen Rudolfplatz 2/1/8 1010 Wien Austria C 76/59 C 76/60
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Cyathus Exquirere Pharma- Ambroxol hydrochloride Mukambro 10 mg/Sprühstoß Lösung 10 mg oral solution oral use EN forschungsGmbH zum Einnehmen Rudolfplatz 2/1/8 1010 Wien Austria
Germany Denk Pharma GmbH & Co. KG Ambroxol hydrochloride Ambrox-Denk 60 mg 60 mg effervescent ta- oral use Prinzregentenstr. 79 blet 81675 München Off Germany icial Jour Germany Divapharma GmbH Ambroxol hydrochloride Neo-bronchol 15 mg oral gum oral use nal Motzener Str. 41 12277 Berlin of Germany the European
Germany Docpharm Arzneimittelvertrieb GmbH & Ambroxol hydrochloride Ambroxol PB 30 mg 30 mg film-coated ta- oral use Co. KG blet Greschbachstr. 7 Uni 76229 Karlsruhe on Germany
Germany Dr. Ritsert Pharma GmbH & Co. KG Ambroxol hydrochloride Expit T Tropfen 7,5 mg oral drops, solu- oral use Klausenweg 12 tion 69412 Eberbach Germany
Germany Dr. Ritsert Pharma GmbH & Co. KG Ambroxol hydrochloride Expit Lösung 15 mg oral solution oral use Klausenweg 12 69412 Eberbach
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany esparma GmbH Ambroxol hydrochlor- Sigamuc 75 mg, 115,4 mg prolonged-re- oral use EN Seepark 7 ide, Doxycycline hyca- lease capsule, 39116 Magdeburg late hard Germany
Germany Aristo Pharma GmbH Ambroxol hydrochloride Ambroxin-Tropfen 7,5 mg oral drops, solu- oral use Wallenroder Str. 8-10 tion 13435 Berlin
Germany Off icial Jour Germany Hemopharm GmbH Ambroxol hydrochloride Ambro-Hemopharm Hustensaft 15 mg prolonged-re- oral use Königsteiner Str. 2 lease capsule, nal
61350 Bad Homburg v.d.H. hard of
Germany the European
Germany Hermes Arzneimittel GmbH Ambroxol hydrochloride Ambroxo Brause 1 Hermes 30 mg effervescent ta- oral use
Georg-Kalb-Str. 5-8 blet Uni 82049 Großhesselohe Germany on
Germany Hermes Arzneimittel GmbH Ambroxol hydrochloride Ambroxo Hermes 60 mg 60 mg effervescent ta- oral use Georg-Kalb-Str. 5-8 blet 82049 Großhesselohe Germany
Germany Hermes Arzneimittel GmbH Ambroxol hydrochloride Ambroxol Brause 60 60 mg effervescent ta- oral use Georg-Kalb-Str. 5-8 blet 82049 Großhesselohe Germany C 76/61 C 76/62
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Heumann Pharma GmbH&Co. KG Gen- Ambroxol hydrochloride Ambroxol Heumann Saft 3 mg oral solution oral use EN erica KG Südwestpark 50 90449 Nürnberg Germany
Germany Heumann Pharma GmbH&Co. KG Gen- Ambroxol hydrochloride Ambroxol Heumann Tropfen 7,5 mg oral drops oral use erica KG Off Südwestpark 50 90449 Nürnberg icial
Germany Jour nal of
Germany Heumann Pharma GmbH&Co. KG Gen- Ambroxol hydrochloride Ambroxol 75 retard Heumann 75 mg prolonged-re- oral use the erica KG lease capsule, Südwestpark 50 hard European 90449 Nürnberg Germany Uni on
Germany Heumann Pharma GmbH&Co. KG Gen- Ambroxol hydrochloride Ambroxol 60 Heumann Brausetabletten 60 mg effervescent ta- oral use erica KG blet Südwestpark 50 90449 Nürnberg Germany
Germany Heumann Pharma GmbH&Co. KG Gen- Ambroxol hydrochloride Ambroxol 30 Heumann 30 mg tablet oral use erica KG Südwestpark 50 90449 Nürnberg Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal injekt 15 mg solution for in- intravenous use, EN Industriestr. 25 jection intramuscular 83607 Holzkirchen use, subcutaneous Germany use
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride AmbroHEXAL Hustensaft für Kinder 3 mg oral solution oral use Industriestr. 25 83607 Holzkirchen Germany Off
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride AmbroHEXAL Hustenlöser 30 mg Table- 30 mg tablet oral use icial Industriestr. 25 tten 83607 Holzkirchen Jour
Germany nal of
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal Hustenlöser retard 75 mg 75 mg prolonged-re- oral use the
Industriestr. 25 lease capsule, European 83607 Holzkirchen hard Germany Uni
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal S Hustensaft 30 mg/5 ml 6 mg oral solution oral use on Industriestr. 25 83607 Holzkirchen Germany
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal S Hustentropfen 15 mg/ml 15 mg oral solution oral use Industriestr. 25 83607 Holzkirchen Germany
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal S Hustenlöser 60 mg Film- 60 mg film-coated ta- oral use Industriestr. 25 tabletten blet 83607 Holzkirchen Germany C 76/63 C 76/64
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Hexal Aktiengesellschaft Ambroxol hydrochloride Ambrohexal Hustenlöser Brausetabletten 60 mg effervescent ta- oral use EN Industriestr. 25 blet 83607 Holzkirchen Germany
Germany Krewel Meuselbach GmbH Ambroxol hydrochloride Ambroxol Krewel Meuselbach Tropfen 7,5 mg oral drops, solu- oral use Krewelstr. 2 7,5 mg/ml tion 53783 Eitorf Germany Off
Germany Krewel Meuselbach GmbH Bromhexine hydrochlor- Bromhexin Krewel Meuselbach Tabletten 12 mg tablet oral use icial Krewelstr. 2 ide 12 mg 53783 Eitorf Jour
Germany nal of
Germany Krewel Meuselbach GmbH Bromhexine hydrochlor- Bromhexin Krewel Meuselbach Tropfen 12 mg oral drops, solu- oral use the
Krewelstr. 2 ide 12 mg tion European 53783 Eitorf Germany Uni
Germany Krewel Meuselbach GmbH Bromhexine hydrochlor- Bromhexin Krewel Meuselbach Tropfen 8 mg oral drops, solu- oral use on Krewelstr. 2 ide 8 mg tion 53783 Eitorf Germany
Germany Krewel Meuselbach GmbH Ambroxol hydrochloride Ambroxol Krewel Meuselbach Sirup 15 mg syrup oral use Krewelstr. 2 15 mg/5 ml 53783 Eitorf Germany
Germany Krewel Meuselbach GmbH Bromhexine hydrochlor- Bromhexin Krewel Meuselbach Husten- 0,8 mg solution oral use Krewelstr. 2 ide saft 8 mg/10 ml 53783 Eitorf
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Meda Pharma GmbH&Co. KG Ambroxol hydrochloride Lindoxyl K Zäpfchen 15 mg suppository rectal use EN Benzstr. 1 61352 Bad Homburg Germany
Germany Pädia Arzneimittel Ambroxol hydrochloride Pädiamuc Saft 15 mg oral solution oral use Gruhlstr. 3 50374 Erftstadt Germany Off
Germany Pharma Stulln GmbH Ambroxol hydrochloride Ambroxol Inhalat 7,5 mg/ml nebuliser solu- inhalation use icial Werkstr. 3 tion 92551 Stulln Jour
Germany nal of
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm Hustentropfen 7,5 mg oral drops, solu- oral use the
Graf-Arco-Str. 3 tion European 89079 Ulm Germany Uni
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 15 mg/2 ml In- 15 mg solution for in- intravenous use, on Graf-Arco-Str. 3 jektionslösung jection intramuscular 89079 Ulm use, subcutaneous Germany use
Germany ratiopharm GmbH Ambroxol hydrochloride Ambro-ratiopharm 3 mg/ml Lösung zum 3 mg oral solution oral use Graf-Arco-Str. 3 Einnehmen 89079 Ulm Germany
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 75 mg Hustenlöser 75 mg prolonged-re- oral use Graf-Arco-Str. 3 lease capsule, 89079 Ulm hard Germany C 76/65 C 76/66
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 30 mg Hustenlöser 30 mg tablet oral use EN Graf-Arco-Str. 3 89079 Ulm Germany
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm Hustensaft 15 mg oral solution oral use Graf-Arco-Str. 3 89079 Ulm Germany Off
Germany ratiopharm GmbH Ambroxol hydrochloride Ambro-ratiopharm 6 mg/ml Lösung zum 6 mg oral solution oral use icial Graf-Arco-Str. 3 Einnehmen 89079 Ulm Jour
Germany nal of
Germany ratiopharm GmbH Ambroxol, Doxycycline Ambroxol comp.-ratiopharm 75 mg/ 75 mg, 115,4 mg prolonged-re- oral use the
Graf-Arco-Str. 3 100 mg Retardkapseln lease capsule, European 89079 Ulm hard Germany Uni
Germany ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 60 mg Hustenlöser 60 mg tablet oral use on Graf-Arco-Str. 3 89079 Ulm Germany
Germany RubiePharm Vertiebs GmbH Ambroxol hydrochloride AMBROinfant 15 mg oral solution oral use Sennelsbachweg 4 36396 Stainau an der Strasse Germany
Germany Sandoz Phamaceuticals GmbH Ambroxol hydrochloride Ambroxol Sandoz 7,5 mg/ml Tropfen 7,5 mg oral drops, solu- oral use Raiffeisenstr. 11 zum Einnehmen, Lösung tion 83607 Holzkirchen
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Sandoz Phamaceuticals GmbH Ambroxol hydrochloride Ambroxol Sandoz 15 mg/5 ml Lösung 15 mg oral solution oral use EN Raiffeisenstr. 11 zum Einnehmen 83607 Holzkirchen Germany
Germany Sandoz Phamaceuticals GmbH Ambroxol hydrochloride Ambroxol Sandoz 30 mg Tabletten 30 mg tablet oral use Raiffeisenstr. 11 83607 Holzkirchen Germany Off
Germany Stadapharm GmbH Ambroxol hydrochloride Ambroxol Stada Hustensaft 15 mg/5 ml, 15 mg solution oral use icial Saalstr. 2.18 Lösung zum Einnehmen 61118 Bad Vilbel Jour
Germany nal of
Germany Stadapharm GmbH Ambroxole, Doxycycline Doxy plus STADA 100 mg/75 mg Hart- 75 mg, 115,4 mg prolonged-re- oral use the
Saalstr. 2.18 hyclate kapseln, retardiert lease capsule, European 61118 Bad Vilbel hard Germany Uni
Germany TAD Pharma GmbH Ambroxol hydrochlor- Doxam 75 mg, 115,4 mg prolonged-re- oral use on Heinz-Lohmann-Str. 5 ide, Doxycycline hyclate lease capsule, 27472 Cuxhaven hard Germany
Germany Takeda GmbH Ambroxol hydrochloride Broncho-Euphyllin retard 30 mg, 350 mg prolonged-re- oral use Byk-Gulden-Str. 2 Theophylline lease capsule, 78467 Konstanz hard Germany
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol Temmler 75 mg Retardkapseln 75 mg prolonged-re- oral use Temmlerstr. 2 lease capsule, 35039 Marburg hard Germany C 76/67 C 76/68
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Axol 60 mg Brausetabletten 60 mg effervescent ta- oral use EN Temmlerstr. 2 blet 35039 Marburg Germany
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol retard Temmler 75 mg prolonged-re- oral use Temmlerstr. 2 lease capsule, 35039 Marburg hard Germany Off
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol Temmler Tropfen 7,5 mg oral drops, solu- oral use icial Temmlerstr. 2 tion 35039 Marburg Jour
Germany nal of
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol Temmler Saft 15 mg oral solution oral use the
Temmlerstr. 2 European 35039 Marburg Germany Uni
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Braxol 60 mg Brausetabletten 60 mg effervescent ta- oral use on Temmlerstr. 2 blet 35039 Marburg Germany
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol Temmler 30 mg Brausetable- 30 mg effervescent ta- oral use Temmlerstr. 2 tten blet 35039 Marburg Germany
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol 7,5 TT Temmler Trinktabletten 7,5 mg soluble tablet oral use Temmlerstr. 2 35039 Marburg
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol 15 TT Temmler Trinktabletten 15 mg soluble tablet oral use EN Temmlerstr. 2 35039 Marburg Germany
Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol 30 TT Temmler Trinktabletten 30 mg tablet oral use Temmlerstr. 2
35039 Marburg Off
Germany icial Jour nal Germany Temmler Pharma GmbH&Co. KG Ambroxol hydrochloride Ambroxol Temmler 60 mg Brausetable- 60 mg effervescent ta- oral use Temmlerstr. 2 tten blet of 35039 Marburg the
Germany European Uni Germany Wick Pharma Ambroxol hydrochloride Ambroxol WICK Schleimlöser für Kinder 15 mg oral solution oral use Zweigniederlassung 3 mg/ml Lösung zum Einnehmen on Procter & Gamble GmbH Sulzbacher Str. 40 65824 Schwalbach/Taunus Germany
Germany Wick Pharma Ambroxol hydrochloride Wick Schleimlöser 30 mg Tabletten 30 mg tablet oral use Zweigniederlassung Procter & Gamble GmbH Sulzbacher Str. 40 65824 Schwalbach/Taunus Germany C 76/69 C 76/70
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Germany Wick Pharma Ambroxol hydrochloride Wick Schleimlöser 6 mg/ml Lösung zum 6 mg oral solution oral use EN Zweigniederlassung Einnehmen Procter & Gamble GmbH Sulzbacher Str. 40 65824 Schwalbach/Taunus Germany
Germany Wick Pharma Ambroxol hydrochloride Wick Schleimlöser 30 mg Brausetabletten 30 mg effervescent ta- oral use Zweigniederlassung blet Procter & Gamble GmbH Off Sulzbacher Str. 40 icial 65824 Schwalbach/Taunus Germany Jour nal of
Germany Wick Pharma Ambroxol hydrochloride Wick Hustenlöser Therapie 30 mg effervescent ta- oral use the Zweigniederlassung blet Procter & Gamble GmbH European Sulzbacher Str. 40 65824 Schwalbach/Taunus
Germany Uni on
Germany Wick Pharma Ambroxol hydrochloride Wick Schleimlöser 75 Einmal Täglich 75 mg prolonged-re- oral use Zweigniederlassung Retardkapseln lease capsule, Procter & Gamble GmbH hard Sulzbacher Str. 40 65824 Schwalbach/Taunus Germany
Greece Adelco A.E. Chrom. Athin. Afoi Koloko- BROMHEXINE Bronchotussine 4 mg/5 ml syrup oral use troni, Peireos 37, Moschato,
Greece 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Alapis Abee, AMBROXOL HYDRO- Amboral 15 mg/5 ml syrup oral use EN Aftokratoros Nikolaou 2, CHLORIDE 11745, Athens, Greece
Greece Alapis Abee, AMBROXOL HYDRO- Amboral 30 mg/5 ml syrup oral use Aftokratoros Nikolaou 2, CHLORIDE 11745, Athens, Greece Off
Greece Angelini Pharma Hellas Anonimi Biomh- AMBROXOL HYDRO- Tussefar 15 mg/5 ml syrup oral use icial xaniki Etaireia Paragogis & Emporias CHLORIDE Farmakon, Achaias & Trizinias, 14564, N. Jour
Kiffisia, Greece nal of
Greece Angelini Pharma Hellas Anonimi Biomh- AMBROXOL HYDRO- Tussefar 30 mg/5 ml syrup oral use the
xaniki Etaireia Paragogis & Emporias CHLORIDE European Farmakon, Achaias & Trizinias, 14564, N. Kiffisia, Greece Uni
Greece Boehringer Ingelheim Ellas Αε, AMBROXOL HYDRO- Mucosolvan 75 mg prolonged-re- oral use on Ellinikou 2, CHLORIDE lease capsule 16777, Ellinikon, Greece
Greece Boehringer Ingelheim Ellas Αε, AMBROXOL HYDRO- Mucosolvan 15 mg/2 ml solution for in- intravenous use Ellinikou 2, CHLORIDE jection 16777, Ellinikon, Greece
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 30 mg/5 ml syrup oral use Ellinikou 2, CHLORIDE 16777, Ellinikon, Athens Greece C 76/71 C 76/72
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 30 mg tablet oral use EN Ellinikou 2, CHLORIDE 16777, Ellinikon, Athens Greece
Greece Boehringer Ingelheim Ellas ΑE, BROMHEXINE Bisolvon 8 mg tablet oral use Ellinikou 2, 16777, Ellinikon, Athens Greece Off
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 15 mg/2 ml solution for in- intramuscular use icial Ellinikou 2, CHLORIDE jection 16777, Ellinikon, Athens Jour
Greece nal of
Greece Boehringer Ingelheim Ellas ΑE, BROMHEXINE Bisolvon 8 mg soluble tablet oral use the
Ellinikou 2, European 16777, Ellinikon, Athens Greece Uni
Greece Boehringer Ingelheim Ellas ΑE, BROMHEXINE Bisolvon 4 mg/5 ml syrup oral use on Ellinikou 2, 16777, Ellinikon, Athens Greece
Greece Boehringer Ingelheim Ellas ΑE, BROMHEXINE Bisolvon 8 mg/5 ml syrup oral use Ellinikou 2, 16777, Ellinikon, Athens Greece
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 15 mg oral gum oral use Ellinikou 2, CHLORIDE 16777, Ellinikon, Athens
Greece 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 15 mg/2 ml solution for in- intravenous use EN Ellinikou 2, CHLORIDE jection 16777, Ellinikon, Athens Greece
Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Mucosolvan 15 mg/5 ml syrup oral use Ellinikou 2, CHLORIDE 16777, Ellinikon, Athens
