# Official Journal C 91/2014

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2014.091.eng |
| --- | --- |
| Official Journal
  of the European Union | C 91 |
| | |
| English edition | Information and Notices | Volume 5728 March 2014 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2014.091.eng

Official Journal

of the European Union

C 91

English edition

Information and Notices

Volume 5728 March 2014

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2014/C 091/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 January 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2014/C 091/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 2 |
| 2014/C 091/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014(decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2014/C 091/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 January 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2014/C 091/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

2

2014/C 091/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014(decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

11

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.3.2014 | EN | Official Journal of the European Union | C 91/1 |
| --- | --- | --- | --- |

28.3.2014

EN

Official Journal of the European Union

C 91/1

---

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

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

2014/C 91/01

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 22.1.2014 | Protaphane | Novo Nordisk A/S |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

22.1.2014

Protaphane

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/234

24.1.2014

31.1.2014

Leflunomide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/11/675

5.2.2014

---

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

---

| 28.3.2014 | EN | Official Journal of the European Union | C 91/2 |
| --- | --- | --- | --- |

28.3.2014

EN

Official Journal of the European Union

C 91/2

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

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

2014/C 91/02

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.2.2014 | Izba | travoprost | Alcon Laboratories (UK) Ltd. |
| Frimley Business Park, Frimley, |
| Camberley, Surrey, GU16 7SR, |
| United Kingdom |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

20.2.2014

Izba

travoprost

Alcon Laboratories (UK) Ltd.

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR,

United Kingdom

EU/1/13/905

Eye drops, solution

S01EE04

24.2.2014

20.2.2014

Neuraceq

florbetaben (18F)

| Piramal Imaging GmbH |
| --- |
| Tegeler Strasse 6-7 |
| 13353 Berlin – Deutschland |

Piramal Imaging GmbH

Tegeler Strasse 6-7

13353 Berlin – Deutschland

EU/1/13/906

Solution for injection

V09AX06

24.2.2014

21.2.2014

Mirvaso

brimonidine

| Galderma International |
| --- |
| Tour Europlaza, |
| 20 avenue André Prothin, |
| La Défense 4, |
| La Défense Cedex 92927, |
| France |

Galderma International

Tour Europlaza,

20 avenue André Prothin,

La Défense 4,

La Défense Cedex 92927,

France

EU/1/13/904

Gel

D11AX21

25.2.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.2.2014 | Cystadane | Orphan Europe S.A.R.L. |
| Immeuble Le Wilson, |
| 70 avenue du Général de Gaulle, |
| F-92 800 Puteaux, |
| France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.2.2014

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson,

70 avenue du Général de Gaulle,

F-92 800 Puteaux,

France

EU/1/06/379

10.2.2014

6.2.2014

Humira

| AbbVie Ltd |
| --- |
| Maidenhead, |
| SL6 4XE, |
| United Kingdom |

AbbVie Ltd

Maidenhead,

SL6 4XE,

United Kingdom

EU/1/03/256

10.2.2014

6.2.2014

Repso

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/11/674

11.2.2014

6.2.2014

Taxotere

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony CEDEX, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony CEDEX,

France

EU/1/95/002

10.2.2014

11.2.2014

Pravafenix

| LABORATOIRES SMB SA |
| --- |
| 26-28 rue de la Pastorale / 26-28 Herdersliedstraat, |
| 1080 Brussel/Bruxelles, |
| Belgique/België |

LABORATOIRES SMB SA

26-28 rue de la Pastorale / 26-28 Herdersliedstraat,

1080 Brussel/Bruxelles,

Belgique/België

EU/1/11/679

13.2.2014

11.2.2014

Sycrest

| Organon N.V. |
| --- |
| Kloosterstraat 6, |
| NL-5349 AB Oss, |
| Nederland |

Organon N.V.

Kloosterstraat 6,

NL-5349 AB Oss,

Nederland

EU/1/10/640

13.2.2014

11.2.2014

Temozolomide Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/606

14.2.2014

12.2.2014

Mozobil

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10, |
| NL-1411 DD Naarden, |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/09/537

13.2.2014

13.2.2014

Lyrica

| Pfizer Limited |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/04/279

17.2.2014

17.2.2014

Conbriza

| Pfizer Limited |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/09/511

19.2.2014

17.2.2014

Modigraf

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, |
| NL-2333 BE Leiden, |
| Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/09/523

19.2.2014

17.2.2014

Victrelis

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/11/704

19.2.2014

20.2.2014

Betmiga

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, |
| NL-2333 BE Leiden, |
| Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/12/809

24.2.2014

20.2.2014

Bosulif

| Pfizer Limited |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ, |
| United Kingdom |

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/13/818

24.2.2014

20.2.2014

Capecitabine Accord

| Accord Healthcare Limited |
| --- |
| Sage House, 319 Pinner Road, |
| North Harrow, |
| Middlesex, HA1 4HF, |
| United Kingdom |

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

United Kingdom

EU/1/12/762

22.2.2014

20.2.2014

Capecitabine Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/12/761

25.2.2014

20.2.2014

Constella

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, |
| E-08022 Barcelona, |
| España |

Almirall, S.A.

Ronda General Mitre, 151,

E-08022 Barcelona,

España

EU/1/12/801

24.2.2014

20.2.2014

Helixate NexGen

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, |
| Deutschland |

Bayer Pharma AG

D-13342 Berlin,

Deutschland

EU/1/00/144

24.2.2014

20.2.2014

KOGENATE Bayer

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, |
| Deutschland |

Bayer Pharma AG

D-13342 Berlin,

Deutschland

EU/1/00/143

24.2.2014

20.2.2014

Metalyse

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/00/169

24.2.2014

20.2.2014

Mycamine

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, |
| NL-2333 BE Leiden, |
| Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62,

NL-2333 BE Leiden,

Nederland

EU/1/08/448

24.2.2014

20.2.2014

Nevirapine Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/09/598

25.2.2014

20.2.2014

Zoledronic acid Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegur 76-78, |
| 220 Hafnarfjörður, |
| Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78,

220 Hafnarfjörður,

Iceland

EU/1/12/759

24.2.2014

20.2.2014

Zoledronic acid Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, |
| F-69800 Saint Priest, |
| France |

Mylan S.A.S

117 allée des Parcs,

F-69800 Saint Priest,

France

EU/1/12/786

24.2.2014

21.2.2014

Celsentri

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex TW8 9GS, |
| United Kingdom |

ViiV Healthcare UK Limited

980 Great West Road,

Brentford,

Middlesex TW8 9GS,

United Kingdom

EU/1/07/418

25.2.2014

21.2.2014

CONTROLOC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, |
| D-78467 Konstanz, |
| Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/515

25.2.2014

21.2.2014

Fertavid

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/510

25.2.2014

21.2.2014

NeuroBloc

| Eisai Limited |
| --- |
| European Knowledge Centre, |
| Mosquito Way, Hatfield, |
| Hertfordshire AL10 9SN, |
| United Kingdom |

Eisai Limited

European Knowledge Centre,

Mosquito Way, Hatfield,

Hertfordshire AL10 9SN,

United Kingdom

EU/1/00/166

25.2.2014

21.2.2014

NovoThirteen

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/12/775

25.2.2014

21.2.2014

PANTECTA Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, |
| D-78467 Konstanz, |
| Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/518

25.2.2014

21.2.2014

PANTOLOC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, |
| D-78467 Konstanz, |
| Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/519

25.2.2014

21.2.2014

PANTOZOL Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, |
| D-78467 Konstanz, |
| Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/517

25.2.2014

21.2.2014

SOMAC Control

| Takeda GmbH |
| --- |
| Byk-Gulden-Straße 2, |
| D-78467 Konstanz, |
| Deutschland |

Takeda GmbH

Byk-Gulden-Straße 2,

D-78467 Konstanz,

Deutschland

EU/1/09/516

25.2.2014

21.2.2014

Stelara

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/08/494

25.2.2014

21.2.2014

Synflorix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/508

25.2.2014

21.2.2014

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061, |
| NL-4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/07/423

25.2.2014

28.2.2014

Adjupanrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/578

4.3.2014

28.2.2014

Capecitabine medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstr. 6, |
| D-22880 Wedel, |
| Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6,

D-22880 Wedel,

Deutschland

EU/1/12/802

4.3.2014

28.2.2014

Effentora

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| NL-3542 DR Utrecht, |
| Nederland |

Teva Pharma B.V.

