# Official Journal C 189/27 M

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 189 |
| | |
| English edition | Information and Notices | Volume 5927 May 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 189

English edition

Information and Notices

Volume 5927 May 2016

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 189/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 189/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 189/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2016/C 189/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 27.5.2016 | EN | Official Journal of the European Union | C 189/1 |
| --- | --- | --- | --- |

27.5.2016

EN

Official Journal of the European Union

C 189/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016

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

(2016/C 189/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.4.2016 | Rasagiline Mylan | rasagiline | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1090 | Tablet | N04BD02 | 6.4.2016 |
| 8.4.2016 | Palonosetron Hospira | palonosetron | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/16/1100 | Solution for injection | A04AA05 | 12.4.2016 |
| 21.4.2016 | Descovy | emtricitabine/tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1099 | Film-coated tablet | J05AR17 | 25.4.2016 |
| 25.4.2016 | Lonsurf | trifluridine/tipiracil | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/16/1096 | Film-coated tablet | L01BC | 27.4.2016 |
| 25.4.2016 | Taltz | ixekizumab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | Solution for injection | L04AC13 | 28.4.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

4.4.2016

Rasagiline Mylan

rasagiline

Mylan S.A.S

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

EU/1/16/1090

Tablet

N04BD02

6.4.2016

8.4.2016

Palonosetron Hospira

palonosetron

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/16/1100

Solution for injection

A04AA05

12.4.2016

21.4.2016

Descovy

emtricitabine/tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1099

Film-coated tablet

J05AR17

25.4.2016

25.4.2016

Lonsurf

trifluridine/tipiracil

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/16/1096

Film-coated tablet

L01BC

27.4.2016

25.4.2016

Taltz

ixekizumab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

Solution for injection

L04AC13

28.4.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.4.2016 | Gardasil 9 | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 6.4.2016 |
| 4.4.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 6.4.2016 |
| 4.4.2016 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 6.4.2016 |
| 4.4.2016 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 6.4.2016 |
| 4.4.2016 | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 6.4.2016 |
| 4.4.2016 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 6.4.2016 |
| 7.4.2016 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 11.4.2016 |
| 7.4.2016 | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 11.4.2016 |
| 7.4.2016 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 11.4.2016 |
| 8.4.2016 | Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/708 | 12.4.2016 |
| 8.4.2016 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 12.4.2016 |
| 8.4.2016 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 12.4.2016 |
| 13.4.2016 | Cholib | BGP Products Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom | EU/1/13/866 | 15.4.2016 |
| 13.4.2016 | Ibandronic acid Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/11/685 | 15.4.2016 |
| 13.4.2016 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 15.4.2016 |
| 13.4.2016 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 15.4.2016 |
| 13.4.2016 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/13/824 | 15.4.2016 |
| 13.4.2016 | Paliperidone Janssen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 15.4.2016 |
| 13.4.2016 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/806 | 15.4.2016 |
| 13.4.2016 | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 15.4.2016 |
| 13.4.2016 | Tresiba | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | 15.4.2016 |
| 13.4.2016 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423 | 15.4.2016 |
| 13.4.2016 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 15.4.2016 |
| 18.4.2016 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 20.4.2016 |
| 18.4.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 20.4.2016 |
| 21.4.2016 | Abilify | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/04/276 | 25.4.2016 |
| 21.4.2016 | Bonviva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/265 | 25.4.2016 |
| 21.4.2016 | Dasselta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/739 | 25.4.2016 |
| 21.4.2016 | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 25.4.2016 |
| 21.4.2016 | Exviera | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/983 | 25.4.2016 |
| 21.4.2016 | Helicobacter Test INFAI | INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH
  Universitätsstraße 142, D-44799 Bochum, Deutschland | EU/1/97/045 | 25.4.2016 |
| 21.4.2016 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 25.4.2016 |
| 21.4.2016 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/697 | 25.4.2016 |
| 21.4.2016 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 25.4.2016 |
| 21.4.2016 | Zoely | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/690 | 25.4.2016 |
| 25.4.2016 | Bondronat | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/012 | 27.4.2016 |
| 25.4.2016 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 27.4.2016 |
| 25.4.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 27.4.2016 |
| 25.4.2016 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 27.4.2016 |
| 25.4.2016 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 27.4.2016 |
| 25.4.2016 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 27.4.2016 |
| 25.4.2016 | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 27.4.2016 |
| 25.4.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 27.4.2016 |
| 28.4.2016 | ABILIFY MAINTENA | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/13/882 | 3.5.2016 |
| 28.4.2016 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 2.5.2016 |
| 28.4.2016 | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/702 | 2.5.2016 |
| 28.4.2016 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 2.5.2016 |
| 28.4.2016 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 3.5.2016 |
| 28.4.2016 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 2.5.2016 |
| 28.4.2016 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 2.5.2016 |
| 28.4.2016 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 2.5.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.4.2016

