# Official Journal C 386/31 O

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 386 |
| | |
| English edition | Information and Notices | Volume 5731 October 2014 |

ISSN 1977-091X

Official Journal

of the European Union

C 386

English edition

Information and Notices

Volume 5731 October 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 386/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 386/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 3 |
| 2014/C 386/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 14 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 386/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014(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

2014/C 386/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014(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)

3

2014/C 386/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014(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)

14

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 31.10.2014 | EN | Official Journal of the European Union | C 386/1 |
| --- | --- | --- | --- |

31.10.2014

EN

Official Journal of the European Union

C 386/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

2014/C 386/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.7.2014 | Simbrinza | Brinzolamide/Brimonidine tartrate | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | Eye drops, suspension | Pending | 23.7.2014 |

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

18.7.2014

Simbrinza

Brinzolamide/Brimonidine tartrate

Alcon Laboratories (UK) Ltd

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

EU/1/14/933

Eye drops, suspension

Pending

23.7.2014

---

(1)  OJ L 136, 30.4.04, p. 1.

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| 31.10.2014 | EN | Official Journal of the European Union | C 386/3 |
| --- | --- | --- | --- |

31.10.2014

EN

Official Journal of the European Union

C 386/3

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

2014/C 386/02

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.9.2014 | Clopidogrel/Acetylsalicylic acid Teva | clopidogrel/acetylsalicylic acid | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/942 | Film-coated tablet | B01AC30 | 3.9.2014 |
| 1.9.2014 | Triumeq | dolutegravir/abacavir/lamivudine | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | Film-coated tablet | J05AR13 | 3.9.2014 |
| 9.9.2014 | ABASRIA | Insulin glargine | Eli Lilly Regional Operations GmbH.
  Kölblgasse 8-10, 1030 Wien, Österreich | EU/1/14/944 | Solution for injection | A10AE04 | 11.9.2014 |
| 18.9.2014 | Accofil | Filgrastim | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | Solution for injection or infusion | L03AA02 | 22.9.2014 |
| 18.9.2014 | Xultophy | insulin degludec/liraglutide | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | Solution for injection in pre-filled pen | Pending | 22.9.2014 |
| 18.9.2014 | Zydelig | idelalisib | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | Film-coated tablet | L01XX47 | 19.9.2014 |
| 22.9.2014 | Busulfan Fresenius Kabi | busulfan | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/14/951 | Concentrate for solution for infusion | L01AB01 | 24.9.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

1.9.2014

Clopidogrel/Acetylsalicylic acid Teva

clopidogrel/acetylsalicylic acid

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/942

Film-coated tablet

B01AC30

3.9.2014

1.9.2014

Triumeq

dolutegravir/abacavir/lamivudine

ViiV Healthcare UK Limited

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

EU/1/14/940

Film-coated tablet

J05AR13

3.9.2014

9.9.2014

ABASRIA

Insulin glargine

Eli Lilly Regional Operations GmbH.

Kölblgasse 8-10, 1030 Wien, Österreich

EU/1/14/944

Solution for injection

A10AE04

11.9.2014

18.9.2014

Accofil

Filgrastim

Accord Healthcare Limited

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

EU/1/14/946

Solution for injection or infusion

L03AA02

22.9.2014

18.9.2014

Xultophy

insulin degludec/liraglutide

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

Solution for injection in pre-filled pen

Pending

22.9.2014

18.9.2014

Zydelig

idelalisib

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

Film-coated tablet

L01XX47

19.9.2014

22.9.2014

Busulfan Fresenius Kabi

busulfan

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/14/951

Concentrate for solution for infusion

L01AB01

24.9.2014

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Daliresp | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/11/668 | 3.9.2014 |
| 1.9.2014 | Daxas | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/10/636 | 3.9.2014 |
| 1.9.2014 | Desloratadine ratiopharm | Ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 4.9.2014 |
| 1.9.2014 | DuoCover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 3.9.2014 |
| 1.9.2014 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 3.9.2014 |
| 1.9.2014 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 3.9.2014 |
| 1.9.2014 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 3.9.2014 |
| 1.9.2014 | Libertek | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/11/666 | 3.9.2014 |
| 1.9.2014 | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Czech Republic | EU/1/05/325 | 3.9.2014 |
| 1.9.2014 | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 3.9.2014 |
| 1.9.2014 | Pixuvri | CTI Life Sciences Ltd
  Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 3.9.2014 |
| 1.9.2014 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 3.9.2014 |
| 1.9.2014 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 3.9.2014 |
| 1.9.2014 | Zoely | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/690 | 4.9.2014 |
| 4.9.2014 | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/817 | 8.9.2014 |
| 4.9.2014 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/046 | 8.9.2014 |
| 4.9.2014 | CoAprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/086 | 8.9.2014 |
| 4.9.2014 | Copalia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/372 | 8.9.2014 |
| 4.9.2014 | Copalia HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575 | 8.9.2014 |
| 4.9.2014 | Dafiro | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/371 | 8.9.2014 |
| 4.9.2014 | Dafiro HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574 | 8.9.2014 |
| 4.9.2014 | Exforge | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/370 | 8.9.2014 |
| 4.9.2014 | Exforge HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569 | 8.9.2014 |
| 4.9.2014 | Exjade | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/356 | 8.9.2014 |
| 4.9.2014 | Extavia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/454 | 8.9.2014 |
| 4.9.2014 | Ifirmacombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 8.9.2014 |
| 4.9.2014 | Ifirmasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/480 | 8.9.2014 |
| 4.9.2014 | Imprida | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/373 | 8.9.2014 |
| 4.9.2014 | Irbesartan HCT Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/377 | 8.9.2014 |
| 4.9.2014 | Irbesartan/Hydrochlorothiazide Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/583 | 8.9.2014 |
| 4.9.2014 | Irbesartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/576 | 8.9.2014 |
| 4.9.2014 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/376 | 8.9.2014 |
| 4.9.2014 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/049 | 8.9.2014 |
| 4.9.2014 | Karvezide | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/085 | 8.9.2014 |
| 4.9.2014 | Kinzalkomb | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214 | 8.9.2014 |
| 4.9.2014 | Kinzalmono | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/98/091 | 8.9.2014 |
| 4.9.2014 | Lucentis | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/374 | 8.9.2014 |
| 4.9.2014 | Micardis | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/98/090 | 8.9.2014 |
| 4.9.2014 | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/02/213 | 8.9.2014 |
| 4.9.2014 | Pritor | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/98/089 | 8.9.2014 |
| 4.9.2014 | PritorPlus | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/215 | 8.9.2014 |
| 4.9.2014 | Rasilez | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405 | 8.9.2014 |
| 4.9.2014 | Rasilez HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/491 | 8.9.2014 |
| 4.9.2014 | Sabervel | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/12/765 | 8.9.2014 |
| 4.9.2014 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/09/595 | 8.9.2014 |
| 4.9.2014 | Simulect | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/084 | 8.9.2014 |
| 4.9.2014 | Telmisartan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/10/639 | 8.9.2014 |
| 4.9.2014 | Telmisartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/610 | 8.9.2014 |
| 4.9.2014 | Telmisartan Teva Pharma | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/719 | 8.9.2014 |
| 4.9.2014 | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 8.9.2014 |
| 4.9.2014 | Tolura | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632 | 8.9.2014 |
| 4.9.2014 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 8.9.2014 |
| 9.9.2014 | Edarbi | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/734 | 11.9.2014 |
| 9.9.2014 | Ipreziv | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/735 | 11.9.2014 |
| 9.9.2014 | Lamivudine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/566 | 12.9.2014 |
| 9.9.2014 | Rasilamlo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/686 | 11.9.2014 |
| 9.9.2014 | Sildenafil ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603 | 11.9.2014 |
| 9.9.2014 | Sildenafil Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/584 | 12.9.2014 |
| 9.9.2014 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | 10.9.2014 |
| 11.9.2014 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 15.9.2014 |
| 11.9.2014 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 15.9.2014 |
| 11.9.2014 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 16.9.2014 |
| 11.9.2014 | Kolbam | ASK Pharmaceuticals GmbH
  Heimeranstraße 35, D-80339 München, Deutschland | EU/1/13/895 | 15.9.2014 |
| 11.9.2014 | Lamivudine Teva Pharma B.V. | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/596 | 15.9.2014 |
| 11.9.2014 | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 15.9.2014 |
| 16.9.2014 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185 | 19.9.2014 |
| 16.9.2014 | Ovaleap | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/871 | 18.9.2014 |
| 16.9.2014 | Zutectra | Biotest Pharma GmbH
  Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | EU/1/09/600 | 18.9.2014 |
| 18.9.2014 | Clopidogrel Apotex | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/09/568 | 22.9.2014 |
| 18.9.2014 | Clopidogrel Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/08/465 | 22.9.2014 |
| 18.9.2014 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 22.9.2014 |
| 18.9.2014 | Hirobriz Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/594 | 22.9.2014 |
| 18.9.2014 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 22.9.2014 |
| 18.9.2014 | Ilaris | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564 | 22.9.2014 |
| 18.9.2014 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 22.9.2014 |
| 18.9.2014 | Noxafil | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/320 | 22.9.2014 |
| 18.9.2014 | Onbrez Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/593 | 22.9.2014 |
| 18.9.2014 | Oslif Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/586 | 22.9.2014 |
| 18.9.2014 | Prevenar 13 | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/590 | 22.9.2014 |
| 18.9.2014 | Prialt | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/302 | 22.9.2014 |
| 18.9.2014 | Rienso | Takeda Pharma A/S
  PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/12/774 | 22.9.2014 |
| 18.9.2014 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 22.9.2014 |
| 18.9.2014 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 22.9.2014 |
| 18.9.2014 | Urorec | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/608 | 22.9.2014 |
| 18.9.2014 | Vantavo | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572 | 22.9.2014 |
| 22.9.2014 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537 | 24.9.2014 |
| 22.9.2014 | Multaq | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/09/591 | 24.9.2014 |
| 30.9.2014 | Cinryze | ViroPharma SPRL-BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 2.10.2014 |
| 30.9.2014 | Humalog | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/96/007 | 2.10.2014 |
| 30.9.2014 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 6.10.2014 |
| 30.9.2014 | Inflectra | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/13/854 | 2.10.2014 |
| 30.9.2014 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 2.10.2014 |
| 30.9.2014 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 2.10.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.9.2014

Daliresp

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/11/668

3.9.2014

1.9.2014

Daxas

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/10/636

3.9.2014

1.9.2014

Desloratadine ratiopharm

Ratiopharm GmbH

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

EU/1/11/746

4.9.2014

1.9.2014

DuoCover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

3.9.2014

1.9.2014

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

3.9.2014

1.9.2014

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

3.9.2014

1.9.2014

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

3.9.2014

1.9.2014

Libertek

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/11/666

3.9.2014

1.9.2014

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Czech Republic

EU/1/05/325

3.9.2014

1.9.2014

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

3.9.2014

1.9.2014

Pixuvri

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

3.9.2014

1.9.2014

RoActemra

Roche Registration Limited

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

EU/1/08/492

3.9.2014

1.9.2014

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

3.9.2014

1.9.2014

Zoely

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/690

4.9.2014

4.9.2014

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/817

8.9.2014

4.9.2014

Aprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/97/046

8.9.2014

4.9.2014

CoAprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/086

8.9.2014

4.9.2014

Copalia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372

8.9.2014

4.9.2014

Copalia HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575

8.9.2014

4.9.2014

Dafiro

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371

8.9.2014

4.9.2014

Dafiro HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574

8.9.2014

4.9.2014

Exforge

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370

8.9.2014

4.9.2014

Exforge HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569

8.9.2014

4.9.2014

Exjade

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/356

8.9.2014

4.9.2014

Extavia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/454

8.9.2014

4.9.2014

Ifirmacombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

8.9.2014

4.9.2014

Ifirmasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

8.9.2014

4.9.2014

Imprida

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373

8.9.2014

4.9.2014

Irbesartan HCT Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/377

8.9.2014

4.9.2014

Irbesartan/Hydrochlorothiazide Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/583

8.9.2014

4.9.2014

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/576

8.9.2014

4.9.2014

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/376

8.9.2014

4.9.2014

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/97/049

8.9.2014

4.9.2014

Karvezide

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/085

8.9.2014

4.9.2014

Kinzalkomb

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

8.9.2014

4.9.2014

Kinzalmono

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091

8.9.2014

4.9.2014

Lucentis

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374

8.9.2014

4.9.2014

Micardis

Boehringer Ingelheim International GmbH

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

EU/1/98/090

8.9.2014

4.9.2014

MicardisPlus

Boehringer Ingelheim International GmbH

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

EU/1/02/213

8.9.2014

4.9.2014

Pritor

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/089

8.9.2014

4.9.2014

PritorPlus

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

8.9.2014

4.9.2014

Rasilez

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

8.9.2014

4.9.2014

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491

8.9.2014

4.9.2014

Sabervel

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/12/765

8.9.2014

4.9.2014

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/09/595

8.9.2014

4.9.2014

Simulect

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/084

8.9.2014

4.9.2014

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/639

8.9.2014

4.9.2014

Telmisartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/610

8.9.2014

4.9.2014

Telmisartan Teva Pharma

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/719

8.9.2014

4.9.2014

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

8.9.2014

4.9.2014

Tolura

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

8.9.2014

4.9.2014

Twynsta

Boehringer Ingelheim International GmbH

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

EU/1/10/648

8.9.2014

9.9.2014

Edarbi

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

11.9.2014

9.9.2014

Ipreziv

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/735

11.9.2014

9.9.2014

Lamivudine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/566

12.9.2014

9.9.2014

Rasilamlo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

11.9.2014

9.9.2014

Sildenafil ratiopharm

ratiopharm GmbH

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

EU/1/09/603

11.9.2014

9.9.2014

Sildenafil Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/584

12.9.2014

9.9.2014

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

10.9.2014

11.9.2014

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

15.9.2014

11.9.2014

Eporatio

ratiopharm GmbH

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

EU/1/09/573

15.9.2014

11.9.2014

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

16.9.2014

11.9.2014

Kolbam

ASK Pharmaceuticals GmbH

Heimeranstraße 35, D-80339 München, Deutschland

EU/1/13/895

15.9.2014

11.9.2014

Lamivudine Teva Pharma B.V.

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/596

15.9.2014

11.9.2014

Relistor

TMC Pharma Services Ltd

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

EU/1/08/463

15.9.2014

16.9.2014

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

19.9.2014

16.9.2014

Ovaleap

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/871

18.9.2014

16.9.2014

Zutectra

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

EU/1/09/600

18.9.2014

18.9.2014

Clopidogrel Apotex

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/09/568

22.9.2014

18.9.2014

Clopidogrel Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

22.9.2014

18.9.2014

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

22.9.2014

18.9.2014

Hirobriz Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/594

22.9.2014

18.9.2014

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

22.9.2014

18.9.2014

Ilaris

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564

22.9.2014

18.9.2014

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

22.9.2014

18.9.2014

Noxafil

Merck Sharp & Dohme Limited

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

EU/1/05/320

22.9.2014

18.9.2014

Onbrez Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593

22.9.2014

18.9.2014

Oslif Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/586

22.9.2014

18.9.2014

Prevenar 13

Pfizer Limited

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

EU/1/09/590

22.9.2014

18.9.2014

Prialt

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/04/302

22.9.2014

18.9.2014

Rienso

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/774

22.9.2014

18.9.2014

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

22.9.2014

18.9.2014

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

22.9.2014

18.9.2014

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608

22.9.2014

18.9.2014

Vantavo

Merck Sharp & Dohme Limited

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

EU/1/09/572

22.9.2014

22.9.2014

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

24.9.2014

22.9.2014

Multaq

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/09/591

24.9.2014

30.9.2014

Cinryze

ViroPharma SPRL-BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688

2.10.2014

30.9.2014

Humalog

Eli Lilly Nederland B.V.

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

EU/1/96/007

2.10.2014

30.9.2014

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

6.10.2014

30.9.2014

Inflectra

Hospira UK Limited

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

EU/1/13/854

2.10.2014

30.9.2014

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

2.10.2014

30.9.2014

Revlimid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/07/391

2.10.2014

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Clopidogrel Qualimed | Qualimed
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/557 | 3.9.2014 |
| 16.9.2014 | Pioglitazone Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/723 | 18.9.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.9.2014

Clopidogrel Qualimed

Qualimed

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

EU/1/09/557

3.9.2014

16.9.2014

Pioglitazone Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/723

18.9.2014

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.9.2014 | Nobilis IB Primo QX | Live avian infectious bronchitis virus, strain D388 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/174 | Lyophilisate and solvent for oculonasal suspension
  Lyophilisate for suspension for spray | QI01AD07 | 8.9.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

4.9.2014

Nobilis IB Primo QX

Live avian infectious bronchitis virus, strain D388

Intervet International B.V.

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

EU/2/14/174

Lyophilisate and solvent for oculonasal suspension

Lyophilisate for suspension for spray

QI01AD07

8.9.2014

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 3.9.2014 |
| 1.9.2014 | Suvaxyn Aujeszky 783 + O/W | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/98/009 | 3.9.2014 |
| 9.9.2014 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 11.9.2014 |
| 9.9.2014 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 11.9.2014 |
| 9.9.2014 | Pirsue | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/00/027 | 11.9.2014 |
| 9.9.2014 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 11.9.2014 |
| 9.9.2014 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 11.9.2014 |
| 16.9.2014 | Zulvac 1+8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 18.9.2014 |
| 30.9.2014 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/07/079 | 2.10.2014 |
| 30.9.2014 | Meloxoral | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/10/111 | 2.10.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.9.2014

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

3.9.2014

1.9.2014

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium S.A.

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

EU/2/98/009

3.9.2014

9.9.2014

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

11.9.2014

9.9.2014

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

11.9.2014

9.9.2014

Pirsue

Zoetis Belgium S.A.

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

EU/2/00/027

11.9.2014

9.9.2014

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

11.9.2014

9.9.2014

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

11.9.2014

16.9.2014

Zulvac 1+8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

18.9.2014

30.9.2014

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

2.10.2014

30.9.2014

Meloxoral

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/10/111

2.10.2014

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

(1)  OJ L 136, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.

---

| 31.10.2014 | EN | Official Journal of the European Union | C 386/14 |
| --- | --- | --- | --- |

31.10.2014

EN

Official Journal of the European Union

C 386/14

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

2014/C 386/03

—   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 |
| --- | --- | --- | --- | --- | --- |
| 1.9.2014 | Domperidone | See Annex I | See Annex I | See Annex I | 2.9.2014 |
| 4.9.2014 | Diacerein | See Annex II | See Annex II | See Annex II | 8.9.2014 |
| 18.9.2014 | Anagrelide | anagrelide | Not applicable | Not applicable | 19.9.2014 |
| 30.9.2014 | Emergency contraceptives — levonorgestrel | See Annex III | See Annex III | See Annex III | 1.10.2014 |
| 1.9.2014 | Baytril (Art. 34) | See Annex IV | See Annex IV | See Annex IV | 2.9.2014 |
| 1.9.2014 | Baytril (Art. 35) | See Annex V | See Annex V | See Annex V | 2.9.2014 |

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

1.9.2014

Domperidone

See Annex I

See Annex I

See Annex I

2.9.2014

4.9.2014

Diacerein

See Annex II

See Annex II

See Annex II

8.9.2014

18.9.2014

Anagrelide

anagrelide

Not applicable

Not applicable

19.9.2014

30.9.2014

Emergency contraceptives — levonorgestrel

See Annex III

See Annex III

See Annex III

1.10.2014

1.9.2014

Baytril (Art. 34)

See Annex IV

See Annex IV

See Annex IV

2.9.2014

1.9.2014

Baytril (Art. 35)

See Annex V

See Annex V

See Annex V

2.9.2014

—   Revocation 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 |
| --- | --- | --- | --- | --- | --- |
| 1.9.2014 | Domperidone | See Annex I | See Annex I | See Annex I | 2.9.2014 |