Greece Off icial Jour Greece Boehringer Ingelheim Ellas ΑE, AMBROXOL HYDRO- Lysopadol 20 mg lozenge oromucosal use Ellinikou 2, CHLORIDE nal
16777, Ellinikon, Athens of
Greece the European
Greece Bros E.P.E., AMBROXOL HYDRO- Ebertuss 30 mg/5 ml syrup oral use
Aygis & Galinis 15, CHLORIDE Uni 14564, Nea Kifissia, Greece on
Greece Coup Abee, AMBROXOL HYDRO- Nibren 30 mg/5 ml syrup oral use Ag. Barbaras 53-55, CHLORIDE 17235 Dafni, Greece
Greece D.A.S.T. Biotech Φαρ/Κη Επε Δ.Τ. D.A.S.T. AMBROXOL HYDRO- Provixen-N 30 mg/5 ml syrup oral use Biotech Pharm Επε, Λαρίσσης 10, CHLORIDE 15351 Athens, Greece C 76/73 C 76/74
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. AMBROXOL HYDRO- Celibron 30 mg tablet oral use EN Marathonos 95, 19009 Pikermi, CHLORIDE Greece
Greece Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. AMBROXOL HYDRO- Celibron 30 mg/5 ml syrup oral use Marathonos 95, 19009 Pikermi, CHLORIDE Greece
Greece Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. AMBROXOL HYDRO- Celibron 15 mg/5 ml syrup oral use Off Marathonos 95, 19009 Pikermi, CHLORIDE icial Greece Jour nal
Greece Farmellas Enterprises Ltd, Cyprus, AMBROXOL HYDRO- Fluibrox 30 mg/5 ml syrup oral use of
Leof. Afxentiou 27, CHLORIDE the Acropolis Centre, Cyprus European
Greece Genepharm Ae, AMBROXOL HYDRO- Grenovix 30 mg/5 ml syrup oral use Uni
18 Km. Leof. Marathonos, CHLORIDE on 15351 Pallini, Greece
Greece Genepharm Ae, AMBROXOL HYDRO- Grenovix 30 mg tablet oral use 18 Km. Leof. Marathonos, CHLORIDE 15351 Pallini, Greece
Greece Help Αβεε, AMBROXOL HYDRO- Abrobion 30 mg tablet oral use Valaoritou 10, CHLORIDE 14452, Metamorfosi,
Greece 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Help Αβεε, AMBROXOL HYDRO- Abrobion 30 mg/5 ml syrup oral use EN Valaoritou 10, CHLORIDE 14452, Metamorfosi, Greece
Greece Help Αβεε, AMBROXOL HYDRO- Abrobion 15 mg/5 ml syrup oral use Valaoritou 10, CHLORIDE 14452, Metamorfosi, Greece Off
Greece Help Αβεε, BROMHEXINE Bron-Hal 4 mg/5 ml syrup oral use icial Valaoritou 10, 14452, Metamorfosi, Jour
Greece nal of
Greece Iasis Pharmac. Hellas Biom. & Emp F/ AMBROXOL HYDRO- Afrodor 30 mg/5 ml syrup oral use the
Kon-Chem/Kon & Kal. Pr. Abee, L. Fylis CHLORIDE European 137, 13451 Kamatero Attikis, Greece Uni on Greece Novendia Farmakeytiki Epe, Leof. Irakliou AMBROXOL HYDRO- Tevoril 30 mg/5 ml syrup oral use 425 & Olympias 28, 14122 N. Iraklio, CHLORIDE Greece
Greece Pharmaswiss Ceska Republika s.r.o., Jan- AMBROXOL HYDRO- Physiosolvan 30 mg/5 ml syrup oral use covcova 1569/2c, 1700 Praha 7, Hole- CHLORIDE sovice, Czech Republic
Greece Pharmaswiss Ceska Republika s.r.o., Jan- AMBROXOL HYDRO- Physiosolvan 15 mg/5 ml syrup oral use covcova 1569/2c, 1700 Praha 7, Hole- CHLORIDE sovice, Czech Republic C 76/75 C 76/76
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Rafarm, AMBROXOL HYDRO- Kriolen 30 mg/5 ml syrup oral use EN 12, Korinthou Str., CHLORIDE New Psychico, Athens 15451, Greece
Greece S.J.A. Pharm Farmakeytiki E.P.E AMBROXOL HYDRO- Stefolant 30 mg/5 ml syrup oral use 11 Arkoleon Str., CHLORIDE Patissia 10445, Greece Off icial Jour Greece Ανφαρμ Ellas A.E., AMBROXOL HYDRO- Aprinol 30 mg/5 ml syrup oral use Perikleous 53-57 CHLORIDE nal
Gerakas 15344, of
Greece the European
Greece Ανφαρμ Ellas A.E., AMBROXOL HYDRO- Aprinol 15 mg/5 ml syrup oral use Perikleous 53-57 CHLORIDE
Gerakas 15344, Uni Greece on
Greece Vianex A.E., AMBROXOL HYDRO- Broncolyn 30 mg/tab tablet oral use Tatoiou Street, 18th Km CHLORIDE National Road Athens-Lamia, 14571 Nea Erythrea, Greece
Greece Vianex A.E., AMBROXOL HYDRO- Broncolyn 30 mg/5 ml syrup oral use Tatoiou Street, 18th Km National Road CHLORIDE Athens-Lamia, 14571 Nea Erythrea,
Greece 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Vianex A.E., AMBROXOL HYDRO- Broncolyn 15 mg/5 ml syrup oral use Tatoiou Street, 18th Km CHLORIDE EN National Road Athens-Lamia, 14571 Nea Erythrea, Greece
Greece Exelixi Emporia Iatr. Eidon A.E., AMBROXOL HYDRO- Saribal 15 mg/5 ml syrup oral use L. Mesogeion 501, CHLORIDE 15343 Athens, Greece Off icial Greece Exelixi Emporia Iatr. Eidon A.E., AMBROXOL HYDRO- Saribal 30 mg/5 ml syrup oral use L. Mesogeion 501, CHLORIDE Jour 15343 Athens, nal Greece of the Greece Ioul. & Eir. Tseti Far/Ka Ergastiria Abee, AMBROXOL HYDRO- Bunafon 15 mg/5 ml syrup oral use Kalyftaki 27, CHLORIDE European 14561 Kifissia, Attiki, Greece Uni
Greece Ioul. & Eir. Tseti Far/Ka Ergastiria Abee, AMBROXOL HYDRO- Bunafon 30 mg/5 ml syrup oral use on Kalyftaki 27, CHLORIDE 14561 Kifissia, Attiki, Greece
Greece Ioul. & Eir. Tseti Far/Ka Ergastiria Abee, AMBROXOL HYDRO- Bunafon 15 mg granules for oral oral use Kalyftaki 27, CHLORIDE solution in sa- 14561 Kifissia, Attiki, chet Greece
Greece Ioul. & Eir. Tseti Far/Ka Ergastiria Abee, AMBROXOL HYDRO- Bunafon 30 mg granules for oral oral use Kalyftaki 27, CHLORIDE solution in sa- 14561 Kifissia, Attiki, chet Greece C 76/77 C 76/78
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Greece Koper Farmakoviomihania A.E., AMBROXOL HYDRO- Mucolin 30 mg/5 ml syrup oral use EN Aristovoulou 64, CHLORIDE 11853 Athens, Greece
Greece Koper Farmakoviomihania A.E., AMBROXOL HYDRO- Mucolin 15 mg/5 ml syrup oral use Aristovoulou 64, CHLORIDE 11853 Athens, Greece Off icial
Greece S.M. Farmakeytika Proionta Epe, AMBROXOL HYDRO- Mucovix 30 mg/5 ml syrup oral use Jour Agiou Orous 43-45, CHLORIDE nal 18545 Peireas, Atiiki, Greece of the European Greece Foinixfarm Epe, AMBROXOL HYDRO- Strubelin 30 mg/5 ml syrup oral use Dervenakion 38 & Sahini, CHLORIDE 15344, Gerakas, Greece Uni on
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROBENE 7,5 mg/ml belsőleges oldat 7,5 mg/ml oral solution oral use Pallagi út 13 Debrecen H-4042 Hungary
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROBENE 15 mg/5 ml szirup 15 mg/5 ml syrup oral use Pallagi út 13 Debrecen H-4042
Hungary 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROBENE 30 mg tabletta 30 mg tablet oral use EN Pallagi út 13 Debrecen H-4042 Hungary
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROBENE 7,5 mg/ml oldatos injekció 7,5 mg/ml solution for in- intravenous use, Pallagi út 13 jection intramuscular Off Debrecen use, subcutaneous H-4042 use icial
Hungary Jour nal of
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROXOL TEVA 6 mg/ml belsőleges 6 mg/ml oral solution oral use the Pallagi út 13 oldat Debrecen European H-4042 Hungary Uni on
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROXOL-TEVA 3 mg/ml szirup 3 mg/ml syrup oral use Pallagi út 13 Debrecen H-4042 Hungary
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROXOL-TEVA 30 mg tabletta 30 mg tablet oral use Pallagi út 13 Debrecen H-4042 Hungary C 76/79 C 76/80
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Hungary Teva Gyógyszergyár Zrt. ambroxol AMBROXOL-TEVA 75 mg retard kemény 75 mg prolonged-re- oral use EN Pallagi út 13 kapszula lease capsule, Debrecen hard H-4042 Hungary
Hungary Berlin-Chemie AG ambroxol FLAVAMED 15 mg/5 ml belsőleges oldat 15 mg/5 ml oral solution oral use
(Menarini Group) Off
Glienicker Weg 125 icial Berlin D-12489
Germany Jour nal of
Hungary Berlin-Chemie AG ambroxol FLAVAMED 30 mg tabletta 30 mg tablet oral use the
(Menarini Group) European Glienicker Weg 125 Berlin D-12489 Germany Uni on
Hungary Berlin-Chemie AG ambroxol FLAVAMED 30 mg/5 ml belsőleges oldat 30 mg/5 ml oral solution oral use (Menarini Group) Glienicker Weg 125 Berlin D-12489 Germany
Hungary EGIS Gyógyszergyár Zrt., ambroxol HALIXOL 30 mg tabletta 30 mg tablet oral use Keresztúri út 30-38. Budapest H-1106 Hungary 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Hungary EGIS Gyógyszergyár Zrt., ambroxol HALIXOL 3 mg/ml szirup 0,3 g/100 ml syrup oral use EN Keresztúri út 30-38. Budapest H-1106 Hungary
Hungary Boehringer Ingelheim International ambroxol MUCOANGIN 20 mg szopogató tabletta 20 mg lozenge oromucosal use GmbH
Binger strasse 173 Off
55216 Ingelheim am Rhein icial Germany Jour nal
Hungary Pharma-Regist Kft., ambroxol MUCOFREE 15 mg/5 ml szirup 15 mg/5 ml syrup oral use of Október 6. u. 7. the
Budapest European 1051 Hungary Uni on Hungary Pharma-Regist Kft., ambroxol MUCOFREE 30 mg/5 ml szirup 30 mg/5 ml syrup oral use Október 6. u. 7. Budapest 1051 Hungary
Hungary PannonPharma Kft. ambroxol MUKAMBRO 10 mg/adag belsőleges 10 mg/dose oromucosal oromucosal use Pannonpharma út 1. oldatos spray spray Pécsvárad H-7720 Hungary C 76/81 C 76/82
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Hungary Divapharma GmbH ambroxol NEO-BRONCHOL szopogató tabletta 15 mg lozenge oromucosal use EN Motzener Str. 41 D-12277 Berlin Germany
Hungary Meditop Gyógyszeripari Kft. bromhexine, oxymeta- NASOPAX orrspray felnőtteknek 0,12 mg/0,025 mg nasal spray, so- nasal use Ady Endre u. 1 zoline oximetazolin-klorid/ lution Pilisborosjenő dose (0,1 ml). H-2097 Off Hungary icial Jour Hungary Meditop Gyógyszeripari Kft. bromhexine, oxymeta- NASOPAX orrspray gyermekeknek 0,06 mg/0,005 mg nasal spray, so- nasal use nal Ady Endre u. 1 zoline oximetazolin-klorid/ lution Pilisborosjenő dose (0,1 ml). of H-2097 the
Hungary European
Hungary EGIS Gyógyszergyár Zrt., bromhexine PAXIRASOL 2 mg/ml belsőleges oldat 2 mg/ml oral solution oral use Keresztúri út 30-38. Uni Budapest H-1106 on Hungary
Hungary EGIS Gyógyszergyár Zrt., bromhexine PAXIRASOL 2 mg/ml oldatos injekció 2 mg/ml solution for in- intravenous use, Keresztúri út 30-38. jection intramuscular Budapest H-1106 use, subcutaneous Hungary use
Hungary EGIS Gyógyszergyár Zrt., bromhexine PAXIRASOL 8 mg tabletta 8 mg tablet oral use Keresztúri út 30-38. Budapest H-1106
Hungary 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Hungary EGIS Gyógyszergyár Zrt., bromhexine PAXIRASOL oldatos orrspray 0,2 mg/dose nasal spray, so- nasal use EN Keresztúri út 30-38. lution Budapest H-1106 Hungary
Iceland Boehringer Ingelheim International G.m. Bromhexinum INN clor- Bisolvon 8 mg tablet oral use b.H., ide Binger Strasse 173, 55216 Ingelheim am Rhein, Germany Off icial Jour Ireland Teva Pharma B.V. Ambroxol hydrochloride Ambrobene 3 mg/ml Oral Solution 3 mg/ml oral solution oral use Computerweg 10 nal
3542 DR Utrecht of
The Netherlands the European
Ireland Teva Pharma B.V. Ambroxol hydrochloride Ambrobene Extra Strength 6 mg/ml Oral 6 mg/ml oral solution oral use Computerweg 10 Solution
3542 DR Utrecht Uni The Netherlands on
Ireland Boehringer Ingelheim Limited, Ambroxol hydrochloride Lysopadol Mint 20 mg Lozenges 20 mg lozenge oral use Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom
Ireland Boehringer Ingelheim Limited Ambroxol hydrochloride Lysopadol 17,86 mg/ml Oromucosal 17,86 mg/ml oromucosal oromucosal use Ellesfield Avenue Spray, Solution spray, solution Bracknell, Berkshire RG12 8YS United Kingdom C 76/83 C 76/84
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Ireland Boehringer Ingelheim Limited, Ambroxol hydrochloride Lysopadol Lemon 20 mg Lozenges 20 mg lozenge oral use EN Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom
Ireland Boehringer Ingelheim Limited, Ambroxol hydrochloride Lysopadol Blackcurrant 20 mg Lozenges 20 mg lozenge oral use Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, Off
United Kingdom icial Jour
Ireland Boehringer Ingelheim Limited, Bromohexine hydro- Bisolvon 4 mg/5 ml Oral Solution 4 mg/5 ml oral solution oral use nal
Ellesfield Avenue chloride of
Bracknell the Berkshire, RG12 8YS United Kingdom European
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 30 mg tablet oral use Uni Via Lorenzini, 8 on 20139 Milano Italy
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 15 mg/2 ml nebuliser solu- inhalation use Via Lorenzini, 8 tion 20139 Milano Italy
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 75 mg prolonged-re- oral use Via Lorenzini, 8 lease capsule, 20139 Milano hard
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan Bambini 30 mg suppository rectal use EN Via Lorenzini, 8 20139 Milano Italy
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 15 mg/5 ml syrup oral use Via Lorenzini, 8 20139 Milano Italy Off icial Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 7,5 mg/ml nebuliser solu- inhalation use
Via Lorenzini, 8 tion Jour 20139 Milano Italy nal of the Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 60 mg granules for oral oral use Via Lorenzini, 8 solution European 20139 Milano Italy Uni
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use on Via Lorenzini, 8 20139 Milano Italy
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Mucosolvan 15 mg oral gum oral use Via Lorenzini, 8 20139 Milano Italy
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron 30 mg tablet oral use Via Palermo, 26/A 43122 Parma Italy C 76/85 C 76/86
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron 15 mg/5 ml syrup oral use EN Via Palermo, 26/A 43122 Parma Italy
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron 0,75 % oral solution or oral use, Via Palermo, 26/A nebuliser solu- inhalation use 43122 Parma tion Italy Off
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron 15 mg/2 ml nebuliser solu- inhalation use icial Via Palermo, 26/A tion 43122 Parma Jour
Italy nal of
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron Adulti 30 mg granules for oral oral use the
Via Palermo, 26/A suspension European 43122 Parma Italy Uni
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron Bambini 15 mg granules for oral oral use on Via Palermo, 26/A suspension 43122 Parma Italy
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron 15 mg/2 ml nebuliser solu- inhalation use Via Palermo, 26/A tion 43122 Parma Italy
Italy Chiesi Farmaceutici S.P.A. Ambroxol hydrochloride Fluibron Adulti 30 mg effervescent ta- oral use Via Palermo, 26/A blet 43122 Parma
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Piam Farmaceutici S.P.A. Ambroxol hydrochloride Muciclar 15 mg/5 ml syrup oral use EN Via Padre Semeria, 5 16131 Genova Italy
Italy Piam Farmaceutici S.P.A. Ambroxol hydrochloride Muciclar 75 mg prolonged-re- oral use Via Padre Semeria, 5 lease capsule 16131 Genova Italy Off
Italy Piam Farmaceutici S.P.A. Ambroxol hydrochloride Muciclar 30 mg granules for oral oral use icial Via Padre Semeria, 5 suspension 16131 Genova Jour
Italy nal of
Italy Piam Farmaceutici S.P.A. Ambroxol hydrochloride Muciclar 15 mg/2 ml nebuliser solu- inhalation use the
Via Padre Semeria, 5 tion European 16131 Genova Italy Uni
Italy Farmaceutici Caber S.P.A. Ambroxol hydrochloride Secretil 15 mg/5 ml syrup oral use on V. Le Citta' D'europa, 681 00100 Roma Italy
Italy Farmaceutici Caber S.P.A. Ambroxol hydrochloride Secretil 15 mg/2 ml nebuliser solu- inhalation use V. Le Citta' D'europa, 681 tion 00100 Roma Italy
Italy Farmaceutici Caber S.P.A. Ambroxol hydrochloride Secretil 60 mg granules for oral oral use V. Le Citta' D'europa, 681 solution 00100 Roma Italy C 76/87 C 76/88
