# Official Journal C 76/26 F

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 76 |
| | |
| English edition | Information and Notices | Volume 5926 February 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 76

English edition

Information and Notices

Volume 5926 February 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | 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 |

Notice No

Contents

page

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)

(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)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

10

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.2.2016 | EN | Official Journal of the European Union | C 76/1 |
| --- | --- | --- | --- |

26.2.2016

EN

Official Journal of the European Union

C 76/1

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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)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.1.2016 | Eptifibatide Accord | eptifibatide | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1065 | Solution for infusion
  Solution for injection | B01AC16 | 13.1.2016 |
| 14.1.2016 | Benepali | etanercept | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | Solution for injection | L04AB01 | 18.1.2016 |
| 14.1.2016 | Briviact | brivaracetam | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | Film-coated tablet
  Oral solution
  Solution for injection or infusion | N03AX23 | 18.1.2016 |
| 14.1.2016 | Episalvan | birch bark extract | Birken AG
  Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland | EU/1/15/1069 | Gel | Pending | 18.1.2016 |
| 14.1.2016 | Lopinavir/Ritonavir Mylan | lopinavir/ritonavir | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1067 | Film-coated tablet | J05AR10 | 18.1.2016 |
| 14.1.2016 | Oncaspar | pegaspargase | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | EU/1/15/1070 | Powder and solvent for solution for injection/infusion | L01XX24 | 18.1.2016 |
| 14.1.2016 | Spectrila | asparaginase | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/15/1072 | Powder for concentrate for solution for infusion | L01XX02 | 18.1.2016 |
| 18.1.2016 | Pemetrexed Accord | pemetrexed | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | Powder for concentrate for solution for infusion | L01BA04 | 20.1.2016 |
| 18.1.2016 | Pemetrexed Actavis | pemetrexed | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/15/1063 | Concentrate for solution for infusion | L01BA04 | 21.1.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

11.1.2016

Eptifibatide Accord

eptifibatide

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1065

Solution for infusion

Solution for injection

B01AC16

13.1.2016

14.1.2016

Benepali

etanercept

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

Solution for injection

L04AB01

18.1.2016

14.1.2016

Briviact

brivaracetam

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/15/1073

Film-coated tablet

Oral solution

Solution for injection or infusion

N03AX23

18.1.2016

14.1.2016

Episalvan

birch bark extract

Birken AG

Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

Gel

Pending

18.1.2016

14.1.2016

Lopinavir/Ritonavir Mylan

lopinavir/ritonavir

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/15/1067

Film-coated tablet

J05AR10

18.1.2016

14.1.2016

Oncaspar

pegaspargase

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

EU/1/15/1070

Powder and solvent for solution for injection/infusion

L01XX24

18.1.2016

14.1.2016

Spectrila

asparaginase

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/15/1072

Powder for concentrate for solution for infusion

L01XX02

18.1.2016

18.1.2016

Pemetrexed Accord

pemetrexed

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/15/1071

Powder for concentrate for solution for infusion

L01BA04

20.1.2016

18.1.2016

Pemetrexed Actavis

pemetrexed

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/15/1063

Concentrate for solution for infusion

L01BA04

21.1.2016

—   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 decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2016 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 11.1.2016 |
| 7.1.2016 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 11.1.2016 |
| 7.1.2016 | Sildenafil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/584 | 11.1.2016 |
| 7.1.2016 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | 11.1.2016 |
| 11.1.2016 | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 13.1.2016 |
| 11.1.2016 | Latuda | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | 13.1.2016 |
| 11.1.2016 | Sivextro | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/991 | 13.1.2016 |
| 11.1.2016 | Yellox | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/11/692 | 13.1.2016 |
| 11.1.2016 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 13.1.2016 |
| 12.1.2016 | Atriance | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/403 | 14.1.2016 |
| 12.1.2016 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 14.1.2016 |
| 12.1.2016 | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 14.1.2016 |
| 12.1.2016 | Gardasil 9 | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 14.1.2016 |
| 12.1.2016 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 14.1.2016 |
| 14.1.2016 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom. | EU/1/12/760 | 18.1.2016 |
| 14.1.2016 | Caprelsa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/749 | 18.1.2016 |
| 14.1.2016 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 18.1.2016 |
| 14.1.2016 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 18.1.2016 |
| 14.1.2016 | Glivec | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/198 | 18.1.2016 |
| 14.1.2016 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 19.1.2016 |
| 14.1.2016 | Lumigan | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/02/205 | 18.1.2016 |
| 14.1.2016 | Pravafenix | LABORATOIRES SMB SA
  26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België | EU/1/11/679 | 18.1.2016 |
| 14.1.2016 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 18.1.2016 |
| 14.1.2016 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 18.1.2016 |
| 14.1.2016 | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 18.1.2016 |
| 14.1.2016 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274 | 18.1.2016 |
| 14.1.2016 | Xeloda | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/163 | 18.1.2016 |
| 18.1.2016 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 20.1.2016 |
| 18.1.2016 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 20.1.2016 |
| 18.1.2016 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 20.1.2016 |
| 22.1.2016 | Clopidogrel Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/561 | 26.1.2016 |
| 22.1.2016 | Kadcyla | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/885 | 26.1.2016 |
| 22.1.2016 | Levitra | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/248 | 26.1.2016 |
| 22.1.2016 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706 | 26.1.2016 |
| 22.1.2016 | Neupro | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/05/331 | 26.1.2016 |
| 22.1.2016 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 26.1.2016 |
| 22.1.2016 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 26.1.2016 |
| 22.1.2016 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 26.1.2016 |
| 22.1.2016 | Topotecan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/09/536 | 27.1.2016 |
| 22.1.2016 | Ulunar Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/917 | 26.1.2016 |
| 22.1.2016 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 26.1.2016 |
| 22.1.2016 | Vivanza | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/249 | 26.1.2016 |
| 25.1.2016 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/05/317 | 27.1.2016 |
| 25.1.2016 | Cyramza | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/957 | 27.1.2016 |
| 25.1.2016 | Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/708 | 27.1.2016 |
| 25.1.2016 | Exviera | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/983 | 27.1.2016 |
| 25.1.2016 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 27.1.2016 |
| 25.1.2016 | NovoRapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119 | 27.1.2016 |
| 25.1.2016 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/05/316 | 27.1.2016 |
| 25.1.2016 | SANCUSO | ProStrakan Limited
  Galabank Business Park, Galashiels TD1 1QH, United Kingdom | EU/1/12/766 | 27.1.2016 |
| 25.1.2016 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/09/595 | 27.1.2016 |
| 25.1.2016 | Sildenafil ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603 | 28.1.2016 |
| 25.1.2016 | Stalevo | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/03/260 | 27.1.2016 |
| 25.1.2016 | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 27.1.2016 |
| 25.1.2016 | Travatan | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/01/199 | 27.1.2016 |
| 25.1.2016 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274 | 27.1.2016 |
| 25.1.2016 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 27.1.2016 |
| 28.1.2016 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 1.2.2016 |
| 28.1.2016 | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 D-Miesbach, Deutschland | EU/1/09/532 | 1.2.2016 |
| 28.1.2016 | Comtess | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/98/082 | 1.2.2016 |
| 28.1.2016 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 1.2.2016 |
| 28.1.2016 | Defitelio | Gentium S.p.A.
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 1.2.2016 |
| 28.1.2016 | Nonafact | Sanquin Plasma Products B.V.
  Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland | EU/1/01/186 | 1.2.2016 |
| 28.1.2016 | Relistor | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/08/463 | 1.2.2016 |
| 28.1.2016 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 1.2.2016 |
| 28.1.2016 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 1.2.2016 |
| 28.1.2016 | Ultibro Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/862 | 1.2.2016 |
| 28.1.2016 | Voriconazole Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | 1.2.2016 |
| 28.1.2016 | Xoterna Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/863 | 1.2.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2016

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

11.1.2016

7.1.2016

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

11.1.2016

7.1.2016

Sildenafil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/584

11.1.2016

7.1.2016

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

11.1.2016

11.1.2016

Cometriq

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

13.1.2016

11.1.2016

Latuda

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

13.1.2016

11.1.2016

Sivextro

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/15/991

13.1.2016

11.1.2016

Yellox

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/11/692

13.1.2016

11.1.2016

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

13.1.2016

12.1.2016

Atriance

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/403

14.1.2016

12.1.2016

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

14.1.2016

12.1.2016

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

14.1.2016

12.1.2016

Gardasil 9

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

14.1.2016

12.1.2016

Silgard

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358

14.1.2016

14.1.2016

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom.

EU/1/12/760

18.1.2016

14.1.2016

Caprelsa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/749

18.1.2016

14.1.2016

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

18.1.2016

14.1.2016

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

18.1.2016

14.1.2016

Glivec

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/198

18.1.2016

14.1.2016

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

19.1.2016

14.1.2016

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

18.1.2016

14.1.2016

Pravafenix

LABORATOIRES SMB SA

26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België

EU/1/11/679

18.1.2016

14.1.2016

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

18.1.2016

14.1.2016

Torisel

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/424

18.1.2016

14.1.2016

Trobalt

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/11/681

18.1.2016

14.1.2016

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

18.1.2016

14.1.2016

Xeloda

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/163

18.1.2016

18.1.2016

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

20.1.2016

18.1.2016

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

20.1.2016

18.1.2016

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

20.1.2016

22.1.2016

Clopidogrel Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/561

26.1.2016

22.1.2016

Kadcyla

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/885

26.1.2016

22.1.2016

Levitra

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/248

26.1.2016

22.1.2016

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

26.1.2016

22.1.2016

Neupro

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

26.1.2016

22.1.2016

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

26.1.2016

22.1.2016

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

26.1.2016

22.1.2016

Optaflu

Novartis Influenza Vaccines Marburg GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

26.1.2016

22.1.2016

Topotecan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/09/536

27.1.2016

22.1.2016

Ulunar Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/917

26.1.2016

22.1.2016

Viagra

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/98/077

26.1.2016

22.1.2016

Vivanza

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/249

26.1.2016

25.1.2016

Corlentor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/05/317

27.1.2016

25.1.2016

Cyramza

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/14/957

27.1.2016

25.1.2016

Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708

27.1.2016

25.1.2016

Exviera

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/983

27.1.2016

25.1.2016

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

27.1.2016

25.1.2016

NovoRapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119

27.1.2016

25.1.2016

Procoralan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/05/316

27.1.2016

25.1.2016

SANCUSO

ProStrakan Limited

Galabank Business Park, Galashiels TD1 1QH, United Kingdom

EU/1/12/766

27.1.2016

25.1.2016

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/09/595

27.1.2016

25.1.2016

Sildenafil ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603

28.1.2016

25.1.2016

Stalevo

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/03/260

27.1.2016

25.1.2016

Tarceva

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311

27.1.2016

25.1.2016

Travatan

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/01/199

27.1.2016

25.1.2016

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

27.1.2016

25.1.2016

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

27.1.2016

28.1.2016

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

1.2.2016

28.1.2016

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 D-Miesbach, Deutschland

EU/1/09/532

1.2.2016

28.1.2016

Comtess

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/98/082

1.2.2016

28.1.2016

Daklinza

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

1.2.2016

28.1.2016

Defitelio

Gentium S.p.A.

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

EU/1/13/878

1.2.2016

28.1.2016

Nonafact

Sanquin Plasma Products B.V.

Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland

EU/1/01/186

1.2.2016

28.1.2016

Relistor

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/08/463

1.2.2016

28.1.2016

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

1.2.2016

28.1.2016

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

1.2.2016

28.1.2016

Ultibro Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/862

1.2.2016

28.1.2016

Voriconazole Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/15/1004

1.2.2016

28.1.2016

Xoterna Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/863

1.2.2016

—   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 decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2016 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/118 | 11.1.2016 |
| 7.1.2016 | CaniLeish | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France | EU/2/11/121 | 11.1.2016 |
| 7.1.2016 | Cimalgex | Vétoquinol SA
  Magny-Vernois, F-70200 Lure, France | EU/2/10/119 | 11.1.2016 |
| 7.1.2016 | Comfortis | Eli Lilly and Company Ltd, Elanco Animal Health
  Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/10/115 | 11.1.2016 |
| 7.1.2016 | Melosus | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, D-31303 Burgdorf, Deutschland | EU/2/10/116 | 11.1.2016 |
| 7.1.2016 | Neocolipor | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/98/008 | 11.1.2016 |
| 7.1.2016 | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 11.1.2016 |
| 7.1.2016 | Zulvac 1 + 8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 11.1.2016 |
| 14.1.2016 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 18.1.2016 |
| 22.1.2016 | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170 Amer (Girona), España | EU/2/14/167 | 26.1.2016 |
| 22.1.2016 | Purevax RCPCh FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/047 | 26.1.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2016

Activyl

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/10/118

11.1.2016

7.1.2016

CaniLeish

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France

EU/2/11/121

11.1.2016

7.1.2016

Cimalgex

Vétoquinol SA

Magny-Vernois, F-70200 Lure, France

EU/2/10/119

11.1.2016

7.1.2016

Comfortis

Eli Lilly and Company Ltd, Elanco Animal Health

Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/10/115

11.1.2016

7.1.2016

Melosus

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, D-31303 Burgdorf, Deutschland

EU/2/10/116

11.1.2016

7.1.2016

Neocolipor

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/98/008

11.1.2016

7.1.2016

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

11.1.2016

7.1.2016

Zulvac 1 + 8 Ovis

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/120

11.1.2016

14.1.2016

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

18.1.2016

22.1.2016

ERYSENG PARVO

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170 Amer (Girona), España

EU/2/14/167

26.1.2016

22.1.2016

Purevax RCPCh FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/047

26.1.2016

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 |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 26.2.2016 | EN | Official Journal of the European Union | C 76/10 |
| --- | --- | --- | --- |

26.2.2016

EN

Official Journal of the European Union

C 76/10

---

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 |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 7.1.2016 | Solamocta | See Annex I | See Annex I | See Annex I | 8.1.2016 |
| 14.1.2016 | Ambroxol or Bromhexine | See Annex II | See Annex II | See Annex II | 15.1.2016 |
| 18.1.2016 | Bimatoprost | Bimatoprost | Not applicable | Not applicable | 19.1.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

7.1.2016

Solamocta

See Annex I

See Annex I

See Annex I

8.1.2016

14.1.2016

Ambroxol or Bromhexine

See Annex II

See Annex II

See Annex II

15.1.2016

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.

---

ANNEX I

List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States

| Member State EU/EEA | Applicant | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Belgium | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Czech Republic | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Denmark | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| France | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Germany | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Greece | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Hungary | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Ireland | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Italy | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Luxembourg | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Poland | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Portugal | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Slovakia | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| Spain | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| The Netherlands | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |
| United Kingdom | Eurovet Animal Health BV Handelsweg 25
  NL-5531 AE Bladel
  The Netherlands | Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys | Amoxicillin trihydrate | 800 mg/g | Powder for use in drinking water | Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys | Oral |