Gardasil 9

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

6.4.2016

4.4.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

6.4.2016

4.4.2016

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

6.4.2016

4.4.2016

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

6.4.2016

4.4.2016

Telzir

ViiV Healthcare UK Limited

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

EU/1/04/282

6.4.2016

4.4.2016

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

6.4.2016

7.4.2016

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

11.4.2016

7.4.2016

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

11.4.2016

7.4.2016

Ziagen

ViiV Healthcare UK Limited

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

EU/1/99/112

11.4.2016

8.4.2016

Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708

12.4.2016

8.4.2016

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

12.4.2016

8.4.2016

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

12.4.2016

13.4.2016

Cholib

BGP Products Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom

EU/1/13/866

15.4.2016

13.4.2016

Ibandronic acid Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/11/685

15.4.2016

13.4.2016

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

15.4.2016

13.4.2016

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

15.4.2016

13.4.2016

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/13/824

15.4.2016

13.4.2016

Paliperidone Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

15.4.2016

13.4.2016

Ryzodeg

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

15.4.2016

13.4.2016

Tamiflu

Roche Registration Limited

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

EU/1/02/222

15.4.2016

13.4.2016

Tresiba

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

15.4.2016

13.4.2016

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

15.4.2016

13.4.2016

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

15.4.2016

18.4.2016

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

20.4.2016

18.4.2016

Tysabri

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

20.4.2016

21.4.2016

Abilify

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

25.4.2016

21.4.2016

Bonviva

Roche Registration Limited

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

EU/1/03/265

25.4.2016

21.4.2016

Dasselta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

25.4.2016

21.4.2016

Desloratadine ratiopharm

ratiopharm GmbH

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

EU/1/11/746

25.4.2016

21.4.2016

Exviera

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/983

25.4.2016

21.4.2016

Helicobacter Test INFAI

INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH

Universitätsstraße 142, D-44799 Bochum, Deutschland

EU/1/97/045

25.4.2016

21.4.2016

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

25.4.2016

21.4.2016

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/697

25.4.2016

21.4.2016

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

25.4.2016

21.4.2016

Zoely

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/690

25.4.2016

25.4.2016

Bondronat

Roche Registration Limited

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

EU/1/96/012

27.4.2016

25.4.2016

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

27.4.2016

25.4.2016

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

27.4.2016

25.4.2016

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

27.4.2016

25.4.2016

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

27.4.2016

25.4.2016

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

27.4.2016

25.4.2016

Trizivir

ViiV Healthcare UK Limited

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

EU/1/00/156

27.4.2016

25.4.2016

Tysabri

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/06/346

27.4.2016

28.4.2016

ABILIFY MAINTENA

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/13/882

3.5.2016

28.4.2016

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

2.5.2016

28.4.2016

Levetiracetam ratiopharm

ratiopharm GmbH

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

EU/1/11/702

2.5.2016

28.4.2016

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

2.5.2016

28.4.2016

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

3.5.2016

28.4.2016

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

2.5.2016

28.4.2016

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

2.5.2016

28.4.2016

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

2.5.2016

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

| Date of the decision | Name of the medicinal product | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.4.2016 | Evalon | Coccidiosis vaccine live for chickens | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/16/194 | Suspension and solvent for oral spray | QI01AN01 | 20.4.2016 |
| 20.4.2016 | LETIFEND | Recombinant Protein Q from L. infantum MON-1 | Laboratorios LETI, S.L.unipersonal
  C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España | EU/2/16/195 | Lyophilisate and solvent for solution for injection | QI07A | 22.4.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

18.4.2016

Evalon

Coccidiosis vaccine live for chickens

Laboratorios Hipra, S.A.

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

EU/2/16/194

Suspension and solvent for oral spray

QI01AN01

20.4.2016

20.4.2016

LETIFEND

Recombinant Protein Q from L. infantum MON-1

Laboratorios LETI, S.L.unipersonal

C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España

EU/2/16/195

Lyophilisate and solvent for solution for injection

QI07A

22.4.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.4.2016 | Meloxidolor | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/13/148 | 6.4.2016 |
| 12.4.2016 | BTVPUR | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/113 | 14.4.2016 |
| 12.4.2016 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/140 | 14.4.2016 |
| 18.4.2016 | CERTIFECT | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/125 | 20.4.2016 |
| 18.4.2016 | Clomicalm | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/007 | 20.4.2016 |
| 18.4.2016 | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 20.4.2016 |
| 18.4.2016 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 20.4.2016 |
| 18.4.2016 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 20.4.2016 |
| 18.4.2016 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 20.4.2016 |
| 18.4.2016 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 20.4.2016 |
| 20.4.2016 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/153 | 22.4.2016 |
| 20.4.2016 | Oncept IL-2 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/150 | 22.4.2016 |
| 27.4.2016 | Draxxin | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 29.4.2016 |
| 27.4.2016 | Naxcel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 29.4.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.4.2016

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/13/148

6.4.2016

12.4.2016

BTVPUR

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

14.4.2016

12.4.2016

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

14.4.2016

18.4.2016

CERTIFECT

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/125

20.4.2016

18.4.2016

Clomicalm

Elanco Europe Ltd

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

EU/2/98/007

20.4.2016

18.4.2016

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland

EU/2/13/149

20.4.2016

18.4.2016

Pexion

Boehringer Ingelheim Vetmedica GmbH

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

EU/2/12/147

20.4.2016

18.4.2016

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

20.4.2016

18.4.2016

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

20.4.2016

18.4.2016

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

20.4.2016

20.4.2016

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/153

22.4.2016

20.4.2016

Oncept IL-2

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

22.4.2016

27.4.2016

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

29.4.2016

27.4.2016

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

29.4.2016

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 27.5.2016 | EN | Official Journal of the European Union | C 189/9 |
| --- | --- | --- | --- |

27.5.2016

EN

Official Journal of the European Union

C 189/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016

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

(2016/C 189/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 4.4.2016 | Baytril — Rectificative Decision — Article 34 | Enrofloxacin | See Annex I | See Annex I | 5.4.2016 |
| 4.4.2016 | Baytril — Rectificative Decision — Article 35 | Enrofloxacin | See Annex II | See Annex II | 5.4.2016 |
| 28.4.2016 | Cymevene intravenous — Art. 30 | ganciclovir | See Annex III | See Annex III | 2.5.2016 |
| 4.4.2016 | Tobramycin VVB — Community Referrals — Article 29 | tobramycin | See Annex IV | See Annex IV | 5.4.2016 |
| 4.4.2016 | Gutal 1 000  g/kg — Corrigendum — Article 33 | zinc oxide | See Annex V | See Annex V | 5.4.2016 |
| 28.4.2016 | Iron containing intravenous medicinal products — Corrigendum — Article 31 | ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex | See Annex VI | See Annex VI | 29.4.2016 |
| 7.4.2016 | Zoledronic acid — Rectificative Decision — PSUSA-3149-201408 | zoledronic acid | Not applicable | Not applicable | 8.4.2016 |
| 25.4.2016 | Aripiprazole — PSUSA_234-201507 — Article 107b | aripiprazole | Not applicable | Not applicable | 26.4.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

4.4.2016

Baytril — Rectificative Decision — Article 34

Enrofloxacin

See Annex I

See Annex I

5.4.2016

4.4.2016

Baytril — Rectificative Decision — Article 35

Enrofloxacin

See Annex II

See Annex II

5.4.2016

28.4.2016

Cymevene intravenous — Art. 30

ganciclovir

See Annex III

See Annex III

2.5.2016

4.4.2016

Tobramycin VVB — Community Referrals — Article 29

tobramycin

See Annex IV

See Annex IV

5.4.2016

4.4.2016

Gutal 1 000  g/kg — Corrigendum — Article 33

zinc oxide

See Annex V

See Annex V

5.4.2016

28.4.2016

Iron containing intravenous medicinal products — Corrigendum — Article 31

ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex

See Annex VI

See Annex VI

29.4.2016

7.4.2016

Zoledronic acid — Rectificative Decision — PSUSA-3149-201408

zoledronic acid

Not applicable

Not applicable

8.4.2016

25.4.2016

Aripiprazole — PSUSA_234-201507 — Article 107b

aripiprazole

Not applicable

Not applicable

26.4.2016

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

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 II

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 | Enrobioflox 5 % | 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 PORCINS | 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 PORCINS | 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 PORCINS | 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 PORCINS | 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 s.r.l.
  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 per 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 Injektionslösung 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 > 25 kg, 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 > 25 kg |
| 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/100 ml, 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 50 Mmg/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 no 96 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

Enrobioflox 5 %

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 PORCINS

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 PORCINS

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 PORCINS

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 PORCINS

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 s.r.l.