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

1.9.2014

Domperidone

See Annex I

See Annex I

See Annex I

2.9.2014

---

(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 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 | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | Domperidone | Motilium 10 mg — Filmtabletten | 10 mg | film-coated tablet | oral use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | Domperidone | Motilium 1 mg/ml — Suspension zum Einnehmen | 1 mg/ml | oral suspension | oral use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | Domperidone | Motilium 10 mg — Zäpfchen | 10 mg | suppository | rectal use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | Domperidone | Motilium 30 mg — Zäpfchen | 30 mg | suppository | rectal use |
| Austria | Janssen-Cilag Pharma GmbH
  Vorgartenstraße 206b
  1020 Wien
  Austria | Domperidone | Motilium 60 mg — Zäpfchen | 60 mg | suppository | rectal use |
| Belgium | Teva Pharma Belgium N.V.
  Laarstraat 16
  2610 Wilrijk
  Belgium | Domperidone maleate | Domperidon teva | 10 mg | film-coated tablet | oral use |
| Belgium | Eurogenerics N.V.
  Heizel Esplanade b22
  1020 Brussels
  Belgium | Domperidone maleate | Domperidone EG | 10 mg | tablet | oral use |
| Belgium | Eurogenerics N.V.
  Heizel Esplanade b22
  1020 Brussels
  Belgium | Domperidone | Domperidone instant EG | 10 mg | orodispersible tablet | oral use |
| Belgium | Mylan BVBA/SPRL
  Terhulpsesteenweg 6A
  1560 Hoeilaart
  Belgium | Domperidone maleate | Domperidone mylan | 10 mg | film-coated tablet | oral use |
| Belgium | Apotex NV
  Av Etienne Demunter 5/8
  1090 Brussels
  Belgium | Domperidone maleate | Domperitop | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone maleate | Motilium | 1 mg/ml | oral suspension | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone maleate | Motilium | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | effervescent granules | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 1 mg/ml | oral suspension | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 30 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium | 60 mg | suppository | rectal use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium instant | 10 mg | orodispersible tablet | oral use |
| Belgium | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Belgium | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Cinnarizine/
  Domperidone maleate | Touristil | 20 mg/
  19 mg | tablet | oral use |
| Belgium | Kela Pharma nv
  Industriepark 68
  9100 Sint-Niklaas
  Belgium | Domperidone maleate | Zilium | 10 mg | tablet | oral use |
| Bulgaria | Johnson & Johnson D.O.O
  Smartinska cesta 53
  1000 Ljubljana
  Slovenia | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Bulgaria | Medochemie Ltd.
  1-10 Astronafton Str.+ Limassol
  3505
  Cyprus | Domperidone | Costi | 10 mg | tablet | oral use |
| Cyprus | MEDOCHEMIE LTD
  1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos
  Cyprus | Domperidone | COSTI TABLETS 10 MG | 10 mg | tablet | oral use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | MOTILIUM ORAL SUSPENSION 1 MG/ML | 1 mg/ml | oral suspension | oral use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | MOTILIUM SUPPOSITORY 30 MG | 30 mg | suppository | rectal use |
| Cyprus | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | MOTILIUM TABLETS 10 MG | 10 mg | tablet | oral use |
| Cyprus | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | OROPERIDYS ORODISPERSIBLE TABLETS 10 MG | 10 mg | orodispersible tablet | oral use |
| Cyprus | REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,
  Cyprus | Domperidone | PEPTOMET FILM COATED TABLETS 10 MG | 10 mg | tablet | oral use |
| Czech Republic | Janssen-Cilag s.r.o.
  Karla Engliše 3201/6
  150 00 Praha 5 — Smíchov
  Czech Republic | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Czech Republic | Pierre Fabre Médicament
  45 Place Abel Gance
  92654 Boulogne Cedex
  France | Domperidone | Oroperidys 10 mg | 10 mg | orodispersible tablet | oral use |
| Denmark | Janssen-Cilag (TIBOTEC)
  Hammerbakken 19
  3460 Birkeroed
  Denmark | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Denmark | Janssen-Cilag (TIBOTEC)
  Hammerbakken 19
  3460 Birkeroed
  Denmark | Domperidone | Motilium | 30 mg | suppository | rectal use |
| Denmark | Alternova A/S
  Lodhusvej 11
  4230 Skaelskoer
  Denmark | Domperidone | Domperidon ‘Alternova’ | 10 mg | tablet | oral use |
| Estonia | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Estonia | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys 10 mg | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | BIPERIDYS 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | BIPERIDYSFLASH 20 mg, comprimé orodispersible | 20 mg | orodispersible tablet | oral use |
| France | ACTAVIS FRANCE
  La Boursidière Centre d'Affaires
  92357 Le Plessis Robinson
  France | Domperidone | DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Domperidone | DOMPERIDONE ALMUS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | ALTER
  3, avenue de la Baltique
  ZI de Courtaboeuf
  91140 Villebon Sur Yvette
  FRANCE | Domperidone | DOMPERIDONE ALTER 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | Domperidone | DOMPERIDONE ARROW 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | Domperidone | DOMPERIDONE ARROW 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | Domperidone | DOMPERIDONE ARROW 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | AUROBINDO PHARMA FRANCE
  22-26 rue des Gaudines
  78100 Saint-Germain-en-Laye
  France | Domperidone | DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Domperidone | DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Domperidone | DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Domperidone | DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | CRISTERS
  22 quai Gallieni
  92150 Suresnes
  France | Domperidone | DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | Domperidone | DOMPERIDONE EG 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | Domperidone | DOMPERIDONE EG 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | Domperidone | DOMPERIDONE EG 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | Domperidone | DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM
  8, rue Bellini
  75116 Paris
  France | Domperidone | DOMPERIDONE GERDA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | Domperidone | DOMPERIDONE MYLAN 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | Domperidone | DOMPERIDONE MYLAN 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | Domperidone | DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | QUALIMED (LYON)
  117, allée des Parcs
  69800 Saint-Priest
  France | Domperidone | DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | RATIOPHARM (ALLEMAGNE)
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Domperidone | DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | RATIOPHARM (ALLEMAGNE)
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Domperidone | DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Ranbaxy Pharmacie Génériques
  11-15 Quai Dion Bouton
  92800 Puteaux
  France | Domperidone | DOMPERIDONE RPG 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Domperidone | DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Domperidone | DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Domperidone | DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | Domperidone | DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  8, rue Bellini
  75116 Paris
  France | Domperidone | DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | Domperidone | DOMPERIDONE TEVA 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | Domperidone | DOMPERIDONE TEVA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | Domperidone | DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable | 20 mg | film-coated tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | Domperidone | DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | Domperidone | DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Sanofi-Aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | Domperidone | DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable. | 20 mg | film-coated tablet | oral use |
| France | ZYDUS FRANCE
  25, rue des Peupliers
  ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
  92000 Nanterre
  France | Domperidone | DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | Domperidone | MOTILIUM 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | Domperidone | MOTILIUM 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| France | Janssen-Cilag
  1, rue Camille Desmoulins
  TSA 91003
  92787 Issy-les-Moulineaux Cedex 9
  France | Domperidone | MOTILIUM 10 mg, granulés effervescents en sachet-dose | 10 mg | effervescent granules | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | OROPERIDYS 10 mg, comprimé orodispersible | 10 mg | orodispersible tablet | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | PERIDYS 1 mg/ml, suspension buvable | 1 mg/ml | oral suspension | oral use |
| France | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | PERIDYS 10 mg, comprimé pelliculé | 10 mg | film-coated tablet | oral use |
| Germany | 1 A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Domperidonemaleat | Domperidon — 1 A Pharma 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-CT 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | AbZ Pharma GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon AbZ 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | Accord Healthcare Limited
  Sage House, 319, Pinner Road
  HA1 4HF North Harrow, Middlesex
  United Kingdom | Domperidonemaleat | Domperidon Accord 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | ALIUD PHARMA GmbH
  Gottlieb-Daimler-Str. 19
  89150 Laichingen
  Germany | Domperidonemaleat | Domperidon AL 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | Betapharm Arzneimittel GmbH
  Kobelweg 95
  86156 Augsburg
  Germany | Domperidonemaleat | Domperidon beta 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | HEXAL AG
  Industriestr. 25
  83607 Holzkirchen
  Germany | Domperidonemaleat | Domperidom Hexal 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | RATIOPHARM GmbH
  Graf Arco Strasse 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-ratiopharm 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | Stadapharm GmbH
  Stadastr. 2-18
  61118 Bad Vilbel
  Germany | Domperidonemaleat | Domperidon STADA 10 mg Tabletten | 12,72 mg | tablet | oral use |
| Germany | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | Domperidone | Motilium Tropfen | 10 mg | oral drops, suspension | oral use |
| Germany | Takeda GmbH
  Byk-Gulden-Str. 2
  78467 Konstanz
  Germany | Domperidone | Motilium | 10 mg | tablet | oral use |
| Germany | TEVA GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domperidon-TEVA 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Germany | TEVA GmbH
  Graf-Arco-Str. 3
  89079 Ulm
  Germany | Domperidonemaleat | Domidon 10 mg Filmtabletten | 12,73 mg | film-coated tablet | oral use |
| Greece | JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
  Epidarvou 4 & Aigialeias
  Maroussi 15125
  Athens,
  Greece | Domperidone | CILROTON | 10 mg | film-coated tablet | oral use |
| Greece | JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
  Epidarvou 4 & Aigialeias
  Maroussi 15125
  Athens,
  Greece | Domperidone | CILROTON | 5 mg/5 ml | oral solution | oral use |
| Greece | PIERRE FABRE MEDICINES SA
  Messogeion 350, Agia Paraskevi 15341
  Athens,
  Greece | Domperidone | OROPERIDYS | 10 mg | orodispersible tablet | oral use |
| Hungary | Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary | Domperidone | Domperidon-EP 10 mg tabletta | 10 mg | tablet | oral use |
| Hungary | Janssen-Cilag Kft.
  Tó park
  H-2045 Törökbálint
  Hungary | Domperidone | Motilium 10 mg filmtabletta | 10 mg | film-coated tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium Fastmelts 10 mg Tablets | 10 mg | tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 10 mg Film-Coated Tablets | 10 mg | tablet | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 10 mg Suppositories | 10 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 30 mg Suppositories | 30 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 60 mg Suppositories | 60 mg | suppository | rectal use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium 1 mg/ml Oral Suspension | 1 mg/ml | oral suspension | oral use |
| Ireland | McNeil Healthcare (Ireland) Limited
  Airton Road
  Tallaght
  Dublin 24
  Ireland | Domperidone | Motilium Rx 10 mg Film-coated Tablets | 10 mg | film-coated tablet | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co Cork
  Ireland | Domperidone | DOMERID 10 mg Tablets. | 10 mg | tablet | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co Cork
  Ireland | Domperidone | Domerid Relief 10 mg Tablets. | 10 mg | tablet | oral use |
| Italy | ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 10 mg | film-coated tablet | oral use |
| Italy | ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 60 mg | suppository | rectal use |
| Italy | ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 30 mg | suppository | rectal use |
| Italy | ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 10 mg | effervescent granules | oral use |
| Italy | ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 1 mg/ml | suspension | oral use |
| Italy | ITALCHIMICI SpA
  Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 20 mg | film-coated tablet | oral use |
| Italy | ITALCHIMICI SpA
  Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy | Domperidone | PERIDON | 20 mg | effervescent granules | oral use |
| Italy | Janssen-Cilag SpA
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 1 mg/ml | suspension | oral use |
| Italy | Janssen-Cilag SpA
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 10 mg | film-coated tablet | oral use |
| Italy | Janssen-Cilag SpA
  Via Michelangelo buonarroti 23
  20093 Cologno Monzese — Milano
  Italy | Domperidone | MOTILIUM | 10 mg | effervescent granules | oral use |
| Italy | DR. REDDY'S S.R.L.
  Via Fernanda Wittgens 3 — 20123 Milano
  Italy | Domperidone | DOMPERIDONE DR. REDDY'S | 10 mg | tablet | oral use |
| Italy | DR. REDDY'S S.R.L.
  Via Fernanda Wittgens 3 — 20123 Milano
  Italy | Domperidone | DOMPERIDONE DR. REDDY'S | 100 mg/100 ml | syrup | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2 20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 5 mg | effervescent granules | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2
  20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 5 mg | chewable tablet | oral use |
| Italy | GIULIANI S.P.A
  Via Palagi 2
  20129 Milano
  Italy | Domperidone | DIGESTIVO GIULIANI | 10 mg | film-coated tablet | oral use |
| Italy | TEVA ITALIA S.R.L.
  Via Messina 38
  20154 Milano
  Italy | Domperidone | DOMPERIDONE TEVA | 10 mg | film-coated tablet | oral use |
| Italy | GERMED PHARMA SpA
  Via Cantù 11
  20092 Cinisello Balsamo — Milano — Italy | Domperidone | DOMPERIDONE GERMED | 10 mg | film-coated tablet | oral use |
| Italy | GERMED PHARMA SpA
  Via Cantù 11
  20092 Cinisello Balsamo — Milano — Italy | Domperidone | DOMPERIDONE GERMED | 10 mg/10 ml | suspension | oral use |
| Italy | ABC FARMACEUTICI SpA,
  Corso Vittorio Emanuele II 72, 10121 Torino
  Italy | Domperidone | DOMPERIDONE ABC | 10 mg | tablet | oral use |
| Italy | MYLAN SpA
  Via Vittor Pisani 20
  20124 Milano
  Italy | Domperidone | DOMPERIDONE MYLAN GENERICS | 10 mg | tablet | oral use |
| Italy | FG S.R.L.
  Via San Rocco 6 -
  85033 Episcopia Potenza
  Italy | Domperidone | DOMPERIDONE FG | 10 mg | tablet | oral use |
| Italy | EG SpA
  Via Domenico Scarlatti 31
  20124 Milano
  Italy | Domperidone | DOMPERIDONE EG | 10 mg | tablet | oral use |
| Italy | LABORATORI ALTER S.R.L.
  Via Egadi 7
  20144 Milano
  Italy | Domperidone | DOMPERIDONE ALTER | 10 mg | tablet | oral use |
| Italy | CRINOS SpA
  Via Pavia 6
  20136 Milano
  Italy | Domperidone | RIGES | 10 mg | tablet | oral use |
| Italy | SANDOZ SpA
  Largo Umberto Boccioni 1
  21040 Origgio — Varese
  Italy | Domperidone | PYNINAT | 10 mg | tablet | oral use |
| Italy | DOC GENERICI S.R.L.
  Via Manunzio 7
  20124 Milano
  Italy | Domperidone | DOMPERIDONE DOC GENERICI | 10 mg | tablet | oral use |
| Italy | ALMUS S.R.L.
  Via Cesarea 11/10
  16121 Genova
  Italy | Domperidone | DOMPERIDONE ALMUS | 10 mg | tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | DALIA | 10 mg | effervescent tablet | oral use |
| Italy | SANDOZ SpA
  Largo Umberto Boccioni 1
  21040 Origgio — Varese
  Italy | Domperidone | DOMPERIDONE SANDOZ | 10 mg | tablet | oral use |
| Italy | PENSA PHARMA SpA
  Via Ippolito Rossellini 12
  20124 Milano
  Italy | Domperidone | DOMPERIDONE PENSA | 10 mg | effervescent tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | GERDI | 5 mg | effervescent tablet | oral use |
| Italy | FARMAKOPEA S.P.A
  Via Cavriana 14
  20134 Milano
  Italy | Domperidone | GERDI | 5 mg | effervescent granules | oral use |
| Italy | CRINOS SpA
  Via Pavia 6
  20136 Milano
  Italy | Domperidone | RAXAR | 10 mg | orodispersible tablet | oral use |
| Italy | PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano
  Italy | Domperidone | NEOPERIDYS | 10 mg | orodispersible tablet | oral use |
| Italy | SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano
  Italy | Domperidone Maleato | PERMOTIL | 10 mg | tablet | oral use |
| Italy | ANGENERICO S.p.a.
  Via Nocera Umbra 75, 00181 Roma
  Italy | Domperidone Maleato | DOMPERIDONE ANGENERICO | 10 mg | tablet | oral use |
| Latvia | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys 10 mg orodispersible tablets | 10 mg | orodispersible tablet | oral use |
| Latvia | UAB ‘Johnson & Johnson’
  Geležinio Vilko g. 18A
  LT-08104 Vilnius
  Lithuania | Domperidone | Motilium 10 mg film-coated tablets | 10 mg | film-coated tablet | oral use |
| Latvia | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis 10 mg tablets | 10 mg | tablet | oral use |
| Lithuania | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Lithuania | Torrent Pharma GmbH
  Sudwestpark 50
  Nurnberg D-90449
  Germany | Domperidone | Domstal | 10 mg | tablet | oral use |
| Lithuania | UAB ‘Johnson & Johnson’
  Geležinio Vilko g. 18A
  LT-08104 Vilnius
  Lithuania | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Lithuania | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Eurogenerics SA esplanade heysel b22 1020 bruxelles
  Belgium | Domperidone (maleate) | Domperidone EG-10 | 10 mg | tablet | oral use |
| Luxembourg | Eurogenerics SA esplanade heysel b22
  1020 bruxelles
  Belgium | Domperidone | Domperidone EG-10 | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium Domperidone Base | 10 mg | coated tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium Instant-10 | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone (maleate) | Motilium-10 | 10 mg | coated tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium pediatrie | 1 mg/ml | oral suspension | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium-1 mg/ml | 1 mg/ml | oral suspension | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium-10 supp | 10 mg | suppository | rectal use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium-30 supp | 30 mg | suppository | rectal use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Domperidone | Motilium-60 supp | 60 mg | suppository | rectal use |
| Luxembourg | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Luxembourg | Johnson & Johnson Consumer N.V.
  Antwerpseweg 15-17
  2340 Beerse
  Belgium | Cinnarizine/Domperidone (maleate) | Touristil | 20 mg/
  15 mg | tablet | oral use |
| Malta | Actavis Group Hf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Domperidone | Domperidon Actavis | 10 mg | tablet | oral use |
| Malta | Medochemie Limited
  PO Box 51409
  Limassol CY-3505
  Cyprus | Domperidone | Costi 10 mg Film coated tablets | 10 mg | film-coated tablet | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | motilium 1 mg/ml oral suspension | 1 mg/ml | oral suspension | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | motilium 10 mg film coated tablets | 10 mg | film-coated tablet | oral use |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340, Beerse
  Belgium | Domperidone | motilium 30 mg Suppositories | 30 mg | suppository | rectal use |
| Poland | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | Domperidone | Oroperidys | 10 mg | orodispersible tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | Domperidone | Cinet | 10 mg | tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | Domperidone | Cinet | 10 mg | dispersible tablet | oral use |
| Portugal | Laboratório Medinfar — Produtos Farmacêuticos, S.A.
  Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova
  2700-547 Amadora
  Portugal | Domperidone | Cinet | 1 mg/ml | oral suspension | oral use |
| Portugal | Actavis A/S Sucursal
  Rua Virgílio Correia, 11 — A
  1600-219 Lisboa
  Portugal | Domperidone | Domperidona Actavis | 10 mg | tablet | oral use |
| Portugal | Baldacci — Portugal, S.A.
  Rua Cândido de Figueiredo, 84-B
  1549-005 Lisboa
  Portugal | Domperidone | Domperidona Baldacci | 10 mg | film-coated tablet | oral use |
| Portugal | Ciclum Farma Unipessoal, Lda.
  Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B
  2770-229 Paço de Arcos
  Portugal | Domperidone | Domperidona Ciclum | 10 mg | tablet | oral use |
| Portugal | GP — Genéricos Portugueses, Lda.
  Rua Henrique Paiva Couceiro, 29 — Venda Nova
  2700-451 Amadora
  Portugal | Domperidone | Domperidona GP | 10 mg | tablet | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Domperidone | Domperidona Generis | 10 mg | film-coated tablet | oral use |
| Portugal | Germed Farmacêutica, Lda.
  Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto
  2790-012 Portela de Carnaxide
  Portugal | Domperidone | Domperidona Germed | 10 mg | film-coated tablet | oral use |
| Portugal | Labesfal Genéricos, S.A.
  Avenida Dr. Afonso Costa, 1370
  3465-051 Campo de Besteiros
  Portugal | Domperidone | Domperidona Labesfal | 10 mg | tablet | oral use |
| Portugal | Mylan, Lda.
  Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4
  1990-095 Lisboa
  Portugal | Domperidone | Domperidona Mylan | 10 mg | film-coated tablet | oral use |
| Portugal | Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo
  Portugal | Domperidone | Domperidona Ratiopharm | 10 mg | film-coated tablet | oral use |
| Portugal | ToLife — Produtos Farmacêuticos, S.A.
  Avenida do Forte, 3 — Edificio Suécia III, Piso 1
  2794-093 Carnaxide
  Portugal | Domperidone | Domperidona ToLife | 10 mg | tablet | oral use |
| Portugal | Wynn Industrial Pharma, S.A.
  Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras
  1070-274 Lisboa
  Portugal | Domperidone | Domperidona Wynn | 10 mg | tablet | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | Domperidone | Motilium | 1 mg/ml | oral suspension | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | Domperidone | Motilium | 10 mg | film-coated tablet | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | Domperidone | Motilium | 10 mg | effervescent granules | oral use |
| Portugal | Johnson & Johnson, Lda.
  Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo
  2730-055 Barcarena
  Portugal | Domperidone | Motilium Rapid | 10 mg | orodispersible tablet | oral use |
| Portugal | Laboratórios Azevedos — Indústria Farmacêutica, S.A.
  Edifícios Azevedos — Estrada Nacional 117-2, Alfragide
  2614-504 Amadora
  Portugal | Domperidone | Remotil | 10 mg | tablet | oral use |
| Romania | S.C. TERAPIA S.A.
  Str. Fabricii nr. 124, Cluj Napoca,
  Romania | DOMPERIDONE | MOTILIUM 10 mg | 10 mg | film-coated tablet | oral use |
| Romania | Pierre Fabre Médicament
  45 place Abel Gance
  92100 Boulogne
  France | DOMPERIDONE | OROPERIDYS 10 mg | 10 mg | orodispersible tablet | oral use |
| Slovak Republic | Pierre Fabre Médicament
  45 Place Abel Gance
  92654 Boulogne Cedex
  France | Domperidone | OROPERIDYS 10 mg | 10 mg | tablet | oral use |
| Slovak Republic | Medochemie Ltd.
  1-10 Constantinoupoleos St.
  P.O. Box: 51409
  3505 Limassol Cyprus | Domperidone | COSTI | 10 mg | tablet | oral use |
| Slovenia | KRKA, tovarna zdravil, d.d., Novo mesto
  Šmarješka cesta 6 8501 Novo mesto Slovenia | Domperidone | Tametil 10 mg filmsko obložene tablete | 10 mg | film-coated tablet | oral use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 30 mg supositorios niños | 30 mg | suppository | rectal use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 10 mg comprimidos recubiertos con película | 10 mg | film-coated tablet | oral use |
| Spain | LABORATORIOS DR. ESTEVE, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | Domperidone | Motilium 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | Janssen-Cilag, S.A.
  Po de Las Doce Estrellas, 5-7
  28042 Madrid
  Spain | Domperidone | Nauzelin 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | Janssen-Cilag, S.A.
  Po de Las Doce Estrellas, 5-7
  28042 Madrid
  Spain | Domperidone | Nauzelin 10 mg comprimidos recubiertos con película | 10 mg | film-coated tablet | oral use |
| Spain | ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain | Domperidone | Domperidona Gamir 10 mg cápsulas duras | 10 mg | capsule, hard | oral use |
| Spain | ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain | Domperidone | Domperidona Gamir 1 mg/ml suspensión oral | 1 mg/ml | oral suspension | oral use |
| Spain | PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos
  Valencia 46015 Spain | Domperidone maleate | Domperidona Pensa 10 mg comprimidos EFG | 12,72 mg | tablet | oral use |
| Spain | Pierre Fabre Médicament
  45 place Abel Gance
  F-92100 Boulogne
  France | Domperidone | Orosperidys 10 mg comprimidos bucodispersables | 10 mg | orodispersible tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium suspensie voor oraal gebruik 1 mg/ml | 1 mg/ml | oral suspension | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor zuigelingen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor kinderen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Motilium zetpillen voor volwassenen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 30 PCH voor kinderen, zetpillen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 60 PCH voor volwassenen, zetpillen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor volwassenen 60 mg | 60 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor kinderen 30 mg | 30 mg | suppository | rectal use |
| The Netherlands | Johnson & Johnson Consumer B.V.
  Rooseveltweg 15
  1314 SJ Almere
  The Netherlands | Domperidone | Domperidon JJC zetpillen voor zuigelingen 10 mg | 10 mg | suppository | rectal use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 30 mg zetpillen Samenwerkende Apothekers | 30 mg | suppository | rectal use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen | 60 mg | suppository | rectal use |
| The Netherlands | Mylan B.V.
  Dieselweg 25
  3752 LB Bunschoten
  The Netherlands | Domperidone | Domperidon Mylan 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmacin B.V.
  Molenvliet 103
  3335 LH Zwijndrecht
  The Netherlands | Domperidone | Domperidon Pharmacin 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 PCH, filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Accord Healthcare Ltd
  Sage House, 319 Pinner Road
  HA1 4 HF North Harrow, Middlesex
  United Kingdom | Domperidone | Domperidon Accord 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Healthypharm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | Domperidone | Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Leidapharm B.V.
  Archimedesweg 2
  2333 CN Leiden
  The Netherlands | Domperidone | Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Stada Arzneimittel AG
  Stadastrasse 2-18
  61118 Bad Vilbel
  Germany | Domperidone | Domperidon STADA 10 mg tabletten | 10 mg | tablet | oral use |
| The Netherlands | Actavis B.V.
  Baarnsche Dijk 1
  3741 LN Baarn
  The Netherlands | Domperidone | Domperidon Actavis 10 mg, omhulde tabletten | 10 mg | coated tablet | oral use |
| The Netherlands | Centrafarm B.V.
  Nieuwe Donk 3
  4879 AC Etten-Leur
  The Netherlands | Domperidone | Domperidon CF 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon PCH 10, filmomhulde tabletten 10 mg | 10 mg | film-coated tablet | oral use |
| The Netherlands | Wise Pharmaceuticals Ltd.
  Hamwells Business Park Unit No7, Hardicker Street
  M19 2RB Manchester
  United Kingdom | Domperidone | Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Marel B.V.
  Archimedesweg 2
  2333 CN Leiden
  The Netherlands | Domperidone | Kruidvat Domperidon 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Sandoz B.V.
  Veluwezoom 22
  1327 AH Almere
  The Netherlands | Domperidone | Domperidon Sandoz 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Sofar S.p.A.
  Via Firenze 40
  20060 Trezzano Rosa (MI)
  Italy | Domperidone | Domperidon Sofar 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Bellwood Pharmaceuticals Ltd.
  First Floor 69, St. Patricks Road
  Dalkey, Co. Dublin
  Ireland | Domperidone | Domperidon Bellwood 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Faribérica, Productos Farmacêuticos, SA
  Estrada da Luz, 90-9o CDE
  1600-160 Lissabon
  Portugal | Domperidone | Domperidon Faribérica 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Actavis Nordic A/S
  Ornegardsvej 16
  2820 Gentofte
  Denmark | Domperidone | Domperidon Actavis 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Mediq Farma B.V.
  Hertogswetering 159
  3543 AS Utrecht
  The Netherlands | Domperidone | Domperidon Mdq 10 mg, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 mg PCH, tabletten | 10 mg | tablet | oral use |
| The Netherlands | Samenwerkende Apothekers Nederland B.V.
  Kralingseweg 201
  3062 CE Rotterdam
  The Netherlands | Domperidone | Domperidon 10 mg tabletten Samenwerkende Apothekers | 10 mg | tablet | oral use |
| The Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA Haarlem
  The Netherlands | Domperidone | Domperidon 10 mg Pharmachemie, tabletten | 10 mg | tablet | oral use |
| The Netherlands | KELA Pharma nv
  Industriepark West 68
  9100 Sint-Niklaas
  Belgium | Domperidone | Domperidon Kela 10 mg, tabletten | 10 mg | tablet | oral use |
| United Kingdom | Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,
  United Kingdom | Domperidone maleate | Domperidone Tablets 10 mg | 10 mg | coated tablet | oral use |
| United Kingdom | Co-Pharma Limited
  Unit 4, Metro Centre
  Tolpits Lane, Watford
  Hertfordshire
  WD18 9SS
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Manx Healthcare Limited
  Taylor Group House
  Wedgnock Lane
  Warwick
  CV34 5YA
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
  United Kingdom | Domperidone maleate | Motilium 10 | 10 mg | tablet | oral use |
| United Kingdom | McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
  United Kingdom | Domperidone maleate | Motilium Instants | 10 mg | orodispersible tablet | oral use |
| United Kingdom | Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS,
  United Kingdom | Domperidone | Domperidone 1 mg/ml Oral Suspension | 5 mg | oral suspension | oral use |
| United Kingdom | Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
  United Kingdom | Domperidone maleate | Motilium 10 mg Film-coated Tablets | 10 mg | film-coated tablet | oral use |
| United Kingdom | Bristol Laboratories Limited
  Unit 3, Canalside
  Northbridge Road, Berkhamsted
  Hertfordshire
  HP4 1EG
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Focus Pharmaceuticals Limited
  Unit 5, Faraday Court
  First Avenue, Centrum 100
  Burton Upon Trent, Staffordshire
  DE14 2WX
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Medreich plc,
  Warwick House, Plane Tree Crescent, Feltham TW13 7HF
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | tablet | oral use |
| United Kingdom | Wockhardt UK Limited
  Ash Road North
  Wrexham Industrial Estate
  Wrexham LL13 9UF
  United Kingdom | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | film-coated tablet | oral use |
| United Kingdom | Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon,
  Ireland | Domperidone maleate | Domperidone 10 mg Tablets | 10 mg | film-coated tablet | oral use |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