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Belgium

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Czech Republic

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Denmark

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

France

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Germany

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Greece

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Hungary

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Ireland

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Italy

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Luxembourg

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Poland

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Portugal

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Slovakia

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

Spain

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

The Netherlands

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

United Kingdom

Eurovet Animal Health BV Handelsweg 25

NL-5531 AE Bladel

The Netherlands

Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Amoxicillin trihydrate

800 mg/g

Powder for use in drinking water

Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys

Oral

---

ANNEX II

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States

| Member State in EEA | Marketing authorisation holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Bromhexidine hydrochloride | Bisolvon Hustenlöser — Saft | 4 mg/5 ml | oral liquid | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Bromhexidine hydrochloride | Bisolvon — Lösung | 8 mg/4 ml | oral solution | oral use |
| Austria | ratiopharm Arzneimittel Vertriebs-GmbH
  Albert Schweitzergasse 3
  Vienna
  1140
  Austria | Ambroxole hydrochloride | Ambrobene retard 75 mg — Kapseln | 75 mg | prolonged-release capsule, hard | oral use |
| Austria | ratiopharm Arzneimittel Vertriebs-GmbH
  Albert Schweitzergasse 3
  Vienna
  1140
  Austria | Ambroxole hydrochloride | Ambrobene 15 mg/5 ml — Saft | 15 mg/5 ml | oral liquid | oral use |
| Austria | Aponova-Pharma Handels GmbH
  Mitterweg 4 Hart
  6265
  Austria | Ambroxole hydrochloride | Ambroxol ‘Aponova’ 60 mg — Brausetabletten | 60 mg | effervescent tablet | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucoangin Johannisbeere 20 mg — Lutschtabletten | 20 mg | lozenge | oral use |
| Austria | ratiopharm Arzneimittel Vertriebs-GmbH
  Albert Schweitzergasse 3
  Vienna
  1140
  Austria | Ambroxole hydrochloride | Ambrobene 30 mg — Tabletten | 30 mg | tablet | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucoangin Zitrone 20 mg Lutschtabletten | 20 mg | lozenge | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride,
  clenbuterol | Mucospas — Tabletten | 30 mg,
  0,02 mg | tablet | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride,
  clenbuterol | Mucospas — Saft | 7,5 mg/5 ml,
  0,0001 g | oral liquid | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosolvan 7,5 mg/1 ml — Lösung | 7,5 mg/ml | oral solution | oral use |
| Austria | ratiopharm Arzneimittel Vertriebs-GmbH
  Albert Schweitzergasse 3
  Vienna
  1140
  Austria | Ambroxole hydrochloride | Ambrobene 15 mg — Ampullen | 15 mg | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Austria | Genericon Pharma GmbH
  Hafnerstrasse 211
  Graz 8054
  Austria | Ambroxole hydrochloride | Ambroxol Genericon 30 mg Tabletten | 30 mg | tablet | oral use |
| Austria | Genericon Pharma GmbH
  Hafnerstrasse 211
  Graz 8054
  Austria | Ambroxole hydrochloride | Ambroxol Genericon Lösung | 7,5 mg/ml | oral solution | oral use |
| Austria | Genericon Pharma GmbH
  Hafnerstrasse 211
  Graz 8054
  Austria | Ambroxole hydrochloride | Ambroxol Genericon Saft | 15 mg/5 ml | oral liquid | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosolvan 15 mg — Lutschpastillen | 15 mg | lozenge | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosan 15 mg — Ampullen | 15 mg | solution for injection | intravenous use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosolvan retard 75 mg — Kapseln | 75 mg | prolonged-release capsule, hard | oral use |
| Austria | 1A Pharma GmbH
  Stella-Klein-Löw-Weg 17
  Vienna
  1020
  Austria | Ambroxole hydrochloride | Ambroxol 1A Pharma 7,5 mg/ml — Lösung | 7,5 mg/ml | oral solution | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucoangin Mint 20 mg — Lutschtabletten | 20 mg | lozenge | oral use |
| Austria | +pharma arzneimittel gmbh
  Hafnerstrasse 211
  Graz 8054
  Austria | Ambroxole hydrochloride | Ambroxol + pharma 60 mg lösliche Tabletten | 60 mg | tablet | oral use |
| Austria | Genericon Pharma GmbH
  Hafnerstrasse 211
  Graz 8054
  Austria | Ambroxole hydrochloride | Ambroxol Genericon 60 mg lösliche Tabletten | 60 mg | effervescent tablet | oral use |
| Austria | ratiopharm Arzneimittel Vertriebs-GmbH
  Albert Schweitzergasse 3
  Vienna
  1140
  Austria | Ambroxole hydrochloride | Ambrobene 7,5 mg/ml — Lösung | 7,5 mg/ml | oral solution | oral use |
| Austria | Hexal Pharma GmbH
  Stella-Klein-Löw-Weg 17
  Vienna
  1020
  Austria | Ambroxole hydrochloride | Ambrohexal 30 mg — lösbare Tabletten | 30 mg | effervescent tablet | oral use |
| Austria | Hexal Pharma GmbH
  Stella-Klein-Löw-Weg 17
  Vienna
  1020
  Austria | Ambroxole hydrochloride | Ambrohexal 7,5 mg/ml — Lösung | 7,5 mg/ml | oral solution | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucoangin 17,86 mg/ml Spray zur Anwendung in der Mundhöhle | 17,86 mg/ml | oromucosal spray | oral use |
| Austria | G.L. Pharma GmbH
  Schlossplatz 1 Lannach
  8502
  Austria | Ambroxole hydrochloride | Ambrolan 30 mg — Tabletten | 30 mg | tablet | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosolvan 30 mg/5 ml — Saft | 30 mg/ml | oral liquid | oral use |
| Austria | Boehringer Ingelheim RCV GmbH & Co KG
  Dr. Boehringergasse 5-11
  Vienna
  1121
  Austria | Ambroxole hydrochloride | Mucosolvan 15 mg/5 ml — Saft für Kinder | 15 mg/5 ml | oral liquid | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Ambroxine | 2,5 mg/ml | oromucosal spray | inhalation use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Ambroxine | 20 mg | pastille | oropharyngeal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Ambroxine | 20 mg | lozenge | oropharyngeal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Bisolangin | 20 mg | pastille | oromucosal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Mucoangin | 2,5 mg/ml | oromucosal spray | oromucosal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Mucoangin Cassis | 20 mg | pastille | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Mucoangin Citron | 20 mg | lozenge | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Mucoangin Menthe | 20 mg | pastille | oropharyngeal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Mucoangin Menthe | 20 mg | lozenge | oropharyngeal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Rexambro | 20 mg | lozenge | oropharyngeal use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Surbronc | 30 mg/5 ml | syrup | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Surbronc | 60 mg | tablet | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Ambroxol Hydrochloride | Surbronc | 60 mg | granules for oral solution | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon | 2 % | nebuliser solution | inhalation use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon | 2 mg/ml | oral drops, solution | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon | 8 mg | tablet | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon | 8 mg/5 ml | syrup | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon Citrus | 8 mg | tablet | oral use |
| Belgium | Boehringer Ingelheim
  S.C.S.-Comm. V.
  Avenue Ariane 16
  1200 Brussels
  Belgium | Bromhexine Hydrochloride | Bisolvon Instant | 8 mg | tablet | oral use |
| Belgium | E.G. S.A.-N.V.
  Heizel Esplanade b22
  1020 Brussels
  Belgium | Bromhexine Hydrochloride | Bromhexine | 8 mg | tablet | oral use |
| Belgium | D.J. Van Tintelen Beheer
  B.V.
  Stijntjesduinstraat 41
  Noordwijk
  The Netherlands | Bromhexine Hydrochloride | Bronchi-Mereprine | 8 mg | tablet | oral use |
| Belgium | Laboratoria Qualiphar N.V/S.A
  Rijksweg 9
  2880 Bornem
  Belgium | Bromhexine Hydrochloride | Toularynx Bromhexine | 5 mg/5 ml | syrup | oral use |
| Bulgaria | Sopharma AD
  16, Iliensko shosse str.
  Sofia 1220
  Bulgaria | Ambroxol hydrochloride | Ambixol | 15 mg/5 ml | syrup | oral use |
| Bulgaria | Nobel Pharma OOD
  24 Simeonovsko shose bulvd.
  1700 Sofia
  Bulgaria | Ambroxol hydrochloride | Ambrex | 15 mg/5 ml | syrup | oral use |
| Bulgaria | Nobel Pharma OOD
  24 Simeonovsko shose bulvd.
  1700 Sofia,
  Bulgaria | Ambroxol hydrochloride | Ambrex | 30 mg/5 ml | syrup | oral use |
| Bulgaria | Tchaikapharma Highquality Medicines
  1 G. M. Dimitrov Blvd
  Sofia, 1172
  Bulgaria | Ambroxol hydrochloride | Ambrin | 30 mg | effervescent tablet | oral use |
| Bulgaria | Hexal AG
  Industriestrasse 25,
  D-83607 Holzkirchen,
  Germany | Ambroxol hydrochloride | Ambro | 3 mg/ml | oral solution | oral use |
| Bulgaria | Hexal AG
  Industriestrasse 25,
  D-83607 Holzkirchen,
  Germany | Ambroxol hydrochloride | Ambro | 30 mg | tablet | oral use |
| Bulgaria | Aliud Pharma GmbH
  19 Gottlieb-Daimler-Str.
  89150 Laichingen,
  Germany | Ambroxol hydrochloride | Ambrolex R | 75 mg | prolonged-release capsule, hard | oral use |
| Bulgaria | Adipharm EAD
  130 Simeonovsko Shosse blvd
  1700 Sofia
  Bulgaria | Ambroxol hydrochloride | Ambroxol Adipharm | 15 mg/5 ml | syrup | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 60 mg | effervescent tablet | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 15 mg/5 ml | oral solution | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Cough Tablets | 30 mg | tablet | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed for children | 15 mg/5 ml | oral solution | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed forte | 30 mg/5 ml | oral solution | oral use |
| Bulgaria | Berlin-Chemie AG
  Glienicker Weg 125 — 127
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed max | 30 mg/5 ml | oral solution | oral use |
| Bulgaria | Cyathus Exquirere Pharmaforschungs GmbH
  Rudolfsplatz 2/1/8
  1010 Wienna
  Austria | Ambroxol hydrochloride | Gogolox | 5 % | oral solution | oral use |
| Bulgaria | Aliud Pharma GmbH
  19 Gottlieb-Daimler-Str.
  89150 Laichingen,
  Germany | Ambroxol hydrochloride | Grippostad Ambro | 30 mg | tablet | oral use |
| Bulgaria | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucoangin | 20 mg | lozenge | oral use |
| Bulgaria | Actavis EAD
  29 Atanas Dukov str.
  1407 Sofia
  Bulgaria | Ambroxol hydrochloride | Mucolisin | 30 mg/5 ml | syrup | oral use |
| Bulgaria | Zentiva, a.s.
  Einsteinova 24
  851 01, Bratislava
  Slovak Republic | Ambroxol hydrochloride | Mucosin Zentiva | 30 mg | tablet | oral use |
| Bulgaria | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 15 mg/5 ml | syrup | oral use |
| Bulgaria | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 15 mg | pastille | oral use |
| Bulgaria | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 75 mg | prolonged-release capsule, hard | oral use |
| Bulgaria | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Bulgaria | Divapharma GmbH
  Motzener Straße 41
  12277 Berlin
  Germany | Ambroxol hydrochloride | Neo-bronchol | 15 mg | lozenge | oral use |
| Bulgaria | KRKA, d.d.
  Smarjeska cesta 6
  Novo mesto, 8501
  Slovenia | Ambroxol hydrochloride | Solvolan | 15 mg/5 ml | syrup | oral use |
| Bulgaria | KRKA, d.d.
  Smarjeska cesta 6
  Novo mesto, 8501
  Slovenia | Ambroxol hydrochloride | Solvolan | 30 mg | tablet | oral use |
| Bulgaria | Actavis EAD
  29 Atanas Dukov str.
  1407 Sofia
  Bulgaria | Bromhexine hydrochloride | Bromhexin Actavis | 4 mg | coated tablet | oral use |
| Bulgaria | Actavis EAD
  29 Atanas Dukov str.
  1407 Sofia
  Bulgaria | Bromhexine hydrochloride | Bromhexin Actavis | 8 mg | coated tablet | oral use |
| Bulgaria | Sopharma AD
  16, Iliensko shosse str.
  Sofia, 1220
  Bulgaria | Bromhexine hydrochloride | Bromhexine Sopharma | 2 mg/ml | solution for injection | intramuscular use, intravenous use |
| Bulgaria | Sopharma AD
  16, Iliensko shosse str.
  Sofia, 1220
  Bulgaria | Bromhexine hydrochloride | Bromhexine Sopharma | 8 mg | tablet | oral use |
| Croatia | Medis Adria d.o.o.
  Kolarova 7, Zagreb
  10000
  Croatia | ambroxolum | Ambrospray 10 mg/potisku spreja, oralna otopina | 50 mg/ml | oral solution | oral use |
| Croatia | Boehringer Ingelheim Zagreb d.o.o.
  Radnička 40-5, Zagreb
  10000
  Croatia | ambroxolum | Mucosolvan 75 mg kapsule s produljenim oslobađanjem | 75 mg | prolonged-release capsule | oral use |
| Croatia | Berlin-Chemie Menarini Hrvatska d.o.o.
  Horvatova 80a, Zagreb
  10000
  Croatia | ambroxolum | Flavamed 15 mg/5 ml oralna otopina | 15 mg/5 ml | oral solution | oral use |
| Croatia | Berlin-Chemie Menarini Hrvatska d.o.o.
  Horvatova 80a, Zagreb
  10000
  Croatia | ambroxolum | Flavamed forte 30 mg/5 ml oralna otopina | 30 mg/5 ml | oral solution | oral use |
| Croatia | Berlin-Chemie Menarini Hrvatska d.o.o.
  Horvatova 80a, Zagreb
  10000
  Croatia | ambroxolum | Flavamed 30 mg tablete | 30 mg | tablet | oral use |
| Croatia | Berlin-Chemie Menarini Hrvatska d.o.o.
  Horvatova 80a, Zagreb
  10000
  Croatia | ambroxolum | Flavamed forte 60 mg šumeće tablete | 60 mg | effervescent tablet | oral use |
| Croatia | Boehringer Ingelheim Zagreb d.o.o.
  Radnička 40-5, Zagreb
  10000
  Croatia | ambroxolum | Mucosolvan 30 mg tablete | 30 mg | tablet | oral use |
| Croatia | Divapharma GmbH
  Motzener Str. 41, Berlin
  12277
  Germany | ambroxolum | neo-bronchol 15 mg pastile | 15 mg | pastille | oral use |
| Croatia | Pliva Hrvatska d.o.o.
  Prilaz baruna Filipovića 25, Zagreb
  10000
  Croatia | bromhexinum | Bisolex 2 mg/ml otopina | 2 mg/ml | oral drops, solution | oral use |
| Croatia | Pliva Hrvatska d.o.o.
  Prilaz baruna Filipovića 25, Zagreb
  10000
  Croatia | bromhexinum | Bisolex 4 mg/5 ml sirup | 4 mg/5 ml | syrup | oral use |
| Croatia | Pliva Hrvatska d.o.o.
  Prilaz baruna Filipovića 25, Zagreb
  10000
  Croatia | bromhexinum | Bisolex 8 mg tablete | 8 mg | tablet | oral use |
| Croatia | Pliva Hrvatska d.o.o.
  Prilaz baruna Filipovića 25, Zagreb
  10000
  Croatia | bromhexinum | Bisolex F 16 mg tablete | 16 mg | tablet | oral use |
| Croatia | Boehringer Ingelheim Zagreb d.o.o.
  Radnička 40-5, Zagreb
  10000
  Croatia | bromhexinum | Bisolvon 2 mg/ml otopina | 2 mg/ml | solution for oral use | oral use |
| Croatia | Boehringer Ingelheim Zagreb d.o.o.
  Radnička 40-5, Zagreb
  10000
  Croatia | bromhexinum | Bisolvon 4 mg/5 ml sirup | 4 mg/5 ml | syrup | oral use |
| Croatia | Boehringer Ingelheim Zagreb d.o.o.
  Radnička 40-5, Zagreb
  10000
  Croatia | bromhexinum | Bisolvon 8 mg tablete | 8 mg | tablet | oral use |
| Cyprus | The Star Medicines Importers & Co Ltd
  9A Loukis Akritas Street
  Lemesos
  3601
  Cyprus | ambroxol hydrochloride | Anavix | 15 mg/5 ml | syrup | oral use |
| Cyprus | Varnavas Hadjipanayis Ltd
  Yiannou Kranidioti Avenue
  226 Latsia/Lefkosia
  2234
  Cyprus | ambroxol hydrochloride | Fluibron | 15 mg/5 ml | syrup | oral use |
| Cyprus | CDL Pharmaceutical Products Ltd
  12 Agiou Spiridonos Street
  Aradippou/Larnaca
  7102
  Cyprus | ambroxol hydrochloride | Hyvotex | 30 mg/5 ml | syrup | oral use |
| Cyprus | Medochemie Ltd
  1-10 Constantinoupoleos
  Street P.O. BOX 51409
  3505 Lemesos
  Cyprus | ambroxol hydrochloride | Medovent | 30 mg | tablet | oral use |
| Cyprus | Medochemie Ltd
  1-10 Constantinoupoleos
  Street P.O. BOX 51409
  3505 Lemesos
  Cyprus | ambroxol hydrochloride | Medovent elixir | 15 mg/5 ml | syrup | oral use |
| Cyprus | Mundipharma Pharmaceuticals Ltd
  13 Othellos Street
  Dhali Industrial Zone
  1685
  Lefkosia
  Cyprus | ambroxol hydrochloride | Mucobroxol | 15 mg/5 ml | syrup | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE
  Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan oral Gum | 15 mg | oral gum | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan | 30 mg | tablet | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE
  Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan | 15 mg/5 ml | syrup | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE
  Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan | 75 mg | prolonged-release tablet | oral use |
| Cyprus | Boehringer Ingelheim Ellas AE
  Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Mucosolvan | 7,5 mg/ml | solution for injection | intramuscular use, intravenous use |
| Cyprus | Boehringer Ingelheim Ellas AE
  Ellinikou 2 Street
  16777
  Athens
  Greece | ambroxol hydrochloride | Lysopadol | 20 mg | lozenge | oral use |
| Cyprus | REMEDICA LTD
  Aharnon street
  P.O. Box 51706
  3508
  Lemesos
  Cyprus | bromhexine hydrochloride | Flecoxin Elixir | 4 mg | syrup | oral use |
| Cyprus | REMEDICA LTD
  Aharnon street
  P.O. Box 51706
  3508
  Lemesos
  Cyprus | bromhexine hydrochloride | Flecoxin | 4 mg | tablet | oral use |
| Cyprus | REMEDICA LTD
  Aharnon street
  P.O. Box 51706
  3508
  Lemesos
  Cyprus | bromhexine hydrochloride | Flecoxin | 8 mg | tablet | oral use |
| Czech Republic | WALMARK, a.s.
  Oldřichovice 44
  739 61 Třinec
  Czech Republic | ambroxol hydrochloride | Ambex | 60 mg | effervescent tablet | oral use |
| Czech Republic | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene | 7,5 mg/ml | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Czech Republic | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 15 mg/5 ml | 3 mg/ml | syrup | oral use |
| Czech Republic | Teva Pharmaceuticals CR, s.r.o.
  Radlická 3185/1c
  150 00 Prague 5
  Czech Republic | ambroxol hydrochloride | Ambrobene 3 mg/ml | 3 mg/ml | oral solution | oral use |
| Czech Republic | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 30 mg | 30 mg | tablet | oral use |
| Czech Republic | Teva Pharmaceuticals CR, s.r.o.
  Radlická 3185/1c
  150 00 Prague 5
  Czech Republic | ambroxol hydrochloride | Ambrobene 6 mg/ml | 6 mg/ml | oral solution | oral use |
| Czech Republic | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 7,5 mg/ml | 7,5 mg/ml | oral solution | oral use |
| Czech Republic | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 75 mg | 75 mg | prolonged-release capsule, hard | oral use |
| Czech Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Prague 4
  Czech Republic | ambroxol hydrochloride | Ambrosan 15 mg | 15 mg | tablet | oral use |
| Czech Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Prague 4
  Czech Republic | ambroxol hydrochloride | Ambrosan 15 mg/5 ml Sirup | 3 mg/ml | syrup | oral use |
| Czech Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Prague 4
  Czech Republic | ambroxol hydrochloride | Ambrosan 30 mg | 30 mg | tablet | oral use |
| Czech Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Prague 4
  Czech Republic | ambroxol hydrochloride | Ambrosan 60 mg | 60 mg | tablet | oral use |
| Czech Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Prague 4
  Czech Republic | ambroxol hydrochloride | Ambrosan kapky | 7,5 mg/ml | oral drops, solution | oral use |
| Czech Republic | CYATHUS Exquirere Pharmaforschungs GmbH
  Rudolfsplatz 2/8
  1010 Wien
  Austria | ambroxol hydrochloride | Ambrospray 5 % | 50 mg/ml | oromucosal spray | oromucosal use |
| Czech Republic | Aliud Pharma GmbH
  Gottlieb-Daimler-Strasse 19
  89150 Laichingen
  Germany | ambroxol hydrochloride | Ambroxol Al 30 | 30 mg | tablet | oral use |
| Czech Republic | Aliud Pharma GmbH
  Gottlieb-Daimler-Strasse 19
  89150 Laichingen
  Germany | ambroxol hydrochloride | Ambroxol Al 75 Retard | 75 mg | prolonged-release capsule, hard | oral use |
| Czech Republic | Aliud Pharma GmbH
  Gottlieb-Daimler-Strasse 19
  89150 Laichingen
  Germany | ambroxol hydrochloride | Ambroxol Al kapky | 7,5 mg/ml | oral drops, solution | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Ambroxol Berlin-Chemie 30 mg/5 ml perorální roztok | 6 mg/ml | oral solution | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 15 mg/5 ml perorální roztok | 3 mg/ml | oral solution | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed effervescent tablet 60 mg | 60 mg | effervescent tablet | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed Forte 30 mg/5 ml | 6 mg/ml | oral solution | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed tablety | 30 mg | tablet | oral use |
| Czech Republic | Egis Pharmaceuticals PLC
  Keresztúri út. 30-38
  1106 Budapest
  Hungary | ambroxol hydrochloride | Halixol 30 mg | 30 mg | tablet | oral use |
| Czech Republic | Zentiva, k.s.
  U kabelovny 130
  Dolni Mėcholupy
  102 37 Prague 10
  Czech Republic | ambroxol hydrochloride | Mucosin s medem sir | 3 mg/ml | syrup | oral use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan | 7,5 mg/ml | oral drops, solution
  /inhalation solution | oral use,
  inhalation use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan | 30 mg | tablet | oral use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan | 15 mg | pastille | oromucosal use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan Junior | 3 mg/ml | syrup | oral use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan Long Effect | 75 mg | prolonged-release capsule, hard | oral use |
| Czech Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucosolvan pro dospělé | 6 mg/ml | syrup | oral use |
| Czech Republic | Divapharma GmbH
  Motzener Str. 41
  12277 Berlin
  Germany | ambroxol hydrochloride | Neo-Bronchol | 15 mg | lozenge | oromucosal use |
| Czech Republic | Krka, d.d., Novo mesto
  Šmarješka cesta 6
  8501 Novo mesto
  Slovenia | ambroxol hydrochloride | Solvolan | 3 mg/ml | syrup | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | bromhexine hydrochloride | Bromhexin 12 BC | 12 mg/ml | oral drops, solution | oral use |
| Czech Republic | Krewel Meuselbach GmbH
  Krewelstrasse 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | Bromhexin 12 KM-kapky | 12 mg/ml | oral drops, solution | oral use |
| Czech Republic | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | bromhexine hydrochloride | Bromhexin 8 Berlin-Chemie | 8 mg | coated tablet | oral use |
| Czech Republic | Krewel Meuselbach GmbH
  Krewelstrasse 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | Bromhexin 8 KM kapky | 8 mg/ml | oral drops, solution | oral use |
| Czech Republic | Krewel Meuselbach GmbH
  Krewelstrasse 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | Bromhexin 8-sirup KM | 0,8 mg/ml | syrup | oral use |
| Czech Republic | GALMED a.s.
  Těšínská 1349/296
  716 00 Ostrava — Radvanice
  Czech Republic | bromhexine hydrochloride | Bromhexin Galmed 12 | 12 mg/ml | oral drops, solution | oral use |
| Czech Republic | GALMED a.s.
  Těšínská 1349/296
  716 00 Ostrava — Radvanice
  Czech Republic | bromhexine hydrochloride | Bromhexin Galmed 8 | 8 mg/ml | oral drops, solution | oral use |
| Czech Republic | Egis Pharmaceuticals PLC
  Keresztúri út. 30-38
  1106 Budapest
  Hungary | bromhexine hydrochloride | Bromhexin-Egis | 2 mg/ml | oral solution | oral use |
| Czech Republic | Egis Pharmaceuticals PLC
  Keresztúri út. 30-38
  1106 Budapest
  Hungary | bromhexine hydrochloride | Paxirasol | 2 mg/ml | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Denmark | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed | 60 mg | effervescent tablet | oral use |
| Denmark | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed | 6 mg/ml | oral solution | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucoangin | 20 mg | compressed lozenge | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucoangin | 2,5 mg/dose | oromucosal spray, solution | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucoangin Citron | 20 mg | compressed lozenge | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol hydrochloride | Mucoangin Cassis | 20 mg | compressed lozenge | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | bromhexine hydrochloride | Bisolvon | 0,8 mg/ml | oral solution | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | bromhexine hydrochloride | Bisolvon | 8 mg | tablet | oral use |
| Denmark | Boehringer Ingelheim Int. GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | bromhexine hydrochloride | Bisolvon | 8 mg | soluble tablet | oral use |
| Denmark | Takeda Pharma A/S
  Dybendal Aile 10
  2630 Taastrup
  Denmark | bromhexine hydrochloride | Bromhexin ‘DAK’ | 0,8 mg/ml | oral solution | oral use |
| Denmark | Takeda Pharma A/S
  Dybendal Aile 10
  2630 Taastrup
  Denmark | bromhexine hydrochloride | Bromhexin ‘DAK’ | 8 mg | tablet | oral use |
| Estonia | AS Grindeks
  Krustpils 53
  1057 Riga
  Latvia | Bromhexine | Bromhexine-Grindeks | 0,8 mg/ml | syrup | oral use |
| Estonia | AS Grindeks
  Krustpils 53
  1057 Riga
  Latvia | Bromhexine | Bromhexine-Grindeks | 8 mg | tablet | oral use |
| Estonia | G.L. Pharma GmbH
  Schlossplatz 1
  8502 Lannach
  Austria | Ambroxol | Ambrolan | 30 mg | tablet | oral use |
| Estonia | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | Ambroxol | Ambroxol Sandoz 15 mg/5 ml | 3 mg/ml | syrup | oral use |
| Estonia | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | Ambroxol | Ambroxol Sandoz 30 mg | 30 mg | tablet | oral use |
| Estonia | PRO. MED. CS. PRAHA a.s
  Telcska 1
  14000 Praha 4
  Czech Republic | Ambroxol | Pro-Ambrosan | 30 mg | tablet | oral use |
| Estonia | BOEHRINGER INGELHEIM INTERNATIONAL GmbH — Binger Strasse 173
  Ingelheim/Rhein
  55216
  Germany | Ambroxol | Lasolvan | 3 mg/ml | syrup | oral use |
| Estonia | ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Ambroxol | Brontex Lahus | 7,5 mg/ml | oral solution | oral use |
| Estonia | ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Ambroxol | Brontex Tabletid | 30 mg | tablet | oral use |
| Estonia | ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Ambroxol | Brontex Siirup | 3 mg/ml | syrup | oral use |
| Estonia | DIVAPHARMA GmbH
  Motzener Str. 41
  12277 Berliin
  Germany | Ambroxol | Neo-Bronchol | 15 mg | pastille | oral use |
| Estonia | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol | Flavamed 30 Mg | 30 mg | tablet | oral use |
| Estonia | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol | Flavamed 60 mg | 60 mg | effervescent tablet | oral use |
| Estonia | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol | Flavamed Forte | 6 mg/ml | oral solution | oral use |
| Estonia | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol | Flavamed Vaarikas | 3 mg/ml | oral solution | oral use |
| Finland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 BERLIN
  Germany | Ambroxol hydrochloride | FLAVAMED | 30 mg | tablet | oral use |
| Finland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 BERLIN
  Germany | Ambroxol hydrochloride | FLAVAMED | 60 mg | effervescent tablet | oral use |
| Finland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 BERLIN
  Germany | Ambroxol hydrochloride | FLAVAMED | 6 mg/ml | oral solution | oral use |
| Finland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 BERLIN
  Germany | Ambroxol hydrochloride | FLAVAMED | 3 mg/ml | oral solution | oral use |
| Finland | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  P.O. BOX 200
  55216 Ingelheim Am Rhein Germany | bromhexine hydrochloride | BISOLVON | 0,8 mg/ml | oral solution | oral use |
| Finland | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  P.O. BOX 200
  55216 Ingelheim Am Rhein Germany | bromhexine hydrochloride | BISOLVON | 8 mg | tablet | oral use |
| Finland | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  P.O. BOX 200
  55216 Ingelheim Am Rhein Germany | bromhexine hydrochloride | BISOLVON | 8 mg | soluble tablet | oral use |
| Finland | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  P.O. BOX 200
  55216 Ingelheim Am Rhein Germany | bromhexine hydrochloride | BISOLVON | 8 mg | oral solution, sachet | oral use |
| Finland | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  P.O. BOX 200
  55216 Ingelheim Am Rhein Germany | bromhexine hydrochloride | BISOLVON STRONG | 1,6 mg/ml | oral solution | oral use |
| Finland | Orion Oyj
  Orionintie 1
  PL 65
  02101 ESPOO
  Finland | bromhexine hydrochloride | MEDIPEKT | 0,8 mg/ml | oral solution | oral use |
| Finland | Orion Oyj
  Orionintie 1
  PL 65
  02101 ESPOO
  Finland | bromhexine hydrochloride | MEDIPEKT | 8 mg | tablet | oral use |
| Finland | Oy Leiras Takeda
  Paciuksenkatu 21
  PL 1406
  00101 HELSINKI
  Finland | bromhexine hydrochloride | MUCOVIN | 0,8 mg/ml | oral solution | oral use |
| France | Laboratoires de l'AEROCID
  248 bis, rue Gabriel Péri
  B.P. 126
  94232 Cachan Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL AEROCID 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | ambroxol (chlorhydrate d') | AMBROXOL ARROW 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | ambroxol (chlorhydrate d') | AMBROXOL ARROW 30 mg, comprimé | 30 mg | tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | ambroxol (chlorhydrate d') | AMBROXOL BIOGARAN CONSEIL 0,6 % SANS SUCRE, solution buvable édulcorée au sorbitol | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | ambroxol (chlorhydrate d') | AMBROXOL BIOGARAN CONSEIL 30 mg, comprimé sécable | 30 mg | tablet | oral use |
| France | EG LABO — Laboratoires EuroGenerics
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL EG 0,3 POUR CENT SANS SUCRE, solution buvable édulcorée au cyclamate de sodium et au sorbitol | 0,3 g per 100 ml of solution | oral solution | oral use |
| France | EG LABO — Laboratoires EuroGenerics
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL EG 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | EG LABO — Laboratoires EuroGenerics
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL EG 30 mg, comprimé sécable | 30 mg | tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | ambroxol (chlorhydrate d') | AMBROXOL MYLAN 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | ambroxol (chlorhydrate d') | AMBROXOL MYLAN 30 mg, comprimé | 30 mg | tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | ambroxol (chlorhydrate d') | AMBROXOL SANDOZ CONSEIL 0,6 % SANS SUCRE, solution buvable édulcorée à la saccharine sodique | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL TEVA CONSEIL 0,3 %, solution buvable | 0,3 g per 100 ml of solution | oral solution | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL TEVA CONSEIL 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | ambroxol (chlorhydrate d') | AMBROXOL TEVA CONSEIL 30 mg, comprimé | 30 mg | tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | ambroxol (chlorhydrate d') | VICKS EXPECTORANT AMBROXOL 0,6 %, solution buvable | 0,6 g per 100 ml of solution | oral solution | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | ambroxol (chlorhydrate d') | VICKS EXPECTORANT AMBROXOL 30 mg, comprimé sécable | 30 mg | tablet | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose | 20 mg | lozenge | oromucosal use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose | 20 mg | lozenge | oromucosal use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose | 20 mg | lozenge | oromucosal use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | SURBRONC 60 mg, comprimé enrobé sécable | 60 mg | tablet | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | SURBRONC 60 mg, granulés pour solution buvable en sachet | 60 mg | granules for oral solution | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable | 30 mg | tablet | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l'acésulfame potassique et au sorbitol | 0,600 g per 100 ml of solution | oral solution | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | ambroxol (chlorhydrate d') | SURBRONC L.P. 75 mg, gélule à libération prolongée | 75 mg | hard capsule, prolonged relase | oral use |
| France | BIOCODEX
  7, avenue Gallieni
  94250 Gentilly
  France | ambroxol (chlorhydrate d') | MUXOL 30 mg, comprimé | 30 mg | tablet | oral use |
| France | BIOCODEX
  7, avenue Gallieni
  94250 Gentilly
  France | ambroxol (chlorhydrate d') | MUXOL, solution buvable | 0,3 g per 100 ml of solution | oral solution | oral use |
| France | CHRIS PHARMAZEUTISCHE HANDELSGESELLSCHAFT mbH
  Weg im Esterholz 6
  82064 Strasslach
  Germany | ambroxol (chlorhydrate d') | MUXOL 60 mg, comprimé effervescent | 60 mg | effervescent tablet | oral use |
| France | RECKITT BENCKISER HEALTHCARE France
  15, rue Ampère
  91748 Massy Cedex
  France | ambroxol (chlorhydrate d') | STREPSILS EXPECTORANT 30 mg/5 ml ADULTES, sirop | 30 mg per 5 ml of syrup | syrup | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | bromhexine (chlorhydrate de) | BISOLVON 0,2 POUR CENT, solution buvable | 200 mg per 100 ml of solution | oral solution | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | bromhexine (chlorhydrate de) | BISOLVON 8 mg, comprimé | 8 mg per tablet | tablet | oral use |
| France | BOEHRINGER INGELHEIM FRANCE
  14, rue Jean Antoine de Baïf
  75013 Paris
  France | bromhexine (chlorhydrate de); tétracycline (chlorhydrate de) | BISOLVOMYCINE, comprimé enrobé | 4 mg per tablet | tablet | oral use |
| Germany | 1 A Pharma
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Ambroxol hydrochloride | Ambroxol 15 Saft — 1A Pharma | 0,3 g | oral solution | oral use |
| Germany | 1 A Pharma
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Ambroxol hydrochloride | Ambroxol 30 Saft — 1A Pharma | 6 mg | oral solution | oral use |
| Germany | 1 A Pharma
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Ambroxol hydrochloride | Ambroxol 30 Tab — 1A Pharma | 30 mg | tablet | oral use |
| Germany | 1 A Pharma
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Ambroxol hydrochloride | Ambroxol 30 Tropfen — 1A Pharma | 15 mg | oral drops, solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambro-AbZ 3 mg/ml Lösung zum Einnehmen | 3 mg | oral solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol AbZ Hustensaft 15 mg/5 ml Lösung zum Einnehmen | 15 mg/5 ml | oral solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-CT Tropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride, Doxycycline hycalate | Doxy comp.-CT 100 mg/75 mg Retardkapseln | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambro-AbZ 6 mg/ml Lösung zum Einnehmen | 6 mg/ml | oral solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambro-CT 3 mg/ml Lösung zum Einnehmen | 3 mg/ml | oral solution | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol AbZ 75 mg Retardkapseln | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | acis Arzneimittel GmbH
  Lil-Dagover-Ring 7
  82031 Grünwald
  Germany | Ambroxol hydrochloride | Ambroxol acis Tropfen | 7,5 mg | oral solution | oral use |
| Germany | acis Arzneimittel GmbH
  Lil-Dagover-Ring 7
  82031 Grünwald
  Germany | Ambroxol hydrochloride | Ambroxol acis 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | acis Arzneimittel GmbH
  Lil-Dagover-Ring 7
  82031 Grünwald
  Germany | Ambroxol hydrochloride | Ambroxol acis Saft | 15 mg | oral solution | oral use |
| Germany | acis Arzneimittel GmbH
  Lil-Dagover-Ring 7
  82031 Grünwald
  Germany | Ambroxol hydrochloride | Ambroxol acis 30 mg Trinktabletten | 30 mg | soluble tablet | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride | Ambroxol AL 30 | 30 mg | tablet | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride, Doxycycline hycalate | Ambroxol AL comp | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride | Ambroxol AL Saft | 15 mg | oral solution | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride | Ambroxol AL 75 retard | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride | Ambroxol AL Tropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | Aliud Pharma GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Ambroxol hydrochloride | Ambroxol AL 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Ambroxol hydrochloride | Ambroxol Aristo Hustentropfen 15 mg/ml | 15 mg | oral solution | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Ambroxol hydrochloride | Ambroxol Aristo Hustentropfen für Kinder 7,5 mg/ml | 7,5 mg | oral solution | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Ambroxol hydrochloride, Doxycycline hycalate | Doxam 100 mg/75 mg Hartkapsel retardiert | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Ambroxol hydrochloride | Ambroxol Aristo Hustensaft 30 mg/5 ml | 30 mg/5 ml | oral solution | oral use |
| Germany | axcount Generika GmbH
  Max-Planck. Str. 36 b
  61381 Friedrichsdorf
  Germany | Ambroxol hydrochloride | Ambroxol axcount Saft | 15 mg | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Hustensaft 30 mg/5 ml Lösung zum Einnehmen | 30 mg/5 ml | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Hustenlöser 30 mg/5 ml Lösung zum Einnehmen | 30 mg/5 ml | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Bromhexine hydrochloride | BROMHEXIN 12 BC | 12 mg | oral drops, solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Bromhexine hydrochloride | BROMHEXIN 4 BC | 4 mg | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Hustensaft | 15 mg | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Hustentabletten | 30 mg | tablet | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Bromhexine hydrochloride | BROMHEXIN 8 Berlin-Chemie | 8 mg | coated tablet | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed Hustensaft 15 mg/5 ml Lösung zum Einnehmen | 15 mg | oral solution | oral use |
| Germany | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Ambroxol hydrochloride | Ambrobeta 30 | 30 mg | effervescent tablet | oral use |
| Germany | betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Ambroxol hydrochloride | Ambrobeta Saft | 3 mg | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Filmtabletten 60 mg | 60 mg | film-coated tablet | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Retardkapseln 75 mg | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride, Clenbuterol hydrochloride | Spasmo-Mucosolvan Saft | 7,5 mg, 0,005 mg | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucoangin gegen Halsschmerzen 20 mg Pastillen | 20 mg | pastille | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucoangin gegen Halsschmerzen Zitrone 20 mg Lutschtabletten | 20 mg | lozenge | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucoangin gegen Halsschmerzen Minze | 20 mg | lozenge | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Hustensaft 30 mg/5 ml | 30 mg/5 ml | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Inhalationslösung 15 mg/2 ml | 15 mg/2 ml | nebuliser solution | inhalation use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Tabletten 30 mg | 30 mg | tablet | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Infusionslösungskonzentrat | 1 mg | concentrate for solution for infusion | intravenous use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Brausetabletten 60 mg | 60 mg | effervescent tablet | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Bromhexine hydrochloride | Bisolvon Hustentropfen | 2 mg | oral drops, solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Kindersaft 30 mg/5 ml | 30 mg/5 ml | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Tropfen 30 mg/2 ml | 30 mg/2 ml | oral drops, solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Tropfen 30 mg/2 ml | 30 mg/2 ml | oral drops, solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Injektionslösung | 15 mg | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucoangin gegen Halsschmerzen Waldbeere | 20 mg | lozenge | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Lutschpastillen 15 mg | 15 mg | pastille | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Ambroxol 60 mg | 60 mg | granules for oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Bromhexine hydrochloride | Bisolvon-Linctus Hustensaft | 0,08 g/100 ml | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Bromhexine hydrochloride | Bisolvon Hustentabletten | 8 mg | tablet | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Kindersaft 15 mg/5 ml | 15 mg | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan Portionsbeutel 30 mg/5 ml | 30 mg | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Ambroxol Portionsbeutel 30 mg/5 mg | 30 mg | oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Mucosolvan 60 mg | 60 mg | granules for oral solution | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride | Bisolaryn gegen Halzschmerzen 20 mg Pastillen | 20 mg | pastille | oromucosal use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Ambroxol hydrochloride, Clenbuterol hydrochloride | Spasmo-Mucosolvan | 30 mg, 0,02 mg | tablet | oral use |
| Germany | Boehringer Ingelheim Pharma GmbH & Co. KG
  Binger Str. 173
  55216 Ingelheim
  Germany | Bromhexine hydrochloride | Bisolvon Hustensaft | 8 mg | oral solution | oral use |
| Germany | Cyathus Exquirere PharmaforschungsGmbH
  Rudolfplatz 2/1/8
  1010 Wien
  Austria | Ambroxol hydrochloride | Ambroxolhydrochloride Cyathus 10 mg/Sprühstoß Lösung zum Einnehmen | 10 mg | oral solution | oral use |
| Germany | Cyathus Exquirere PharmaforschungsGmbH
  Rudolfplatz 2/1/8
  1010 Wien
  Austria | Ambroxol hydrochloride | Mukambro 10 mg/Sprühstoß Lösung zum Einnehmen | 10 mg | oral solution | oral use |
| Germany | Denk Pharma GmbH & Co. KG
  Prinzregentenstr. 79
  81675 München
  Germany | Ambroxol hydrochloride | Ambrox-Denk 60 mg | 60 mg | effervescent tablet | oral use |
| Germany | Divapharma GmbH
  Motzener Str. 41
  12277 Berlin
  Germany | Ambroxol hydrochloride | Neo-bronchol | 15 mg | oral gum | oral use |
| Germany | Docpharm Arzneimittelvertrieb GmbH & Co. KG
  Greschbachstr. 7
  76229 Karlsruhe
  Germany | Ambroxol hydrochloride | Ambroxol PB 30 mg | 30 mg | film-coated tablet | oral use |
| Germany | Dr. Ritsert Pharma GmbH & Co. KG
  Klausenweg 12
  69412 Eberbach
  Germany | Ambroxol hydrochloride | Expit T Tropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | Dr. Ritsert Pharma GmbH & Co. KG
  Klausenweg 12
  69412 Eberbach
  Germany | Ambroxol hydrochloride | Expit Lösung | 15 mg | oral solution | oral use |
| Germany | esparma GmbH
  Seepark 7
  39116 Magdeburg
  Germany | Ambroxol hydrochloride, Doxycycline hycalate | Sigamuc | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | Aristo Pharma GmbH
  Wallenroder Str. 8-10
  13435 Berlin
  Germany | Ambroxol hydrochloride | Ambroxin-Tropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | Hemopharm GmbH
  Königsteiner Str. 2
  61350 Bad Homburg v.d.H.
  Germany | Ambroxol hydrochloride | Ambro-Hemopharm Hustensaft | 15 mg | prolonged-release capsule, hard | oral use |
| Germany | Hermes Arzneimittel GmbH
  Georg-Kalb-Str. 5-8
  82049 Großhesselohe
  Germany | Ambroxol hydrochloride | Ambroxo Brause 1 Hermes | 30 mg | effervescent tablet | oral use |
| Germany | Hermes Arzneimittel GmbH
  Georg-Kalb-Str. 5-8
  82049 Großhesselohe
  Germany | Ambroxol hydrochloride | Ambroxo Hermes 60 mg | 60 mg | effervescent tablet | oral use |
| Germany | Hermes Arzneimittel GmbH
  Georg-Kalb-Str. 5-8
  82049 Großhesselohe
  Germany | Ambroxol hydrochloride | Ambroxol Brause 60 | 60 mg | effervescent tablet | oral use |
| Germany | Heumann Pharma GmbH&Co. KG Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Ambroxol hydrochloride | Ambroxol Heumann Saft | 3 mg | oral solution | oral use |
| Germany | Heumann Pharma GmbH&Co. KG Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Ambroxol hydrochloride | Ambroxol Heumann Tropfen | 7,5 mg | oral drops | oral use |
| Germany | Heumann Pharma GmbH&Co. KG Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Ambroxol hydrochloride | Ambroxol 75 retard Heumann | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Heumann Pharma GmbH&Co. KG Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Ambroxol hydrochloride | Ambroxol 60 Heumann Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Heumann Pharma GmbH&Co. KG Generica KG
  Südwestpark 50
  90449 Nürnberg
  Germany | Ambroxol hydrochloride | Ambroxol 30 Heumann | 30 mg | tablet | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal injekt | 15 mg | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | AmbroHEXAL Hustensaft für Kinder | 3 mg | oral solution | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | AmbroHEXAL Hustenlöser 30 mg Tabletten | 30 mg | tablet | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal Hustenlöser retard 75 mg | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal S Hustensaft 30 mg/5 ml | 6 mg | oral solution | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal S Hustentropfen 15 mg/ml | 15 mg | oral solution | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal S Hustenlöser 60 mg Filmtabletten | 60 mg | film-coated tablet | oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal Hustenlöser Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Ambroxol hydrochloride | Ambroxol Krewel Meuselbach Tropfen 7,5 mg/ml | 7,5 mg | oral drops, solution | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Bromhexine hydrochloride | Bromhexin Krewel Meuselbach Tabletten 12 mg | 12 mg | tablet | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Bromhexine hydrochloride | Bromhexin Krewel Meuselbach Tropfen 12 mg | 12 mg | oral drops, solution | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Bromhexine hydrochloride | Bromhexin Krewel Meuselbach Tropfen 8 mg | 8 mg | oral drops, solution | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Ambroxol hydrochloride | Ambroxol Krewel Meuselbach Sirup 15 mg/5 ml | 15 mg | syrup | oral use |
| Germany | Krewel Meuselbach GmbH
  Krewelstr. 2
  53783 Eitorf
  Germany | Bromhexine hydrochloride | Bromhexin Krewel Meuselbach Hustensaft 8 mg/10 ml | 0,8 mg | solution | oral use |
| Germany | Meda Pharma GmbH&Co. KG
  Benzstr. 1
  61352 Bad Homburg
  Germany | Ambroxol hydrochloride | Lindoxyl K Zäpfchen | 15 mg | suppository | rectal use |
| Germany | Pädia Arzneimittel
  Gruhlstr. 3
  50374 Erftstadt
  Germany | Ambroxol hydrochloride | Pädiamuc Saft | 15 mg | oral solution | oral use |
| Germany | Pharma Stulln GmbH
  Werkstr. 3
  92551 Stulln
  Germany | Ambroxol hydrochloride | Ambroxol Inhalat | 7,5 mg/ml | nebuliser solution | inhalation use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm Hustentropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 15 mg/2 ml Injektionslösung | 15 mg | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambro-ratiopharm 3 mg/ml Lösung zum Einnehmen | 3 mg | oral solution | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 75 mg Hustenlöser | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 30 mg Hustenlöser | 30 mg | tablet | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm Hustensaft | 15 mg | oral solution | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambro-ratiopharm 6 mg/ml Lösung zum Einnehmen | 6 mg | oral solution | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol, Doxycycline | Ambroxol comp.-ratiopharm 75 mg/100 mg Retardkapseln | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 60 mg Hustenlöser | 60 mg | tablet | oral use |
| Germany | RubiePharm Vertiebs GmbH