Computerweg 10,

NL-3542 DR Utrecht,

Nederland

EU/1/08/441

5.3.2014

28.2.2014

Instanyl

| Takeda Pharma A/S |
| --- |
| Langebjerg 1, |
| DK-4000 Roskilde, |
| Danmark |

Takeda Pharma A/S

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/09/531

4.3.2014

28.2.2014

Ixiaro

| Valneva Austria GmbH |
| --- |
| Campus Vienna Biocenter 3, |
| A-1030 Wien, |
| Österreich |

Valneva Austria GmbH

Campus Vienna Biocenter 3,

A-1030 Wien,

Österreich

EU/1/08/501

4.3.2014

28.2.2014

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/614

4.3.2014

28.2.2014

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/051

4.3.2014

28.2.2014

PecFent

| Archimedes Development Ltd |
| --- |
| Albert Einstein Centre, |
| Nottingham Science and Technology Park, |
| University Boulevard NG7 2 TN Nottingham, |
| United Kingdom |

Archimedes Development Ltd

Albert Einstein Centre,

Nottingham Science and Technology Park,

University Boulevard NG7 2 TN Nottingham,

United Kingdom

EU/1/10/644

4.3.2014

28.2.2014

Prepandrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/08/453

4.3.2014

28.2.2014

Pumarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/10/664

3.3.2014

28.2.2014

Rebif

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, |
| London E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall,

London E14 9TP,

United Kingdom

EU/1/98/063

4.3.2014

28.2.2014

Samsca

| Otsuka Pharmaceutical Europe Ltd. |
| --- |
| Gallions, Wexham Springs, |
| Framewood Road, |
| Wexham, SL3 6PJ, |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs,

Framewood Road,

Wexham, SL3 6PJ,

United Kingdom

EU/1/09/539

4.3.2014

28.2.2014

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/050

4.3.2014

28.2.2014

Temozolomide Hospira

| Hospira UK Limited |
| --- |
| Queensway, |
| Royal Leamington Spa, |
| Warwickshire CV31 3RW, |
| United Kingdom |

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/615

4.3.2014

28.2.2014

Xolair

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, |
| Horsham, |
| West Sussex RH12 5AB, |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex RH12 5AB,

United Kingdom

EU/1/05/319

4.3.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 17.2.2014 | Onduarp | Boehringer Ingelheim International GmbH |
| Binger Straße 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

17.2.2014

Onduarp

Boehringer Ingelheim International GmbH

Binger Straße 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729

19.2.2014

—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 21.2.2014 | Luminity | Lantheus MI UK Limited |
| Festival House, |
| 39 Oxford Street, |
| Newbury, |
| Berkshire RG14 1JG, |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

21.2.2014

Luminity

Lantheus MI UK Limited

Festival House,

39 Oxford Street,

Newbury,

Berkshire RG14 1JG,

United Kingdom

EU/1/06/361

25.2.2014

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.2.2014 | Bravecto | Fluralaner | Intervet International B.V. |
| Wim de Körverstraat 35, |
| NL-5831 AN Boxmeer, |
| Nederland |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

11.2.2014

Bravecto

Fluralaner

Intervet International B.V.

Wim de Körverstraat 35,

NL-5831 AN Boxmeer,

Nederland

EU/2/13/158

Chewable tablet

QP53BX

13.2.2014

11.2.2014

NexGard

afoxolaner

| Merial |
| --- |
| 29 avenue Tony Garnier, |
| F-69007 Lyon, |
| France |

Merial

29 avenue Tony Garnier,

F-69007 Lyon,

France

EU/2/13/159

Chewable tablet

QP53BX04

13.2.2014

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.2.2014 | Melovem | Dopharma Research B.V. |
| Zalmweg 24, |
| NL-4941 VX Raamsdonksveer, |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.2.2014

Melovem

Dopharma Research B.V.

Zalmweg 24,

NL-4941 VX Raamsdonksveer,

Nederland

EU/2/09/098

10.2.2014

10.2.2014

Startvac

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, |
| E-17170- Amer (Girona), |
| España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135,

E-17170- Amer (Girona),

España

EU/2/08/092

12.2.2014

13.2.2014

Contacera

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, |
| 1348 Louvain-La-Neuve, |
| Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1,

1348 Louvain-La-Neuve,

Belgique

EU/2/12/144

17.2.2014

13.2.2014

Melosus

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13, |
| D-31303 Burgdorf, |
| Deutschland |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13,

D-31303 Burgdorf,

Deutschland

EU/2/10/116

17.2.2014

20.2.2014

CaniLeish

| VIRBAC S.A. |
| --- |
| 1ère Avenue - 2065 m - L.I.D., |
| F-06516 Carros CEDEX, |
| France |

VIRBAC S.A.

1ère Avenue - 2065 m - L.I.D.,

F-06516 Carros CEDEX,

France

EU/2/11/121

24.2.2014

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

---

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

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

---

| 28.3.2014 | EN | Official Journal of the European Union | C 91/11 |
| --- | --- | --- | --- |

28.3.2014

EN

Official Journal of the European Union

C 91/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

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

2014/C 91/03

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 20.2.2014 | Acipimox | See Annex I | See Annex I | See Annex I | 24.2.2014 |
| 28.2.2014 | Nanotop | See Annex II | See Annex II | See Annex II | 3.3.2014 |
| 28.2.2014 | Enrofloxacin | See Annex III | See Annex III | See Annex III | 4.3.2014 |
| 28.2.2014 | Fentanyl | fentanyl (single substance- transmucosal formulations) | Not applicable | Not applicable | 3.3.2014 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.2.2014

Acipimox

See Annex I

See Annex I

See Annex I

24.2.2014

28.2.2014

Nanotop

See Annex II

See Annex II

See Annex II

3.3.2014

28.2.2014

Enrofloxacin

See Annex III

See Annex III

See Annex III

4.3.2014

28.2.2014

Fentanyl

fentanyl (single substance- transmucosal formulations)

Not applicable

Not applicable

3.3.2014

---

(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 FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (in EEA) | Marketing authorisaton holder | INN | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| 1210 Vienna |
| Austria |

Member State

(in EEA)

Marketing authorisaton holder

INN

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Vienna

Austria

Acipimox

Olbetam - Kapseln

250 mg

capsule

oral use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Ixelles |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine 17

1050 Ixelles

Belgium

Acipimox

Olbetam

250 mg

capsule

oral use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup

Denmark

Acipimox

Olbetam

250 mg

capsule, hard

oral use

Hungary

| Pfizer Gyógyszerkereskedelmi Kft. |
| --- |
| Alkotás St 53 |
| 1123 Budapest |
| Hungary |

Pfizer Gyógyszerkereskedelmi Kft.