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Farmaceutici Caber S.P.A. Ambroxol hydrochloride Secretil 30 mg/4 ml nebuliser solu- inhalation use V. Le Citta' D'europa, 681 tion EN 00100 Roma Italy
Italy Abc Farmaceutici S.P.A. Corso Ambroxol hydrochloride Ambroxolo ABC 30 mg tablet oral use V. Emanuele Ii, 72 10121 Torino Italy Off Italy Abc Farmaceutici S.P.A. Corso Ambroxol hydrochloride Ambroxolo ABC 15 mg nebuliser solu- inhalation use V. Emanuele Ii, 72 10121 tion icial
Torino Jour Italy nal
Italy Abc Farmaceutici S.P.A. Corso V. Ema- Ambroxol hydrochloride Ambroxolo ABC 30 mg suppository rectal use of nuele Ii, 72 10121 the
Torino European Italy
Italy Abc Farmaceutici S.P.A. Corso Ambroxol hydrochloride Ambroxolo ABC 15 mg granules for oral oral use Uni V. Emanuele Ii, 72 10121 suspension Torino on Italy
Italy Abc Farmaceutici S.P.A. Corso V. Ema- Ambroxol hydrochloride Ambroxolo ABC 30 mg granules for oral oral use nuele Ii, 72 10121 suspension Torino Italy
Italy Laboratorio Farmaceutico Sit Specialita' Ambroxol hydrochloride Tauxolo 3 mg/ml syrup oral use Igienico Terapeutiche S.R.L., Via Cavour, 70 Mede 27035 Pavia Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy S.F. Group S.R.L. Ambroxol hydrochloride Broxol 15 mg/5 ml syrup oral use Via Beniamino Segre, 59 EN 00134 Roma Italy
Italy S.F. Group S.R.L. Ambroxol hydrochloride Broxol Adulti 30 mg granules oral use Via Beniamino Segre, 59 00134 Roma Italy
Italy S.F. Group S.R.L. Ambroxol hydrochloride Broxol 0,75 % nebuliser solu- inhalation use
Via Beniamino Segre, 59 tion Off
00134 Roma icial Italy Jour
Italy Actavis Group Ptc Ehf Ambroxol hydrochloride Ambroxolo Actavis 0,30 % syrup oral use nal Reykjavikurvegi 76-78 220 Hafnarfjördur of Iceland the European Italy Istituto Chimico Ambroxol hydrochloride Amobronc 15 mg/2 ml nebuliser solu- inhalation use Internazionale Dr. Giuseppe tion Rende S.R.L. Via Salaria, 1240 Uni 00138 Roma on Italy
Italy Istituto Chimico Ambroxol hydrochloride Amobronc 15 mg/5 ml syrup oral use Internazionale Dr. Giuseppe Rende S.R.L. Via Salaria, 1240 00138 Roma Italy
Italy Boehringer Ingelheim Italia Ambroxol hydrochloride Surfactal 1 g/50 ml solution for in- intravenous use S.P.A. fusion Via Lorenzini, 8 20139 Milano Italy C 76/89 C 76/90
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Farmapro S.R.L. Ambroxol hydrochloride Ambroxolo Pharmentis 15 mg/2 ml nebuliser solu- inhalation use EN Via Beato Sebastiano Valfre 4, 10121 tion Torino Italy
Italy Ratiopharm Gmbh Ambroxol hydrochloride Ambroxolo Ratiopharm 30 mg/10 ml syrup oral use Graf-Arco Strasse 3 D-89079 Ulm Germany Off icial
Italy Hexal S.P.A. Ambroxol hydrochloride Ambroxolo Hexal 7,5 mg/ml nebuliser solu- inhalation use Jour Largo Umberto Boccioni, 1 tion nal 21040 Origgio Varese Italy of the European Italy Hexal S.P.A. Ambroxol hydrochloride Ambroxolo Hexal 3 mg/ml syrup oral use Largo Umberto Boccioni, 1 21040 Origgio Varese Italy Uni on
Italy A. Menarini Industrie Farmaceutiche Ambroxol hydrochloride Mucoaricodil 30 mg tablet oral use Riunite S.R.L. Via Sette Santi, 3 50131 Firenze Italy
Italy A. Menarini Industrie Farmaceutiche Ambroxol hydrochloride Mucoaricodil 30 mg/10 ml syrup oral use Riunite S.R.L. Via Sette Santi, 3 50131 Firenze
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Teva Italia S.R.L. Ambroxol hydrochloride Ambroxol Dorom 15 mg/2 ml nebuliser solu- inhalation use EN Via Messina, 38 tion 20154 Milano Italy
Italy Alfa Wassermann S.P.A. Ambroxol hydrochloride Lintos 15 mg/2 ml nebuliser solu- inhalation use Via Enrico Fermi, 1 tion 65020 Alanno — Pescara Italy Off icial
Italy Alfa Wassermann S.P.A. Ambroxol hydrochloride Lintos 30 mg/10 ml syrup oral use Jour Via Enrico Fermi, 1 65020 Alanno — Pescara nal
Italy of the European Italy Eg S.P.A. Ambroxol hydrochloride Ambroxolo EG 15 mg/2 ml nebuliser solu- inhalation use Via Pavia 6 tion 20136
Milano Uni Italy on
Italy Eg S.P.A. Ambroxol hydrochloride Ambroxolo EG 15 mg/5 ml syrup oral use Via Pavia 6 20136 Milano Italy
Italy Eg S.P.A. Ambroxol hydrochloride Ambroxolo EG 30 mg/10 ml syrup oral use Via Pavia 6 20136 Milano Italy C 76/91 C 76/92
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Epifarma S.R.L Ambroxol hydrochloride Ambrotus 15 mg/2 ml nebuliser solu- inhalation use EN Via S. Rocco, 6 tion 85033 Episcopia -Potenza Italy
Italy Epifarma S.R.L Ambroxol hydrochloride Ambrotus 30 mg/10 ml syrup oral use Via S. Rocco, 6 85033 Episcopia -Potenza Italy
Italy Farmakopea S.P.A. Ambroxol hydrochloride Gammaxol 15 mg/5 ml syrup oral use Off
Via Cavriana, 14 icial 20134 Milano Italy Jour nal
Italy Farmakopea S.P.A. Ambroxol hydrochloride Gammaxol 15 mg/2 ml nebuliser solu- inhalation use of Via Cavriana, 14 tion the
20134 Milano European Italy
Italy Farmakopea S.P.A. Ambroxol hydrochloride Gammaxol 0,75 % nebuliser solu- inhalation use Uni
Via Cavriana, 14 tion on 20134 Milano Italy
Italy Union Health S.R.L. Ambroxol hydrochloride Ambroxol 3 mg/ml syrup oral use Via Adige, 5 66020 San Giovanni Teatino — Chieti Italy
Italy Union Health S.R.L. Ambroxol hydrochloride Ambroxol 7,5 mg/ml nebuliser solu- inhalation use Via Adige, 5 tion 66020 San Giovanni Teatino — Chieti
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Union Health S.R.L. Ambroxol hydrochloride Ambroxol 0,75 % nebuliser solu- inhalation use EN Via Adige, 5 tion 66020 San Giovanni Teatino — Chieti Italy
Italy Union Health S.R.L. Ambroxol hydrochloride Ambroxol 15 mg/2 ml nebuliser solu- inhalation use Via Adige, 5 tion 66020 San Giovanni Teatino — Chieti Italy Off
Italy Tecnigen S.R.L. Ambroxol hydrochloride Ambroxol Tecnigen 15 mg/2 ml nebuliser solu- inhalation use icial Via Galileo Galilei 40 tion 20092 Cinisello Balsamo — Milano Jour
Italy nal of
Italy Tecnigen S.R.L. Ambroxol hydrochloride Ambroxol Tecnigen 30 mg/10 ml syrup oral use the
Via Galileo Galilei 40 European 20092 Cinisello Balsamo — Milano Italy Uni
Italy Procter & Gamble S.R.L. Ambroxol hydrochloride Vicks tosse mucolitico 30 mg effervescent ta- oral use on Viale G. Ribotta, 11 blet 00144 Roma Italy
Italy Procter & Gamble S.R.L. Ambroxol hydrochloride Vicks tosse mucolitico 30 mg effervescent ta- oral use Viale G. Ribotta, 11 blet 00144 Roma Italy
Italy Almus S.R.L. Ambroxol hydrochloride Ambroxolo Almus 30 mg/10 ml syrup oral use Via Cesarea, 11/10 16121 Genova Italy C 76/93 C 76/94
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Almus S.R.L. Ambroxol hydrochloride Ambroxolo Almus 15 mg/2 ml nebuliser solu- inhalation use EN Via Cesarea, 11/10 tion 16121 Genova Italy
Italy Angenerico S.P.A. Ambroxol hydrochloride Ambroxolo Angenerico 7,5 mg/ml nebuliser solu- inhalation use Via Nocera Umbra, 75 tion 00181 Roma
Italy Off icial Jour Italy Angenerico S.P.A. Ambroxol hydrochloride Ambroxolo Angenerico 3 mg/ml syrup oral use Via Nocera Umbra, 75 nal
00181 Roma of
Italy the European
Italy Boehringer Ingelheim Italia S.P.A. Ambroxol hydrochloride Zerinol Gola menta 20 mg tablet oral use
Via Lorenzini, 8 Uni 20139 Milano Italy on
Italy Boehringer Ingelheim International Ambroxol hydrochloride Zerinol Gola ribes nero 20 mg tablet oral use Gmbh Binger Strasse 173 D55216 Ingelheim Am Rhein Germany
Italy Wellington Street Development Pharma Ambroxol hydrochloride Brufix 0,75 % nebuliser solu- inhalation use Limited 47, Oaklands Drive Rathgar tion Dublino 6 Ireland 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Germed Pharma S.P.A. Ambroxol hydrochloride Ambroxolo Germed 15 mg/5 ml syrup oral use EN Via Cantu', 11 20092 Cinisello Balsamo — Milano Italy
Italy Mylan S.P.A. Ambroxol hydrochloride Ambroxolo Mylan Generics 15 mg/5 ml syrup oral use Via Vittor Pisani, 20 20124 Milano Italy Off icial
Italy Abc Farmaceutici S.P.A. Ambroxol hydrochloride Viscomucil 3 mg/ml syrup oral use Jour Corso V. Emanuele Ii, 72 10121 Torino nal
Italy of the European Italy Cyathus Exquirere Ambroxol hydrochloride Mukambro 10 mg/erogazione oral solution oral use Pharmaforschungsgmbh Rudolfsplatz 2/1/8
1010 Vienna Uni Austria on
Italy Cyathus Exquirere Ambroxol hydrochloride Gogolox 10 mg/erogazione oral solution oral use Pharmaforschungsgmbh Rudolfsplatz 2/1/8 1010 Vienna Austria
Italy Boehringer Ingelheim Italia Bromhexine hydrochlor- Bisolvon 2 mg/ml oral solution oral use S.P.A. ide Via Lorenzini, 8 20139 Milano Italy C 76/95 C 76/96
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Boehringer Ingelheim Italia Bromhexine hydrochlor- Bisolvon 8 mg tablet oral use EN S.P.A. ide Via Lorenzini, 8 20139 Milano Italy
Italy Boehringer Ingelheim Italia Bromhexine hydrochlor- Bisolvon 4 mg/2 ml solution for in- injection use S.P.A. ide jection Via Lorenzini, 8 Off 20139 Milano Italy icial Jour nal Italy Boehringer Ingelheim Italia S.P.A. Bromhexine hydrochlor- Bisolvon 4 mg/5 ml syrup oral use Via Lorenzini, 8 ide of 20139 Milano the
Italy European
Italy Boehringer Ingelheim Italia S.P.A. Bromhexine hydrochlor- Bisolvon 8 mg soluble tablet oral use Via Lorenzini, 8 ide Uni 20139 Milano on Italy
Italy Boehringer Ingelheim Italia S.P.A. Bromhexine hydrochlor- Bisolvon 8 mg/5 ml syrup oral use Via Lorenzini, 8 ide 20139 Milano Italy
Italy Boots Pharmaceuticals S.R.L. Bromhexine hydrochlor- Nirolex tosse e catarro 4 mg/5 ml syrup oral use Via Cesarea 11/10 ide 16121 Genova
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Aesculapius Farmaceutici Srl Bromhexine hydrochlor- Flutoxil 4 mg/5 ml syrup oral use EN Via Cozzaglio, 24 ide 25125 Brescia Italy
Italy Farmapro S.R.L. Bromhexine hydrochlor- Bromexina Pharmentis 4 mg/5 ml syrup oral use Via Beato Sebastiano Valfre 4, ide 10121 Torino Italy Off
Italy Germed Pharma S.P.A. Bromhexine hydrochlor- Bromexina Germed 4 mg/5 ml syrup oral use icial Via Cantu', 11 ide 20092 Cinisello Balsamo — Milano Jour
Italy nal of
Italy Laboratorio Farmaceutico Sit Bromhexine hydrochlor- Tauglicolo 40 mg syrup oral use the
Specialita' Igienico ide European Terapeutiche S.R.L., Via Cavour, 70 Mede 27035 Pavia Italy Uni on
Italy Laboratorio Farmaceutico Sit Bromhexine hydrochlor- Tauglicolo Adulti 6 mg suppository rectal use Specialita' Igienico ide Terapeutiche S.R.L., Via Cavour, 70 Mede 27035 Pavia Italy
Italy Laboratorio Farmaceutico Sit Bromhexine hydrochlor- Tauglicolo Bambini 3 mg suppository rectal use Specialita' Igienico ide Terapeutiche S.R.L., Via Cavour, 70 Mede 27035 Pavia Italy C 76/97 C 76/98
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Laboratorio Farmaceutico Sit Bromhexine hydrochlor- Tauglicolo 4 mg + 3,86 mg solution for in- injection use EN Specialita' Igienico ide/sulphuguaiacol jection Terapeutiche S.R.L., Via Cavour, 70 Mede 27035 Pavia Italy
Italy Promedica Srl Ambroxol hydrochloride Ventibron 15 mg/5 ml syrup oral use Via Palermo, 26/A Off 43122 Parma Italy icial Jour nal Italy Promedica Srl Ambroxol hydrochloride Ventibron 15 mg/2 ml nebuliser solu- inhalation use Via Palermo, 26/A tion of 43122 Parma the
Italy European
Italy Promedica Srl Ambroxol hydrochloride Ventibron 0,75 % oral solution oral use Via Palermo, 26/A nebuliser solu- inhalation use Uni 43122 Parma tion on Italy
Italy Promedica Srl Ambroxol hydrochloride Ventibron 30 mg tablet oral use Via Palermo, 26/A 43122 Parma Italy
Italy Promedica Srl Ambroxol hydrochloride Ventibron 15 mg granules for sus- oral use Via Palermo, 26/A pension 43122 Parma
Italy 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Italy Promedica Srl Ambroxol hydrochloride Ventibron 30 mg granules for sus- oral use EN Via Palermo, 26/A pension 43122 Parma Italy
Latvia EGIS PHARMACEUTICALS ambroxol hydrochloride Halixol 15 mg/5 ml syrup 15 mg/5 ml syrup oral use PLC., 1106 BUDAPEST, Kereszturi ut 30-38, Hungary Off icial Latvia EGIS PHARMACEUTICALS ambroxol hydrochloride Halixol 30 mg tablets 30 mg tablet oral use PLC., 1106 BUDAPEST, Jour
Kereszturi ut 30-38, nal Hungary of the
Latvia PRO.MED.CS Praha a.s., ambroxol hydrochloride Ambrosan 30 mg tablets 30 mg tablet oral use European Telcska 1, 140 00 Praha 4, Czech Republic Uni
Latvia G. L. Pharma GmbH, ambroxol hydrochloride Ambrolan 30 mg tablets 30 mg tablet oral use on Schlossplatz 1, 8502 Lannach, Austria
Latvia STIROLBIOFARM BALTIKUM ambroxol hydrochloride Ambroksols Stirol 75 mg prolonged- 75 mg prolonged-re- oral use SIA, Rasas iela 5, Riga, release tablets lease tablet Latvia
Latvia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 60 mg effervescent tablets 60 mg effervescent ta- oral use (MENARINI GROUP), blet Glienicker Weg 125, 12489 Berlin, Germany C 76/99 C 76/100
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Latvia ratiopharm GmbH, ambroxol hydrochloride Brontex 3 mg/ml syrup 3 mg/ml syrup oral use EN Graf-Arco-Str. 3, 89079 Ulm, Germany
Latvia ratiopharm GmbH, ambroxol hydrochloride Brontex 30 mg tablets 30 mg tablet oral use Graf-Arco-Str. 3, 89079 Ulm, Germany Off icial
Latvia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 30 mg tablets 30 mg tablet oral use Jour (MENARINI GROUP), nal Glienicker Weg 125, 12489 Berlin, of Germany the European
Latvia BERLIN-CHEMIE AG ambroxol hydrochloride Tusmed 30 mg/5 ml oral solution 30 mg/5 ml oral solution oral use (MENARINI GROUP), Glienicker Weg 125, Uni 12489 Berlin, on Germany
Latvia AS ‘Olainfarm’, ambroxol hydrochloride Ambroksol 30 mg tablets 30 mg tablet oral use Rūpnīcu iela 5, Olaine, 2114, Latvia
Latvia Sandoz d.d., ambroxol hydrochloride Ambroxol Sandoz 15 mg/5 ml syrup 15 mg/5 ml syrup oral use Verovskova 57, 1000 Ljubljana,
Slovenia 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Latvia Sandoz d.d., ambroxol hydrochloride Ambroxol Sandoz 30 mg tablets 30 mg tablet oral use EN Verovskova 57, 1000 Ljubljana, Slovenia
Latvia CYATHUS Exquirere ambroxol hydrochloride Mukambro 10 mg/spray puff oral solu- 10 mg/spray puff oral solution oral use Pharmaforschungs GmbH, tion Rudolfsplatz 2/1/8, 1010 Vienna, Austria Off icial Latvia BERLIN-CHEMIE AG (MENARINI ambroxol hydrochloride Flavamed for children 15 mg/5 ml oral 15 mg/5 ml oral solution oral use GROUP), Glienicker Weg 125, solution Jour
12489 Berlin, nal Germany of the
Latvia Boehringer Ingelheim ambroxol hydrochloride Lasolvan 15 mg/5 ml syrup 15 mg/5 ml syrup oral use European International GmbH, Binger Strasse 173, 55216 Ingelheim am Rein, Germany Uni on Latvia Divapharma GmbH, Motzener Str. 41, ambroxol hydrochloride Neo-bronchol 15 mg lozenges 15 mg lozenge oral use 12277 Berlin, Germany
Latvia SIA Briz, ambroxol hydrochloride Ambroxol — BCPP 30 mg tablets 30 mg tablet oral use Rasas iela 5, Riga, 1057, Latvia
Latvia BERLIN-CHEMIE AG (MENARINI ambroxol hydrochloride Flavamed 30 mg/5 ml oral solution 30 mg/5 ml oral solution oral use GROUP), Glienicker Weg 125, 12489 Berlin,
Germany C 76/101 C 76/102