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 per 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 Injektionslösung 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 > 25 kg, 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 > 25 kg

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/100 ml, 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 50 Mmg/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 no 96 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

---

ANNEX III

List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holder in the member states

| Member State
  EU/EEA | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of Administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Roche Austria GmbH
  Engelhorngasse 3
  1211 Vienna
  Austria | Cymevene ‘Roche’ 500 mg — Trockensubstanz zur Infusionsbereitung | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Belgium | N.V. Roche S.A.
  Rue Dante 75
  B-1070 Brussels
  Belgium | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Bulgaria | Roche Bulgaria EOOD
  16, Byalo pole Str.
  1618 Sofia,
  Bulgaria | Симевен 500 mg прах за инфузионен разтвор | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Croatia | Roche d.o.o.
  Ulica grada Vukovara 269a
  10 000 Zagreb
  Croatia | Cymevene 500 mg prašak za otopinu za infuziju | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Cyprus | G. A. Stamatis & Co. Ltd
  27, Andreas Araouzos
  P.O. Box 21305
  1506 Nicosia
  Cyprus | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Czech Republic | Roche s.r.o.
  Dukelských hrdinů 567/52,
  170 00 Praha 7
  Czech Republic | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Denmark | Roche A/S
  Industriholmen 59
  2650 Hvidovre
  Denmark | Cymevene | 500 mg | Powder for concentrate for infusion for solution | Intravenous use | 50 mg/ml |
| Estonia | Roche Eesti OÜ
  Lõõtsa 2,
  11415 Tallinn,
  Estonia | Cymevene | 500 mg | Powder for concentrate for solution for infusion | Intravenous use | 50 mg/ml |
| Finland | Roche Oy
  Klovinpellontie 3
  P.O. Box 12
  02181 Espoo
  Finland | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| France | Roche
  30, cours de l’Ile Seguin
  92650 Boulogne
  Billancourt Cedex
  France | CYMEVAN 500 mg, lyophilisat pour usage parentéral (perfusion) | 500 mg | Lyophilisate for parenteral use (infusion) | Intravenous use | 50 mg/ml |
| Germany | Roche Pharma AG
  Emil-Barell-Straße 1
  79639 Grenzach-Wyhlen
  Germany | Cymeven® i. v. | 500 mg | Powder for concentrate for solution for infusion | Intravenous use | 50 mg/ml |
| Greece | Roche Hellas A.E.
  4, Alamanas & Delfon str.
  151 25 Maroussi
  Greece | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Hungary | Roche (Hungary) Ltd
  Edison str 1.
  Budaörs H-2040
  Hungary | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Iceland | Roche A/S
  Industriholmen 59
  2650 Hvidovre
  Denmark | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Ireland | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Cymevene 500 mg Powder for Concentrate for Solution for Infusion | 500 mg | Powder for Concentrate for Solution for Infusion | Intravenous use | 50 mg/ml |
| Italy | Roche S.p.A.,
  Piazza Durante 11
  Milan
  Italy | Citovirax | 500 mg | Powder for concentrate for solution for infusion | Intravenous use | 50 mg/ml |
| Lithuania | UAB ‘Roche Lietuva’
  J.Jasinskio str. 16B
  LT-03163 Vilnius
  Lithuania | Cymevene | 500 mg | Powder for concentrate for solution for infusion | Intravenous use | 50 mg/ml |
| Luxembourg | N.V. Roche S.A.
  Rue Dante 75
  B-1070 Brussels
  Belgium | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| The Netherlands | Roche Nederland B.V.
  Beneluxlaan 2a
  3446 GR Woerden
  The Netherlands | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Norway | Roche Norge AS
  Brynsengfaret 6B
  Postboks 6610 Etterstad
  0607 Oslo
  Norway | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Poland | Roche Polska Sp. z o.o.
  ul. Domaniewska 39 B
  02-672 Warsaw,
  Poland | Cymevene | 500 mg | Powder for concentrate for solution for infusion | Intravenous use | 50 mg/ml |
| Portugal | Roche Farmacêutica Química, Lda.
  Estrada Nacional 249-1
  2720-413 Amadora
  Portugal | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg |
| Romania | Roche România SRL
  Piata Presei Libere, Nr. 3-5, Clădirea City Gate — Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti România | Cymevene 500 mg pulbere pentru soluţie perfuzabilă | 500 mg | powder for solution for infusion | Intravenous use | 50 mg/ml |
| Slovak Republic | Roche Slovensko s.r.o.
  Cintorínska 3/A
  Bratislava 811 08
  Slovak Republic | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Spain | Roche Farma, S.A.
  Eucalipto no 33,
  28016 Madrid
  Spain | Cymevene 500 mg polvo para solución para perfusión | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| Sweden | Roche AB
  Liljeholmsstranden 5
  Box 47327
  100 74 Stockholm
  Sweden | Cymevene | 500 mg | Powder for solution for infusion | Intravenous use | 50 mg/ml |
| United Kingdom | Roche Products Limited,
  6 Falcon Way, Shire Park,
  Welwyn Garden City,
  AL7 1TW,
  United Kingdom | Cymevene powder for infusion | 500 mg | Powder for Infusion | Intravenous use | 50 mg/ml |

Member State

EU/EEA

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of Administration

Content (concentration)

Austria

Roche Austria GmbH

Engelhorngasse 3

1211 Vienna

Austria

Cymevene ‘Roche’ 500 mg — Trockensubstanz zur Infusionsbereitung

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Belgium

N.V. Roche S.A.

Rue Dante 75

B-1070 Brussels

Belgium

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Bulgaria

Roche Bulgaria EOOD

16, Byalo pole Str.

1618 Sofia,

Bulgaria

Симевен 500 mg прах за инфузионен разтвор

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Croatia

Roche d.o.o.