Alkotás St 53

1123 Budapest

Hungary

Acipimox

Olbetam 250 mg kemény kapszula

250 mg

capsule, hard

oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| via Isonzo, 71 |
| 04100 Latina |
| Italy |

Pfizer Italia S.r.l.

via Isonzo, 71

04100 Latina

Italy

Acipimox

OLBETAM

250 mg

capsule, hard

oral use

Luxembourg

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Ixelles |
| Belgium |

PFIZER S.A.

Boulevard de la Plaine 17

1050 Ixelles

Belgium

Acipimox

Olbetam

250 mg

capsule

oral use

The Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD, Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD, Capelle a/d Ijssel

The Netherlands

Acipimox

Olbetam

250 mg

capsule

oral use

United Kingdom

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich, Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich, Kent CT13 9NJ

United Kingdom

Acipimox

Olbetam 250 mg Capsules

250 mg

capsule

oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/ MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | ROTOP Pharmaka AG |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

NANOTOP 0,5 mg Kit für ein radioaktives Arzneimittel

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Finland

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| 01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

01328 Dresden

Germany

ROTOP-NanoHSA

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

France

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

ROTOP-NanoHSA 0,5 mg Trousse pour préparation radiopharmaceutique

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Germany

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

NANOTOP

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Italy

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

NANOTOP

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Norway

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

Nanotop

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Portugal

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

NANOTOP

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use or intravenous use

Spain

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

ROTOP-NanoHSA 500 microgramos equipo de reactivos para preparación radiofarmacéutica

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

Sweden

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

NanoHSA

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use

United Kingdom

| ROTOP Pharmaka AG |
| --- |
| Bautzner Landstraße 400 |
| D-01328 Dresden |
| Germany |

ROTOP Pharmaka AG

Bautzner Landstraße 400

D-01328 Dresden

Germany

Nanotop

0,5 mg

Kit for radiopharmaceutical preparation

Subcutaneous use, Intravenous use

---

ANNEX III

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 | Route of administration | Animal species |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH, |
| Lerchenfelder Guertel 9-11 |
| 1160 Wien |
| Austria |

Member State EU/EEA

Applicant/marketing authorisation holder

Product name

INN

Strength

Pharmaceutical form

Route of administration

Animal species

Austria

Bayer Austria GmbH,

Lerchenfelder Guertel 9-11

1160 Wien

Austria

Baytril 100 mg/ml - Lösung zum Eingeben für Hühner und Puten

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Austria

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enrox 100 mg/ml Lösung zum Eingeben für Hühner und Puten

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens (broilers, broiler breeders, replacement chickens), turkeys

Austria

| Pro Zoon Pharma GmbH, |
| --- |
| Karl Schoenherr Strasse 3 |
| 4600 Wels |
| Austria |

Pro Zoon Pharma GmbH,

Karl Schoenherr Strasse 3

4600 Wels

Austria

Enrozid TWS 100 mg/ml Lösung zum Eingeben für Hühner und Puten

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken and turkeys

Belgium

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem (Machelen) |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem (Machelen)

Belgium

Baytril 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Enro-K 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Enroshort 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Enroveto 100 mg/ml

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Belgium

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

Floxamax 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and rabbits

Belgium

| HIPRA LABORATORIOS |
| --- |
| Avda. La Selva 135, |
| 17170 Amer (Girona) |
| Spain |

HIPRA LABORATORIOS

Avda. La Selva 135,

17170 Amer (Girona)

Spain

Spectron 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Belgium

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Bulgaria

| VET - PARTNERS Ltd. |
| --- |
| 25 Ivan Asen II Str. |
| 4270 Parvomay |
| Bulgaria |

VET - PARTNERS Ltd.

25 Ivan Asen II Str.

4270 Parvomay

Bulgaria

Полистар Енро

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

Bulgaria

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Квиноекс -10

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Bulgaria

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Квинокол орален разтвор

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Bulgaria

| Laboratorios Syva, s.a.u, |
| --- |
| Avenue Parroco Pablo Diez 49-57, |
| 24010 Leon, |
| Spain |

Laboratorios Syva, s.a.u,

Avenue Parroco Pablo Diez 49-57,

24010 Leon,

Spain

Сиваквинол 10 % орал

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broilers

Bulgaria

| Asklep Farma |
| --- |
| Lyulin 7, bl. 711, mag. 3 |
| Sofia 1324 |
| Bulgaria |

Asklep Farma

Lyulin 7, bl. 711, mag. 3

Sofia 1324

Bulgaria

Роксацин БГ орален

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broilers

Bulgaria

| Farma vet Ltd. |
| --- |
| 40 Otec Paisii Str. |
| Shumen 9700 |
| Bulgaria |

Farma vet Ltd.

40 Otec Paisii Str.

Shumen 9700

Bulgaria

Енрофлоксацин 10 % разтвор

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broilers

Bulgaria

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

Байтрил 10 % перорален разтвор

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Bulgaria

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Флоксацин 100 mg/ml концентрат за орален разтвор за пилета и пуйки

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Bulgaria

| Interchemie Werken De Adelaar BV |
| --- |
| Metaalweg 8 |
| 5804 CG Venray |
| The Netherlands |

Interchemie Werken De Adelaar BV

Metaalweg 8

5804 CG Venray

The Netherlands

Интерфлокс орален

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Cyprus

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer Animal Health GmbH

51368 Leverkusen

Germany

Baytril oral solution 10 % for chickens (broilers and breeders) and turkeys

Enrofloxacin

10 %

Solution for oral use

Oral

Chickens (broilers and breeders), turkeys

Cyprus

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer Animal Health GmbH

51368 Leverkusen

Germany

Baytril oral solution 0,5 %

Enrofloxacin

0,5 %

Solution for oral use

Oral

Broilers, rearing poultry, turkeys

Cyprus

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

K-flox 100 mg/ml oral solution for broilers and rabbits

Enrofloxacin

100 mg/ml

Solution for oral use

Oral

Chickens and rabbits

Cyprus

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg concentrated solution for oral solution for chickens and turkeys

Enrofloxacin

100 mg/ml

Solution for oral use

Oral

Chickens and turkeys

Czech Republic

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Enro-K 10 % (w/v) perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and turkey

Czech Republic

| Vétoquinol s.r.o., |
| --- |
| Zámečnická 411, |
| 288 02 Nymburk |
| Czech Republic |

Vétoquinol s.r.o.,

Zámečnická 411,

288 02 Nymburk

Czech Republic

ENROBIOFLOX 100 mg/ml perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler chicken, non-ruminating calves and pigs

Czech Republic

| INTERSIGN |
| --- |
| Pechačkova 5, |
| 150 00 Prague 5 |
| Czech Republic |

INTERSIGN

Pechačkova 5,

150 00 Prague 5

Czech Republic

ENROFLOXAN 100 mg/ml perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler chicken, non-ruminating calves and pigs

Czech Republic

| Pharmagal spol. s.r.o., |
| --- |
| Murgašova 5, |
| 949 01 Nitra |
| Slovak Republic |