  Sennelsbachweg 4
  36396 Stainau an der Strasse
  Germany | Ambroxol hydrochloride | AMBROinfant | 15 mg | oral solution | oral use |
| Germany | Sandoz Phamaceuticals GmbH
  Raiffeisenstr. 11
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambroxol Sandoz 7,5 mg/ml Tropfen zum Einnehmen, Lösung | 7,5 mg | oral drops, solution | oral use |
| Germany | Sandoz Phamaceuticals GmbH
  Raiffeisenstr. 11
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambroxol Sandoz 15 mg/5 ml Lösung zum Einnehmen | 15 mg | oral solution | oral use |
| Germany | Sandoz Phamaceuticals GmbH
  Raiffeisenstr. 11
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambroxol Sandoz 30 mg Tabletten | 30 mg | tablet | oral use |
| Germany | Stadapharm GmbH
  Saalstr. 2.18
  61118 Bad Vilbel
  Germany | Ambroxol hydrochloride | Ambroxol Stada Hustensaft 15 mg/5 ml, Lösung zum Einnehmen | 15 mg | solution | oral use |
| Germany | Stadapharm GmbH
  Saalstr. 2.18
  61118 Bad Vilbel
  Germany | Ambroxole, Doxycycline hyclate | Doxy plus STADA 100 mg/75 mg Hartkapseln, retardiert | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | TAD Pharma GmbH
  Heinz-Lohmann-Str. 5
  27472 Cuxhaven
  Germany | Ambroxol hydrochloride, Doxycycline hyclate | Doxam | 75 mg, 115,4 mg | prolonged-release capsule, hard | oral use |
| Germany | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | Ambroxol hydrochloride Theophylline | Broncho-Euphyllin retard | 30 mg, 350 mg | prolonged-release capsule, hard | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol Temmler 75 mg Retardkapseln | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Axol 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol retard Temmler | 75 mg | prolonged-release capsule, hard | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol Temmler Tropfen | 7,5 mg | oral drops, solution | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol Temmler Saft | 15 mg | oral solution | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Braxol 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol Temmler 30 mg Brausetabletten | 30 mg | effervescent tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol 7,5 TT Temmler Trinktabletten | 7,5 mg | soluble tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol 15 TT Temmler Trinktabletten | 15 mg | soluble tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol 30 TT Temmler Trinktabletten | 30 mg | tablet | oral use |
| Germany | Temmler Pharma GmbH&Co. KG
  Temmlerstr. 2
  35039 Marburg
  Germany | Ambroxol hydrochloride | Ambroxol Temmler 60 mg Brausetabletten | 60 mg | effervescent tablet | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Ambroxol WICK Schleimlöser für Kinder 3 mg/ml Lösung zum Einnehmen | 15 mg | oral solution | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Wick Schleimlöser 30 mg Tabletten | 30 mg | tablet | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Wick Schleimlöser 6 mg/ml Lösung zum Einnehmen | 6 mg | oral solution | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Wick Schleimlöser 30 mg Brausetabletten | 30 mg | effervescent tablet | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Wick Hustenlöser Therapie | 30 mg | effervescent tablet | oral use |
| Germany | Wick Pharma
  Zweigniederlassung
  Procter & Gamble GmbH
  Sulzbacher Str. 40
  65824 Schwalbach/Taunus
  Germany | Ambroxol hydrochloride | Wick Schleimlöser 75 Einmal Täglich Retardkapseln | 75 mg | prolonged-release capsule, hard | oral use |
| Greece | Adelco A.E. Chrom. Athin. Afoi Kolokotroni,
  Peireos 37,
  Moschato,
  Greece | BROMHEXINE | Bronchotussine | 4 mg/5 ml | syrup | oral use |
| Greece | Alapis Abee,
  Aftokratoros Nikolaou 2,
  11745, Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Amboral | 15 mg/5 ml | syrup | oral use |
| Greece | Alapis Abee,
  Aftokratoros Nikolaou 2,
  11745, Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Amboral | 30 mg/5 ml | syrup | oral use |
| Greece | Angelini Pharma Hellas Anonimi Biomhxaniki Etaireia Paragogis & Emporias Farmakon, Achaias & Trizinias, 14564, N. Kiffisia, Greece | AMBROXOL HYDROCHLORIDE | Tussefar | 15 mg/5 ml | syrup | oral use |
| Greece | Angelini Pharma Hellas Anonimi Biomhxaniki Etaireia Paragogis & Emporias Farmakon, Achaias & Trizinias, 14564, N. Kiffisia, Greece | AMBROXOL HYDROCHLORIDE | Tussefar | 30 mg/5 ml | syrup | oral use |
| Greece | Boehringer Ingelheim Ellas Αε,
  Ellinikou 2,
  16777, Ellinikon,
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 75 mg | prolonged-release capsule | oral use |
| Greece | Boehringer Ingelheim Ellas Αε,
  Ellinikou 2,
  16777, Ellinikon,
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 15 mg/2 ml | solution for injection | intravenous use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 30 mg | tablet | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | BROMHEXINE | Bisolvon | 8 mg | tablet | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 15 mg/2 ml | solution for injection | intramuscular use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | BROMHEXINE | Bisolvon | 8 mg | soluble tablet | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | BROMHEXINE | Bisolvon | 4 mg/5 ml | syrup | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | BROMHEXINE | Bisolvon | 8 mg/5 ml | syrup | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 15 mg | oral gum | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 15 mg/2 ml | solution for injection | intravenous use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Mucosolvan | 15 mg/5 ml | syrup | oral use |
| Greece | Boehringer Ingelheim Ellas ΑE,
  Ellinikou 2,
  16777, Ellinikon, Athens
  Greece | AMBROXOL HYDROCHLORIDE | Lysopadol | 20 mg | lozenge | oromucosal use |
| Greece | Bros E.P.E.,
  Aygis & Galinis 15,
  14564, Nea Kifissia,
  Greece | AMBROXOL HYDROCHLORIDE | Ebertuss | 30 mg/5 ml | syrup | oral use |
| Greece | Coup Abee,
  Ag. Barbaras 53-55,
  17235 Dafni,
  Greece | AMBROXOL HYDROCHLORIDE | Nibren | 30 mg/5 ml | syrup | oral use |
| Greece | D.A.S.T. Biotech Φαρ/Κη Επε Δ.Τ. D.A.S.T. Biotech Pharm Επε, Λαρίσσης 10,
  15351 Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Provixen-N | 30 mg/5 ml | syrup | oral use |
| Greece | Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,
  Greece | AMBROXOL HYDROCHLORIDE | Celibron | 30 mg | tablet | oral use |
| Greece | Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,
  Greece | AMBROXOL HYDROCHLORIDE | Celibron | 30 mg/5 ml | syrup | oral use |
| Greece | Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,
  Greece | AMBROXOL HYDROCHLORIDE | Celibron | 15 mg/5 ml | syrup | oral use |
| Greece | Farmellas Enterprises Ltd, Cyprus,
  Leof. Afxentiou 27,
  Acropolis Centre,
  Cyprus | AMBROXOL HYDROCHLORIDE | Fluibrox | 30 mg/5 ml | syrup | oral use |
| Greece | Genepharm Ae,
  18 Km. Leof. Marathonos,
  15351 Pallini,
  Greece | AMBROXOL HYDROCHLORIDE | Grenovix | 30 mg/5 ml | syrup | oral use |
| Greece | Genepharm Ae,
  18 Km. Leof. Marathonos,
  15351 Pallini,
  Greece | AMBROXOL HYDROCHLORIDE | Grenovix | 30 mg | tablet | oral use |
| Greece | Help Αβεε,
  Valaoritou 10,
  14452, Metamorfosi,
  Greece | AMBROXOL HYDROCHLORIDE | Abrobion | 30 mg | tablet | oral use |
| Greece | Help Αβεε,
  Valaoritou 10,
  14452, Metamorfosi,
  Greece | AMBROXOL HYDROCHLORIDE | Abrobion | 30 mg/5 ml | syrup | oral use |
| Greece | Help Αβεε,
  Valaoritou 10,
  14452, Metamorfosi,
  Greece | AMBROXOL HYDROCHLORIDE | Abrobion | 15 mg/5 ml | syrup | oral use |
| Greece | Help Αβεε,
  Valaoritou 10,
  14452, Metamorfosi,
  Greece | BROMHEXINE | Bron-Hal | 4 mg/5 ml | syrup | oral use |
| Greece | Iasis Pharmac. Hellas Biom. & Emp F/Kon-Chem/Kon & Kal. Pr. Abee, L. Fylis 137,
  13451 Kamatero Attikis,
  Greece | AMBROXOL HYDROCHLORIDE | Afrodor | 30 mg/5 ml | syrup | oral use |
| Greece | Novendia Farmakeytiki Epe, Leof. Irakliou 425 & Olympias 28, 14122 N. Iraklio, Greece | AMBROXOL HYDROCHLORIDE | Tevoril | 30 mg/5 ml | syrup | oral use |
| Greece | Pharmaswiss Ceska Republika s.r.o., Jancovcova 1569/2c, 1700 Praha 7, Holesovice,
  Czech Republic | AMBROXOL HYDROCHLORIDE | Physiosolvan | 30 mg/5 ml | syrup | oral use |
| Greece | Pharmaswiss Ceska Republika s.r.o., Jancovcova 1569/2c, 1700 Praha 7, Holesovice,
  Czech Republic | AMBROXOL HYDROCHLORIDE | Physiosolvan | 15 mg/5 ml | syrup | oral use |
| Greece | Rafarm,
  12, Korinthou Str.,
  New Psychico,
  Athens 15451,
  Greece | AMBROXOL HYDROCHLORIDE | Kriolen | 30 mg/5 ml | syrup | oral use |
| Greece | S.J.A. Pharm Farmakeytiki E.P.E
  11 Arkoleon Str.,
  Patissia 10445,
  Greece | AMBROXOL HYDROCHLORIDE | Stefolant | 30 mg/5 ml | syrup | oral use |
| Greece | Ανφαρμ Ellas A.E.,
  Perikleous 53-57
  Gerakas 15344,
  Greece | AMBROXOL HYDROCHLORIDE | Aprinol | 30 mg/5 ml | syrup | oral use |
| Greece | Ανφαρμ Ellas A.E.,
  Perikleous 53-57
  Gerakas 15344,
  Greece | AMBROXOL HYDROCHLORIDE | Aprinol | 15 mg/5 ml | syrup | oral use |
| Greece | Vianex A.E.,
  Tatoiou Street, 18th Km
  National Road Athens-Lamia,
  14571 Nea Erythrea,
  Greece | AMBROXOL HYDROCHLORIDE | Broncolyn | 30 mg/tab | tablet | oral use |
| Greece | Vianex A.E.,
  Tatoiou Street, 18th Km National Road Athens-Lamia,
  14571 Nea Erythrea,
  Greece | AMBROXOL HYDROCHLORIDE | Broncolyn | 30 mg/5 ml | syrup | oral use |
| Greece | Vianex A.E.,
  Tatoiou Street, 18th Km
  National Road Athens-Lamia,
  14571 Nea Erythrea,
  Greece | AMBROXOL HYDROCHLORIDE | Broncolyn | 15 mg/5 ml | syrup | oral use |
| Greece | Exelixi Emporia Iatr. Eidon A.E.,
  L. Mesogeion 501,
  15343 Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Saribal | 15 mg/5 ml | syrup | oral use |
| Greece | Exelixi Emporia Iatr. Eidon A.E.,
  L. Mesogeion 501,
  15343 Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Saribal | 30 mg/5 ml | syrup | oral use |
| Greece | Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,
  Kalyftaki 27,
  14561 Kifissia, Attiki,
  Greece | AMBROXOL HYDROCHLORIDE | Bunafon | 15 mg/5 ml | syrup | oral use |
| Greece | Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,
  Kalyftaki 27,
  14561 Kifissia, Attiki,
  Greece | AMBROXOL HYDROCHLORIDE | Bunafon | 30 mg/5 ml | syrup | oral use |
| Greece | Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,
  Kalyftaki 27,
  14561 Kifissia, Attiki,
  Greece | AMBROXOL HYDROCHLORIDE | Bunafon | 15 mg | granules for oral solution in sachet | oral use |
| Greece | Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,
  Kalyftaki 27,
  14561 Kifissia, Attiki,
  Greece | AMBROXOL HYDROCHLORIDE | Bunafon | 30 mg | granules for oral solution in sachet | oral use |
| Greece | Koper Farmakoviomihania A.E.,
  Aristovoulou 64,
  11853 Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Mucolin | 30 mg/5 ml | syrup | oral use |
| Greece | Koper Farmakoviomihania A.E.,
  Aristovoulou 64,
  11853 Athens,
  Greece | AMBROXOL HYDROCHLORIDE | Mucolin | 15 mg/5 ml | syrup | oral use |
| Greece | S.M. Farmakeytika Proionta Epe,
  Agiou Orous 43-45,
  18545 Peireas, Atiiki,
  Greece | AMBROXOL HYDROCHLORIDE | Mucovix | 30 mg/5 ml | syrup | oral use |
| Greece | Foinixfarm Epe,
  Dervenakion 38 & Sahini,
  15344, Gerakas,
  Greece | AMBROXOL HYDROCHLORIDE | Strubelin | 30 mg/5 ml | syrup | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROBENE 7,5 mg/ml belsőleges oldat | 7,5 mg/ml | oral solution | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROBENE 15 mg/5 ml szirup | 15 mg/5 ml | syrup | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROBENE 30 mg tabletta | 30 mg | tablet | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROBENE 7,5 mg/ml oldatos injekció | 7,5 mg/ml | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROXOL TEVA 6 mg/ml belsőleges oldat | 6 mg/ml | oral solution | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROXOL-TEVA 3 mg/ml szirup | 3 mg/ml | syrup | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROXOL-TEVA 30 mg tabletta | 30 mg | tablet | oral use |
| Hungary | Teva Gyógyszergyár Zrt.
  Pallagi út 13
  Debrecen
  H-4042
  Hungary | ambroxol | AMBROXOL-TEVA 75 mg retard kemény kapszula | 75 mg | prolonged-release capsule, hard | oral use |
| Hungary | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  Berlin D-12489
  Germany | ambroxol | FLAVAMED 15 mg/5 ml belsőleges oldat | 15 mg/5 ml | oral solution | oral use |
| Hungary | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  Berlin D-12489
  Germany | ambroxol | FLAVAMED 30 mg tabletta | 30 mg | tablet | oral use |
| Hungary | Berlin-Chemie AG
  (Menarini Group)
  Glienicker Weg 125
  Berlin D-12489
  Germany | ambroxol | FLAVAMED 30 mg/5 ml belsőleges oldat | 30 mg/5 ml | oral solution | oral use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | ambroxol | HALIXOL 30 mg tabletta | 30 mg | tablet | oral use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | ambroxol | HALIXOL 3 mg/ml szirup | 0,3 g/100 ml | syrup | oral use |
| Hungary | Boehringer Ingelheim International GmbH
  Binger strasse 173
  55216 Ingelheim am Rhein
  Germany | ambroxol | MUCOANGIN 20 mg szopogató tabletta | 20 mg | lozenge | oromucosal use |
| Hungary | Pharma-Regist Kft.,
  Október 6. u. 7.
  Budapest
  1051
  Hungary | ambroxol | MUCOFREE 15 mg/5 ml szirup | 15 mg/5 ml | syrup | oral use |
| Hungary | Pharma-Regist Kft.,
  Október 6. u. 7.
  Budapest
  1051
  Hungary | ambroxol | MUCOFREE 30 mg/5 ml szirup | 30 mg/5 ml | syrup | oral use |
| Hungary | PannonPharma Kft.
  Pannonpharma út 1.
  Pécsvárad
  H-7720
  Hungary | ambroxol | MUKAMBRO 10 mg/adag belsőleges oldatos spray | 10 mg/dose | oromucosal spray | oromucosal use |
| Hungary | Divapharma GmbH
  Motzener Str. 41
  D-12277 Berlin
  Germany | ambroxol | NEO-BRONCHOL szopogató tabletta | 15 mg | lozenge | oromucosal use |
| Hungary | Meditop Gyógyszeripari Kft.
  Ady Endre u. 1
  Pilisborosjenő
  H-2097
  Hungary | bromhexine, oxymetazoline | NASOPAX orrspray felnőtteknek | 0,12 mg/0,025 mg oximetazolin-klorid/dose (0,1 ml). | nasal spray, solution | nasal use |
| Hungary | Meditop Gyógyszeripari Kft.
  Ady Endre u. 1
  Pilisborosjenő
  H-2097
  Hungary | bromhexine, oxymetazoline | NASOPAX orrspray gyermekeknek | 0,06 mg/0,005 mg oximetazolin-klorid/dose (0,1 ml). | nasal spray, solution | nasal use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | bromhexine | PAXIRASOL 2 mg/ml belsőleges oldat | 2 mg/ml | oral solution | oral use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | bromhexine | PAXIRASOL 2 mg/ml oldatos injekció | 2 mg/ml | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | bromhexine | PAXIRASOL 8 mg tabletta | 8 mg | tablet | oral use |
| Hungary | EGIS Gyógyszergyár Zrt.,
  Keresztúri út 30-38.
  Budapest H-1106
  Hungary | bromhexine | PAXIRASOL oldatos orrspray | 0,2 mg/dose | nasal spray, solution | nasal use |
| Iceland | Boehringer Ingelheim International G.m.b.H.,
  Binger Strasse 173, 55216
  Ingelheim am Rhein,
  Germany | Bromhexinum INN cloride | Bisolvon | 8 mg | tablet | oral use |
| Ireland | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Ambroxol hydrochloride | Ambrobene 3 mg/ml Oral Solution | 3 mg/ml | oral solution | oral use |
| Ireland | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Ambroxol hydrochloride | Ambrobene Extra Strength 6 mg/ml Oral Solution | 6 mg/ml | oral solution | oral use |
| Ireland | Boehringer Ingelheim Limited,
  Ellesfield Avenue,
  Bracknell,
  Berkshire, RG12 8YS,
  United Kingdom | Ambroxol hydrochloride | Lysopadol Mint 20 mg Lozenges | 20 mg | lozenge | oral use |
| Ireland | Boehringer Ingelheim Limited
  Ellesfield Avenue
  Bracknell,
  Berkshire RG12 8YS
  United Kingdom | Ambroxol hydrochloride | Lysopadol 17,86 mg/ml Oromucosal Spray, Solution | 17,86 mg/ml | oromucosal spray, solution | oromucosal use |
| Ireland | Boehringer Ingelheim Limited,
  Ellesfield Avenue,
  Bracknell,
  Berkshire, RG12 8YS,
  United Kingdom | Ambroxol hydrochloride | Lysopadol Lemon 20 mg Lozenges | 20 mg | lozenge | oral use |
| Ireland | Boehringer Ingelheim Limited,
  Ellesfield Avenue,
  Bracknell,
  Berkshire, RG12 8YS,
  United Kingdom | Ambroxol hydrochloride | Lysopadol Blackcurrant 20 mg Lozenges | 20 mg | lozenge | oral use |
| Ireland | Boehringer Ingelheim Limited,
  Ellesfield Avenue
  Bracknell
  Berkshire, RG12 8YS
  United Kingdom | Bromohexine hydrochloride | Bisolvon 4 mg/5 ml Oral Solution | 4 mg/5 ml | oral solution | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 30 mg | tablet | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 75 mg | prolonged-release capsule, hard | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan Bambini | 30 mg | suppository | rectal use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 15 mg/5 ml | syrup | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 7,5 mg/ml | nebuliser solution | inhalation use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 60 mg | granules for oral solution | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8 20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Mucosolvan | 15 mg | oral gum | oral use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron | 30 mg | tablet | oral use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron | 15 mg/5 ml | syrup | oral use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron | 0,75 % | oral solution or nebuliser solution | oral use,
  inhalation use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron Adulti | 30 mg | granules for oral suspension | oral use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron Bambini | 15 mg | granules for oral suspension | oral use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Chiesi Farmaceutici S.P.A.
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Fluibron Adulti | 30 mg | effervescent tablet | oral use |
| Italy | Piam Farmaceutici S.P.A.
  Via Padre Semeria, 5
  16131 Genova
  Italy | Ambroxol hydrochloride | Muciclar | 15 mg/5 ml | syrup | oral use |
| Italy | Piam Farmaceutici S.P.A.
  Via Padre Semeria, 5
  16131 Genova
  Italy | Ambroxol hydrochloride | Muciclar | 75 mg | prolonged-release capsule | oral use |
| Italy | Piam Farmaceutici S.P.A.
  Via Padre Semeria, 5
  16131 Genova
  Italy | Ambroxol hydrochloride | Muciclar | 30 mg | granules for oral suspension | oral use |
| Italy | Piam Farmaceutici S.P.A.
  Via Padre Semeria, 5
  16131 Genova
  Italy | Ambroxol hydrochloride | Muciclar | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Farmaceutici Caber S.P.A.
  V. Le Citta' D'europa, 681
  00100 Roma
  Italy | Ambroxol hydrochloride | Secretil | 15 mg/5 ml | syrup | oral use |
| Italy | Farmaceutici Caber S.P.A.
  V. Le Citta' D'europa, 681
  00100 Roma
  Italy | Ambroxol hydrochloride | Secretil | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Farmaceutici Caber S.P.A.
  V. Le Citta' D'europa, 681
  00100 Roma
  Italy | Ambroxol hydrochloride | Secretil | 60 mg | granules for oral solution | oral use |
| Italy | Farmaceutici Caber S.P.A.
  V. Le Citta' D'europa, 681
  00100 Roma
  Italy | Ambroxol hydrochloride | Secretil | 30 mg/4 ml | nebuliser solution | inhalation use |
| Italy | Abc Farmaceutici S.P.A. Corso
  V. Emanuele Ii, 72 10121
  Torino
  Italy | Ambroxol hydrochloride | Ambroxolo ABC | 30 mg | tablet | oral use |
| Italy | Abc Farmaceutici S.P.A. Corso
  V. Emanuele Ii, 72 10121
  Torino
  Italy | Ambroxol hydrochloride | Ambroxolo ABC | 15 mg | nebuliser solution | inhalation use |
| Italy | Abc Farmaceutici S.P.A. Corso V. Emanuele Ii, 72 10121
  Torino
  Italy | Ambroxol hydrochloride | Ambroxolo ABC | 30 mg | suppository | rectal use |
| Italy | Abc Farmaceutici S.P.A. Corso
  V. Emanuele Ii, 72 10121
  Torino
  Italy | Ambroxol hydrochloride | Ambroxolo ABC | 15 mg | granules for oral suspension | oral use |
| Italy | Abc Farmaceutici S.P.A. Corso V. Emanuele Ii, 72 10121
  Torino
  Italy | Ambroxol hydrochloride | Ambroxolo ABC | 30 mg | granules for oral suspension | oral use |
| Italy | Laboratorio Farmaceutico Sit Specialita' Igienico
  Terapeutiche S.R.L.,
  Via Cavour, 70
  Mede 27035 Pavia
  Italy | Ambroxol hydrochloride | Tauxolo | 3 mg/ml | syrup | oral use |
| Italy | S.F. Group S.R.L.
  Via Beniamino Segre, 59
  00134 Roma
  Italy | Ambroxol hydrochloride | Broxol | 15 mg/5 ml | syrup | oral use |
| Italy | S.F. Group S.R.L.
  Via Beniamino Segre, 59 00134 Roma
  Italy | Ambroxol hydrochloride | Broxol Adulti | 30 mg | granules | oral use |
| Italy | S.F. Group S.R.L.
  Via Beniamino Segre, 59
  00134 Roma
  Italy | Ambroxol hydrochloride | Broxol | 0,75 % | nebuliser solution | inhalation use |
| Italy | Actavis Group Ptc Ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Ambroxol hydrochloride | Ambroxolo Actavis | 0,30 % | syrup | oral use |
| Italy | Istituto Chimico
  Internazionale Dr. Giuseppe
  Rende S.R.L.
  Via Salaria, 1240
  00138 Roma
  Italy | Ambroxol hydrochloride | Amobronc | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Istituto Chimico
  Internazionale Dr. Giuseppe
  Rende S.R.L.
  Via Salaria, 1240
  00138 Roma
  Italy | Ambroxol hydrochloride | Amobronc | 15 mg/5 ml | syrup | oral use |
| Italy | Boehringer Ingelheim Italia
  S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Surfactal | 1 g/50 ml | solution for infusion | intravenous use |
| Italy | Farmapro S.R.L.
  Via Beato Sebastiano Valfre 4, 10121 Torino
  Italy | Ambroxol hydrochloride | Ambroxolo Pharmentis | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Ratiopharm Gmbh
  Graf-Arco Strasse 3
  D-89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxolo Ratiopharm | 30 mg/10 ml | syrup | oral use |
| Italy | Hexal S.P.A.
  Largo Umberto Boccioni, 1
  21040 Origgio Varese
  Italy | Ambroxol hydrochloride | Ambroxolo Hexal | 7,5 mg/ml | nebuliser solution | inhalation use |
| Italy | Hexal S.P.A.
  Largo Umberto Boccioni, 1
  21040 Origgio Varese
  Italy | Ambroxol hydrochloride | Ambroxolo Hexal | 3 mg/ml | syrup | oral use |
| Italy | A. Menarini Industrie Farmaceutiche Riunite S.R.L.
  Via Sette Santi, 3
  50131 Firenze
  Italy | Ambroxol hydrochloride | Mucoaricodil | 30 mg | tablet | oral use |
| Italy | A. Menarini Industrie Farmaceutiche Riunite S.R.L.
  Via Sette Santi, 3
  50131 Firenze
  Italy | Ambroxol hydrochloride | Mucoaricodil | 30 mg/10 ml | syrup | oral use |
| Italy | Teva Italia S.R.L.
  Via Messina, 38
  20154 Milano
  Italy | Ambroxol hydrochloride | Ambroxol Dorom | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Alfa Wassermann S.P.A.
  Via Enrico Fermi, 1
  65020 Alanno — Pescara
  Italy | Ambroxol hydrochloride | Lintos | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Alfa Wassermann S.P.A.
  Via Enrico Fermi, 1
  65020 Alanno — Pescara
  Italy | Ambroxol hydrochloride | Lintos | 30 mg/10 ml | syrup | oral use |
| Italy | Eg S.P.A.
  Via Pavia 6
  20136
  Milano
  Italy | Ambroxol hydrochloride | Ambroxolo EG | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Eg S.P.A.
  Via Pavia 6
  20136
  Milano
  Italy | Ambroxol hydrochloride | Ambroxolo EG | 15 mg/5 ml | syrup | oral use |
| Italy | Eg S.P.A.
  Via Pavia 6
  20136
  Milano
  Italy | Ambroxol hydrochloride | Ambroxolo EG | 30 mg/10 ml | syrup | oral use |
| Italy | Epifarma S.R.L
  Via S. Rocco, 6
  85033 Episcopia -Potenza Italy | Ambroxol hydrochloride | Ambrotus | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Epifarma S.R.L
  Via S. Rocco, 6
  85033 Episcopia -Potenza Italy | Ambroxol hydrochloride | Ambrotus | 30 mg/10 ml | syrup | oral use |
| Italy | Farmakopea S.P.A.
  Via Cavriana, 14
  20134 Milano
  Italy | Ambroxol hydrochloride | Gammaxol | 15 mg/5 ml | syrup | oral use |
| Italy | Farmakopea S.P.A.
  Via Cavriana, 14
  20134 Milano
  Italy | Ambroxol hydrochloride | Gammaxol | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Farmakopea S.P.A.
  Via Cavriana, 14
  20134 Milano
  Italy | Ambroxol hydrochloride | Gammaxol | 0,75 % | nebuliser solution | inhalation use |
| Italy | Union Health S.R.L.
  Via Adige, 5
  66020 San Giovanni Teatino — Chieti
  Italy | Ambroxol hydrochloride | Ambroxol | 3 mg/ml | syrup | oral use |
| Italy | Union Health S.R.L.
  Via Adige, 5
  66020 San Giovanni Teatino — Chieti
  Italy | Ambroxol hydrochloride | Ambroxol | 7,5 mg/ml | nebuliser solution | inhalation use |
| Italy | Union Health S.R.L.
  Via Adige, 5
  66020 San Giovanni Teatino — Chieti
  Italy | Ambroxol hydrochloride | Ambroxol | 0,75 % | nebuliser solution | inhalation use |
| Italy | Union Health S.R.L.
  Via Adige, 5
  66020 San Giovanni Teatino — Chieti
  Italy | Ambroxol hydrochloride | Ambroxol | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Tecnigen S.R.L.
  Via Galileo Galilei 40
  20092 Cinisello Balsamo — Milano
  Italy | Ambroxol hydrochloride | Ambroxol Tecnigen | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Tecnigen S.R.L.
  Via Galileo Galilei 40
  20092 Cinisello Balsamo — Milano
  Italy | Ambroxol hydrochloride | Ambroxol Tecnigen | 30 mg/10 ml | syrup | oral use |
| Italy | Procter & Gamble S.R.L.
  Viale G. Ribotta, 11
  00144 Roma
  Italy | Ambroxol hydrochloride | Vicks tosse mucolitico | 30 mg | effervescent tablet | oral use |
| Italy | Procter & Gamble S.R.L.
  Viale G. Ribotta, 11
  00144 Roma
  Italy | Ambroxol hydrochloride | Vicks tosse mucolitico | 30 mg | effervescent tablet | oral use |
| Italy | Almus S.R.L.
  Via Cesarea, 11/10
  16121 Genova
  Italy | Ambroxol hydrochloride | Ambroxolo Almus | 30 mg/10 ml | syrup | oral use |
| Italy | Almus S.R.L.
  Via Cesarea, 11/10
  16121 Genova
  Italy | Ambroxol hydrochloride | Ambroxolo Almus | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Angenerico S.P.A.
  Via Nocera Umbra, 75
  00181 Roma
  Italy | Ambroxol hydrochloride | Ambroxolo Angenerico | 7,5 mg/ml | nebuliser solution | inhalation use |
| Italy | Angenerico S.P.A.
  Via Nocera Umbra, 75
  00181 Roma
  Italy | Ambroxol hydrochloride | Ambroxolo Angenerico | 3 mg/ml | syrup | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Ambroxol hydrochloride | Zerinol Gola menta | 20 mg | tablet | oral use |
| Italy | Boehringer Ingelheim International Gmbh
  Binger Strasse 173
  D55216 Ingelheim Am Rhein Germany | Ambroxol hydrochloride | Zerinol Gola ribes nero | 20 mg | tablet | oral use |
| Italy | Wellington Street Development Pharma Limited 47, Oaklands Drive Rathgar
  Dublino 6
  Ireland | Ambroxol hydrochloride | Brufix | 0,75 % | nebuliser solution | inhalation use |
| Italy | Germed Pharma S.P.A.
  Via Cantu', 11
  20092 Cinisello Balsamo — Milano
  Italy | Ambroxol hydrochloride | Ambroxolo Germed | 15 mg/5 ml | syrup | oral use |
| Italy | Mylan S.P.A.
  Via Vittor Pisani, 20
  20124 Milano
  Italy | Ambroxol hydrochloride | Ambroxolo Mylan Generics | 15 mg/5 ml | syrup | oral use |
| Italy | Abc Farmaceutici S.P.A.
  Corso V. Emanuele Ii, 72
  10121 Torino
  Italy | Ambroxol hydrochloride | Viscomucil | 3 mg/ml | syrup | oral use |
| Italy | Cyathus Exquirere
  Pharmaforschungsgmbh
  Rudolfsplatz 2/1/8
  1010 Vienna
  Austria | Ambroxol hydrochloride | Mukambro | 10 mg/erogazione | oral solution | oral use |
| Italy | Cyathus Exquirere
  Pharmaforschungsgmbh
  Rudolfsplatz 2/1/8
  1010 Vienna
  Austria | Ambroxol hydrochloride | Gogolox | 10 mg/erogazione | oral solution | oral use |
| Italy | Boehringer Ingelheim Italia
  S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 2 mg/ml | oral solution | oral use |
| Italy | Boehringer Ingelheim Italia
  S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 8 mg | tablet | oral use |
| Italy | Boehringer Ingelheim Italia
  S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 4 mg/2 ml | solution for injection | injection use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 4 mg/5 ml | syrup | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 8 mg | soluble tablet | oral use |
| Italy | Boehringer Ingelheim Italia S.P.A.
  Via Lorenzini, 8
  20139 Milano
  Italy | Bromhexine hydrochloride | Bisolvon | 8 mg/5 ml | syrup | oral use |
| Italy | Boots Pharmaceuticals S.R.L.
  Via Cesarea 11/10
  16121 Genova
  Italy | Bromhexine hydrochloride | Nirolex tosse e catarro | 4 mg/5 ml | syrup | oral use |
| Italy | Aesculapius Farmaceutici Srl
  Via Cozzaglio, 24
  25125 Brescia
  Italy | Bromhexine hydrochloride | Flutoxil | 4 mg/5 ml | syrup | oral use |
| Italy | Farmapro S.R.L.
  Via Beato Sebastiano Valfre 4,
  10121 Torino
  Italy | Bromhexine hydrochloride | Bromexina Pharmentis | 4 mg/5 ml | syrup | oral use |
| Italy | Germed Pharma S.P.A.
  Via Cantu', 11
  20092 Cinisello Balsamo — Milano
  Italy | Bromhexine hydrochloride | Bromexina Germed | 4 mg/5 ml | syrup | oral use |
| Italy | Laboratorio Farmaceutico Sit
  Specialita' Igienico
  Terapeutiche S.R.L.,
  Via Cavour, 70
  Mede 27035 Pavia
  Italy | Bromhexine hydrochloride | Tauglicolo | 40 mg | syrup | oral use |
| Italy | Laboratorio Farmaceutico Sit
  Specialita' Igienico
  Terapeutiche S.R.L.,
  Via Cavour, 70
  Mede 27035 Pavia
  Italy | Bromhexine hydrochloride | Tauglicolo Adulti | 6 mg | suppository | rectal use |
| Italy | Laboratorio Farmaceutico Sit
  Specialita' Igienico
  Terapeutiche S.R.L.,
  Via Cavour, 70
  Mede 27035 Pavia
  Italy | Bromhexine hydrochloride | Tauglicolo Bambini | 3 mg | suppository | rectal use |
| Italy | Laboratorio Farmaceutico Sit
  Specialita' Igienico
  Terapeutiche S.R.L.,
  Via Cavour, 70
  Mede 27035 Pavia
  Italy | Bromhexine hydrochloride/sulphuguaiacol | Tauglicolo | 4 mg +3,86 mg | solution for injection | injection use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 15 mg/5 ml | syrup | oral use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 15 mg/2 ml | nebuliser solution | inhalation use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 0,75 % | oral solution nebuliser solution | oral use
  inhalation use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 30 mg | tablet | oral use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 15 mg | granules for suspension | oral use |
| Italy | Promedica Srl
  Via Palermo, 26/A
  43122 Parma
  Italy | Ambroxol hydrochloride | Ventibron | 30 mg | granules for suspension | oral use |
| Latvia | EGIS PHARMACEUTICALS
  PLC., 1106 BUDAPEST,
  Kereszturi ut 30-38,
  Hungary | ambroxol hydrochloride | Halixol 15 mg/5 ml syrup | 15 mg/5 ml | syrup | oral use |
| Latvia | EGIS PHARMACEUTICALS
  PLC., 1106 BUDAPEST,
  Kereszturi ut 30-38,
  Hungary | ambroxol hydrochloride | Halixol 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | PRO.MED.CS Praha a.s.,
  Telcska 1, 140 00 Praha 4,
  Czech Republic | ambroxol hydrochloride | Ambrosan 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | G. L. Pharma GmbH,
  Schlossplatz 1, 8502 Lannach,
  Austria | ambroxol hydrochloride | Ambrolan 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | STIROLBIOFARM BALTIKUM
  SIA, Rasas iela 5, Riga,
  Latvia | ambroxol hydrochloride | Ambroksols Stirol 75 mg prolonged-release tablets | 75 mg | prolonged-release tablet | oral use |
| Latvia | BERLIN-CHEMIE AG
  (MENARINI GROUP),
  Glienicker Weg 125,
  12489 Berlin,
  Germany | ambroxol hydrochloride | Flavamed 60 mg effervescent tablets | 60 mg | effervescent tablet | oral use |
| Latvia | ratiopharm GmbH,
  Graf-Arco-Str. 3,
  89079 Ulm,
  Germany | ambroxol hydrochloride | Brontex 3 mg/ml syrup | 3 mg/ml | syrup | oral use |
| Latvia | ratiopharm GmbH,
  Graf-Arco-Str. 3,
  89079 Ulm,
  Germany | ambroxol hydrochloride | Brontex 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | BERLIN-CHEMIE AG
  (MENARINI GROUP),
  Glienicker Weg 125,
  12489 Berlin,
  Germany | ambroxol hydrochloride | Flavamed 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | BERLIN-CHEMIE AG
  (MENARINI GROUP),
  Glienicker Weg 125,
  12489 Berlin,
  Germany | ambroxol hydrochloride | Tusmed 30 mg/5 ml oral solution | 30 mg/5 ml | oral solution | oral use |
| Latvia | AS ‘Olainfarm’,
  Rūpnīcu iela 5,
  Olaine, 2114,
  Latvia | ambroxol hydrochloride | Ambroksol 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | Sandoz d.d.,
  Verovskova 57,
  1000 Ljubljana,
  Slovenia | ambroxol hydrochloride | Ambroxol Sandoz 15 mg/5 ml syrup | 15 mg/5 ml | syrup | oral use |
| Latvia | Sandoz d.d.,
  Verovskova 57,
  1000 Ljubljana,
  Slovenia | ambroxol hydrochloride | Ambroxol Sandoz 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | CYATHUS Exquirere
  Pharmaforschungs GmbH,
  Rudolfsplatz 2/1/8, 1010
  Vienna,
  Austria | ambroxol hydrochloride | Mukambro 10 mg/spray puff oral solution | 10 mg/spray puff | oral solution | oral use |
| Latvia | BERLIN-CHEMIE AG (MENARINI GROUP), Glienicker Weg 125,
  12489 Berlin,
  Germany | ambroxol hydrochloride | Flavamed for children 15 mg/5 ml oral solution | 15 mg/5 ml | oral solution | oral use |
| Latvia | Boehringer Ingelheim
  International GmbH, Binger Strasse 173,
  55216 Ingelheim am Rein,
  Germany | ambroxol hydrochloride | Lasolvan 15 mg/5 ml syrup | 15 mg/5 ml | syrup | oral use |
| Latvia | Divapharma GmbH, Motzener Str. 41,
  12277 Berlin,
  Germany | ambroxol hydrochloride | Neo-bronchol 15 mg lozenges | 15 mg | lozenge | oral use |
| Latvia | SIA Briz,
  Rasas iela 5,
  Riga, 1057,
  Latvia | ambroxol hydrochloride | Ambroxol — BCPP 30 mg tablets | 30 mg | tablet | oral use |
| Latvia | BERLIN-CHEMIE AG (MENARINI GROUP), Glienicker Weg 125,
  12489 Berlin,
  Germany | ambroxol hydrochloride | Flavamed 30 mg/5 ml oral solution | 30 mg/5 ml | oral solution | oral use |
| Latvia | Actavis Nordic A/S, Ornegardsvej 16,
  2820 Gentofte,
  Denmark | bromhexine hydrochloride | Bromhexin Actavis 8 mg tablets | 8 mg | tablet | oral use |
| Latvia | SIA Briz,
  Rasas iela 5,
  Riga,
  1057,
  Latvia | bromhexine hydrochloride | Bromhexin Sopharma 8 mg tablets | 8 mg | tablet | oral use |
| Latvia | AS GRINDEKS.
  Krustpils, 53,
  Riga, 1057,
  Latvia | bromhexine hydrochloride | Bromhexine-Grindeks 4 mg tabletes | 4 mg | tablet | oral use |
| Latvia | AS GRINDEKS.
  Krustpils, 53,
  Riga, 1057,
  Latvia | bromhexine hydrochloride | Bromhexine-Grindeks 8 mg tabletes | 8 mg | tablet | oral use |
| Latvia | AS GRINDEKS.
  Krustpils, 53,
  Riga, 1057,
  Latvia | bromhexine hydrochloride | Bromhexine-Grindeks 4 mg/5 ml syrup | 4 mg/5 ml | syrup | oral use |
| Latvia | SIA Briz,
  Rasas iela 5,
  Riga, 1057,
  Latvia | bromhexine hydrochloride | Bromhexin Sopharma 4 mg/5 ml syrup | 4 mg/5 ml | syrup | oral use |
| Lithuania | CYATHUS Exquirere
  Pharmaforschungs GmbH
  Rudolfsplatz 2/1/8
  1010 Vienna
  Austria | Ambroxol hydrochloride | AMBROSPRAY | 10 mg/0,2 ml | oral solution | oral use |
| Lithuania | G.L. Pharma GmbH
  Schlossplatz 1
  8502 Lannach
  Austria | Ambroxol hydrochloride | Ambrolan | 30 mg | tablet | oral use |
| Lithuania | PRO.MED.CS Praha a.s.
  Telčska 1140 00 Praha,
  Czech Republic | Ambroxol hydrochloride | Ambrosan | 30 mg | tablet | oral use |
| Lithuania | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana
  Slovenia | Ambroxol hydrochloride | Ambroxol Sandoz | 30 mg | tablet | oral use |
| Lithuania | Sandoz d.d.
  Verovškova 57,
  1000 Ljubljana
  Slovenia | Ambroxol hydrochloride | Ambroxol Sandoz | 15 mg/5 ml | syrup | oral use |
| Lithuania | ratiopharm GmbH
  Graf — Arco — Str. 3
  89079 Ulm,
  Germany | Ambroxol hydrochloride | Brontex | 30 mg | tablet | oral use |
| Lithuania | ratiopharm GmbH
  Graf — Arco — Str. 3
  89079 Ulm,
  Germany | Ambroxol hydrochloride | Brontex | 7,5 mg/ml | oral drops, solution | oral use |
| Lithuania | ratiopharm GmbH
  Graf — Arco — Str. 3
  89079 Ulm,
  Germany | Ambroxol hydrochloride | Brontex | 15 mg/5 ml | syrup | oral use |
| Lithuania | BERLIN-CHEMIE AG (MENARINI GROUP)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 30 mg | tablet | oral use |
| Lithuania | BERLIN-CHEMIE AG (MENARINI GROUP)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 60 mg | effervescent tablet | oral use |
| Lithuania | BERLIN-CHEMIE AG (MENARINI GROUP)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 30 mg/5 ml | oral solution | oral use |
| Lithuania | BERLIN-CHEMIE AG (MENARINI GROUP)
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 15 mg/5 ml | oral solution | oral use |
| Lithuania | EGIS PHARMACEUTICALS PLC
  1106 Budapest
  Keresztúri út 30-38
  Hungary | Ambroxol hydrochloride | Halixol | 15 mg/5 ml | syrup | oral use |
| Lithuania | EGIS PHARMACEUTICALS PLC
  1106 Budapest
  Keresztúri út 30-38
  Hungary | Ambroxol hydrochloride | Halixol | 30 mg | tablet | oral use |
| Lithuania | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Lasolvan | 15 mg/5 ml | syrup | oral use |
| Lithuania | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Lasolvan | 15 mg/2 ml | inhalation vapour, solution | oral use |
| Lithuania | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Lasolvan | 30 mg | tablet | oral use |
| Lithuania | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Lasolvan | 75 mg | prolonged-release capsule, hard | oral use |
| Lithuania | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Tussisol | 30 mg/5 ml | oral solution | oral use |
| Lithuania | Divapharma GmbH
  Motzener Str. 41
  12277 Berlin
  Germany | Ambroxol hydrochloride | neo-bronchol | 15 mg | lozenge | oral use |
| Lithuania | AS GRINDEKS
  Krustpils 53
  Rīga 1057
  Latvia | Bromhexine hydrochloride | BROMHEXINE-GRINDEKS | 4 mg/5 ml | syrup | oral use |
| Lithuania | AS GRINDEKS
  Krustpils 53
  Rīga 1057
  Latvia | Bromhexine hydrochloride | BROMHEXINE-GRINDEKS | 4 mg | tablet | oral use |
| Lithuania | AS GRINDEKS
  Krustpils 53
  Rīga 1057
  Latvia | Bromhexine hydrochloride | BROMHEXINE-GRINDEKS | 8 mg | tablet | oral use |
| Lithuania | Actavis Nordic A/S
  Ørnegårdsvej 16,
  2820 Gentofte
  Denmark | Bromhexine hydrochloride | Bromhexin Actavis | 8 mg | tablet | oral use |
| Lithuania | BERLIN-CHEMIE AG (MENARINI GROUP)
  Glienicker Weg 125
  12489 Berlin
  Germany | Bromhexine hydrochloride | Bromhexin Berlin-Chemie | 8 mg | coated tablet | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Bisolvon | 8 mg | tablet | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Bisolvon | 8 mg/5 ml | syrup | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Bisolvon | 0,20 % | oral solution | oral use |
| Luxembourg | Eurogenerics
  Heizel Esplanade b22
  1020 Brussel
  Belgium | Bromhexine chlorhydrate | Bromhexine EG | 8 mg | tablet | oral use |
| Luxembourg | D.J.VAN TINTELEN BEHEER B.V.
  Keyserwey 20
  2201 CW Noordwijk Zh
  The Netherlands | Bromhexine chlorhydrate | Bronchi-Mereprine | 8 mg | tablet | oral use |
| Luxembourg | Qualiphar Laboratoire
  Rijksweg 9
  2880 Bornem
  Belgium | Bromhexine chlorhydrate | Toularynx Bromhexine | 5 mg/5 ml | syrup | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Ambroxine | 20 mg | lozenge | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Mucoangin Citron 20 mg | 20 mg | lozenge | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Mucoangine Cassis | 20 mg | lozenge | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Bromhexine chlorhydrate | Mucoangine Menthe | 20 mg | lozenge | oral use |
| Luxembourg | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal Hustenlöser | 30 mg | tablet | oral use |
| Luxembourg | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal Hustentropfen | 7,5 mg/ml | oral drops, solution | oral use |
| Luxembourg | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal Hustensaft für Kinder | 15 mg/5 ml | oral solution | oral use |
| Luxembourg | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambroxhexal Hustenlöser retard | 75 mg | prolonged-release capsule, hard | oral use |
| Luxembourg | Hexal AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Ambroxol hydrochloride | Ambrohexal S Brausetablette | 60 mg | effervescent tablet | oral use |
| Luxembourg | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 30 mg Hustenlöser | 30 mg | tablet | oral use |
| Luxembourg | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 75 mg Hustenlöser | 75 mg | prolonged-release capsule, hard | oral use |
| Luxembourg | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm Hustensaft | 15 mg/5 ml | oral solution | oral use |
| Luxembourg | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm Hustentropfen | 7,5 mg/ml | oral drops, solution | oral use |
| Luxembourg | ratiopharm GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Ambroxol hydrochloride | Ambroxol-ratiopharm 15 mg/2 ml Injektionslösung | 15 mg/2 ml | solution for injection | intravenous use |
| Luxembourg | Biocodex
  Avenue Gallieni 7
  94250 Gentilly
  France | Ambroxol hydrochloride | Muxol | 30 mg | tablet | oral use |
| Luxembourg | Biocodex
  Avenue Gallieni 7
  94250 Gentilly
  France | Ambroxol hydrochloride | Muxol | 3 mg/ml | oral solution | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Ambroxol hydrochloride | Surbronc | 60 mg | coated tablet | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Ambroxol hydrochloride | Surbronc | 30 mg/5 ml | syrup | oral use |
| Luxembourg | SCS Boehringer Ingelheim Comm. V.
  Vesalius Science Park
  Avenue Ariane 16
  1200 Bruxelles
  Belgium | Ambroxol hydrochloride | Surbronc | 60 mg/3 g | powder for oral solution | oral use |
| Malta | Medochemie Ltd.
  1-10 Constantinoupoleos Street, 3011, P.O. Box 51409,
  3505 Limassol,
  Cyprus | Ambroxol Hydrochloride | Medovent Elixir Syrup 15 mg/5 ml | 15 mg/5 ml | oral solution | oral use |
| Malta | Mundipharma Pharmaceuticals Ltd.
  13 Othellos Street, Dhali
  Industrial Zone, Nicosia,
  Cyprus | Ambroxol Hyrdochloride | Mucobroxol Syrup | 15 mg/5 ml | syrup | oral use |
| Malta | Actavis EAD
  29, Atanas Dukov Street, Sofia 1407
  Bulgaria | Ambroxol Hydrochloride | MUCOLISIN 30 mg/5 ml syrup | 30 mg/5 ml | syrup | oral use |
| Malta | Aflofarm Farmacja Polska SP. zo. o.
  ul. Partyzancka 133/151 95-200 Pabianice,
  Poland | Ambroxol Hydrochloride | Entus Max 30 mg/5 ml syrup | 30 mg/5 ml | syrup | oral use |
| Malta | PIAM Farmaceutici S.P.A.
  Via Padre G. Semeria, 5, I-16131, Genoa,
  Italy | Ambroxol Hydrochloride | Muciclar | 3 mg/ml | syrup | oral use |
| Malta | PIAM Farmaceutici S.P.A.
  Via Padre G. Semeria, 5, I-16131, Genoa,
  Italy | Ambroxol Hydrochloride | Muciclar | 75 mg | modified release capsule | oral use |
| Malta | Boehringer Ingelheim Ellas A.E.
  Ellinikou 2, 167 77 Elliniko, Athens,
  Greece | Ambroxol Hydrochloride (Cyclohexanol Hydrochloride) | Mucosolvan | 15 mg/5 ml | syrup | oral use |
| Malta | Boehringer Ingelheim Ellas A.E.
  Ellinikou 2, 167 77 Elliniko, Athens,
  Greece | Ambroxol Hydrochloride (Cyclohexanol Hydrochloride) | Mucosolvan | 30 mg | tablet | oral use |
| Malta | Sopharma PLC
  16, Iliensko Shosse Str.
  1220 Sofia,
  Bulgaria | Bromhexine hydrochloride | BROMHEXINE SOPHARMA 4 mg/5 ml syrup | 4 mg/5 ml | syrup | oral use |
| Malta | Adelco-Chromatourgia Anthinon E. Colocotronis Bros S.A.
  37 Pireos Str, 183 46, Moschato, Athens,
  Greece | Bromhexine Hydrochloride | Bronchotussine | 4 mg/5 ml | syrup | oral use |
| Malta | Boehringer Ingelheim Limited
  Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS,
  United Kingdom | Bromhexine Hydrochloride | Bisolvon 4 mg/5 ml Oral Solution | 4 mg/5 ml | oral solution | oral use |
| Malta | Remedica Ltd.
  Limassol Industrial Estate,
  Aharnon Street, P.O. Box
  51706, 3508 Limassol, Cyprus | Bromhexine Hydrochloride BP | Flecoxin 8 Tablets | 8 mg | tablet | oral use |
| Norway | AS Den norske Eterfabrikk, Karihaugveien 22, 1086 Oslo,
  Norway | Bromhexine hydrochloride | Bromhexine DnE | 1,6 mg/ml | oral solution | oral use |
| Norway | AS Den norske Eterfabrikk, Karihaugveien 22, 1086 Oslo,
  Norway | Bromhexine hydrochloride | Bromhexine DnE | 0,8 mg/ml | oral solution | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216
  Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 0,8 mg/ml | oral solution | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216
  Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 1,6 mg/ml | oral solution | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216 Ingelheim am Rhein, Germany | Bromhexine hydrochloride | Bisolvon | 0,8 mg/ml | oral solution | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216
  Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 1,6 mg/ml | oral solution | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216
  Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 8 mg | tablet | oral use |
| Norway | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216
  Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 8 mg | soluble tablet | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice,
  170 00
  Czech Republic | Ambroxol hydrochloride | Aflegan | 7,5 mg/ml | solution for injection | intravenous use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  6250 Kundl
  Austria | Ambroxol hydrochloride | Ambrohexal | 7,5 mg/ml | solution for injection | intravenous use, intramuscular use, subcutaneous use |
| Poland | Takeda Pharma Sp. z o.o.
  Al. Jerozolimskie 146 A
  02-305 Warszawa
  Poland | Ambroxol hydrochloride | Ambroksol Takeda | 15 mg/5 ml | syrup | oral use |
| Poland | Takeda Pharma Sp. z o.o.
  Al. Jerozolimskie 146 A
  02-305 Warszawa
  Poland | Ambroxol hydrochloride | Ambroksol Takeda | 30 mg/5 ml | syrup | oral use |
| Poland | PRO.MED.CS. Praha a.s.
  Telcska 1
  Praha 4
  140 00
  Czech Republic | Ambroxol hydrochloride | Ambrosan | 30 mg | tablet | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambrosol Teva | 15 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambrosol Teva | 30 mg | tablet | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambrosol Teva | 30 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambrosolvan | 15 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambrosolvan | 30 mg/5 ml | syrup | oral use |
| Poland | Sopharma Warszawa Sp. z o.o.
  ul. Ostrobramska 91
  04-118 Warszawa
  Poland | Ambroxol hydrochloride | Ambrotaxer | 15 mg/5 ml | syrup | oral use |
| Poland | 123ratio Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambroxol 123ratio | 3 mg/ml | oral solution | oral use |
| Poland | 123ratio Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warszawa
  Poland | Ambroxol hydrochloride | Ambroxol 123ratio | 6 mg/ml | oral solution | oral use |
| Poland | Cyathus Exquirere Pharmaforschungs GmbH
  Rudolfsplatz 2/1/8
  1010 Wienn
  Austria | Ambroxol hydrochloride | Ambroxol hydrochloride Cyathus | 10 mg/dawkę | oral solution | oral use |
| Poland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Ambroxoli hydrochloridum Fontane | 15 mg/5 ml | oral solution | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice,
  170 00
  Czech Republic | Ambroxol hydrochloride | Deflegmin | 7,5 mg/ml | oral drops, solution | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice
  17000
  Czech Republic | Ambroxol hydrochloride | Deflegmin | 30 mg | tablet | oral use |
| Poland | ICN Polfa Rzeszów S.A.
  ul. Przemysłowa 2
  35-959 Rzeszów
  Poland | Ambroxol hydrochloride | Deflegmin | 30 mg/5 ml | syrup | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice,
  17000
  Czech Republic | Ambroxol hydrochloride | Deflegmin | 75 mg | prolonged-release capsule | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice,
  17000