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Latvia Actavis Nordic A/S, Ornegardsvej 16, bromhexine hydrochlor- Bromhexin Actavis 8 mg tablets 8 mg tablet oral use 2820 Gentofte, ide EN Denmark
Latvia SIA Briz, bromhexine hydrochlor- Bromhexin Sopharma 8 mg tablets 8 mg tablet oral use Rasas iela 5, ide Riga, 1057, Latvia Off
Latvia AS GRINDEKS. bromhexine hydrochlor- Bromhexine-Grindeks 4 mg tabletes 4 mg tablet oral use icial Krustpils, 53, ide Riga, 1057, Jour Latvia nal of
Latvia AS GRINDEKS. bromhexine hydrochlor- Bromhexine-Grindeks 8 mg tabletes 8 mg tablet oral use the Krustpils, 53, ide Riga, 1057, European Latvia
Latvia AS GRINDEKS. bromhexine hydrochlor- Bromhexine-Grindeks 4 mg/5 ml syrup 4 mg/5 ml syrup oral use Uni Krustpils, 53, ide on Riga, 1057, Latvia
Latvia SIA Briz, bromhexine hydrochlor- Bromhexin Sopharma 4 mg/5 ml syrup 4 mg/5 ml syrup oral use Rasas iela 5, ide Riga, 1057, Latvia
Lithuania CYATHUS Exquirere Ambroxol hydrochloride AMBROSPRAY 10 mg/0,2 ml oral solution oral use Pharmaforschungs GmbH Rudolfsplatz 2/1/8 1010 Vienna
Austria 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Lithuania G.L. Pharma GmbH Ambroxol hydrochloride Ambrolan 30 mg tablet oral use EN Schlossplatz 1 8502 Lannach Austria
Lithuania PRO.MED.CS Praha a.s. Ambroxol hydrochloride Ambrosan 30 mg tablet oral use Telčska 1140 00 Praha, Czech Republic Off Lithuania Sandoz d.d. Ambroxol hydrochloride Ambroxol Sandoz 30 mg tablet oral use icial Verovškova 57,
1000 Ljubljana Jour Slovenia nal of
Lithuania Sandoz d.d. Ambroxol hydrochloride Ambroxol Sandoz 15 mg/5 ml syrup oral use the Verovškova 57, 1000 Ljubljana European Slovenia Uni Lithuania ratiopharm GmbH Ambroxol hydrochloride Brontex 30 mg tablet oral use Graf — Arco — Str. 3 on 89079 Ulm, Germany
Lithuania ratiopharm GmbH Ambroxol hydrochloride Brontex 7,5 mg/ml oral drops, solu- oral use Graf — Arco — Str. 3 tion 89079 Ulm, Germany
Lithuania ratiopharm GmbH Ambroxol hydrochloride Brontex 15 mg/5 ml syrup oral use Graf — Arco — Str. 3 89079 Ulm,
Germany C 76/103 C 76/104
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Lithuania BERLIN-CHEMIE AG (MENARINI Ambroxol hydrochloride Flavamed 30 mg tablet oral use EN GROUP) Glienicker Weg 125 12489 Berlin Germany
Lithuania BERLIN-CHEMIE AG (MENARINI Ambroxol hydrochloride Flavamed 60 mg effervescent ta- oral use
GROUP) blet Off
Glienicker Weg 125 icial 12489 Berlin
Germany Jour nal of
Lithuania BERLIN-CHEMIE AG (MENARINI Ambroxol hydrochloride Flavamed 30 mg/5 ml oral solution oral use the
GROUP) European Glienicker Weg 125 12489 Berlin Germany Uni on
Lithuania BERLIN-CHEMIE AG (MENARINI Ambroxol hydrochloride Flavamed 15 mg/5 ml oral solution oral use GROUP) Glienicker Weg 125 12489 Berlin Germany
Lithuania EGIS PHARMACEUTICALS PLC Ambroxol hydrochloride Halixol 15 mg/5 ml syrup oral use 1106 Budapest Keresztúri út 30-38 Hungary 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Lithuania EGIS PHARMACEUTICALS PLC Ambroxol hydrochloride Halixol 30 mg tablet oral use EN 1106 Budapest Keresztúri út 30-38 Hungary
Lithuania Boehringer Ingelheim International Ambroxol hydrochloride Lasolvan 15 mg/5 ml syrup oral use GmbH Binger Strasse 173 55216 Ingelheim am Rhein
Germany Off icial
Lithuania Boehringer Ingelheim International Ambroxol hydrochloride Lasolvan 15 mg/2 ml inhalation va- oral use Jour
GmbH pour, solution nal Binger Strasse 173 55216 Ingelheim am Rhein of Germany the European
Lithuania Boehringer Ingelheim International Ambroxol hydrochloride Lasolvan 30 mg tablet oral use GmbH Binger Strasse 173 Uni
55216 Ingelheim am Rhein on Germany
Lithuania Boehringer Ingelheim International Ambroxol hydrochloride Lasolvan 75 mg prolonged-re- oral use GmbH lease capsule, Binger Strasse 173 hard 55216 Ingelheim am Rhein Germany
Lithuania BERLIN-CHEMIE AG Ambroxol hydrochloride Tussisol 30 mg/5 ml oral solution oral use Glienicker Weg 125 12489 Berlin Germany C 76/105 C 76/106
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Lithuania Divapharma GmbH Ambroxol hydrochloride neo-bronchol 15 mg lozenge oral use Motzener Str. 41 EN 12277 Berlin Germany
Lithuania AS GRINDEKS Bromhexine hydrochlor- BROMHEXINE-GRINDEKS 4 mg/5 ml syrup oral use Krustpils 53 ide Rīga 1057 Latvia Off Lithuania AS GRINDEKS Bromhexine hydrochlor- BROMHEXINE-GRINDEKS 4 mg tablet oral use Krustpils 53 ide icial
Rīga 1057 Jour Latvia nal
Lithuania AS GRINDEKS Bromhexine hydrochlor- BROMHEXINE-GRINDEKS 8 mg tablet oral use of Krustpils 53 ide the
Rīga 1057 European Latvia
Lithuania Actavis Nordic A/S Bromhexine hydrochlor- Bromhexin Actavis 8 mg tablet oral use Uni Ørnegårdsvej 16, ide 2820 Gentofte on Denmark
Lithuania BERLIN-CHEMIE AG (MENARINI Bromhexine hydrochlor- Bromhexin Berlin-Chemie 8 mg coated tablet oral use GROUP) ide Glienicker Weg 125 12489 Berlin Germany
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Bisolvon 8 mg tablet oral use Vesalius Science Park drate Avenue Ariane 16 1200 Bruxelles Belgium 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Bisolvon 8 mg/5 ml syrup oral use Vesalius Science Park drate EN Avenue Ariane 16 1200 Bruxelles Belgium
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Bisolvon 0,20 % oral solution oral use Vesalius Science Park drate Avenue Ariane 16 1200 Bruxelles
Belgium Off icial Luxembourg Eurogenerics Bromhexine chlorhy- Bromhexine EG 8 mg tablet oral use
Heizel Esplanade b22 drate Jour 1020 Brussel nal Belgium of
Luxembourg D.J.VAN TINTELEN BEHEER B.V. Bromhexine chlorhy- Bronchi-Mereprine 8 mg tablet oral use the
Keyserwey 20 drate European 2201 CW Noordwijk Zh The Netherlands
Luxembourg Qualiphar Laboratoire Bromhexine chlorhy- Toularynx Bromhexine 5 mg/5 ml syrup oral use Uni Rijksweg 9 drate on 2880 Bornem Belgium
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Ambroxine 20 mg lozenge oral use Vesalius Science Park drate Avenue Ariane 16 1200 Bruxelles Belgium
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Mucoangin Citron 20 mg 20 mg lozenge oral use Vesalius Science Park drate Avenue Ariane 16 1200 Bruxelles
Belgium C 76/107 C 76/108
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Mucoangine Cassis 20 mg lozenge oral use EN Vesalius Science Park drate Avenue Ariane 16 1200 Bruxelles Belgium
Luxembourg SCS Boehringer Ingelheim Comm. V. Bromhexine chlorhy- Mucoangine Menthe 20 mg lozenge oral use Vesalius Science Park drate Avenue Ariane 16 Off 1200 Bruxelles Belgium icial Jour nal Luxembourg Hexal AG Ambroxol hydrochloride Ambrohexal Hustenlöser 30 mg tablet oral use Industriestr. 25 of 83607 Holzkirchen the
Germany European
Luxembourg Hexal AG Ambroxol hydrochloride Ambrohexal Hustentropfen 7,5 mg/ml oral drops, solu- oral use Industriestr. 25 tion Uni 83607 Holzkirchen on Germany
Luxembourg Hexal AG Ambroxol hydrochloride Ambrohexal Hustensaft für Kinder 15 mg/5 ml oral solution oral use Industriestr. 25 83607 Holzkirchen Germany
Luxembourg Hexal AG Ambroxol hydrochloride Ambroxhexal Hustenlöser retard 75 mg prolonged-re- oral use Industriestr. 25 lease capsule, 83607 Holzkirchen hard
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Luxembourg Hexal AG Ambroxol hydrochloride Ambrohexal S Brausetablette 60 mg effervescent ta- oral use EN Industriestr. 25 blet 83607 Holzkirchen Germany
Luxembourg ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 30 mg Hustenlöser 30 mg tablet oral use Graf Arco Strasse 3 89079 Ulm Germany Off
Luxembourg ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 75 mg Hustenlöser 75 mg prolonged-re- oral use icial Graf Arco Strasse 3 lease capsule, 89079 Ulm hard Jour
Germany nal of
Luxembourg ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm Hustensaft 15 mg/5 ml oral solution oral use the
Graf Arco Strasse 3 European 89079 Ulm Germany Uni
Luxembourg ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm Hustentropfen 7,5 mg/ml oral drops, solu- oral use on Graf Arco Strasse 3 tion 89079 Ulm Germany
Luxembourg ratiopharm GmbH Ambroxol hydrochloride Ambroxol-ratiopharm 15 mg/2 ml In- 15 mg/2 ml solution for in- intravenous use Graf Arco Strasse 3 jektionslösung jection 89079 Ulm Germany
Luxembourg Biocodex Ambroxol hydrochloride Muxol 30 mg tablet oral use Avenue Gallieni 7 94250 Gentilly
France C 76/109 C 76/110
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Luxembourg Biocodex Ambroxol hydrochloride Muxol 3 mg/ml oral solution oral use EN Avenue Gallieni 7 94250 Gentilly France
Luxembourg SCS Boehringer Ingelheim Comm. V. Ambroxol hydrochloride Surbronc 60 mg coated tablet oral use Vesalius Science Park Avenue Ariane 16 1200 Bruxelles
Belgium Off icial
Luxembourg SCS Boehringer Ingelheim Comm. V. Ambroxol hydrochloride Surbronc 30 mg/5 ml syrup oral use Jour
Vesalius Science Park nal Avenue Ariane 16 1200 Bruxelles of Belgium the European
Luxembourg SCS Boehringer Ingelheim Comm. V. Ambroxol hydrochloride Surbronc 60 mg/3 g powder for oral oral use Vesalius Science Park solution Avenue Ariane 16 Uni
1200 Bruxelles on Belgium
Malta Medochemie Ltd. Ambroxol Hydrochlor- Medovent Elixir Syrup 15 mg/5 ml 15 mg/5 ml oral solution oral use 1-10 Constantinoupoleos Street, 3011, P. ide O. Box 51409, 3505 Limassol, Cyprus
Malta Mundipharma Pharmaceuticals Ltd. Ambroxol Hyrdochlor- Mucobroxol Syrup 15 mg/5 ml syrup oral use 13 Othellos Street, Dhali ide Industrial Zone, Nicosia,
Cyprus 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Malta Actavis EAD Ambroxol Hydrochlor- MUCOLISIN 30 mg/5 ml syrup 30 mg/5 ml syrup oral use EN 29, Atanas Dukov Street, Sofia 1407 ide Bulgaria
Malta Aflofarm Farmacja Polska SP. zo. o. Ambroxol Hydrochlor- Entus Max 30 mg/5 ml syrup 30 mg/5 ml syrup oral use ul. Partyzancka 133/151 95-200 Pabia- ide nice, Poland Off icial Malta PIAM Farmaceutici S.P.A. Ambroxol Hydrochlor- Muciclar 3 mg/ml syrup oral use Via Padre G. Semeria, 5, I-16131, Genoa, ide Jour
Italy nal of the Malta PIAM Farmaceutici S.P.A. Ambroxol Hydrochlor- Muciclar 75 mg modified release oral use Via Padre G. Semeria, 5, I-16131, Genoa, ide capsule European Italy Uni
Malta Boehringer Ingelheim Ellas A.E. Ambroxol Hydrochlor- Mucosolvan 15 mg/5 ml syrup oral use on Ellinikou 2, 167 77 Elliniko, Athens, ide (Cyclohexanol Hy- Greece drochloride)
Malta Boehringer Ingelheim Ellas A.E. Ambroxol Hydrochlor- Mucosolvan 30 mg tablet oral use Ellinikou 2, 167 77 Elliniko, Athens, ide (Cyclohexanol Hy- Greece drochloride)
Malta Sopharma PLC Bromhexine hydrochlor- BROMHEXINE SOPHARMA 4 mg/5 ml 4 mg/5 ml syrup oral use 16, Iliensko Shosse Str. ide syrup 1220 Sofia, Bulgaria C 76/111 C 76/112
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Malta Adelco-Chromatourgia Anthinon E. Co- Bromhexine Hydro- Bronchotussine 4 mg/5 ml syrup oral use EN locotronis Bros S.A. chloride 37 Pireos Str, 183 46, Moschato, Athens, Greece
Malta Boehringer Ingelheim Limited Bromhexine Hydro- Bisolvon 4 mg/5 ml Oral Solution 4 mg/5 ml oral solution oral use Ellesfield Avenue, Bracknell, Berkshire, chloride RG12 8YS, United Kingdom Off icial Malta Remedica Ltd. Bromhexine Hydro- Flecoxin 8 Tablets 8 mg tablet oral use Limassol Industrial Estate, chloride BP Jour
Aharnon Street, P.O. Box nal 51706, 3508 Limassol, Cyprus of the
Norway AS Den norske Eterfabrikk, Karihaug- Bromhexine hydrochlor- Bromhexine DnE 1,6 mg/ml oral solution oral use European veien 22, 1086 Oslo, ide Norway Uni
Norway AS Den norske Eterfabrikk, Karihaug- Bromhexine hydrochlor- Bromhexine DnE 0,8 mg/ml oral solution oral use on veien 22, 1086 Oslo, ide Norway
Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 0,8 mg/ml oral solution oral use GmbH, Binger Strasse 173, 55 216 ide Ingelheim am Rhein, Germany
Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 1,6 mg/ml oral solution oral use GmbH, Binger Strasse 173, 55 216 ide Ingelheim am Rhein,
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 0,8 mg/ml oral solution oral use EN GmbH, Binger Strasse 173, 55 216 ide Ingelheim am Rhein, Germany
Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 1,6 mg/ml oral solution oral use GmbH, Binger Strasse 173, 55 216 ide Ingelheim am Rhein, Germany Off icial Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 8 mg tablet oral use GmbH, Binger Strasse 173, 55 216 ide Jour
Ingelheim am Rhein, nal Germany of the European Norway Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 8 mg soluble tablet oral use GmbH, Binger Strasse 173, 55 216 ide Ingelheim am Rhein,
Germany Uni on
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Aflegan 7,5 mg/ml solution for in- intravenous use Jankovcova 1569/2c jection Praha 7 Holesovice, 170 00 Czech Republic
Poland Sandoz GmbH Ambroxol hydrochloride Ambrohexal 7,5 mg/ml solution for in- intravenous use, Biochemiestrasse 10 jection intramuscular 6250 Kundl use, subcutaneous Austria use C 76/113 C 76/114
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Takeda Pharma Sp. z o.o. Ambroxol hydrochloride Ambroksol Takeda 15 mg/5 ml syrup oral use Al. Jerozolimskie 146 A EN 02-305 Warszawa Poland
Poland Takeda Pharma Sp. z o.o. Ambroxol hydrochloride Ambroksol Takeda 30 mg/5 ml syrup oral use Al. Jerozolimskie 146 A 02-305 Warszawa Poland Off
Poland PRO.MED.CS. Praha a.s. Ambroxol hydrochloride Ambrosan 30 mg tablet oral use icial Telcska 1 Praha 4 Jour 140 00 nal Czech Republic of the Poland Teva Pharmaceuticals Polska Sp. z o.o. Ambroxol hydrochloride Ambrosol Teva 15 mg/5 ml syrup oral use ul. Emilii Plater 53 European 00-113 Warszawa Poland Uni
Poland Teva Pharmaceuticals Polska Sp. z o.o. Ambroxol hydrochloride Ambrosol Teva 30 mg tablet oral use on ul. Emilii Plater 53 00-113 Warszawa Poland
Poland Teva Pharmaceuticals Polska Sp. z o.o. Ambroxol hydrochloride Ambrosol Teva 30 mg/5 ml syrup oral use ul. Emilii Plater 53 00-113 Warszawa Poland
Poland Teva Pharmaceuticals Polska Sp. z o.o. Ambroxol hydrochloride Ambrosolvan 15 mg/5 ml syrup oral use ul. Emilii Plater 53 00-113 Warszawa
Poland 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Teva Pharmaceuticals Polska Sp. z o.o. Ambroxol hydrochloride Ambrosolvan 30 mg/5 ml syrup oral use EN ul. Emilii Plater 53 00-113 Warszawa Poland
Poland Sopharma Warszawa Sp. z o.o. Ambroxol hydrochloride Ambrotaxer 15 mg/5 ml syrup oral use ul. Ostrobramska 91 04-118 Warszawa
Poland Off icial
Poland 123ratio Sp. z o.o. Ambroxol hydrochloride Ambroxol 123ratio 3 mg/ml oral solution oral use Jour
ul. Emilii Plater 53 nal 00-113 Warszawa of Poland the European
Poland 123ratio Sp. z o.o. Ambroxol hydrochloride Ambroxol 123ratio 6 mg/ml oral solution oral use ul. Emilii Plater 53
00-113 Warszawa Uni
Poland on
Poland Cyathus Exquirere Pharmaforschungs Ambroxol hydrochloride Ambroxol hydrochloride Cyathus 10 mg/dawkę oral solution oral use GmbH Rudolfsplatz 2/1/8 1010 Wienn Austria
Poland Berlin-Chemie AG Ambroxol hydrochloride Ambroxoli hydrochloridum Fontane 15 mg/5 ml oral solution oral use Glienicker Weg 125 12489 Berlin Germany C 76/115 C 76/116