Pharmagal spol. s.r.o.,

Murgašova 5,

949 01 Nitra

Slovak Republic

ENROGAL 100 mg/ml perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Pigs, calves, chicken (broilers), turkeys

Czech Republic

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml, perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Czech Republic

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

FLOXACIN 100 mg/ml, koncentrát pro přípravu perorálního roztoku pro kura domácího a krůty

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Czech Republic

| Ceva Animal Health Slovakia, spol s.r.o., |
| --- |
| Račianska 77, |
| 831 02 Bratislava, |
| Slovak Republic |

Ceva Animal Health Slovakia, spol s.r.o.,

Račianska 77,

831 02 Bratislava,

Slovak Republic

QUINOEX 100 mg/ml perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken broilers, turkey

Czech Republic

| Laboratorios Calier S.A., |
| --- |
| C/Barcelones, 26 (Pla del Ramassa), |
| 08520 Les Franqueses del Valles, Barcelona |
| Spain |

Laboratorios Calier S.A.,

C/Barcelones, 26 (Pla del Ramassa),

08520 Les Franqueses del Valles, Barcelona

Spain

ROXACIN 100 mg/ml perorální roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken broilers

Czech Republic

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

SPECTRON 100 mg/ml roztok pro podání v pitné vodě pro kuřata a krůty

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

Czech Republic

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

UNISOL 100 mg/ml perorální roztok pro podání v pitné vodě pro kuřata a krůt

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chicken - broilers and turkey

Denmark

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Denmark

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

Baytril Vet

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry, non egglayers

Estonia

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Quinoflox

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Estonia

| Industrial Veterinaria S.A. |
| --- |
| Esmeralda, 19. |
| 08950 Espluges de Llobregat, Barcelona |
| Spain |

Industrial Veterinaria S.A.

Esmeralda, 19.

08950 Espluges de Llobregat, Barcelona

Spain

Ganadexil Enrofloxacina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler

Estonia

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Enrobioflox 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Cattle (calves), pigs, chicken (broilers), cats, dogs

Estonia

| Interchemie werken "De Adelaar" Eesti AS, |
| --- |
| Vanapere tee 14, |
| Pringi 74001 Viimsi, Harjumaa, |
| Estonia |

Interchemie werken "De Adelaar" Eesti AS,

Vanapere tee 14,

Pringi 74001 Viimsi, Harjumaa,

Estonia

Interflox Oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

France

| Bayer Sante |
| --- |
| 220 Avenue de la Recherche |
| 59120 Loos |
| France |

Bayer Sante

220 Avenue de la Recherche

59120 Loos

France

BAYTRIL 10 % solution buvable

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, turkeys and rabbits

France

| Virbac |
| --- |
| 1ere Avenue 2065 M L I D |
| 06516 Carros Cedex |
| Spain |

Virbac

1ere Avenue 2065 M L I D

06516 Carros Cedex

Spain

TENOTRYL 10 % solution buvable

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

France

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

LANFLOX 100 MG/ML solution pour utilisation dans l'eau de boisson pour poulets et dindes

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

France

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

KARIFLOX 10 % solution buvable pour poulets et dindes

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

France

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

QUINOFLOX 10 % solution buvable

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

France

| Sogeval |
| --- |
| 200 Avenue De Mayenne |
| Zone Industrielle Des Touches |
| 53000 Laval |
| France |

Sogeval

200 Avenue De Mayenne

Zone Industrielle Des Touches

53000 Laval

France

ENROVAL 10 % solution buvable pour volailles

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens (broilers, replacement chickens, broiler breeders) and turkeys

France

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

SPECTRON 100 MG/ML solution pour utilisation dans l'eau de boisson pour poulets et dindes

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

France

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

NYOFLOX 100 MG/ML solution pour administration dans l'eau de boisson pour poulets et lapins

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens (broilers, replacement chickens, broiler breeders) and rabbits

Germany

| Bayer Vital GmbH |
| --- |
| Kaiser-Wilhelm-Allee |
| 51373 Leverkusen |
| Germany |

Bayer Vital GmbH

Kaiser-Wilhelm-Allee

51373 Leverkusen

Germany

Baytril 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Lanflox 100 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron 100 mg/ml oral solution for chicken and turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken (broilers, broiler parent animals, pullets), rabbit

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Enro-Sleecol

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Enro-K 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 100 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| bioptivet Tierarzneimittel GmbH & Co. |
| --- |
| Im Landwehrwinkel 22 |
| 59073 Hamm |
| Germany |

bioptivet Tierarzneimittel GmbH & Co.

Im Landwehrwinkel 22

59073 Hamm

Germany

Enrobioflox 100 mg/ml Lösung

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Germany

| bioptivet Tierarzneimittel GmbH & Co. |
| --- |
| Im Landwehrwinkel 22 |
| 59073 Hamm |
| Germany |

bioptivet Tierarzneimittel GmbH & Co.

Im Landwehrwinkel 22

59073 Hamm

Germany

Enroflox 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Greece

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

BAYTRIL 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and turkey

Greece

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

BAYTRIL 0,5

Enrofloxacin

5 mg/ml

Oral solution

Oral

Chicken - broilers and turkey

Greece

| VIRBAC SA, |
| --- |
| 13e Rue LID |
| BP 27 |
| 06511 Carros cedex |
| France |

VIRBAC SA,

13e Rue LID

BP 27

06511 Carros cedex

France

FLOXATRIL

Enrofloxacin

100 mg/m

Oral solution

Oral

Chicken - broilers and turkey

Greece

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

ENROFLOXACIN 10 %

Enrofloxacin

100 mg/m

Oral solution

Oral

Chicken - broilers and turkey

Greece

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

FLEXIN

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and turkey

Greece

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

LEVOFLOK

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and rabbits

Greece

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

AMIPLUS

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and rabbits

Greece

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

SPECTRON

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and turkey

Greece

| Laboratorios Maymo, S.A., |
| --- |
| Via Augusta 302, |
| 08017 Barcelona |
| Spain |

Laboratorios Maymo, S.A.,

Via Augusta 302,

08017 Barcelona

Spain

QUIMIOCOLI

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken broiler

Hungary

| Bayer Hungária Kft, |
| --- |
| Alkotás u. 50. |
| 1123 Budapest |
| Hungary |

Bayer Hungária Kft,

Alkotás u. 50.

1123 Budapest

Hungary

Baytril 10 % belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Enrobioflox 10 % belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Swine, cattle (calves), broiler chickens, dogs, cats

Hungary

| Lavet Pharmaceuticals Ltd., |
| --- |
| Ottó u. 14., |
| 1161 Budapest, |
| Hungary |

Lavet Pharmaceuticals Ltd.,

Ottó u. 14.,

1161 Budapest,

Hungary

Enrocin 10 % oldat

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Hungary

| DIVASA - FARMAVIC, S.A. |
| --- |
| Ctra Sant Hipolit Km 71 |
| 08503 Gurb-Vic |
| Barcelona |
| Spain |

DIVASA - FARMAVIC, S.A.

Ctra Sant Hipolit Km 71

08503 Gurb-Vic

Barcelona

Spain

Enrovet 10 % belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens

Hungary

| VMD Állatgyógyászati Kft. |
| --- |
| Közraktár u. 22/b. |
| 1093 Budapest |
| Hungary |

VMD Állatgyógyászati Kft.

Közraktár u. 22/b.