  Czech Republic | Ambroxol hydrochloride | Deflegmin | 15 mg/5 ml | syrup | oral use |
| Poland | PharmaSwiss Ceska Republika s.r.o.
  Jankovcova 1569/2c
  Praha 7
  Holesovice,
  17000
  Czech Republic | Ambroxol hydrochloride | Deflegmin | 10 mg/ml | oral solution | oral use |
| Poland | Aflofarm Farmacja Polska Sp. z o.o.
  ul. Partyzancka 133/151
  95-200 Pabianice
  Poland | Ambroxol hydrochloride | Entus Junior | 15 mg/5 ml | syrup | oral use |
| Poland | Aflofarm Farmacja Polska Sp. z o.o.
  ul. Partyzancka 133/151
  95-200 Pabianice
  Poland | Ambroxol hydrochloride | Entus Max | 30 mg/5 ml | syrup | oral use |
| Poland | Aflofarm Farmacja Polska Sp. z o.o.
  ul. Partyzancka 133/151
  95-200 Pabianice
  Poland | Ambroxol hydrochloride | Envil kaszel | 30 mg/5 ml | syrup | oral use |
| Poland | Aflofarm Farmacja Polska Sp. z o.o.
  ul. Partyzancka 133/151
  95-200 Pabianice
  Poland | Ambroxol hydrochloride | Envil kaszel | 30 mg | tablet | oral use |
| Poland | Aflofarm Farmacja Polska Sp. z o.o.
  ul. Partyzancka 133/151
  95-200 Pabianice
  Poland | Ambroxol hydrochloride | Envil kaszel junior | 15 mg/5 ml | syrup | oral use |
| Poland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 15 mg/5 ml | syrup | oral use |
| Poland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 30 mg | tablet | oral use |
| Poland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed | 60 mg | effervescent tablet | oral use |
| Poland | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | Ambroxol hydrochloride | Flavamed max | 30 mg/5 ml | oral solution | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina | 8 mg | tablet | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina Baby | 2 mg/ml | oral drops, solution | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina o smaku malinowym | 4 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina o smaku miętowym | 4 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina o smaku miętowym bez cukru | 4 mg/5 ml | syrup | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Wsrszawa
  Poland | Bromhexine hydrochloride | Flegamina o smaku truskawkowym | 2 mg/5 ml | syrup | oral use |
| Poland | Herbapol — Lublin S.A.
  ul. Diamentowa 25
  20-471 Lublin
  Poland | Bromhexine hydrochloride Extractum fluidum aquosum ex Plantaginis lanceolatae folii et Verbasci floribus | Flegatussin | (0,0026 g +2,35 g)/5 ml | syrup | oral use |
| Poland | Zentiva, k.s.
  U kabelovny 130
  Praga 10,
  10237 Dolni Mecholupy
  Czech Republic | Ambroxol hydrochloride | MEDOX | 15 mg/5 ml | syrup | oral use |
| Poland | Zentiva, k.s.
  U kabelovny 130
  Praga 10,
  10237 Dolni Mecholupy
  Czech Republic | Ambroxol hydrochloride | Medox | 30 mg | tablet | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucoangin | 20 mg | chewable tablet | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 30 mg | tablet | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan | 15 mg | pastille | oral use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan inhalacje | 15 mg/2 ml | nebuliser liquid | inhalation use |
| Poland | Boehringer Ingelheim International GmbH
  Binger Str 173
  55216 Ingelheim am Rhein
  Germany | Ambroxol hydrochloride | Mucosolvan mini | 15 mg/5 ml | syrup | oral use |
| Poland | Biofarm Sp. z o.o.
  ul. Wałbrzyska 13
  60-198 Poznań
  Poland | Ambroxol hydrochloride | Tussal Expectorans | 30 mg | tablet | oral use |
| Portugal | Laboratórios Azevedos — Indústria Farmacêutica, S.A.
  Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
  2614-503 Amadora
  Portugal | Ambroxol | Ambroxol Tussilene | 6 mg/ml | syrup | oral use |
| Portugal | Cinfa Portugal, Lda.
  Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark
  2790-221 Carnaxide
  Portugal | Ambroxol | Ambroxol Cinfa 3 mg/ml Xarope | 3 mg/ml | syrup | oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2, Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Ambroxol Farmoz 15 mg/5 ml Xarope | 3 mg/ml | syrup | oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2, Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Ambroxol Farmoz 30 mg Comprimidos | 30 mg | tablet | oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2, Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Ambroxol Farmoz 30 mg/5 ml Xarope | 6 mg/ml | syrup | oral use |
| Portugal | Baldacci — Portugal, S.A.
  Rua Cândido de Figueiredo, 84-B
  1549-005 Lisboa
  Portugal | Ambroxol | Ambroxol Fluidox 30 mg Comprimidos | 30 mg | tablet | oral use |
| Portugal | Baldacci — Portugal, S.A.
  Rua Cândido de Figueiredo, 84-B
  1549-005 Lisboa
  Portugal | Ambroxol | Ambroxol Fluidox 6 mg/ml Xarope | 6 mg/ml | syrup | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Ambroxol | Ambroxol Generis 3 mg/ml Xarope | 3 mg/ml | syrup | oral use |
| Portugal | Germed Farmacêutica, Lda.
  Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
  2790-012 Portela de Carnaxide
  Portugal | Ambroxol | Ambroxol Germed 3 mg/ml Xarope | 3 mg/ml | syrup | oral use |
| Portugal | Germed Farmacêutica, Lda.
  Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
  2790-012 Portela de Carnaxide
  Portugal | Ambroxol | Ambroxol Germed 6 mg/ml Xarope | 6 mg/ml | syrup | oral use |
| Portugal | Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Lagoas Park, Edifício 5 A, Piso 2
  2740-245 Porto Salvo
  Portugal | Ambroxol | Ambroxol Ratiopharm | 6 mg/ml | oral solution | oral use |
| Portugal | Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Lagoas Park, Edifício 5 A, Piso 2
  2740-245 Porto Salvo
  Portugal | Ambroxol | Ambroxol Ratiopharm | 3 mg/ml | oral solution | oral use |
| Portugal | Sandoz Farmacêutica, Lda.
  Avenida Professor Doutor Cavaco Silva, 10E — Taguspark
  2740-255 Porto Salvo
  Portugal | Ambroxol | Ambroxol Sandoz | 6 mg/ml | syrup | oral use |
| Portugal | Laboratórios Atral, S.A.
  Rua da Estação, 42 — Vala do Carregado
  2600-726 Castanheira do Ribatejo
  Portugal | Ambroxol | Benflux | 30 mg | tablet | oral use |
| Portugal | Laboratórios Atral, S.A.
  Rua da Estação, 42 — Vala do Carregado
  2600-726 Castanheira do Ribatejo
  Portugal | Ambroxol | Benflux | 3 mg/ml | syrup | oral use |
| Portugal | Laboratórios Atral, S.A.
  Rua da Estação, 42 — Vala do Carregado
  2600-726 Castanheira do Ribatejo
  Portugal | Ambroxol | Benflux Forte | 6 mg/ml | syrup | oral use |
| Portugal | Farma 1000 — Prod. Farmacêuticos, Lda.
  Avenida Mestre Cid, 8 — 1o Esq. Frente
  2070-012 Cartaxo
  Portugal | Ambroxol | Bromax | 120 mg | prolonged-release capsule, hard | oral use |
| Portugal | Farma 1000 — Prod. Farmacêuticos, Lda.
  Avenida Mestre Cid, 8 — 1o Esq. Frente
  2070-012 Cartaxo
  Portugal | Ambroxol | Bromax | 30 mg | tablet | oral use |
| Portugal | Farma 1000 — Prod. Farmacêuticos, Lda.
  Avenida Mestre Cid, 8 — 1o Esq. Frente
  2070-012 Cartaxo
  Portugal | Ambroxol | Bromax | 6 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Broncoliber | 30 mg | tablet | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Broncoliber | 3 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Broncoliber | 6 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Broncoliber | 120 mg | prolonged-release capsule, hard | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol | Broncoliber | 50 mg/ml | oral solution | oral use |
| Portugal | Laboratórios Basi — Indústria Farmacêutica, S.A
  Parque Industrial Manuel Lourenço Ferreira, Lote 15
  3450-232 Mortágua
  Portugal | Ambroxol | Broncosil | 6 mg/ml | syrup | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Ambroxol | Bronxol | 30 mg | tablet | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Ambroxol | Bronxol | 6 mg/ml | syrup | oral use |
| Portugal | Pentafarma — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Clembroxol | 3 mg/ml + 0,002 mg/ml | syrup | oral use |
| Portugal | Pentafarma — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Clembroxol | 30 mg + 0,02 mg | tablet | oral use |
| Portugal | Pentafarma — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Clembroxol | 1,5 mg/ml + 0,001 mg/ml | syrup | oral use |
| Portugal | Pentafarma — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Clembroxol | 30 mg + 0,02 mg | granules | oral use |
| Portugal | Laboratórios Vitória, S.A.
  Rua Elias Garcia, 28 — Venda Nova
  2700-327 Amadora
  Portugal | Ambroxol | Drenoxol | 30 mg | tablet | oral use |
| Portugal | Laboratórios Vitória, S.A.
  Rua Elias Garcia, 28 — Venda Nova
  2700-327 Amadora
  Portugal | Ambroxol | Drenoxol | 30 mg/10 ml | syrup | oral use |
| Portugal | Laboratórios Vitória, S.A.
  Rua Elias Garcia, 28 — Venda Nova
  2700-327 Amadora
  Portugal | Ambroxol | Drenoxol | 3 mg/ml | syrup | oral use |
| Portugal | Sofex Farmacêutica, Lda.
  Rua Sebastião e Silva, 25
  2745-838 Massamá
  Portugal | Ambroxol | Fluidrenol | 6 mg/ml | syrup | oral use |
| Portugal | Sofex Farmacêutica, Lda.
  Rua Sebastião e Silva, 25
  2745-838 Massamá
  Portugal | Ambroxol | Fluidrenol | 30 mg | tablet | oral use |
| Portugal | Distrifarma — Companhia de Distribuição Farmacêutica, S.A.
  Estrada Consiglieri Pedroso, 80 — Lt. 3 — Armz. 1/12 — Queluz de Baixo
  2745-553 Barcarena
  Portugal | Ambroxol | Lactucol | 6 mg/ml | syrup | oral use |
| Portugal | Medinfar Consumer Health — Produtos Farmacêuticos, Lda.
  Rua Henrique Paiva Couceiro, 27 — Venda Nova
  2700-451 Amadora
  Portugal | Ambroxol | Mucodrenol | 6 mg/ml | syrup | oral use |
| Portugal | Medinfar Consumer Health — Produtos Farmacêuticos, Lda.
  Rua Henrique Paiva Couceiro, 27 — Venda Nova
  2700-451 Amadora
  Portugal | Ambroxol | Mucodrenol | 30 mg/5 ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan | 15 mg/2 ml | solution for injection | intravenous use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan | 6 mg/ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan | 15 mg | pastille | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan | 30 mg | tablet | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol | Mucosolvan Perlonguets | 75 mg | prolonged-release capsule, hard | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol + Clenbuterol | Mucospas | 3 mg/ml + 0,002 mg/ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Ambroxol + Clenbuterol | Mucospas | 1,5 mg/ml + 0,001 mg/ml | syrup | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Ambroxol | Mucotosse | 6 mg/ml | syrup | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Ambroxol | Mucotosse | 30 mg | tablet | oral use |
| Portugal | Sociedade Farmacêutica Gestafarma, Lda.
  Rua Aquilino Ribeiro, 6-A
  2790-027 Carnaxide
  Portugal | Ambroxol | Spectorum Expectorante | 6 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Ventoliber | 1,5 mg/ml + 0,001 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Ventoliber | 3 mg/ml + 0,002 mg/ml | syrup | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Ventoliber | 30 mg + 0,02 mg | granules | oral use |
| Portugal | Tecnimede — Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2 — Abrunheira
  2710-089 Sintra
  Portugal | Ambroxol + Clenbuterol | Ventoliber | 30 mg + 0,02 mg | tablet | oral use |
| Portugal | Laboratórios Basi — Indústria Farmacêutica, S.A
  Parque Industrial Manuel Lourenço Ferreira, Lote 15
  3450-232 Mortágua
  Portugal | Bromhexine | Basiflux | 0,8 mg/ml | syrup | oral use |
| Portugal | Laboratórios Basi — Indústria Farmacêutica, S.A
  Parque Industrial Manuel Lourenço Ferreira, Lote 15
  3450-232 Mortágua
  Portugal | Bromhexine | Basiflux | 1,6 mg/ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon | 8 mg | tablet | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon | 8 mg/5 ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon | 8 mg | dispersible tablet | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon | 2 mg/ml | oral solution | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon Linctus Adulto | 1,6 mg/ml | syrup | oral use |
| Portugal | Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.
  Avenida de Pádua, 11
  1800-294 Lisboa
  Portugal | Bromhexine | Bisolvon Linctus Criança | 0,8 mg/ml | syrup | oral use |
| Portugal | Laboratórios Azevedos — Indústria Farmacêutica, S.A.
  Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
  2614-503 Amadora
  Portugal | Bromhexine | Bromexina Tussilene | 0,8 mg/ml | syrup | oral use |
| Portugal | Bluepharma Genéricos — Comércio de Medicamentos, S.A.
  São Martinho do Bispo
  3045-016 Coimbra
  Portugal | Bromhexine | Bromexina Bluepharma | 1,6 mg/ml | syrup | oral use |
| Portugal | Bluepharma Genéricos — Comércio de Medicamentos, S.A.
  São Martinho do Bispo
  3045-016 Coimbra
  Portugal | Bromhexine | Bromexina Bluepharma | 0,8 mg/ml | syrup | oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2, Abrunheira
  2710-089 Sintra
  Portugal | Bromhexine | Bromexina Farmoz | 1,6 mg/ml | syrup | oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2, Abrunheira
  2710-089 Sintra
  Portugal | Bromhexine | Bromexina Farmoz | 0,8 mg/ml | syrup | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Bromhexine | Bromexina Generis | 0,8 mg/ml | syrup | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Bromhexine | Bromexina Generis | 1,6 mg/ml | syrup | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Bromhexine | Bromexina Wynn | 1,6 mg/ml | syrup | oral use |
| Portugal | Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
  Edifício Labialfarma, 1 — Felgueira
  3450-336 Sobral — Mortágua
  Portugal | Bromhexine | Bromexina Wynn | 0,8 mg/ml | syrup | oral use |
| Portugal | Caldeira & Metelo, Lda.
  Estrada de Paço de Arcos, 88 — Cacém Park, Armazém 27
  2735-307 Agualva-Cacém
  Portugal | Bromhexine | Bromocal | 0,8 mg/ml | syrup | oral use |
| Portugal | Laboratórios Atral, S.A.
  Rua da Estação, 42 — Vala do Carregado
  2600-726 Castanheira do Ribatejo
  Portugal | Bromhexine | Lisomucin | 2 mg/ml | oral drops, solution | oral use |
| Portugal | Laboratórios Atral, S.A.
  Rua da Estação, 42 — Vala do Carregado
  2600-726 Castanheira do Ribatejo
  Portugal | Bromhexine | Lisomucin | 1,6 mg/ml | syrup | oral use |
| Portugal | Medinfar Consumer Health — Produtos Farmacêuticos, Lda.
  Rua Henrique Paiva Couceiro, 27 — Venda Nova
  2700-451 Amadora
  Portugal | Bromhexine | Tosseque | 0,8 mg/ml | syrup | oral use |
| Romania | BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein, Germany | ambroxol hydrochloride | MUCOSOLVAN JUNIOR 15 mg/5 ml | 15 mg/5 ml | syrup | oral use |
| Romania | BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,
  Germany | ambroxol hydrochloride | MUCOSOLVAN 30 mg/5 ml | 30 mg/5 ml | syrup | oral use |
| Romania | BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,
  Germany | ambroxol hydrochloride | MUCOSOLVAN 30 mg | 30 mg | tablet | oral use |
| Romania | BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,
  Germany | ambroxol hydrochloride | MUCOSOLVAN MAX | 75 mg | prolonged-release capsule, hard | oral use |
| Romania | BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,
  Germany | ambroxol hydrochloride | MUCOSOLVAN 15 mg gumă orală | 15 mg | oral gum | oral use |
| Romania | ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,
  Germany | ambroxol hydrochloride | AMBROXOL AL 15 mg/5 ml | 15 mg/5 ml | syrup | oral use |
| Romania | ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,
  Germany | ambroxol hydrochloride | AMBROXOL AL 7,5 mg/ml | 7,5 mg/ml | oral drops, solution | oral use |
| Romania | ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,
  Germany | ambroxol hydrochloride | AMBROXOL AL 30 mg | 30 mg | tablet | oral use |
| Romania | S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2, Bucureşti, cod postal 024022,
  Romania | ambroxol hydrochloride | AMBROXOL ARENA 30 mg | 30 mg | tablet | oral use |
| Romania | Zentiva, k.s.
  U kabelovny 130
  Dolni Mėcholupy
  102 37 Praha 10
  Czech Republic | ambroxol hydrochloride | MUCOSIN CU MIERE sirop, 15 mg/5 ml | 15 mg/5 ml | syrup | oral use |
| Romania | Zentiva, a.s.
  Einsteinova 24
  851 01, Bratislava
  Slovak Republic | ambroxol hydrochloride | MUCOSIN 30 mg comprimate | 30 mg | tablet | oral use |
| Romania | HEXAL AG,
  Industriestrasse 25,
  D-83607 Holzkirchen,
  Germany | ambroxol hydrochloride | AMBROXOL SANDOZ comprimate, 30 mg | 30 mg | tablet | oral use |
| Romania | HEXAL AG,
  Industriestrasse 25,
  D-83607 Holzkirchen,
  Germany | ambroxol hydrochloride | AMBROXOL SANDOZ SIROP | 3 mg/ml | syrup | oral use |
| Romania | BERLIN-CHEMIE AG (Menarini Group)
  Glienicker Weg 125
  D-12489 Berlin,
  Germany | ambroxol hydrochloride | FLAVAMED 60 mg | 60 mg | effervescent tablet | oral use |
| Romania | BERLIN-CHEMIE AG (Menarini Group)
  Glienicker Weg 125
  D-12489 Berlin,
  Germany | ambroxol hydrochloride | FLAVAMED 30 mg | 30 mg | tablet | oral use |
| Romania | BERLIN-CHEMIE AG (Menarini Group)
  Glienicker Weg 125
  D-12489 Berlin,
  Germany | ambroxol hydrochloride | FLAVAMED 30 mg/5 ml soluţie orală | 30 mg/5 ml | oral solution | oral use |
| Romania | BERLIN-CHEMIE AG (Menarini Group)
  Glienicker Weg 125
  D-12489 Berlin,
  Germany | ambroxol hydrochloride | FLAVAMED 15 mg/5 ml | 15 mg/5 ml | oral solution | oral use |
| Romania | VIM SPECTRUM SRL, ROMANIA
  Şos. Sighişoarei nr. 409,
  Târgu Mureş (Corunca),
  Romania | ambroxol hydrochloride | AMBROXOL 30 mg | 30 mg | tablet | oral use |
| Romania | Egis Pharmaceuticals Plc
  Kereszturi ut 30-38
  Budapest
  H-1106
  Hungary | ambroxol hydrochloride | AMBROXOL EGIS sirop, 3 mg/ml | 3 mg/ml | syrup | oral use |
| Romania | Egis Pharmaceuticals Plc
  Kereszturi ut 30-38
  Budapest
  H-1106
  Hungary | ambroxol hydrochloride | AMBROXOL EGIS, comprimate, 30 mg | 30 mg | tablet | oral use |
| Romania | GEDEON RICHTER ROMÂNIA S.A., ROMANIA
  Str. Cuza-Vodă nr. 99-105,
  Târgu Mureş,
  Romania | ambroxol hydrochloride | AMBROXOL 30 mg/5 ml | 30 mg/5 ml | syrup | oral use |
| Romania | GEDEON RICHTER ROMÂNIA S.A., ROMANIA
  Str. Cuza-Vodă nr. 99-105,
  Târgu Mureş,
  Romania | ambroxol hydrochloride | AMBROXOL RICHTER 30 mg | 30 mg | tablet | oral use |
| Romania | TIS FARMACEUTIC SA, Sos. Industriilor nr. 16
  Sector 3, Bucuresti,
  Romania | ambroxol hydrochloride | AMBROXOL 0,3 % soluţie orală | 0,30 % | oral solution | oral use |
| Romania | TIS FARMACEUTIC SA, Sos. Industriilor nr. 16
  Sector 3, Bucuresti,
  Romania | ambroxol hydrochloride | AMBROXOL 0,75 % picaturi orale soluţie | 0,75 % | oral drops, solution | oral use |
| Romania | CYATHUS EXQUIRERE PharmaforschungsGmbH
  Rudolfsplatz 2/1/8 A-1010
  Viena,
  Austria | ambroxol hydrochloride | AMBROSPRAY | 10 mg/pulverizare | oromucosal spray | oral use |
| Romania | BIOFARM S.A.,
  Str.Logofat Tautu Nr. 99
  Sector 3, Bucureşti
  031212
  Romania | ambroxol hydrochloride | AMBROXOL BIOFARM 15 mg/5 ml, sirop | 15 mg/5 ml | syrup | oral use |
| Romania | Farmaceutica REMEDIA S.A. Blv. Metalurgiei nr. 78, sector 4, 041836 Bucureşti,
  Romania | ambroxol hydrochloride | Neo-bronchol 15 mg pastile | 15 mg | lozenge | oral use |
| Romania | ROMPHARM COMPANY SRL, Str. Eroilor, 1A, Otopeni,
  Romania | ambroxol hydrochloride | AMBROXOL ROMPHARM 15 mg/5 ml, sirop | 15 mg/5 ml | oral solution | oral use |
| Romania | LAROPHARM SRL,
  Sos. Alexandriei 145 A,
  B07 Bragadiru,
  Judetul Ilfov,
  Romania | ambroxol hydrochloride | AMBROXOL LAROPHARM 30 mg, comprimate | 30 mg | tablet | oral use |
| Romania | LAROPHARM SRL,
  Sos. Alexandriei 145 A,
  B07 Bragadiru,
  Judetul Ilfov,
  Romania | ambroxol hydrochloride | AMBROXOL LAROPHARM 15 mg/5 ml soluţie orală | 15 mg/5 ml | oral solution | oral use |
| Romania | SOLACIUM PHARMA S.R.L., str. Calea Rahovei nr. 266-268, corp. 60, axele A-B,
  stalpii 11-16, etaj II, birou 1, sector 5, Bucuresti
  Romania | bromhexine hydrochloride | BROMHEXIN SOLACIUM 8 mg | 8 mg | tablet | oral use |
| Romania | LAROPHARM SRL,
  Sos. Alexandriei 145 A,
  B07 Bragadiru,
  Judetul Ilfov,
  Romania | bromhexine hydrochloride | BRONHOSOLV
  10 mg/5 ml | 10 mg/5 ml | oral solution | oral use |
| Romania | LABORMED PHARMA S.A.
  Adresa: Bd. Theodor Pallady
  nr. 44B, sector 3, Bucuresti
  032266
  Romania | bromhexine hydrochloride | BROMHEXIN LABORMED 8 mg | 8 mg | tablet | oral use |
| Romania | MAGISTRA C & C, Bd. Aurel Vlaicu nr. 82A, 900055
  Constanta, Romania | bromhexine hydrochloride | BROMHEXIN® 8 mg | 8 mg | tablet | oral use |
| Romania | LAROPHARM SRL,
  Sos. Alexandriei 145 A,
  B07 Bragadiru,
  Judetul Ilfov,
  Romania | bromhexine hydrochloride | BRONHOSOLV | 8 mg | tablet | oral use |
| Romania | TIS FARMACEUTIC SA, Sos. Industriilor nr. 16
  Sector 3, Bucuresti,
  Romania | bromhexine hydrochloride | BROMHEXIN — T | 2 mg/ml | oral drops, solution | oral use |
| Romania | BIO EEL SRL, str. Bega nr. 4, Targu-Mures,
  540390,
  Romania | bromhexine hydrochloride | BROMFLUEX 8 mg | 8 mg | tablet | oral use |
| Romania | BIO EEL SRL, str. Bega nr. 4, Targu-Mures,
  540390,
  Romania | bromhexine hydrochloride | BROMFLUEX 12 mg | 12 mg | tablet | oral use |
| Romania | A.C. HELCOR PHARMA SRL, str. Dr. Victor Babeş nr. 50,
  Baia Mare, Maramureş,
  Romania | bromhexine hydrochloride | BROMHEXIN HELCOR 8 mg | 8 mg | tablet | oral use |
| Romania | ARENA GROUP SA,
  Bucuresti, str. Stefan Mihaileanu, nr. 31, sector 2,
  Romania | bromhexine hydrochloride | BROMHEXIN ARENA 8 mg | 8 mg | tablet | oral use |
| Romania | ARENA GROUP SA, Bucuresti, str. Stefan Mihaileanu, nr. 31,
  sector 2, Romania | bromhexine hydrochloride | BROMHEXIN ARENA 12 mg | 12 mg | tablet | oral use |
| Romania | LAROPHARM SRL,
  Sos. Alexandriei 145 A,
  B07 Bragadiru,
  Judetul Ilfov,
  Romania | bromhexine hydrochloride | BROMHEXIN LAROPHARM 12 mg | 12 mg | tablet | oral use |
| Romania | ROMPHARM COMPANY SRL,
  Str. Eroilor, 1A, Otopeni,
  Romania | bromhexine hydrochloride | BROMHEXIN ROMPHARM 2 mg/ml | 2 mg/ml | oral drops, solution | oral use |
| Romania | SLAVIA PHARM SRL, Bd.
  Pallady Theodor, 44C,
  Bucuresti-Sector 3,
  021 304 6385,
  Romania | bromhexine hydrochloride | ROMHEXIN SLAVIA 8 mg | 8 mg | tablet | oral use |
| Romania | FARMACOM S.A.,
  str. Zizinului nr. 112, 500407, Brasov,
  Romania | bromhexine hydrochloride | BROMHEXIN FARMACOM 8 mg | 8 mg | tablet | oral use |
| Romania | ANTIBIOTICE SA
  Str. Valea Lupului nr. 1,
  Iasi 707410,
  Romania | bromhexine hydrochloride | BROMHEXIN ATB 8 mg | 8 mg | tablet | oral use |
| Romania | BIOFARM S.A., Str.Logofat Tautu Nr. 99 Sector 3 031212
  Romania | bromhexine hydrochloride | BROMHEXIN BIOFARM 8 mg | 8 mg | tablet | oral use |
| Romania | BIOFARM S.A., Str.Logofat Tautu Nr. 99 Sector 3 031212
  Romania | bromhexine hydrochloride | BROMHEXIN BIOFARM 12 mg | 12 mg | tablet | oral use |
| Slovak Republic | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 15 mg | 15 mg/2 ml | solution for injection | intravenous use |
| Slovak Republic | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 15 mg/5 ml | 15 mg/5 ml | syrup | oral use |
| Slovak Republic | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 30 mg | 30 mg | tablet | oral use |
| Slovak Republic | TEVA Pharmaceuticals Slovakia, s.r.o.
  Teslova 26
  821 02 Bratislava
  Slovak Republic | ambroxol hydrochloride | Ambrobene 6 mg/ml oral solution | 6 mg/1 ml | oral solution | oral use |
| Slovak Republic | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene 7,5 mg/ml | 7,5 mg/ml | oral/inhalation solution | oral use,
  inhalation use |
| Slovak Republic | ratiopharm GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | ambroxol hydrochloride | Ambrobene retard 75 mg | 75 mg | prolonged-release capsule | oral use |
| Slovak Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Praha 4
  Czech Republic | ambroxol hydrochloride | AMBROSAN 15 mg/5 ml sirup | 15 mg/5 ml | syrup | oral use |
| Slovak Republic | PRO.MED.CS Praha a.s.
  Telčská 1
  140 00 Praha 4
  Czech Republic | ambroxol hydrochloride | Ambrosan 30 mg | 30 mg | tablet | oral use |
| Slovak Republic | ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19, 89150 Laichingen Germany | ambroxol hydrochloride | Ambroxol AL 75 retard | 75 mg | prolonged-release capsule | oral use |
| Slovak Republic | ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19,
  89150 Laichingen
  Germany | ambroxol hydrochloride | AMBROXOL AL KVAPKY | 7,5 mg/1 ml | oral drops | oral use |
| Slovak Republic | Berlin-Chemie AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 15 mg/5 ml perorálny roztok | 3 mg/1 ml | oral solution | oral use |
| Slovak Republic | Berlin-Chemie AG Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed Cough Tablets | 30 mg | tablet | oral use |
| Slovak Republic | Berlin-Chemie AG Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed forte perorálny roztok | 6 mg/1 ml | oral solution | oral use |
| Slovak Republic | Berlin-Chemie AG Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed šumivé tablety | 60 mg | effervescent tablet | oral use |
| Slovak Republic | CYATHUS EXQUIRERE PharmaforschungsGmbH Rudolfsplatz 2/1/8
  1010 Wien
  Austria | ambroxol hydrochloride | GOGOLOX | 50 mg/1 g | oral solution | oral use |
| Slovak Republic | EGIS Pharmaceuticals PLC Keresztúri út 30-38.
  1106 Budapest
  Hungary | ambroxol hydrochloride | Halixol 30 mg | 30 mg | tablet | oral use |
| Slovak Republic | Zentiva, k.s.
  U Kabelovny 130
  102 37 Praha 10
  Czech Republic | ambroxol hydrochloride | MUCOSIN s medom sir | 15 mg/5 ml | syrup | oral use |
| Slovak Republic | Zentiva, a.s.
  Einsteinova 24
  851 01, Bratislava
  Slovak Republic | ambroxol hydrochloride | MUCOSIN tablety | 30 mg | tablet | oral use |
| Slovak Republic | Boehringer Ingelheim International GmbH Binger Strasse 173
  55216 Ingelheim am Rhein Germany | ambroxol hydrochloride | Mucosolvan | 15 mg | pastille | oral use |
| Slovak Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein Germany | ambroxol hydrochloride | Mucosolvan | 30 mg/5 ml | syrup | oral use |
| Slovak Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein Germany | ambroxol hydrochloride | Mucosolvan Junior | 3 mg/1 ml | syrup | oral use |
| Slovak Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein Germany | ambroxol hydrochloride | Mucosolvan Retard | 75 mg | prolonged-release capsule | oral use |
| Slovak Republic | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  55216 Ingelheim am Rhein Germany | ambroxol hydrochloride | Mucosolvan Tablety | 30 mg | tablet | oral use |
| Slovak Republic | Divapharma GmbH
  Motzener Straße 41
  12277 Berlin
  Germany | ambroxol hydrochloride | neo-bronchol | 15 mg | pastille | oral use |
| Slovak Republic | KRKA, d.d.
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ambroxol hydrochloride | Solvolan | 30 mg | tablet | oral use |
| Slovak Republic | KRKA, d.d.
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ambroxol hydrochloride | Solvolan | 15 mg/5 ml | syrup | oral use |
| Slovak Republic | WALMARK, a.s.
  Oldřichovice 44
  739 61 Třinec
  Czech Republic | ambroxol hydrochloride | Stopex na vykašliavanie | 60 mg | effervescent tablet | oral use |
| Slovak Republic | Berlin-Chemie AG Glienicker Weg 125
  12489 Berlin
  Germany | bromhexine hydrochloride | Bromhexin 12 BC | 12 mg/1 ml | oral solution | oral use |
| Slovak Republic | Berlin-Chemie AG Glienicker Weg 125
  12489 Berlin
  Germany | bromhexine hydrochloride | Bromhexin 8 Berlin-Chemie | 8 mg | film-coated tablet | oral use |
| Slovak Republic | Krewel Meuselbach GmbH Krewelstraße 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | BROMHEXIN 12 KVAPKY KM | 12 mg/1 ml | oral drops | oral use |
| Slovak Republic | Krewel Meuselbach GmbH Krewelstraße 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | Bromhexin 8 sirup KM | 8 mg/10 ml | syrup | oral use |
| Slovak Republic | Krewel Meuselbach GmbH Krewelstraße 2
  53783 Eitorf
  Germany | bromhexine hydrochloride | Bromhexin 8-kvapky KM | 8 mg/ml | oral solution | oral use |
| Slovak Republic | Zentiva a.s.
  Nitrianska 100
  Hlohovec 920 27
  Slovak Republic | bromhexine hydrochloride,
  mentholum,
  oleum foeniculi,
  oleum anisi,
  oleum origani,
  oleum menthae piperitae,
  oleum eucalypti | BRONCHOSAN | 8 mg/ml
  1,5 mg/ml
  0,75 mg/ml
  0,250 mg/ml
  0,250 mg/ml
  0,250 mg/ml
  0,250 mg/ml | oral drops | oral use |
| Slovenia | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  D-55216 Ingelheim am Rhein Germany | bromhexine hydrochloride | BISOLVON 4 mg/5 ml sirup | 4 mg/5 ml | syrup | oral use |
| Slovenia | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  D-55216 Ingelheim am Rhein Germany | bromhexine hydrochloride | Bisolvon 8 mg tablete | 8 mg | tablet | oral use |
| Slovenia | Boehringer Ingelheim International GmbH
  Binger Strasse 173
  D-55216 Ingelheim am Rhein Germany | bromhexine hydrochloride | Bisolvon 2 mg/ml peroralna raztopina/inhalacijska raztopina za nebulator | 2 mg/ml | oral solution/nebuliser solution | oral use,
  inhalation use |
| Slovenia | KRKA, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ambroxol hydrochloride | Solvolan 3 mg/ml sirup | 3 mg/ml | syrup | oral use |
| Slovenia | KRKA, d.d., Novo mesto
  Šmarješka cesta 6
  8000 Novo mesto
  Slovenia | ambroxol hydrochloride | Solvolan 30 mg tablete | 30 mg | tablet | oral use |
| Slovenia | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 3 mg/ml peroralna raztopina | 3 mg/ml | oral solution | oral use |
| Slovenia | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 30 mg tablete | 30 mg | tablet | oral use |
| Slovenia | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 6 mg/ml peroralna raztopina | 6 mg/ml | oral solution | oral use |
| Slovenia | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Flavamed 60 mg šumeče tablete | 60 mg | effervescent tablet | oral use |
| Slovenia | Medis, d.o.o.
  Brnčičeva 1
  1000 Ljubljana
  Slovenia | ambroxol hydrochloride | Ambrospray 10 mg/vpih peroralna raztopina | 10 mg/spray puff | oral solution | oral use |
| Slovenia | BERLIN-CHEMIE AG
  Glienicker Weg 125
  12489 Berlin
  Germany | ambroxol hydrochloride | Ambroksolijev klorid Berlin-Chemie 6 mg/ml peroralna raztopina | 6 mg/ml | oral solution | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Motosol 3 mg/ml jarabe | 3 mg/ml | syrup | oral use |
| Spain | ARISTO PHARMA IBERICA, S.L.
  Solana, 26 28850 Torrejón de Ardoz Madrid Spain | Ambroxol hydrochloride | Ambroxol Edigen jarabe EFG | 15 mg/5 ml | syrup | oral use |
| Spain | LABORATORIOS CINFA S.A.
  Olaz-Chipi, 10 Poligono Indistrial Areta
  31620 Huarte-Pamplona
  Navarra
  Spain | Ambroxol hydrochloride | Ambroxol cinfa 15 mg/5 ml jarabe EFG | 15 mg/5 ml | syrup | oral use |
| Spain | LABORATORIOS NORMON S.A.
  Ronda de Valdecarrizo, 6
  28760 Tres Cantos
  Madrid
  Spain | Ambroxol hydrochloride | Ambroxol Normon 3 mg/ml solucion EFG | 3 mg/ml | oral solution | oral use |
| Spain | APOTEX EUROPE B.V:
  Darwinweg, 20
  2333 CR Leiden
  The Netherlands | Ambroxol hydrochloride | Ambroxol Apotex 15 ml/5 ml jarabe EFG | 15 mg/5 ml | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan 30 mg comprimidos | 30 mg | tablet | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Motosol 7,5 mg/ml solucion inyectable | 7,5 mg/ml | solution for injection | intravenous use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan Pediátrico 3 mg/ml jarabe | 3 mg/ml | syrup | oral use |
| Spain | FERRER INTERNACIONAL S.A.
  Gran Via Carlos III, 94
  08028 Barcelona
  Spain | Ambroxol hydrochloride | Naxpa jarabe | 15 mg/5 ml | syrup | oral use |
| Spain | LABORATORIOS NORMON S.A.
  Ronda de Valdecarrizo, 6
  28760 Tres cantos
  Madrid
  Spain | Ambroxol hydrochloride | Mucibron 3 mg/ml solucion oral | 3 mg/ml | oral solution | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan Retard 75 mg cápsulas de liberación prolongada | 75 mg | prolonged-release capsule, hard | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Motosol Retard 75 mg cápsulas de liberación prolongada | 75 mg | prolonged-release capsule, hard | oral use |
| Spain | WAAS_ANITA S.A.
  General Prim 13
  28035 Madrid
  Spain | Ambroxol hydrochloride | Dinobroxol jarabe | 15 mg/5 ml | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan 60 mg polvo para solución oral | 15 mg/5 ml | powder for oral suspension | oral use |
| Spain | RATIOPHARM ESPAÑA S.A.
  Avda Burgos, 16 D 5a Planta
  28036 Madrid
  Spain | ambroxol hydrochloride | Ambroxol ratiopharm 3 mg/ml jarabe EFG | 3 mg/ml | syrup | oral use |
| Spain | SANDOZ FARMACEUTICA S.A.
  Avda Osa Mayor, 4
  28023 Aravaca
  Madrid
  Spain | Ambroxol hydrochloride | Ambroxol Sandoz 3 mg/ml jarabe EFG | 3 mg/ml | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan 6 mg/ml jarabe | 6 mg/ml | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan 15 mg pastillas de goma | 15 mg | oral gum | oral use |
| Spain | CYATHUS EXQUIRERE PHARMAFORSCHUNGS GMBH
  Rudolfsplatz 2/1/8
  1010 Viena
  Austria | Ambroxol hydrochloride | Ambroxol Exquirere 10 mg pulsación solucion oral | 10 mg/pulsation | oral solution | oral use |
| Spain | LABORATORIOS VICKS S.L.
  Avda Bruselas, 24
  28108 Alcobendas
  Madrid
  Spain | Ambroxol hydrochloride | Formulamucol 6 mg/ml solución oral EFG | 6 mg/ml | oral solution | oral use |
| Spain | LABORATORIOS VICKS S.L.
  Avda Bruselas, 24
  28108 Alcobendas
  Madrid
  Spain | Ambroxol hydrochloride | Formulamucol 3 mg/ml solución oral EFG | 3 mg/ml | oral solution | oral use |
| Spain | TEVA PHARMA S.L.U.
  C/Anabel Segura 11 Edificio Albatros B 1a Planta
  28108 Alcobendas
  Madrid
  Spain | Ambroxol hydrochloride | Ambroxol Tevapharma 3 mg/ml solución | 3 mg/ml | oral solution | oral use |
| Spain | TEVA PHARMA S.L.U.
  C/Anabel Segura 11 Edificio Albatros B 1a Planta
  28108 Alcobendas
  Madrid
  Spain | Ambroxol hydrochloride | Ambroxol Tevapharma 6 mg/ml solución | 6 mg/ml | oral solution | oral use |
| Spain | RATIOPHARM ESPAÑA S.A. C/Anabel Segura 11 Edificio
  Albatros B 1a Planta 28108
  Alcobendas Madrid
  Spain | Ambroxol hydrochloride | Ambroxol ratio 6 mg/ml solucion oral EFG | 6 mg/ml | oral solution | oral use |
| Spain | RATIOPHARM ESPAÑA S.A. C/Anabel Segura 11 Edificio Albatros B 1a Planta 28108 Alcobendas Madrid
  Spain | Ambroxol hydrochloride | Ambroxol ratio 3 mg/ml solución oral EFG | 3 mg/ml | oral solution | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Lizipadol 20 mg pastillas para chupar | 20 mg | lozenge | oromucosal use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Ambroxol hydrochloride | Mucosan 30 mg jarabe en sobres | 30 mg | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Bromhexine hydrochloride | Bisolmed 2 mg/ml solución inyectable y para perfusión | 2 mg/ml | solution for injection/infusion | intravenous use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Bromhexine hydrochloride | Bisolmed 2 mg/ml solución oral/concentrado para solución para inhalación por nebulizador | 2 mg/ml | oral solution/concentrate for nebuliser solution | oral use |
| Spain | LABORATORIOS CINFA S.A.
  Olaz-Chipi, 10
  Poligono Indistrial Areta
  31620 Huarte Pamplona
  Navarrra
  Spain | Bromhexine hydrochloride + Sulfamethoxazole hydrochloride + Trimethoprim + balsam tolu aqueous extract | Bactopumon | 2 mg + 400 mg + 80 mg + 75 mg/5 ml | oral suspension | oral use |
| Spain | DESMA LABORATORIO FARMACEUTICO, S.L.
  Cuatro amigos 7, escalera 2, 1oD
  28029 Madrid
  Spain | bromhexine hydrochloride + Sulfamethoxazole hydrochloride + Trimethoprim | Balsoprim suspensión | 50 mg + 2 660 mg + 540 mg/100 ml | oral suspension | oral use |
| Spain | FAES FARMA, S.A.
  Maximo Aguirre, 14
  48940
  Lamiaco-Lejona Vizcaya
  Spain | Bromhexine hydrochloride + benzoate sodium + Sulfamethoxazole + Trimethoprim + Balsam Tolú syrup | Bronquidiazina CR suspensión | 4 mg + 250 mg + 400 mg + 80 mg + 325 mg/7,5 ml | oral suspension | oral use |
| Spain | GLAXOSMITHKLINE, S.A.
  Severo Ochoa, 2
  28760 Tres Cantos
  Madrid
  Spain | Bromhexine hydrochloride + Amoxicilin trihydrate | Clamoxyl mucolítico 500 mg cápsulas | 8 mg + 500 mg | capsule, hard | oral use |
| Spain | GLAXOSMITHKLINE, S.A.
  Severo Ochoa, 2
  28760 Tres Cantos
  Madrid
  Spain | Bromhexine hydrochloride + Amoxicilin trihydrate | Clamoxyl mucolítico 250 mg suspensión extemporánea | 4 mg + 250 mg/5 ml | powder for oral suspension | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Bromhexine hydrochloride | Bisolvon mucolítico 1,6 mg/ml jarabe | 8 mg/5 ml | syrup | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Bromhexine hydrochloride | Bisolvon mucolítico 8 mg comprimidos solubles | 8 mg | soluble tablet | oral use |
| Spain | BOEHRINGER INGELHEIM ESPAÑA, S.A.
  Prat de la Riba, 50
  08174 Sant Cugat del Vallés Barcelona
  Spain | Bromhexine hydrochloride | Bisolvon mucolítico infantil 0,8 mg/ml jarabe | 0,8 mg/ml | syrup | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Ambroxolol hydrochloride | Mucoangin Svartvinbär | 20 mg | lozenge | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Ambroxolol hydrochloride | Mucoangin | 20 mg | lozenge | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Ambroxolol hydrochloride | Mucoangin Citron | 20 mg | lozenge | oral use |
| Sweden | BioPhausia AB,
  Blasieholmsgatan 2,
  111 48 Stockholm,
  Sweden | Bromhexine hydrochloride + ephedrine hydrochloride | Mollipect | 0,5 mg/ml + 1 mg/ml | oral solution | oral use |
| Sweden | Apofri AB, Box 120,
  182 12 Danderyd,
  Sweden | Bromhexine hydrochloride | Bromhexin Apofri | 0,8 mg/ml | oral solution | oral use |
| Sweden | Apofri AB, Box 120,
  182 12 Danderyd,
  Sweden | Bromhexine hydrochloride | Bromhexin Apofri | 1,6 mg/ml | oral solution | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 8 mg | tablet | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 0,8 mg/ml | oral solution | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 1,6 mg/ml | oral solution | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon | 8 mg | soluble tablet | oral use |
| Sweden | Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,
  Germany | Bromhexine hydrochloride | Bisolvon Jordgubb | 0,8 mg/ml | oral solution | oral use |
| Sweden | McNeil Sweden AB,
  169 90 Solna,
  Sweden | Bromhexine hydrochloride | Bromhex | 0,8 mg/ml | oral solution | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | ambroxol hydrochloride | Mucoangin, zuigtabletten
  20 mg | 20 mg | lozenge | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | ambroxol hydrochloride | Mucoangin Citroen 20 mg, zuigtabletten | 20 mg | lozenge | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | ambroxol hydrochloride | Rexambro 20 mg, zuigtabletten | 20 mg | lozenge | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon drank in sachet,
  8 mg | 8 mg | oral solution in sachet | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon drank voor kinderen met aardbeiensmaak, 4 mg/5 ml | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon drank voor kinderen, 4 mg/5 ml | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon drank, 8 mg/5 ml | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon druppels voor kinderen, oplossing 2 mg/ml | 2 mg/ml | oral solution | oral use |
| The Netherlands | Boehringer Ingelheim B.V.
  Comeniusstraat 6
  1817 MS Alkmaar
  The Netherlands | bromhexine hydrochloride | Bisolvon tabletten, 8 mg | 8 mg | tablet | oral use |
| The Netherlands | Sameko BV
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCI 8 mg Sameko, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl CF 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl CF 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC ETTEN LEUR
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl CF 8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Basic Pharma Manufacturing bv
  Burgemeester Lemmensstraat 352
  6163 JT GELEEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl drank
  4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Basic Pharma Manufacturing bv
  Burgemeester Lemmensstraat 352
  6163 JT GELEEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl drank
  8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Apotex Europe B.V.
  Darwinweg 20
  2333 CR LEIDEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl hoestdrank extra sterk suikervrij Apotex 8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Apotex Europe B.V.
  Darwinweg 20
  2333 CR LEIDEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl hoestdrank suikervrij Apotex 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Apotex Europe B.V.
  Darwinweg 20
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Apotex
  8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Mediq Farma B.V.
  Hertogswetering 159
  3543 AS UTRECHT
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Mdq
  4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Mediq Farma B.V.
  Hertogswetering 159
  3543 AS UTRECHT
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Mdq 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Mediq Farma B.V.
  Hertogswetering 159
  3543 AS UTRECHT
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Mdq
  8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | RXT
  Amsterdamsestraatweg 22
  1391 AB ABCOUDE
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl RXT 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Nederlandse Service Apotheek Beheer B.V.
  Vonderweg 39a
  7468 DC ENTER
  The Netherlands | bromhexine hydrochloride | Broomhexine HCI SAM
  8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Sandoz B.V.
  Veluwezoom 22
  1327 AH ALMERE
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Sandoz 0,8 mg/ml, drank | 0,8 mg/ml | oral solution | oral use |
| The Netherlands | MAE Holding BV
  Amsterdamsestraatweg 22
  1391 AB ABCOUDE
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Triangle Pharma 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | MAE Holding BV
  Amsterdamsestraatweg 22
  1391 AB ABCOUDE
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl Triangle Pharma 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl 4=5 PCH, drank 4 mg/5 ml | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Basic Pharma Manufacturing bv
  Burgemeester Lemmensstraat 352
  6163 JT GELEEN
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl 8 PCH, tabletten 8 mg | 8 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA HAARLEM
  The Netherlands | bromhexine hydrochloride | Broomhexine HCl 8=5 PCH, drank 8 mg/5 ml | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE ROTTERDAM
  The Netherlands | bromhexine hydrochloride | Broomhexinehydrochloride
  8 mg tabletten Samenwerkende Apothekers | 8 mg | tablet | oral use |
| The Netherlands | Sameko BV
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | C1000 Hoestdrank Broomhexine HCl 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Sameko BV
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | C1000 Hoestdrank Extra Sterk Broomhexine HCI 8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Sameko BV
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | C1000 Hoesttabletten Broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | HEMA B.V.
  NDSM-straat 10
  1033 SB AMSTERDAM
  The Netherlands | bromhexine hydrochloride | HEMA Hoestdrank Broomhexine HCl 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | HEMA B.V.
  NDSM-straat 10
  1033 SB AMSTERDAM
  The Netherlands | bromhexine hydrochloride | HEMA Hoestdrank Broomhexine HCl 8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | HEMA B.V.
  NDSM-straat 10
  1033 SB AMSTERDAM
  The Netherlands | bromhexine hydrochloride | HEMA Hoesttabletten Broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | HTP Huisapotheek B.V.
  Nieuwe Donk 3
  4879 AC ETTEN-LEUR
  The Netherlands | bromhexine hydrochloride | Hoestdrank Broomhexine HCl 4 mg/5 ml HTP Huisapotheek, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | HTP Huisapotheek B.V.
  Nieuwe Donk 3
  4879 AC ETTEN-LEUR
  The Netherlands | bromhexine hydrochloride | Hoestdrank Broomhexine HCl 8 mg/5 ml HTP Huisapotheek, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | HTP Huisapotheek B.V.
  Nieuwe Donk 3
  4879 AC ETTEN-LEUR
  The Netherlands | bromhexine hydrochloride | Hoesttabletten Broomhexine HCl 8 mg HTP Huisapotheek, tabletten | 8 mg | tablet | oral use |
| The Netherlands | SDG Farma B.V.
  Treubweg 11
  1112 BA DIEMEN
  The Netherlands | bromhexine hydrochloride | IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | SDG Farma B.V.
  Treubweg 11
  1112 BA DIEMEN
  The Netherlands | bromhexine hydrochloride | IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Jumbo Supermarkten B.V.
  Rijksweg 15
  5462 CE VEGHEL
  The Netherlands | bromhexine hydrochloride | JUMBO Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Jumbo Supermarkten B.V.
  Rijksweg 15
  5462 CE VEGHEL
  The Netherlands | bromhexine hydrochloride | JUMBO hoestdrank extra sterk broomhexine HCl
  8 mg/5 ml suikervrij, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Jumbo Supermarkten B.V.
  Rijksweg 15
  5462 CE VEGHEL
  The Netherlands | bromhexine hydrochloride | JUMBO hoesttabletten broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Kruidvat HOESTDRANK Broomhexine HCl 4 mg/5 ml suikervrij, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Leidapharm B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Leidapharm Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Leidapharm B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Leidapharm Hoestdrank Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Nedac Sorbo B.V.
  Innovatie 1
  6921 RN DUIVEN
  The Netherlands | bromhexine hydrochloride | NEDAC SORBO Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Nedac Sorbo B.V.
  Innovatie 1
  6921 RN DUIVEN
  The Netherlands | bromhexine hydrochloride | NEDAC SORBO Hoestdrank Extra Sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Nedac Sorbo B.V.
  Innovatie 1
  6921 RN DUIVEN
  The Netherlands | bromhexine hydrochloride | NEDAC SORBO Hoesttabletten Broomhexine HCl 8 mg, tabletten | 8 mg | tablet | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | bromhexine hydrochloride | Otrivin Broomhexine HCI
  8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | bromhexine hydrochloride | Otrivin Broomhexine HCl 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Trekpleister HOESTDRANK Broomhexine HCl 4 mg/5 ml suikervrij, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Trekpleister HOESTDRANK Broomhexine HCl 4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Trekpleister HOESTDRANK Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Trekpleister HOESTDRANK EXTRA STERK Broomhexine HCl 8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN LEIDEN
  The Netherlands | bromhexine hydrochloride | Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg | 8 mg | tablet | oral use |
| The Netherlands | Procter & Gamble Nederland B.V.
  Watermanweg 100
  3067 GG ROTTERDAM
  The Netherlands | bromhexine hydrochloride | Vicks Hoestdrank broomhexinehydrochloride
  8 mg/5 ml, drank | 8 mg/5 ml | oral solution | oral use |
| The Netherlands | Procter & Gamble Nederland B.V.
  Watermanweg 100
  3067 GG ROTTERDAM
  The Netherlands | bromhexine hydrochloride | Vicks Hoestdrank voor Kinderen broomhexinehydrochloride
  4 mg/5 ml, drank | 4 mg/5 ml | oral solution | oral use |