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Deflegmin 7,5 mg/ml oral drops, solu- oral use EN Jankovcova 1569/2c tion Praha 7 Holesovice, 170 00 Czech Republic
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Deflegmin 30 mg tablet oral use
Jankovcova 1569/2c Off Praha 7 Holesovice icial
17000 Jour Czech Republic nal of
Poland ICN Polfa Rzeszów S.A. Ambroxol hydrochloride Deflegmin 30 mg/5 ml syrup oral use the
ul. Przemysłowa 2 European 35-959 Rzeszów Poland Uni
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Deflegmin 75 mg prolonged-re- oral use on Jankovcova 1569/2c lease capsule Praha 7 Holesovice, 17000 Czech Republic
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Deflegmin 15 mg/5 ml syrup oral use Jankovcova 1569/2c Praha 7 Holesovice, 17000
Czech Republic 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland PharmaSwiss Ceska Republika s.r.o. Ambroxol hydrochloride Deflegmin 10 mg/ml oral solution oral use EN Jankovcova 1569/2c Praha 7 Holesovice, 17000 Czech Republic
Poland Aflofarm Farmacja Polska Sp. z o.o. Ambroxol hydrochloride Entus Junior 15 mg/5 ml syrup oral use ul. Partyzancka 133/151 Off 95-200 Pabianice Poland icial Jour nal Poland Aflofarm Farmacja Polska Sp. z o.o. Ambroxol hydrochloride Entus Max 30 mg/5 ml syrup oral use ul. Partyzancka 133/151 of 95-200 Pabianice the
Poland European
Poland Aflofarm Farmacja Polska Sp. z o.o. Ambroxol hydrochloride Envil kaszel 30 mg/5 ml syrup oral use ul. Partyzancka 133/151 Uni 95-200 Pabianice on Poland
Poland Aflofarm Farmacja Polska Sp. z o.o. Ambroxol hydrochloride Envil kaszel 30 mg tablet oral use ul. Partyzancka 133/151 95-200 Pabianice Poland
Poland Aflofarm Farmacja Polska Sp. z o.o. Ambroxol hydrochloride Envil kaszel junior 15 mg/5 ml syrup oral use ul. Partyzancka 133/151 95-200 Pabianice Poland C 76/117 C 76/118
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Berlin-Chemie AG Ambroxol hydrochloride Flavamed 15 mg/5 ml syrup oral use EN Glienicker Weg 125 12489 Berlin Germany
Poland Berlin-Chemie AG Ambroxol hydrochloride Flavamed 30 mg tablet oral use Glienicker Weg 125 12489 Berlin Germany Off
Poland Berlin-Chemie AG Ambroxol hydrochloride Flavamed 60 mg effervescent ta- oral use icial Glienicker Weg 125 blet 12489 Berlin Jour
Germany nal of
Poland Berlin-Chemie AG Ambroxol hydrochloride Flavamed max 30 mg/5 ml oral solution oral use the
Glienicker Weg 125 European 12489 Berlin Germany Uni
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina 8 mg tablet oral use on ul. Emilii Plater 53 ide 00-113 Wsrszawa Poland
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina Baby 2 mg/ml oral drops, solu- oral use ul. Emilii Plater 53 ide tion 00-113 Wsrszawa Poland
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina o smaku malinowym 4 mg/5 ml syrup oral use ul. Emilii Plater 53 ide 00-113 Wsrszawa
Poland 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina o smaku miętowym 4 mg/5 ml syrup oral use EN ul. Emilii Plater 53 ide 00-113 Wsrszawa Poland
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina o smaku miętowym bez cukru 4 mg/5 ml syrup oral use ul. Emilii Plater 53 ide 00-113 Wsrszawa Poland Off icial
Poland Teva Pharmaceuticals Polska Sp. z o.o. Bromhexine hydrochlor- Flegamina o smaku truskawkowym 2 mg/5 ml syrup oral use Jour ul. Emilii Plater 53 ide 00-113 Wsrszawa nal
Poland of the European Poland Herbapol — Lublin S.A. Bromhexine hydrochlor- Flegatussin (0,0026 g + 2,35 g)/ syrup oral use ul. Diamentowa 25 ide Extractum fluidum 5 ml 20-471 Lublin aquosum ex Plantaginis
Poland lanceolatae folii et Ver- Uni basci floribus on
Poland Zentiva, k.s. Ambroxol hydrochloride MEDOX 15 mg/5 ml syrup oral use U kabelovny 130 Praga 10, 10237 Dolni Mecholupy Czech Republic
Poland Zentiva, k.s. Ambroxol hydrochloride Medox 30 mg tablet oral use U kabelovny 130 Praga 10, 10237 Dolni Mecholupy Czech Republic C 76/119 C 76/120
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucoangin 20 mg chewable tablet oral use EN GmbH Binger Str 173 55216 Ingelheim am Rhein Germany
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use GmbH Off Binger Str 173 55216 Ingelheim am Rhein icial
Germany Jour nal of
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 30 mg tablet oral use the GmbH Binger Str 173 European 55216 Ingelheim am Rhein Germany Uni on
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use GmbH Binger Str 173 55216 Ingelheim am Rhein Germany
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan 15 mg pastille oral use GmbH Binger Str 173 55216 Ingelheim am Rhein Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan inhalacje 15 mg/2 ml nebuliser liquid inhalation use EN GmbH Binger Str 173 55216 Ingelheim am Rhein Germany
Poland Boehringer Ingelheim International Ambroxol hydrochloride Mucosolvan mini 15 mg/5 ml syrup oral use GmbH Off Binger Str 173 55216 Ingelheim am Rhein icial
Germany Jour nal of
Poland Biofarm Sp. z o.o. Ambroxol hydrochloride Tussal Expectorans 30 mg tablet oral use the ul. Wałbrzyska 13 60-198 Poznań European Poland Uni on Portugal Laboratórios Azevedos — Indústria Ambroxol Ambroxol Tussilene 6 mg/ml syrup oral use Farmacêutica, S.A. Edifícios Azevedos — Estrada Nacional 117-2, Alfragide 2614-503 Amadora Portugal
Portugal Cinfa Portugal, Lda. Ambroxol Ambroxol Cinfa 3 mg/ml Xarope 3 mg/ml syrup oral use Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark 2790-221 Carnaxide Portugal C 76/121 C 76/122
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Farmoz — Sociedade Técnico Medicinal, Ambroxol Ambroxol Farmoz 15 mg/5 ml Xarope 3 mg/ml syrup oral use EN S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
Portugal Farmoz — Sociedade Técnico Medicinal, Ambroxol Ambroxol Farmoz 30 mg Comprimidos 30 mg tablet oral use S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Off
Portugal icial Jour
Portugal Farmoz — Sociedade Técnico Medicinal, Ambroxol Ambroxol Farmoz 30 mg/5 ml Xarope 6 mg/ml syrup oral use nal
S.A. of
Rua da Tapada Grande, 2, Abrunheira the 2710-089 Sintra Portugal European
Portugal Baldacci — Portugal, S.A. Ambroxol Ambroxol Fluidox 30 mg Comprimidos 30 mg tablet oral use Uni Rua Cândido de Figueiredo, 84-B on 1549-005 Lisboa Portugal
Portugal Baldacci — Portugal, S.A. Ambroxol Ambroxol Fluidox 6 mg/ml Xarope 6 mg/ml syrup oral use Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Portugal Generis Farmacêutica, S.A. Ambroxol Ambroxol Generis 3 mg/ml Xarope 3 mg/ml syrup oral use Rua João de Deus, 19 2700-487 Amadora
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Germed Farmacêutica, Lda. Ambroxol Ambroxol Germed 3 mg/ml Xarope 3 mg/ml syrup oral use EN Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto 2790-012 Portela de Carnaxide Portugal
Portugal Germed Farmacêutica, Lda. Ambroxol Ambroxol Germed 6 mg/ml Xarope 6 mg/ml syrup oral use Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
2790-012 Portela de Carnaxide Off Portugal icial Jour Portugal Ratiopharm — Comércio e Indústria de Ambroxol Ambroxol Ratiopharm 6 mg/ml oral solution oral use Produtos Farmacêuticos, Lda. nal
Lagoas Park, Edifício 5 A, Piso 2 of
2740-245 Porto Salvo the Portugal European
Portugal Ratiopharm — Comércio e Indústria de Ambroxol Ambroxol Ratiopharm 3 mg/ml oral solution oral use
Produtos Farmacêuticos, Lda. Uni Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo on Portugal
Portugal Sandoz Farmacêutica, Lda. Ambroxol Ambroxol Sandoz 6 mg/ml syrup oral use Avenida Professor Doutor Cavaco Silva, 10E — Taguspark 2740-255 Porto Salvo Portugal
Portugal Laboratórios Atral, S.A. Ambroxol Benflux 30 mg tablet oral use Rua da Estação, 42 — Vala do Carregado 2600-726 Castanheira do Ribatejo
Portugal C 76/123 C 76/124
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration EN Portugal Laboratórios Atral, S.A. Ambroxol Benflux 3 mg/ml syrup oral use Rua da Estação, 42 — Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
Portugal Laboratórios Atral, S.A. Ambroxol Benflux Forte 6 mg/ml syrup oral use
Rua da Estação, 42 — Vala do Carregado Off
2600-726 Castanheira do Ribatejo icial Portugal Jour nal of
Portugal Farma 1000 — Prod. Farmacêuticos, Lda. Ambroxol Bromax 120 mg prolonged-re- oral use the o Avenida Mestre Cid, 8 — 1 Esq. Frente lease capsule, European 2070-012 Cartaxo hard Portugal Uni on
Portugal Farma 1000 — Prod. Farmacêuticos, Lda. Ambroxol Bromax 30 mg tablet oral use Avenida Mestre Cid, 8 — 1o Esq. Frente 2070-012 Cartaxo Portugal
Portugal Farma 1000 — Prod. Farmacêuticos, Lda. Ambroxol Bromax 6 mg/ml syrup oral use Avenida Mestre Cid, 8 — 1o Esq. Frente 2070-012 Cartaxo Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol Broncoliber 30 mg tablet oral use EN inal, S.A. Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra Portugal
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol Broncoliber 3 mg/ml syrup oral use inal, S.A. Off Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra icial
Portugal Jour nal of
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol Broncoliber 6 mg/ml syrup oral use the inal, S.A. Rua da Tapada Grande, 2 — Abrunheira European 2710-089 Sintra Portugal Uni on
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol Broncoliber 120 mg prolonged-re- oral use inal, S.A. lease capsule, Rua da Tapada Grande, 2 — Abrunheira hard 2710-089 Sintra Portugal
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol Broncoliber 50 mg/ml oral solution oral use inal, S.A. Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra Portugal C 76/125 C 76/126
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Laboratórios Basi — Indústria Farmacêu- Ambroxol Broncosil 6 mg/ml syrup oral use EN tica, S.A Parque Industrial Manuel Lourenço Fer- reira, Lote 15 3450-232 Mortágua Portugal
Portugal Labialfarma — Laboratório de Produtos Ambroxol Bronxol 30 mg tablet oral use
Farmacêuticos e Nutracêuticos, S.A. Off Edifício Labialfarma, 1 — Felgueira 3450-336 Sobral — Mortágua icial
Portugal Jour nal
Portugal Labialfarma — Laboratório de Produtos Ambroxol Bronxol 6 mg/ml syrup oral use of Farmacêuticos e Nutracêuticos, S.A. the
Edifício Labialfarma, 1 — Felgueira European 3450-336 Sobral — Mortágua Portugal Uni
Portugal Pentafarma — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Clembroxol 3 mg/ml + syrup oral use on inal, S.A. 0,002 mg/ml Rua da Tapada Grande, no2 — Abrun- heira 2710-089 Sintra Portugal
Portugal Pentafarma — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Clembroxol 30 mg + 0,02 mg tablet oral use inal, S.A. Rua da Tapada Grande, no2 — Abrun- heira 2710-089 Sintra
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Pentafarma — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Clembroxol 1,5 mg/ml + syrup oral use EN inal, S.A. 0,001 mg/ml Rua da Tapada Grande, no2 — Abrun- heira 2710-089 Sintra Portugal
Portugal Pentafarma — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Clembroxol 30 mg + 0,02 mg granules oral use Off
inal, S.A. icial Rua da Tapada Grande, no2 — Abrun-
heira Jour 2710-089 Sintra Portugal nal of the European Portugal Laboratórios Vitória, S.A. Ambroxol Drenoxol 30 mg tablet oral use Rua Elias Garcia, 28 — Venda Nova 2700-327 Amadora Portugal Uni on
Portugal Laboratórios Vitória, S.A. Ambroxol Drenoxol 30 mg/10 ml syrup oral use Rua Elias Garcia, 28 — Venda Nova 2700-327 Amadora Portugal
Portugal Laboratórios Vitória, S.A. Ambroxol Drenoxol 3 mg/ml syrup oral use Rua Elias Garcia, 28 — Venda Nova 2700-327 Amadora Portugal C 76/127 C 76/128
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Sofex Farmacêutica, Lda. Ambroxol Fluidrenol 6 mg/ml syrup oral use Rua Sebastião e Silva, 25 EN 2745-838 Massamá Portugal
Portugal Sofex Farmacêutica, Lda. Ambroxol Fluidrenol 30 mg tablet oral use Rua Sebastião e Silva, 25 2745-838 Massamá Portugal Off
Portugal Distrifarma — Companhia de Distribui- Ambroxol Lactucol 6 mg/ml syrup oral use icial ção Farmacêutica, S.A.
Estrada Consiglieri Pedroso, 80 — Lt. 3 Jour — Armz. 1/12 — Queluz de Baixo 2745-553 Barcarena nal
Portugal of the
Portugal Medinfar Consumer Health — Produtos Ambroxol Mucodrenol 6 mg/ml syrup oral use European Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 — Venda Nova Uni 2700-451 Amadora Portugal on
Portugal Medinfar Consumer Health — Produtos Ambroxol Mucodrenol 30 mg/5 ml syrup oral use Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 — Venda Nova 2700-451 Amadora Portugal
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan 15 mg/2 ml solution for in- intravenous use atórios Farmacêuticos, Lda. jection Avenida de Pádua, 11 1800-294 Lisboa
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan 30 mg/5 ml syrup oral use EN atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan 6 mg/ml syrup oral use atórios Farmacêuticos, Lda. Off Avenida de Pádua, 11 1800-294 Lisboa icial
Portugal Jour nal of
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan 15 mg pastille oral use the atórios Farmacêuticos, Lda. Avenida de Pádua, 11 European 1800-294 Lisboa Portugal Uni on
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan 30 mg tablet oral use atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal
Portugal Unilfarma — União Internacional Labor- Ambroxol Mucosolvan Perlonguets 75 mg prolonged-re- oral use atórios Farmacêuticos, Lda. lease capsule, Avenida de Pádua, 11 hard 1800-294 Lisboa Portugal C 76/129 C 76/130
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Unilfarma — União Internacional Labor- Ambroxol + Clenbuterol Mucospas 3 mg/ml + syrup oral use EN atórios Farmacêuticos, Lda. 0,002 mg/ml Avenida de Pádua, 11 1800-294 Lisboa Portugal
Portugal Unilfarma — União Internacional Labor- Ambroxol + Clenbuterol Mucospas 1,5 mg/ml + syrup oral use atórios Farmacêuticos, Lda. 0,001 mg/ml Avenida de Pádua, 11
1800-294 Lisboa Off Portugal icial Jour Portugal Labialfarma — Laboratório de Produtos Ambroxol Mucotosse 6 mg/ml syrup oral use Farmacêuticos e Nutracêuticos, S.A. nal
Edifício Labialfarma, 1 — Felgueira of
3450-336 Sobral — Mortágua the Portugal European
Portugal Labialfarma — Laboratório de Produtos Ambroxol Mucotosse 30 mg tablet oral use
Farmacêuticos e Nutracêuticos, S.A. Uni Edifício Labialfarma, 1 — Felgueira 3450-336 Sobral — Mortágua on Portugal
Portugal Sociedade Farmacêutica Gestafarma, Lda. Ambroxol Spectorum Expectorante 6 mg/ml syrup oral use Rua Aquilino Ribeiro, 6-A 2790-027 Carnaxide Portugal
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Ventoliber 1,5 mg/ml + syrup oral use inal, S.A. 0,001 mg/ml Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Ventoliber 3 mg/ml + syrup oral use EN inal, S.A. 0,002 mg/ml Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra Portugal
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Ventoliber 30 mg + 0,02 mg granules oral use inal, S.A.