1093 Budapest

Hungary

Enroveto-20 belsőleges oldat

Enrofloxacin

200 mg/ml

Concentrate for oral solution

Oral

Chickens, pigs and turkeys

Hungary

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 % belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg/ml koncentrátum belsőleges oldathoz házityúk és pulyka részére

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Hungary

| Dunavet-B Zrt. |
| --- |
| Dolgos u. 2., |
| 1126 Budapest, |
| Hungary |

Dunavet-B Zrt.

Dolgos u. 2.,

1126 Budapest,

Hungary

Ganadexil Enrofloxacina belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler chickens

Hungary

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Kariflox 10 % belsőleges oldat házityúk és pulyka részére

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

LANFLOX 100 mg/ml oldat ivóvízbe keveréshez házityúk és pulyka részére

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| TolnAgro Kft. |
| --- |
| Rákóczi u. 146. |
| 7100 Szekszárd, |
| Hungary |

TolnAgro Kft.

Rákóczi u. 146.

7100 Szekszárd,

Hungary

Neoflox 10 % belsőleges oldat házityúk (brojler csirke) és házinyúl számára

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and rabbits

Hungary

| Novimed Kft., |
| --- |
| Kiss Ernő u. 3. |
| P+P Kereskedőház |
| 1046 Budapest, |
| Hungary |

Novimed Kft.,

Kiss Ernő u. 3.

P+P Kereskedőház

1046 Budapest,

Hungary

Novicen Flox belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens

Hungary

| CEVA-Phylaxia Zrt. |
| --- |
| Szállás u. 5. |
| 1107 Budapest, |
| Hungary |

CEVA-Phylaxia Zrt.

Szállás u. 5.

1107 Budapest,

Hungary

Quinoex 10 belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| CEVA-Phylaxia Zrt. |
| --- |
| Szállás u. 5. |
| 1107 Budapest, |
| Hungary |

CEVA-Phylaxia Zrt.

Szállás u. 5.

1107 Budapest,

Hungary

QUINOFLOX 100 mg/ml belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron 100 mg/ml belsőleges oldat csirkék és pulykák részére

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Hungary

| Laboratorios Syva, s.a.u, |
| --- |
| Avenue Parroco Pablo Diez 49-57, |
| 24010 Leon, |
| Spain |

Laboratorios Syva, s.a.u,

Avenue Parroco Pablo Diez 49-57,

24010 Leon,

Spain

Syvaquinol 10 % belsőleges oldat

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler chickens

Ireland

| Bayer Limited, |
| --- |
| The Atrium, |
| Blackthorn Road, |
| Dublin 18 |
| Ireland |

Bayer Limited,

The Atrium,

Blackthorn Road,

Dublin 18

Ireland

Baytril 10 % Oral Solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enrox Oral Solution 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens (broilers, broiler breeders, replacement chickens), turkeys

Ireland

| Universal Farma, S.L., |
| --- |
| Gran Via Carlos III, 98-7a, |
| 08028 Barcelona |
| Spain |

Universal Farma, S.L.,

Gran Via Carlos III, 98-7a,

08028 Barcelona

Spain

Lanflox 100 mg/ml Oral Solution

Enrofloxacin

10 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Universal Farma, S.L., |
| --- |
| Gran Via Carlos III, 98-7a, |
| 08028 Barcelona |
| Spain |

Universal Farma, S.L.,

Gran Via Carlos III, 98-7a,

08028 Barcelona

Spain

Unisol 10 % Oral Solution

Enrofloxacin

10 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

ENRO-K 10 % Oral Solution

Enrofloxacin

10 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Kariflox 10 % Oral Solution for Chickens and Turkeys

Enrofloxacin

10 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

Floxamax Enrofloxacin 10 % Concentrate for Oral

Enrofloxacin

10 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron 100 mg/ml Solution for use in Drinking Water for Chickens and Turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Enro-Sleecol 100 mg/ml oral solution for chickens and turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Ireland

| HCS bvba, |
| --- |
| H. Kennisstraat 53, |
| 2650 Edegem, |
| Belgium |

HCS bvba,

H. Kennisstraat 53,

2650 Edegem,

Belgium

Enrofloxacin HCS 100 mg/ml oral solution for chickens and turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron 100 mg/ml concentrate for oral solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 10 % oral solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Cevaflox 100 mg/ml oral solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| DOX-AL Italia S.p.A. |
| --- |
| Largo Donegani 2 |
| 20121 Milano |
| Italy |

DOX-AL Italia S.p.A.

Largo Donegani 2

20121 Milano

Italy

Floxadox

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, turkeys, guinea fowl, ducks, pheasant, quails, rabbits

Italy

| Virbac SA |
| --- |
| Rue 13eme Rue |
| 06511 Carros Cedex, |
| France |

Virbac SA

Rue 13eme Rue

06511 Carros Cedex,

France

Floxatril

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox 100 mg/ml solution for use in drinking water, chicken and rabbits

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, rabbits

Italy

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Levoflok 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, rabbits

Italy

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

K-Flox oral solution for broilers and rabbits

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, rabbits

Italy

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

Floxavex

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Italy

| Bayer |
| --- |
| Viale Certosa 130 |
| 20156 Milano |
| Italy |

Bayer

Viale Certosa 130

20156 Milano

Italy

Baytril 10 % O.L.

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens, turkeys, rabbits

Latvia

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Latvia

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

Latvia

| Vet Line SIA |
| --- |
| Mazā Rāmavas 2, Valdlauči, |
| Ķekavas novads, |
| Latvia |

Vet Line SIA

Mazā Rāmavas 2, Valdlauči,

Ķekavas novads,

Latvia

Interflox Oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Latvia

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Quinoflox

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Latvia

| Laboratorios Calier S.A., |
| --- |
| C/Barcelones 26 (Pla del Ramassa), |
| 08520 Les Franqueses del Valles, Barcelona |
| Spain |

Laboratorios Calier S.A.,

C/Barcelones 26 (Pla del Ramassa),

08520 Les Franqueses del Valles, Barcelona

Spain

Roxacin

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens

Latvia

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Enrobioflox 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Calves, pigs, dogs, cats, chickens (broilers), pigeons

Lithuania

| CENAVISA, S.A., |
| --- |
| Cami Pedra Estela s/n, |
| 43205 Reus (Tarragona) |
| Spain |

CENAVISA, S.A.,

Cami Pedra Estela s/n,

43205 Reus (Tarragona)

Spain

E-FLOX, geriamasis tirpalas

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broiler chickens

Lithuania

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

ENROBIOFLOX 10 %, geriamasis tirpalas

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken, cattle, swine, pigeons, dogs and cats

Lithuania

| Lavet Pharmaceuticals Ltd., |
| --- |
| Ottó u. 14., |
| 1161 Budapest, |
| Hungary |

Lavet Pharmaceuticals Ltd.,

Ottó u. 14.,

1161 Budapest,

Hungary

ENROCIN 10 %, geriamasis tirpalas

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Lithuania

| PPHU "INEX" Partnership, |
| --- |
| ul. Bialostocka 12, |
| 11-500 Giżycko |
| Poland |

PPHU "INEX" Partnership,

ul. Bialostocka 12,

11-500 Giżycko

Poland

ENROFLOXAN 10 %, geriamasis tirpalas

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken, turkey, pigeons, cattle, swine, dogs and cats

Lithuania

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 100 mg/ml geriamasis tirpalas paukščiams

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

Lithuania

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

QUINOFLOX 100 mg/ml geriamasis tirpalas

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Lithuania

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

SPECTRON 100 mg/ml tirpalas girdyti su geriamuoju vandeniu vištoms ir kalakutams

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Luxembourg

| Bayer Belgium |
| --- |
| J.E. Mommaertslaan 14 |
| B-1831 Diegem (Machelen) |
| Belgium |

Bayer Belgium

J.E. Mommaertslaan 14

B-1831 Diegem (Machelen)

Belgium

Baytril 10 % solution orale

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Chickens and turkeys

Luxembourg

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg/ml solution orale pour poulets et dindes

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Luxembourg

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml pour poulets et dindes

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Malta

| Industrial Veterinaria S.A. |
| --- |
| Esmeralda, 19. |
| 08950 Espluges de Llobregat, Barcelona |
| Spain |

Industrial Veterinaria S.A.