Member State in EEA

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Bromhexidine hydrochloride

Bisolvon Hustenlöser — Saft

4 mg/5 ml

oral liquid

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Bromhexidine hydrochloride

Bisolvon — Lösung

8 mg/4 ml

oral solution

oral use

Austria

ratiopharm Arzneimittel Vertriebs-GmbH

Albert Schweitzergasse 3

Vienna

1140

Austria

Ambroxole hydrochloride

Ambrobene retard 75 mg — Kapseln

75 mg

prolonged-release capsule, hard

oral use

Austria

ratiopharm Arzneimittel Vertriebs-GmbH

Albert Schweitzergasse 3

Vienna

1140

Austria

Ambroxole hydrochloride

Ambrobene 15 mg/5 ml — Saft

15 mg/5 ml

oral liquid

oral use

Austria

Aponova-Pharma Handels GmbH

Mitterweg 4 Hart

6265

Austria

Ambroxole hydrochloride

Ambroxol ‘Aponova’ 60 mg — Brausetabletten

60 mg

effervescent tablet

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucoangin Johannisbeere 20 mg — Lutschtabletten

20 mg

lozenge

oral use

Austria

ratiopharm Arzneimittel Vertriebs-GmbH

Albert Schweitzergasse 3

Vienna

1140

Austria

Ambroxole hydrochloride

Ambrobene 30 mg — Tabletten

30 mg

tablet

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucoangin Zitrone 20 mg Lutschtabletten

20 mg

lozenge

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride,

clenbuterol

Mucospas — Tabletten

30 mg,

0,02 mg

tablet

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride,

clenbuterol

Mucospas — Saft

7,5 mg/5 ml,

0,0001 g

oral liquid

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosolvan 7,5 mg/1 ml — Lösung

7,5 mg/ml

oral solution

oral use

Austria

ratiopharm Arzneimittel Vertriebs-GmbH

Albert Schweitzergasse 3

Vienna

1140

Austria

Ambroxole hydrochloride

Ambrobene 15 mg — Ampullen

15 mg

solution for injection

intravenous use, intramuscular use, subcutaneous use

Austria

Genericon Pharma GmbH

Hafnerstrasse 211

Graz 8054

Austria

Ambroxole hydrochloride

Ambroxol Genericon 30 mg Tabletten

30 mg

tablet

oral use

Austria

Genericon Pharma GmbH

Hafnerstrasse 211

Graz 8054

Austria

Ambroxole hydrochloride

Ambroxol Genericon Lösung

7,5 mg/ml

oral solution

oral use

Austria

Genericon Pharma GmbH

Hafnerstrasse 211

Graz 8054

Austria

Ambroxole hydrochloride

Ambroxol Genericon Saft

15 mg/5 ml

oral liquid

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosolvan 15 mg — Lutschpastillen

15 mg

lozenge

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosan 15 mg — Ampullen

15 mg

solution for injection

intravenous use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosolvan retard 75 mg — Kapseln

75 mg

prolonged-release capsule, hard

oral use

Austria

1A Pharma GmbH

Stella-Klein-Löw-Weg 17

Vienna

1020

Austria

Ambroxole hydrochloride

Ambroxol 1A Pharma 7,5 mg/ml — Lösung

7,5 mg/ml

oral solution

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucoangin Mint 20 mg — Lutschtabletten

20 mg

lozenge

oral use

Austria

+pharma arzneimittel gmbh

Hafnerstrasse 211

Graz 8054

Austria

Ambroxole hydrochloride

Ambroxol + pharma 60 mg lösliche Tabletten

60 mg

tablet

oral use

Austria

Genericon Pharma GmbH

Hafnerstrasse 211

Graz 8054

Austria

Ambroxole hydrochloride

Ambroxol Genericon 60 mg lösliche Tabletten

60 mg

effervescent tablet

oral use

Austria

ratiopharm Arzneimittel Vertriebs-GmbH

Albert Schweitzergasse 3

Vienna

1140

Austria

Ambroxole hydrochloride

Ambrobene 7,5 mg/ml — Lösung

7,5 mg/ml

oral solution

oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

Vienna

1020

Austria

Ambroxole hydrochloride

Ambrohexal 30 mg — lösbare Tabletten

30 mg

effervescent tablet

oral use

Austria

Hexal Pharma GmbH

Stella-Klein-Löw-Weg 17

Vienna

1020

Austria

Ambroxole hydrochloride

Ambrohexal 7,5 mg/ml — Lösung

7,5 mg/ml

oral solution

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucoangin 17,86 mg/ml Spray zur Anwendung in der Mundhöhle

17,86 mg/ml

oromucosal spray

oral use

Austria

G.L. Pharma GmbH

Schlossplatz 1 Lannach

8502

Austria

Ambroxole hydrochloride

Ambrolan 30 mg — Tabletten

30 mg

tablet

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosolvan 30 mg/5 ml — Saft

30 mg/ml

oral liquid

oral use

Austria

Boehringer Ingelheim RCV GmbH & Co KG

Dr. Boehringergasse 5-11

Vienna

1121

Austria

Ambroxole hydrochloride

Mucosolvan 15 mg/5 ml — Saft für Kinder

15 mg/5 ml

oral liquid

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Ambroxine

2,5 mg/ml

oromucosal spray

inhalation use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Ambroxine

20 mg

pastille

oropharyngeal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Ambroxine

20 mg

lozenge

oropharyngeal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Bisolangin

20 mg

pastille

oromucosal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Mucoangin

2,5 mg/ml

oromucosal spray

oromucosal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Mucoangin Cassis

20 mg

pastille

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Mucoangin Citron

20 mg

lozenge

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Mucoangin Menthe

20 mg

pastille

oropharyngeal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Mucoangin Menthe

20 mg

lozenge

oropharyngeal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Rexambro

20 mg

lozenge

oropharyngeal use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Surbronc

30 mg/5 ml

syrup

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Surbronc

60 mg

tablet

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Ambroxol Hydrochloride

Surbronc

60 mg

granules for oral solution

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon

2 %

nebuliser solution

inhalation use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon

2 mg/ml

oral drops, solution

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon

8 mg

tablet

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon

8 mg/5 ml

syrup

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon Citrus

8 mg

tablet

oral use

Belgium

Boehringer Ingelheim

S.C.S.-Comm. V.

Avenue Ariane 16

1200 Brussels

Belgium

Bromhexine Hydrochloride

Bisolvon Instant

8 mg

tablet

oral use

Belgium

E.G. S.A.-N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Bromhexine Hydrochloride

Bromhexine

8 mg

tablet

oral use

Belgium

D.J. Van Tintelen Beheer

B.V.

Stijntjesduinstraat 41

Noordwijk

The Netherlands

Bromhexine Hydrochloride

Bronchi-Mereprine

8 mg

tablet

oral use

Belgium

Laboratoria Qualiphar N.V/S.A

Rijksweg 9

2880 Bornem

Belgium

Bromhexine Hydrochloride

Toularynx Bromhexine

5 mg/5 ml

syrup

oral use

Bulgaria

Sopharma AD

16, Iliensko shosse str.

Sofia 1220

Bulgaria

Ambroxol hydrochloride

Ambixol

15 mg/5 ml

syrup

oral use

Bulgaria

Nobel Pharma OOD

24 Simeonovsko shose bulvd.

1700 Sofia

Bulgaria

Ambroxol hydrochloride

Ambrex

15 mg/5 ml

syrup

oral use

Bulgaria

Nobel Pharma OOD

24 Simeonovsko shose bulvd.

1700 Sofia,

Bulgaria

Ambroxol hydrochloride

Ambrex

30 mg/5 ml

syrup

oral use

Bulgaria

Tchaikapharma Highquality Medicines

1 G. M. Dimitrov Blvd

Sofia, 1172

Bulgaria

Ambroxol hydrochloride

Ambrin

30 mg

effervescent tablet

oral use

Bulgaria

Hexal AG

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

Ambroxol hydrochloride

Ambro

3 mg/ml

oral solution

oral use

Bulgaria

Hexal AG

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

Ambroxol hydrochloride

Ambro

30 mg

tablet

oral use

Bulgaria

Aliud Pharma GmbH

19 Gottlieb-Daimler-Str.

89150 Laichingen,

Germany

Ambroxol hydrochloride

Ambrolex R

75 mg

prolonged-release capsule, hard

oral use

Bulgaria

Adipharm EAD

130 Simeonovsko Shosse blvd

1700 Sofia

Bulgaria

Ambroxol hydrochloride

Ambroxol Adipharm

15 mg/5 ml

syrup

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

60 mg

effervescent tablet

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

15 mg/5 ml

oral solution

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Cough Tablets

30 mg

tablet

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed for children

15 mg/5 ml

oral solution

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed forte

30 mg/5 ml

oral solution

oral use

Bulgaria

Berlin-Chemie AG

Glienicker Weg 125 — 127

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed max

30 mg/5 ml

oral solution

oral use

Bulgaria

Cyathus Exquirere Pharmaforschungs GmbH

Rudolfsplatz 2/1/8

1010 Wienna

Austria

Ambroxol hydrochloride

Gogolox

5 %

oral solution

oral use

Bulgaria

Aliud Pharma GmbH

19 Gottlieb-Daimler-Str.

89150 Laichingen,

Germany

Ambroxol hydrochloride

Grippostad Ambro

30 mg

tablet

oral use

Bulgaria

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucoangin

20 mg

lozenge

oral use

Bulgaria

Actavis EAD

29 Atanas Dukov str.

1407 Sofia

Bulgaria

Ambroxol hydrochloride

Mucolisin

30 mg/5 ml

syrup

oral use

Bulgaria

Zentiva, a.s.

Einsteinova 24

851 01, Bratislava

Slovak Republic

Ambroxol hydrochloride

Mucosin Zentiva

30 mg

tablet

oral use

Bulgaria

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

15 mg/5 ml

syrup

oral use

Bulgaria

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

15 mg

pastille

oral use

Bulgaria

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

75 mg

prolonged-release capsule, hard

oral use

Bulgaria

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Bulgaria

Divapharma GmbH

Motzener Straße 41

12277 Berlin

Germany

Ambroxol hydrochloride

Neo-bronchol

15 mg

lozenge

oral use

Bulgaria

KRKA, d.d.

Smarjeska cesta 6

Novo mesto, 8501

Slovenia

Ambroxol hydrochloride

Solvolan

15 mg/5 ml

syrup

oral use

Bulgaria

KRKA, d.d.

Smarjeska cesta 6

Novo mesto, 8501

Slovenia

Ambroxol hydrochloride

Solvolan

30 mg

tablet

oral use

Bulgaria

Actavis EAD

29 Atanas Dukov str.

1407 Sofia

Bulgaria

Bromhexine hydrochloride

Bromhexin Actavis

4 mg

coated tablet

oral use

Bulgaria

Actavis EAD

29 Atanas Dukov str.

1407 Sofia

Bulgaria

Bromhexine hydrochloride

Bromhexin Actavis

8 mg

coated tablet

oral use

Bulgaria

Sopharma AD

16, Iliensko shosse str.

Sofia, 1220

Bulgaria

Bromhexine hydrochloride

Bromhexine Sopharma

2 mg/ml

solution for injection

intramuscular use, intravenous use

Bulgaria

Sopharma AD

16, Iliensko shosse str.

Sofia, 1220

Bulgaria

Bromhexine hydrochloride

Bromhexine Sopharma

8 mg

tablet

oral use

Croatia

Medis Adria d.o.o.

Kolarova 7, Zagreb

10000

Croatia

ambroxolum

Ambrospray 10 mg/potisku spreja, oralna otopina

50 mg/ml

oral solution

oral use

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Radnička 40-5, Zagreb

10000

Croatia

ambroxolum

Mucosolvan 75 mg kapsule s produljenim oslobađanjem

75 mg

prolonged-release capsule

oral use

Croatia

Berlin-Chemie Menarini Hrvatska d.o.o.

Horvatova 80a, Zagreb

10000

Croatia

ambroxolum

Flavamed 15 mg/5 ml oralna otopina

15 mg/5 ml

oral solution

oral use

Croatia

Berlin-Chemie Menarini Hrvatska d.o.o.

Horvatova 80a, Zagreb

10000

Croatia

ambroxolum

Flavamed forte 30 mg/5 ml oralna otopina

30 mg/5 ml

oral solution

oral use

Croatia

Berlin-Chemie Menarini Hrvatska d.o.o.

Horvatova 80a, Zagreb

10000

Croatia

ambroxolum

Flavamed 30 mg tablete

30 mg

tablet

oral use

Croatia

Berlin-Chemie Menarini Hrvatska d.o.o.

Horvatova 80a, Zagreb

10000

Croatia

ambroxolum

Flavamed forte 60 mg šumeće tablete

60 mg

effervescent tablet

oral use

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Radnička 40-5, Zagreb

10000

Croatia

ambroxolum

Mucosolvan 30 mg tablete

30 mg

tablet

oral use

Croatia

Divapharma GmbH

Motzener Str. 41, Berlin

12277

Germany

ambroxolum

neo-bronchol 15 mg pastile

15 mg

pastille

oral use

Croatia

Pliva Hrvatska d.o.o.

Prilaz baruna Filipovića 25, Zagreb

10000

Croatia

bromhexinum

Bisolex 2 mg/ml otopina

2 mg/ml

oral drops, solution

oral use

Croatia

Pliva Hrvatska d.o.o.

Prilaz baruna Filipovića 25, Zagreb

10000

Croatia

bromhexinum

Bisolex 4 mg/5 ml sirup

4 mg/5 ml

syrup

oral use

Croatia

Pliva Hrvatska d.o.o.

Prilaz baruna Filipovića 25, Zagreb

10000

Croatia

bromhexinum

Bisolex 8 mg tablete

8 mg

tablet

oral use

Croatia

Pliva Hrvatska d.o.o.

Prilaz baruna Filipovića 25, Zagreb

10000

Croatia

bromhexinum

Bisolex F 16 mg tablete

16 mg

tablet

oral use

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Radnička 40-5, Zagreb

10000

Croatia

bromhexinum

Bisolvon 2 mg/ml otopina

2 mg/ml

solution for oral use

oral use

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Radnička 40-5, Zagreb

10000

Croatia

bromhexinum

Bisolvon 4 mg/5 ml sirup

4 mg/5 ml

syrup

oral use

Croatia

Boehringer Ingelheim Zagreb d.o.o.

Radnička 40-5, Zagreb

10000

Croatia

bromhexinum

Bisolvon 8 mg tablete

8 mg

tablet

oral use

Cyprus

The Star Medicines Importers & Co Ltd

9A Loukis Akritas Street

Lemesos

3601

Cyprus

ambroxol hydrochloride

Anavix

15 mg/5 ml

syrup

oral use

Cyprus

Varnavas Hadjipanayis Ltd

Yiannou Kranidioti Avenue

226 Latsia/Lefkosia

2234

Cyprus

ambroxol hydrochloride

Fluibron

15 mg/5 ml

syrup

oral use

Cyprus

CDL Pharmaceutical Products Ltd

12 Agiou Spiridonos Street

Aradippou/Larnaca

7102

Cyprus

ambroxol hydrochloride

Hyvotex

30 mg/5 ml

syrup

oral use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos

Street P.O. BOX 51409

3505 Lemesos

Cyprus

ambroxol hydrochloride

Medovent

30 mg

tablet

oral use

Cyprus

Medochemie Ltd

1-10 Constantinoupoleos

Street P.O. BOX 51409

3505 Lemesos

Cyprus

ambroxol hydrochloride

Medovent elixir

15 mg/5 ml

syrup

oral use

Cyprus

Mundipharma Pharmaceuticals Ltd

13 Othellos Street

Dhali Industrial Zone

1685

Lefkosia

Cyprus

ambroxol hydrochloride

Mucobroxol

15 mg/5 ml

syrup

oral use

Cyprus

Boehringer Ingelheim Ellas AE

Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Cyprus

Boehringer Ingelheim Ellas AE Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan oral Gum

15 mg

oral gum

oral use

Cyprus

Boehringer Ingelheim Ellas AE Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan

30 mg

tablet

oral use

Cyprus

Boehringer Ingelheim Ellas AE

Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan

15 mg/5 ml

syrup

oral use

Cyprus

Boehringer Ingelheim Ellas AE

Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan

75 mg

prolonged-release tablet

oral use

Cyprus

Boehringer Ingelheim Ellas AE

Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Mucosolvan

7,5 mg/ml

solution for injection

intramuscular use, intravenous use

Cyprus

Boehringer Ingelheim Ellas AE

Ellinikou 2 Street

16777

Athens

Greece

ambroxol hydrochloride

Lysopadol

20 mg

lozenge

oral use

Cyprus

REMEDICA LTD

Aharnon street

P.O. Box 51706

3508

Lemesos

Cyprus

bromhexine hydrochloride

Flecoxin Elixir

4 mg

syrup

oral use

Cyprus

REMEDICA LTD

Aharnon street

P.O. Box 51706

3508

Lemesos

Cyprus

bromhexine hydrochloride

Flecoxin

4 mg

tablet

oral use

Cyprus

REMEDICA LTD

Aharnon street

P.O. Box 51706

3508

Lemesos

Cyprus

bromhexine hydrochloride

Flecoxin

8 mg

tablet

oral use

Czech Republic

WALMARK, a.s.

Oldřichovice 44

739 61 Třinec

Czech Republic

ambroxol hydrochloride

Ambex

60 mg

effervescent tablet

oral use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene

7,5 mg/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 15 mg/5 ml

3 mg/ml

syrup

oral use

Czech Republic

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Prague 5

Czech Republic

ambroxol hydrochloride

Ambrobene 3 mg/ml

3 mg/ml

oral solution

oral use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 30 mg

30 mg

tablet

oral use

Czech Republic

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Prague 5

Czech Republic

ambroxol hydrochloride

Ambrobene 6 mg/ml

6 mg/ml

oral solution

oral use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 7,5 mg/ml

7,5 mg/ml

oral solution

oral use

Czech Republic

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 75 mg

75 mg

prolonged-release capsule, hard

oral use

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

Czech Republic

ambroxol hydrochloride

Ambrosan 15 mg

15 mg

tablet

oral use

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

Czech Republic

ambroxol hydrochloride

Ambrosan 15 mg/5 ml Sirup

3 mg/ml

syrup

oral use

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

Czech Republic

ambroxol hydrochloride

Ambrosan 30 mg

30 mg

tablet

oral use

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

Czech Republic

ambroxol hydrochloride

Ambrosan 60 mg

60 mg

tablet

oral use

Czech Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Prague 4

Czech Republic

ambroxol hydrochloride

Ambrosan kapky

7,5 mg/ml

oral drops, solution

oral use

Czech Republic

CYATHUS Exquirere Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

ambroxol hydrochloride

Ambrospray 5 %

50 mg/ml

oromucosal spray

oromucosal use

Czech Republic

Aliud Pharma GmbH

Gottlieb-Daimler-Strasse 19

89150 Laichingen

Germany

ambroxol hydrochloride

Ambroxol Al 30

30 mg

tablet

oral use

Czech Republic

Aliud Pharma GmbH

Gottlieb-Daimler-Strasse 19

89150 Laichingen

Germany

ambroxol hydrochloride

Ambroxol Al 75 Retard

75 mg

prolonged-release capsule, hard

oral use

Czech Republic

Aliud Pharma GmbH

Gottlieb-Daimler-Strasse 19

89150 Laichingen

Germany

ambroxol hydrochloride

Ambroxol Al kapky

7,5 mg/ml

oral drops, solution

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Ambroxol Berlin-Chemie 30 mg/5 ml perorální roztok

6 mg/ml

oral solution

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 15 mg/5 ml perorální roztok

3 mg/ml

oral solution

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed effervescent tablet 60 mg

60 mg

effervescent tablet

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed Forte 30 mg/5 ml

6 mg/ml

oral solution

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed tablety

30 mg

tablet

oral use

Czech Republic

Egis Pharmaceuticals PLC

Keresztúri út. 30-38

1106 Budapest

Hungary

ambroxol hydrochloride

Halixol 30 mg

30 mg

tablet

oral use

Czech Republic

Zentiva, k.s.

U kabelovny 130

Dolni Mėcholupy

102 37 Prague 10

Czech Republic

ambroxol hydrochloride

Mucosin s medem sir

3 mg/ml

syrup

oral use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan

7,5 mg/ml

oral drops, solution

/inhalation solution

oral use,

inhalation use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan

30 mg

tablet

oral use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan

15 mg

pastille

oromucosal use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan Junior

3 mg/ml

syrup

oral use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan Long Effect

75 mg

prolonged-release capsule, hard

oral use

Czech Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucosolvan pro dospělé

6 mg/ml

syrup

oral use

Czech Republic

Divapharma GmbH

Motzener Str. 41

12277 Berlin

Germany

ambroxol hydrochloride

Neo-Bronchol

15 mg

lozenge

oromucosal use

Czech Republic

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

ambroxol hydrochloride

Solvolan

3 mg/ml

syrup

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

bromhexine hydrochloride

Bromhexin 12 BC

12 mg/ml

oral drops, solution

oral use

Czech Republic

Krewel Meuselbach GmbH

Krewelstrasse 2

53783 Eitorf

Germany

bromhexine hydrochloride

Bromhexin 12 KM-kapky

12 mg/ml

oral drops, solution

oral use

Czech Republic

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

bromhexine hydrochloride

Bromhexin 8 Berlin-Chemie

8 mg

coated tablet

oral use

Czech Republic

Krewel Meuselbach GmbH

Krewelstrasse 2

53783 Eitorf

Germany

bromhexine hydrochloride

Bromhexin 8 KM kapky

8 mg/ml

oral drops, solution

oral use

Czech Republic

Krewel Meuselbach GmbH

Krewelstrasse 2

53783 Eitorf

Germany

bromhexine hydrochloride

Bromhexin 8-sirup KM

0,8 mg/ml

syrup

oral use

Czech Republic

GALMED a.s.

Těšínská 1349/296

716 00 Ostrava — Radvanice

Czech Republic

bromhexine hydrochloride

Bromhexin Galmed 12

12 mg/ml

oral drops, solution

oral use

Czech Republic

GALMED a.s.