Domperidone

Motilium 10 mg — Filmtabletten

10 mg

film-coated tablet

oral use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

Domperidone

Motilium 1 mg/ml — Suspension zum Einnehmen

1 mg/ml

oral suspension

oral use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

Domperidone

Motilium 10 mg — Zäpfchen

10 mg

suppository

rectal use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

Domperidone

Motilium 30 mg — Zäpfchen

30 mg

suppository

rectal use

Austria

Janssen-Cilag Pharma GmbH

Vorgartenstraße 206b

1020 Wien

Austria

Domperidone

Motilium 60 mg — Zäpfchen

60 mg

suppository

rectal use

Belgium

Teva Pharma Belgium N.V.

Laarstraat 16

2610 Wilrijk

Belgium

Domperidone maleate

Domperidon teva

10 mg

film-coated tablet

oral use

Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Domperidone maleate

Domperidone EG

10 mg

tablet

oral use

Belgium

Eurogenerics N.V.

Heizel Esplanade b22

1020 Brussels

Belgium

Domperidone

Domperidone instant EG

10 mg

orodispersible tablet

oral use

Belgium

Mylan BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

Domperidone maleate

Domperidone mylan

10 mg

film-coated tablet

oral use

Belgium

Apotex NV

Av Etienne Demunter 5/8

1090 Brussels

Belgium

Domperidone maleate

Domperitop

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone maleate

Motilium

1 mg/ml

oral suspension

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone maleate

Motilium

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

effervescent granules

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

1 mg/ml

oral suspension

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

30 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium

60 mg

suppository

rectal use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium instant

10 mg

orodispersible tablet

oral use

Belgium

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Belgium

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Cinnarizine/

Domperidone maleate

Touristil

20 mg/

19 mg

tablet

oral use

Belgium

Kela Pharma nv

Industriepark 68

9100 Sint-Niklaas

Belgium

Domperidone maleate

Zilium

10 mg

tablet

oral use

Bulgaria

Johnson & Johnson D.O.O

Smartinska cesta 53

1000 Ljubljana

Slovenia

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Bulgaria

Medochemie Ltd.

1-10 Astronafton Str.+ Limassol

3505

Cyprus

Domperidone

Costi

10 mg

tablet

oral use

Cyprus

MEDOCHEMIE LTD

1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos

Cyprus

Domperidone

COSTI TABLETS 10 MG

10 mg

tablet

oral use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

MOTILIUM ORAL SUSPENSION 1 MG/ML

1 mg/ml

oral suspension

oral use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

MOTILIUM SUPPOSITORY 30 MG

30 mg

suppository

rectal use

Cyprus

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

MOTILIUM TABLETS 10 MG

10 mg

tablet

oral use

Cyprus

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

OROPERIDYS ORODISPERSIBLE TABLETS 10 MG

10 mg

orodispersible tablet

oral use

Cyprus

REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos,

Cyprus

Domperidone

PEPTOMET FILM COATED TABLETS 10 MG

10 mg

tablet

oral use

Czech Republic

Janssen-Cilag s.r.o.

Karla Engliše 3201/6

150 00 Praha 5 — Smíchov

Czech Republic

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Czech Republic

Pierre Fabre Médicament

45 Place Abel Gance

92654 Boulogne Cedex

France

Domperidone

Oroperidys 10 mg

10 mg

orodispersible tablet

oral use

Denmark

Janssen-Cilag (TIBOTEC)

Hammerbakken 19

3460 Birkeroed

Denmark

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Denmark

Janssen-Cilag (TIBOTEC)

Hammerbakken 19

3460 Birkeroed

Denmark

Domperidone

Motilium

30 mg

suppository

rectal use

Denmark

Alternova A/S

Lodhusvej 11

4230 Skaelskoer

Denmark

Domperidone

Domperidon ‘Alternova’

10 mg

tablet

oral use

Estonia

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis

10 mg

tablet

oral use

Estonia

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys 10 mg

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

BIPERIDYS 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

BIPERIDYSFLASH 20 mg, comprimé orodispersible

20 mg

orodispersible tablet

oral use

France

ACTAVIS FRANCE

La Boursidière Centre d'Affaires

92357 Le Plessis Robinson

France

Domperidone

DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Domperidone

DOMPERIDONE ALMUS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

FRANCE

Domperidone

DOMPERIDONE ALTER 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Domperidone

DOMPERIDONE ARROW 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Domperidone

DOMPERIDONE ARROW 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

Domperidone

DOMPERIDONE ARROW 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

AUROBINDO PHARMA FRANCE

22-26 rue des Gaudines

78100 Saint-Germain-en-Laye

France

Domperidone

DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Domperidone

DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Domperidone

DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

Domperidone

DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

CRISTERS

22 quai Gallieni

92150 Suresnes

France

Domperidone

DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Domperidone

DOMPERIDONE EG 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Domperidone

DOMPERIDONE EG 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Domperidone

DOMPERIDONE EG 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

Domperidone

DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM

8, rue Bellini

75116 Paris

France

Domperidone

DOMPERIDONE GERDA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Domperidone

DOMPERIDONE MYLAN 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Domperidone

DOMPERIDONE MYLAN 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

Domperidone

DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

Domperidone

DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Germany

Domperidone

DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Germany

Domperidone

DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Ranbaxy Pharmacie Génériques

11-15 Quai Dion Bouton

92800 Puteaux

France

Domperidone

DOMPERIDONE RPG 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Domperidone

DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Domperidone

DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Domperidone

DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

Domperidone

DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

SUBSTIPHARM DEVELOPPEMENT

8, rue Bellini

75116 Paris

France

Domperidone

DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Domperidone

DOMPERIDONE TEVA 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Domperidone

DOMPERIDONE TEVA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

Domperidone

DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable

20 mg

film-coated tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Domperidone

DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Domperidone

DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Sanofi-Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Domperidone

DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable.

20 mg

film-coated tablet

oral use

France

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers

92000 Nanterre

France

Domperidone

DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

Domperidone

MOTILIUM 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

Domperidone

MOTILIUM 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

France

Janssen-Cilag

1, rue Camille Desmoulins

TSA 91003

92787 Issy-les-Moulineaux Cedex 9

France

Domperidone

MOTILIUM 10 mg, granulés effervescents en sachet-dose

10 mg

effervescent granules

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

OROPERIDYS 10 mg, comprimé orodispersible

10 mg

orodispersible tablet

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

PERIDYS 1 mg/ml, suspension buvable

1 mg/ml

oral suspension

oral use

France

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

PERIDYS 10 mg, comprimé pelliculé

10 mg

film-coated tablet

oral use

Germany

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Domperidonemaleat

Domperidon — 1 A Pharma 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-CT 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

AbZ Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon AbZ 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

Accord Healthcare Limited

Sage House, 319, Pinner Road

HA1 4HF North Harrow, Middlesex

United Kingdom

Domperidonemaleat

Domperidon Accord 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Domperidonemaleat

Domperidon AL 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

Betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

Domperidonemaleat

Domperidon beta 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

HEXAL AG

Industriestr. 25

83607 Holzkirchen

Germany

Domperidonemaleat

Domperidom Hexal 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

RATIOPHARM GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-ratiopharm 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Domperidonemaleat

Domperidon STADA 10 mg Tabletten

12,72 mg

tablet

oral use

Germany

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Domperidone

Motilium Tropfen

10 mg

oral drops, suspension

oral use

Germany

Takeda GmbH

Byk-Gulden-Str. 2

78467 Konstanz

Germany

Domperidone

Motilium

10 mg

tablet

oral use

Germany

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domperidon-TEVA 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Germany

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Domperidonemaleat

Domidon 10 mg Filmtabletten

12,73 mg

film-coated tablet

oral use

Greece

JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA

Epidarvou 4 & Aigialeias

Maroussi 15125

Athens,

Greece

Domperidone

CILROTON

10 mg

film-coated tablet

oral use

Greece

JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA

Epidarvou 4 & Aigialeias

Maroussi 15125

Athens,

Greece

Domperidone

CILROTON

5 mg/5 ml

oral solution

oral use

Greece

PIERRE FABRE MEDICINES SA

Messogeion 350, Agia Paraskevi 15341

Athens,

Greece

Domperidone

OROPERIDYS

10 mg

orodispersible tablet

oral use

Hungary

Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary

Domperidone

Domperidon-EP 10 mg tabletta

10 mg

tablet

oral use

Hungary

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Hungary

Domperidone

Motilium 10 mg filmtabletta

10 mg

film-coated tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium Fastmelts 10 mg Tablets

10 mg

tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 10 mg Film-Coated Tablets

10 mg

tablet

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 10 mg Suppositories

10 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 30 mg Suppositories

30 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 60 mg Suppositories

60 mg

suppository

rectal use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium 1 mg/ml Oral Suspension

1 mg/ml

oral suspension

oral use

Ireland

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

Domperidone

Motilium Rx 10 mg Film-coated Tablets

10 mg

film-coated tablet

oral use

Ireland

Rowex Ltd

Bantry

Co Cork

Ireland

Domperidone

DOMERID 10 mg Tablets.

10 mg

tablet

oral use

Ireland

Rowex Ltd

Bantry

Co Cork

Ireland

Domperidone

Domerid Relief 10 mg Tablets.

10 mg

tablet

oral use

Italy

ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

10 mg

film-coated tablet

oral use

Italy

ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

60 mg

suppository

rectal use

Italy

ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

30 mg

suppository

rectal use

Italy

ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

10 mg

effervescent granules

oral use

Italy

ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

1 mg/ml

suspension

oral use

Italy

ITALCHIMICI SpA

Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

20 mg

film-coated tablet

oral use

Italy

ITALCHIMICI SpA

Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy

Domperidone

PERIDON

20 mg

effervescent granules

oral use

Italy

Janssen-Cilag SpA

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

1 mg/ml

suspension

oral use

Italy

Janssen-Cilag SpA

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

10 mg

film-coated tablet

oral use

Italy

Janssen-Cilag SpA

Via Michelangelo buonarroti 23

20093 Cologno Monzese — Milano

Italy

Domperidone

MOTILIUM

10 mg

effervescent granules

oral use

Italy

DR. REDDY'S S.R.L.

Via Fernanda Wittgens 3 — 20123 Milano

Italy

Domperidone

DOMPERIDONE DR. REDDY'S

10 mg

tablet

oral use

Italy

DR. REDDY'S S.R.L.

Via Fernanda Wittgens 3 — 20123 Milano

Italy

Domperidone

DOMPERIDONE DR. REDDY'S

100 mg/100 ml

syrup

oral use

Italy

GIULIANI S.P.A

Via Palagi 2 20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

5 mg

effervescent granules

oral use

Italy

GIULIANI S.P.A

Via Palagi 2

20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

5 mg

chewable tablet

oral use

Italy

GIULIANI S.P.A

Via Palagi 2

20129 Milano

Italy

Domperidone

DIGESTIVO GIULIANI

10 mg

film-coated tablet

oral use

Italy

TEVA ITALIA S.R.L.

Via Messina 38

20154 Milano

Italy

Domperidone

DOMPERIDONE TEVA

10 mg

film-coated tablet

oral use

Italy

GERMED PHARMA SpA

Via Cantù 11

20092 Cinisello Balsamo — Milano — Italy

Domperidone

DOMPERIDONE GERMED

10 mg

film-coated tablet

oral use

Italy

GERMED PHARMA SpA

Via Cantù 11

20092 Cinisello Balsamo — Milano — Italy

Domperidone

DOMPERIDONE GERMED

10 mg/10 ml

suspension

oral use

Italy

ABC FARMACEUTICI SpA,

Corso Vittorio Emanuele II 72, 10121 Torino

Italy

Domperidone

DOMPERIDONE ABC

10 mg

tablet

oral use

Italy

MYLAN SpA

Via Vittor Pisani 20

20124 Milano

Italy

Domperidone

DOMPERIDONE MYLAN GENERICS

10 mg

tablet

oral use

Italy

FG S.R.L.

Via San Rocco 6 -

85033 Episcopia Potenza

Italy

Domperidone

DOMPERIDONE FG

10 mg

tablet

oral use

Italy

EG SpA

Via Domenico Scarlatti 31

20124 Milano

Italy

Domperidone

DOMPERIDONE EG

10 mg

tablet

oral use

Italy

LABORATORI ALTER S.R.L.

Via Egadi 7

20144 Milano

Italy

Domperidone

DOMPERIDONE ALTER

10 mg

tablet

oral use

Italy

CRINOS SpA

Via Pavia 6

20136 Milano

Italy

Domperidone

RIGES

10 mg

tablet

oral use

Italy

SANDOZ SpA

Largo Umberto Boccioni 1

21040 Origgio — Varese

Italy

Domperidone

PYNINAT

10 mg

tablet

oral use

Italy

DOC GENERICI S.R.L.

Via Manunzio 7

20124 Milano

Italy

Domperidone

DOMPERIDONE DOC GENERICI

10 mg

tablet

oral use

Italy

ALMUS S.R.L.

Via Cesarea 11/10

16121 Genova

Italy

Domperidone

DOMPERIDONE ALMUS

10 mg

tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

DALIA

10 mg

effervescent tablet

oral use

Italy

SANDOZ SpA

Largo Umberto Boccioni 1

21040 Origgio — Varese

Italy

Domperidone

DOMPERIDONE SANDOZ

10 mg

tablet

oral use

Italy

PENSA PHARMA SpA

Via Ippolito Rossellini 12

20124 Milano

Italy

Domperidone

DOMPERIDONE PENSA

10 mg

effervescent tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

GERDI

5 mg

effervescent tablet

oral use

Italy

FARMAKOPEA S.P.A

Via Cavriana 14

20134 Milano

Italy

Domperidone

GERDI

5 mg

effervescent granules

oral use

Italy

CRINOS SpA

Via Pavia 6

20136 Milano

Italy

Domperidone

RAXAR

10 mg

orodispersible tablet

oral use

Italy

PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano

Italy

Domperidone

NEOPERIDYS

10 mg

orodispersible tablet

oral use

Italy

SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano

Italy

Domperidone Maleato

PERMOTIL

10 mg

tablet

oral use

Italy

ANGENERICO S.p.a.

Via Nocera Umbra 75, 00181 Roma

Italy

Domperidone Maleato

DOMPERIDONE ANGENERICO

10 mg

tablet

oral use

Latvia

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys 10 mg orodispersible tablets

10 mg

orodispersible tablet

oral use

Latvia

UAB ‘Johnson & Johnson’

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

Domperidone

Motilium 10 mg film-coated tablets

10 mg

film-coated tablet

oral use

Latvia

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis 10 mg tablets

10 mg

tablet

oral use

Lithuania

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis

10 mg

tablet

oral use

Lithuania

Torrent Pharma GmbH

Sudwestpark 50

Nurnberg D-90449

Germany

Domperidone

Domstal

10 mg

tablet

oral use

Lithuania

UAB ‘Johnson & Johnson’

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Lithuania

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Luxembourg

Eurogenerics SA esplanade heysel b22 1020 bruxelles

Belgium

Domperidone (maleate)

Domperidone EG-10

10 mg

tablet

oral use

Luxembourg

Eurogenerics SA esplanade heysel b22

1020 bruxelles

Belgium

Domperidone

Domperidone EG-10

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium Domperidone Base

10 mg

coated tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium Instant-10

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone (maleate)

Motilium-10

10 mg

coated tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium pediatrie

1 mg/ml

oral suspension

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium-1 mg/ml

1 mg/ml

oral suspension

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium-10 supp

10 mg

suppository

rectal use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium-30 supp

30 mg

suppository

rectal use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Domperidone

Motilium-60 supp

60 mg

suppository

rectal use

Luxembourg

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Luxembourg

Johnson & Johnson Consumer N.V.

Antwerpseweg 15-17

2340 Beerse

Belgium

Cinnarizine/Domperidone (maleate)

Touristil

20 mg/

15 mg

tablet

oral use

Malta

Actavis Group Hf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Domperidone

Domperidon Actavis

10 mg

tablet

oral use

Malta

Medochemie Limited

PO Box 51409

Limassol CY-3505

Cyprus

Domperidone

Costi 10 mg Film coated tablets

10 mg

film-coated tablet

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

motilium 1 mg/ml oral suspension

1 mg/ml

oral suspension

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

motilium 10 mg film coated tablets

10 mg

film-coated tablet

oral use

Malta

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340, Beerse

Belgium

Domperidone

motilium 30 mg Suppositories

30 mg

suppository

rectal use

Poland

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

Domperidone

Oroperidys

10 mg

orodispersible tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

Domperidone

Cinet

10 mg

tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

Domperidone

Cinet

10 mg

dispersible tablet

oral use

Portugal

Laboratório Medinfar — Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova

2700-547 Amadora

Portugal

Domperidone

Cinet

1 mg/ml

oral suspension

oral use

Portugal

Actavis A/S Sucursal

Rua Virgílio Correia, 11 — A

1600-219 Lisboa

Portugal

Domperidone

Domperidona Actavis

10 mg

tablet

oral use

Portugal

Baldacci — Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

Domperidone

Domperidona Baldacci

10 mg

film-coated tablet

oral use

Portugal

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Domperidone

Domperidona Ciclum

10 mg

tablet

oral use

Portugal

GP — Genéricos Portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 — Venda Nova

2700-451 Amadora

Portugal

Domperidone

Domperidona GP

10 mg

tablet

oral use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Domperidone

Domperidona Generis

10 mg

film-coated tablet

oral use

Portugal

Germed Farmacêutica, Lda.

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

2790-012 Portela de Carnaxide

Portugal

Domperidone

Domperidona Germed

10 mg

film-coated tablet

oral use

Portugal

Labesfal Genéricos, S.A.

Avenida Dr. Afonso Costa, 1370

3465-051 Campo de Besteiros

Portugal

Domperidone

Domperidona Labesfal

10 mg

tablet

oral use

Portugal

Mylan, Lda.

Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4

1990-095 Lisboa

Portugal

Domperidone

Domperidona Mylan

10 mg

film-coated tablet

oral use

Portugal

Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda.

Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo

Portugal

Domperidone

Domperidona Ratiopharm

10 mg

film-coated tablet

oral use

Portugal

ToLife — Produtos Farmacêuticos, S.A.

Avenida do Forte, 3 — Edificio Suécia III, Piso 1

2794-093 Carnaxide

Portugal

Domperidone

Domperidona ToLife

10 mg

tablet

oral use

Portugal

Wynn Industrial Pharma, S.A.

Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras

1070-274 Lisboa

Portugal

Domperidone

Domperidona Wynn

10 mg

tablet

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

Domperidone

Motilium

1 mg/ml

oral suspension

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

Domperidone

Motilium

10 mg

film-coated tablet

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

Domperidone

Motilium

10 mg

effervescent granules

oral use

Portugal

Johnson & Johnson, Lda.

Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo

2730-055 Barcarena

Portugal

Domperidone

Motilium Rapid

10 mg

orodispersible tablet

oral use

Portugal

Laboratórios Azevedos — Indústria Farmacêutica, S.A.

Edifícios Azevedos — Estrada Nacional 117-2, Alfragide

2614-504 Amadora

Portugal

Domperidone

Remotil

10 mg

tablet

oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii nr. 124, Cluj Napoca,

Romania

DOMPERIDONE

MOTILIUM 10 mg

10 mg

film-coated tablet

oral use

Romania

Pierre Fabre Médicament

45 place Abel Gance

92100 Boulogne

France

DOMPERIDONE

OROPERIDYS 10 mg

10 mg

orodispersible tablet

oral use

Slovak Republic

Pierre Fabre Médicament

45 Place Abel Gance

92654 Boulogne Cedex

France

Domperidone

OROPERIDYS 10 mg

10 mg

tablet

oral use

Slovak Republic

Medochemie Ltd.

1-10 Constantinoupoleos St.

P.O. Box: 51409

3505 Limassol Cyprus

Domperidone

COSTI

10 mg

tablet

oral use

Slovenia

KRKA, tovarna zdravil, d.d., Novo mesto

Šmarješka cesta 6 8501 Novo mesto Slovenia

Domperidone

Tametil 10 mg filmsko obložene tablete

10 mg

film-coated tablet

oral use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 30 mg supositorios niños

30 mg

suppository

rectal use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 10 mg comprimidos recubiertos con película

10 mg

film-coated tablet

oral use

Spain

LABORATORIOS DR. ESTEVE, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

Domperidone

Motilium 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

Janssen-Cilag, S.A.

Po de Las Doce Estrellas, 5-7

28042 Madrid

Spain

Domperidone

Nauzelin 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

Janssen-Cilag, S.A.

Po de Las Doce Estrellas, 5-7

28042 Madrid

Spain

Domperidone

Nauzelin 10 mg comprimidos recubiertos con película

10 mg

film-coated tablet

oral use

Spain

ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain

Domperidone

Domperidona Gamir 10 mg cápsulas duras

10 mg

capsule, hard

oral use

Spain

ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain

Domperidone

Domperidona Gamir 1 mg/ml suspensión oral

1 mg/ml

oral suspension

oral use

Spain

PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos

Valencia 46015 Spain

Domperidone maleate

Domperidona Pensa 10 mg comprimidos EFG

12,72 mg

tablet

oral use

Spain

Pierre Fabre Médicament

45 place Abel Gance

F-92100 Boulogne

France

Domperidone

Orosperidys 10 mg comprimidos bucodispersables

10 mg

orodispersible tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium suspensie voor oraal gebruik 1 mg/ml

1 mg/ml

oral suspension

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor zuigelingen 10 mg

10 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor kinderen 30 mg

30 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Motilium zetpillen voor volwassenen 60 mg

60 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg

10 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 30 PCH voor kinderen, zetpillen 30 mg

30 mg

suppository

rectal use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 60 PCH voor volwassenen, zetpillen 60 mg

60 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor volwassenen 60 mg

60 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor kinderen 30 mg

30 mg

suppository

rectal use

The Netherlands

Johnson & Johnson Consumer B.V.

Rooseveltweg 15

1314 SJ Almere

The Netherlands

Domperidone

Domperidon JJC zetpillen voor zuigelingen 10 mg

10 mg

suppository

rectal use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 30 mg zetpillen Samenwerkende Apothekers

30 mg

suppository

rectal use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen

60 mg

suppository

rectal use

The Netherlands

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Domperidone

Domperidon Mylan 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmacin B.V.

Molenvliet 103

3335 LH Zwijndrecht

The Netherlands

Domperidone

Domperidon Pharmacin 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 PCH, filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Accord Healthcare Ltd

Sage House, 319 Pinner Road

HA1 4 HF North Harrow, Middlesex

United Kingdom

Domperidone

Domperidon Accord 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Healthypharm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

Domperidone

Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Leidapharm B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Domperidone

Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Domperidone

Domperidon STADA 10 mg tabletten

10 mg

tablet

oral use

The Netherlands

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Domperidone

Domperidon Actavis 10 mg, omhulde tabletten

10 mg

coated tablet

oral use

The Netherlands

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

The Netherlands

Domperidone

Domperidon CF 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon PCH 10, filmomhulde tabletten 10 mg

10 mg

film-coated tablet

oral use

The Netherlands

Wise Pharmaceuticals Ltd.

Hamwells Business Park Unit No7, Hardicker Street

M19 2RB Manchester

United Kingdom

Domperidone

Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Marel B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

Domperidone

Kruidvat Domperidon 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Domperidone

Domperidon Sandoz 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Sofar S.p.A.

Via Firenze 40

20060 Trezzano Rosa (MI)

Italy

Domperidone

Domperidon Sofar 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Bellwood Pharmaceuticals Ltd.

First Floor 69, St. Patricks Road

Dalkey, Co. Dublin

Ireland

Domperidone

Domperidon Bellwood 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Faribérica, Productos Farmacêuticos, SA

Estrada da Luz, 90-9o CDE

1600-160 Lissabon

Portugal

Domperidone

Domperidon Faribérica 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Actavis Nordic A/S

Ornegardsvej 16

2820 Gentofte

Denmark

Domperidone

Domperidon Actavis 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Mediq Farma B.V.

Hertogswetering 159

3543 AS Utrecht

The Netherlands

Domperidone

Domperidon Mdq 10 mg, tabletten

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 mg PCH, tabletten

10 mg

tablet

oral use

The Netherlands

Samenwerkende Apothekers Nederland B.V.

Kralingseweg 201

3062 CE Rotterdam

The Netherlands

Domperidone

Domperidon 10 mg tabletten Samenwerkende Apothekers

10 mg

tablet

oral use

The Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Domperidone

Domperidon 10 mg Pharmachemie, tabletten

10 mg

tablet

oral use

The Netherlands

KELA Pharma nv

Industriepark West 68

9100 Sint-Niklaas

Belgium

Domperidone

Domperidon Kela 10 mg, tabletten

10 mg

tablet

oral use

United Kingdom

Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG,

United Kingdom

Domperidone maleate

Domperidone Tablets 10 mg

10 mg

coated tablet

oral use

United Kingdom

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane, Watford

Hertfordshire

WD18 9SS

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Manx Healthcare Limited

Taylor Group House

Wedgnock Lane

Warwick

CV34 5YA

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,

United Kingdom

Domperidone maleate

Motilium 10

10 mg

tablet

oral use

United Kingdom

McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,

United Kingdom

Domperidone maleate

Motilium Instants

10 mg

orodispersible tablet

oral use

United Kingdom

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS,

United Kingdom

Domperidone

Domperidone 1 mg/ml Oral Suspension

5 mg

oral suspension

oral use

United Kingdom

Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS

United Kingdom

Domperidone maleate

Motilium 10 mg Film-coated Tablets

10 mg

film-coated tablet

oral use

United Kingdom

Bristol Laboratories Limited

Unit 3, Canalside

Northbridge Road, Berkhamsted

Hertfordshire

HP4 1EG

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Focus Pharmaceuticals Limited

Unit 5, Faraday Court

First Avenue, Centrum 100

Burton Upon Trent, Staffordshire

DE14 2WX

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Medreich plc,

Warwick House, Plane Tree Crescent, Feltham TW13 7HF

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

tablet

oral use

United Kingdom

Wockhardt UK Limited

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

film-coated tablet

oral use

United Kingdom

Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon,

Ireland

Domperidone maleate

Domperidone 10 mg Tablets

10 mg

film-coated tablet

oral use

---

ANNEX II

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States

| Member State (in EEA) | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
  2355 Wiener Neudorf
  Austria | ARTROLYT 50 mg Kapseln | 50 mg | capsule, hard | oral use |
| Austria | TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
  2355 Wiener Neudorf
  Austria | VERBORIL 50 mg Kapseln | 50 mg | capsule, hard | oral use |
| Czech Republic | TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
  2355 Wiener Neudorf
  Austria | ARTRODAR | 50 mg | capsule, hard | oral use |
| France | NEGMA
  10, rue Paul Dautier
  78140 Vélizy Villacoublay
  France | ART 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | ACTAVIS GROUP (ISLANDE)
  Reykjavikurvegur 76-78
  220 Hafnarfjordur
  Iceland | DIACEREINE ACTAVIS 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | ARROW GENERIQUES
  26, avenue Tony Garnier
  69007 Lyon
  France | DIACEREINE ARROW 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | DIACEREINE BIOGARAN 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | CRISTERS
  22 quai Gallieni
  92150 Suresnes
  France | DIACEREINE CRISTERS 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | EG LABO — LABORATOIRES EUROGENERICS
  ‘Le Quintet’ — bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | DIACEREINE EG 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | EVOLUPHARM
  rue Irène Caron
  Zone Industrielle d'Auneuil
  60390 Auneuil
  France | DIACEREINE EVOLUGEN 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | MAZAL PHARMACEUTIQUE
  11, rue Rontgen
  BP 1309
  29103 Quimper
  France | DIACEREINE MAZAL 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | DIACEREINE MYLAN 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | NEGMA
  10, rue Paul Dautier
  78140 Vélizy Villacoublay
  France | DIACEREINE NEGMA 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | LABORATOIRES PHARMA 2000
  10 rue Paul Dautier
  78140 Vélizy Villacoublay
  France | DIACEREINE PHARMA 2000 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | RANBAXY PHARMACIE GENERIQUES
  11-15 Quai de Dion Bouton
  92800 Puteaux
  France | DIACEREINE RANBAXY 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | DIACEREINE RATIOPHARM 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | BIOGARAN
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | DIACEREINE REF 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | DIACEREINE SANDOZ 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | SUBSTIPHARM DEVELOPPEMENT
  24, rue Erlanger
  75016 Paris
  FRANCE | DIACEREINE SUBSTIPHARM 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  France | DIACEREINE TEVA 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | SANOFI AVENTIS FRANCE
  1-13, boulevard Romain Rolland
  75014 Paris
  France | DIACEREINE ZENTIVA 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | ZYDUS FRANCE
  25, rue des Peupliers
  ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers
  92000 Nanterre
  France | DIACEREINE ZYDUS 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | MAZAL PHARMACEUTIQUE
  11, rue Rontgen
  BP 1309
  29103 Quimper
  France | MAZART 50 mg, gélule | 50 mg | capsule, hard | oral use |
| France | NIVERPHARM
  10 rue Paul Dautier
  78140 Vélizy Villacoublay
  France | ZONDAR 50 mg, gélule | 50 mg | capsule, hard | oral use |
| Greece | ANGELINI PHARMA HELLAS
  Achaias and Troizinias, Nea Kifissia 14564, Athens
  Greece | VERBORIL | 50 mg | capsule, hard | oral use |
| Greece | AURORA PHARMACEUTICALS S.A.
  Evrou 4 and Messinias 2,
  Gerakas 15344
  Greece | ARTHROREIN | 50 mg | capsule, hard | oral use |
| Greece | VOCATE Pharmaceuticals S.A.,
  Gounari 150, Glyfada 16674 Athens
  Greece | ARTHROFAR | 50 mg | capsule, hard | oral use |
| Greece | RAFARM AEBE
  korinthou 12, Neo Psychiko, 15451
  Greece | IDEALITE | 50 mg | capsule, hard | oral use |
| Greece | HELP ABEE
  Valaoritou 10, Metamorfosi, Attikis, 14452
  Greece | INFLABION | 50 mg | capsule, hard | oral use |
| Greece | BROS EPE
  Avgis & Gallinis 15, n. Kifissia, 14564
  Greece | REUMANISAL | 50 mg | capsule, hard | oral use |
| Greece | FARMEDIA A.E.
  Athinas 22 & Apollonos
  Gerakas, Attikis, 15344
  Greece | OSTIREIN | 50 mg | capsule, hard | oral use |
| Greece | GENEPHARM A.E.
  18th km Marathonos Avenue, Pallini, Attikis, 15351
  Greece | MYOBLOC | 50 mg | capsule, hard | oral use |
| Greece | PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS
  Dilou 9, Peristeri, Attikis, 12134
  Greece | DIACEREIN/PROEL | 50 mg | capsule, hard | oral use |
| Greece | NORMA HELLAS A.E.
  Menandrou 54, Athens, 10431
  Greece | DIACEREIN/NORMA | 50 mg | capsule, hard | oral use |
| Greece | S.M. Pharmaceutical Products Ltd,
  Agiou Orous 43-45 Piraeus 18545
  Greece | DESEREIN | 50 mg | capsule, hard | oral use |
| Greece | PROTON PHARMA
  Achaias 4 and Trizoinias,
  Nea Kifissia 14564
  Greece | DIACERIL | 50 mg | capsule, hard | oral use |
| Italy | ABIOGEN PHARMA S.p.A.
  Via Meucci 36
  56121 Ospedaletto — Pisa
  Italy | FISIODAR | 50 mg | capsule, hard | oral use |
| Portugal | Neo-Farmacêutica, S.A.
  Av. D. João II,
  Lote 1.02.2.1 D-2o

  1990-090 Lisboa
  Portugal | Artrolyt | 50 mg | capsule, hard | oral use |
| Slovak Republic | TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG
  2355 Wiener Neudorf
  Austria | ARTRODAR | 50 mg | capsule, hard | oral use |
| Spain | ROTTAPHARM S.L. Avda. Diagonal, 67-69 08019 Barcelona ESPAÑA | GLIZOLAN 50 mg cápsulas | 50 mg | capsule, hard | Oral use |
| Spain | NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F-78771 France | ARTRIZAN 50 mg cápsulas | 50 mg | capsule, hard | Oral use |
| Spain | LACER S.A. Sardenya, 350 08025 Barcelona Spain | GALAXDAR 50 mg cápsulas | 50 mg | capsule, hard | Oral use |
| Spain | LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain | DIACEREINA NORMON 50 mg cápsulas duras EFG | 50 mg | capsule, hard | Oral use |
| Spain | IBERMEDGEN S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain | DIACEREINA PANLUETOL 50 mg cápsulas duras EFG | 50 mg | capsule, hard | Oral use |
| Spain | MG PHARMA
  8, Rue Bellini 75116 Paris France | REINART 50 mg cápsulas duras EFG | 50 mg | capsule, hard | Oral use |

Member State (in EEA)

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG

2355 Wiener Neudorf

Austria

ARTROLYT 50 mg Kapseln

50 mg

capsule, hard

oral use

Austria

TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG

2355 Wiener Neudorf

Austria

VERBORIL 50 mg Kapseln

50 mg

capsule, hard

oral use

Czech Republic

TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG

2355 Wiener Neudorf

Austria

ARTRODAR

50 mg

capsule, hard

oral use

France

NEGMA

10, rue Paul Dautier

78140 Vélizy Villacoublay

France

ART 50 mg, gélule

50 mg

capsule, hard

oral use

France

ACTAVIS GROUP (ISLANDE)

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

DIACEREINE ACTAVIS 50 mg, gélule

50 mg

capsule, hard

oral use

France

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

DIACEREINE ARROW 50 mg, gélule

50 mg

capsule, hard

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

DIACEREINE BIOGARAN 50 mg, gélule

50 mg

capsule, hard

oral use

France

CRISTERS

22 quai Gallieni

92150 Suresnes

France

DIACEREINE CRISTERS 50 mg, gélule

50 mg

capsule, hard

oral use

France

EG LABO — LABORATOIRES EUROGENERICS

‘Le Quintet’ — bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

DIACEREINE EG 50 mg, gélule

50 mg

capsule, hard

oral use

France

EVOLUPHARM

rue Irène Caron

Zone Industrielle d'Auneuil

60390 Auneuil

France

DIACEREINE EVOLUGEN 50 mg, gélule

50 mg

capsule, hard

oral use

France

MAZAL PHARMACEUTIQUE

11, rue Rontgen

BP 1309

29103 Quimper

France

DIACEREINE MAZAL 50 mg, gélule

50 mg

capsule, hard

oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

DIACEREINE MYLAN 50 mg, gélule

50 mg

capsule, hard

oral use

France

NEGMA

10, rue Paul Dautier

78140 Vélizy Villacoublay

France

DIACEREINE NEGMA 50 mg, gélule

50 mg

capsule, hard

oral use

France

LABORATOIRES PHARMA 2000

10 rue Paul Dautier

78140 Vélizy Villacoublay

France

DIACEREINE PHARMA 2000 50 mg, gélule

50 mg

capsule, hard

oral use

France

RANBAXY PHARMACIE GENERIQUES

11-15 Quai de Dion Bouton

92800 Puteaux

France

DIACEREINE RANBAXY 50 mg, gélule

50 mg

capsule, hard

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

DIACEREINE RATIOPHARM 50 mg, gélule

50 mg

capsule, hard

oral use

France

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

DIACEREINE REF 50 mg, gélule

50 mg

capsule, hard

oral use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

DIACEREINE SANDOZ 50 mg, gélule

50 mg

capsule, hard

oral use

France

SUBSTIPHARM DEVELOPPEMENT

24, rue Erlanger

75016 Paris

FRANCE

DIACEREINE SUBSTIPHARM 50 mg, gélule

50 mg

capsule, hard

oral use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

DIACEREINE TEVA 50 mg, gélule

50 mg

capsule, hard

oral use

France

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DIACEREINE ZENTIVA 50 mg, gélule

50 mg

capsule, hard

oral use

France

ZYDUS FRANCE

25, rue des Peupliers

ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers

92000 Nanterre

France

DIACEREINE ZYDUS 50 mg, gélule

50 mg

capsule, hard

oral use

France

MAZAL PHARMACEUTIQUE

11, rue Rontgen

BP 1309

29103 Quimper

France

MAZART 50 mg, gélule

50 mg

capsule, hard

oral use

France

NIVERPHARM

10 rue Paul Dautier

78140 Vélizy Villacoublay

France

ZONDAR 50 mg, gélule

50 mg

capsule, hard

oral use

Greece

ANGELINI PHARMA HELLAS

Achaias and Troizinias, Nea Kifissia 14564, Athens

Greece

VERBORIL

50 mg

capsule, hard

oral use

Greece

AURORA PHARMACEUTICALS S.A.

Evrou 4 and Messinias 2,

Gerakas 15344

Greece

ARTHROREIN

50 mg

capsule, hard

oral use

Greece

VOCATE Pharmaceuticals S.A.,

Gounari 150, Glyfada 16674 Athens

Greece

ARTHROFAR

50 mg

capsule, hard

oral use

Greece

RAFARM AEBE

korinthou 12, Neo Psychiko, 15451

Greece

IDEALITE

50 mg

capsule, hard

oral use

Greece

HELP ABEE

Valaoritou 10, Metamorfosi, Attikis, 14452

Greece

INFLABION

50 mg

capsule, hard

oral use

Greece

BROS EPE

Avgis & Gallinis 15, n. Kifissia, 14564

Greece

REUMANISAL

50 mg

capsule, hard

oral use

Greece

FARMEDIA A.E.

Athinas 22 & Apollonos

Gerakas, Attikis, 15344

Greece

OSTIREIN

50 mg

capsule, hard

oral use

Greece

GENEPHARM A.E.

18th km Marathonos Avenue, Pallini, Attikis, 15351

Greece

MYOBLOC

50 mg

capsule, hard

oral use

Greece

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9, Peristeri, Attikis, 12134

Greece

DIACEREIN/PROEL

50 mg

capsule, hard

oral use

Greece

NORMA HELLAS A.E.

Menandrou 54, Athens, 10431

Greece

DIACEREIN/NORMA

50 mg

capsule, hard

oral use

Greece

S.M. Pharmaceutical Products Ltd,

Agiou Orous 43-45 Piraeus 18545

Greece

DESEREIN

50 mg

capsule, hard

oral use

Greece

PROTON PHARMA

Achaias 4 and Trizoinias,

Nea Kifissia 14564

Greece

DIACERIL

50 mg

capsule, hard

oral use

Italy

ABIOGEN PHARMA S.p.A.

Via Meucci 36

56121 Ospedaletto — Pisa

Italy

FISIODAR

50 mg

capsule, hard

oral use

Portugal

Neo-Farmacêutica, S.A.