Esmeralda, 19.

08950 Espluges de Llobregat, Barcelona

Spain

Ganadexil Enrofloxacino

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broilers

Malta

| Laboratorios Syva, s.a.u, |
| --- |
| Avenue Parroco Pablo Diez 49-57, |
| 24010 Leon, |
| Spain |

Laboratorios Syva, s.a.u,

Avenue Parroco Pablo Diez 49-57,

24010 Leon,

Spain

Syvaquinol 10 % oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

Malta

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

Floxavex Oral solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Malta

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Hipralona Enro-S

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Malta

| Aerden L V.M.D |
| --- |
| Hoge Mauw 900 |
| 2370 Arendonk |
| Belgium |

Aerden L V.M.D

Hoge Mauw 900

2370 Arendonk

Belgium

Enroveto-20

Enrofloxacin

200 mg/ml

Oral solution

Oral

Chickens and turkeys

Malta

| Romvac Co.S.A, |
| --- |
| 7 Soseaua Centurii, |
| Voluntari, IF-077190 |
| Romania |

Romvac Co.S.A,

7 Soseaua Centurii,

Voluntari, IF-077190

Romania

Enrofloxarom 10 % solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Malta

| Pharmagal spol. s r.o., |
| --- |
| Murgašova 5, |
| 949 01 Nitra, |
| Slovakia |

Pharmagal spol. s r.o.,

Murgašova 5,

949 01 Nitra,

Slovakia

Enrogal oral solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| Bayer B.V. |
| --- |
| Animal Health Division |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Bayer B.V.

Animal Health Division

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Baytril 10 % orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enrox 100 mg/ml orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

Kariflox 10 % orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Lanflox 100 mg/ml orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

Floxamax 10 % orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Netherlands

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron 100 mg/ml orale oplossing

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Poland

| Przedsiębiorstwo Farmaceutyczne Okoniewscy "Vetos-Farma" Sp. z o.o., |
| --- |
| ul. Dzierżoniowska 21, |
| 58-260 Bielawa |
| Poland |

Przedsiębiorstwo Farmaceutyczne Okoniewscy "Vetos-Farma" Sp. z o.o.,

ul. Dzierżoniowska 21,

58-260 Bielawa

Poland

Enrofloksacyna 10 % płyn, enrofloksacyna 100 mg/ml roztwór doustny dla kur i indyków

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Poland

| Biowet Puławy Sp. z o.o. |
| --- |
| ul. Arciucha 2, |
| 24-100 Puławy |
| Poland |

Biowet Puławy Sp. z o.o.

ul. Arciucha 2,

24-100 Puławy

Poland

Enflocyna Sol, 50 mg/ml, roztwór doustny dla bydła, świń, psów, kur, indyków i gołębi

Enrofloxacin

50 mg/ml

Oral solution

Oral

Cattle, pig, dog, chicken, turkey and pigeon

Poland

| Biofaktor Sp. z o.o., |
| --- |
| ul. Czysta 4, |
| 96-100 Skierniewice, |
| Poland |

Biofaktor Sp. z o.o.,

ul. Czysta 4,

96-100 Skierniewice,

Poland

Enrofloxan 10 % roztwór, enrofloksacyna 100 mg/ml roztwór do podawania w wodzie do picia dla świń, kur i gołębi

Enrofloxacin

100 mg/ml

Oral solution for use in drinking water

Oral

Pig, chicken (broilers and laying hens) and pigeon

Poland

| Laboratorios Calier S.A., |
| --- |
| C/Barcelones, 26 (Pla del Ramassa), |
| 08520 Les Franqueses del Valles, Barcelona |
| Spain |

Laboratorios Calier S.A.,

C/Barcelones, 26 (Pla del Ramassa),

08520 Les Franqueses del Valles, Barcelona

Spain

Roxacin 10 % oral solution, enrofloksacyna 100 mg/ml, roztwór doustny dla kur

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken

Poland

| Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o., |
| --- |
| ul. Gliniana 32, |
| 20-616 Lublin, |
| Poland |

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

ul. Gliniana 32,

20-616 Lublin,

Poland

Enrocin 10 % Oral, enrofloksacyna 100 mg/ml, roztwór doustny dla kur i gołębi

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Chicken and pigeon

Poland

| Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A. |
| --- |
| ul. Grójecka 6, |
| 05-651 Drwalew, |
| Poland |

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

ul. Grójecka 6,

05-651 Drwalew,

Poland

ENROFLOKSACYNA 10 %, enrofloksacyna 100 mg/ml roztwór doustny dla kur, indyków i gołębi

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken, turkey and pigeon

Poland

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Enrobioflox 10 %, 100 mg/ml, roztwór doustny dla kur, bydła, świń, psów, kotów i gołębi

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken, cattle, pig, dog, cat and pigeon

Poland

| Scan Vet Poland Sp. z o.o. |
| --- |
| Skiereszowo, |
| ul. Kiszkowska 9, |
| 62-200 Gniezno |
| Poland |

Scan Vet Poland Sp. z o.o.

Skiereszowo,

ul. Kiszkowska 9,

62-200 Gniezno

Poland

Scanoflox 10 % Oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys (broilers); pigeons not intended for human consumption

Poland

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

Quinoex-10, 100 mg/ml roztwór doustny dla kur i indyków

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Poland

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 10 % roztwór doustny do podania w wodzie do picia dla kurcząt i indyków

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Poland

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

ENRO-K roztwór doustny

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Poland

| MEDIVET S.A., |
| --- |
| ul. Szkolna 17, |
| 63-100 Śrem |
| Poland |

MEDIVET S.A.,

ul. Szkolna 17,

63-100 Śrem

Poland

MEDOXIL ORAL 100 mg/ml roztwór doustny dla kur i królików

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and rabbits

Poland

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg/ml koncentrat do sporządzania roztworu doustnego dla kur i indyków

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Poland

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron 100 mg/ml roztwór do podawania w wodzie do picia dla kurcząt i indyków

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

Poland

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chicken (broilers, replacement chickens, broiler breeders), rabbit

Poland

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 % Oral

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chicken

Portugal

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox 100 mg/ml solução para administração na água de bebida para frangos e coelhos

Enrofloxacin

100 mg/ml

Concentrate for oral solution for use in drinking water

Oral

Chickens (broilers, replacement chickens, broiler breeders) and rabbits

Portugal

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Levoflok 100 mg/ml solução oral para frangos de carne e coelhos (niflox)

Enrofloxacin

100 mg/ml

Oral solution to be administered in drinking water

Oral

Chicken - broilers and rabbits

Portugal

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

K-Flok 100 mg/ml solução oral para frangos de carne e coelhos

Enrofloxacin

100 mg/ml

Oral solution to be administered in drinking water

Oral

Chicken - broilers and rabbits

Portugal

| VETLIMA - Soc. distribuidora de produtos agro-pecuários, LDA |
| --- |
| Av. 5 de Outubro, 35-3o Esq. |
| 1050-047 Lisboa |
| Portugal |

VETLIMA - Soc. distribuidora de produtos agro-pecuários, LDA

Av. 5 de Outubro, 35-3o Esq.