Ulica grada Vukovara 269a

10 000 Zagreb

Croatia

Cymevene 500 mg prašak za otopinu za infuziju

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Cyprus

G. A. Stamatis & Co. Ltd

27, Andreas Araouzos

P.O. Box 21305

1506 Nicosia

Cyprus

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Czech Republic

Roche s.r.o.

Dukelských hrdinů 567/52,

170 00 Praha 7

Czech Republic

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Denmark

Roche A/S

Industriholmen 59

2650 Hvidovre

Denmark

Cymevene

500 mg

Powder for concentrate for infusion for solution

Intravenous use

50 mg/ml

Estonia

Roche Eesti OÜ

Lõõtsa 2,

11415 Tallinn,

Estonia

Cymevene

500 mg

Powder for concentrate for solution for infusion

Intravenous use

50 mg/ml

Finland

Roche Oy

Klovinpellontie 3

P.O. Box 12

02181 Espoo

Finland

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

France

Roche

30, cours de l’Ile Seguin

92650 Boulogne

Billancourt Cedex

France

CYMEVAN 500 mg, lyophilisat pour usage parentéral (perfusion)

500 mg

Lyophilisate for parenteral use (infusion)

Intravenous use

50 mg/ml

Germany

Roche Pharma AG

Emil-Barell-Straße 1

79639 Grenzach-Wyhlen

Germany

Cymeven® i. v.

500 mg

Powder for concentrate for solution for infusion

Intravenous use

50 mg/ml

Greece

Roche Hellas A.E.

4, Alamanas & Delfon str.

151 25 Maroussi

Greece

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Hungary

Roche (Hungary) Ltd

Edison str 1.

Budaörs H-2040

Hungary

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Iceland

Roche A/S

Industriholmen 59

2650 Hvidovre

Denmark

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Ireland

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Cymevene 500 mg Powder for Concentrate for Solution for Infusion

500 mg

Powder for Concentrate for Solution for Infusion

Intravenous use

50 mg/ml

Italy

Roche S.p.A.,

Piazza Durante 11

Milan

Italy

Citovirax

500 mg

Powder for concentrate for solution for infusion

Intravenous use

50 mg/ml

Lithuania

UAB ‘Roche Lietuva’

J.Jasinskio str. 16B

LT-03163 Vilnius

Lithuania

Cymevene

500 mg

Powder for concentrate for solution for infusion

Intravenous use

50 mg/ml

Luxembourg

N.V. Roche S.A.

Rue Dante 75

B-1070 Brussels

Belgium

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

The Netherlands

Roche Nederland B.V.

Beneluxlaan 2a

3446 GR Woerden

The Netherlands

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Norway

Roche Norge AS

Brynsengfaret 6B

Postboks 6610 Etterstad

0607 Oslo

Norway

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Poland

Roche Polska Sp. z o.o.

ul. Domaniewska 39 B

02-672 Warsaw,

Poland

Cymevene

500 mg

Powder for concentrate for solution for infusion

Intravenous use

50 mg/ml

Portugal

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 Amadora

Portugal

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg

Romania

Roche România SRL

Piata Presei Libere, Nr. 3-5, Clădirea City Gate — Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti România

Cymevene 500 mg pulbere pentru soluţie perfuzabilă

500 mg

powder for solution for infusion

Intravenous use

50 mg/ml

Slovak Republic

Roche Slovensko s.r.o.

Cintorínska 3/A

Bratislava 811 08

Slovak Republic

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Spain

Roche Farma, S.A.

Eucalipto no 33,

28016 Madrid

Spain

Cymevene 500 mg polvo para solución para perfusión

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

Sweden

Roche AB

Liljeholmsstranden 5

Box 47327

100 74 Stockholm

Sweden

Cymevene

500 mg

Powder for solution for infusion

Intravenous use

50 mg/ml

United Kingdom

Roche Products Limited,

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

Cymevene powder for infusion

500 mg

Powder for Infusion

Intravenous use

50 mg/ml

---

ANNEX IV

List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States

| Member State EU/EEA | Applicant
  company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Bulgaria | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Тобрамицин ВBБ | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Estonia | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Hungary | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Latvia | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB
  300 mg/5 ml šķīdums izsmidzināšanai | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Lithuania | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Poland | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |
| Romania | UAB ‘VVB’
  9-ojo Forto str. 70
  LT-48179 Kaunas
  Lithuania | Tobramycin VVB | 300 mg/5 ml | nebuliser solution | inhalation use | 6 % |

Member State EU/EEA

Applicant

company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Bulgaria

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Тобрамицин ВBБ

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Estonia

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Hungary

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Latvia

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml šķīdums izsmidzināšanai

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Lithuania

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Poland

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml

nebuliser solution

inhalation use

6 %

Romania

UAB ‘VVB’

9-ojo Forto str. 70

LT-48179 Kaunas

Lithuania

Tobramycin VVB

300 mg/5 ml

nebuliser solution

inhalation use

6 %

---

ANNEX V

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States

| Member State
  (EU/EEA) | Applicant | Product name | INN | Strength | Pharmaceutical
  form | Animal species | Route of
  administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Belgium | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Bulgaria | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Cyprus | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Czech Republic | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Denmark | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Estonia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| France | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Germany | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Greece | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Hungary | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Ireland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Italy | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Latvia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Lithuania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Luxembourg | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Malta | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| The Netherlands | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Poland | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Portugal | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Romania | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovakia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Slovenia | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| Spain | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |
| United Kingdom | Huvepharma NV Uitbreidingstraat 80
  2600 Antwerp
  Belgium | Gutal 1 000  g/kg premix for medicated feeding stuff for piglets | Zinc oxide | 1 000  g/kg | Premix for medicated feeding stuff | Piglet (weaned piglets) | For incorporation into dry feed at the registered mill. Oral use only. |

Member State

(EU/EEA)

Applicant

Product name

INN

Strength

Pharmaceutical

form

Animal species

Route of

administration

Austria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Belgium

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Bulgaria

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Cyprus

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Czech Republic

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Denmark

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Estonia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

France

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Germany

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Greece

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Hungary

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Ireland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Italy

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Latvia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Lithuania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Luxembourg

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Malta

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

The Netherlands

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Poland

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Portugal

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Romania

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovakia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Slovenia

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

Spain

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

United Kingdom

Huvepharma NV Uitbreidingstraat 80

2600 Antwerp

Belgium

Gutal 1 000  g/kg premix for medicated feeding stuff for piglets

Zinc oxide

1 000  g/kg

Premix for medicated feeding stuff

Piglet (weaned piglets)

For incorporation into dry feed at the registered mill. Oral use only.