Av. D. João II,

Lote 1.02.2.1 D-2o

1990-090 Lisboa

Portugal

Artrolyt

50 mg

capsule, hard

oral use

Slovak Republic

TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG

2355 Wiener Neudorf

Austria

ARTRODAR

50 mg

capsule, hard

oral use

Spain

ROTTAPHARM S.L. Avda. Diagonal, 67-69 08019 Barcelona ESPAÑA

GLIZOLAN 50 mg cápsulas

50 mg

capsule, hard

Oral use

Spain

NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F-78771 France

ARTRIZAN 50 mg cápsulas

50 mg

capsule, hard

Oral use

Spain

LACER S.A. Sardenya, 350 08025 Barcelona Spain

GALAXDAR 50 mg cápsulas

50 mg

capsule, hard

Oral use

Spain

LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

DIACEREINA NORMON 50 mg cápsulas duras EFG

50 mg

capsule, hard

Oral use

Spain

IBERMEDGEN S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain

DIACEREINA PANLUETOL 50 mg cápsulas duras EFG

50 mg

capsule, hard

Oral use

Spain

MG PHARMA

8, Rue Bellini 75116 Paris France

REINART 50 mg cápsulas duras EFG

50 mg

capsule, hard

Oral use

---

ANNEX III

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

Levonorgestrel-containing emergency contraceptive medicinal products

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor 1  500 Mikrogramm-Tablette | 1,5 mg | Tablet | Oral use |
| Austria | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Vikela 750 Mikrogramm- Tabletten | 0,75 mg | Tablet | Oral use |
| Austria | Laboratoire HRA Pharma
  15. rue Béranger
  FR-75003 Paris
  France | Vikela 1,5 Milligramm-Tablette | 1,5 mg | Tablet | Oral use |
| Austria | Velvian Germany GmbH
  Carl-Zeiss-Ring 9
  85737 Ismaning
  Germany | Velafam 1,5 mg Tabletten | 1,5 mg | Tablet | Oral use |
| Austria | Velvian Germany GmbH
  Carl-Zeiss-Ring 9
  85737 Ismaning
  Germany | Velafam 750 Mikrogramm Tabletten | 0,75 mg | Tablet | Oral use |
| Belgium | Sandoz N.V.
  Telecom Gardens
  Medialaan 40
  1800 Vilvoorde
  Belgium | Levodonna | 1,5 mg | Tablet | Oral use |
| Belgium | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Belgium | Laboratoire HRA Pharma
  15. rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Belgium | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 1,5 mg | Tablet | Oral use |
| Belgium | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 0,75 mg | Tablet | Oral use |
| Bulgaria | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Escapelle | 1,5 mg | Tablet | Oral use |
| Bulgaria | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Ramonna | 1,5 mg | Tablet | Oral use |
| Bulgaria | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Postinor-Duo | 0,75 mg | Tablet | Oral use |
| Bulgaria | Laboratorios Leon Farma SA
  Poligono Industrial Navatejera,
  La Vallina s/n,
  24008 Villaquilambre, Leon
  Spain | Etiyone | 1,5 mg | Tablet | Oral use |
| Bulgaria | Laboratorios Leon Farma SA
  Poligono Industrial Navatejera,
  La Vallina s/n,
  24008 Villaquilambre, Leon
  Spain | Melkidos | 0,75 mg | Tablet | Oral use |
| Croatia | Arenda d.o.o.,
  Medarska ulica 56b
  Zagreb 10090
  Croatia | Vikela 1,5 mg tableta | 1,5 mg | Tablet | Oral use |
| Croatia | Sandoz d.o.o.
  Maksimirska 120
  Zagreb 10000
  Croatia | Escapelle | 1,5 mg | Tablet | Oral use |
| Cyprus | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Cyprus | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Czech Republic | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Escapelle | 1,5 mg | Tablet | Oral use |
| Czech Republic | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Postinor-2 | 0,75 mg | Tablet | Oral use |
| Czech Republic | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Ramonna | 1,5 mg | Tablet | Oral use |
| Czech Republic | Egis Pharmaceuticals PLC
  Keresztúri út 30-38
  H-1106 Budapest
  Hungary | Egianti 0,75 mg | 0,75 mg | Tablet | Oral use |
| Czech Republic | Laboratorios León Farma S.A.
  Calle La Vallina s/n
  Polígono Industrial Navatejera
  24008 — Navatejera — León
  Spain | Nopregy 1,5 mg tablety | 1,5 mg | Tablet | Oral use |
| Denmark | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Denmark | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Denmark | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 København S
  Denmark | Levodonna | 1,5 mg | Tablet | Oral use |
| Estonia | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | RAMONNA | 1,5 mg | Tablet | Oral use |
| Estonia | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | ESCAPELLE | 1,5 mg | Tablet | Oral use |
| Estonia | Orivas UAB
  J.Jasinskio 16B
  LT-01112 Vilnius
  Lithuania | LEVIDON | 0,75 mg | Tablet | Oral use |
| Estonia | Sandoz Pharmaceuticals Verovškova 57
  1000 Ljubljana
  Slovenia | LEVODONNA | 1,5 mg | Tablet | Oral use |
| Estonia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | LEVONORGESTREL ACTAVIS | 0,75 mg | Tablet | Oral use |
| Estonia | Orivas UAB
  J.Jasinskio 16B
  LT-01112 Vilnius
  Lithuania | ELISTREL | 1,5 mg | Tablet | Oral use |
| Finland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Finland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| France | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | ANTHIA 750 microgrammes, comprimé | 0,75 mg | Tablet | Oral use |
| France | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | LEVONORGESTREL BIOGARAN 1  500 microgrammes, comprimé | 1,5 mg | Tablet | Oral use |
| France | MYLAN SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | LEVONORGESTREL MYLAN 1,5 mg, comprimé | 1,5 mg | Tablet | Oral use |
| France | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO 1,5 mg, comprimé | 1,5 mg | Tablet | Oral use |
| France | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO 750 microgrammes, comprimé | 0,75 mg | Tablet | Oral use |
| France | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | VIKELA 1,5 mg, comprimé | 1,5 mg | Tablet | Oral use |
| France | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | VIKELA 750 microgrammes, comprimé | 0,75 mg | Tablet | Oral use |
| Germany | VELVIAN Germany GmbH
  Carl-Zeiss-Ring 9
  85737 Ismaning
  Germany | Navela 0,75 mg Tabletten | 0,75 mg | Tablet | Oral use |
| Germany | VELVIAN Germany GmbH
  Carl-Zeiss-Ring 9
  85737 Ismaning
  Germany | Navela 1,5 mg Tabletten | 1,5 mg | Tablet | Oral use |
| Germany | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | PiDaNa 1,5 mg Tablette | 1,5 mg | Tablet | Oral use |
| Germany | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor 1  500 Mikrogramm Tablette | 1,5 mg | Tablet | Oral use |
| Germany | Hexal Aktiengesellschaft
  Industriestr. 25
  83607 Holzkirchen
  Germany | unofem HEXAL 1,5 mg Tabletten | 1,5 mg | Tablet | Oral use |
| Germany | Laboratorios Leon Farma, SA
  Poligono Industrial Navatejera
  C/La Vallina s/n
  24008 Navatejera — Villaquilambre
  Spain | Etiyone 1  500 Mikrogramm Tabletten | 1,5 mg | Tablet | Oral use |
| Greece | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 0,75 mg | Tablet | Oral use |
| Greece | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 1,5 mg | Tablet | Oral use |
| Greece | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | POSTINOR | 1,5 mg | Tablet | Oral use |
| Hungary | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Escapelle | 1,5 mg | Tablet | Oral use |
| Hungary | Egis Pharmaceuticals PLC
  Keresztúri út 30-38
  H-1106 Budapest
  Hungary | Empil 0,75 mg tabletta | 0,75 mg | Tablet | Oral use |
| Hungary | Actavis Group PTC ehf Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Helibona | 1,5 mg | Tablet | Oral use |
| Hungary | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Rigesoft | 0,75 mg | Tablet | Oral use |
| Iceland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Iceland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Iceland | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 1,5 mg | Tablet | Oral use |
| Ireland | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Levonelle 1  500 microgram Tablet | 1,5 mg | Tablet | Oral use |
| Ireland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO 750 micrograms tablet | 0,75 mg | Tablet | Oral use |
| Ireland | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO 1,5 mg tablet | 1,5 mg | Tablet | Oral use |
| Ireland | Laboratorios Leon Farma, S.A.
  C/Roa de la Vega 15, 1
  24008 Leon
  Spain | Tyedra 1  500 micrograms tablet | 1,5 mg | Tablet | Oral use |
| Italy | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 0,75 mg | Tablet | Oral use |
| Italy | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 1,5 mg | Tablet | Oral use |
| Italy | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | LONEL | 1,5 mg | Tablet | Oral use |
| Latvia | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Escapelle 1,5 mg tablets | 1,5 mg | Tablet | Oral use |
| Latvia | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Ramonna 1  500micrograms tablets | 1,5 mg | Tablet | Oral use |
| Latvia | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Postinor-Duo 750 micrograms tablets | 0,75 mg | Tablet | Oral use |
| Latvia | UAB ‘Orivas’
  J. Jasinskio g. 16B
  LT- 01112 Vilnius
  Lithuania | Elistrel 1  500 micrograms tablets | 1,5 mg | Tablet | Oral use |
| Latvia | UAB ‘Orivas’
  J. Jasinskio g. 16B
  LT- 01112 Vilnius
  Lithuania | Levidon 750 micrograms tablets | 0,75 mg | Tablet | Oral use |
| Latvia | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Levonorgestrel Actavis 750 micrograms tablets | 0,75 mg | Tablet | Oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | ESCAPELLE | 1,5 mg | Tablet | Oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | RAMONNA | 1,5 mg | Tablet | Oral use |
| Lithuania | UAB ‘Orivas’
  J. Jasinskio g. 16B
  LT- 01112 Vilnius
  Lithuania | Elistrel | 1,5 mg | Tablet | Oral use |
| Lithuania | UAB ‘Orivas’
  J. Jasinskio g. 16B
  LT- 01112 Vilnius
  Lithuania | Levidon | 0,75 mg | Tablet | Oral use |
| Lithuania | UAB Inteli Generics Nord
  Šeimyniškių 3
  LT-09312 Vilnius
  Lithuania | Avodele | 0,75 mg | Tablet | Oral use |
| Lithuania | UAB Inteli Generics Nord
  Šeimyniškių 3
  LT-09312 Vilnius
  Lithuania | Avodele | 1,5 mg | Tablet | Oral use |
| Lithuania | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | POSTINOR-DUO | 0,75 mg | Tablet | Oral use |
| Luxembourg | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Luxembourg | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Luxembourg | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 0,75 mg | Tablet | Oral use |
| Luxembourg | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 1,5 mg | Tablet | Oral use |
| Norway | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 0,75 mg | Tablet | Oral use |
| Norway | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | NORLEVO | 1,5 mg | Tablet | Oral use |
| Norway | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | POSTINOR | 1,5 mg | Tablet | Oral use |
| Norway | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 København S
  Denmark | Isteranda | 1,5 mg | Tablet | Oral use |
| Poland | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Escapelle tabletka 1  500 mikrogramów | 1,5 mg | Tablet | Oral use |
| Poland | Gedeon Richter Polska Sp. z o.o.
  5 Ks. J. Poniatowskiego Street
  05-825 Grodzisk Mazowiecki
  Poland | Ramonna | 1,5 mg | Tablet | Oral use |
| Portugal | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Portugal | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Portugal | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 1,5 mg | Tablet | Oral use |
| Romania | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | ESCAPELLE | 1,5 mg | Tablet | Oral use |
| Romania | Gedeon Richter Romania S.A.
  Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306
  Romania | RAMONNA | 1,5 mg | Tablet | Oral use |
| Romania | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | POSTINOR-2 750 micrograme | 0,75 mg | Tablet | Oral use |
| Slovak Republic | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | ESCAPELLE | 1,5 mg | Tablet | Oral use |
| Slovak Republic | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Ramona | 1,5 mg | Tablet | Oral use |
| Slovak Republic | Egis Pharmaceuticals PLC
  Keresztúri út 30-38
  H-1106 Budapest
  Hungary | EGIANTI 0,75 mg tablety | 0,75 mg | Tablet | Oral use |
| Slovak Republic | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Helibona 1,5 mg | 1,5 mg | Tablet | Oral use |
| Slovenia | Gedeon Richter Plc.
  Gyömrői út 19-21.
  H-1103 Budapest
  Hungary | Escapelle 1,5 mg tableta | 1,5 mg | Tablet | Oral use |
| Slovenia | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris France | NORLEVO 1,5 mg tableta | 1,5 mg | Tablet | Oral use |
| Slovenia | Gedeon Richter Plc.
  Gyömrői út 19-21.
  H-1103 Budapest
  Hungary | Ramonna 1,5 mg tableta | 1,5 mg | Tablet | Oral use |
| Spain | CHIESI ESPAÑA, S.A.
  Plaça d'Europa, 41-43 planta 10
  08908 L'Hospitalet de Llobregat (Barcelona)
  Spain | Norlevo 750 microgramos comprimidos | 0,75 mg | Tablet | Oral use |
| Spain | CHIESI ESPAÑA, S.A.
  Plaça d'Europa, 41-43 planta 10
  08908 L'Hospitalet de Llobregat (Barcelona)
  Spain | Norlevo 1  500 microgramos comprimido | 1,5 mg | Tablet | Oral use |
| Spain | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor 1  500 microgramos comprimido | 1,5 mg | Tablet | Oral use |
| Spain | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur
  Iceland | Julirona 1,5 mg comprimido EFG | 1,5 mg | Tablet | Oral use |
| Sweden | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 0,75 mg | Tablet | Oral use |
| Sweden | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo | 1,5 mg | Tablet | Oral use |
| Sweden | Sandoz A/S
  Edvard Thomsens Vej 14
  DK-2300 København S
  Denmark | Levodonna | 1,5 mg | Tablet | Oral use |
| Sweden | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor | 1,5 mg | Tablet | Oral use |
| The Netherlands | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo, tabletten 0,75 mg | 0,75 mg | Tablet | Oral use |
| The Netherlands | Laboratoire HRA Pharma
  15, rue Béranger
  FR-75003 Paris
  France | Norlevo 1,5 mg, tabletten | 1,5 mg | Tablet | Oral use |
| The Netherlands | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Postinor 1  500 microgram, tablet | 1,5 mg | Tablet | Oral use |
| The Netherlands | Perryment Ltd
  42-46 High street
  Esher, KT10 9QY Surrey
  United Kingdom | Vikela, tabletten 750 microgram | 0,75 mg | Tablet | Oral use |
| United Kingdom | Sandoz Limited
  Frimley Business Park
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | Isteranda 1,5 mg Tablets | 1,5 mg | Tablet | Oral use |
| United Kingdom | Gedeon Richter Plc.
  Gyömröí út 19-21
  HU-1103 Budapest
  Hungary | Upostelle 1  500 Microgram Tablets | 1,5 mg | Tablet | Oral use |
| United Kingdom | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Levonelle-2 750 Microgram Tablet | 0,75 mg | Tablet | Oral use |
| United Kingdom | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Levonelle 1  500Microgram Tablet | 1,5 mg | Tablet | Oral use |
| United Kingdom | Medimpex UK Limited
  127 Shirland Road
  London W9 2EP
  United Kingdom | Levonelle One Step 1  500 Microgram Tablet/Boots Emergency Contraceptive 1,5 mg Tablet | 1,5 mg | Tablet | Oral use |
| United Kingdom | Laboratorios Leon Farma SA
  Calle La Vallina S/N
  Poligono Industrial Navatejera
  Navatejera, Leon E-24008
  Spain | Melkine 1,5 mg Tablet | 1,5 mg | Tablet | Oral use |

Member State

(in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor 1  500 Mikrogramm-Tablette

1,5 mg

Tablet

Oral use

Austria

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Vikela 750 Mikrogramm- Tabletten

0,75 mg

Tablet

Oral use

Austria

Laboratoire HRA Pharma

15. rue Béranger

FR-75003 Paris

France

Vikela 1,5 Milligramm-Tablette

1,5 mg

Tablet

Oral use

Austria

Velvian Germany GmbH

Carl-Zeiss-Ring 9

85737 Ismaning

Germany

Velafam 1,5 mg Tabletten

1,5 mg

Tablet

Oral use

Austria

Velvian Germany GmbH

Carl-Zeiss-Ring 9

85737 Ismaning

Germany

Velafam 750 Mikrogramm Tabletten

0,75 mg

Tablet

Oral use

Belgium

Sandoz N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Levodonna

1,5 mg

Tablet

Oral use

Belgium

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Belgium

Laboratoire HRA Pharma

15. rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Belgium

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

1,5 mg

Tablet

Oral use

Belgium

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

0,75 mg

Tablet

Oral use

Bulgaria

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Escapelle

1,5 mg

Tablet

Oral use

Bulgaria

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Ramonna

1,5 mg

Tablet

Oral use

Bulgaria

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Postinor-Duo

0,75 mg

Tablet

Oral use

Bulgaria

Laboratorios Leon Farma SA

Poligono Industrial Navatejera,

La Vallina s/n,

24008 Villaquilambre, Leon

Spain

Etiyone

1,5 mg

Tablet

Oral use

Bulgaria

Laboratorios Leon Farma SA

Poligono Industrial Navatejera,

La Vallina s/n,

24008 Villaquilambre, Leon

Spain

Melkidos

0,75 mg

Tablet

Oral use

Croatia

Arenda d.o.o.,

Medarska ulica 56b

Zagreb 10090

Croatia

Vikela 1,5 mg tableta

1,5 mg

Tablet

Oral use

Croatia

Sandoz d.o.o.

Maksimirska 120

Zagreb 10000

Croatia

Escapelle

1,5 mg

Tablet

Oral use

Cyprus

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Cyprus

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Czech Republic

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Escapelle

1,5 mg

Tablet

Oral use

Czech Republic

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Postinor-2

0,75 mg

Tablet

Oral use

Czech Republic

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Ramonna

1,5 mg

Tablet

Oral use

Czech Republic

Egis Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Hungary

Egianti 0,75 mg

0,75 mg

Tablet

Oral use

Czech Republic

Laboratorios León Farma S.A.

Calle La Vallina s/n

Polígono Industrial Navatejera

24008 — Navatejera — León

Spain

Nopregy 1,5 mg tablety

1,5 mg

Tablet

Oral use

Denmark

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Denmark

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Denmark

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Levodonna

1,5 mg

Tablet

Oral use

Estonia

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

RAMONNA

1,5 mg

Tablet

Oral use

Estonia

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

ESCAPELLE

1,5 mg

Tablet

Oral use

Estonia

Orivas UAB

J.Jasinskio 16B

LT-01112 Vilnius

Lithuania

LEVIDON

0,75 mg

Tablet

Oral use

Estonia

Sandoz Pharmaceuticals Verovškova 57

1000 Ljubljana

Slovenia

LEVODONNA

1,5 mg

Tablet

Oral use

Estonia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

LEVONORGESTREL ACTAVIS

0,75 mg

Tablet

Oral use

Estonia

Orivas UAB

J.Jasinskio 16B

LT-01112 Vilnius

Lithuania

ELISTREL

1,5 mg

Tablet

Oral use

Finland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Finland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

France

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

ANTHIA 750 microgrammes, comprimé

0,75 mg

Tablet

Oral use

France

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

LEVONORGESTREL BIOGARAN 1  500 microgrammes, comprimé

1,5 mg

Tablet

Oral use

France

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

LEVONORGESTREL MYLAN 1,5 mg, comprimé

1,5 mg

Tablet

Oral use

France

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO 1,5 mg, comprimé

1,5 mg

Tablet

Oral use

France

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO 750 microgrammes, comprimé

0,75 mg

Tablet

Oral use

France

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

VIKELA 1,5 mg, comprimé

1,5 mg

Tablet

Oral use

France

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

VIKELA 750 microgrammes, comprimé

0,75 mg

Tablet

Oral use

Germany

VELVIAN Germany GmbH

Carl-Zeiss-Ring 9

85737 Ismaning

Germany

Navela 0,75 mg Tabletten

0,75 mg

Tablet

Oral use

Germany

VELVIAN Germany GmbH

Carl-Zeiss-Ring 9

85737 Ismaning

Germany

Navela 1,5 mg Tabletten

1,5 mg

Tablet

Oral use

Germany

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

PiDaNa 1,5 mg Tablette

1,5 mg

Tablet

Oral use

Germany

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor 1  500 Mikrogramm Tablette

1,5 mg

Tablet

Oral use

Germany

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

unofem HEXAL 1,5 mg Tabletten

1,5 mg

Tablet

Oral use

Germany

Laboratorios Leon Farma, SA

Poligono Industrial Navatejera

C/La Vallina s/n

24008 Navatejera — Villaquilambre

Spain

Etiyone 1  500 Mikrogramm Tabletten

1,5 mg

Tablet

Oral use

Greece

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

0,75 mg

Tablet

Oral use

Greece

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

1,5 mg

Tablet

Oral use

Greece

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

POSTINOR

1,5 mg

Tablet

Oral use

Hungary

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Escapelle

1,5 mg

Tablet

Oral use

Hungary

Egis Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Hungary

Empil 0,75 mg tabletta

0,75 mg

Tablet

Oral use

Hungary

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Helibona

1,5 mg

Tablet

Oral use

Hungary

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Rigesoft

0,75 mg

Tablet

Oral use

Iceland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Iceland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Iceland

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

1,5 mg

Tablet

Oral use

Ireland

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Levonelle 1  500 microgram Tablet

1,5 mg

Tablet

Oral use

Ireland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO 750 micrograms tablet

0,75 mg

Tablet

Oral use

Ireland

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO 1,5 mg tablet

1,5 mg

Tablet

Oral use

Ireland

Laboratorios Leon Farma, S.A.

C/Roa de la Vega 15, 1

24008 Leon

Spain

Tyedra 1  500 micrograms tablet

1,5 mg

Tablet

Oral use

Italy

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

0,75 mg

Tablet

Oral use

Italy

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

1,5 mg

Tablet

Oral use

Italy

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

LONEL

1,5 mg

Tablet

Oral use

Latvia

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Escapelle 1,5 mg tablets

1,5 mg

Tablet

Oral use

Latvia

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Ramonna 1  500micrograms tablets

1,5 mg

Tablet

Oral use

Latvia

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Postinor-Duo 750 micrograms tablets

0,75 mg

Tablet

Oral use

Latvia

UAB ‘Orivas’

J. Jasinskio g. 16B

LT- 01112 Vilnius

Lithuania

Elistrel 1  500 micrograms tablets

1,5 mg

Tablet

Oral use

Latvia

UAB ‘Orivas’

J. Jasinskio g. 16B

LT- 01112 Vilnius

Lithuania

Levidon 750 micrograms tablets

0,75 mg

Tablet

Oral use

Latvia

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Levonorgestrel Actavis 750 micrograms tablets

0,75 mg

Tablet

Oral use

Lithuania

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

ESCAPELLE

1,5 mg

Tablet

Oral use

Lithuania

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

RAMONNA

1,5 mg

Tablet

Oral use

Lithuania

UAB ‘Orivas’

J. Jasinskio g. 16B

LT- 01112 Vilnius

Lithuania

Elistrel

1,5 mg

Tablet

Oral use

Lithuania

UAB ‘Orivas’

J. Jasinskio g. 16B

LT- 01112 Vilnius

Lithuania

Levidon

0,75 mg

Tablet

Oral use

Lithuania

UAB Inteli Generics Nord

Šeimyniškių 3

LT-09312 Vilnius

Lithuania

Avodele

0,75 mg

Tablet

Oral use

Lithuania

UAB Inteli Generics Nord

Šeimyniškių 3

LT-09312 Vilnius

Lithuania

Avodele

1,5 mg

Tablet

Oral use

Lithuania

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

POSTINOR-DUO

0,75 mg

Tablet

Oral use

Luxembourg

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Luxembourg

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Luxembourg

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

0,75 mg

Tablet

Oral use

Luxembourg

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

1,5 mg

Tablet

Oral use

Norway

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

0,75 mg

Tablet

Oral use

Norway

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

NORLEVO

1,5 mg

Tablet

Oral use

Norway

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

POSTINOR

1,5 mg

Tablet

Oral use

Norway

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Isteranda

1,5 mg

Tablet

Oral use

Poland

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Escapelle tabletka 1  500 mikrogramów

1,5 mg

Tablet

Oral use

Poland

Gedeon Richter Polska Sp. z o.o.