Rua da Tapada Grande, 2 — Abrunheira Off
2710-089 Sintra icial Portugal Jour nal
Portugal Tecnimede — Sociedade Técnico-Medic- Ambroxol + Clenbuterol Ventoliber 30 mg + 0,02 mg tablet oral use of
inal, S.A. the Rua da Tapada Grande, 2 — Abrunheira 2710-089 Sintra European Portugal Uni
Portugal Laboratórios Basi — Indústria Farmacêu- Bromhexine Basiflux 0,8 mg/ml syrup oral use on tica, S.A Parque Industrial Manuel Lourenço Fer- reira, Lote 15 3450-232 Mortágua Portugal
Portugal Laboratórios Basi — Indústria Farmacêu- Bromhexine Basiflux 1,6 mg/ml syrup oral use tica, S.A Parque Industrial Manuel Lourenço Fer- reira, Lote 15 3450-232 Mortágua Portugal C 76/131 C 76/132
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon 8 mg tablet oral use EN atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon 8 mg/5 ml syrup oral use atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa Off Portugal icial
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon 8 mg dispersible tablet oral use Jour
atórios Farmacêuticos, Lda. nal Avenida de Pádua, 11 1800-294 Lisboa of Portugal the European
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon 2 mg/ml oral solution oral use atórios Farmacêuticos, Lda. Avenida de Pádua, 11 Uni
1800-294 Lisboa on Portugal
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon Linctus Adulto 1,6 mg/ml syrup oral use atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa Portugal
Portugal Unilfarma — União Internacional Labor- Bromhexine Bisolvon Linctus Criança 0,8 mg/ml syrup oral use atórios Farmacêuticos, Lda. Avenida de Pádua, 11 1800-294 Lisboa
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Laboratórios Azevedos — Indústria Bromhexine Bromexina Tussilene 0,8 mg/ml syrup oral use EN Farmacêutica, S.A. Edifícios Azevedos — Estrada Nacional 117-2, Alfragide 2614-503 Amadora Portugal
Portugal Bluepharma Genéricos — Comércio de Bromhexine Bromexina Bluepharma 1,6 mg/ml syrup oral use Medicamentos, S.A. Off
São Martinho do Bispo icial 3045-016 Coimbra Portugal Jour nal of
Portugal Bluepharma Genéricos — Comércio de Bromhexine Bromexina Bluepharma 0,8 mg/ml syrup oral use the
Medicamentos, S.A. European São Martinho do Bispo 3045-016 Coimbra Portugal Uni on
Portugal Farmoz — Sociedade Técnico Medicinal, Bromhexine Bromexina Farmoz 1,6 mg/ml syrup oral use S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal
Portugal Farmoz — Sociedade Técnico Medicinal, Bromhexine Bromexina Farmoz 0,8 mg/ml syrup oral use S.A. Rua da Tapada Grande, 2, Abrunheira 2710-089 Sintra Portugal C 76/133 C 76/134
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Generis Farmacêutica, S.A. Bromhexine Bromexina Generis 0,8 mg/ml syrup oral use EN Rua João de Deus, 19 2700-487 Amadora Portugal
Portugal Generis Farmacêutica, S.A. Bromhexine Bromexina Generis 1,6 mg/ml syrup oral use Rua João de Deus, 19 2700-487 Amadora Portugal Off icial
Portugal Labialfarma — Laboratório de Produtos Bromhexine Bromexina Wynn 1,6 mg/ml syrup oral use Jour Farmacêuticos e Nutracêuticos, S.A. Edifício Labialfarma, 1 — Felgueira nal
3450-336 Sobral — Mortágua of
Portugal the European
Portugal Labialfarma — Laboratório de Produtos Bromhexine Bromexina Wynn 0,8 mg/ml syrup oral use Farmacêuticos e Nutracêuticos, S.A.
Edifício Labialfarma, 1 — Felgueira Uni 3450-336 Sobral — Mortágua on Portugal
Portugal Caldeira & Metelo, Lda. Bromhexine Bromocal 0,8 mg/ml syrup oral use Estrada de Paço de Arcos, 88 — Cacém Park, Armazém 27 2735-307 Agualva-Cacém Portugal
Portugal Laboratórios Atral, S.A. Bromhexine Lisomucin 2 mg/ml oral drops, solu- oral use Rua da Estação, 42 — Vala do Carregado tion 2600-726 Castanheira do Ribatejo
Portugal 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Portugal Laboratórios Atral, S.A. Bromhexine Lisomucin 1,6 mg/ml syrup oral use EN Rua da Estação, 42 — Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
Portugal Medinfar Consumer Health — Produtos Bromhexine Tosseque 0,8 mg/ml syrup oral use Farmacêuticos, Lda. Rua Henrique Paiva Couceiro, 27 —
Venda Nova Off 2700-451 Amadora icial Portugal Jour nal Romania BOEHRINGER INGELHEIM INTER- ambroxol hydrochloride MUCOSOLVAN JUNIOR 15 mg/5 ml 15 mg/5 ml syrup oral use of NATIONAL GmbH Binger Strasse 173, D- the 55 216 Ingelheim am Rhein, Germany European
Romania BOEHRINGER INGELHEIM INTER- ambroxol hydrochloride MUCOSOLVAN 30 mg/5 ml 30 mg/5 ml syrup oral use
NATIONAL GmbH Binger Strasse 173, D- Uni
55 216 Ingelheim am Rhein, on Germany
Romania BOEHRINGER INGELHEIM INTER- ambroxol hydrochloride MUCOSOLVAN 30 mg 30 mg tablet oral use NATIONAL GmbH Binger Strasse 173, D- 55 216 Ingelheim am Rhein, Germany
Romania BOEHRINGER INGELHEIM INTER- ambroxol hydrochloride MUCOSOLVAN MAX 75 mg prolonged-re- oral use NATIONAL GmbH Binger Strasse 173, D- lease capsule, 55 216 Ingelheim am Rhein, hard Germany C 76/135 C 76/136
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania BOEHRINGER INGELHEIM INTER- ambroxol hydrochloride MUCOSOLVAN 15 mg gumă orală 15 mg oral gum oral use EN NATIONAL GmbH Binger Strasse 173, D- 55 216 Ingelheim am Rhein, Germany
Romania ALIUD PHARMA GmbH & Co. KG ambroxol hydrochloride AMBROXOL AL 15 mg/5 ml 15 mg/5 ml syrup oral use Gottlieb-Daimler-Straβe 19, 89150 Lai- chingen,
Germany Off icial
Romania ALIUD PHARMA GmbH & Co. KG ambroxol hydrochloride AMBROXOL AL 7,5 mg/ml 7,5 mg/ml oral drops, solu- oral use Jour
Gottlieb-Daimler-Straβe 19, 89150 Lai- tion nal chingen, of Germany the European
Romania ALIUD PHARMA GmbH & Co. KG ambroxol hydrochloride AMBROXOL AL 30 mg 30 mg tablet oral use Gottlieb-Daimler-Straβe 19, 89150 Lai-
chingen, Uni
Germany on
Romania S.C. ARENA GROUP S.A. Str. Ştefan ambroxol hydrochloride AMBROXOL ARENA 30 mg 30 mg tablet oral use Mihăileanu nr. 31, Sector 2, Bucureşti, cod postal 024022, Romania
Romania Zentiva, k.s. ambroxol hydrochloride MUCOSIN CU MIERE sirop, 15 mg/5 ml 15 mg/5 ml syrup oral use U kabelovny 130 Dolni Mėcholupy 102 37 Praha 10 Czech Republic 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania Zentiva, a.s. ambroxol hydrochloride MUCOSIN 30 mg comprimate 30 mg tablet oral use EN Einsteinova 24 851 01, Bratislava Slovak Republic
Romania HEXAL AG, ambroxol hydrochloride AMBROXOL SANDOZ comprimate, 30 mg tablet oral use Industriestrasse 25, 30 mg D-83607 Holzkirchen,
Germany Off icial Jour Romania HEXAL AG, ambroxol hydrochloride AMBROXOL SANDOZ SIROP 3 mg/ml syrup oral use Industriestrasse 25, nal
D-83607 Holzkirchen, of
Germany the European
Romania BERLIN-CHEMIE AG (Menarini Group) ambroxol hydrochloride FLAVAMED 60 mg 60 mg effervescent ta- oral use
Glienicker Weg 125 blet Uni D-12489 Berlin, Germany on
Romania BERLIN-CHEMIE AG (Menarini Group) ambroxol hydrochloride FLAVAMED 30 mg 30 mg tablet oral use Glienicker Weg 125 D-12489 Berlin, Germany
Romania BERLIN-CHEMIE AG (Menarini Group) ambroxol hydrochloride FLAVAMED 30 mg/5 ml soluţie orală 30 mg/5 ml oral solution oral use Glienicker Weg 125 D-12489 Berlin, Germany C 76/137 C 76/138
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania BERLIN-CHEMIE AG (Menarini Group) ambroxol hydrochloride FLAVAMED 15 mg/5 ml 15 mg/5 ml oral solution oral use EN Glienicker Weg 125 D-12489 Berlin, Germany
Romania VIM SPECTRUM SRL, ROMANIA ambroxol hydrochloride AMBROXOL 30 mg 30 mg tablet oral use Şos. Sighişoarei nr. 409, Târgu Mureş (Corunca), Romania Off icial Romania Egis Pharmaceuticals Plc ambroxol hydrochloride AMBROXOL EGIS sirop, 3 mg/ml 3 mg/ml syrup oral use Kereszturi ut 30-38 Jour
Budapest nal H-1106 Hungary of the European Romania Egis Pharmaceuticals Plc ambroxol hydrochloride AMBROXOL EGIS, comprimate, 30 mg 30 mg tablet oral use Kereszturi ut 30-38 Budapest H-1106 Uni
Hungary on
Romania GEDEON RICHTER ROMÂNIA S.A., ambroxol hydrochloride AMBROXOL 30 mg/5 ml 30 mg/5 ml syrup oral use ROMANIA Str. Cuza-Vodă nr. 99-105, Târgu Mureş, Romania
Romania GEDEON RICHTER ROMÂNIA S.A., ambroxol hydrochloride AMBROXOL RICHTER 30 mg 30 mg tablet oral use ROMANIA Str. Cuza-Vodă nr. 99-105, Târgu Mureş,
Romania 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania TIS FARMACEUTIC SA, Sos. Industriilor ambroxol hydrochloride AMBROXOL 0,3 % soluţie orală 0,30 % oral solution oral use EN nr. 16 Sector 3, Bucuresti, Romania
Romania TIS FARMACEUTIC SA, Sos. Industriilor ambroxol hydrochloride AMBROXOL 0,75 % picaturi orale soluţie 0,75 % oral drops, solu- oral use nr. 16 tion Sector 3, Bucuresti,
Romania Off icial Jour Romania CYATHUS EXQUIRERE Pharma- ambroxol hydrochloride AMBROSPRAY 10 mg/pulverizare oromucosal oral use forschungsGmbH spray nal
Rudolfsplatz 2/1/8 A-1010 of
Viena, the Austria European
Romania BIOFARM S.A., ambroxol hydrochloride AMBROXOL BIOFARM 15 mg/5 ml, 15 mg/5 ml syrup oral use Uni Str.Logofat Tautu Nr. 99 sirop Sector 3, Bucureşti on 031212 Romania
Romania Farmaceutica REMEDIA S.A. Blv. Meta- ambroxol hydrochloride Neo-bronchol 15 mg pastile 15 mg lozenge oral use lurgiei nr. 78, sector 4, 041836 Bucureşti, Romania
Romania ROMPHARM COMPANY SRL, Str. Eroi- ambroxol hydrochloride AMBROXOL ROMPHARM 15 mg/5 ml, 15 mg/5 ml oral solution oral use lor, 1A, Otopeni, sirop Romania C 76/139 C 76/140
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania LAROPHARM SRL, ambroxol hydrochloride AMBROXOL LAROPHARM 30 mg, 30 mg tablet oral use EN Sos. Alexandriei 145 A, comprimate B07 Bragadiru, Judetul Ilfov, Romania
Romania LAROPHARM SRL, ambroxol hydrochloride AMBROXOL LAROPHARM 15 mg/5 ml 15 mg/5 ml oral solution oral use Sos. Alexandriei 145 A, soluţie orală Off B07 Bragadiru, Judetul Ilfov, icial
Romania Jour nal of
Romania SOLACIUM PHARMA S.R.L., str. Calea bromhexine hydrochlor- BROMHEXIN SOLACIUM 8 mg 8 mg tablet oral use the Rahovei nr. 266-268, corp. 60, axele A-B, ide stalpii 11-16, etaj II, birou 1, sector 5, European Bucuresti Romania Uni on
Romania LAROPHARM SRL, bromhexine hydrochlor- BRONHOSOLV 10 mg/5 ml oral solution oral use Sos. Alexandriei 145 A, ide 10 mg/5 ml B07 Bragadiru, Judetul Ilfov, Romania
Romania LABORMED PHARMA S.A. bromhexine hydrochlor- BROMHEXIN LABORMED 8 mg 8 mg tablet oral use Adresa: Bd. Theodor Pallady ide nr. 44B, sector 3, Bucuresti 032266 Romania 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania MAGISTRA C & C, Bd. Aurel Vlaicu nr. bromhexine hydrochlor- BROMHEXIN® 8 mg 8 mg tablet oral use EN 82A, 900055 ide Constanta, Romania
Romania LAROPHARM SRL, bromhexine hydrochlor- BRONHOSOLV 8 mg tablet oral use Sos. Alexandriei 145 A, ide B07 Bragadiru, Judetul Ilfov, Romania Off icial Romania TIS FARMACEUTIC SA, Sos. Industriilor bromhexine hydrochlor- BROMHEXIN — T 2 mg/ml oral drops, solu- oral use nr. 16 ide tion Jour
Sector 3, Bucuresti, nal Romania of the
Romania BIO EEL SRL, str. Bega nr. 4, Targu-Mures, bromhexine hydrochlor- BROMFLUEX 8 mg 8 mg tablet oral use European 540390, ide Romania Uni
Romania BIO EEL SRL, str. Bega nr. 4, Targu-Mures, bromhexine hydrochlor- BROMFLUEX 12 mg 12 mg tablet oral use on 540390, ide Romania
Romania A.C. HELCOR PHARMA SRL, str. Dr. bromhexine hydrochlor- BROMHEXIN HELCOR 8 mg 8 mg tablet oral use Victor Babeş nr. 50, ide Baia Mare, Maramureş, Romania
Romania ARENA GROUP SA, bromhexine hydrochlor- BROMHEXIN ARENA 8 mg 8 mg tablet oral use Bucuresti, str. Stefan Mihaileanu, nr. 31, ide sector 2, Romania C 76/141 C 76/142
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania ARENA GROUP SA, Bucuresti, str. Stefan bromhexine hydrochlor- BROMHEXIN ARENA 12 mg 12 mg tablet oral use EN Mihaileanu, nr. 31, ide sector 2, Romania
Romania LAROPHARM SRL, bromhexine hydrochlor- BROMHEXIN LAROPHARM 12 mg 12 mg tablet oral use Sos. Alexandriei 145 A, ide B07 Bragadiru, Judetul Ilfov, Romania Off icial Romania ROMPHARM COMPANY SRL, bromhexine hydrochlor- BROMHEXIN ROMPHARM 2 mg/ml 2 mg/ml oral drops, solu- oral use Str. Eroilor, 1A, Otopeni, ide tion Jour
Romania nal of
Romania SLAVIA PHARM SRL, Bd. bromhexine hydrochlor- ROMHEXIN SLAVIA 8 mg 8 mg tablet oral use the
Pallady Theodor, 44C, ide European Bucuresti-Sector 3, 021 304 6385, Romania Uni on Romania FARMACOM S.A., bromhexine hydrochlor- BROMHEXIN FARMACOM 8 mg 8 mg tablet oral use str. Zizinului nr. 112, 500407, Brasov, ide Romania
Romania ANTIBIOTICE SA bromhexine hydrochlor- BROMHEXIN ATB 8 mg 8 mg tablet oral use Str. Valea Lupului nr. 1, ide Iasi 707410, Romania
Romania BIOFARM S.A., Str.Logofat Tautu Nr. 99 bromhexine hydrochlor- BROMHEXIN BIOFARM 8 mg 8 mg tablet oral use Sector 3 031212 ide
Romania 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Romania BIOFARM S.A., Str.Logofat Tautu Nr. 99 bromhexine hydrochlor- BROMHEXIN BIOFARM 12 mg 12 mg tablet oral use EN Sector 3 031212 ide Romania
Slovak Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 15 mg 15 mg/2 ml solution for in- intravenous use Graf-Arco-Str. 3 jection 89079 Ulm Germany Off Slovak Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 15 mg/5 ml 15 mg/5 ml syrup oral use icial Graf-Arco-Str. 3
89079 Ulm Jour Germany nal of
Slovak Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 30 mg 30 mg tablet oral use the Graf-Arco-Str. 3 89079 Ulm European Germany Uni Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o. ambroxol hydrochloride Ambrobene 6 mg/ml oral solution 6 mg/1 ml oral solution oral use Teslova 26 on 821 02 Bratislava Slovak Republic
Slovak Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene 7,5 mg/ml 7,5 mg/ml oral/inhalation oral use, Graf-Arco-Str. 3 solution inhalation use 89079 Ulm Germany
Slovak Republic ratiopharm GmbH ambroxol hydrochloride Ambrobene retard 75 mg 75 mg prolonged-re- oral use Graf-Arco-Str. 3 lease capsule 89079 Ulm
Germany C 76/143 C 76/144
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovak Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride AMBROSAN 15 mg/5 ml sirup 15 mg/5 ml syrup oral use EN Telčská 1 140 00 Praha 4 Czech Republic
Slovak Republic PRO.MED.CS Praha a.s. ambroxol hydrochloride Ambrosan 30 mg 30 mg tablet oral use Telčská 1 140 00 Praha 4 Czech Republic Off icial Slovak Republic ALIUD PHARMA GmbH Gottlieb-Daim- ambroxol hydrochloride Ambroxol AL 75 retard 75 mg prolonged-re- oral use Jour ler-Straße 19, 89150 Laichingen Ger- lease capsule