---

The annexes to Commission Implementing Decision C(2013)5970 final shall read as attached below.

ANNEX VI

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 | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml Injektionslösung und Infusionslösung | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Austria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Austria | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Austria | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Austria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer 100 mg/ml Injektions- oder Infusionslösung | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Austria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Belgium | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Belgium | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Belgium | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Belgium | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric Carboxymaltose | Injectafer | 50,00  mg/ml | Solution for injection/infusion | Intravenous use |
| Bulgaria | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Bulgaria | Pharmalog AG,
  33 Cherni vrah blvd.,
  1421 Sofia
  Bulgaria | Iron sucrose complex | Idafer | 20 mg/ml | Solution for injection | Intravenous use |
| Bulgaria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection | Intravenous use |
| Bulgaria | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Cyprus | The Star Medicines Importers & co ltd,
  9A Loukis Akritas Street,
  P.O.box 50151,
  3601 Lemesos, Cyprus | Iron sucrose complex | VENOFER INJECTION 100 MG IRON/5 ML | 100 mg/5 ml | Solution for injection | Intravenous use |
| Cyprus | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Czech Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 20 mg/ml | Solution for injection | Intravenous use |
| Czech Republic | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERROLOGIC 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | PHARMABIDE LTD
  20, Lakonias str,
  15234 Halandri
  Athens — Greece | Iron sucrose complex | IRON SUCROSE PHARMABIDE 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | FERION 20 MG/ML | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Czech Republic | Sanofi-Aventis, s.r.o.
  Evropská 846/176a
  160 00 Praha 6
  Czech Republic | sodium ferric gluconate complex | FERRLECIT | 12,5  mg/ml | Solution for injection | Intravenous use |
| Czech Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Denmark | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Jerndextran ‘Pharmacosmos’ | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Denmark | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Estonia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Estonia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Estonia | Lek Pharmaceuticals d.d.
  Verovškova 57
  1526 Ljubljana
  Slovenia | Iron (III) hydroxide dextran complex | Ferrum Lek | 50 mg/ml | Solution for injection | Intramuscular use |
| Finland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Finland | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Finland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Finland | Alternova A/S
  Lodshusvej 11
  4230 Skaelskoer
  Denmark | Iron sucrose complex | Venotrix | 20 mg/ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Finland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Finland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| France | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric Carboxymaltose | FERINJECT 50 mg/ml, solution injectable/pour perfusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| France | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER 20 mg/ml, solution injectable | 20 mg/ml | Solution for injection | Intravenous use |
| France | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | FERRISAT 50 mg/ml, solution injectable ou pour perfusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| France | Pharmaki Generics Ltd
  5 Bourlet Close
  W1W 7BL London
  United Kingdom | Iron sucrose complex | FER ACTAVIS 100 mg/5 ml, solution injectable | 100 mg/5 ml | Solution for injection | Intravenous use |
| France | IBD3 Pharma Consulting
  Immeuble l’Orient
  10, place Charles Béraudier
  69003 Lyon
  France | Iron sucrose complex | FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | Mylan SAS
  117, allée des Parcs
  69800 Saint-Priest
  France | Iron sucrose complex | FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | SANDOZ
  49, avenue Georges Pompidou
  92300 Levallois-Perret France | Iron sucrose complex | FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| France | TEVA SANTE
  110, Esplanade du Général de Gaulle
  92931 Paris La Défense Cedex
  FRANCE | Iron sucrose complex | FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV) | 100 mg/5 ml | Solution for injection | Intravenous use |
| Germany | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung | 1 709  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Germany | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FerMed | 1 563 — 1 887  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Germany | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | Nefro-Fer | 1 563 — 1 887  mg/5 ml | Solution for injection | Intravenous use |
| Germany | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer 100 mg/ml Lösung zur Injektion/Infusion | 377-465 mg/ml | Solution for injection/infusion | Intravenous use |
| Germany | Sanofi-Aventis Deutschland GmbH
  Brüningstrasse 50,
  D-65926 Frankfurt am Main Germany | sodium ferric gluconate complex | Ferrlecit 40 mg | 1 288,9  mg/3,2  ml | Solution for injection | Intravenous use |
| Germany | Sanofi-Aventis Deutschland GmbH
  Brüningstrasse 50,
  D-65926 Frankfurt am Main Germany | sodium ferric gluconate complex | Ferrlecit 62,5  mg | 2 013,9  mg/5 ml | Solution for injection | Intravenous use |
| Germany | Pharmacosmos A/S
  Roervangsvei 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml Injektionslösong und Infusionslösung | 312,5  mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Germany | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose complex | FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung | 180 mg/ml | Solution for injection/infusion | Intravenous use |
| Germany | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg FR/ml Injektionslösung | 2 700  mg/5 ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Greece | Medicus SA
  Valaoritou 10
  Metamorfosi
  Attikis 14452
  Greece | Iron sucrose complex | REOXYL | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Vianex S.A.
  Tatoiou Street
  Nea Erythrea 14671
  Greece | Iron sucrose complex | INTRAFER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Alapis ABEE
  Aftokratoros Nikolaou 2
  Athens 17671
  Greece | Iron sucrose complex | FAREMIO | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Intermed ABEE
  Kalyftaki 27
  Athens 14564
  Greece | Iron sucrose complex | DEXTRIFER-S | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Demo ABEE
  21ST Km National Highway
  Athens-Lamia, 14565
  Greece | Iron (III) hydroxide dextran | COSMOFER | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Rafarm AEBE
  Korinthou 12,
  N. Psychiko, 15451
  Greece | Iron sucrose complex | FERROVIN | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Nephrotech S.A.
  Parnithos 44
  Metamorfosi Attikis 14452
  Greece | Iron sucrose complex | SUCRO-FER | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Uni-Pharma Kleon Tseitis
  Pharmaceutical Laboratories
  14KM National Highway
  Athens-Lamia
  Kifissia 14564
  Greece | Iron sucrose complex | HEMAFER-S | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Verisfield (UK) Ltd, U.K.
  41 Chalton street
  London, NW1 1JD
  United Kingdom | Iron sucrose complex | NEPHROFEROL | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | HELP ABEE
  Valaoritou 10
  Metamorfosi
  Attikis, 14452
  Greece | Iron sucrose complex | FERRINEMIA | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | Specifar AEBE
  28th October Street 1
  Agia Barbara 12351
  Greece | Iron sucrose complex | ALVOFER | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Alet Pharmaceuticals
  M. Alexander 121,
  Agia Varvara, 12351
  Greece | Iron sucrose complex | SUCROVEN | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Target Pharma Ltd
  Menandrou 54
  Athens 10431
  Greece | Iron sucrose complex | IRONCROSE | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Greece | HELP ABEE
  Valaoritou 10
  Metamorfosi
  Attikis, 14452
  Greece | Iron (III) hydroxide dextran complex | IRONATE | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Demo ABEE
  21st km National Highway
  Athens-Lamia, 14565
  Greece | Iron(III) isomaltoside complex | MONOFER | 100 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Greece | Viofar EPE
  Ethnikis Antistaseos & Trifyllias,
  Aharnai, 13671
  Greece | Iron sucrose complex | VENIRON | 100 mg/5 ml | Concentrate for solution for infusion | Intravenous use |
| Greece | Medicus SA
  Valaoritou 10
  Metamorfosi
  Attikis 14452
  Greece | Iron (III) hydroxide dextran complex | IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Hungary | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Hungary | Sanofi-Aventis Zrt
  Tó utca 1-5,
  1045 Budapest
  Hungary | Sodium ferric gluconate complex | Ferrlecit | 12,5  mg/ml | Solution for injection | Intravenous use |
| Iceland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Iceland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for infusion | Intravenous use |