1050-047 Lisboa

Portugal

Vetaflox 100 mg/ml solução oral para frangos de engorda e coelhos

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and rabbits

Portugal

| Prodivet-Zn, Nutrição e Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA |
| --- |
| Av. Infante D. Henrique no 333 H 3o Piso Esc. 41 |
| 1800-282 Lisboa |
| Portugal |

Prodivet-Zn, Nutrição e Comércio de Produtos Químicos, Farmacêuticos e Cosméticos, SA

Av. Infante D. Henrique no 333 H 3o Piso Esc. 41

1800-282 Lisboa

Portugal

Prodirox 100 mg/ml solução oral para frangos e coelhos

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken - broilers and rabbits

Portugal

| ESTEVE FARMA, LDA |
| --- |
| Av. Do Forte 3 - Edifício Suécia II, Piso 4A |
| 2794-044 Carnaxide |
| Portugal |

ESTEVE FARMA, LDA

Av. Do Forte 3 - Edifício Suécia II, Piso 4A

2794-044 Carnaxide

Portugal

ALSIR 100 mg/ml solução oral para frangos, galinhas e perus

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Portugal

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

Bayer Portugal S.A.

Rua Quinta do Pinheiro 5

2794-003 Carnaxide

Portugal

Baytril 10 % sol. oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens

Portugal

| Calier Portugal, S.A |
| --- |
| Centro Empresarial Sintra Estoril II, Ed. C, |
| R. Pé do Mouro Estrada de Albarraque |
| 2710-335 Sintra |
| Portugal |

Calier Portugal, S.A

Centro Empresarial Sintra Estoril II, Ed. C,

R. Pé do Mouro Estrada de Albarraque

2710-335 Sintra

Portugal

Roxacin oral, enrofloxacina 100 g/l solução oral

Enrofloxacin

100 g/ 1 L

Oral solution.

Oral

Chickens (broilers)

Portugal

| Representagro – Representaçoes LDA |
| --- |
| Estrada da Lapa 1, |
| 2665-540 Venda do Pinheiro, |
| Portugal |

Representagro – Representaçoes LDA

Estrada da Lapa 1,

2665-540 Venda do Pinheiro,

Portugal

COLMYC-P solução oral 10 % para frangos de carne

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Broilers

Portugal

| CENAVISA, S.A., |
| --- |
| Cami Pedra Estela s/n, |
| 43205 Reus (Tarragona) |
| Spain |

CENAVISA, S.A.,

Cami Pedra Estela s/n,

43205 Reus (Tarragona)

Spain

ACROLIN 10 solução oral para frangos de carne

Enrofloxacin

100 mg/ml

Oral solution

Oral

Broilers

Portugal

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg/ml concentrado para solução oral, para frangos e perús

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Romania

| INVESA |
| --- |
| C/ Esmeralda 19-21 |
| 08950 Esplugues de Llobregat, Barcelona |
| Spain |

INVESA

C/ Esmeralda 19-21

08950 Esplugues de Llobregat, Barcelona

Spain

Ganadexil Enrofloxacina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

Romania

| S.C. Romvac Company S.A. |
| --- |
| Șos. Centurii, nr. 7, Voluntari |
| Romania |

S.C. Romvac Company S.A.

Șos. Centurii, nr. 7, Voluntari

Romania

Enrofloxarom 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| S.C. CRIDA PHARM S.R.L. |
| --- |
| Str. Stadionului nr. 1, Oltenita |
| Romania |

S.C. CRIDA PHARM S.R.L.

Str. Stadionului nr. 1, Oltenita

Romania

Enroflox lich. 10 %

Enrofloxacin

100 mg/g

Oral solution

Oral

Poultry and pigs

Romania

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

Baytril 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| DIVASA - FARMAVIC, S.A. |
| --- |
| Ctra Sant Hipolit Km 71 |
| 08503 Gurb-Vic |
| Barcelona |
| Spain |

DIVASA - FARMAVIC, S.A.

Ctra Sant Hipolit Km 71

08503 Gurb-Vic

Barcelona

Spain

Enrovet 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| Laboratorios Syva, s.a.u, |
| --- |
| Avenue Parroco Pablo Diez 49-57, |
| 24010 Leon |
| Spain |

Laboratorios Syva, s.a.u,

Avenue Parroco Pablo Diez 49-57,

24010 Leon

Spain

Syvaquinol 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry

Romania

| Lavet Pharmaceuticals Ltd., |
| --- |
| Ottó u. 14., |
| 1161 Budapest, |
| Hungary |

Lavet Pharmaceuticals Ltd.,

Ottó u. 14.,

1161 Budapest,

Hungary

Enrocin 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| Hipra Laboratorios |
| --- |
| Avda. La Selva, 135, |
| 17170 Amer (Girona) |
| Spain |

Hipra Laboratorios

Avda. La Selva, 135,

17170 Amer (Girona)

Spain

Hipralona Enro S

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (chicken)

Romania

| S.C.MARAVET SRL |
| --- |
| 9 Europa, |
| Baia Mare |
| Romania |

S.C.MARAVET SRL

9 Europa,

Baia Mare

Romania

Anka-floxacin 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| UNIVERSAL PHARMA |
| --- |
| Gran Via Carlos III 98-7a |
| 08028-Barcelona |
| Spain |

UNIVERSAL PHARMA

Gran Via Carlos III 98-7a

08028-Barcelona

Spain

Lanflox 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Romania

| CEVA SANTE ANIMALE |
| --- |
| ZI Très le Bois - BP 372 |
| 22603 Loudeac Cedex |
| France |

CEVA SANTE ANIMALE

ZI Très le Bois - BP 372

22603 Loudeac Cedex

France

Quinoex 10

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (broiler chickens, breeder hens, turkeys, breeder turkeys)

Romania

| DELOS IMPEX’ 96 SRL |
| --- |
| Str. Horia, Cloșca și Crișan, |
| nr. 81, Otopeni, Jud. Ilfov, |
| Romania |

DELOS IMPEX’ 96 SRL

Str. Horia, Cloșca și Crișan,

nr. 81, Otopeni, Jud. Ilfov,

Romania

Enrodem 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry, pigs

Romania

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry, rabbits

Romania

| Vetoquinol Biowet Sp. z.o.o., |
| --- |
| ul. Kosynierów Gdynskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z.o.o.,

ul. Kosynierów Gdynskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Enrobioflox 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (broilers), bovine (calves), pigs

Romania

| Pasteur - Filiala Filipesti SRL |
| --- |
| Str. Principala nr. 944 |
| Filipestii de Padure, Jud. Prahova, |
| Romania |

Pasteur - Filiala Filipesti SRL

Str. Principala nr. 944

Filipestii de Padure, Jud. Prahova,

Romania

Enrofloxacina 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Calves, lambs, kids, piglets, poultry, dogs, cats

Romania

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Floxacin 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovakia

| Pharmagal spol. s r.o., |
| --- |
| Murgašova 5, |
| 949 01 Nitra, |
| Slovakia |

Pharmagal spol. s r.o.,

Murgašova 5,

949 01 Nitra,

Slovakia

Enrogal 100 mg/ml perorálny roztok

Enrofloxacin

100 mg/ml

Oral solution for use in drinking water

Oral

Pigs, calves, lambs, kids, poultry (chicken and turkey)

Slovakia

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 10 % sol. ad us.vet.