many nal of the Slovak Republic ALIUD PHARMA GmbH Gottlieb-Daim- ambroxol hydrochloride AMBROXOL AL KVAPKY 7,5 mg/1 ml oral drops oral use ler-Straße 19, European 89150 Laichingen Germany Uni on Slovak Republic Berlin-Chemie AG ambroxol hydrochloride Flavamed 15 mg/5 ml perorálny roztok 3 mg/1 ml oral solution oral use Glienicker Weg 125 12489 Berlin Germany
Slovak Republic Berlin-Chemie AG Glienicker Weg 125 ambroxol hydrochloride Flavamed Cough Tablets 30 mg tablet oral use 12489 Berlin Germany
Slovak Republic Berlin-Chemie AG Glienicker Weg 125 ambroxol hydrochloride Flavamed forte perorálny roztok 6 mg/1 ml oral solution oral use 12489 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovak Republic Berlin-Chemie AG Glienicker Weg 125 ambroxol hydrochloride Flavamed šumivé tablety 60 mg effervescent ta- oral use EN 12489 Berlin blet Germany
Slovak Republic CYATHUS EXQUIRERE Pharma- ambroxol hydrochloride GOGOLOX 50 mg/1 g oral solution oral use forschungsGmbH Rudolfsplatz 2/1/8 1010 Wien Austria Off
Slovak Republic EGIS Pharmaceuticals PLC Keresztúri út ambroxol hydrochloride Halixol 30 mg 30 mg tablet oral use icial 30-38. 1106 Budapest Jour
Hungary nal of
Slovak Republic Zentiva, k.s. ambroxol hydrochloride MUCOSIN s medom sir 15 mg/5 ml syrup oral use the
U Kabelovny 130 European 102 37 Praha 10 Czech Republic Uni
Slovak Republic Zentiva, a.s. ambroxol hydrochloride MUCOSIN tablety 30 mg tablet oral use on Einsteinova 24 851 01, Bratislava Slovak Republic
Slovak Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan 15 mg pastille oral use GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Slovak Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan 30 mg/5 ml syrup oral use GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany C 76/145 C 76/146
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovak Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan Junior 3 mg/1 ml syrup oral use EN GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Slovak Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan Retard 75 mg prolonged-re- oral use GmbH lease capsule Binger Strasse 173 55216 Ingelheim am Rhein Germany Off
Slovak Republic Boehringer Ingelheim International ambroxol hydrochloride Mucosolvan Tablety 30 mg tablet oral use icial GmbH Binger Strasse 173 Jour
55216 Ingelheim am Rhein Germany nal of
Slovak Republic Divapharma GmbH ambroxol hydrochloride neo-bronchol 15 mg pastille oral use the
Motzener Straße 41 European 12277 Berlin Germany Uni
Slovak Republic KRKA, d.d. ambroxol hydrochloride Solvolan 30 mg tablet oral use on Šmarješka cesta 6 8000 Novo mesto Slovenia
Slovak Republic KRKA, d.d. ambroxol hydrochloride Solvolan 15 mg/5 ml syrup oral use Šmarješka cesta 6 8000 Novo mesto Slovenia
Slovak Republic WALMARK, a.s. ambroxol hydrochloride Stopex na vykašliavanie 60 mg effervescent ta- oral use Oldřichovice 44 blet 739 61 Třinec
Czech Republic 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovak Republic Berlin-Chemie AG Glienicker Weg 125 bromhexine hydrochlor- Bromhexin 12 BC 12 mg/1 ml oral solution oral use EN 12489 Berlin ide Germany
Slovak Republic Berlin-Chemie AG Glienicker Weg 125 bromhexine hydrochlor- Bromhexin 8 Berlin-Chemie 8 mg film-coated ta- oral use 12489 Berlin ide blet Germany Off icial Slovak Republic Krewel Meuselbach GmbH Krewelstraße 2 bromhexine hydrochlor- BROMHEXIN 12 KVAPKY KM 12 mg/1 ml oral drops oral use
53783 Eitorf ide Jour Germany nal of the Slovak Republic Krewel Meuselbach GmbH Krewelstraße 2 bromhexine hydrochlor- Bromhexin 8 sirup KM 8 mg/10 ml syrup oral use 53783 Eitorf ide European Germany Uni
Slovak Republic Krewel Meuselbach GmbH Krewelstraße 2 bromhexine hydrochlor- Bromhexin 8-kvapky KM 8 mg/ml oral solution oral use on 53783 Eitorf ide Germany
Slovak Republic Zentiva a.s. bromhexine hydrochlor- BRONCHOSAN 8 mg/ml oral drops oral use Nitrianska 100 ide, 1,5 mg/ml Hlohovec 920 27 mentholum, 0,75 mg/ml Slovak Republic oleum foeniculi, 0,250 mg/ml oleum anisi, 0,250 mg/ml oleum origani, 0,250 mg/ml oleum menthae piperi- 0,250 mg/ml tae, oleum eucalypti C 76/147 C 76/148
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovenia Boehringer Ingelheim International bromhexine hydrochlor- BISOLVON 4 mg/5 ml sirup 4 mg/5 ml syrup oral use EN GmbH ide Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
Slovenia Boehringer Ingelheim International bromhexine hydrochlor- Bisolvon 8 mg tablete 8 mg tablet oral use GmbH ide Binger Strasse 173 D-55216 Ingelheim am Rhein Germany Off
Slovenia Boehringer Ingelheim International bromhexine hydrochlor- Bisolvon 2 mg/ml peroralna raztopina/ 2 mg/ml oral solution/ oral use, icial GmbH ide inhalacijska raztopina za nebulator nebuliser solu- inhalation use Binger Strasse 173 tion Jour
D-55216 Ingelheim am Rhein Germany nal of
Slovenia KRKA, d.d., Novo mesto ambroxol hydrochloride Solvolan 3 mg/ml sirup 3 mg/ml syrup oral use the
Šmarješka cesta 6 European 8000 Novo mesto Slovenia Uni
Slovenia KRKA, d.d., Novo mesto ambroxol hydrochloride Solvolan 30 mg tablete 30 mg tablet oral use on Šmarješka cesta 6 8000 Novo mesto Slovenia
Slovenia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 3 mg/ml peroralna raztopina 3 mg/ml oral solution oral use Glienicker Weg 125 12489 Berlin Germany
Slovenia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 30 mg tablete 30 mg tablet oral use Glienicker Weg 125 12489 Berlin
Germany 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Slovenia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 6 mg/ml peroralna raztopina 6 mg/ml oral solution oral use EN Glienicker Weg 125 12489 Berlin Germany
Slovenia BERLIN-CHEMIE AG ambroxol hydrochloride Flavamed 60 mg šumeče tablete 60 mg effervescent ta- oral use Glienicker Weg 125 blet 12489 Berlin Germany Off icial Jour
Slovenia Medis, d.o.o. ambroxol hydrochloride Ambrospray 10 mg/vpih peroralna raz- 10 mg/spray puff oral solution oral use nal Brnčičeva 1 topina 1000 Ljubljana of Slovenia the European
Slovenia BERLIN-CHEMIE AG ambroxol hydrochloride Ambroksolijev klorid Berlin-Chemie 6 mg/ml oral solution oral use Glienicker Weg 125 6 mg/ml peroralna raztopina Uni
12489 Berlin on Germany
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Motosol 3 mg/ml jarabe 3 mg/ml syrup oral use Prat de la Riba, 50 08174 Sant Cugat del Vallés Barcelona Spain
Spain ARISTO PHARMA IBERICA, S.L. Ambroxol hydrochloride Ambroxol Edigen jarabe EFG 15 mg/5 ml syrup oral use Solana, 26 28850 Torrejón de Ardoz Madrid Spain C 76/149 C 76/150
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration EN Spain LABORATORIOS CINFA S.A. Ambroxol hydrochloride Ambroxol cinfa 15 mg/5 ml jarabe EFG 15 mg/5 ml syrup oral use Olaz-Chipi, 10 Poligono Indistrial Areta 31620 Huarte-Pamplona Navarra Spain
Spain LABORATORIOS NORMON S.A. Ambroxol hydrochloride Ambroxol Normon 3 mg/ml solucion 3 mg/ml oral solution oral use Ronda de Valdecarrizo, 6 EFG Off 28760 Tres Cantos icial Madrid Jour Spain nal of the
Spain APOTEX EUROPE B.V: Ambroxol hydrochloride Ambroxol Apotex 15 ml/5 ml jarabe EFG 15 mg/5 ml syrup oral use European Darwinweg, 20 2333 CR Leiden The Netherlands Uni on
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan 30 mg comprimidos 30 mg tablet oral use Prat de la Riba, 50 08174 Sant Cugat del Vallés Barcelona Spain
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Motosol 7,5 mg/ml solucion inyectable 7,5 mg/ml solution for in- intravenous use Prat de la Riba, 50 jection 08174 Sant Cugat del Vallés Barcelona Spain 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan Pediátrico 3 mg/ml jarabe 3 mg/ml syrup oral use EN Prat de la Riba, 50 08174 Sant Cugat del Vallés Barcelona Spain
Spain FERRER INTERNACIONAL S.A. Ambroxol hydrochloride Naxpa jarabe 15 mg/5 ml syrup oral use Gran Via Carlos III, 94 08028 Barcelona
Spain Off icial
Spain LABORATORIOS NORMON S.A. Ambroxol hydrochloride Mucibron 3 mg/ml solucion oral 3 mg/ml oral solution oral use Jour
Ronda de Valdecarrizo, 6 nal 28760 Tres cantos of Madrid the Spain European
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan Retard 75 mg cápsulas de 75 mg prolonged-re- oral use
Prat de la Riba, 50 liberación prolongada lease capsule, Uni
08174 Sant Cugat del Vallés Barcelona hard on Spain
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Motosol Retard 75 mg cápsulas de 75 mg prolonged-re- oral use Prat de la Riba, 50 liberación prolongada lease capsule, 08174 Sant Cugat del Vallés Barcelona hard Spain
Spain WAAS_ANITA S.A. Ambroxol hydrochloride Dinobroxol jarabe 15 mg/5 ml syrup oral use General Prim 13 28035 Madrid Spain C 76/151 C 76/152
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan 60 mg polvo para solución oral 15 mg/5 ml powder for oral oral use EN Prat de la Riba, 50 suspension 08174 Sant Cugat del Vallés Barcelona Spain
Spain RATIOPHARM ESPAÑA S.A. ambroxol hydrochloride Ambroxol ratiopharm 3 mg/ml jarabe 3 mg/ml syrup oral use Avda Burgos, 16 D 5a Planta EFG 28036 Madrid Spain Off icial
Spain SANDOZ FARMACEUTICA S.A. Ambroxol hydrochloride Ambroxol Sandoz 3 mg/ml jarabe EFG 3 mg/ml syrup oral use Jour Avda Osa Mayor, 4 nal 28023 Aravaca Madrid of Spain the European
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan 6 mg/ml jarabe 6 mg/ml syrup oral use Prat de la Riba, 50 08174 Sant Cugat del Vallés Barcelona Uni Spain on
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan 15 mg pastillas de goma 15 mg oral gum oral use Prat de la Riba, 50 08174 Sant Cugat del Vallés Barcelona Spain
Spain CYATHUS EXQUIRERE PHARMA- Ambroxol hydrochloride Ambroxol Exquirere 10 mg pulsación 10 mg/pulsation oral solution oral use FORSCHUNGS GMBH solucion oral Rudolfsplatz 2/1/8 1010 Viena
Austria 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Spain LABORATORIOS VICKS S.L. Ambroxol hydrochloride Formulamucol 6 mg/ml solución oral 6 mg/ml oral solution oral use EN Avda Bruselas, 24 EFG 28108 Alcobendas Madrid Spain
Spain LABORATORIOS VICKS S.L. Ambroxol hydrochloride Formulamucol 3 mg/ml solución oral 3 mg/ml oral solution oral use Avda Bruselas, 24 EFG
28108 Alcobendas Off
Madrid icial Spain Jour nal
Spain TEVA PHARMA S.L.U. Ambroxol hydrochloride Ambroxol Tevapharma 3 mg/ml solución 3 mg/ml oral solution oral use of a
C/Anabel Segura 11 Edificio Albatros B 1 the Planta 28108 Alcobendas European Madrid Spain Uni on Spain TEVA PHARMA S.L.U. Ambroxol hydrochloride Ambroxol Tevapharma 6 mg/ml solución 6 mg/ml oral solution oral use C/Anabel Segura 11 Edificio Albatros B 1a Planta 28108 Alcobendas Madrid Spain
Spain RATIOPHARM ESPAÑA S.A. C/Anabel Ambroxol hydrochloride Ambroxol ratio 6 mg/ml solucion oral 6 mg/ml oral solution oral use Segura 11 Edificio EFG Albatros B 1a Planta 28108 Alcobendas Madrid Spain C 76/153 C 76/154
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration EN Spain RATIOPHARM ESPAÑA S.A. C/Anabel Ambroxol hydrochloride Ambroxol ratio 3 mg/ml solución oral 3 mg/ml oral solution oral use Segura 11 Edificio Albatros B 1a Planta EFG 28108 Alcobendas Madrid Spain
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Lizipadol 20 mg pastillas para chupar 20 mg lozenge oromucosal use
Prat de la Riba, 50 Off
08174 Sant Cugat del Vallés Barcelona icial Spain Jour nal of
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Ambroxol hydrochloride Mucosan 30 mg jarabe en sobres 30 mg syrup oral use the
Prat de la Riba, 50 European 08174 Sant Cugat del Vallés Barcelona Spain Uni on
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Bromhexine hydrochlor- Bisolmed 2 mg/ml solución inyectable y 2 mg/ml solution for in- intravenous use Prat de la Riba, 50 ide para perfusión jection/infusion 08174 Sant Cugat del Vallés Barcelona Spain
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Bromhexine hydrochlor- Bisolmed 2 mg/ml solución oral/concen- 2 mg/ml oral solution/ oral use Prat de la Riba, 50 ide trado para solución para inhalación por concentrate for 08174 Sant Cugat del Vallés Barcelona nebulizador nebuliser solu- Spain tion 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Spain LABORATORIOS CINFA S.A. Bromhexine hydrochlor- Bactopumon 2 mg + 400 mg + oral suspension oral use EN Olaz-Chipi, 10 ide + Sulfamethoxazole 80 mg + 75 mg/5 ml Poligono Indistrial Areta hydrochloride + Tri- 31620 Huarte Pamplona methoprim + balsam Navarrra tolu aqueous extract Spain
Spain DESMA LABORATORIO FARMACEUTI- bromhexine hydrochlor- Balsoprim suspensión 50 mg + 2 660 mg + oral suspension oral use CO, S.L. ide + Sulfamethoxazole 540 mg/100 ml Off o Cuatro amigos 7, escalera 2, 1 D hydrochloride + Tri- icial 28029 Madrid methoprim Spain Jour nal of
Spain FAES FARMA, S.A. Bromhexine hydrochlor- Bronquidiazina CR suspensión 4 mg + 250 mg + oral suspension oral use the
Maximo Aguirre, 14 ide + benzoate sodium + 400 mg + 80 mg + European 48940 Sulfamethoxazole + Tri- 325 mg/7,5 ml Lamiaco-Lejona Vizcaya methoprim + Balsam Spain Tolú syrup Uni on
Spain GLAXOSMITHKLINE, S.A. Bromhexine hydrochlor- Clamoxyl mucolítico 500 mg cápsulas 8 mg + 500 mg capsule, hard oral use Severo Ochoa, 2 ide + Amoxicilin trihy- 28760 Tres Cantos drate Madrid Spain
Spain GLAXOSMITHKLINE, S.A. Bromhexine hydrochlor- Clamoxyl mucolítico 250 mg suspensión 4 mg + 250 mg/5 ml powder for oral oral use Severo Ochoa, 2 ide + Amoxicilin trihy- extemporánea suspension 28760 Tres Cantos drate Madrid Spain C 76/155 C 76/156
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Bromhexine hydrochlor- Bisolvon mucolítico 1,6 mg/ml jarabe 8 mg/5 ml syrup oral use EN Prat de la Riba, 50 ide 08174 Sant Cugat del Vallés Barcelona Spain
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Bromhexine hydrochlor- Bisolvon mucolítico 8 mg comprimidos 8 mg soluble tablet oral use Prat de la Riba, 50 ide solubles 08174 Sant Cugat del Vallés Barcelona Spain Off
Spain BOEHRINGER INGELHEIM ESPAÑA, S.A. Bromhexine hydrochlor- Bisolvon mucolítico infantil 0,8 mg/ml 0,8 mg/ml syrup oral use icial Prat de la Riba, 50 ide jarabe 08174 Sant Cugat del Vallés Barcelona Jour
Spain nal of
Sweden Boehringer Ingelheim International Ambroxolol hydrochlor- Mucoangin Svartvinbär 20 mg lozenge oral use the
GmbH, Binger Strasse 173, DE-55216 ide European Ingelheim am Rhein, Germany Uni
Sweden Boehringer Ingelheim International Ambroxolol hydrochlor- Mucoangin 20 mg lozenge oral use on GmbH, Binger Strasse 173, DE-55216 ide Ingelheim am Rhein, Germany