Těšínská 1349/296

716 00 Ostrava — Radvanice

Czech Republic

bromhexine hydrochloride

Bromhexin Galmed 8

8 mg/ml

oral drops, solution

oral use

Czech Republic

Egis Pharmaceuticals PLC

Keresztúri út. 30-38

1106 Budapest

Hungary

bromhexine hydrochloride

Bromhexin-Egis

2 mg/ml

oral solution

oral use

Czech Republic

Egis Pharmaceuticals PLC

Keresztúri út. 30-38

1106 Budapest

Hungary

bromhexine hydrochloride

Paxirasol

2 mg/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Denmark

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed

60 mg

effervescent tablet

oral use

Denmark

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed

6 mg/ml

oral solution

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucoangin

20 mg

compressed lozenge

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucoangin

2,5 mg/dose

oromucosal spray, solution

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucoangin Citron

20 mg

compressed lozenge

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol hydrochloride

Mucoangin Cassis

20 mg

compressed lozenge

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

bromhexine hydrochloride

Bisolvon

0,8 mg/ml

oral solution

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

bromhexine hydrochloride

Bisolvon

8 mg

tablet

oral use

Denmark

Boehringer Ingelheim Int. GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

bromhexine hydrochloride

Bisolvon

8 mg

soluble tablet

oral use

Denmark

Takeda Pharma A/S

Dybendal Aile 10

2630 Taastrup

Denmark

bromhexine hydrochloride

Bromhexin ‘DAK’

0,8 mg/ml

oral solution

oral use

Denmark

Takeda Pharma A/S

Dybendal Aile 10

2630 Taastrup

Denmark

bromhexine hydrochloride

Bromhexin ‘DAK’

8 mg

tablet

oral use

Estonia

AS Grindeks

Krustpils 53

1057 Riga

Latvia

Bromhexine

Bromhexine-Grindeks

0,8 mg/ml

syrup

oral use

Estonia

AS Grindeks

Krustpils 53

1057 Riga

Latvia

Bromhexine

Bromhexine-Grindeks

8 mg

tablet

oral use

Estonia

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

Ambroxol

Ambrolan

30 mg

tablet

oral use

Estonia

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Ambroxol

Ambroxol Sandoz 15 mg/5 ml

3 mg/ml

syrup

oral use

Estonia

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Ambroxol

Ambroxol Sandoz 30 mg

30 mg

tablet

oral use

Estonia

PRO. MED. CS. PRAHA a.s

Telcska 1

14000 Praha 4

Czech Republic

Ambroxol

Pro-Ambrosan

30 mg

tablet

oral use

Estonia

BOEHRINGER INGELHEIM INTERNATIONAL GmbH — Binger Strasse 173

Ingelheim/Rhein

55216

Germany

Ambroxol

Lasolvan

3 mg/ml

syrup

oral use

Estonia

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Ambroxol

Brontex Lahus

7,5 mg/ml

oral solution

oral use

Estonia

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Ambroxol

Brontex Tabletid

30 mg

tablet

oral use

Estonia

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Ambroxol

Brontex Siirup

3 mg/ml

syrup

oral use

Estonia

DIVAPHARMA GmbH

Motzener Str. 41

12277 Berliin

Germany

Ambroxol

Neo-Bronchol

15 mg

pastille

oral use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol

Flavamed 30 Mg

30 mg

tablet

oral use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol

Flavamed 60 mg

60 mg

effervescent tablet

oral use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol

Flavamed Forte

6 mg/ml

oral solution

oral use

Estonia

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol

Flavamed Vaarikas

3 mg/ml

oral solution

oral use

Finland

Berlin-Chemie AG

Glienicker Weg 125

12489 BERLIN

Germany

Ambroxol hydrochloride

FLAVAMED

30 mg

tablet

oral use

Finland

Berlin-Chemie AG

Glienicker Weg 125

12489 BERLIN

Germany

Ambroxol hydrochloride

FLAVAMED

60 mg

effervescent tablet

oral use

Finland

Berlin-Chemie AG

Glienicker Weg 125

12489 BERLIN

Germany

Ambroxol hydrochloride

FLAVAMED

6 mg/ml

oral solution

oral use

Finland

Berlin-Chemie AG

Glienicker Weg 125

12489 BERLIN

Germany

Ambroxol hydrochloride

FLAVAMED

3 mg/ml

oral solution

oral use

Finland

Boehringer Ingelheim International GmbH

Binger Strasse 173

P.O. BOX 200

55216 Ingelheim Am Rhein Germany

bromhexine hydrochloride

BISOLVON

0,8 mg/ml

oral solution

oral use

Finland

Boehringer Ingelheim International GmbH

Binger Strasse 173

P.O. BOX 200

55216 Ingelheim Am Rhein Germany

bromhexine hydrochloride

BISOLVON

8 mg

tablet

oral use

Finland

Boehringer Ingelheim International GmbH

Binger Strasse 173

P.O. BOX 200

55216 Ingelheim Am Rhein Germany

bromhexine hydrochloride

BISOLVON

8 mg

soluble tablet

oral use

Finland

Boehringer Ingelheim International GmbH

Binger Strasse 173

P.O. BOX 200

55216 Ingelheim Am Rhein Germany

bromhexine hydrochloride

BISOLVON

8 mg

oral solution, sachet

oral use

Finland

Boehringer Ingelheim International GmbH

Binger Strasse 173

P.O. BOX 200

55216 Ingelheim Am Rhein Germany

bromhexine hydrochloride

BISOLVON STRONG

1,6 mg/ml

oral solution

oral use

Finland

Orion Oyj

Orionintie 1

PL 65

02101 ESPOO

Finland

bromhexine hydrochloride

MEDIPEKT

0,8 mg/ml

oral solution

oral use

Finland

Orion Oyj

Orionintie 1

PL 65

02101 ESPOO

Finland

bromhexine hydrochloride

MEDIPEKT

8 mg

tablet

oral use

Finland

Oy Leiras Takeda

Paciuksenkatu 21

PL 1406

00101 HELSINKI

Finland

bromhexine hydrochloride

MUCOVIN

0,8 mg/ml

oral solution

oral use

France

Laboratoires de l'AEROCID

248 bis, rue Gabriel Péri

B.P. 126

94232 Cachan Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL AEROCID 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

ambroxol (chlorhydrate d')

AMBROXOL ARROW 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

ambroxol (chlorhydrate d')

AMBROXOL ARROW 30 mg, comprimé

30 mg

tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

ambroxol (chlorhydrate d')

AMBROXOL BIOGARAN CONSEIL 0,6 % SANS SUCRE, solution buvable édulcorée au sorbitol

0,6 g per 100 ml of solution

oral solution

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

ambroxol (chlorhydrate d')

AMBROXOL BIOGARAN CONSEIL 30 mg, comprimé sécable

30 mg

tablet

oral use

France

EG LABO — Laboratoires EuroGenerics

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL EG 0,3 POUR CENT SANS SUCRE, solution buvable édulcorée au cyclamate de sodium et au sorbitol

0,3 g per 100 ml of solution

oral solution

oral use

France

EG LABO — Laboratoires EuroGenerics

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL EG 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

EG LABO — Laboratoires EuroGenerics

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL EG 30 mg, comprimé sécable

30 mg

tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

ambroxol (chlorhydrate d')

AMBROXOL MYLAN 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

ambroxol (chlorhydrate d')

AMBROXOL MYLAN 30 mg, comprimé

30 mg

tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ambroxol (chlorhydrate d')

AMBROXOL SANDOZ CONSEIL 0,6 % SANS SUCRE, solution buvable édulcorée à la saccharine sodique

0,6 g per 100 ml of solution

oral solution

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL TEVA CONSEIL 0,3 %, solution buvable

0,3 g per 100 ml of solution

oral solution

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL TEVA CONSEIL 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

ambroxol (chlorhydrate d')

AMBROXOL TEVA CONSEIL 30 mg, comprimé

30 mg

tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

ambroxol (chlorhydrate d')

VICKS EXPECTORANT AMBROXOL 0,6 %, solution buvable

0,6 g per 100 ml of solution

oral solution

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

ambroxol (chlorhydrate d')

VICKS EXPECTORANT AMBROXOL 30 mg, comprimé sécable

30 mg

tablet

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose

20 mg

lozenge

oromucosal use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose

20 mg

lozenge

oromucosal use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose

20 mg

lozenge

oromucosal use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

SURBRONC 60 mg, comprimé enrobé sécable

60 mg

tablet

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

SURBRONC 60 mg, granulés pour solution buvable en sachet

60 mg

granules for oral solution

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable

30 mg

tablet

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l'acésulfame potassique et au sorbitol

0,600 g per 100 ml of solution

oral solution

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

ambroxol (chlorhydrate d')

SURBRONC L.P. 75 mg, gélule à libération prolongée

75 mg

hard capsule, prolonged relase

oral use

France

BIOCODEX

7, avenue Gallieni

94250 Gentilly

France

ambroxol (chlorhydrate d')

MUXOL 30 mg, comprimé

30 mg

tablet

oral use

France

BIOCODEX

7, avenue Gallieni

94250 Gentilly

France

ambroxol (chlorhydrate d')

MUXOL, solution buvable

0,3 g per 100 ml of solution

oral solution

oral use

France

CHRIS PHARMAZEUTISCHE HANDELSGESELLSCHAFT mbH

Weg im Esterholz 6

82064 Strasslach

Germany

ambroxol (chlorhydrate d')

MUXOL 60 mg, comprimé effervescent

60 mg

effervescent tablet

oral use

France

RECKITT BENCKISER HEALTHCARE France

15, rue Ampère

91748 Massy Cedex

France

ambroxol (chlorhydrate d')

STREPSILS EXPECTORANT 30 mg/5 ml ADULTES, sirop

30 mg per 5 ml of syrup

syrup

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

bromhexine (chlorhydrate de)

BISOLVON 0,2 POUR CENT, solution buvable

200 mg per 100 ml of solution

oral solution

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

bromhexine (chlorhydrate de)

BISOLVON 8 mg, comprimé

8 mg per tablet

tablet

oral use

France

BOEHRINGER INGELHEIM FRANCE

14, rue Jean Antoine de Baïf

75013 Paris

France

bromhexine (chlorhydrate de); tétracycline (chlorhydrate de)

BISOLVOMYCINE, comprimé enrobé

4 mg per tablet

tablet

oral use

Germany

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Ambroxol hydrochloride

Ambroxol 15 Saft — 1A Pharma

0,3 g

oral solution

oral use

Germany

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Ambroxol hydrochloride

Ambroxol 30 Saft — 1A Pharma

6 mg

oral solution

oral use

Germany

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Ambroxol hydrochloride

Ambroxol 30 Tab — 1A Pharma

30 mg

tablet

oral use

Germany

1 A Pharma

Keltenring 1 + 3

82041 Oberhaching

Germany

Ambroxol hydrochloride

Ambroxol 30 Tropfen — 1A Pharma

15 mg

oral drops, solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambro-AbZ 3 mg/ml Lösung zum Einnehmen

3 mg

oral solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol AbZ Hustensaft 15 mg/5 ml Lösung zum Einnehmen

15 mg/5 ml

oral solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-CT Tropfen

7,5 mg

oral drops, solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride, Doxycycline hycalate

Doxy comp.-CT 100 mg/75 mg Retardkapseln

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambro-AbZ 6 mg/ml Lösung zum Einnehmen

6 mg/ml

oral solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambro-CT 3 mg/ml Lösung zum Einnehmen

3 mg/ml

oral solution

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol AbZ 75 mg Retardkapseln

75 mg

prolonged-release capsule, hard

oral use

Germany

acis Arzneimittel GmbH

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Ambroxol hydrochloride

Ambroxol acis Tropfen

7,5 mg

oral solution

oral use

Germany

acis Arzneimittel GmbH

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Ambroxol hydrochloride

Ambroxol acis 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

acis Arzneimittel GmbH

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Ambroxol hydrochloride

Ambroxol acis Saft

15 mg

oral solution

oral use

Germany

acis Arzneimittel GmbH

Lil-Dagover-Ring 7

82031 Grünwald

Germany

Ambroxol hydrochloride

Ambroxol acis 30 mg Trinktabletten

30 mg

soluble tablet

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride

Ambroxol AL 30

30 mg

tablet

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride, Doxycycline hycalate

Ambroxol AL comp

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride

Ambroxol AL Saft

15 mg

oral solution

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride

Ambroxol AL 75 retard

75 mg

prolonged-release capsule, hard

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride

Ambroxol AL Tropfen

7,5 mg

oral drops, solution

oral use

Germany

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Ambroxol hydrochloride

Ambroxol AL 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Ambroxol hydrochloride

Ambroxol Aristo Hustentropfen 15 mg/ml

15 mg

oral solution

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Ambroxol hydrochloride

Ambroxol Aristo Hustentropfen für Kinder 7,5 mg/ml

7,5 mg

oral solution

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Ambroxol hydrochloride, Doxycycline hycalate

Doxam 100 mg/75 mg Hartkapsel retardiert

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Ambroxol hydrochloride

Ambroxol Aristo Hustensaft 30 mg/5 ml

30 mg/5 ml

oral solution

oral use

Germany

axcount Generika GmbH

Max-Planck. Str. 36 b

61381 Friedrichsdorf

Germany

Ambroxol hydrochloride

Ambroxol axcount Saft

15 mg

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Hustensaft 30 mg/5 ml Lösung zum Einnehmen

30 mg/5 ml

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Hustenlöser 30 mg/5 ml Lösung zum Einnehmen

30 mg/5 ml

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Bromhexine hydrochloride

BROMHEXIN 12 BC

12 mg

oral drops, solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Bromhexine hydrochloride

BROMHEXIN 4 BC

4 mg

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Hustensaft

15 mg

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Hustentabletten

30 mg

tablet

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Bromhexine hydrochloride

BROMHEXIN 8 Berlin-Chemie

8 mg

coated tablet

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed Hustensaft 15 mg/5 ml Lösung zum Einnehmen

15 mg

oral solution

oral use

Germany

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Ambroxol hydrochloride

Ambrobeta 30

30 mg

effervescent tablet

oral use

Germany

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Ambroxol hydrochloride

Ambrobeta Saft

3 mg

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Filmtabletten 60 mg

60 mg

film-coated tablet

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Retardkapseln 75 mg

75 mg

prolonged-release capsule, hard

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride, Clenbuterol hydrochloride

Spasmo-Mucosolvan Saft

7,5 mg, 0,005 mg

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucoangin gegen Halsschmerzen 20 mg Pastillen

20 mg

pastille

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucoangin gegen Halsschmerzen Zitrone 20 mg Lutschtabletten

20 mg

lozenge

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucoangin gegen Halsschmerzen Minze

20 mg

lozenge

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Hustensaft 30 mg/5 ml

30 mg/5 ml

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Inhalationslösung 15 mg/2 ml

15 mg/2 ml

nebuliser solution

inhalation use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Tabletten 30 mg

30 mg

tablet

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Infusionslösungskonzentrat

1 mg

concentrate for solution for infusion

intravenous use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Brausetabletten 60 mg

60 mg

effervescent tablet

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Bromhexine hydrochloride

Bisolvon Hustentropfen

2 mg

oral drops, solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Kindersaft 30 mg/5 ml

30 mg/5 ml

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Tropfen 30 mg/2 ml

30 mg/2 ml

oral drops, solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Tropfen 30 mg/2 ml

30 mg/2 ml

oral drops, solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Injektionslösung

15 mg

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucoangin gegen Halsschmerzen Waldbeere

20 mg

lozenge

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Lutschpastillen 15 mg

15 mg

pastille

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Ambroxol 60 mg

60 mg

granules for oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Bromhexine hydrochloride

Bisolvon-Linctus Hustensaft

0,08 g/100 ml

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Bromhexine hydrochloride

Bisolvon Hustentabletten

8 mg

tablet

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Kindersaft 15 mg/5 ml

15 mg

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan Portionsbeutel 30 mg/5 ml

30 mg

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Ambroxol Portionsbeutel 30 mg/5 mg

30 mg

oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Mucosolvan 60 mg

60 mg

granules for oral solution

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride

Bisolaryn gegen Halzschmerzen 20 mg Pastillen

20 mg

pastille

oromucosal use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Ambroxol hydrochloride, Clenbuterol hydrochloride

Spasmo-Mucosolvan

30 mg, 0,02 mg

tablet

oral use

Germany

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Str. 173

55216 Ingelheim

Germany

Bromhexine hydrochloride

Bisolvon Hustensaft

8 mg

oral solution

oral use

Germany

Cyathus Exquirere PharmaforschungsGmbH

Rudolfplatz 2/1/8

1010 Wien

Austria

Ambroxol hydrochloride

Ambroxolhydrochloride Cyathus 10 mg/Sprühstoß Lösung zum Einnehmen

10 mg

oral solution

oral use

Germany

Cyathus Exquirere PharmaforschungsGmbH

Rudolfplatz 2/1/8

1010 Wien

Austria

Ambroxol hydrochloride

Mukambro 10 mg/Sprühstoß Lösung zum Einnehmen

10 mg

oral solution

oral use

Germany

Denk Pharma GmbH & Co. KG

Prinzregentenstr. 79

81675 München

Germany

Ambroxol hydrochloride

Ambrox-Denk 60 mg

60 mg

effervescent tablet

oral use

Germany

Divapharma GmbH

Motzener Str. 41

12277 Berlin

Germany

Ambroxol hydrochloride

Neo-bronchol

15 mg

oral gum

oral use

Germany

Docpharm Arzneimittelvertrieb GmbH & Co. KG

Greschbachstr. 7

76229 Karlsruhe

Germany

Ambroxol hydrochloride

Ambroxol PB 30 mg

30 mg

film-coated tablet

oral use

Germany

Dr. Ritsert Pharma GmbH & Co. KG

Klausenweg 12

69412 Eberbach

Germany

Ambroxol hydrochloride

Expit T Tropfen

7,5 mg

oral drops, solution

oral use

Germany

Dr. Ritsert Pharma GmbH & Co. KG

Klausenweg 12

69412 Eberbach

Germany

Ambroxol hydrochloride

Expit Lösung

15 mg

oral solution

oral use

Germany

esparma GmbH

Seepark 7

39116 Magdeburg

Germany

Ambroxol hydrochloride, Doxycycline hycalate

Sigamuc

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Ambroxol hydrochloride

Ambroxin-Tropfen

7,5 mg

oral drops, solution

oral use

Germany

Hemopharm GmbH

Königsteiner Str. 2

61350 Bad Homburg v.d.H.

Germany

Ambroxol hydrochloride

Ambro-Hemopharm Hustensaft

15 mg

prolonged-release capsule, hard

oral use

Germany

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Ambroxol hydrochloride

Ambroxo Brause 1 Hermes

30 mg

effervescent tablet

oral use

Germany

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Ambroxol hydrochloride

Ambroxo Hermes 60 mg

60 mg

effervescent tablet

oral use

Germany

Hermes Arzneimittel GmbH

Georg-Kalb-Str. 5-8

82049 Großhesselohe

Germany

Ambroxol hydrochloride

Ambroxol Brause 60

60 mg

effervescent tablet

oral use

Germany

Heumann Pharma GmbH&Co. KG Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Ambroxol hydrochloride

Ambroxol Heumann Saft

3 mg

oral solution

oral use

Germany

Heumann Pharma GmbH&Co. KG Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Ambroxol hydrochloride

Ambroxol Heumann Tropfen

7,5 mg

oral drops

oral use

Germany

Heumann Pharma GmbH&Co. KG Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Ambroxol hydrochloride

Ambroxol 75 retard Heumann

75 mg

prolonged-release capsule, hard

oral use

Germany

Heumann Pharma GmbH&Co. KG Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Ambroxol hydrochloride

Ambroxol 60 Heumann Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Heumann Pharma GmbH&Co. KG Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Ambroxol hydrochloride

Ambroxol 30 Heumann

30 mg

tablet

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal injekt

15 mg

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

AmbroHEXAL Hustensaft für Kinder

3 mg

oral solution

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

AmbroHEXAL Hustenlöser 30 mg Tabletten

30 mg

tablet

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal Hustenlöser retard 75 mg

75 mg

prolonged-release capsule, hard

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal S Hustensaft 30 mg/5 ml

6 mg

oral solution

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal S Hustentropfen 15 mg/ml

15 mg

oral solution

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal S Hustenlöser 60 mg Filmtabletten

60 mg

film-coated tablet

oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal Hustenlöser Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Ambroxol hydrochloride

Ambroxol Krewel Meuselbach Tropfen 7,5 mg/ml

7,5 mg

oral drops, solution

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Bromhexine hydrochloride

Bromhexin Krewel Meuselbach Tabletten 12 mg

12 mg

tablet

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Bromhexine hydrochloride

Bromhexin Krewel Meuselbach Tropfen 12 mg

12 mg

oral drops, solution

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Bromhexine hydrochloride

Bromhexin Krewel Meuselbach Tropfen 8 mg

8 mg

oral drops, solution

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Ambroxol hydrochloride

Ambroxol Krewel Meuselbach Sirup 15 mg/5 ml

15 mg

syrup

oral use

Germany

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Bromhexine hydrochloride

Bromhexin Krewel Meuselbach Hustensaft 8 mg/10 ml

0,8 mg

solution

oral use

Germany

Meda Pharma GmbH&Co. KG

Benzstr. 1

61352 Bad Homburg

Germany

Ambroxol hydrochloride

Lindoxyl K Zäpfchen

15 mg

suppository

rectal use

Germany

Pädia Arzneimittel

Gruhlstr. 3

50374 Erftstadt

Germany

Ambroxol hydrochloride

Pädiamuc Saft

15 mg

oral solution

oral use

Germany

Pharma Stulln GmbH

Werkstr. 3

92551 Stulln

Germany

Ambroxol hydrochloride

Ambroxol Inhalat

7,5 mg/ml

nebuliser solution

inhalation use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm Hustentropfen

7,5 mg

oral drops, solution

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 15 mg/2 ml Injektionslösung

15 mg

solution for injection

intravenous use, intramuscular use, subcutaneous use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambro-ratiopharm 3 mg/ml Lösung zum Einnehmen

3 mg

oral solution

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 75 mg Hustenlöser

75 mg

prolonged-release capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 30 mg Hustenlöser

30 mg

tablet

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm Hustensaft

15 mg

oral solution

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambro-ratiopharm 6 mg/ml Lösung zum Einnehmen

6 mg

oral solution

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol, Doxycycline

Ambroxol comp.-ratiopharm 75 mg/100 mg Retardkapseln

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 60 mg Hustenlöser

60 mg

tablet

oral use

Germany

RubiePharm Vertiebs GmbH

Sennelsbachweg 4

36396 Stainau an der Strasse

Germany

Ambroxol hydrochloride

AMBROinfant

15 mg

oral solution

oral use

Germany

Sandoz Phamaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambroxol Sandoz 7,5 mg/ml Tropfen zum Einnehmen, Lösung

7,5 mg

oral drops, solution

oral use

Germany

Sandoz Phamaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambroxol Sandoz 15 mg/5 ml Lösung zum Einnehmen

15 mg

oral solution

oral use

Germany

Sandoz Phamaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambroxol Sandoz 30 mg Tabletten

30 mg

tablet

oral use

Germany

Stadapharm GmbH

Saalstr. 2.18

61118 Bad Vilbel

Germany

Ambroxol hydrochloride

Ambroxol Stada Hustensaft 15 mg/5 ml, Lösung zum Einnehmen

15 mg

solution

oral use

Germany

Stadapharm GmbH

Saalstr. 2.18

61118 Bad Vilbel

Germany

Ambroxole, Doxycycline hyclate

Doxy plus STADA 100 mg/75 mg Hartkapseln, retardiert

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

27472 Cuxhaven

Germany

Ambroxol hydrochloride, Doxycycline hyclate

Doxam

75 mg, 115,4 mg

prolonged-release capsule, hard

oral use

Germany

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Ambroxol hydrochloride Theophylline

Broncho-Euphyllin retard

30 mg, 350 mg

prolonged-release capsule, hard

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol Temmler 75 mg Retardkapseln

75 mg

prolonged-release capsule, hard

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Axol 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol retard Temmler

75 mg

prolonged-release capsule, hard

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol Temmler Tropfen

7,5 mg

oral drops, solution

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol Temmler Saft

15 mg

oral solution

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Braxol 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol Temmler 30 mg Brausetabletten

30 mg

effervescent tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol 7,5 TT Temmler Trinktabletten

7,5 mg

soluble tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol 15 TT Temmler Trinktabletten

15 mg

soluble tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol 30 TT Temmler Trinktabletten

30 mg

tablet

oral use

Germany

Temmler Pharma GmbH&Co. KG

Temmlerstr. 2

35039 Marburg

Germany

Ambroxol hydrochloride

Ambroxol Temmler 60 mg Brausetabletten

60 mg

effervescent tablet

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Ambroxol WICK Schleimlöser für Kinder 3 mg/ml Lösung zum Einnehmen

15 mg

oral solution

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Wick Schleimlöser 30 mg Tabletten

30 mg

tablet

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Wick Schleimlöser 6 mg/ml Lösung zum Einnehmen

6 mg

oral solution

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Wick Schleimlöser 30 mg Brausetabletten

30 mg

effervescent tablet

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Wick Hustenlöser Therapie

30 mg

effervescent tablet

oral use

Germany

Wick Pharma

Zweigniederlassung

Procter & Gamble GmbH

Sulzbacher Str. 40

65824 Schwalbach/Taunus

Germany

Ambroxol hydrochloride

Wick Schleimlöser 75 Einmal Täglich Retardkapseln

75 mg

prolonged-release capsule, hard

oral use

Greece

Adelco A.E. Chrom. Athin. Afoi Kolokotroni,

Peireos 37,

Moschato,

Greece

BROMHEXINE

Bronchotussine

4 mg/5 ml

syrup

oral use

Greece

Alapis Abee,

Aftokratoros Nikolaou 2,

11745, Athens,

Greece

AMBROXOL HYDROCHLORIDE

Amboral

15 mg/5 ml

syrup

oral use

Greece

Alapis Abee,

Aftokratoros Nikolaou 2,

11745, Athens,

Greece

AMBROXOL HYDROCHLORIDE

Amboral

30 mg/5 ml

syrup

oral use

Greece

Angelini Pharma Hellas Anonimi Biomhxaniki Etaireia Paragogis & Emporias Farmakon, Achaias & Trizinias, 14564, N. Kiffisia, Greece

AMBROXOL HYDROCHLORIDE

Tussefar

15 mg/5 ml

syrup

oral use

Greece

Angelini Pharma Hellas Anonimi Biomhxaniki Etaireia Paragogis & Emporias Farmakon, Achaias & Trizinias, 14564, N. Kiffisia, Greece

AMBROXOL HYDROCHLORIDE

Tussefar

30 mg/5 ml

syrup

oral use

Greece

Boehringer Ingelheim Ellas Αε,

Ellinikou 2,

16777, Ellinikon,

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

75 mg

prolonged-release capsule

oral use

Greece

Boehringer Ingelheim Ellas Αε,

Ellinikou 2,

16777, Ellinikon,

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

15 mg/2 ml

solution for injection

intravenous use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

30 mg/5 ml

syrup

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

30 mg

tablet

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

BROMHEXINE

Bisolvon

8 mg

tablet

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

15 mg/2 ml

solution for injection

intramuscular use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

BROMHEXINE

Bisolvon

8 mg

soluble tablet

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

BROMHEXINE

Bisolvon

4 mg/5 ml

syrup

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

BROMHEXINE

Bisolvon

8 mg/5 ml

syrup

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

15 mg

oral gum

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

15 mg/2 ml

solution for injection

intravenous use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Mucosolvan

15 mg/5 ml

syrup

oral use

Greece

Boehringer Ingelheim Ellas ΑE,

Ellinikou 2,

16777, Ellinikon, Athens

Greece

AMBROXOL HYDROCHLORIDE

Lysopadol

20 mg

lozenge

oromucosal use

Greece

Bros E.P.E.,

Aygis & Galinis 15,

14564, Nea Kifissia,

Greece

AMBROXOL HYDROCHLORIDE

Ebertuss

30 mg/5 ml

syrup

oral use

Greece

Coup Abee,

Ag. Barbaras 53-55,

17235 Dafni,

Greece

AMBROXOL HYDROCHLORIDE

Nibren

30 mg/5 ml

syrup

oral use

Greece

D.A.S.T. Biotech Φαρ/Κη Επε Δ.Τ. D.A.S.T. Biotech Pharm Επε, Λαρίσσης 10,

15351 Athens,

Greece

AMBROXOL HYDROCHLORIDE

Provixen-N

30 mg/5 ml

syrup

oral use

Greece

Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,

Greece

AMBROXOL HYDROCHLORIDE

Celibron

30 mg

tablet

oral use

Greece

Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,

Greece

AMBROXOL HYDROCHLORIDE

Celibron

30 mg/5 ml

syrup

oral use

Greece

Elpen Ae Φαρμακευτικη Βιομηχανια, Leof. Marathonos 95, 19009 Pikermi,

Greece

AMBROXOL HYDROCHLORIDE

Celibron

15 mg/5 ml

syrup

oral use

Greece

Farmellas Enterprises Ltd, Cyprus,

Leof. Afxentiou 27,

Acropolis Centre,

Cyprus

AMBROXOL HYDROCHLORIDE

Fluibrox

30 mg/5 ml

syrup

oral use

Greece

Genepharm Ae,

18 Km. Leof. Marathonos,

15351 Pallini,

Greece

AMBROXOL HYDROCHLORIDE

Grenovix

30 mg/5 ml

syrup

oral use

Greece

Genepharm Ae,

18 Km. Leof. Marathonos,

15351 Pallini,

Greece

AMBROXOL HYDROCHLORIDE

Grenovix

30 mg

tablet

oral use

Greece

Help Αβεε,

Valaoritou 10,

14452, Metamorfosi,

Greece

AMBROXOL HYDROCHLORIDE

Abrobion

30 mg

tablet

oral use

Greece

Help Αβεε,

Valaoritou 10,

14452, Metamorfosi,

Greece

AMBROXOL HYDROCHLORIDE

Abrobion

30 mg/5 ml

syrup

oral use

Greece

Help Αβεε,

Valaoritou 10,

14452, Metamorfosi,

Greece

AMBROXOL HYDROCHLORIDE

Abrobion

15 mg/5 ml

syrup

oral use

Greece

Help Αβεε,

Valaoritou 10,

14452, Metamorfosi,

Greece

BROMHEXINE

Bron-Hal

4 mg/5 ml

syrup

oral use

Greece

Iasis Pharmac. Hellas Biom. & Emp F/Kon-Chem/Kon & Kal. Pr. Abee, L. Fylis 137,

13451 Kamatero Attikis,

Greece

AMBROXOL HYDROCHLORIDE

Afrodor

30 mg/5 ml

syrup

oral use

Greece

Novendia Farmakeytiki Epe, Leof. Irakliou 425 & Olympias 28, 14122 N. Iraklio, Greece

AMBROXOL HYDROCHLORIDE

Tevoril

30 mg/5 ml

syrup

oral use

Greece

Pharmaswiss Ceska Republika s.r.o., Jancovcova 1569/2c, 1700 Praha 7, Holesovice,

Czech Republic

AMBROXOL HYDROCHLORIDE

Physiosolvan

30 mg/5 ml

syrup

oral use

Greece

Pharmaswiss Ceska Republika s.r.o., Jancovcova 1569/2c, 1700 Praha 7, Holesovice,

Czech Republic

AMBROXOL HYDROCHLORIDE

Physiosolvan

15 mg/5 ml

syrup

oral use

Greece

Rafarm,

12, Korinthou Str.,

New Psychico,

Athens 15451,

Greece

AMBROXOL HYDROCHLORIDE

Kriolen

30 mg/5 ml

syrup

oral use

Greece

S.J.A. Pharm Farmakeytiki E.P.E

11 Arkoleon Str.,

Patissia 10445,

Greece

AMBROXOL HYDROCHLORIDE

Stefolant

30 mg/5 ml

syrup

oral use

Greece

Ανφαρμ Ellas A.E.,

Perikleous 53-57

Gerakas 15344,

Greece

AMBROXOL HYDROCHLORIDE

Aprinol

30 mg/5 ml

syrup

oral use

Greece

Ανφαρμ Ellas A.E.,

Perikleous 53-57

Gerakas 15344,

Greece

AMBROXOL HYDROCHLORIDE

Aprinol

15 mg/5 ml

syrup

oral use

Greece

Vianex A.E.,

Tatoiou Street, 18th Km

National Road Athens-Lamia,

14571 Nea Erythrea,

Greece

AMBROXOL HYDROCHLORIDE

Broncolyn

30 mg/tab

tablet

oral use

Greece

Vianex A.E.,

Tatoiou Street, 18th Km National Road Athens-Lamia,

14571 Nea Erythrea,

Greece

AMBROXOL HYDROCHLORIDE

Broncolyn

30 mg/5 ml

syrup

oral use

Greece

Vianex A.E.,

Tatoiou Street, 18th Km

National Road Athens-Lamia,

14571 Nea Erythrea,

Greece

AMBROXOL HYDROCHLORIDE

Broncolyn

15 mg/5 ml

syrup

oral use

Greece

Exelixi Emporia Iatr. Eidon A.E.,

L. Mesogeion 501,

15343 Athens,

Greece

AMBROXOL HYDROCHLORIDE

Saribal

15 mg/5 ml

syrup

oral use

Greece

Exelixi Emporia Iatr. Eidon A.E.,

L. Mesogeion 501,

15343 Athens,

Greece

AMBROXOL HYDROCHLORIDE

Saribal

30 mg/5 ml

syrup

oral use

Greece

Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,

Kalyftaki 27,

14561 Kifissia, Attiki,

Greece

AMBROXOL HYDROCHLORIDE

Bunafon

15 mg/5 ml

syrup

oral use

Greece

Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,

Kalyftaki 27,

14561 Kifissia, Attiki,

Greece

AMBROXOL HYDROCHLORIDE

Bunafon

30 mg/5 ml

syrup

oral use

Greece

Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,

Kalyftaki 27,

14561 Kifissia, Attiki,

Greece

AMBROXOL HYDROCHLORIDE

Bunafon

15 mg

granules for oral solution in sachet

oral use

Greece

Ioul. & Eir. Tseti Far/Ka Ergastiria Abee,

Kalyftaki 27,

14561 Kifissia, Attiki,

Greece

AMBROXOL HYDROCHLORIDE

Bunafon

30 mg

granules for oral solution in sachet

oral use

Greece

Koper Farmakoviomihania A.E.,

Aristovoulou 64,

11853 Athens,

Greece

AMBROXOL HYDROCHLORIDE

Mucolin

30 mg/5 ml

syrup

oral use

Greece

Koper Farmakoviomihania A.E.,

Aristovoulou 64,

11853 Athens,

Greece

AMBROXOL HYDROCHLORIDE

Mucolin

15 mg/5 ml

syrup

oral use

Greece

S.M. Farmakeytika Proionta Epe,

Agiou Orous 43-45,

18545 Peireas, Atiiki,

Greece

AMBROXOL HYDROCHLORIDE

Mucovix

30 mg/5 ml

syrup

oral use

Greece

Foinixfarm Epe,

Dervenakion 38 & Sahini,

15344, Gerakas,

Greece

AMBROXOL HYDROCHLORIDE

Strubelin

30 mg/5 ml

syrup

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROBENE 7,5 mg/ml belsőleges oldat

7,5 mg/ml

oral solution

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROBENE 15 mg/5 ml szirup

15 mg/5 ml

syrup

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROBENE 30 mg tabletta

30 mg

tablet

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROBENE 7,5 mg/ml oldatos injekció

7,5 mg/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROXOL TEVA 6 mg/ml belsőleges oldat

6 mg/ml

oral solution

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROXOL-TEVA 3 mg/ml szirup

3 mg/ml

syrup

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROXOL-TEVA 30 mg tabletta

30 mg

tablet

oral use

Hungary

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen

H-4042

Hungary

ambroxol

AMBROXOL-TEVA 75 mg retard kemény kapszula

75 mg

prolonged-release capsule, hard

oral use

Hungary

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

Berlin D-12489

Germany

ambroxol

FLAVAMED 15 mg/5 ml belsőleges oldat

15 mg/5 ml

oral solution

oral use

Hungary

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

Berlin D-12489

Germany

ambroxol

FLAVAMED 30 mg tabletta

30 mg

tablet

oral use

Hungary

Berlin-Chemie AG

(Menarini Group)

Glienicker Weg 125

Berlin D-12489

Germany

ambroxol

FLAVAMED 30 mg/5 ml belsőleges oldat

30 mg/5 ml

oral solution

oral use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

ambroxol

HALIXOL 30 mg tabletta

30 mg

tablet

oral use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

ambroxol

HALIXOL 3 mg/ml szirup

0,3 g/100 ml

syrup

oral use

Hungary

Boehringer Ingelheim International GmbH

Binger strasse 173

55216 Ingelheim am Rhein

Germany

ambroxol

MUCOANGIN 20 mg szopogató tabletta

20 mg

lozenge

oromucosal use

Hungary

Pharma-Regist Kft.,

Október 6. u. 7.

Budapest

1051

Hungary

ambroxol

MUCOFREE 15 mg/5 ml szirup

15 mg/5 ml

syrup

oral use

Hungary

Pharma-Regist Kft.,

Október 6. u. 7.

Budapest

1051

Hungary

ambroxol

MUCOFREE 30 mg/5 ml szirup

30 mg/5 ml

syrup

oral use

Hungary

PannonPharma Kft.

Pannonpharma út 1.

Pécsvárad

H-7720

Hungary

ambroxol

MUKAMBRO 10 mg/adag belsőleges oldatos spray

10 mg/dose

oromucosal spray

oromucosal use

Hungary

Divapharma GmbH

Motzener Str. 41

D-12277 Berlin

Germany

ambroxol

NEO-BRONCHOL szopogató tabletta

15 mg

lozenge

oromucosal use

Hungary

Meditop Gyógyszeripari Kft.

Ady Endre u. 1

Pilisborosjenő

H-2097

Hungary

bromhexine, oxymetazoline

NASOPAX orrspray felnőtteknek

0,12 mg/0,025 mg oximetazolin-klorid/dose (0,1 ml).

nasal spray, solution

nasal use

Hungary

Meditop Gyógyszeripari Kft.

Ady Endre u. 1

Pilisborosjenő

H-2097

Hungary

bromhexine, oxymetazoline

NASOPAX orrspray gyermekeknek

0,06 mg/0,005 mg oximetazolin-klorid/dose (0,1 ml).

nasal spray, solution

nasal use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

bromhexine

PAXIRASOL 2 mg/ml belsőleges oldat

2 mg/ml

oral solution

oral use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

bromhexine

PAXIRASOL 2 mg/ml oldatos injekció

2 mg/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

bromhexine

PAXIRASOL 8 mg tabletta

8 mg

tablet

oral use

Hungary

EGIS Gyógyszergyár Zrt.,

Keresztúri út 30-38.

Budapest H-1106

Hungary

bromhexine

PAXIRASOL oldatos orrspray

0,2 mg/dose

nasal spray, solution

nasal use

Iceland

Boehringer Ingelheim International G.m.b.H.,

Binger Strasse 173, 55216

Ingelheim am Rhein,

Germany

Bromhexinum INN cloride

Bisolvon

8 mg

tablet

oral use

Ireland

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Ambroxol hydrochloride

Ambrobene 3 mg/ml Oral Solution

3 mg/ml

oral solution

oral use

Ireland

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Ambroxol hydrochloride

Ambrobene Extra Strength 6 mg/ml Oral Solution

6 mg/ml

oral solution

oral use

Ireland

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell,

Berkshire, RG12 8YS,

United Kingdom

Ambroxol hydrochloride

Lysopadol Mint 20 mg Lozenges

20 mg

lozenge

oral use

Ireland

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell,

Berkshire RG12 8YS

United Kingdom

Ambroxol hydrochloride

Lysopadol 17,86 mg/ml Oromucosal Spray, Solution

17,86 mg/ml

oromucosal spray, solution

oromucosal use

Ireland

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell,

Berkshire, RG12 8YS,

United Kingdom

Ambroxol hydrochloride

Lysopadol Lemon 20 mg Lozenges

20 mg

lozenge

oral use

Ireland

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell,

Berkshire, RG12 8YS,

United Kingdom

Ambroxol hydrochloride

Lysopadol Blackcurrant 20 mg Lozenges

20 mg

lozenge

oral use

Ireland

Boehringer Ingelheim Limited,

Ellesfield Avenue

Bracknell

Berkshire, RG12 8YS

United Kingdom

Bromohexine hydrochloride

Bisolvon 4 mg/5 ml Oral Solution

4 mg/5 ml

oral solution

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

30 mg

tablet

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

75 mg

prolonged-release capsule, hard

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan Bambini

30 mg

suppository

rectal use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

15 mg/5 ml

syrup

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

7,5 mg/ml

nebuliser solution

inhalation use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

60 mg

granules for oral solution

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8 20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Mucosolvan

15 mg

oral gum

oral use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron

30 mg

tablet

oral use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron

15 mg/5 ml

syrup

oral use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron

0,75 %

oral solution or nebuliser solution

oral use,

inhalation use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron Adulti

30 mg

granules for oral suspension

oral use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron Bambini

15 mg

granules for oral suspension

oral use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Chiesi Farmaceutici S.P.A.

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Fluibron Adulti

30 mg

effervescent tablet

oral use

Italy

Piam Farmaceutici S.P.A.

Via Padre Semeria, 5

16131 Genova

Italy

Ambroxol hydrochloride

Muciclar

15 mg/5 ml

syrup

oral use

Italy

Piam Farmaceutici S.P.A.

Via Padre Semeria, 5

16131 Genova

Italy

Ambroxol hydrochloride

Muciclar

75 mg

prolonged-release capsule

oral use

Italy

Piam Farmaceutici S.P.A.

Via Padre Semeria, 5

16131 Genova

Italy

Ambroxol hydrochloride

Muciclar

30 mg

granules for oral suspension

oral use

Italy

Piam Farmaceutici S.P.A.

Via Padre Semeria, 5

16131 Genova

Italy

Ambroxol hydrochloride

Muciclar

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Farmaceutici Caber S.P.A.

V. Le Citta' D'europa, 681

00100 Roma

Italy

Ambroxol hydrochloride

Secretil

15 mg/5 ml

syrup

oral use

Italy

Farmaceutici Caber S.P.A.

V. Le Citta' D'europa, 681

00100 Roma

Italy

Ambroxol hydrochloride

Secretil

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Farmaceutici Caber S.P.A.

V. Le Citta' D'europa, 681

00100 Roma

Italy

Ambroxol hydrochloride

Secretil

60 mg

granules for oral solution

oral use

Italy

Farmaceutici Caber S.P.A.

V. Le Citta' D'europa, 681

00100 Roma

Italy

Ambroxol hydrochloride

Secretil

30 mg/4 ml

nebuliser solution

inhalation use

Italy

Abc Farmaceutici S.P.A. Corso

V. Emanuele Ii, 72 10121

Torino

Italy

Ambroxol hydrochloride

Ambroxolo ABC

30 mg

tablet

oral use

Italy

Abc Farmaceutici S.P.A. Corso

V. Emanuele Ii, 72 10121

Torino

Italy

Ambroxol hydrochloride

Ambroxolo ABC

15 mg

nebuliser solution

inhalation use

Italy

Abc Farmaceutici S.P.A. Corso V. Emanuele Ii, 72 10121

Torino

Italy

Ambroxol hydrochloride

Ambroxolo ABC

30 mg

suppository

rectal use

Italy

Abc Farmaceutici S.P.A. Corso

V. Emanuele Ii, 72 10121

Torino

Italy

Ambroxol hydrochloride

Ambroxolo ABC

15 mg

granules for oral suspension

oral use

Italy

Abc Farmaceutici S.P.A. Corso V. Emanuele Ii, 72 10121

Torino

Italy

Ambroxol hydrochloride

Ambroxolo ABC

30 mg

granules for oral suspension

oral use

Italy

Laboratorio Farmaceutico Sit Specialita' Igienico

Terapeutiche S.R.L.,

Via Cavour, 70

Mede 27035 Pavia

Italy

Ambroxol hydrochloride

Tauxolo

3 mg/ml

syrup

oral use

Italy

S.F. Group S.R.L.