5 Ks. J. Poniatowskiego Street

05-825 Grodzisk Mazowiecki

Poland

Ramonna

1,5 mg

Tablet

Oral use

Portugal

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Portugal

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Portugal

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

1,5 mg

Tablet

Oral use

Romania

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

ESCAPELLE

1,5 mg

Tablet

Oral use

Romania

Gedeon Richter Romania S.A.

Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306

Romania

RAMONNA

1,5 mg

Tablet

Oral use

Romania

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

POSTINOR-2 750 micrograme

0,75 mg

Tablet

Oral use

Slovak Republic

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

ESCAPELLE

1,5 mg

Tablet

Oral use

Slovak Republic

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Ramona

1,5 mg

Tablet

Oral use

Slovak Republic

Egis Pharmaceuticals PLC

Keresztúri út 30-38

H-1106 Budapest

Hungary

EGIANTI 0,75 mg tablety

0,75 mg

Tablet

Oral use

Slovak Republic

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Helibona 1,5 mg

1,5 mg

Tablet

Oral use

Slovenia

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Hungary

Escapelle 1,5 mg tableta

1,5 mg

Tablet

Oral use

Slovenia

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris France

NORLEVO 1,5 mg tableta

1,5 mg

Tablet

Oral use

Slovenia

Gedeon Richter Plc.

Gyömrői út 19-21.

H-1103 Budapest

Hungary

Ramonna 1,5 mg tableta

1,5 mg

Tablet

Oral use

Spain

CHIESI ESPAÑA, S.A.

Plaça d'Europa, 41-43 planta 10

08908 L'Hospitalet de Llobregat (Barcelona)

Spain

Norlevo 750 microgramos comprimidos

0,75 mg

Tablet

Oral use

Spain

CHIESI ESPAÑA, S.A.

Plaça d'Europa, 41-43 planta 10

08908 L'Hospitalet de Llobregat (Barcelona)

Spain

Norlevo 1  500 microgramos comprimido

1,5 mg

Tablet

Oral use

Spain

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor 1  500 microgramos comprimido

1,5 mg

Tablet

Oral use

Spain

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

Julirona 1,5 mg comprimido EFG

1,5 mg

Tablet

Oral use

Sweden

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

0,75 mg

Tablet

Oral use

Sweden

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo

1,5 mg

Tablet

Oral use

Sweden

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Levodonna

1,5 mg

Tablet

Oral use

Sweden

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor

1,5 mg

Tablet

Oral use

The Netherlands

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo, tabletten 0,75 mg

0,75 mg

Tablet

Oral use

The Netherlands

Laboratoire HRA Pharma

15, rue Béranger

FR-75003 Paris

France

Norlevo 1,5 mg, tabletten

1,5 mg

Tablet

Oral use

The Netherlands

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Postinor 1  500 microgram, tablet

1,5 mg

Tablet

Oral use

The Netherlands

Perryment Ltd

42-46 High street

Esher, KT10 9QY Surrey

United Kingdom

Vikela, tabletten 750 microgram

0,75 mg

Tablet

Oral use

United Kingdom

Sandoz Limited

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Isteranda 1,5 mg Tablets

1,5 mg

Tablet

Oral use

United Kingdom

Gedeon Richter Plc.

Gyömröí út 19-21

HU-1103 Budapest

Hungary

Upostelle 1  500 Microgram Tablets

1,5 mg

Tablet

Oral use

United Kingdom

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Levonelle-2 750 Microgram Tablet

0,75 mg

Tablet

Oral use

United Kingdom

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Levonelle 1  500Microgram Tablet

1,5 mg

Tablet

Oral use

United Kingdom

Medimpex UK Limited

127 Shirland Road

London W9 2EP

United Kingdom

Levonelle One Step 1  500 Microgram Tablet/Boots Emergency Contraceptive 1,5 mg Tablet

1,5 mg

Tablet

Oral use

United Kingdom

Laboratorios Leon Farma SA

Calle La Vallina S/N

Poligono Industrial Navatejera

Navatejera, Leon E-24008

Spain

Melkine 1,5 mg Tablet

1,5 mg

Tablet

Oral use

---

ANNEX IV

List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States

| Member State EU/EEA | Marketing authorisation holder | Product name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH
  Herbststraße 6-10
  1160 Wien
  Austria | Baytril 25 mg/ml — Injektionslösung für Tiere | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw) |
| Austria | Bayer Austria GmbH
  Herbststraße 6-10
  1160 Wien
  Austria | Baytril 50 mg/ml — Injektionslösung für Tiere | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Austria | Bayer Austria GmbH
  Herbststraße 6-10
  1160 Wien
  Austria | Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen)
  Belgium | Baytril 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Cats, dogs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen)
  Belgium | Baytril Piglet | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen)
  Belgium | Baytril 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen)
  Belgium | Baytril 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem (Machelen)
  Belgium | Baytril Swine | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs |
| Bulgaria | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Байтрил 5 % инжективен разтвор | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Cyprus | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | BAYTRIL INJECTION 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Czech Republic | BAYER s.r.o.
  Siemensova 2717/4
  155 00 Praha 5
  Czech Republic | BAYTRIL 2,5 % (w/v) injekční roztok | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Czech Republic | BAYER s.r.o.
  Siemensova 2717/4
  155 00 Praha 5
  Czech Republic | BAYTRIL 5 % (w/v) injekční roztok | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Denmark | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril Vet. | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cats, cattle, poultry, pigs |
| Denmark | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril Vet. | Enrofloxacin | 100 mg/ml | Solution for injection | Dogs, cats, cattle
  poultry, pigs |
| Finland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril 5 % inj. | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, dogs, sheep, cattle, pigs, goats |
| Finland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril 10 % inj. | Enrofloxacin | 100 mg/ml | Solution for injection | Sheep, cattle, pigs, goats |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 Loos
  France | BAYTRIL 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 Loos
  France | BAYTRIL 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 Loos
  France | BAYTRIL 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Bayer Vital GmbH
  Kaiser-Wilhelm-Allee
  D-51373 Leverkusen
  Germany | Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen | Enrofloxacin | 25 mg/ml | Solution for injection | Pig, rabbits, dogs, cats |
| Germany | Bayer Vital GmbH
  Kaiser-Wilhelm-Allee
  D-51373 Leverkusen
  Germany | Baytril — Das Original — 5 % Injektionslösung | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dogs |
| Germany | Bayer Vital GmbH
  Kaiser-Wilhelm-Allee
  D-51373 Leverkusen
  Germany | Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | BAYTRIL 2,5 % inj.sol | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs |
| Greece | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | BAYTRIL 5 % inj.sol | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, cattle, pigs, dogs |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50
  1123 Budapest
  Hungary | Baytril 2,5 % injekció A.U.V. | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles) |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50
  1123 Budapest
  Hungary | Baytril 5 % injekció A.U.V. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50
  1123 Budapest
  Hungary | Baytril 10 % injekció A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Iceland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, poultry, dogs, cats |
| Iceland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 100 mg/ml | Solution for injection | Calves, pigs, poultry, dogs, cats |
| Ireland | Bayer Limited
  Animal Health Division
  The Atrium
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 2,5 % Solution for Injection | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Ireland | Bayer Limited
  Animal Health Division
  The Atrium
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 5 % Solution for Injection | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | Bayer Limited
  Animal Health Division
  The Atrium
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 10 % Solution for Injection | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Italy | Bayer S.p.A.
  Viale Certosa, 130
  20156 Milano
  Italy | Baytril | Enrofloxacin | 25 mg/ml and
  50 mg/ml | Solution for injection | Cattle, dogs, sheep, goats, cats, rabbits, pigs |
| Italy | Bayer S.p.A.
  Viale Certosa, 130
  20156 Milano
  Italy | Baytril 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats |
| Norway | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, cattle, dogs, cats |
| Norway | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs, cattle, dogs, cats |
| Poland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Poland | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Bayer Portugal S.A.
  Rua Quinta do Pinheiro, 5
  2794-003 Carnaxide
  Portugal | BAYTRIL 2,5 % solução injectável | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Portugal | Bayer Portugal S.A.
  Rua Quinta do Pinheiro, 5
  2794-003 Carnaxide
  Portugal | Baytril 5 % solução injectável | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cattle, pigs |
| Portugal | Bayer Portugal S.A.
  Rua Quinta do Pinheiro, 5
  2794-003 Carnaxide
  Portugal | Baytril 10 % solução injectável | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | Bayer Health Care AG
  D-51368 Leverkusen
  Germany | Baytril 5 % | Enrofloxacin | 50 mg/ml | solution for injection | Calves, pigs, dogs |
| Romania | Bayer Health Care AG
  D-51368 Leverkusen
  Germany | Baytril 10 % | Enrofloxacin | 100 mg/ml | solution for injection | Cattle, pigs |
| Slovakia | Bayer s.r.o.
  Litvínovská 609/3
  190 21 Praha 9
  Czech Republic | Baytril 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Slovakia | Bayer s.r.o.
  Litvínovská 609/3
  190 21 Praha 9
  Czech Republic | Baytril 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Slovenia | Bayer d.o.o.
  Bravničarjeva 13
  Ljubljana
  Slovenia | Baytril® 5 % raztopina za injiciranje | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Slovenia | Bayer d.o.o.
  Bravničarjeva 13
  Ljubljana
  Slovenia | Baytril® 10 % raztopina za injiciranje | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | Bayer Hispania S.L.
  Avda Baix LLObregat, 3-5
  08970, Saint Joan Despí
  Barcelona
  Spain | Baytril 2,5 % solución inyectable | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana)) |
| Spain | Bayer Hispania S.L.
  Avda Baix LLObregat, 3-5
  08970, Saint Joan Despí
  Barcelona
  Spain | Baytril 5 % solución inyectable | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cattle, pigs |
| Spain | Bayer Hispania S.L.
  Avda Baix LLObregat, 3-5
  08970, Saint Joan Despí
  Barcelona
  Spain | Baytril 10 % solución inyectable | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Sweden | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril®vet | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, pigs, cattle, cats |
| Sweden | Bayer Animal Health GmbH
  D-51368 Leverkusen
  Germany | Baytril®vet | Enrofloxacin | 100 mg/ml | Solution for injection | Dogs, pigs, cattle, cats |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | Baytril Piglet 25 mg/ml inspuitbare oplossing | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | BAYTRIL 2,5 % INJEKTIEVLOEISTOF | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | BAYTRIL 5 % INJECTIEOPLOSSING | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | BAYTRIL 5 % INJEKTIEVLOEISTOF | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | BAYTRIL 10 % INJECTIEOPLOSSING | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Bayer BV
  Energieweg 1
  3641 RT Mijdrecht
  The Netherlands | BAYTRIL INJEKTIEVLOEISTOF 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs, cattle |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury, Berkshire
  RG14 1JA
  United Kingdom | Baytril 2,5 % Solution for Injection | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats and exotic animals (small mammals, reptiles and avian species) |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury, Berkshire
  RG14 1JA
  United Kingdom | Baytril 5 % Solution for Injection | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury, Berkshire
  RG14 1JA
  United Kingdom | Baytril 10 % Solution for Injection | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |

Member State EU/EEA

Marketing authorisation holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Austria

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

Austria

Baytril 25 mg/ml — Injektionslösung für Tiere

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)

Austria

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

Austria

Baytril 50 mg/ml — Injektionslösung für Tiere

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Austria

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

Austria

Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Cats, dogs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril Piglet

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril Swine

Enrofloxacin

100 mg/ml

Solution for injection

Pigs

Bulgaria

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Байтрил 5 % инжективен разтвор

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Cyprus

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

BAYTRIL INJECTION 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Czech Republic

BAYER s.r.o.

Siemensova 2717/4

155 00 Praha 5

Czech Republic

BAYTRIL 2,5 % (w/v) injekční roztok

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Czech Republic

BAYER s.r.o.

Siemensova 2717/4

155 00 Praha 5

Czech Republic

BAYTRIL 5 % (w/v) injekční roztok

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Denmark

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril Vet.

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cats, cattle, poultry, pigs

Denmark

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril Vet.

Enrofloxacin

100 mg/ml

Solution for injection

Dogs, cats, cattle

poultry, pigs

Finland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril 5 % inj.

Enrofloxacin

50 mg/ml

Solution for injection

Cats, dogs, sheep, cattle, pigs, goats

Finland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril 10 % inj.

Enrofloxacin

100 mg/ml

Solution for injection

Sheep, cattle, pigs, goats

France

Bayer Sante

220 Avenue de la Recherche

59120 Loos

France

BAYTRIL 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

France

Bayer Sante

220 Avenue de la Recherche

59120 Loos

France

BAYTRIL 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

France

Bayer Sante

220 Avenue de la Recherche

59120 Loos

France

BAYTRIL 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Germany

Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen

Enrofloxacin

25 mg/ml

Solution for injection

Pig, rabbits, dogs, cats

Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Germany

Baytril — Das Original — 5 % Injektionslösung

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dogs

Germany

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

D-51373 Leverkusen

Germany

Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

BAYTRIL 2,5 % inj.sol

Enrofloxacin

25 mg/ml

Solution for injection

Dogs

Greece

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

BAYTRIL 5 % inj.sol

Enrofloxacin

50 mg/ml

Solution for injection

Calves, cattle, pigs, dogs

Hungary

Bayer Hungária Kft.

Alkotás u. 50

1123 Budapest

Hungary

Baytril 2,5 % injekció A.U.V.

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles)

Hungary

Bayer Hungária Kft.

Alkotás u. 50

1123 Budapest

Hungary

Baytril 5 % injekció A.U.V.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Hungary

Bayer Hungária Kft.

Alkotás u. 50

1123 Budapest

Hungary

Baytril 10 % injekció A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Iceland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, poultry, dogs, cats

Iceland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

100 mg/ml

Solution for injection

Calves, pigs, poultry, dogs, cats

Ireland

Bayer Limited

Animal Health Division

The Atrium

Blackthorn Road

Dublin 18

Ireland

Baytril 2,5 % Solution for Injection

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Ireland

Bayer Limited

Animal Health Division

The Atrium

Blackthorn Road

Dublin 18

Ireland

Baytril 5 % Solution for Injection

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

Bayer Limited

Animal Health Division

The Atrium

Blackthorn Road

Dublin 18

Ireland

Baytril 10 % Solution for Injection

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Italy

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italy

Baytril

Enrofloxacin

25 mg/ml and

50 mg/ml

Solution for injection

Cattle, dogs, sheep, goats, cats, rabbits, pigs

Italy

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italy

Baytril 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats

Norway

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, cattle, dogs, cats

Norway

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

100 mg/ml

Solution for injection

Pigs, cattle, dogs, cats

Poland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Poland

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Portugal

Bayer Portugal S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

BAYTRIL 2,5 % solução injectável

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Portugal

Bayer Portugal S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Baytril 5 % solução injectável

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cattle, pigs

Portugal

Bayer Portugal S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Baytril 10 % solução injectável

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

Bayer Health Care AG

D-51368 Leverkusen

Germany

Baytril 5 %

Enrofloxacin

50 mg/ml

solution for injection

Calves, pigs, dogs

Romania

Bayer Health Care AG

D-51368 Leverkusen

Germany

Baytril 10 %

Enrofloxacin

100 mg/ml

solution for injection

Cattle, pigs

Slovakia

Bayer s.r.o.

Litvínovská 609/3

190 21 Praha 9

Czech Republic

Baytril 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Slovakia

Bayer s.r.o.

Litvínovská 609/3

190 21 Praha 9

Czech Republic

Baytril 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Slovenia

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Slovenia

Baytril® 5 % raztopina za injiciranje

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Slovenia

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Slovenia

Baytril® 10 % raztopina za injiciranje

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

Bayer Hispania S.L.

Avda Baix LLObregat, 3-5

08970, Saint Joan Despí

Barcelona

Spain

Baytril 2,5 % solución inyectable

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))

Spain

Bayer Hispania S.L.

Avda Baix LLObregat, 3-5

08970, Saint Joan Despí

Barcelona

Spain

Baytril 5 % solución inyectable

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cattle, pigs

Spain

Bayer Hispania S.L.

Avda Baix LLObregat, 3-5

08970, Saint Joan Despí

Barcelona

Spain

Baytril 10 % solución inyectable

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Sweden

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril®vet

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, pigs, cattle, cats

Sweden

Bayer Animal Health GmbH

D-51368 Leverkusen

Germany

Baytril®vet

Enrofloxacin

100 mg/ml

Solution for injection

Dogs, pigs, cattle, cats

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Baytril Piglet 25 mg/ml inspuitbare oplossing

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

BAYTRIL 2,5 % INJEKTIEVLOEISTOF

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

BAYTRIL 5 % INJECTIEOPLOSSING

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

BAYTRIL 5 % INJEKTIEVLOEISTOF

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

BAYTRIL 10 % INJECTIEOPLOSSING

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Bayer BV

Energieweg 1

3641 RT Mijdrecht

The Netherlands

BAYTRIL INJEKTIEVLOEISTOF 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Pigs, cattle

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

United Kingdom

Baytril 2,5 % Solution for Injection

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats and exotic animals (small mammals, reptiles and avian species)