Sweden Boehringer Ingelheim International Ambroxolol hydrochlor- Mucoangin Citron 20 mg lozenge oral use GmbH, Binger Strasse 173, DE-55216 ide Ingelheim am Rhein, Germany
Sweden BioPhausia AB, Bromhexine hydrochlor- Mollipect 0,5 mg/ml + 1 mg/ oral solution oral use Blasieholmsgatan 2, ide + ephedrine hydro- ml 111 48 Stockholm, chloride
Sweden 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Sweden Apofri AB, Box 120, Bromhexine hydrochlor- Bromhexin Apofri 0,8 mg/ml oral solution oral use EN 182 12 Danderyd, ide Sweden
Sweden Apofri AB, Box 120, Bromhexine hydrochlor- Bromhexin Apofri 1,6 mg/ml oral solution oral use 182 12 Danderyd, ide Sweden
Sweden Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 8 mg tablet oral use Off
GmbH, Binger Strasse 173, DE-55216 ide icial Ingelheim am Rhein, Germany Jour nal
Sweden Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 0,8 mg/ml oral solution oral use of GmbH, Binger Strasse 173, DE-55216 ide the
Ingelheim am Rhein, European Germany
Sweden Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 1,6 mg/ml oral solution oral use Uni
GmbH, Binger Strasse 173, DE-55216 ide on Ingelheim am Rhein, Germany
Sweden Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon 8 mg soluble tablet oral use GmbH, Binger Strasse 173, DE-55216 ide Ingelheim am Rhein, Germany
Sweden Boehringer Ingelheim International Bromhexine hydrochlor- Bisolvon Jordgubb 0,8 mg/ml oral solution oral use GmbH, Binger Strasse 173, DE-55216 ide Ingelheim am Rhein, Germany C 76/157 C 76/158
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
Sweden McNeil Sweden AB, Bromhexine hydrochlor- Bromhex 0,8 mg/ml oral solution oral use EN 169 90 Solna, ide Sweden
The Netherlands Boehringer Ingelheim B.V. ambroxol hydrochloride Mucoangin, zuigtabletten 20 mg lozenge oral use Comeniusstraat 6 20 mg 1817 MS Alkmaar The Netherlands Off The Netherlands Boehringer Ingelheim B.V. ambroxol hydrochloride Mucoangin Citroen 20 mg, zuigtabletten 20 mg lozenge oral use icial Comeniusstraat 6
1817 MS Alkmaar Jour The Netherlands nal of
The Netherlands Boehringer Ingelheim B.V. ambroxol hydrochloride Rexambro 20 mg, zuigtabletten 20 mg lozenge oral use the Comeniusstraat 6 1817 MS Alkmaar European The Netherlands Uni The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon drank in sachet, 8 mg oral solution in oral use Comeniusstraat 6 ide 8 mg sachet on 1817 MS Alkmaar The Netherlands
The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon drank voor kinderen met aard- 4 mg/5 ml oral solution oral use Comeniusstraat 6 ide beiensmaak, 4 mg/5 ml 1817 MS Alkmaar The Netherlands
The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon drank voor kinderen, 4 mg/5 ml 4 mg/5 ml oral solution oral use Comeniusstraat 6 ide 1817 MS Alkmaar
The Netherlands 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon drank, 8 mg/5 ml 8 mg/5 ml oral solution oral use EN Comeniusstraat 6 ide 1817 MS Alkmaar The Netherlands
The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon druppels voor kinderen, oploss- 2 mg/ml oral solution oral use Comeniusstraat 6 ide ing 2 mg/ml 1817 MS Alkmaar The Netherlands Off
The Netherlands Boehringer Ingelheim B.V. bromhexine hydrochlor- Bisolvon tabletten, 8 mg 8 mg tablet oral use icial Comeniusstraat 6 ide 1817 MS Alkmaar Jour
The Netherlands nal of
The Netherlands Sameko BV bromhexine hydrochlor- Broomhexine HCI 8 mg Sameko, table- 8 mg tablet oral use the
Archimedesweg 2 ide tten European 2333 CN LEIDEN The Netherlands Uni
The Netherlands Centrafarm B.V. bromhexine hydrochlor- Broomhexine HCl CF 4 mg/5 ml, drank 4 mg/5 ml oral solution oral use on Nieuwe Donk 3 ide 4879 AC ETTEN LEUR The Netherlands
The Netherlands Centrafarm B.V. bromhexine hydrochlor- Broomhexine HCl CF 8 mg, tabletten 8 mg tablet oral use Nieuwe Donk 3 ide 4879 AC ETTEN LEUR The Netherlands
The Netherlands Centrafarm B.V. bromhexine hydrochlor- Broomhexine HCl CF 8 mg/5 ml, drank 8 mg/5 ml oral solution oral use Nieuwe Donk 3 ide 4879 AC ETTEN LEUR
The Netherlands C 76/159 C 76/160
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Basic Pharma Manufacturing bv bromhexine hydrochlor- Broomhexine HCl drank 4 mg/5 ml oral solution oral use EN Burgemeester Lemmensstraat 352 ide 4 mg/5 ml, drank 6163 JT GELEEN The Netherlands
The Netherlands Basic Pharma Manufacturing bv bromhexine hydrochlor- Broomhexine HCl drank 8 mg/5 ml oral solution oral use Burgemeester Lemmensstraat 352 ide 8 mg/5 ml, drank 6163 JT GELEEN The Netherlands Off icial The Netherlands Apotex Europe B.V. bromhexine hydrochlor- Broomhexine HCl hoestdrank extra sterk 8 mg/5 ml oral solution oral use
Darwinweg 20 ide suikervrij Apotex 8 mg/5 ml, drank Jour 2333 CR LEIDEN The Netherlands nal of the The Netherlands Apotex Europe B.V. bromhexine hydrochlor- Broomhexine HCl hoestdrank suikervrij 4 mg/5 ml oral solution oral use Darwinweg 20 ide Apotex 4 mg/5 ml, drank European 2333 CR LEIDEN The Netherlands Uni
The Netherlands Apotex Europe B.V. bromhexine hydrochlor- Broomhexine HCl Apotex 8 mg tablet oral use on Darwinweg 20 ide 8 mg, tabletten The Netherlands
The Netherlands Mediq Farma B.V. bromhexine hydrochlor- Broomhexine HCl Mdq 4 mg/5 ml oral solution oral use Hertogswetering 159 ide 4 mg/5 ml, drank 3543 AS UTRECHT The Netherlands
The Netherlands Mediq Farma B.V. bromhexine hydrochlor- Broomhexine HCl Mdq 8 mg, tabletten 8 mg tablet oral use Hertogswetering 159 ide 3543 AS UTRECHT
The Netherlands 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Mediq Farma B.V. bromhexine hydrochlor- Broomhexine HCl Mdq 8 mg/5 ml oral solution oral use Hertogswetering 159 ide 8 mg/5 ml, drank EN 3543 AS UTRECHT The Netherlands
The Netherlands RXT bromhexine hydrochlor- Broomhexine HCl RXT 8 mg, tabletten 8 mg tablet oral use Amsterdamsestraatweg 22 ide 1391 AB ABCOUDE The Netherlands Off
The Netherlands Nederlandse Service Apotheek Beheer B. bromhexine hydrochlor- Broomhexine HCI SAM 8 mg tablet oral use icial V. ide 8 mg, tabletten Vonderweg 39a Jour 7468 DC ENTER nal The Netherlands of the The Netherlands Sandoz B.V. bromhexine hydrochlor- Broomhexine HCl Sandoz 0,8 mg/ml, 0,8 mg/ml oral solution oral use Veluwezoom 22 ide drank European 1327 AH ALMERE The Netherlands Uni
The Netherlands MAE Holding BV bromhexine hydrochlor- Broomhexine HCl Triangle Pharma 8 mg, 8 mg tablet oral use on Amsterdamsestraatweg 22 ide tabletten 1391 AB ABCOUDE The Netherlands
The Netherlands MAE Holding BV bromhexine hydrochlor- Broomhexine HCl Triangle Pharma 8 mg, 8 mg tablet oral use Amsterdamsestraatweg 22 ide tabletten 1391 AB ABCOUDE The Netherlands
The Netherlands Pharmachemie B.V. bromhexine hydrochlor- Broomhexine HCl 4=5 PCH, drank 4 mg/ 4 mg/5 ml oral solution oral use Swensweg 5 ide 5 ml 2031 GA HAARLEM
The Netherlands C 76/161 C 76/162
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Basic Pharma Manufacturing bv bromhexine hydrochlor- Broomhexine HCl 8 mg, tabletten 8 mg tablet oral use Burgemeester Lemmensstraat 352 ide EN 6163 JT GELEEN The Netherlands
The Netherlands Pharmachemie B.V. bromhexine hydrochlor- Broomhexine HCl 8 PCH, tabletten 8 mg 8 mg tablet oral use Swensweg 5 ide 2031 GA HAARLEM The Netherlands Off
The Netherlands Pharmachemie B.V. bromhexine hydrochlor- Broomhexine HCl 8=5 PCH, drank 8 mg/ 8 mg/5 ml oral solution oral use icial Swensweg 5 ide 5 ml 2031 GA HAARLEM Jour The Netherlands nal of
The Netherlands Samenwerkende Apothekers Nederland B. bromhexine hydrochlor- Broomhexinehydrochloride 8 mg tablet oral use the V. ide 8 mg tabletten Samenwerkende Apothe- Kralingseweg 201 kers European 3062 CE ROTTERDAM The Netherlands Uni
The Netherlands Sameko BV bromhexine hydrochlor- C1000 Hoestdrank Broomhexine HCl 4 mg/5 ml oral solution oral use on Archimedesweg 2 ide 4 mg/5 ml, drank 2333 CN LEIDEN The Netherlands
The Netherlands Sameko BV bromhexine hydrochlor- C1000 Hoestdrank Extra Sterk Broom- 8 mg/5 ml oral solution oral use Archimedesweg 2 ide hexine HCI 8 mg/5 ml, drank 2333 CN LEIDEN The Netherlands
The Netherlands Sameko BV bromhexine hydrochlor- C1000 Hoesttabletten Broomhexine HCl 8 mg tablet oral use Archimedesweg 2 ide 8 mg, tabletten 2333 CN LEIDEN
The Netherlands 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands HEMA B.V. bromhexine hydrochlor- HEMA Hoestdrank Broomhexine HCl 4 mg/5 ml oral solution oral use EN NDSM-straat 10 ide 4 mg/5 ml, drank 1033 SB AMSTERDAM The Netherlands
The Netherlands HEMA B.V. bromhexine hydrochlor- HEMA Hoestdrank Broomhexine HCl 8 mg/5 ml oral solution oral use NDSM-straat 10 ide 8 mg/5 ml, drank 1033 SB AMSTERDAM The Netherlands Off
The Netherlands HEMA B.V. bromhexine hydrochlor- HEMA Hoesttabletten Broomhexine HCl 8 mg tablet oral use icial NDSM-straat 10 ide 8 mg, tabletten 1033 SB AMSTERDAM Jour
The Netherlands nal of
The Netherlands HTP Huisapotheek B.V. bromhexine hydrochlor- Hoestdrank Broomhexine HCl 4 mg/5 ml 4 mg/5 ml oral solution oral use the
Nieuwe Donk 3 ide HTP Huisapotheek, drank European 4879 AC ETTEN-LEUR The Netherlands Uni
The Netherlands HTP Huisapotheek B.V. bromhexine hydrochlor- Hoestdrank Broomhexine HCl 8 mg/5 ml 8 mg/5 ml oral solution oral use on Nieuwe Donk 3 ide HTP Huisapotheek, drank 4879 AC ETTEN-LEUR The Netherlands
The Netherlands HTP Huisapotheek B.V. bromhexine hydrochlor- Hoesttabletten Broomhexine HCl 8 mg 8 mg tablet oral use Nieuwe Donk 3 ide HTP Huisapotheek, tabletten 4879 AC ETTEN-LEUR The Netherlands
The Netherlands SDG Farma B.V. bromhexine hydrochlor- IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml oral solution oral use Treubweg 11 ide 4 mg/5 ml, drank 1112 BA DIEMEN
The Netherlands C 76/163 C 76/164
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands SDG Farma B.V. bromhexine hydrochlor- IDYL Hoesttabletten Broomhexine HCl 8 mg tablet oral use EN Treubweg 11 ide 8 mg, tabletten 1112 BA DIEMEN The Netherlands
The Netherlands Jumbo Supermarkten B.V. bromhexine hydrochlor- JUMBO Hoestdrank Broomhexine HCl 4 mg/5 ml oral solution oral use Rijksweg 15 ide 4 mg/5 ml suikervrij, drank 5462 CE VEGHEL The Netherlands Off
The Netherlands Jumbo Supermarkten B.V. bromhexine hydrochlor- JUMBO hoestdrank extra sterk broom- 8 mg/5 ml oral solution oral use icial Rijksweg 15 ide hexine HCl 5462 CE VEGHEL 8 mg/5 ml suikervrij, drank Jour
The Netherlands nal of
The Netherlands Jumbo Supermarkten B.V. bromhexine hydrochlor- JUMBO hoesttabletten broomhexine HCl 8 mg tablet oral use the
Rijksweg 15 ide 8 mg, tabletten European 5462 CE VEGHEL The Netherlands Uni
The Netherlands Marel B.V. bromhexine hydrochlor- Kruidvat HOESTDRANK Broomhexine 4 mg/5 ml oral solution oral use on Archimedesweg 2 ide HCl 4 mg/5 ml suikervrij, drank 2333 CN LEIDEN The Netherlands
The Netherlands Marel B.V. bromhexine hydrochlor- Kruidvat HOESTDRANK Extra sterk 8 mg/5 ml oral solution oral use Archimedesweg 2 ide Boomhexine HCl 8 mg/5 ml suikervrij, 2333 CN LEIDEN drank The Netherlands
The Netherlands Leidapharm B.V. bromhexine hydrochlor- Leidapharm Hoestdrank Broomhexine 4 mg/5 ml oral solution oral use Archimedesweg 2 ide HCl 4 mg/5 ml suikervrij, drank 2333 CN LEIDEN
The Netherlands 26.2.2016 26.2.2016
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Leidapharm B.V. bromhexine hydrochlor- Leidapharm Hoestdrank Extra sterk 8 mg/5 ml oral solution oral use EN Archimedesweg 2 ide Broomhexine HCl 8 mg/5 ml suikervrij, 2333 CN LEIDEN drank The Netherlands
The Netherlands Nedac Sorbo B.V. bromhexine hydrochlor- NEDAC SORBO Hoestdrank Broomhex- 4 mg/5 ml oral solution oral use Innovatie 1 ide ine HCl 4 mg/5 ml suikervrij, drank 6921 RN DUIVEN The Netherlands Off
The Netherlands Nedac Sorbo B.V. bromhexine hydrochlor- NEDAC SORBO Hoestdrank Extra Sterk 8 mg/5 ml oral solution oral use icial Innovatie 1 ide Broomhexine HCl 8 mg/5 ml suikervrij, 6921 RN DUIVEN drank Jour
The Netherlands nal of
The Netherlands Nedac Sorbo B.V. bromhexine hydrochlor- NEDAC SORBO Hoesttabletten Broom- 8 mg tablet oral use the
Innovatie 1 ide hexine HCl 8 mg, tabletten European 6921 RN DUIVEN The Netherlands Uni
The Netherlands Centrafarm B.V. bromhexine hydrochlor- Otrivin Broomhexine HCI 8 mg/5 ml oral solution oral use on Nieuwe Donk 3 ide 8 mg/5 ml, drank 4879 AC Etten-Leur The Netherlands
The Netherlands Centrafarm B.V. bromhexine hydrochlor- Otrivin Broomhexine HCl 4 mg/5 ml, 4 mg/5 ml oral solution oral use Nieuwe Donk 3 ide drank 4879 AC Etten-Leur The Netherlands
The Netherlands Marel B.V. bromhexine hydrochlor- Trekpleister HOESTDRANK Broomhexine 4 mg/5 ml oral solution oral use Archimedesweg 2 ide HCl 4 mg/5 ml suikervrij, drank 2333 CN LEIDEN
The Netherlands C 76/165 C 76/166
Member State in Pharmaceutical Route of adminis- Marketing authorisation holder INN Invented name Strength EEA form tration
The Netherlands Marel B.V. bromhexine hydrochlor- Trekpleister HOESTDRANK Broomhexine 4 mg/5 ml oral solution oral use
Archimedesweg 2 ide HCl 4 mg/5 ml, drank EN 2333 CN LEIDEN The Netherlands The Netherlands Marel B.V. bromhexine hydrochlor- Trekpleister HOESTDRANK Extra sterk 8 mg/5 ml oral solution oral use Archimedesweg 2 ide Broomhexine HCl 8 mg/5 ml suikervrij, 2333 CN LEIDEN drank The Netherlands The Netherlands Marel B.V. bromhexine hydrochlor- Trekpleister HOESTDRANK EXTRA 8 mg/5 ml oral solution oral use Archimedesweg 2 ide STERK Broomhexine HCl 8 mg/5 ml,
2333 CN LEIDEN drank Off
The Netherlands icial The Netherlands Marel B.V. bromhexine hydrochlor- Trekpleister hoesttabletten bij vastzittende 8 mg tablet oral use Archimedesweg 2 ide hoest 8, tabletten 8 mg Jour
2333 CN LEIDEN nal
The Netherlands of
The Netherlands Procter & Gamble Nederland B.V. bromhexine hydrochlor- Vicks Hoestdrank broomhexinehy- 8 mg/5 ml oral solution oral use the
Watermanweg 100 ide drochloride European 3067 GG ROTTERDAM 8 mg/5 ml, drank The Netherlands The Netherlands Procter & Gamble Nederland B.V. bromhexine hydrochlor- Vicks Hoestdrank voor Kinderen broom- 4 mg/5 ml oral solution oral use Watermanweg 100 ide hexinehydrochloride Uni
3067 GG ROTTERDAM 4 mg/5 ml, drank on The Netherlands 26.2.2016
ISSN 1977-091X (electronic edition) ISSN 1725-2423 (paper edition)
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