Via Beniamino Segre, 59

00134 Roma

Italy

Ambroxol hydrochloride

Broxol

15 mg/5 ml

syrup

oral use

Italy

S.F. Group S.R.L.

Via Beniamino Segre, 59 00134 Roma

Italy

Ambroxol hydrochloride

Broxol Adulti

30 mg

granules

oral use

Italy

S.F. Group S.R.L.

Via Beniamino Segre, 59

00134 Roma

Italy

Ambroxol hydrochloride

Broxol

0,75 %

nebuliser solution

inhalation use

Italy

Actavis Group Ptc Ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Ambroxol hydrochloride

Ambroxolo Actavis

0,30 %

syrup

oral use

Italy

Istituto Chimico

Internazionale Dr. Giuseppe

Rende S.R.L.

Via Salaria, 1240

00138 Roma

Italy

Ambroxol hydrochloride

Amobronc

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Istituto Chimico

Internazionale Dr. Giuseppe

Rende S.R.L.

Via Salaria, 1240

00138 Roma

Italy

Ambroxol hydrochloride

Amobronc

15 mg/5 ml

syrup

oral use

Italy

Boehringer Ingelheim Italia

S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Surfactal

1 g/50 ml

solution for infusion

intravenous use

Italy

Farmapro S.R.L.

Via Beato Sebastiano Valfre 4, 10121 Torino

Italy

Ambroxol hydrochloride

Ambroxolo Pharmentis

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Ratiopharm Gmbh

Graf-Arco Strasse 3

D-89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxolo Ratiopharm

30 mg/10 ml

syrup

oral use

Italy

Hexal S.P.A.

Largo Umberto Boccioni, 1

21040 Origgio Varese

Italy

Ambroxol hydrochloride

Ambroxolo Hexal

7,5 mg/ml

nebuliser solution

inhalation use

Italy

Hexal S.P.A.

Largo Umberto Boccioni, 1

21040 Origgio Varese

Italy

Ambroxol hydrochloride

Ambroxolo Hexal

3 mg/ml

syrup

oral use

Italy

A. Menarini Industrie Farmaceutiche Riunite S.R.L.

Via Sette Santi, 3

50131 Firenze

Italy

Ambroxol hydrochloride

Mucoaricodil

30 mg

tablet

oral use

Italy

A. Menarini Industrie Farmaceutiche Riunite S.R.L.

Via Sette Santi, 3

50131 Firenze

Italy

Ambroxol hydrochloride

Mucoaricodil

30 mg/10 ml

syrup

oral use

Italy

Teva Italia S.R.L.

Via Messina, 38

20154 Milano

Italy

Ambroxol hydrochloride

Ambroxol Dorom

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Alfa Wassermann S.P.A.

Via Enrico Fermi, 1

65020 Alanno — Pescara

Italy

Ambroxol hydrochloride

Lintos

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Alfa Wassermann S.P.A.

Via Enrico Fermi, 1

65020 Alanno — Pescara

Italy

Ambroxol hydrochloride

Lintos

30 mg/10 ml

syrup

oral use

Italy

Eg S.P.A.

Via Pavia 6

20136

Milano

Italy

Ambroxol hydrochloride

Ambroxolo EG

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Eg S.P.A.

Via Pavia 6

20136

Milano

Italy

Ambroxol hydrochloride

Ambroxolo EG

15 mg/5 ml

syrup

oral use

Italy

Eg S.P.A.

Via Pavia 6

20136

Milano

Italy

Ambroxol hydrochloride

Ambroxolo EG

30 mg/10 ml

syrup

oral use

Italy

Epifarma S.R.L

Via S. Rocco, 6

85033 Episcopia -Potenza Italy

Ambroxol hydrochloride

Ambrotus

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Epifarma S.R.L

Via S. Rocco, 6

85033 Episcopia -Potenza Italy

Ambroxol hydrochloride

Ambrotus

30 mg/10 ml

syrup

oral use

Italy

Farmakopea S.P.A.

Via Cavriana, 14

20134 Milano

Italy

Ambroxol hydrochloride

Gammaxol

15 mg/5 ml

syrup

oral use

Italy

Farmakopea S.P.A.

Via Cavriana, 14

20134 Milano

Italy

Ambroxol hydrochloride

Gammaxol

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Farmakopea S.P.A.

Via Cavriana, 14

20134 Milano

Italy

Ambroxol hydrochloride

Gammaxol

0,75 %

nebuliser solution

inhalation use

Italy

Union Health S.R.L.

Via Adige, 5

66020 San Giovanni Teatino — Chieti

Italy

Ambroxol hydrochloride

Ambroxol

3 mg/ml

syrup

oral use

Italy

Union Health S.R.L.

Via Adige, 5

66020 San Giovanni Teatino — Chieti

Italy

Ambroxol hydrochloride

Ambroxol

7,5 mg/ml

nebuliser solution

inhalation use

Italy

Union Health S.R.L.

Via Adige, 5

66020 San Giovanni Teatino — Chieti

Italy

Ambroxol hydrochloride

Ambroxol

0,75 %

nebuliser solution

inhalation use

Italy

Union Health S.R.L.

Via Adige, 5

66020 San Giovanni Teatino — Chieti

Italy

Ambroxol hydrochloride

Ambroxol

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Tecnigen S.R.L.

Via Galileo Galilei 40

20092 Cinisello Balsamo — Milano

Italy

Ambroxol hydrochloride

Ambroxol Tecnigen

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Tecnigen S.R.L.

Via Galileo Galilei 40

20092 Cinisello Balsamo — Milano

Italy

Ambroxol hydrochloride

Ambroxol Tecnigen

30 mg/10 ml

syrup

oral use

Italy

Procter & Gamble S.R.L.

Viale G. Ribotta, 11

00144 Roma

Italy

Ambroxol hydrochloride

Vicks tosse mucolitico

30 mg

effervescent tablet

oral use

Italy

Procter & Gamble S.R.L.

Viale G. Ribotta, 11

00144 Roma

Italy

Ambroxol hydrochloride

Vicks tosse mucolitico

30 mg

effervescent tablet

oral use

Italy

Almus S.R.L.

Via Cesarea, 11/10

16121 Genova

Italy

Ambroxol hydrochloride

Ambroxolo Almus

30 mg/10 ml

syrup

oral use

Italy

Almus S.R.L.

Via Cesarea, 11/10

16121 Genova

Italy

Ambroxol hydrochloride

Ambroxolo Almus

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Angenerico S.P.A.

Via Nocera Umbra, 75

00181 Roma

Italy

Ambroxol hydrochloride

Ambroxolo Angenerico

7,5 mg/ml

nebuliser solution

inhalation use

Italy

Angenerico S.P.A.

Via Nocera Umbra, 75

00181 Roma

Italy

Ambroxol hydrochloride

Ambroxolo Angenerico

3 mg/ml

syrup

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Ambroxol hydrochloride

Zerinol Gola menta

20 mg

tablet

oral use

Italy

Boehringer Ingelheim International Gmbh

Binger Strasse 173

D55216 Ingelheim Am Rhein Germany

Ambroxol hydrochloride

Zerinol Gola ribes nero

20 mg

tablet

oral use

Italy

Wellington Street Development Pharma Limited 47, Oaklands Drive Rathgar

Dublino 6

Ireland

Ambroxol hydrochloride

Brufix

0,75 %

nebuliser solution

inhalation use

Italy

Germed Pharma S.P.A.

Via Cantu', 11

20092 Cinisello Balsamo — Milano

Italy

Ambroxol hydrochloride

Ambroxolo Germed

15 mg/5 ml

syrup

oral use

Italy

Mylan S.P.A.

Via Vittor Pisani, 20

20124 Milano

Italy

Ambroxol hydrochloride

Ambroxolo Mylan Generics

15 mg/5 ml

syrup

oral use

Italy

Abc Farmaceutici S.P.A.

Corso V. Emanuele Ii, 72

10121 Torino

Italy

Ambroxol hydrochloride

Viscomucil

3 mg/ml

syrup

oral use

Italy

Cyathus Exquirere

Pharmaforschungsgmbh

Rudolfsplatz 2/1/8

1010 Vienna

Austria

Ambroxol hydrochloride

Mukambro

10 mg/erogazione

oral solution

oral use

Italy

Cyathus Exquirere

Pharmaforschungsgmbh

Rudolfsplatz 2/1/8

1010 Vienna

Austria

Ambroxol hydrochloride

Gogolox

10 mg/erogazione

oral solution

oral use

Italy

Boehringer Ingelheim Italia

S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

2 mg/ml

oral solution

oral use

Italy

Boehringer Ingelheim Italia

S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

8 mg

tablet

oral use

Italy

Boehringer Ingelheim Italia

S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

4 mg/2 ml

solution for injection

injection use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

4 mg/5 ml

syrup

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

8 mg

soluble tablet

oral use

Italy

Boehringer Ingelheim Italia S.P.A.

Via Lorenzini, 8

20139 Milano

Italy

Bromhexine hydrochloride

Bisolvon

8 mg/5 ml

syrup

oral use

Italy

Boots Pharmaceuticals S.R.L.

Via Cesarea 11/10

16121 Genova

Italy

Bromhexine hydrochloride

Nirolex tosse e catarro

4 mg/5 ml

syrup

oral use

Italy

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

Bromhexine hydrochloride

Flutoxil

4 mg/5 ml

syrup

oral use

Italy

Farmapro S.R.L.

Via Beato Sebastiano Valfre 4,

10121 Torino

Italy

Bromhexine hydrochloride

Bromexina Pharmentis

4 mg/5 ml

syrup

oral use

Italy

Germed Pharma S.P.A.

Via Cantu', 11

20092 Cinisello Balsamo — Milano

Italy

Bromhexine hydrochloride

Bromexina Germed

4 mg/5 ml

syrup

oral use

Italy

Laboratorio Farmaceutico Sit

Specialita' Igienico

Terapeutiche S.R.L.,

Via Cavour, 70

Mede 27035 Pavia

Italy

Bromhexine hydrochloride

Tauglicolo

40 mg

syrup

oral use

Italy

Laboratorio Farmaceutico Sit

Specialita' Igienico

Terapeutiche S.R.L.,

Via Cavour, 70

Mede 27035 Pavia

Italy

Bromhexine hydrochloride

Tauglicolo Adulti

6 mg

suppository

rectal use

Italy

Laboratorio Farmaceutico Sit

Specialita' Igienico

Terapeutiche S.R.L.,

Via Cavour, 70

Mede 27035 Pavia

Italy

Bromhexine hydrochloride

Tauglicolo Bambini

3 mg

suppository

rectal use

Italy

Laboratorio Farmaceutico Sit

Specialita' Igienico

Terapeutiche S.R.L.,

Via Cavour, 70

Mede 27035 Pavia

Italy

Bromhexine hydrochloride/sulphuguaiacol

Tauglicolo

4 mg +3,86 mg

solution for injection

injection use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

15 mg/5 ml

syrup

oral use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

15 mg/2 ml

nebuliser solution

inhalation use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

0,75 %

oral solution nebuliser solution

oral use

inhalation use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

30 mg

tablet

oral use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

15 mg

granules for suspension

oral use

Italy

Promedica Srl

Via Palermo, 26/A

43122 Parma

Italy

Ambroxol hydrochloride

Ventibron

30 mg

granules for suspension

oral use

Latvia

EGIS PHARMACEUTICALS

PLC., 1106 BUDAPEST,

Kereszturi ut 30-38,

Hungary

ambroxol hydrochloride

Halixol 15 mg/5 ml syrup

15 mg/5 ml

syrup

oral use

Latvia

EGIS PHARMACEUTICALS

PLC., 1106 BUDAPEST,

Kereszturi ut 30-38,

Hungary

ambroxol hydrochloride

Halixol 30 mg tablets

30 mg

tablet

oral use

Latvia

PRO.MED.CS Praha a.s.,

Telcska 1, 140 00 Praha 4,

Czech Republic

ambroxol hydrochloride

Ambrosan 30 mg tablets

30 mg

tablet

oral use

Latvia

G. L. Pharma GmbH,

Schlossplatz 1, 8502 Lannach,

Austria

ambroxol hydrochloride

Ambrolan 30 mg tablets

30 mg

tablet

oral use

Latvia

STIROLBIOFARM BALTIKUM

SIA, Rasas iela 5, Riga,

Latvia

ambroxol hydrochloride

Ambroksols Stirol 75 mg prolonged-release tablets

75 mg

prolonged-release tablet

oral use

Latvia

BERLIN-CHEMIE AG

(MENARINI GROUP),

Glienicker Weg 125,

12489 Berlin,

Germany

ambroxol hydrochloride

Flavamed 60 mg effervescent tablets

60 mg

effervescent tablet

oral use

Latvia

ratiopharm GmbH,

Graf-Arco-Str. 3,

89079 Ulm,

Germany

ambroxol hydrochloride

Brontex 3 mg/ml syrup

3 mg/ml

syrup

oral use

Latvia

ratiopharm GmbH,

Graf-Arco-Str. 3,

89079 Ulm,

Germany

ambroxol hydrochloride

Brontex 30 mg tablets

30 mg

tablet

oral use

Latvia

BERLIN-CHEMIE AG

(MENARINI GROUP),

Glienicker Weg 125,

12489 Berlin,

Germany

ambroxol hydrochloride

Flavamed 30 mg tablets

30 mg

tablet

oral use

Latvia

BERLIN-CHEMIE AG

(MENARINI GROUP),

Glienicker Weg 125,

12489 Berlin,

Germany

ambroxol hydrochloride

Tusmed 30 mg/5 ml oral solution

30 mg/5 ml

oral solution

oral use

Latvia

AS ‘Olainfarm’,

Rūpnīcu iela 5,

Olaine, 2114,

Latvia

ambroxol hydrochloride

Ambroksol 30 mg tablets

30 mg

tablet

oral use

Latvia

Sandoz d.d.,

Verovskova 57,

1000 Ljubljana,

Slovenia

ambroxol hydrochloride

Ambroxol Sandoz 15 mg/5 ml syrup

15 mg/5 ml

syrup

oral use

Latvia

Sandoz d.d.,

Verovskova 57,

1000 Ljubljana,

Slovenia

ambroxol hydrochloride

Ambroxol Sandoz 30 mg tablets

30 mg

tablet

oral use

Latvia

CYATHUS Exquirere

Pharmaforschungs GmbH,

Rudolfsplatz 2/1/8, 1010

Vienna,

Austria

ambroxol hydrochloride

Mukambro 10 mg/spray puff oral solution

10 mg/spray puff

oral solution

oral use

Latvia

BERLIN-CHEMIE AG (MENARINI GROUP), Glienicker Weg 125,

12489 Berlin,

Germany

ambroxol hydrochloride

Flavamed for children 15 mg/5 ml oral solution

15 mg/5 ml

oral solution

oral use

Latvia

Boehringer Ingelheim

International GmbH, Binger Strasse 173,

55216 Ingelheim am Rein,

Germany

ambroxol hydrochloride

Lasolvan 15 mg/5 ml syrup

15 mg/5 ml

syrup

oral use

Latvia

Divapharma GmbH, Motzener Str. 41,

12277 Berlin,

Germany

ambroxol hydrochloride

Neo-bronchol 15 mg lozenges

15 mg

lozenge

oral use

Latvia

SIA Briz,

Rasas iela 5,

Riga, 1057,

Latvia

ambroxol hydrochloride

Ambroxol — BCPP 30 mg tablets

30 mg

tablet

oral use

Latvia

BERLIN-CHEMIE AG (MENARINI GROUP), Glienicker Weg 125,

12489 Berlin,

Germany

ambroxol hydrochloride

Flavamed 30 mg/5 ml oral solution

30 mg/5 ml

oral solution

oral use

Latvia

Actavis Nordic A/S, Ornegardsvej 16,

2820 Gentofte,

Denmark

bromhexine hydrochloride

Bromhexin Actavis 8 mg tablets

8 mg

tablet

oral use

Latvia

SIA Briz,

Rasas iela 5,

Riga,

1057,

Latvia

bromhexine hydrochloride

Bromhexin Sopharma 8 mg tablets

8 mg

tablet

oral use

Latvia

AS GRINDEKS.

Krustpils, 53,

Riga, 1057,

Latvia

bromhexine hydrochloride

Bromhexine-Grindeks 4 mg tabletes

4 mg

tablet

oral use

Latvia

AS GRINDEKS.

Krustpils, 53,

Riga, 1057,

Latvia

bromhexine hydrochloride

Bromhexine-Grindeks 8 mg tabletes

8 mg

tablet

oral use

Latvia

AS GRINDEKS.

Krustpils, 53,

Riga, 1057,

Latvia

bromhexine hydrochloride

Bromhexine-Grindeks 4 mg/5 ml syrup

4 mg/5 ml

syrup

oral use

Latvia

SIA Briz,

Rasas iela 5,

Riga, 1057,

Latvia

bromhexine hydrochloride

Bromhexin Sopharma 4 mg/5 ml syrup

4 mg/5 ml

syrup

oral use

Lithuania

CYATHUS Exquirere

Pharmaforschungs GmbH

Rudolfsplatz 2/1/8

1010 Vienna

Austria

Ambroxol hydrochloride

AMBROSPRAY

10 mg/0,2 ml

oral solution

oral use

Lithuania

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

Ambroxol hydrochloride

Ambrolan

30 mg

tablet

oral use

Lithuania

PRO.MED.CS Praha a.s.

Telčska 1140 00 Praha,

Czech Republic

Ambroxol hydrochloride

Ambrosan

30 mg

tablet

oral use

Lithuania

Sandoz d.d.

Verovškova 57,

1000 Ljubljana

Slovenia

Ambroxol hydrochloride

Ambroxol Sandoz

30 mg

tablet

oral use

Lithuania

Sandoz d.d.

Verovškova 57,

1000 Ljubljana

Slovenia

Ambroxol hydrochloride

Ambroxol Sandoz

15 mg/5 ml

syrup

oral use

Lithuania

ratiopharm GmbH

Graf — Arco — Str. 3

89079 Ulm,

Germany

Ambroxol hydrochloride

Brontex

30 mg

tablet

oral use

Lithuania

ratiopharm GmbH

Graf — Arco — Str. 3

89079 Ulm,

Germany

Ambroxol hydrochloride

Brontex

7,5 mg/ml

oral drops, solution

oral use

Lithuania

ratiopharm GmbH

Graf — Arco — Str. 3

89079 Ulm,

Germany

Ambroxol hydrochloride

Brontex

15 mg/5 ml

syrup

oral use

Lithuania

BERLIN-CHEMIE AG (MENARINI GROUP)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

30 mg

tablet

oral use

Lithuania

BERLIN-CHEMIE AG (MENARINI GROUP)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

60 mg

effervescent tablet

oral use

Lithuania

BERLIN-CHEMIE AG (MENARINI GROUP)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

30 mg/5 ml

oral solution

oral use

Lithuania

BERLIN-CHEMIE AG (MENARINI GROUP)

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

15 mg/5 ml

oral solution

oral use

Lithuania

EGIS PHARMACEUTICALS PLC

1106 Budapest

Keresztúri út 30-38

Hungary

Ambroxol hydrochloride

Halixol

15 mg/5 ml

syrup

oral use

Lithuania

EGIS PHARMACEUTICALS PLC

1106 Budapest

Keresztúri út 30-38

Hungary

Ambroxol hydrochloride

Halixol

30 mg

tablet

oral use

Lithuania

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Lasolvan

15 mg/5 ml

syrup

oral use

Lithuania

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Lasolvan

15 mg/2 ml

inhalation vapour, solution

oral use

Lithuania

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Lasolvan

30 mg

tablet

oral use

Lithuania

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Lasolvan

75 mg

prolonged-release capsule, hard

oral use

Lithuania

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Tussisol

30 mg/5 ml

oral solution

oral use

Lithuania

Divapharma GmbH

Motzener Str. 41

12277 Berlin

Germany

Ambroxol hydrochloride

neo-bronchol

15 mg

lozenge

oral use

Lithuania

AS GRINDEKS

Krustpils 53

Rīga 1057

Latvia

Bromhexine hydrochloride

BROMHEXINE-GRINDEKS

4 mg/5 ml

syrup

oral use

Lithuania

AS GRINDEKS

Krustpils 53

Rīga 1057

Latvia

Bromhexine hydrochloride

BROMHEXINE-GRINDEKS

4 mg

tablet

oral use

Lithuania

AS GRINDEKS

Krustpils 53

Rīga 1057

Latvia

Bromhexine hydrochloride

BROMHEXINE-GRINDEKS

8 mg

tablet

oral use

Lithuania

Actavis Nordic A/S

Ørnegårdsvej 16,

2820 Gentofte

Denmark

Bromhexine hydrochloride

Bromhexin Actavis

8 mg

tablet

oral use

Lithuania

BERLIN-CHEMIE AG (MENARINI GROUP)

Glienicker Weg 125

12489 Berlin

Germany

Bromhexine hydrochloride

Bromhexin Berlin-Chemie

8 mg

coated tablet

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Bisolvon

8 mg

tablet

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Bisolvon

8 mg/5 ml

syrup

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Bisolvon

0,20 %

oral solution

oral use

Luxembourg

Eurogenerics

Heizel Esplanade b22

1020 Brussel

Belgium

Bromhexine chlorhydrate

Bromhexine EG

8 mg

tablet

oral use

Luxembourg

D.J.VAN TINTELEN BEHEER B.V.

Keyserwey 20

2201 CW Noordwijk Zh

The Netherlands

Bromhexine chlorhydrate

Bronchi-Mereprine

8 mg

tablet

oral use

Luxembourg

Qualiphar Laboratoire

Rijksweg 9

2880 Bornem

Belgium

Bromhexine chlorhydrate

Toularynx Bromhexine

5 mg/5 ml

syrup

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Ambroxine

20 mg

lozenge

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Mucoangin Citron 20 mg

20 mg

lozenge

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Mucoangine Cassis

20 mg

lozenge

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Bromhexine chlorhydrate

Mucoangine Menthe

20 mg

lozenge

oral use

Luxembourg

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal Hustenlöser

30 mg

tablet

oral use

Luxembourg

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal Hustentropfen

7,5 mg/ml

oral drops, solution

oral use

Luxembourg

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal Hustensaft für Kinder

15 mg/5 ml

oral solution

oral use

Luxembourg

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambroxhexal Hustenlöser retard

75 mg

prolonged-release capsule, hard

oral use

Luxembourg

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Ambroxol hydrochloride

Ambrohexal S Brausetablette

60 mg

effervescent tablet

oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 30 mg Hustenlöser

30 mg

tablet

oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 75 mg Hustenlöser

75 mg

prolonged-release capsule, hard

oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm Hustensaft

15 mg/5 ml

oral solution

oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm Hustentropfen

7,5 mg/ml

oral drops, solution

oral use

Luxembourg

ratiopharm GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Ambroxol hydrochloride

Ambroxol-ratiopharm 15 mg/2 ml Injektionslösung

15 mg/2 ml

solution for injection

intravenous use

Luxembourg

Biocodex

Avenue Gallieni 7

94250 Gentilly

France

Ambroxol hydrochloride

Muxol

30 mg

tablet

oral use

Luxembourg

Biocodex

Avenue Gallieni 7

94250 Gentilly

France

Ambroxol hydrochloride

Muxol

3 mg/ml

oral solution

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Ambroxol hydrochloride

Surbronc

60 mg

coated tablet

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Ambroxol hydrochloride

Surbronc

30 mg/5 ml

syrup

oral use

Luxembourg

SCS Boehringer Ingelheim Comm. V.

Vesalius Science Park

Avenue Ariane 16

1200 Bruxelles

Belgium

Ambroxol hydrochloride

Surbronc

60 mg/3 g

powder for oral solution

oral use

Malta

Medochemie Ltd.

1-10 Constantinoupoleos Street, 3011, P.O. Box 51409,

3505 Limassol,

Cyprus

Ambroxol Hydrochloride

Medovent Elixir Syrup 15 mg/5 ml

15 mg/5 ml

oral solution

oral use

Malta

Mundipharma Pharmaceuticals Ltd.

13 Othellos Street, Dhali

Industrial Zone, Nicosia,

Cyprus

Ambroxol Hyrdochloride

Mucobroxol Syrup

15 mg/5 ml

syrup

oral use

Malta

Actavis EAD

29, Atanas Dukov Street, Sofia 1407

Bulgaria

Ambroxol Hydrochloride

MUCOLISIN 30 mg/5 ml syrup

30 mg/5 ml

syrup

oral use

Malta

Aflofarm Farmacja Polska SP. zo. o.

ul. Partyzancka 133/151 95-200 Pabianice,

Poland

Ambroxol Hydrochloride

Entus Max 30 mg/5 ml syrup

30 mg/5 ml

syrup

oral use

Malta

PIAM Farmaceutici S.P.A.

Via Padre G. Semeria, 5, I-16131, Genoa,

Italy

Ambroxol Hydrochloride

Muciclar

3 mg/ml

syrup

oral use

Malta

PIAM Farmaceutici S.P.A.

Via Padre G. Semeria, 5, I-16131, Genoa,

Italy

Ambroxol Hydrochloride

Muciclar

75 mg

modified release capsule

oral use

Malta

Boehringer Ingelheim Ellas A.E.

Ellinikou 2, 167 77 Elliniko, Athens,

Greece

Ambroxol Hydrochloride (Cyclohexanol Hydrochloride)

Mucosolvan

15 mg/5 ml

syrup

oral use

Malta

Boehringer Ingelheim Ellas A.E.

Ellinikou 2, 167 77 Elliniko, Athens,

Greece

Ambroxol Hydrochloride (Cyclohexanol Hydrochloride)

Mucosolvan

30 mg

tablet

oral use

Malta

Sopharma PLC

16, Iliensko Shosse Str.

1220 Sofia,

Bulgaria

Bromhexine hydrochloride

BROMHEXINE SOPHARMA 4 mg/5 ml syrup

4 mg/5 ml

syrup

oral use

Malta

Adelco-Chromatourgia Anthinon E. Colocotronis Bros S.A.

37 Pireos Str, 183 46, Moschato, Athens,

Greece

Bromhexine Hydrochloride

Bronchotussine

4 mg/5 ml

syrup

oral use

Malta

Boehringer Ingelheim Limited

Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS,

United Kingdom

Bromhexine Hydrochloride

Bisolvon 4 mg/5 ml Oral Solution

4 mg/5 ml

oral solution

oral use

Malta

Remedica Ltd.

Limassol Industrial Estate,

Aharnon Street, P.O. Box

51706, 3508 Limassol, Cyprus

Bromhexine Hydrochloride BP

Flecoxin 8 Tablets

8 mg

tablet

oral use

Norway

AS Den norske Eterfabrikk, Karihaugveien 22, 1086 Oslo,

Norway

Bromhexine hydrochloride

Bromhexine DnE

1,6 mg/ml

oral solution

oral use

Norway

AS Den norske Eterfabrikk, Karihaugveien 22, 1086 Oslo,

Norway

Bromhexine hydrochloride

Bromhexine DnE

0,8 mg/ml

oral solution

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216

Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

0,8 mg/ml

oral solution

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216

Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

1,6 mg/ml

oral solution

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216 Ingelheim am Rhein, Germany

Bromhexine hydrochloride

Bisolvon

0,8 mg/ml

oral solution

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216

Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

1,6 mg/ml

oral solution

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216

Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

8 mg

tablet

oral use

Norway

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55 216

Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

8 mg

soluble tablet

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice,

170 00

Czech Republic

Ambroxol hydrochloride

Aflegan

7,5 mg/ml

solution for injection

intravenous use

Poland

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Ambroxol hydrochloride

Ambrohexal

7,5 mg/ml

solution for injection

intravenous use, intramuscular use, subcutaneous use

Poland

Takeda Pharma Sp. z o.o.

Al. Jerozolimskie 146 A

02-305 Warszawa

Poland

Ambroxol hydrochloride

Ambroksol Takeda

15 mg/5 ml

syrup

oral use

Poland

Takeda Pharma Sp. z o.o.

Al. Jerozolimskie 146 A

02-305 Warszawa

Poland

Ambroxol hydrochloride

Ambroksol Takeda

30 mg/5 ml

syrup

oral use

Poland

PRO.MED.CS. Praha a.s.

Telcska 1

Praha 4

140 00

Czech Republic

Ambroxol hydrochloride

Ambrosan

30 mg

tablet

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambrosol Teva

15 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambrosol Teva

30 mg

tablet

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambrosol Teva

30 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambrosolvan

15 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambrosolvan

30 mg/5 ml

syrup

oral use

Poland

Sopharma Warszawa Sp. z o.o.

ul. Ostrobramska 91

04-118 Warszawa

Poland

Ambroxol hydrochloride

Ambrotaxer

15 mg/5 ml

syrup

oral use

Poland

123ratio Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambroxol 123ratio

3 mg/ml

oral solution

oral use

Poland

123ratio Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Ambroxol hydrochloride

Ambroxol 123ratio

6 mg/ml

oral solution

oral use

Poland

Cyathus Exquirere Pharmaforschungs GmbH

Rudolfsplatz 2/1/8

1010 Wienn

Austria

Ambroxol hydrochloride

Ambroxol hydrochloride Cyathus

10 mg/dawkę

oral solution

oral use

Poland

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Ambroxoli hydrochloridum Fontane

15 mg/5 ml

oral solution

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice,

170 00

Czech Republic

Ambroxol hydrochloride

Deflegmin

7,5 mg/ml

oral drops, solution

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice

17000

Czech Republic

Ambroxol hydrochloride

Deflegmin

30 mg

tablet

oral use

Poland

ICN Polfa Rzeszów S.A.

ul. Przemysłowa 2

35-959 Rzeszów

Poland

Ambroxol hydrochloride

Deflegmin

30 mg/5 ml

syrup

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice,

17000

Czech Republic

Ambroxol hydrochloride

Deflegmin

75 mg

prolonged-release capsule

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice,

17000

Czech Republic

Ambroxol hydrochloride

Deflegmin

15 mg/5 ml

syrup

oral use

Poland

PharmaSwiss Ceska Republika s.r.o.

Jankovcova 1569/2c

Praha 7

Holesovice,

17000

Czech Republic

Ambroxol hydrochloride

Deflegmin

10 mg/ml

oral solution

oral use

Poland

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Poland

Ambroxol hydrochloride

Entus Junior

15 mg/5 ml

syrup

oral use

Poland

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Poland

Ambroxol hydrochloride

Entus Max

30 mg/5 ml

syrup

oral use

Poland

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Poland

Ambroxol hydrochloride

Envil kaszel

30 mg/5 ml

syrup

oral use

Poland

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Poland

Ambroxol hydrochloride

Envil kaszel

30 mg

tablet

oral use

Poland

Aflofarm Farmacja Polska Sp. z o.o.

ul. Partyzancka 133/151

95-200 Pabianice

Poland

Ambroxol hydrochloride

Envil kaszel junior

15 mg/5 ml

syrup

oral use

Poland

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

15 mg/5 ml

syrup

oral use

Poland

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

30 mg

tablet

oral use

Poland

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed

60 mg

effervescent tablet

oral use

Poland

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

Ambroxol hydrochloride

Flavamed max

30 mg/5 ml

oral solution

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina

8 mg

tablet

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina Baby

2 mg/ml

oral drops, solution

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina o smaku malinowym

4 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina o smaku miętowym

4 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina o smaku miętowym bez cukru

4 mg/5 ml

syrup

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Wsrszawa

Poland

Bromhexine hydrochloride

Flegamina o smaku truskawkowym

2 mg/5 ml

syrup

oral use

Poland

Herbapol — Lublin S.A.

ul. Diamentowa 25

20-471 Lublin

Poland

Bromhexine hydrochloride Extractum fluidum aquosum ex Plantaginis lanceolatae folii et Verbasci floribus

Flegatussin

(0,0026 g +2,35 g)/5 ml

syrup

oral use

Poland

Zentiva, k.s.

U kabelovny 130

Praga 10,

10237 Dolni Mecholupy

Czech Republic

Ambroxol hydrochloride

MEDOX

15 mg/5 ml

syrup

oral use

Poland

Zentiva, k.s.

U kabelovny 130

Praga 10,

10237 Dolni Mecholupy

Czech Republic

Ambroxol hydrochloride

Medox

30 mg

tablet

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucoangin

20 mg

chewable tablet

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

30 mg

tablet

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan

15 mg

pastille

oral use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan inhalacje

15 mg/2 ml

nebuliser liquid

inhalation use

Poland

Boehringer Ingelheim International GmbH

Binger Str 173

55216 Ingelheim am Rhein

Germany

Ambroxol hydrochloride

Mucosolvan mini

15 mg/5 ml

syrup

oral use

Poland

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Poland

Ambroxol hydrochloride

Tussal Expectorans

30 mg

tablet

oral use

Portugal

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Edifícios Azevedos — Estrada Nacional 117-2, Alfragide

2614-503 Amadora

Portugal

Ambroxol

Ambroxol Tussilene

6 mg/ml

syrup

oral use

Portugal

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 — Bloco 2, 3o F — Edifício Neopark

2790-221 Carnaxide

Portugal

Ambroxol

Ambroxol Cinfa 3 mg/ml Xarope

3 mg/ml

syrup

oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Ambroxol Farmoz 15 mg/5 ml Xarope

3 mg/ml

syrup

oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Ambroxol Farmoz 30 mg Comprimidos

30 mg

tablet

oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Ambroxol Farmoz 30 mg/5 ml Xarope

6 mg/ml

syrup

oral use

Portugal

Baldacci — Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

Ambroxol

Ambroxol Fluidox 30 mg Comprimidos

30 mg

tablet

oral use

Portugal

Baldacci — Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

Ambroxol

Ambroxol Fluidox 6 mg/ml Xarope

6 mg/ml

syrup

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Ambroxol

Ambroxol Generis 3 mg/ml Xarope

3 mg/ml

syrup

oral use

Portugal

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Ambroxol

Ambroxol Germed 3 mg/ml Xarope

3 mg/ml

syrup

oral use

Portugal

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Ambroxol

Ambroxol Germed 6 mg/ml Xarope

6 mg/ml

syrup

oral use

Portugal

Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.

Lagoas Park, Edifício 5 A, Piso 2

2740-245 Porto Salvo

Portugal

Ambroxol

Ambroxol Ratiopharm

6 mg/ml

oral solution

oral use

Portugal

Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.

Lagoas Park, Edifício 5 A, Piso 2

2740-245 Porto Salvo

Portugal

Ambroxol

Ambroxol Ratiopharm

3 mg/ml

oral solution

oral use

Portugal

Sandoz Farmacêutica, Lda.

Avenida Professor Doutor Cavaco Silva, 10E — Taguspark

2740-255 Porto Salvo

Portugal

Ambroxol

Ambroxol Sandoz

6 mg/ml

syrup

oral use

Portugal

Laboratórios Atral, S.A.

Rua da Estação, 42 — Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

Ambroxol

Benflux

30 mg

tablet

oral use

Portugal

Laboratórios Atral, S.A.

Rua da Estação, 42 — Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

Ambroxol

Benflux

3 mg/ml

syrup

oral use

Portugal

Laboratórios Atral, S.A.

Rua da Estação, 42 — Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

Ambroxol

Benflux Forte

6 mg/ml

syrup

oral use

Portugal

Farma 1000 — Prod. Farmacêuticos, Lda.

Avenida Mestre Cid, 8 — 1o Esq. Frente

2070-012 Cartaxo

Portugal

Ambroxol

Bromax

120 mg

prolonged-release capsule, hard

oral use

Portugal

Farma 1000 — Prod. Farmacêuticos, Lda.

Avenida Mestre Cid, 8 — 1o Esq. Frente

2070-012 Cartaxo

Portugal

Ambroxol

Bromax

30 mg

tablet

oral use

Portugal

Farma 1000 — Prod. Farmacêuticos, Lda.

Avenida Mestre Cid, 8 — 1o Esq. Frente

2070-012 Cartaxo

Portugal

Ambroxol

Bromax

6 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Broncoliber

30 mg

tablet

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Broncoliber

3 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Broncoliber

6 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Broncoliber

120 mg

prolonged-release capsule, hard

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol

Broncoliber

50 mg/ml

oral solution

oral use

Portugal

Laboratórios Basi — Indústria Farmacêutica, S.A

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Ambroxol

Broncosil

6 mg/ml

syrup

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Ambroxol

Bronxol

30 mg

tablet

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Ambroxol

Bronxol

6 mg/ml

syrup

oral use

Portugal

Pentafarma — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Clembroxol

3 mg/ml + 0,002 mg/ml

syrup

oral use

Portugal

Pentafarma — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Clembroxol

30 mg + 0,02 mg

tablet

oral use

Portugal

Pentafarma — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Clembroxol

1,5 mg/ml + 0,001 mg/ml

syrup

oral use

Portugal

Pentafarma — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Clembroxol

30 mg + 0,02 mg

granules

oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 — Venda Nova

2700-327 Amadora

Portugal

Ambroxol

Drenoxol

30 mg

tablet

oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 — Venda Nova

2700-327 Amadora

Portugal

Ambroxol

Drenoxol

30 mg/10 ml

syrup

oral use

Portugal

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 — Venda Nova

2700-327 Amadora

Portugal

Ambroxol

Drenoxol

3 mg/ml

syrup

oral use

Portugal

Sofex Farmacêutica, Lda.

Rua Sebastião e Silva, 25

2745-838 Massamá

Portugal

Ambroxol

Fluidrenol

6 mg/ml

syrup

oral use

Portugal

Sofex Farmacêutica, Lda.

Rua Sebastião e Silva, 25

2745-838 Massamá

Portugal

Ambroxol

Fluidrenol

30 mg

tablet

oral use

Portugal

Distrifarma — Companhia de Distribuição Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 80 — Lt. 3 — Armz. 1/12 — Queluz de Baixo

2745-553 Barcarena

Portugal

Ambroxol

Lactucol

6 mg/ml

syrup

oral use

Portugal

Medinfar Consumer Health — Produtos Farmacêuticos, Lda.

Rua Henrique Paiva Couceiro, 27 — Venda Nova

2700-451 Amadora

Portugal

Ambroxol

Mucodrenol

6 mg/ml

syrup

oral use

Portugal

Medinfar Consumer Health — Produtos Farmacêuticos, Lda.