| Iceland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml solution for infusion and injection | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover 100 mg/ml solution for injection/infusion (ampoules) | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover 100 mg/ml solution for injection/infusion (vials) | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT 50 mg iron/ml solution for injection/infusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex) | Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Ireland | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion | 20 mg/ml | Solution for injection | Intravenous use |
| Italy | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Italy | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FERRO SACCARATO FME | 20 mg/ml | Concentrate for solution for infusion/solution for injection | Intravenous use |
| Italy | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER | 20 mg/ml | Solution for injection | Intravenous use |
| Italy | Sanofi-Aventis SPA
  Viale Luigi Bodio, 37/B
  20158 Milano
  Italy | sodium ferric gluconate complex | FERLIXIT | 62,5  mg/5 ml | Oral solution or solution for infusion | Oral use
  Intravenous use |
| Latvia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Latvia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Latvia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Latvia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Latvia | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Lithuania | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Lithuania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Lithuania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Ferric (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Luxembourg | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Injectafer-50 mg/l | 50 mg/ml | Solution for injection | Intravenous use |
| Luxembourg | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer-50 mg/ml | 50 mg/ml | Solution for injection | Intravenous use |
| Luxembourg | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | Fermed-100 mg/5 ml | 100 mg/5 ml | Solution for perfusion | Intravenous use |
| Luxembourg | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic-20 mg/ml | 20 mg/ml | Solution for perfusion | Intravenous use |
| Malta | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | ferric carboxymaltose | FERINJECT 50 mg iron/ml solution for injection/infusion | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Malta | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex. | Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Norway | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Parenteral use |
| Norway | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Uniferon | 200 mg/ml | Solution for injection | Parenteral use |
| Norway | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Parenteral use |
| Poland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Poland | VIFOR France SA
  123 Rue Jules Guesde
  92200 Neuilly-sur-Seine
  France | ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection | Intravenous use |
| Poland | VIFOR France SA
  123 Rue Jules Guesde
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| Poland | Fresenius Medical Care Nephrologica Deutschland GmbH
  61346 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  A-6250 Kundl
  Austria | Iron(III) isomaltoside complex | Ferrum-Lek | 50 mg/ml | Solution for injection | Intramuscular use |
| Poland | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monover | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Portugal | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Referen | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Vifor France, SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Combino Pharm Portugal, Unipessoal, Lda.
  Lagoas Park
  Edifício 8
  Piso 0 2740-268 Porto Salvo
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Combino | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2,
  Abrunheira
  2710-089 Sintra
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Farmoz | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Generis Farmacêutica, S.A.
  Rua João de Deus, 19
  2700-487 Amadora
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Generis | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Laboratórios Normon, S.A.
  Rua Armando Villar,
  Lote 42 1o Dto. Quinta das Patinhas, Cobre
  2750 — 777 Cascais
  Portugal | Iron sucrose complex | Óxido Férrico Sacarosado Normon | 100 mg/5 ml | Solution for injection | Intravenous use |
| Portugal | Vifor France, SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Portugal | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Portugal | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Monofar | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| Romania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER® | 20 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Romania | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFER 100 mg/ml | 100 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Romania | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg fer/ml | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| Slovak Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Slovak Republic | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovak Republic | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovak Republic | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection | Intravenous use |
| Slovenia | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Slovenia | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | carboxymaltose | Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| Slovenia | Lek farmacevtska družba d.d.,
  Verovškova 57,
  1000 Ljubljana
  Slovenia | Iron sucrose complex | Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION | 50 mg/ml | Solution for injection
  Solution for infusion | Intravenous use
  intramuscular use |
| Spain | GUERBET B.P.
  57400 ROISSY CdG
  Cedex F-95943
  France | Iron sucrose complex | ENDOREM 11,2  mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION | 11,2  mg/ml | Concentrate for suspension for infusion | Intravenous use |
| Spain | G.E.S. Genericos Espanoles Laboratorio
  S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas
  28230 MADRID
  Spain | Iron sucrose complex | FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61346 Bad Homburg
  Germany | Iron sucrose complex | HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Laboratorios Normon S.A.
  Ronda de Valdecarrizo 6
  28760 Tres Cantos
  Madrid
  Spain | Iron sucrose complex | HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37
  DE-58638 Iserlohn
  Germany | Iron sucrose complex | FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 100 mg/5 ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| Spain | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION | 50 mg/ml | Solution for injection
  Solution for infusion | Intravenous use |
| Spain | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN | 100 mg/ml | Solution for injection
  Solution for infusion | Intravenous use |
| Sweden | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer® | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer® | 50 mg/ml | Solution for injection | Intravenous use |
| Sweden | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92200 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection | Intravenous use |
| Sweden | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61346 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Orion Corporation,
  Orionintie 1,
  FI-02200 Espoo,
  Finland | Iron sucrose complex | Ferion | 20 mg/ml | Concentrate for solution for injection | Intravenous use |
| Sweden | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer® | 100 mg/ml | Solution for injection | Intravenous use |
| The Netherlands | Pharmamatch B.V.
  Egelenburg 2
  Amsterdam GK — 1081
  The Netherlands | Iron sucrose complex | IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | MonoFer 100 mg/ml oplossing voor injectie/infusie | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| The Netherlands | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | CosmoFer 50 mg/ml oplossing voor infusie en injectie | 50 mg/ml | Solution for injection/infusion | Intravenous use |
| The Netherlands | Pharmachemie B.V.
  Haarlem — 2031 GA
  The Netherlands | Iron sucrose complex | IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| United Kingdom | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Iron sucrose complex | Venofer | 20 mg/ml | Solution for injection/infusion | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Monofer | 100 mg/ml | Solution for injection/infusion | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron(III) isomaltoside complex | Diafer | 50 mg/ml | Solution for injection | Intravenous use |
| United Kingdom | Pharmacosmos A/S
  Roervangsvej 30
  Holbaek DK-4300
  Denmark | Iron (III) hydroxide dextran complex | Cosmofer | 50 mg/ml | Solution for injection/infusion | Intravenous use
  intramuscular use |
| United Kingdom | Fresenius Medical Care Nephrologica Deutschland GmbH
  Else-Kröner-Strasse 1
  61352 Bad Homburg
  Germany | Iron sucrose complex | Ferrologic | 20 mg/ml | Solution for injection
  Concentrate for solution for infusion | Intravenous use |
| United Kingdom | VIFOR France SA
  7-13 Boulevard Paul Emile Victor
  92521 Neuilly-sur-Seine
  France | Ferric carboxymaltose | Ferinject | 50 mg/ml | Solution for injection/infusion | Intravenous use |