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

United Kingdom

Baytril 5 % Solution for Injection

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury, Berkshire

RG14 1JA

United Kingdom

Baytril 10 % Solution for Injection

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

---

ANNEX V

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Product name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, pigs, rabbits |
| Austria | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (Calves), pigs, dogs |
| Austria | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 100, 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Austria | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml Injektionslösung für Tiere | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Austria | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Austria | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Enrodexil, 100 mg/ml, Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Austria | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Austria | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Austria | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Unisol 100 mg/ml, Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Austria | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Austria | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | BAYTRIL PIGLET | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | BAYTRIL 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Cats, dogs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | BAYTRIL 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | BAYTRIL SWINE | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs |
| Belgium | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | BAYTRIL 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle |
| Belgium | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FENOFLOX 50 MG/ML | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Belgium | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FENOFLOX 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | EMDOKA bvba
  John Lijsenstraat 16
  B-2321 Hoogstraten
  Belgium | FLOXADIL 50 MG/ML | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | EMDOKA bvba
  John Lijsenstraat 16
  B-2321 Hoogstraten
  Belgium | FLOXADIL 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 25 MG/ML | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Belgium | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 50 MG/ML | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Belgium | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | COLMYC 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Vandenbussche Farma Service
  Brusselsesteenweg 396
  1980 Eppegem
  Belgium | FLOXAVET 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | DORAFLOX 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Belgium | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | UNISOL 100 MG/ML | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Bulgaria | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Байтрил 5 % инжективен разтвор | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Bulgaria | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Ганадексил 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dogs |
| Bulgaria | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Роксацин БГ инжективен | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Bulgaria | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Ценеровиг — 10 ГБ Инж. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Bulgaria | Laboratorios Hipra S.A.
  Avda. La Selva, 135
  17170 Amer
  Girona
  Spain | Хипралона Енро — И | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Bulgaria | Laboratorios Syva S.A.
  Parroco Pablo Diez, 49 — 57
  24010 Leon
  Spain | Сиваквинол — 100 Инжекционен разтвор | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Bulgaria | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Кинофлокс 100 mg/ml инжекционен разтвор за говеда и свине | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Bulgaria | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Колмик 100 мг/мл инжекционен разтвор за говеда и свине | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Cyprus | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril 5 %, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Czech Republic | Bayer s.r.o.
  Siemensova 2717/4
  155 00 Praha 5
  Czech Republic | BAYTRIL 2,5 % (w/v) injekční roztok
  Přípravek s indikačním omezením | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Czech Republic | BAYER s.r.o.
  Siemensova 2717/4
  155 00 Praha 5
  Czech Republic | BAYTRIL 5 % (w/v) injekční roztok
  Přípravek s indikačním omezením | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Czech Republic | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml injekční roztok pro psy, kočky a exotická zvířata | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats exotic animals (small mammals, reptiles and birds) |
| Czech Republic | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Czech Republic | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml injekční roztok pro skot a prasata | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Czech Republic | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 50 mg/ml injekční roztok | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Czech Republic | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 100 mg/ml injekční roztok | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Czech Republic | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 mg/ml injekční roztok | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs and calves |
| Denmark | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril Vet | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cattle, poultry, cats, pigs |
| Denmark | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril Vet | Enrofloxacin | 100 mg/ml | Solution for injection | Dogs, cattle, poultry, cats, pigs |
| Denmark | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cattle, poultry, cats, pigs |
| Estonia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Estonia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Estonia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Estonia | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Ganadexil Enrofloxacina 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dogs |
| Estonia | Laboratorios Hipra S.A.
  Avda. La Selva, 135
  17170 Amer
  Girona
  Spain | Hipralona Enro-I | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Estonia | Vetoquinol Biowet Sp z o.o.
  13/14 Kosynierów Gdyńskich St.
  66-400 Gorzów Wlkp.
  Poland | Enrobioflox5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dogs |
| Finland | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, dogs, sheep, cattle, pigs, goats |
| Finland | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox vet | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, dogs, cattle, pigs |
| France | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | ENROCARE 25 MG/ML INJECTABLE POUR CHIENS CHATS ET NAC | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| France | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | ENROCARE 50 MG/ML INJECTABLE POUR BOVINS PORCINS CHIENS ET CHATS | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| France | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | ENROCARE 100 MG/ML INJECTABLE POUR BOVINS ET PORCINS | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 LOOS
  France | BAYTRIL 2,5 % SOLUTION INJECTABLE | Enrofloxacin | 25 mg/ml | Solution for injection | Cattle, pigs, dogs |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 LOOS
  France | BAYTRIL 5 % SOLUTION INJECTABLE | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| France | Bayer Sante
  220 Avenue de la Recherche
  59120 LOOS
  France | BAYTRIL 10 % SOLUTION INJECTABLE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| France | BIOLIS
  21 Montee De La Garde
  69340 Francheville
  France | QUINOTRYL 50 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| France | BIOLIS
  21 Montee De La Garde
  69340 Francheville
  France | QUINOTRYL 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCI NS | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| France | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | CHANENRO 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| France | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FLOXIBAC 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| France | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | CHANENRO 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| France | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FLOXIBAC 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Albrecht GmbH
  Hauptstr. 6-8
  D-88326 Aulendorf
  Germany | Enro-Sleecol 50 mg/ml | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Albrecht GmbH
  Hauptstr. 6-8
  D-88326 Aulendorf
  Germany | Enro-Sleecol 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 25 | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, rabbits, dogs, cats |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 50 | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 100 | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, rabbits, dogs, cats |
| Germany | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril — Das Original — 5 % Injektionslösung | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Calluna Pharma bvba
  Treslong 34
  B-2322 Hoogstraaten
  Belgium | Enrofloxacin 2,5 % WDT, Injektionslösung | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Germany | Calluna Pharma bvba
  Treslong 34
  B-2322 Hoogstraaten
  Belgium | Enrofloxacin 5 % WDT, Injektionslösung | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Calluna Pharma bvba
  Treslong 34
  B-2322 Hoogstraaten
  Belgium | Enrofloxacin 10 % WDT, Injektionslösung | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Germany | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Enrodexil 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Roxacin 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Medistar Arzneimittel-Vertrieb GmbH
  Lüdinghauser Str. 23
  D-59387 Ascheberg
  Germany | Enrostar 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Medistar Arzneimittel-Vertrieb GmbH
  Lüdinghauser Str. 23
  D-59387 Ascheberg
  Germany | Enrostar 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Serumwerk Bernburg AG
  Hallesche Landstr. 105b
  D-06406 Bernburg
  Germany | Ursofloxacin 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dog |
| Germany | Serumwerk Bernburg AG
  Hallesche Landstr. 105b
  D-06406 Bernburg
  Germany | Ursofloxacin 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml Inyectable | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Doraflox 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Unisol | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Germany | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Germany | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs |
| Greece | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs |
| Greece | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FLOXIBAC 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Greece | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | FLOXIBAC 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROFLOXACIN/HEALTHCARE | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| Greece | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROFLOXACIN/HEALTHCARE | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Greece | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROFLOXACIN/HEALTHCARE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | COLMYC | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Greece | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | DORAFLOX | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50.
  1123 Budapest
  Hungary | Baytril 2,5 % injekció A.U.V. | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles) |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50.
  1123 Budapest
  Hungary | Baytril 5 % injekció A.U.V. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Hungary | Bayer Hungária Kft.
  Alkotás u. 50.
  1123 Budapest
  Hungary | Baytril 10 % injekció A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Hungary | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml injekció szarvasmarha és sertés részére A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml injekció kutyák, macskák és egzotikus állatok részére A.U.V. | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Hungary | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Hungary | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml injekció szarvasmarha és sertés részére A.U.V | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 5 % injekció A.U.V. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, sheep, goats |
| Hungary | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 10 % injekció A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Laboratorios Syva S.A.
  Parroco Pablo Diez, 49-57
  24010 Leon
  Spain | Syvaquinol 100 injekció A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml injekció szarvasmarha és sertés részére A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | DORAFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Hungary | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | LANFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Iceland | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril vet. | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, poultry dogs, cats |
| Iceland | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril vet. | Enrofloxacin | 100 mg/ml | Solution for injection | Calves, pigs, poultry dogs, cats |
| Ireland | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats and exotic animals (small mammals, reptiles and avian species) |
| Ireland | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs weighing more than 25 kg, dogs, cats |
| Ireland | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs weighing more than 25 kg |
| Ireland | Bayer Limited
  The Atruim
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 2,5 % Solution for Injection | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Ireland | Bayer Limited
  The Atruim
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 5 % Solution for Injection | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | Bayer Limited
  The Atruim
  Blackthorn Road
  Dublin 18
  Ireland | Baytril 10 % Solution for Injection | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml Solution for injection for dogs, cats and exotic animals | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Ireland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml Solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Global Vet Health SL
  c/Capcanes, no 12-bajos
  Poligon Agro-Reus
  Reus 43206
  Spain | Quinoflox 100 mg/ml solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL 100 mg/ml solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 50 mg/ml solution for injection for calves, pigs and dogs | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Ireland | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 100 mg/ml solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 mg/ml solution for injection for cattle and pig | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Doraflox 100 mg/ml solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Unisol 100 mg/ml solution for injection for cattle and pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Ireland | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats.
  Enrofloxacin. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Ireland | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 100 mg/ml solution for injection for cattle and pigs
  Enrofloxacin | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Italy | Bayer SpA
  Viale Certosa, 130
  20156 Milano
  Italy | Baytril | Enrofloxacin | 25 mg/ml and 50 mg/ml | Solution for injection | Cattle, dogs, sheep, goats, cats, rabbits, pigs |
| Italy | Bayer SpA
  Viale Certosa, 130
  20156 Milano
  Italy | Baytril 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats |
| Italy | CEVA Salute Animale
  viale Colleoni, 15
  20864 Agrate Brianza (MB)
  Italy | CEVAFLOX iniettabile, 100 mg/ml, soluzione iniettabile per bovini, ovini, suini | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, sheep |
| Italy | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | GELLIFLOX 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini e suini | Enrofloxacin | 100 mg/ml (or 50 mg/ml) | Solution for injection | Cattle, pigs |
| Italy | Drugs Italia srl
  Via G. Puecher, 8
  20037 Paderno Dugnano (MI)
  Italy | EFLOXIN soluzione iniettabile | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, sheep |
| Italy | Fatro s.p.a.
  Via Emilia, 285
  Ozzano Emilia (BO)
  Italy | VALEMAS 10 (or 5) 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini, ovi-caprini e suini | Enrofloxacin | 100 mg/ml (or 50 mg/ml) | Solution for injection | Cattle, pigs, sheep, goats |
| Italy | Friulchem
  via San Marco, 23
  33099 Vivaro (PN)
  Italy | TENOTRIL 100 mg/ml soluzione iniettabile epr bovini, suini, ovicaprini | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats |
| Italy | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL 100 mg/ml soluzione iniettabile per bovini e suini | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Italy | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 mg/ml soluzione iniettabile per bovini e suini | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Italy | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | COLMYC 100 mg/ml soluzione iniettabile | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Italy | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | LANFLOX 100 mg/ml soluzione iniettabile per bovini e suini | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Latvia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| Latvia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Latvia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Lithuania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 25 mg/ml, injekcinis tirpalas šunims, katėms ir egzotiniams gyvūnams | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and avian species) |
| Lithuania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Lithuania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 100 mg/ml, injekcinis tirpalas galvijams ir kiaulėms | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Lithuania | Vetoquinol Biowet Sp z o.o.
  13/14 Kosynierów Gdyńskich St.
  66-400 Gorzów Wlkp.
  Poland | ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Luxembourg | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 25 mg/ml Injektionsl! osung für Hunde, katzen und exotische Tiere | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals (small mammals, reptiles and birds) |
| Luxembourg | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 50 mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs >25kg, dogs, cats |
| Luxembourg | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 100 mg/ml Injektionslösung für Rinder und Schweine | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs >25kg |
| Luxembourg | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | Baytril piglet 25 mg/ml | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| Luxembourg | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | Baytril 2,5 % | Enrofloxacin | 25 mg/ml | Solution for injection | Cats, dogs |
| Luxembourg | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | Baytril 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Luxembourg | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | Baytril 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle |
| Luxembourg | Bayer SA-NV
  J.E. Mommaertslaan 14
  1831 Diegem
  Machelen
  Belgium | Baytril Swine 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs |
| Luxembourg | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml solution injectable pour bovins, porcins, chiens et chats | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Luxembourg | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml solution injectable pour bovins et porcins | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Luxembourg | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc injectable Bovins Porcins | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Malta | Farmcare Ltd
  Florence A triq il Fran
  Qormi
  Malta | Baytril 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Malta | Industrial Veterinaria, S.A
  Esmeralda, 19,
  08950 Esplugues de Llobreget
  Barcelona
  Spain | Ganadexil Enrofloxacino 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Malta | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Roxacin injection | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs |
| Malta | Laboratorios Syva S.A.
  Parroco Pablo Diez, 49-57
  24010 Leon
  Spain | Syvaquinol 25 % | Enrofloxacin | 25 mg/ml | Solution for injection | Calves, piglets, dogs |
| Malta | Laboratorios Syva S.A.
  Parroco Pablo Diez, 49-57
  24010 Leon
  Spain | Syvaquinol 100 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Norway | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs, cattle, dogs, cats |
| Norway | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril vet | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs, cattle, dogs, cats |
| Norway | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Poland | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Poland | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Poland | Biowet Puławy Sp. z o.o.
  2 Arciucha Str.
  24-100
  Puławy
  Poland | Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Poland | Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
  6 Grójecka Str.
  05-651 Drwalew
  Poland | Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle |
| Poland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| Poland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Poland | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Poland | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Enrodexil, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Poland | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Poland | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Roxacin, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Poland | PFO ‘Vetos-Farma’ Sp. z o.o.
  21 Dzierżoniowska Str.
  58-260
  Bielawa
  Poland | Enrofloxacyna 5 % iniekcja, enrofloxacyna 5 g/100ml, roztwór dla bydła, świń, psów i kotów | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Poland | PFO ‘Vetos-Farma’ Sp. z o.o.
  21 Dzierżoniowska Str.
  58-260
  Bielawa
  Poland | Enrofloxacyna 10 % iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Poland | Pharmagal, s.r.o.
  Murgasova 5
  949 01, Nitra
  Slovakia | Enrogal 50 mg/ml roztwór do wstrzykiwań | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Poland | Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o.
  32 Gliniana Str.
  20-616
  Lublin
  Poland | Enrocin 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Poland | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Poland | Vetoquinol Biowet Sp z o.o.
  13/14 Kosynierów Gdyńskich St.
  66-400 Gorzów Wlkp.
  Poland | Enrobioflox 5 % Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Poland | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Lanflox, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Bayer PORTUGAL S.A.
  Rua Quinta do Pinheiro, 5
  2794-003 Carnaxide
  Portugal | BAYTRIL 2,5 % solução injectável | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Portugal | Bayer PORTUGAL S.A.
  Rua Quinta do Pinheiro, 5
  2794-003 Carnaxide
  Portugal | Baytril 5 % solução injectável | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, cattle and pigs |
| Portugal | Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal | Baytril 10 % solução injectável | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml solução injectável para bovinos, suínos, cães e gatos | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Portugal | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Portugal | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 100 mg/ml solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | ESTEVE FARMA, LDA
  Av. Do Forte, 3
  Edifício Suécia II
  Piso 4A
  2794-044 Carnaxide
  Portugal | ALSIR 25 mg/ml solução injectável para Cães e Gatos | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Portugal | ESTEVE FARMA, LDA
  Av. Do Forte, 3
  Edifício Suécia II
  Piso 4A
  2794-044 Carnaxide
  Portugal | ALSIR 50Mmg/ml Solução Injectável | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Portugal | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml Solução injectável para cães, gatos e animais exóticos | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic Animals (small mammals, reptiles and avian species) |
| Portugal | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Portugal | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Global Vet Health SL
  c/Capcanes, no 12-bajos
  Poligon Agro-Reus
  Reus 43206
  Spain | Quinoflox 100 mg/ml solução injetável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 mg/ml solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml Solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | LANFLOX 100 mg/ml solução injectável para bovinos e suínos. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Portugal | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | ENRODEXIL 100 mg/ml solução injectável para bovinos e suínos | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | CENAVISA SA LABORATORIOS
  Cami Pedra Estela s/n
  43205 REUS
  Spain | CENAMICINA 10 PLUS | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Romania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 25 mg/ml | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| Romania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 50 mg/ml | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Romania | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | ENROTRON 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pig |
| Romania | Global Vet Health SL
  c/Capcanes, no 12-bajos
  Poligon Agro-Reus
  Reus 43206
  Spain | QUINOFLOX 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | GANADEXIL ENROFLOXACINA
  5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, |
| Romania | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL 50 mg/ml | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, goats, sheep, dogs |
| Romania | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | Laboratorios Hipra S.A.
  Avda. La Selva, 135
  17170 Amer
  Girona
  Spain | HIPRALONA ENRO I | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs |
| Romania | Laboratorios Syva S.A.
  Parroco Pablo Diez, 49-57
  24010 Leon
  Spain | SYVAQUINOL 100 injectable | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | LABORATORIOS VELVIAN S.L
  C/Vitoria 9, 2 B
  09004
  Burgos
  Spain | ENRODEXIL 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | PASTEUR
  Filiala Filipesti SRL
  Str. Principala nr. 944
  Filipestii de Padure
  Jud. Prahova
  Romania | Enrofloxacina 5 % injectable solution | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, sheep, goats, pigs, dogs, cats |
| Romania | PASTEUR
  Filiala Filipesti SRL
  Str. Principala nr. 944
  Filipestii de Padure
  Jud. Prahova
  Romania | Enrofloxacina 10 % injectable solution | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, sheep, goats, pigs, dogs, cats |
| Romania | S.C. ROMVAC COMPANY S.A.
  Şos. Centurii, nr. 7
  Voluntari
  Romania | Enrofloxarom 5 % | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, sheep, pigs, dogs |
| Romania | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml inyectable solution | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Romania | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | DORAFLOX 100 mg/ml | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovakia | Bayer s.r.o.
  Litvínovská 609/3
  190 21 Praha 9
  Czech Republic | Baytril 2,5 % inj. ad us. vet. | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Slovakia | Bayer s.r.o.
  Litvínovská 609/3
  190 21 Praha 9
  Czech Republic | Baytril 5 % (w/v) injekčný roztok | Enrofloxacin | 50 mg/ml | Solution for injection | Dogs, pigs, calves |
| Slovakia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml injekčný roztok pre psy, mačky a exotické živočíchy | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| Slovakia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| Slovakia | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml injekčný roztok | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovakia | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 5 % inj. ad us. vet. | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, sheep, goats, pigs, dogs |
| Slovakia | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 10 % inj. ad us. vet. | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovakia | Laboratorios Hipra S.A.
  Avda. La Selva, 135
  17170 Amer
  Girona
  Spain | Hipralona Enro — I 50 mg/ml injekčný roztok | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs |
| Slovakia | Pharmagal, s.r.o.
  Murgasova 5
  949 01, Nitra
  Slovakia | Enrogal 50 mg/ml injekčný roztok | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Slovenia | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, pigs, rabbits |
| Slovenia | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle (calves), pigs, dogs |
| Slovenia | aniMedica GmbH
  Im Südfeld 9
  48308 Senden-Bösensell
  Germany | ENROTRON 100, 100 mg/ml raztopina za injiciranje za govedo in prašiče | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovenia | Bayer d.o.o.
  Bravničarjeva 13
  Ljubljana
  Slovenia | Baytril® 5 % raztopina za injiciranje | Enrofloxacin | 50 mg/ml | Solution for injection | Calves, pigs, dogs |
| Slovenia | Bayer d.o.o.
  Bravničarjeva 13
  Ljubljana
  Slovenia | Baytril® 10 % raztopina za injiciranje | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovenia | GENERA Slovenia d.o.o.
  Dunajska 51
  1000 Ljubljana
  Slovenia | VETOFLOK 10 % raztopina za injiciranje | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovenia | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, sheep, goats, pigs, dogs |
| Slovenia | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROX 100 mg/ml raztopina za injiciranje za govedo in prašiče | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Slovenia | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL 100 mg/ml raztopina za injiciranje za govedo in prašiče | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | Hifarmax, Produtos e serviços veterinários, Lda
  Av. Marechal Craveiro Lopes no96 R/C
  Dto 2775-696 Carcavelos
  Portugal | ENROCILL 50 mg/ml solución inyectable para bovino, porcino y perros | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Spain | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | ENRODEXIL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | ROXACIN 100 mg/ml SOLUCION INYECTABLE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | Laboratorios Dr. Esteve, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | ALSIR 2,5 % SOLUCION INYECTABLE | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| Spain | Laboratorios Dr. Esteve, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | ALSIR 5 % SOLUCION INYECTABLE | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| Spain | Laboratorios Dr. Esteve, S.A.
  Avda. Mare de Déu de Montserrat, 221
  08041 Barcelona
  Spain | ALSIR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | QUINOLCEN 100 mg/ml SOLUCION INYECTABLE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | FLOXAVEX 100 mg/ml SOLUCION INYECTABLE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Spain | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | LANFLOX 100 mg/ml SOLUCION INYECTABLE | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| Sweden | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril® vet. | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, pigs, cattle, cats |
| Sweden | Bayer Animal Health GmbH
  Kaiser-Wilhelm-Allee 50
  51368 Leverkusen
  Germany | Baytril® vet. | Enrofloxacin | 100 mg/ml | Solution for injection | Dog, pigs, cattle, cats |
| Sweden | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox vet | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, exotic animals |
| The Netherlands | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| The Netherlands | Animalcare Group plc.
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Floxadil 100 mg/ml, oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | BAYTRIL 2,5 % INJEKTIEVLOEISTOF | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | Baytril Piglet 25 mg/ml inspuitbare oplossing | Enrofloxacin | 25 mg/ml | Solution for injection | Pigs |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | BAYTRIL 5 % INJEKTIEVLOEISTOF | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | BAYTRIL 5 % INJECTIEOPLOSSING | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, dogs, pigs |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | BAYTRIL INJEKTIEVLOEISTOF 10 % | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Bayer B.V.
  Energieweg 1
  3641 RT Mijdrecht
  Netherlands | BAYTRIL 10 % INJECTIEOPLOSSING | Enrofloxacin | 100 mg/ml | Solution for injection | Pigs, cattle |
| The Netherlands | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml Oplossing voor injectie | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| The Netherlands | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml Oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml, oplossing voor injectie | Enrofloxacin | 25 mg/ml | Solution for injection | Dogs, cats, cage birds, reptiles |
| The Netherlands | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| The Netherlands | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml, oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs |
| The Netherlands | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | ENROXIL 100 MG/ML SOLUTION FOR INJECTION | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Laboratorios Calier, S.A.
  c/Barcelonès, 26 (Pla del Ramassà)
  08520 Les Franqueses del Valles
  Barcelona
  Spain | Roxacin 100 mg/ml, oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Romikim Farma SL
  Gran Via Carlos III, 98,6
  8027 Barcelona
  Spain | Enrodexil 100 mg/ml oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | SP Veterinaria SA
  Ctra. Reus Vinyols km 4.1
  43330 Riudoms
  Tarragona
  Spain | Colmyc 100 mg/ml injectieoplossing voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Doraflox 100 mg/ml, oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Unisol 100 mg/ml, oplossing voor injectie voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| The Netherlands | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, pigs, dogs, cats |
| The Netherlands | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox Oplossing voor injectie 100 mg/ml voor runderen en varkens | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Animalcare Ltd
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals | Enrofloxacin | 25 mg/ml | Solution for injection | Cage birds, cats, dogs, exotic animals, reptiles, small mammals |
| United Kingdom | Animalcare Ltd
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, pigs |
| United Kingdom | Animalcare Ltd
  10 Great North Way
  York Business Park
  Nether Poppleton
  York
  YO26 6RB
  United Kingdom | Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury
  Berkshire
  RG14 1JA
  United Kingdom | Baytril 2,5 % Solution for Injection | Enrofloxacin | 25 mg/ml | Solution for injection | Cage birds, cats, dogs, exotic animals, reptiles, small mammals |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury
  Berkshire
  RG14 1JA
  United Kingdom | Baytril 5 % Solution for Injection | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, pigs |
| United Kingdom | Bayer plc
  Animal Health Division
  Bayer House
  Strawberry Hill
  Newbury
  Berkshire
  RG14 1JA
  United Kingdom | Baytril 10 % Solution for Injection | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, pigs |
| United Kingdom | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, Pigs |
| United Kingdom | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Chanelle Pharmaceuticals Manufacturing Ltd.
  Loughrea
  Co. Galway
  Ireland | Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals | Enrofloxacin | 25 mg/ml | Solution for injection | Cage birds, cats, dogs, exotic animals, reptiles, small mammals |
| United Kingdom | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, pigs |
| United Kingdom | FORTE Healthcare Limited
  Cougar Lane
  Naul
  Co. Dublin
  Ireland | Enrotron 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Global Vet Health SL
  c/Capcanes, no 12-bajos
  Poligon Agro-Reus
  Reus 43206
  Spain | Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Industrial Veterinaria SA
  C/Esmeralda 19-21
  08950 Esplugues de Llobregat
  Barcelona
  Spain | Enrodexil 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs | Enrofloxacin | 50 mg/ml | Solution for injection | Cattle, dogs, pigs |
| United Kingdom | Krka d.d.
  Novo mesto
  Smarjeska cesta 6
  8501 Novo Mesto
  Slovenia | Enroxil 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Vetpharma Animal Health, S.L.
  Les Corts 23.
  08028 Barcelona
  Spain | Unisol 100 mg/ml Solution for Injection for Cattle and Pigs | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |
| United Kingdom | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin | Enrofloxacin | 50 mg/ml | Solution for injection | Cats, cattle, dogs, pigs |
| United Kingdom | Virbac S.A.
  1ére Avenue L.I.D. 2065m
  06516 Carros Cedex
  France | Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs Enrofloxacin | Enrofloxacin | 100 mg/ml | Solution for injection | Cattle, pigs |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Austria

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, pigs, rabbits

Austria

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (Calves), pigs, dogs

Austria

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 100, 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Austria

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml Injektionslösung für Tiere

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Austria

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Austria

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Enrodexil, 100 mg/ml, Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Austria

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Austria

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Austria

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Unisol 100 mg/ml, Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Austria

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Austria

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

BAYTRIL PIGLET

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

BAYTRIL 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Cats, dogs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

BAYTRIL 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

BAYTRIL SWINE

Enrofloxacin

100 mg/ml

Solution for injection

Pigs

Belgium

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

BAYTRIL 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle

Belgium

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FENOFLOX 50 MG/ML

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Belgium

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FENOFLOX 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

FLOXADIL 50 MG/ML

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Belgium

EMDOKA bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

FLOXADIL 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 25 MG/ML

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Belgium

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 50 MG/ML

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Belgium

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

COLMYC 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Vandenbussche Farma Service

Brusselsesteenweg 396

1980 Eppegem

Belgium

FLOXAVET 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Belgium

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

DORAFLOX 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Belgium

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

UNISOL 100 MG/ML

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Bulgaria

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Байтрил 5 % инжективен разтвор

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Bulgaria

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Ганадексил 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dogs

Bulgaria

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Роксацин БГ инжективен

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Bulgaria

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Ценеровиг — 10 ГБ Инж.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, dogs

Bulgaria

Laboratorios Hipra S.A.

Avda. La Selva, 135

17170 Amer

Girona

Spain

Хипралона Енро — И

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Bulgaria

Laboratorios Syva S.A.