Rua Henrique Paiva Couceiro, 27 — Venda Nova

2700-451 Amadora

Portugal

Ambroxol

Mucodrenol

30 mg/5 ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan

15 mg/2 ml

solution for injection

intravenous use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan

30 mg/5 ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan

6 mg/ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan

15 mg

pastille

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan

30 mg

tablet

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol

Mucosolvan Perlonguets

75 mg

prolonged-release capsule, hard

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol + Clenbuterol

Mucospas

3 mg/ml + 0,002 mg/ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Ambroxol + Clenbuterol

Mucospas

1,5 mg/ml + 0,001 mg/ml

syrup

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Ambroxol

Mucotosse

6 mg/ml

syrup

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Ambroxol

Mucotosse

30 mg

tablet

oral use

Portugal

Sociedade Farmacêutica Gestafarma, Lda.

Rua Aquilino Ribeiro, 6-A

2790-027 Carnaxide

Portugal

Ambroxol

Spectorum Expectorante

6 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Ventoliber

1,5 mg/ml + 0,001 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Ventoliber

3 mg/ml + 0,002 mg/ml

syrup

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Ventoliber

30 mg + 0,02 mg

granules

oral use

Portugal

Tecnimede — Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 — Abrunheira

2710-089 Sintra

Portugal

Ambroxol + Clenbuterol

Ventoliber

30 mg + 0,02 mg

tablet

oral use

Portugal

Laboratórios Basi — Indústria Farmacêutica, S.A

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Bromhexine

Basiflux

0,8 mg/ml

syrup

oral use

Portugal

Laboratórios Basi — Indústria Farmacêutica, S.A

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Bromhexine

Basiflux

1,6 mg/ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon

8 mg

tablet

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon

8 mg/5 ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon

8 mg

dispersible tablet

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon

2 mg/ml

oral solution

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon Linctus Adulto

1,6 mg/ml

syrup

oral use

Portugal

Unilfarma — União Internacional Laboratórios Farmacêuticos, Lda.

Avenida de Pádua, 11

1800-294 Lisboa

Portugal

Bromhexine

Bisolvon Linctus Criança

0,8 mg/ml

syrup

oral use

Portugal

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Edifícios Azevedos — Estrada Nacional 117-2, Alfragide

2614-503 Amadora

Portugal

Bromhexine

Bromexina Tussilene

0,8 mg/ml

syrup

oral use

Portugal

Bluepharma Genéricos — Comércio de Medicamentos, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Bromhexine

Bromexina Bluepharma

1,6 mg/ml

syrup

oral use

Portugal

Bluepharma Genéricos — Comércio de Medicamentos, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Bromhexine

Bromexina Bluepharma

0,8 mg/ml

syrup

oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Bromhexine

Bromexina Farmoz

1,6 mg/ml

syrup

oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2, Abrunheira

2710-089 Sintra

Portugal

Bromhexine

Bromexina Farmoz

0,8 mg/ml

syrup

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Bromhexine

Bromexina Generis

0,8 mg/ml

syrup

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Bromhexine

Bromexina Generis

1,6 mg/ml

syrup

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Bromhexine

Bromexina Wynn

1,6 mg/ml

syrup

oral use

Portugal

Labialfarma — Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.

Edifício Labialfarma, 1 — Felgueira

3450-336 Sobral — Mortágua

Portugal

Bromhexine

Bromexina Wynn

0,8 mg/ml

syrup

oral use

Portugal

Caldeira & Metelo, Lda.

Estrada de Paço de Arcos, 88 — Cacém Park, Armazém 27

2735-307 Agualva-Cacém

Portugal

Bromhexine

Bromocal

0,8 mg/ml

syrup

oral use

Portugal

Laboratórios Atral, S.A.

Rua da Estação, 42 — Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

Bromhexine

Lisomucin

2 mg/ml

oral drops, solution

oral use

Portugal

Laboratórios Atral, S.A.

Rua da Estação, 42 — Vala do Carregado

2600-726 Castanheira do Ribatejo

Portugal

Bromhexine

Lisomucin

1,6 mg/ml

syrup

oral use

Portugal

Medinfar Consumer Health — Produtos Farmacêuticos, Lda.

Rua Henrique Paiva Couceiro, 27 — Venda Nova

2700-451 Amadora

Portugal

Bromhexine

Tosseque

0,8 mg/ml

syrup

oral use

Romania

BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein, Germany

ambroxol hydrochloride

MUCOSOLVAN JUNIOR 15 mg/5 ml

15 mg/5 ml

syrup

oral use

Romania

BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,

Germany

ambroxol hydrochloride

MUCOSOLVAN 30 mg/5 ml

30 mg/5 ml

syrup

oral use

Romania

BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,

Germany

ambroxol hydrochloride

MUCOSOLVAN 30 mg

30 mg

tablet

oral use

Romania

BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,

Germany

ambroxol hydrochloride

MUCOSOLVAN MAX

75 mg

prolonged-release capsule, hard

oral use

Romania

BOEHRINGER INGELHEIM INTERNATIONAL GmbH Binger Strasse 173, D-55 216 Ingelheim am Rhein,

Germany

ambroxol hydrochloride

MUCOSOLVAN 15 mg gumă orală

15 mg

oral gum

oral use

Romania

ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,

Germany

ambroxol hydrochloride

AMBROXOL AL 15 mg/5 ml

15 mg/5 ml

syrup

oral use

Romania

ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,

Germany

ambroxol hydrochloride

AMBROXOL AL 7,5 mg/ml

7,5 mg/ml

oral drops, solution

oral use

Romania

ALIUD PHARMA GmbH & Co. KG Gottlieb-Daimler-Straβe 19, 89150 Laichingen,

Germany

ambroxol hydrochloride

AMBROXOL AL 30 mg

30 mg

tablet

oral use

Romania

S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr. 31, Sector 2, Bucureşti, cod postal 024022,

Romania

ambroxol hydrochloride

AMBROXOL ARENA 30 mg

30 mg

tablet

oral use

Romania

Zentiva, k.s.

U kabelovny 130

Dolni Mėcholupy

102 37 Praha 10

Czech Republic

ambroxol hydrochloride

MUCOSIN CU MIERE sirop, 15 mg/5 ml

15 mg/5 ml

syrup

oral use

Romania

Zentiva, a.s.

Einsteinova 24

851 01, Bratislava

Slovak Republic

ambroxol hydrochloride

MUCOSIN 30 mg comprimate

30 mg

tablet

oral use

Romania

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

ambroxol hydrochloride

AMBROXOL SANDOZ comprimate, 30 mg

30 mg

tablet

oral use

Romania

HEXAL AG,

Industriestrasse 25,

D-83607 Holzkirchen,

Germany

ambroxol hydrochloride

AMBROXOL SANDOZ SIROP

3 mg/ml

syrup

oral use

Romania

BERLIN-CHEMIE AG (Menarini Group)

Glienicker Weg 125

D-12489 Berlin,

Germany

ambroxol hydrochloride

FLAVAMED 60 mg

60 mg

effervescent tablet

oral use

Romania

BERLIN-CHEMIE AG (Menarini Group)

Glienicker Weg 125

D-12489 Berlin,

Germany

ambroxol hydrochloride

FLAVAMED 30 mg

30 mg

tablet

oral use

Romania

BERLIN-CHEMIE AG (Menarini Group)

Glienicker Weg 125

D-12489 Berlin,

Germany

ambroxol hydrochloride

FLAVAMED 30 mg/5 ml soluţie orală

30 mg/5 ml

oral solution

oral use

Romania

BERLIN-CHEMIE AG (Menarini Group)

Glienicker Weg 125

D-12489 Berlin,

Germany

ambroxol hydrochloride

FLAVAMED 15 mg/5 ml

15 mg/5 ml

oral solution

oral use

Romania

VIM SPECTRUM SRL, ROMANIA

Şos. Sighişoarei nr. 409,

Târgu Mureş (Corunca),

Romania

ambroxol hydrochloride

AMBROXOL 30 mg

30 mg

tablet

oral use

Romania

Egis Pharmaceuticals Plc

Kereszturi ut 30-38

Budapest

H-1106

Hungary

ambroxol hydrochloride

AMBROXOL EGIS sirop, 3 mg/ml

3 mg/ml

syrup

oral use

Romania

Egis Pharmaceuticals Plc

Kereszturi ut 30-38

Budapest

H-1106

Hungary

ambroxol hydrochloride

AMBROXOL EGIS, comprimate, 30 mg

30 mg

tablet

oral use

Romania

GEDEON RICHTER ROMÂNIA S.A., ROMANIA

Str. Cuza-Vodă nr. 99-105,

Târgu Mureş,

Romania

ambroxol hydrochloride

AMBROXOL 30 mg/5 ml

30 mg/5 ml

syrup

oral use

Romania

GEDEON RICHTER ROMÂNIA S.A., ROMANIA

Str. Cuza-Vodă nr. 99-105,

Târgu Mureş,

Romania

ambroxol hydrochloride

AMBROXOL RICHTER 30 mg

30 mg

tablet

oral use

Romania

TIS FARMACEUTIC SA, Sos. Industriilor nr. 16

Sector 3, Bucuresti,

Romania

ambroxol hydrochloride

AMBROXOL 0,3 % soluţie orală

0,30 %

oral solution

oral use

Romania

TIS FARMACEUTIC SA, Sos. Industriilor nr. 16

Sector 3, Bucuresti,

Romania

ambroxol hydrochloride

AMBROXOL 0,75 % picaturi orale soluţie

0,75 %

oral drops, solution

oral use

Romania

CYATHUS EXQUIRERE PharmaforschungsGmbH

Rudolfsplatz 2/1/8 A-1010

Viena,

Austria

ambroxol hydrochloride

AMBROSPRAY

10 mg/pulverizare

oromucosal spray

oral use

Romania

BIOFARM S.A.,

Str.Logofat Tautu Nr. 99

Sector 3, Bucureşti

031212

Romania

ambroxol hydrochloride

AMBROXOL BIOFARM 15 mg/5 ml, sirop

15 mg/5 ml

syrup

oral use

Romania

Farmaceutica REMEDIA S.A. Blv. Metalurgiei nr. 78, sector 4, 041836 Bucureşti,

Romania

ambroxol hydrochloride

Neo-bronchol 15 mg pastile

15 mg

lozenge

oral use

Romania

ROMPHARM COMPANY SRL, Str. Eroilor, 1A, Otopeni,

Romania

ambroxol hydrochloride

AMBROXOL ROMPHARM 15 mg/5 ml, sirop

15 mg/5 ml

oral solution

oral use

Romania

LAROPHARM SRL,

Sos. Alexandriei 145 A,

B07 Bragadiru,

Judetul Ilfov,

Romania

ambroxol hydrochloride

AMBROXOL LAROPHARM 30 mg, comprimate

30 mg

tablet

oral use

Romania

LAROPHARM SRL,

Sos. Alexandriei 145 A,

B07 Bragadiru,

Judetul Ilfov,

Romania

ambroxol hydrochloride

AMBROXOL LAROPHARM 15 mg/5 ml soluţie orală

15 mg/5 ml

oral solution

oral use

Romania

SOLACIUM PHARMA S.R.L., str. Calea Rahovei nr. 266-268, corp. 60, axele A-B,

stalpii 11-16, etaj II, birou 1, sector 5, Bucuresti

Romania

bromhexine hydrochloride

BROMHEXIN SOLACIUM 8 mg

8 mg

tablet

oral use

Romania

LAROPHARM SRL,

Sos. Alexandriei 145 A,

B07 Bragadiru,

Judetul Ilfov,

Romania

bromhexine hydrochloride

BRONHOSOLV

10 mg/5 ml

10 mg/5 ml

oral solution

oral use

Romania

LABORMED PHARMA S.A.

Adresa: Bd. Theodor Pallady

nr. 44B, sector 3, Bucuresti

032266

Romania

bromhexine hydrochloride

BROMHEXIN LABORMED 8 mg

8 mg

tablet

oral use

Romania

MAGISTRA C & C, Bd. Aurel Vlaicu nr. 82A, 900055

Constanta, Romania

bromhexine hydrochloride

BROMHEXIN® 8 mg

8 mg

tablet

oral use

Romania

LAROPHARM SRL,

Sos. Alexandriei 145 A,

B07 Bragadiru,

Judetul Ilfov,

Romania

bromhexine hydrochloride

BRONHOSOLV

8 mg

tablet

oral use

Romania

TIS FARMACEUTIC SA, Sos. Industriilor nr. 16

Sector 3, Bucuresti,

Romania

bromhexine hydrochloride

BROMHEXIN — T

2 mg/ml

oral drops, solution

oral use

Romania

BIO EEL SRL, str. Bega nr. 4, Targu-Mures,

540390,

Romania

bromhexine hydrochloride

BROMFLUEX 8 mg

8 mg

tablet

oral use

Romania

BIO EEL SRL, str. Bega nr. 4, Targu-Mures,

540390,

Romania

bromhexine hydrochloride

BROMFLUEX 12 mg

12 mg

tablet

oral use

Romania

A.C. HELCOR PHARMA SRL, str. Dr. Victor Babeş nr. 50,

Baia Mare, Maramureş,

Romania

bromhexine hydrochloride

BROMHEXIN HELCOR 8 mg

8 mg

tablet

oral use

Romania

ARENA GROUP SA,

Bucuresti, str. Stefan Mihaileanu, nr. 31, sector 2,

Romania

bromhexine hydrochloride

BROMHEXIN ARENA 8 mg

8 mg

tablet

oral use

Romania

ARENA GROUP SA, Bucuresti, str. Stefan Mihaileanu, nr. 31,

sector 2, Romania

bromhexine hydrochloride

BROMHEXIN ARENA 12 mg

12 mg

tablet

oral use

Romania

LAROPHARM SRL,

Sos. Alexandriei 145 A,

B07 Bragadiru,

Judetul Ilfov,

Romania

bromhexine hydrochloride

BROMHEXIN LAROPHARM 12 mg

12 mg

tablet

oral use

Romania

ROMPHARM COMPANY SRL,

Str. Eroilor, 1A, Otopeni,

Romania

bromhexine hydrochloride

BROMHEXIN ROMPHARM 2 mg/ml

2 mg/ml

oral drops, solution

oral use

Romania

SLAVIA PHARM SRL, Bd.

Pallady Theodor, 44C,

Bucuresti-Sector 3,

021 304 6385,

Romania

bromhexine hydrochloride

ROMHEXIN SLAVIA 8 mg

8 mg

tablet

oral use

Romania

FARMACOM S.A.,

str. Zizinului nr. 112, 500407, Brasov,

Romania

bromhexine hydrochloride

BROMHEXIN FARMACOM 8 mg

8 mg

tablet

oral use

Romania

ANTIBIOTICE SA

Str. Valea Lupului nr. 1,

Iasi 707410,

Romania

bromhexine hydrochloride

BROMHEXIN ATB 8 mg

8 mg

tablet

oral use

Romania

BIOFARM S.A., Str.Logofat Tautu Nr. 99 Sector 3 031212

Romania

bromhexine hydrochloride

BROMHEXIN BIOFARM 8 mg

8 mg

tablet

oral use

Romania

BIOFARM S.A., Str.Logofat Tautu Nr. 99 Sector 3 031212

Romania

bromhexine hydrochloride

BROMHEXIN BIOFARM 12 mg

12 mg

tablet

oral use

Slovak Republic

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 15 mg

15 mg/2 ml

solution for injection

intravenous use

Slovak Republic

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 15 mg/5 ml

15 mg/5 ml

syrup

oral use

Slovak Republic

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 30 mg

30 mg

tablet

oral use

Slovak Republic

TEVA Pharmaceuticals Slovakia, s.r.o.

Teslova 26

821 02 Bratislava

Slovak Republic

ambroxol hydrochloride

Ambrobene 6 mg/ml oral solution

6 mg/1 ml

oral solution

oral use

Slovak Republic

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene 7,5 mg/ml

7,5 mg/ml

oral/inhalation solution

oral use,

inhalation use

Slovak Republic

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ambroxol hydrochloride

Ambrobene retard 75 mg

75 mg

prolonged-release capsule

oral use

Slovak Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Praha 4

Czech Republic

ambroxol hydrochloride

AMBROSAN 15 mg/5 ml sirup

15 mg/5 ml

syrup

oral use

Slovak Republic

PRO.MED.CS Praha a.s.

Telčská 1

140 00 Praha 4

Czech Republic

ambroxol hydrochloride

Ambrosan 30 mg

30 mg

tablet

oral use

Slovak Republic

ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19, 89150 Laichingen Germany

ambroxol hydrochloride

Ambroxol AL 75 retard

75 mg

prolonged-release capsule

oral use

Slovak Republic

ALIUD PHARMA GmbH Gottlieb-Daimler-Straße 19,

89150 Laichingen

Germany

ambroxol hydrochloride

AMBROXOL AL KVAPKY

7,5 mg/1 ml

oral drops

oral use

Slovak Republic

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 15 mg/5 ml perorálny roztok

3 mg/1 ml

oral solution

oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed Cough Tablets

30 mg

tablet

oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed forte perorálny roztok

6 mg/1 ml

oral solution

oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed šumivé tablety

60 mg

effervescent tablet

oral use

Slovak Republic

CYATHUS EXQUIRERE PharmaforschungsGmbH Rudolfsplatz 2/1/8

1010 Wien

Austria

ambroxol hydrochloride

GOGOLOX

50 mg/1 g

oral solution

oral use

Slovak Republic

EGIS Pharmaceuticals PLC Keresztúri út 30-38.

1106 Budapest

Hungary

ambroxol hydrochloride

Halixol 30 mg

30 mg

tablet

oral use

Slovak Republic

Zentiva, k.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

ambroxol hydrochloride

MUCOSIN s medom sir

15 mg/5 ml

syrup

oral use

Slovak Republic

Zentiva, a.s.

Einsteinova 24

851 01, Bratislava

Slovak Republic

ambroxol hydrochloride

MUCOSIN tablety

30 mg

tablet

oral use

Slovak Republic

Boehringer Ingelheim International GmbH Binger Strasse 173

55216 Ingelheim am Rhein Germany

ambroxol hydrochloride

Mucosolvan

15 mg

pastille

oral use

Slovak Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein Germany

ambroxol hydrochloride

Mucosolvan

30 mg/5 ml

syrup

oral use

Slovak Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein Germany

ambroxol hydrochloride

Mucosolvan Junior

3 mg/1 ml

syrup

oral use

Slovak Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein Germany

ambroxol hydrochloride

Mucosolvan Retard

75 mg

prolonged-release capsule

oral use

Slovak Republic

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein Germany

ambroxol hydrochloride

Mucosolvan Tablety

30 mg

tablet

oral use

Slovak Republic

Divapharma GmbH

Motzener Straße 41

12277 Berlin

Germany

ambroxol hydrochloride

neo-bronchol

15 mg

pastille

oral use

Slovak Republic

KRKA, d.d.

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ambroxol hydrochloride

Solvolan

30 mg

tablet

oral use

Slovak Republic

KRKA, d.d.

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ambroxol hydrochloride

Solvolan

15 mg/5 ml

syrup

oral use

Slovak Republic

WALMARK, a.s.

Oldřichovice 44

739 61 Třinec

Czech Republic

ambroxol hydrochloride

Stopex na vykašliavanie

60 mg

effervescent tablet

oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125

12489 Berlin

Germany

bromhexine hydrochloride

Bromhexin 12 BC

12 mg/1 ml

oral solution

oral use

Slovak Republic

Berlin-Chemie AG Glienicker Weg 125

12489 Berlin

Germany

bromhexine hydrochloride

Bromhexin 8 Berlin-Chemie

8 mg

film-coated tablet

oral use

Slovak Republic

Krewel Meuselbach GmbH Krewelstraße 2

53783 Eitorf

Germany

bromhexine hydrochloride

BROMHEXIN 12 KVAPKY KM

12 mg/1 ml

oral drops

oral use

Slovak Republic

Krewel Meuselbach GmbH Krewelstraße 2

53783 Eitorf

Germany

bromhexine hydrochloride

Bromhexin 8 sirup KM

8 mg/10 ml

syrup

oral use

Slovak Republic

Krewel Meuselbach GmbH Krewelstraße 2

53783 Eitorf

Germany

bromhexine hydrochloride

Bromhexin 8-kvapky KM

8 mg/ml

oral solution

oral use

Slovak Republic

Zentiva a.s.

Nitrianska 100

Hlohovec 920 27

Slovak Republic

bromhexine hydrochloride,

mentholum,

oleum foeniculi,

oleum anisi,

oleum origani,

oleum menthae piperitae,

oleum eucalypti

BRONCHOSAN

8 mg/ml

1,5 mg/ml

0,75 mg/ml

0,250 mg/ml

0,250 mg/ml

0,250 mg/ml

0,250 mg/ml

oral drops

oral use

Slovenia

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein Germany

bromhexine hydrochloride

BISOLVON 4 mg/5 ml sirup

4 mg/5 ml

syrup

oral use

Slovenia

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein Germany

bromhexine hydrochloride

Bisolvon 8 mg tablete

8 mg

tablet

oral use

Slovenia

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein Germany

bromhexine hydrochloride

Bisolvon 2 mg/ml peroralna raztopina/inhalacijska raztopina za nebulator

2 mg/ml

oral solution/nebuliser solution

oral use,

inhalation use

Slovenia

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ambroxol hydrochloride

Solvolan 3 mg/ml sirup

3 mg/ml

syrup

oral use

Slovenia

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8000 Novo mesto

Slovenia

ambroxol hydrochloride

Solvolan 30 mg tablete

30 mg

tablet

oral use

Slovenia

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 3 mg/ml peroralna raztopina

3 mg/ml

oral solution

oral use

Slovenia

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 30 mg tablete

30 mg

tablet

oral use

Slovenia

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 6 mg/ml peroralna raztopina

6 mg/ml

oral solution

oral use

Slovenia

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Flavamed 60 mg šumeče tablete

60 mg

effervescent tablet

oral use

Slovenia

Medis, d.o.o.

Brnčičeva 1

1000 Ljubljana

Slovenia

ambroxol hydrochloride

Ambrospray 10 mg/vpih peroralna raztopina

10 mg/spray puff

oral solution

oral use

Slovenia

BERLIN-CHEMIE AG

Glienicker Weg 125

12489 Berlin

Germany

ambroxol hydrochloride

Ambroksolijev klorid Berlin-Chemie 6 mg/ml peroralna raztopina

6 mg/ml

oral solution

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Motosol 3 mg/ml jarabe

3 mg/ml

syrup

oral use

Spain

ARISTO PHARMA IBERICA, S.L.

Solana, 26 28850 Torrejón de Ardoz Madrid Spain

Ambroxol hydrochloride

Ambroxol Edigen jarabe EFG

15 mg/5 ml

syrup

oral use

Spain

LABORATORIOS CINFA S.A.

Olaz-Chipi, 10 Poligono Indistrial Areta

31620 Huarte-Pamplona

Navarra

Spain

Ambroxol hydrochloride

Ambroxol cinfa 15 mg/5 ml jarabe EFG

15 mg/5 ml

syrup

oral use

Spain

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid

Spain

Ambroxol hydrochloride

Ambroxol Normon 3 mg/ml solucion EFG

3 mg/ml

oral solution

oral use

Spain

APOTEX EUROPE B.V:

Darwinweg, 20

2333 CR Leiden

The Netherlands

Ambroxol hydrochloride

Ambroxol Apotex 15 ml/5 ml jarabe EFG

15 mg/5 ml

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan 30 mg comprimidos

30 mg

tablet

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Motosol 7,5 mg/ml solucion inyectable

7,5 mg/ml

solution for injection

intravenous use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan Pediátrico 3 mg/ml jarabe

3 mg/ml

syrup

oral use

Spain

FERRER INTERNACIONAL S.A.

Gran Via Carlos III, 94

08028 Barcelona

Spain

Ambroxol hydrochloride

Naxpa jarabe

15 mg/5 ml

syrup

oral use

Spain

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6

28760 Tres cantos

Madrid

Spain

Ambroxol hydrochloride

Mucibron 3 mg/ml solucion oral

3 mg/ml

oral solution

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan Retard 75 mg cápsulas de liberación prolongada

75 mg

prolonged-release capsule, hard

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Motosol Retard 75 mg cápsulas de liberación prolongada

75 mg

prolonged-release capsule, hard

oral use

Spain

WAAS_ANITA S.A.

General Prim 13

28035 Madrid

Spain

Ambroxol hydrochloride

Dinobroxol jarabe

15 mg/5 ml

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan 60 mg polvo para solución oral

15 mg/5 ml

powder for oral suspension

oral use

Spain

RATIOPHARM ESPAÑA S.A.

Avda Burgos, 16 D 5a Planta

28036 Madrid

Spain

ambroxol hydrochloride

Ambroxol ratiopharm 3 mg/ml jarabe EFG

3 mg/ml

syrup

oral use

Spain

SANDOZ FARMACEUTICA S.A.

Avda Osa Mayor, 4

28023 Aravaca

Madrid

Spain

Ambroxol hydrochloride

Ambroxol Sandoz 3 mg/ml jarabe EFG

3 mg/ml

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan 6 mg/ml jarabe

6 mg/ml

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan 15 mg pastillas de goma

15 mg

oral gum

oral use

Spain

CYATHUS EXQUIRERE PHARMAFORSCHUNGS GMBH

Rudolfsplatz 2/1/8

1010 Viena

Austria

Ambroxol hydrochloride

Ambroxol Exquirere 10 mg pulsación solucion oral

10 mg/pulsation

oral solution

oral use

Spain

LABORATORIOS VICKS S.L.

Avda Bruselas, 24

28108 Alcobendas

Madrid

Spain

Ambroxol hydrochloride

Formulamucol 6 mg/ml solución oral EFG

6 mg/ml

oral solution

oral use

Spain

LABORATORIOS VICKS S.L.

Avda Bruselas, 24

28108 Alcobendas

Madrid

Spain

Ambroxol hydrochloride

Formulamucol 3 mg/ml solución oral EFG

3 mg/ml

oral solution

oral use

Spain

TEVA PHARMA S.L.U.

C/Anabel Segura 11 Edificio Albatros B 1a Planta

28108 Alcobendas

Madrid

Spain

Ambroxol hydrochloride

Ambroxol Tevapharma 3 mg/ml solución

3 mg/ml

oral solution

oral use

Spain

TEVA PHARMA S.L.U.

C/Anabel Segura 11 Edificio Albatros B 1a Planta

28108 Alcobendas

Madrid

Spain

Ambroxol hydrochloride

Ambroxol Tevapharma 6 mg/ml solución

6 mg/ml

oral solution

oral use

Spain

RATIOPHARM ESPAÑA S.A. C/Anabel Segura 11 Edificio

Albatros B 1a Planta 28108

Alcobendas Madrid

Spain

Ambroxol hydrochloride

Ambroxol ratio 6 mg/ml solucion oral EFG

6 mg/ml

oral solution

oral use

Spain

RATIOPHARM ESPAÑA S.A. C/Anabel Segura 11 Edificio Albatros B 1a Planta 28108 Alcobendas Madrid

Spain

Ambroxol hydrochloride

Ambroxol ratio 3 mg/ml solución oral EFG

3 mg/ml

oral solution

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Lizipadol 20 mg pastillas para chupar

20 mg

lozenge

oromucosal use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Ambroxol hydrochloride

Mucosan 30 mg jarabe en sobres

30 mg

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Bromhexine hydrochloride

Bisolmed 2 mg/ml solución inyectable y para perfusión

2 mg/ml

solution for injection/infusion

intravenous use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Bromhexine hydrochloride

Bisolmed 2 mg/ml solución oral/concentrado para solución para inhalación por nebulizador

2 mg/ml

oral solution/concentrate for nebuliser solution

oral use

Spain

LABORATORIOS CINFA S.A.

Olaz-Chipi, 10

Poligono Indistrial Areta

31620 Huarte Pamplona

Navarrra

Spain

Bromhexine hydrochloride + Sulfamethoxazole hydrochloride + Trimethoprim + balsam tolu aqueous extract

Bactopumon

2 mg + 400 mg + 80 mg + 75 mg/5 ml

oral suspension

oral use

Spain

DESMA LABORATORIO FARMACEUTICO, S.L.

Cuatro amigos 7, escalera 2, 1oD

28029 Madrid

Spain

bromhexine hydrochloride + Sulfamethoxazole hydrochloride + Trimethoprim

Balsoprim suspensión

50 mg + 2 660 mg + 540 mg/100 ml

oral suspension

oral use

Spain

FAES FARMA, S.A.

Maximo Aguirre, 14

48940

Lamiaco-Lejona Vizcaya

Spain

Bromhexine hydrochloride + benzoate sodium + Sulfamethoxazole + Trimethoprim + Balsam Tolú syrup

Bronquidiazina CR suspensión

4 mg + 250 mg + 400 mg + 80 mg + 325 mg/7,5 ml

oral suspension

oral use

Spain

GLAXOSMITHKLINE, S.A.

Severo Ochoa, 2

28760 Tres Cantos

Madrid

Spain

Bromhexine hydrochloride + Amoxicilin trihydrate

Clamoxyl mucolítico 500 mg cápsulas

8 mg + 500 mg

capsule, hard

oral use

Spain

GLAXOSMITHKLINE, S.A.

Severo Ochoa, 2

28760 Tres Cantos

Madrid

Spain

Bromhexine hydrochloride + Amoxicilin trihydrate

Clamoxyl mucolítico 250 mg suspensión extemporánea

4 mg + 250 mg/5 ml

powder for oral suspension

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Bromhexine hydrochloride

Bisolvon mucolítico 1,6 mg/ml jarabe

8 mg/5 ml

syrup

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Bromhexine hydrochloride

Bisolvon mucolítico 8 mg comprimidos solubles

8 mg

soluble tablet

oral use

Spain

BOEHRINGER INGELHEIM ESPAÑA, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallés Barcelona

Spain

Bromhexine hydrochloride

Bisolvon mucolítico infantil 0,8 mg/ml jarabe

0,8 mg/ml

syrup

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Ambroxolol hydrochloride

Mucoangin Svartvinbär

20 mg

lozenge

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Ambroxolol hydrochloride

Mucoangin

20 mg

lozenge

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Ambroxolol hydrochloride

Mucoangin Citron

20 mg

lozenge

oral use

Sweden

BioPhausia AB,

Blasieholmsgatan 2,

111 48 Stockholm,

Sweden

Bromhexine hydrochloride + ephedrine hydrochloride

Mollipect

0,5 mg/ml + 1 mg/ml

oral solution

oral use

Sweden

Apofri AB, Box 120,

182 12 Danderyd,

Sweden

Bromhexine hydrochloride

Bromhexin Apofri

0,8 mg/ml

oral solution

oral use

Sweden

Apofri AB, Box 120,

182 12 Danderyd,

Sweden

Bromhexine hydrochloride

Bromhexin Apofri

1,6 mg/ml

oral solution

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

8 mg

tablet

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

0,8 mg/ml

oral solution

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

1,6 mg/ml

oral solution

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon

8 mg

soluble tablet

oral use

Sweden

Boehringer Ingelheim International GmbH, Binger Strasse 173, DE-55216 Ingelheim am Rhein,

Germany

Bromhexine hydrochloride

Bisolvon Jordgubb

0,8 mg/ml

oral solution

oral use

Sweden

McNeil Sweden AB,

169 90 Solna,

Sweden

Bromhexine hydrochloride

Bromhex

0,8 mg/ml

oral solution

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

ambroxol hydrochloride

Mucoangin, zuigtabletten

20 mg

20 mg

lozenge

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

ambroxol hydrochloride

Mucoangin Citroen 20 mg, zuigtabletten

20 mg

lozenge

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

ambroxol hydrochloride

Rexambro 20 mg, zuigtabletten

20 mg

lozenge

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon drank in sachet,

8 mg

8 mg

oral solution in sachet

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon drank voor kinderen met aardbeiensmaak, 4 mg/5 ml

4 mg/5 ml

oral solution

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon drank voor kinderen, 4 mg/5 ml

4 mg/5 ml

oral solution

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon drank, 8 mg/5 ml

8 mg/5 ml

oral solution

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon druppels voor kinderen, oplossing 2 mg/ml

2 mg/ml

oral solution

oral use

The Netherlands

Boehringer Ingelheim B.V.

Comeniusstraat 6

1817 MS Alkmaar

The Netherlands

bromhexine hydrochloride

Bisolvon tabletten, 8 mg

8 mg

tablet

oral use

The Netherlands

Sameko BV

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCI 8 mg Sameko, tabletten

8 mg

tablet

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

bromhexine hydrochloride

Broomhexine HCl CF 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

bromhexine hydrochloride

Broomhexine HCl CF 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC ETTEN LEUR

The Netherlands

bromhexine hydrochloride

Broomhexine HCl CF 8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Basic Pharma Manufacturing bv

Burgemeester Lemmensstraat 352

6163 JT GELEEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCl drank

4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Basic Pharma Manufacturing bv

Burgemeester Lemmensstraat 352

6163 JT GELEEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCl drank

8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR LEIDEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCl hoestdrank extra sterk suikervrij Apotex 8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

2333 CR LEIDEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCl hoestdrank suikervrij Apotex 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Apotex Europe B.V.

Darwinweg 20

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Apotex

8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Mediq Farma B.V.

Hertogswetering 159

3543 AS UTRECHT

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Mdq

4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Mediq Farma B.V.

Hertogswetering 159

3543 AS UTRECHT

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Mdq 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Mediq Farma B.V.

Hertogswetering 159

3543 AS UTRECHT

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Mdq

8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

RXT

Amsterdamsestraatweg 22

1391 AB ABCOUDE

The Netherlands

bromhexine hydrochloride

Broomhexine HCl RXT 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Nederlandse Service Apotheek Beheer B.V.

Vonderweg 39a

7468 DC ENTER

The Netherlands

bromhexine hydrochloride

Broomhexine HCI SAM

8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Sandoz 0,8 mg/ml, drank

0,8 mg/ml

oral solution

oral use

The Netherlands

MAE Holding BV

Amsterdamsestraatweg 22

1391 AB ABCOUDE

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Triangle Pharma 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

MAE Holding BV

Amsterdamsestraatweg 22

1391 AB ABCOUDE

The Netherlands

bromhexine hydrochloride

Broomhexine HCl Triangle Pharma 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

bromhexine hydrochloride

Broomhexine HCl 4=5 PCH, drank 4 mg/5 ml

4 mg/5 ml

oral solution

oral use

The Netherlands

Basic Pharma Manufacturing bv

Burgemeester Lemmensstraat 352

6163 JT GELEEN

The Netherlands

bromhexine hydrochloride

Broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

bromhexine hydrochloride

Broomhexine HCl 8 PCH, tabletten 8 mg

8 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA HAARLEM

The Netherlands

bromhexine hydrochloride

Broomhexine HCl 8=5 PCH, drank 8 mg/5 ml

8 mg/5 ml

oral solution

oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE ROTTERDAM

The Netherlands

bromhexine hydrochloride

Broomhexinehydrochloride

8 mg tabletten Samenwerkende Apothekers

8 mg

tablet

oral use

The Netherlands

Sameko BV

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

C1000 Hoestdrank Broomhexine HCl 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Sameko BV

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

C1000 Hoestdrank Extra Sterk Broomhexine HCI 8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Sameko BV

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

C1000 Hoesttabletten Broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

HEMA B.V.

NDSM-straat 10

1033 SB AMSTERDAM

The Netherlands

bromhexine hydrochloride

HEMA Hoestdrank Broomhexine HCl 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

HEMA B.V.

NDSM-straat 10

1033 SB AMSTERDAM

The Netherlands

bromhexine hydrochloride

HEMA Hoestdrank Broomhexine HCl 8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

HEMA B.V.

NDSM-straat 10

1033 SB AMSTERDAM

The Netherlands

bromhexine hydrochloride

HEMA Hoesttabletten Broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

HTP Huisapotheek B.V.

Nieuwe Donk 3

4879 AC ETTEN-LEUR

The Netherlands

bromhexine hydrochloride

Hoestdrank Broomhexine HCl 4 mg/5 ml HTP Huisapotheek, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

HTP Huisapotheek B.V.

Nieuwe Donk 3

4879 AC ETTEN-LEUR

The Netherlands

bromhexine hydrochloride

Hoestdrank Broomhexine HCl 8 mg/5 ml HTP Huisapotheek, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

HTP Huisapotheek B.V.

Nieuwe Donk 3

4879 AC ETTEN-LEUR

The Netherlands

bromhexine hydrochloride

Hoesttabletten Broomhexine HCl 8 mg HTP Huisapotheek, tabletten

8 mg

tablet

oral use

The Netherlands

SDG Farma B.V.

Treubweg 11

1112 BA DIEMEN

The Netherlands

bromhexine hydrochloride

IDYL Hoestdrank Broomhexine HCl 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

SDG Farma B.V.

Treubweg 11

1112 BA DIEMEN

The Netherlands

bromhexine hydrochloride

IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Jumbo Supermarkten B.V.

Rijksweg 15

5462 CE VEGHEL

The Netherlands

bromhexine hydrochloride

JUMBO Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Jumbo Supermarkten B.V.

Rijksweg 15

5462 CE VEGHEL

The Netherlands

bromhexine hydrochloride

JUMBO hoestdrank extra sterk broomhexine HCl

8 mg/5 ml suikervrij, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Jumbo Supermarkten B.V.

Rijksweg 15

5462 CE VEGHEL

The Netherlands

bromhexine hydrochloride

JUMBO hoesttabletten broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Kruidvat HOESTDRANK Broomhexine HCl 4 mg/5 ml suikervrij, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Leidapharm B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Leidapharm Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Leidapharm B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Leidapharm Hoestdrank Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Nedac Sorbo B.V.

Innovatie 1

6921 RN DUIVEN

The Netherlands

bromhexine hydrochloride

NEDAC SORBO Hoestdrank Broomhexine HCl 4 mg/5 ml suikervrij, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Nedac Sorbo B.V.

Innovatie 1

6921 RN DUIVEN

The Netherlands

bromhexine hydrochloride

NEDAC SORBO Hoestdrank Extra Sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Nedac Sorbo B.V.

Innovatie 1

6921 RN DUIVEN

The Netherlands

bromhexine hydrochloride

NEDAC SORBO Hoesttabletten Broomhexine HCl 8 mg, tabletten

8 mg

tablet

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

bromhexine hydrochloride

Otrivin Broomhexine HCI

8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

bromhexine hydrochloride

Otrivin Broomhexine HCl 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Trekpleister HOESTDRANK Broomhexine HCl 4 mg/5 ml suikervrij, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Trekpleister HOESTDRANK Broomhexine HCl 4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Trekpleister HOESTDRANK Extra sterk Broomhexine HCl 8 mg/5 ml suikervrij, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Trekpleister HOESTDRANK EXTRA STERK Broomhexine HCl 8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN LEIDEN

The Netherlands

bromhexine hydrochloride

Trekpleister hoesttabletten bij vastzittende hoest 8, tabletten 8 mg

8 mg

tablet

oral use

The Netherlands

Procter & Gamble Nederland B.V.

Watermanweg 100

3067 GG ROTTERDAM

The Netherlands

bromhexine hydrochloride

Vicks Hoestdrank broomhexinehydrochloride

8 mg/5 ml, drank

8 mg/5 ml

oral solution

oral use

The Netherlands

Procter & Gamble Nederland B.V.

Watermanweg 100

3067 GG ROTTERDAM

The Netherlands

bromhexine hydrochloride

Vicks Hoestdrank voor Kinderen broomhexinehydrochloride

4 mg/5 ml, drank

4 mg/5 ml

oral solution

oral use

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