Member State

(in EEA)

Marketing authorisation holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösung und Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Solution for injection/infusion

Intravenous use

Austria

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Austria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Injektions- oder Infusionslösung

100 mg/ml

Solution for injection/infusion

Intravenous use

Austria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Belgium

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

Injectafer

50,00  mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Bulgaria

Pharmalog AG,

33 Cherni vrah blvd.,

1421 Sofia

Bulgaria

Iron sucrose complex

Idafer

20 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection

Intravenous use

Bulgaria

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML

100 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML

50 mg/ml

Solution for injection/infusion

Intravenous use

Cyprus

The Star Medicines Importers & co ltd,

9A Loukis Akritas Street,

P.O.box 50151,

3601 Lemesos, Cyprus

Iron sucrose complex

VENOFER INJECTION 100 MG IRON/5 ML

100 mg/5 ml

Solution for injection

Intravenous use

Cyprus

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML

20 mg/ml

Solution for injection/infusion

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Czech Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERROLOGIC 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

PHARMABIDE LTD

20, Lakonias str,

15234 Halandri

Athens — Greece

Iron sucrose complex

IRON SUCROSE PHARMABIDE 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

FERION 20 MG/ML

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Czech Republic

Sanofi-Aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

sodium ferric gluconate complex

FERRLECIT

12,5  mg/ml

Solution for injection

Intravenous use

Czech Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Jerndextran ‘Pharmacosmos’

50 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer

100 mg/ml

Solution for injection/infusion

Intravenous use

Denmark

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Estonia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Estonia

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

Iron (III) hydroxide dextran complex

Ferrum Lek

50 mg/ml

Solution for injection

Intramuscular use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Finland

Alternova A/S

Lodshusvej 11

4230 Skaelskoer

Denmark

Iron sucrose complex

Venotrix

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

Finland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric Carboxymaltose

FERINJECT 50 mg/ml, solution injectable/pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml, solution injectable

20 mg/ml

Solution for injection

Intravenous use

France

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

FERRISAT 50 mg/ml, solution injectable ou pour perfusion

50 mg/ml

Solution for injection/infusion

Intravenous use

France

Pharmaki Generics Ltd

5 Bourlet Close

W1W 7BL London

United Kingdom

Iron sucrose complex

FER ACTAVIS 100 mg/5 ml, solution injectable

100 mg/5 ml

Solution for injection

Intravenous use

France

IBD3 Pharma Consulting

Immeuble l’Orient

10, place Charles Béraudier

69003 Lyon

France

Iron sucrose complex

FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

Iron sucrose complex

FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret France

Iron sucrose complex

FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

France

TEVA SANTE

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

FRANCE

Iron sucrose complex

FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)

100 mg/5 ml

Solution for injection

Intravenous use

Germany

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung

1 709  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FerMed

1 563 — 1 887  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Germany

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Nefro-Fer

1 563 — 1 887  mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer 100 mg/ml Lösung zur Injektion/Infusion

377-465 mg/ml

Solution for injection/infusion

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main Germany

sodium ferric gluconate complex

Ferrlecit 40 mg

1 288,9  mg/3,2  ml

Solution for injection

Intravenous use

Germany

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50,

D-65926 Frankfurt am Main Germany

sodium ferric gluconate complex

Ferrlecit 62,5  mg

2 013,9  mg/5 ml

Solution for injection

Intravenous use

Germany

Pharmacosmos A/S

Roervangsvei 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml Injektionslösong und Infusionslösung

312,5  mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose complex

FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung

180 mg/ml

Solution for injection/infusion

Intravenous use

Germany

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg FR/ml Injektionslösung

2 700  mg/5 ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron sucrose complex

REOXYL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Vianex S.A.

Tatoiou Street

Nea Erythrea 14671

Greece

Iron sucrose complex

INTRAFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Alapis ABEE

Aftokratoros Nikolaou 2

Athens 17671

Greece

Iron sucrose complex

FAREMIO

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Intermed ABEE

Kalyftaki 27

Athens 14564

Greece

Iron sucrose complex

DEXTRIFER-S

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Demo ABEE

21ST Km National Highway

Athens-Lamia, 14565

Greece

Iron (III) hydroxide dextran

COSMOFER

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Rafarm AEBE

Korinthou 12,

N. Psychiko, 15451

Greece

Iron sucrose complex

FERROVIN

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Nephrotech S.A.

Parnithos 44

Metamorfosi Attikis 14452

Greece

Iron sucrose complex

SUCRO-FER

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Uni-Pharma Kleon Tseitis

Pharmaceutical Laboratories

14KM National Highway

Athens-Lamia

Kifissia 14564

Greece

Iron sucrose complex

HEMAFER-S

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Verisfield (UK) Ltd, U.K.