Parroco Pablo Diez, 49 — 57

24010 Leon

Spain

Сиваквинол — 100 Инжекционен разтвор

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Bulgaria

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Кинофлокс 100 mg/ml инжекционен разтвор за говеда и свине

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Bulgaria

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Колмик 100 мг/мл инжекционен разтвор за говеда и свине

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Cyprus

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril 5 %, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Czech Republic

Bayer s.r.o.

Siemensova 2717/4

155 00 Praha 5

Czech Republic

BAYTRIL 2,5 % (w/v) injekční roztok

Přípravek s indikačním omezením

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Czech Republic

BAYER s.r.o.

Siemensova 2717/4

155 00 Praha 5

Czech Republic

BAYTRIL 5 % (w/v) injekční roztok

Přípravek s indikačním omezením

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Czech Republic

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml injekční roztok pro psy, kočky a exotická zvířata

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats exotic animals (small mammals, reptiles and birds)

Czech Republic

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Czech Republic

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml injekční roztok pro skot a prasata

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Czech Republic

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 50 mg/ml injekční roztok

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Czech Republic

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml injekční roztok

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Czech Republic

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 mg/ml injekční roztok

Enrofloxacin

100 mg/ml

Solution for injection

Pigs and calves

Denmark

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril Vet

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cattle, poultry, cats, pigs

Denmark

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril Vet

Enrofloxacin

100 mg/ml

Solution for injection

Dogs, cattle, poultry, cats, pigs

Denmark

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cattle, poultry, cats, pigs

Estonia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Estonia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Estonia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Estonia

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Ganadexil Enrofloxacina 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dogs

Estonia

Laboratorios Hipra S.A.

Avda. La Selva, 135

17170 Amer

Girona

Spain

Hipralona Enro-I

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Estonia

Vetoquinol Biowet Sp z o.o.

13/14 Kosynierów Gdyńskich St.

66-400 Gorzów Wlkp.

Poland

Enrobioflox5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dogs

Finland

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

50 mg/ml

Solution for injection

Cats, dogs, sheep, cattle, pigs, goats

Finland

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox vet

Enrofloxacin

50 mg/ml

Solution for injection

Cats, dogs, cattle, pigs

France

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

ENROCARE 25 MG/ML INJECTABLE POUR CHIENS CHATS ET NAC

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

France

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

ENROCARE 50 MG/ML INJECTABLE POUR BOVINS PORCINS CHIENS ET CHATS

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

France

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

ENROCARE 100 MG/ML INJECTABLE POUR BOVINS ET PORCINS

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

France

Bayer Sante

220 Avenue de la Recherche

59120 LOOS

France

BAYTRIL 2,5 % SOLUTION INJECTABLE

Enrofloxacin

25 mg/ml

Solution for injection

Cattle, pigs, dogs

France

Bayer Sante

220 Avenue de la Recherche

59120 LOOS

France

BAYTRIL 5 % SOLUTION INJECTABLE

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

France

Bayer Sante

220 Avenue de la Recherche

59120 LOOS

France

BAYTRIL 10 % SOLUTION INJECTABLE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

France

BIOLIS

21 Montee De La Garde

69340 Francheville

France

QUINOTRYL 50 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

France

BIOLIS

21 Montee De La Garde

69340 Francheville

France

QUINOTRYL 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCI NS

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

France

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

CHANENRO 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

France

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FLOXIBAC 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

France

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

CHANENRO 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

France

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FLOXIBAC 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCIN S

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Albrecht GmbH

Hauptstr. 6-8

D-88326 Aulendorf

Germany

Enro-Sleecol 50 mg/ml

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Albrecht GmbH

Hauptstr. 6-8

D-88326 Aulendorf

Germany

Enro-Sleecol 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 25

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, rabbits, dogs, cats

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 50

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 100

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, rabbits, dogs, cats

Germany

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril — Das Original — 5 % Injektionslösung

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Calluna Pharma bvba

Treslong 34

B-2322 Hoogstraaten

Belgium

Enrofloxacin 2,5 % WDT, Injektionslösung

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Germany

Calluna Pharma bvba

Treslong 34

B-2322 Hoogstraaten

Belgium

Enrofloxacin 5 % WDT, Injektionslösung

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Calluna Pharma bvba

Treslong 34

B-2322 Hoogstraaten

Belgium

Enrofloxacin 10 % WDT, Injektionslösung

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Germany

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Enrodexil 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Roxacin 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Medistar Arzneimittel-Vertrieb GmbH

Lüdinghauser Str. 23

D-59387 Ascheberg

Germany

Enrostar 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Medistar Arzneimittel-Vertrieb GmbH

Lüdinghauser Str. 23

D-59387 Ascheberg

Germany

Enrostar 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Serumwerk Bernburg AG

Hallesche Landstr. 105b

D-06406 Bernburg

Germany

Ursofloxacin 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dog

Germany

Serumwerk Bernburg AG

Hallesche Landstr. 105b

D-06406 Bernburg

Germany

Ursofloxacin 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml Inyectable

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Doraflox 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Unisol

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Germany

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Germany

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Dogs

Greece

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs

Greece

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FLOXIBAC 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Greece

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

FLOXIBAC 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROFLOXACIN/HEALTHCARE

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

Greece

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROFLOXACIN/HEALTHCARE

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Greece

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROFLOXACIN/HEALTHCARE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

COLMYC

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Greece

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

DORAFLOX

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Bayer Hungária Kft.

Alkotás u. 50.

1123 Budapest

Hungary

Baytril 2,5 % injekció A.U.V.

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)

Hungary

Bayer Hungária Kft.

Alkotás u. 50.

1123 Budapest

Hungary

Baytril 5 % injekció A.U.V.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Hungary

Bayer Hungária Kft.

Alkotás u. 50.

1123 Budapest

Hungary

Baytril 10 % injekció A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Hungary

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml injekció kutyák, macskák és egzotikus állatok részére A.U.V.

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Hungary

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Hungary

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml injekció szarvasmarha és sertés részére A.U.V

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 5 % injekció A.U.V.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, sheep, goats

Hungary

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 % injekció A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Laboratorios Syva S.A.

Parroco Pablo Diez, 49-57

24010 Leon

Spain

Syvaquinol 100 injekció A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

DORAFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Hungary

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

LANFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Iceland

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril vet.

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, poultry dogs, cats

Iceland

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril vet.

Enrofloxacin

100 mg/ml

Solution for injection

Calves, pigs, poultry dogs, cats

Ireland

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats and exotic animals (small mammals, reptiles and avian species)

Ireland

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs weighing more than 25 kg, dogs, cats

Ireland

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs weighing more than 25 kg

Ireland

Bayer Limited

The Atruim

Blackthorn Road

Dublin 18

Ireland

Baytril 2,5 % Solution for Injection

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Ireland

Bayer Limited

The Atruim

Blackthorn Road

Dublin 18

Ireland

Baytril 5 % Solution for Injection

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

Bayer Limited

The Atruim

Blackthorn Road

Dublin 18

Ireland

Baytril 10 % Solution for Injection

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml Solution for injection for dogs, cats and exotic animals

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Ireland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml Solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Global Vet Health SL

c/Capcanes, no 12-bajos

Poligon Agro-Reus

Reus 43206

Spain

Quinoflox 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 50 mg/ml solution for injection for calves, pigs and dogs

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Ireland

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 mg/ml solution for injection for cattle and pig

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Doraflox 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Unisol 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Ireland

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats.

Enrofloxacin.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Ireland

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 100 mg/ml solution for injection for cattle and pigs

Enrofloxacin

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Italy

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Baytril

Enrofloxacin

25 mg/ml and 50 mg/ml

Solution for injection

Cattle, dogs, sheep, goats, cats, rabbits, pigs

Italy

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Baytril 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats

Italy

CEVA Salute Animale

viale Colleoni, 15

20864 Agrate Brianza (MB)

Italy

CEVAFLOX iniettabile, 100 mg/ml, soluzione iniettabile per bovini, ovini, suini

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, sheep

Italy

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

GELLIFLOX 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini e suini

Enrofloxacin

100 mg/ml (or 50 mg/ml)

Solution for injection

Cattle, pigs

Italy

Drugs Italia srl

Via G. Puecher, 8

20037 Paderno Dugnano (MI)

Italy

EFLOXIN soluzione iniettabile

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, sheep

Italy

Fatro s.p.a.

Via Emilia, 285

Ozzano Emilia (BO)

Italy

VALEMAS 10 (or 5) 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini, ovi-caprini e suini

Enrofloxacin

100 mg/ml (or 50 mg/ml)

Solution for injection

Cattle, pigs, sheep, goats

Italy

Friulchem

via San Marco, 23

33099 Vivaro (PN)

Italy

TENOTRIL 100 mg/ml soluzione iniettabile epr bovini, suini, ovicaprini

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats

Italy

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL 100 mg/ml soluzione iniettabile per bovini e suini

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Italy

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 mg/ml soluzione iniettabile per bovini e suini

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Italy

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

COLMYC 100 mg/ml soluzione iniettabile

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Italy

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

LANFLOX 100 mg/ml soluzione iniettabile per bovini e suini

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Latvia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

Latvia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Latvia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Lithuania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 25 mg/ml, injekcinis tirpalas šunims, katėms ir egzotiniams gyvūnams

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and avian species)

Lithuania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Lithuania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 100 mg/ml, injekcinis tirpalas galvijams ir kiaulėms

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Lithuania

Vetoquinol Biowet Sp z o.o.

13/14 Kosynierów Gdyńskich St.

66-400 Gorzów Wlkp.

Poland

ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Luxembourg

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 25 mg/ml Injektionsl! osung für Hunde, katzen und exotische Tiere

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals (small mammals, reptiles and birds)

Luxembourg

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 50 mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs >25kg, dogs, cats

Luxembourg

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 100 mg/ml Injektionslösung für Rinder und Schweine

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs >25kg

Luxembourg

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

Baytril piglet 25 mg/ml

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

Luxembourg

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

Baytril 2,5 %

Enrofloxacin

25 mg/ml

Solution for injection

Cats, dogs

Luxembourg

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

Baytril 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Luxembourg

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

Baytril 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle

Luxembourg

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Machelen

Belgium

Baytril Swine 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Pigs

Luxembourg

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml solution injectable pour bovins, porcins, chiens et chats

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Luxembourg

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml solution injectable pour bovins et porcins

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Luxembourg

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc injectable Bovins Porcins

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Malta

Farmcare Ltd

Florence A triq il Fran

Qormi

Malta

Baytril 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Malta

Industrial Veterinaria, S.A

Esmeralda, 19,

08950 Esplugues de Llobreget

Barcelona

Spain

Ganadexil Enrofloxacino 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Malta

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Roxacin injection

Enrofloxacin

100 mg/ml

Solution for injection

Pigs

Malta

Laboratorios Syva S.A.

Parroco Pablo Diez, 49-57

24010 Leon

Spain

Syvaquinol 25 %

Enrofloxacin

25 mg/ml

Solution for injection

Calves, piglets, dogs

Malta

Laboratorios Syva S.A.

Parroco Pablo Diez, 49-57

24010 Leon

Spain

Syvaquinol 100 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Norway

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

25 mg/ml

Solution for injection

Pigs, cattle, dogs, cats

Norway

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril vet

Enrofloxacin

100 mg/ml

Solution for injection

Pigs, cattle, dogs, cats

Norway

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Poland

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Poland

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Poland

Biowet Puławy Sp. z o.o.

2 Arciucha Str.

24-100

Puławy

Poland

Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Poland

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

6 Grójecka Str.

05-651 Drwalew

Poland

Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła

Enrofloxacin

100 mg/ml

Solution for injection

Cattle

Poland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

Poland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Poland

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Poland

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Enrodexil, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Poland

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Poland

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Roxacin, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Poland

PFO ‘Vetos-Farma’ Sp. z o.o.

21 Dzierżoniowska Str.

58-260

Bielawa

Poland

Enrofloxacyna 5 % iniekcja, enrofloxacyna 5 g/100ml, roztwór dla bydła, świń, psów i kotów

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Poland

PFO ‘Vetos-Farma’ Sp. z o.o.

21 Dzierżoniowska Str.

58-260

Bielawa

Poland

Enrofloxacyna 10 % iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Poland

Pharmagal, s.r.o.

Murgasova 5

949 01, Nitra

Slovakia

Enrogal 50 mg/ml roztwór do wstrzykiwań

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Poland

Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o.

32 Gliniana Str.

20-616

Lublin

Poland

Enrocin 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Poland

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Poland

Vetoquinol Biowet Sp z o.o.

13/14 Kosynierów Gdyńskich St.

66-400 Gorzów Wlkp.

Poland

Enrobioflox 5 % Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Poland

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Lanflox, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Bayer PORTUGAL S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

BAYTRIL 2,5 % solução injectável

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Portugal

Bayer PORTUGAL S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Baytril 5 % solução injectável

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, cattle and pigs

Portugal

Bayer PORTUGAL S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal

Baytril 10 % solução injectável

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml solução injectável para bovinos, suínos, cães e gatos

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Portugal

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Portugal

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 100 mg/ml solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

ESTEVE FARMA, LDA

Av. Do Forte, 3

Edifício Suécia II

Piso 4A

2794-044 Carnaxide

Portugal

ALSIR 25 mg/ml solução injectável para Cães e Gatos

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Portugal

ESTEVE FARMA, LDA

Av. Do Forte, 3

Edifício Suécia II

Piso 4A

2794-044 Carnaxide

Portugal

ALSIR 50Mmg/ml Solução Injectável

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Portugal

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml Solução injectável para cães, gatos e animais exóticos

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic Animals (small mammals, reptiles and avian species)

Portugal

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Portugal

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Global Vet Health SL

c/Capcanes, no 12-bajos

Poligon Agro-Reus

Reus 43206

Spain

Quinoflox 100 mg/ml solução injetável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 mg/ml solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml Solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

LANFLOX 100 mg/ml solução injectável para bovinos e suínos.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Portugal

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

ENRODEXIL 100 mg/ml solução injectável para bovinos e suínos

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

CENAVISA SA LABORATORIOS

Cami Pedra Estela s/n

43205 REUS

Spain

CENAMICINA 10 PLUS

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs, dogs

Romania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 25 mg/ml

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

Romania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 50 mg/ml

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Romania

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

ENROTRON 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pig

Romania

Global Vet Health SL

c/Capcanes, no 12-bajos

Poligon Agro-Reus

Reus 43206

Spain

QUINOFLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

GANADEXIL ENROFLOXACINA

5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs,

Romania

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 50 mg/ml

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, goats, sheep, dogs

Romania

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

Laboratorios Hipra S.A.

Avda. La Selva, 135

17170 Amer

Girona

Spain

HIPRALONA ENRO I

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs

Romania

Laboratorios Syva S.A.

Parroco Pablo Diez, 49-57

24010 Leon

Spain

SYVAQUINOL 100 injectable

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

LABORATORIOS VELVIAN S.L

C/Vitoria 9, 2 B

09004

Burgos

Spain

ENRODEXIL 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

PASTEUR

Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

Romania

Enrofloxacina 5 % injectable solution

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, sheep, goats, pigs, dogs, cats

Romania

PASTEUR

Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure

Jud. Prahova

Romania

Enrofloxacina 10 % injectable solution

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, sheep, goats, pigs, dogs, cats

Romania

S.C. ROMVAC COMPANY S.A.

Şos. Centurii, nr. 7

Voluntari

Romania

Enrofloxarom 5 %

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, sheep, pigs, dogs

Romania

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml inyectable solution

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Romania

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

DORAFLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovakia

Bayer s.r.o.

Litvínovská 609/3

190 21 Praha 9

Czech Republic

Baytril 2,5 % inj. ad us. vet.

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Slovakia

Bayer s.r.o.

Litvínovská 609/3

190 21 Praha 9

Czech Republic

Baytril 5 % (w/v) injekčný roztok

Enrofloxacin

50 mg/ml

Solution for injection

Dogs, pigs, calves

Slovakia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml injekčný roztok pre psy, mačky a exotické živočíchy

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

Slovakia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

Slovakia

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml injekčný roztok

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovakia

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 5 % inj. ad us. vet.

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, sheep, goats, pigs, dogs

Slovakia

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 % inj. ad us. vet.

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovakia

Laboratorios Hipra S.A.

Avda. La Selva, 135

17170 Amer

Girona

Spain

Hipralona Enro — I 50 mg/ml injekčný roztok

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs

Slovakia

Pharmagal, s.r.o.

Murgasova 5

949 01, Nitra

Slovakia

Enrogal 50 mg/ml injekčný roztok

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Slovenia

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, pigs, rabbits

Slovenia

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse

Enrofloxacin

50 mg/ml

Solution for injection

Cattle (calves), pigs, dogs

Slovenia

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

ENROTRON 100, 100 mg/ml raztopina za injiciranje za govedo in prašiče

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovenia

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Slovenia

Baytril® 5 % raztopina za injiciranje

Enrofloxacin

50 mg/ml

Solution for injection

Calves, pigs, dogs

Slovenia

Bayer d.o.o.

Bravničarjeva 13

Ljubljana

Slovenia

Baytril® 10 % raztopina za injiciranje

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovenia

GENERA Slovenia d.o.o.

Dunajska 51

1000 Ljubljana

Slovenia

VETOFLOK 10 % raztopina za injiciranje

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovenia

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, sheep, goats, pigs, dogs

Slovenia

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROX 100 mg/ml raztopina za injiciranje za govedo in prašiče

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Slovenia

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 100 mg/ml raztopina za injiciranje za govedo in prašiče

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

Hifarmax, Produtos e serviços veterinários, Lda

Av. Marechal Craveiro Lopes no96 R/C

Dto 2775-696 Carcavelos

Portugal

ENROCILL 50 mg/ml solución inyectable para bovino, porcino y perros

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Spain

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

ENRODEXIL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

ROXACIN 100 mg/ml SOLUCION INYECTABLE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

Laboratorios Dr. Esteve, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

ALSIR 2,5 % SOLUCION INYECTABLE

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

Spain

Laboratorios Dr. Esteve, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

ALSIR 5 % SOLUCION INYECTABLE

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

Spain

Laboratorios Dr. Esteve, S.A.

Avda. Mare de Déu de Montserrat, 221

08041 Barcelona

Spain

ALSIR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

QUINOLCEN 100 mg/ml SOLUCION INYECTABLE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

FLOXAVEX 100 mg/ml SOLUCION INYECTABLE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Spain

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

LANFLOX 100 mg/ml SOLUCION INYECTABLE

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

Sweden

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril® vet.

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, pigs, cattle, cats

Sweden

Bayer Animal Health GmbH

Kaiser-Wilhelm-Allee 50

51368 Leverkusen

Germany

Baytril® vet.

Enrofloxacin

100 mg/ml

Solution for injection

Dog, pigs, cattle, cats

Sweden

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox vet

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, exotic animals

The Netherlands

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

The Netherlands

Animalcare Group plc.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Floxadil 100 mg/ml, oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

BAYTRIL 2,5 % INJEKTIEVLOEISTOF

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

Baytril Piglet 25 mg/ml inspuitbare oplossing

Enrofloxacin

25 mg/ml

Solution for injection

Pigs

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

BAYTRIL 5 % INJEKTIEVLOEISTOF

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

BAYTRIL 5 % INJECTIEOPLOSSING

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, dogs, pigs

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

BAYTRIL INJEKTIEVLOEISTOF 10 %

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Bayer B.V.

Energieweg 1

3641 RT Mijdrecht

Netherlands

BAYTRIL 10 % INJECTIEOPLOSSING

Enrofloxacin

100 mg/ml

Solution for injection

Pigs, cattle

The Netherlands

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml Oplossing voor injectie

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

The Netherlands

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml Oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml, oplossing voor injectie

Enrofloxacin

25 mg/ml

Solution for injection

Dogs, cats, cage birds, reptiles

The Netherlands

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

The Netherlands

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml, oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs

The Netherlands

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 100 MG/ML SOLUTION FOR INJECTION

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Laboratorios Calier, S.A.

c/Barcelonès, 26 (Pla del Ramassà)

08520 Les Franqueses del Valles

Barcelona

Spain

Roxacin 100 mg/ml, oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Romikim Farma SL

Gran Via Carlos III, 98,6

8027 Barcelona

Spain

Enrodexil 100 mg/ml oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

SP Veterinaria SA

Ctra. Reus Vinyols km 4.1

43330 Riudoms

Tarragona

Spain

Colmyc 100 mg/ml injectieoplossing voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Doraflox 100 mg/ml, oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Unisol 100 mg/ml, oplossing voor injectie voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

The Netherlands

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, pigs, dogs, cats

The Netherlands

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox Oplossing voor injectie 100 mg/ml voor runderen en varkens

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Animalcare Ltd

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals

Enrofloxacin

25 mg/ml

Solution for injection

Cage birds, cats, dogs, exotic animals, reptiles, small mammals

United Kingdom

Animalcare Ltd

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, pigs

United Kingdom

Animalcare Ltd

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

United Kingdom

Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Baytril 2,5 % Solution for Injection

Enrofloxacin

25 mg/ml

Solution for injection

Cage birds, cats, dogs, exotic animals, reptiles, small mammals

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Baytril 5 % Solution for Injection

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, pigs

United Kingdom

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

Baytril 10 % Solution for Injection

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, pigs

United Kingdom

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, Pigs

United Kingdom

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals

Enrofloxacin

25 mg/ml

Solution for injection

Cage birds, cats, dogs, exotic animals, reptiles, small mammals

United Kingdom

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, pigs

United Kingdom

FORTE Healthcare Limited

Cougar Lane

Naul

Co. Dublin

Ireland

Enrotron 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Global Vet Health SL

c/Capcanes, no 12-bajos

Poligon Agro-Reus

Reus 43206

Spain

Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Industrial Veterinaria SA

C/Esmeralda 19-21

08950 Esplugues de Llobregat

Barcelona

Spain

Enrodexil 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs

Enrofloxacin

50 mg/ml

Solution for injection

Cattle, dogs, pigs

United Kingdom

Krka d.d.

Novo mesto

Smarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Vetpharma Animal Health, S.L.

Les Corts 23.

08028 Barcelona

Spain

Unisol 100 mg/ml Solution for Injection for Cattle and Pigs

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

United Kingdom

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin

Enrofloxacin

50 mg/ml

Solution for injection

Cats, cattle, dogs, pigs

United Kingdom

Virbac S.A.

1ére Avenue L.I.D. 2065m

06516 Carros Cedex

France

Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs Enrofloxacin

Enrofloxacin

100 mg/ml

Solution for injection

Cattle, pigs

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