41 Chalton street

London, NW1 1JD

United Kingdom

Iron sucrose complex

NEPHROFEROL

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron sucrose complex

FERRINEMIA

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

Specifar AEBE

28th October Street 1

Agia Barbara 12351

Greece

Iron sucrose complex

ALVOFER

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Alet Pharmaceuticals

M. Alexander 121,

Agia Varvara, 12351

Greece

Iron sucrose complex

SUCROVEN

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Target Pharma Ltd

Menandrou 54

Athens 10431

Greece

Iron sucrose complex

IRONCROSE

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Greece

HELP ABEE

Valaoritou 10

Metamorfosi

Attikis, 14452

Greece

Iron (III) hydroxide dextran complex

IRONATE

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Demo ABEE

21st km National Highway

Athens-Lamia, 14565

Greece

Iron(III) isomaltoside complex

MONOFER

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Greece

Viofar EPE

Ethnikis Antistaseos & Trifyllias,

Aharnai, 13671

Greece

Iron sucrose complex

VENIRON

100 mg/5 ml

Concentrate for solution for infusion

Intravenous use

Greece

Medicus SA

Valaoritou 10

Metamorfosi

Attikis 14452

Greece

Iron (III) hydroxide dextran complex

IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection/infusion

Intravenous use

Hungary

Sanofi-Aventis Zrt

Tó utca 1-5,

1045 Budapest

Hungary

Sodium ferric gluconate complex

Ferrlecit

12,5  mg/ml

Solution for injection

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Iceland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for infusion

Intravenous use

Iceland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml solution for infusion and injection

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (ampoules)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover 100 mg/ml solution for injection/infusion (vials)

100 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex)

Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial

20 mg/ml

Solution for injection/infusion

Intravenous use

Ireland

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT

50 mg/ml

Solution for injection/infusion

Intravenous use

Italy

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FERRO SACCARATO FME

20 mg/ml

Concentrate for solution for infusion/solution for injection

Intravenous use

Italy

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER

20 mg/ml

Solution for injection

Intravenous use

Italy

Sanofi-Aventis SPA

Viale Luigi Bodio, 37/B

20158 Milano

Italy

sodium ferric gluconate complex

FERLIXIT

62,5  mg/5 ml

Oral solution or solution for infusion

Oral use

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Latvia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Latvia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Latvia

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Lithuania

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

Lithuania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Ferric (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Luxembourg

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Injectafer-50 mg/l

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer-50 mg/ml

50 mg/ml

Solution for injection

Intravenous use

Luxembourg

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

Fermed-100 mg/5 ml

100 mg/5 ml

Solution for perfusion

Intravenous use

Luxembourg

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic-20 mg/ml

20 mg/ml

Solution for perfusion

Intravenous use

Malta

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

FERINJECT 50 mg iron/ml solution for injection/infusion

50 mg/ml

Solution for injection/infusion

Intravenous use

Malta

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex.

Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Parenteral use

Norway

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Uniferon

200 mg/ml

Solution for injection

Parenteral use

Norway

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Parenteral use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer

50 mg/ml

Solution for injection/infusion

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Poland

VIFOR France SA

123 Rue Jules Guesde

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

Poland

Fresenius Medical Care Nephrologica Deutschland GmbH

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Poland

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Iron(III) isomaltoside complex

Ferrum-Lek

50 mg/ml

Solution for injection

Intramuscular use

Poland

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monover

100 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Referen

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Combino Pharm Portugal, Unipessoal, Lda.

Lagoas Park

Edifício 8

Piso 0 2740-268 Porto Salvo

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Combino

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Farmoz

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Generis

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Laboratórios Normon, S.A.

Rua Armando Villar,

Lote 42 1o Dto. Quinta das Patinhas, Cobre

2750 — 777 Cascais

Portugal

Iron sucrose complex

Óxido Férrico Sacarosado Normon

100 mg/5 ml

Solution for injection

Intravenous use

Portugal

Vifor France, SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Portugal

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Monofar

100 mg/ml

Solution for injection/infusion

Intravenous use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER®

20 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFER 100 mg/ml

100 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Romania

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg fer/ml

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovak Republic

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovak Republic

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection

Intravenous use

Slovenia

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Slovenia

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

carboxymaltose

Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje

50 mg/ml

Solution for injection/infusion

Intravenous use

Slovenia

Lek farmacevtska družba d.d.,

Verovškova 57,

1000 Ljubljana

Slovenia

Iron sucrose complex

Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

intramuscular use

Spain

GUERBET B.P.

57400 ROISSY CdG

Cedex F-95943

France

Iron sucrose complex

ENDOREM 11,2  mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION

11,2  mg/ml

Concentrate for suspension for infusion

Intravenous use

Spain

G.E.S. Genericos Espanoles Laboratorio

S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas

28230 MADRID

Spain

Iron sucrose complex

FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos

Madrid

Spain

Iron sucrose complex

HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

DE-58638 Iserlohn

Germany

Iron sucrose complex

FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

100 mg/5 ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

Spain

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION

50 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Spain

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN

100 mg/ml

Solution for injection

Solution for infusion

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer®

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer®

50 mg/ml

Solution for injection

Intravenous use

Sweden

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92200 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection

Intravenous use

Sweden

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61346 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Orion Corporation,

Orionintie 1,

FI-02200 Espoo,

Finland

Iron sucrose complex

Ferion

20 mg/ml

Concentrate for solution for injection

Intravenous use

Sweden

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer®

100 mg/ml

Solution for injection

Intravenous use

The Netherlands

Pharmamatch B.V.

Egelenburg 2

Amsterdam GK — 1081

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

MonoFer 100 mg/ml oplossing voor injectie/infusie

100 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

The Netherlands

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

CosmoFer 50 mg/ml oplossing voor infusie en injectie

50 mg/ml

Solution for injection/infusion

Intravenous use

The Netherlands

Pharmachemie B.V.

Haarlem — 2031 GA

The Netherlands

Iron sucrose complex

IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Iron sucrose complex

Venofer

20 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Monofer

100 mg/ml

Solution for injection/infusion

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron(III) isomaltoside complex

Diafer

50 mg/ml

Solution for injection

Intravenous use

United Kingdom

Pharmacosmos A/S

Roervangsvej 30

Holbaek DK-4300

Denmark

Iron (III) hydroxide dextran complex

Cosmofer

50 mg/ml

Solution for injection/infusion

Intravenous use

intramuscular use

United Kingdom

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Strasse 1

61352 Bad Homburg

Germany

Iron sucrose complex

Ferrologic

20 mg/ml

Solution for injection

Concentrate for solution for infusion

Intravenous use

United Kingdom

VIFOR France SA

7-13 Boulevard Paul Emile Victor

92521 Neuilly-sur-Seine

France

Ferric carboxymaltose

Ferinject

50 mg/ml

Solution for injection/infusion

Intravenous use

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