Enrofloxacin

100 mg/ml

Oral solution for use in drinking water

Oral

Chickens and turkeys

Slovakia

| Ceva Animal Health Slovakia, spol s r.o., |
| --- |
| Račianska 77, |
| 831 02 Bratislava, |
| Slovakia |

Ceva Animal Health Slovakia, spol s r.o.,

Račianska 77,

831 02 Bratislava,

Slovakia

Quinoex 100 mg/ml perorálny roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovakia

| Laboratorios Calier S.A., |
| --- |
| C/Barcelones, 26 (Pla del Ramassa), |
| 08520 Les Franqueses del Valles, Barcelona |
| Spain |

Laboratorios Calier S.A.,

C/Barcelones, 26 (Pla del Ramassa),

08520 Les Franqueses del Valles, Barcelona

Spain

Roxacin 100 mg/ml perorálny roztok

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chicken

Slovakia

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

Spectron 100 mg/ml roytok na použitie v pitnej vode pre kurčatá a morkz

Enrofloxacin

100 mg/ml

Solution for use in drinking water

Oral

Chickens and turkeys

Slovakia

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 100 mg/ml perorálny roztok na použitie v pitnej vode pre kurčatá a morky

Enrofloxacin

100 mg

Oral solution

Oral

Chickens and turkeys

Slovenia

| Bayer d.o.o., |
| --- |
| Bravničarjeva 13 |
| Ljubljana |
| Slovenia |

Bayer d.o.o.,

Bravničarjeva 13

Ljubljana

Slovenia

BAYTRIL 10 % peroralna raztopina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovenia

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROX 100 mg/ml peroralna raztopina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovenia

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

ENROXIL 100 mg/ml peroralna raztopina za perutnino

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovenia

| GENERA SI d.o.o., |
| --- |
| Dunajska 51, |
| 1000 Ljubljana |
| Slovenia |

GENERA SI d.o.o.,

Dunajska 51,

1000 Ljubljana

Slovenia

VETOFLOK 10 % peroralna raztopina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Slovenia

| Ceva Santé Animale, |
| --- |
| 10 avenue de La Ballastière, |
| 33500 Libourne |
| France |

Ceva Santé Animale,

10 avenue de La Ballastière,

33500 Libourne

France

QUINOFLOX 100 mg/ml peroralna raztopina

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Spain

| Laboratorios Ovejero, S.A. |
| --- |
| Ctra León - Vilecha no 30, |
| 24192 León |
| Spain |

Laboratorios Ovejero, S.A.

Ctra León - Vilecha no 30,

24192 León

Spain

QUINOVET F

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens and turkeys

Spain

| Labiana Life Sciences, S.A. |
| --- |
| C/ Venus, 26 |
| Can Parellada Industrial |
| 08228 Tarrassa |
| Spain |

Labiana Life Sciences, S.A.

C/ Venus, 26

Can Parellada Industrial

08228 Tarrassa

Spain

KIN-O-FLOX

Enrofloxacin

100 g/1 l

Oral solution

Oral

Poultry (broilers)

Spain

| MEVET S.A.U. |
| --- |
| Polígono Industrial El Segre, P. 410. |
| 25191 Lérida |
| Spain |

MEVET S.A.U.

Polígono Industrial El Segre, P. 410.

25191 Lérida

Spain

ENROVALL ORAL

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| Laboratorios Calier S.A., |
| --- |
| C/Barcelones, 26 (Pla del Ramassa), |
| 08520 Les Franqueses del Valles, Barcelona |
| Spain |

Laboratorios Calier S.A.,

C/Barcelones, 26 (Pla del Ramassa),

08520 Les Franqueses del Valles, Barcelona

Spain

ROXACIN SOLUCION ORAL

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| Laboratorio JAER. |
| --- |
| C/Barcelona 411. |
| 08620 Sant Vicenc del Horts, Barcelona |
| Spain |

Laboratorio JAER.

C/Barcelona 411.

08620 Sant Vicenc del Horts, Barcelona

Spain

SORANOX

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens and turkeys

Spain

| DIVASA - FARMAVIC, S.A. |
| --- |
| Ctra Sant Hipolit Km 71 |
| 08503 Gurb-Vic |
| Barcelona |
| Spain |

DIVASA - FARMAVIC, S.A.

Ctra Sant Hipolit Km 71

08503 Gurb-Vic

Barcelona

Spain

ENROVET 10 %

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

Spain

| POLICHEM, S.A. |
| --- |
| Ctra Reus- Cambrils, Km 3. |
| 43206 Reus. Tarragona |
| Spain |

POLICHEM, S.A.

Ctra Reus- Cambrils, Km 3.

43206 Reus. Tarragona

Spain

POLISTAR

Enrofloxacin

100 g/l

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| Industrial Veterinaria S.A. |
| --- |
| Esmeralda, 19. |
| 08950 Espluges de Llobregat, Barcelona |
| Spain |

Industrial Veterinaria S.A.

Esmeralda, 19.

08950 Espluges de Llobregat, Barcelona

Spain

FENUTIN

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| CHEMO IBÉRICA, S.A. |
| --- |
| Gran Vía Carlos III 98 - 7a, |
| 08028 Barcelona |
| Spain |

CHEMO IBÉRICA, S.A.

Gran Vía Carlos III 98 - 7a,

08028 Barcelona

Spain

ENROFLOXACINO CHEMO 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades, 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades, 11-12,

08140 Caldes de Montbui, Barcelona

Spain

CONFLOX 100 mg/ml solucion oral para pollos

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chickens (broilers)

Spain

| Industrial Veterinaria S.A. |
| --- |
| Esmeralda, 19 |
| 08950 Espluges de Llobregat, Barcelona |
| Spain |

Industrial Veterinaria S.A.

Esmeralda, 19

08950 Espluges de Llobregat, Barcelona

Spain

Ganadexil enrofloxacino solucion oral

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chicken - broilers and rabbits

Spain

| Laboratorios Karizoo S.A., |
| --- |
| Pol. Ind. La Borda, |
| Mas Pujades 11-12, |
| 08140 Caldes de Montbui, Barcelona |
| Spain |

Laboratorios Karizoo S.A.,

Pol. Ind. La Borda,

Mas Pujades 11-12,

08140 Caldes de Montbui, Barcelona

Spain

K-FLOX 100 mg/ml solucion oral para pollos y conejos

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chicken - broilers and rabbits

Spain

| Universal Farma, S.L., |
| --- |
| Gran Via Carlos III 98 - 7a, |
| 08028 Barcelona |
| Spain |

Universal Farma, S.L.,

Gran Via Carlos III 98 - 7a,

08028 Barcelona

Spain

Enrofloxacino Universal 100 mg/ml solucion oral para pollos y conejos

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Chicken - broilers and rabbits

Spain

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

FLOXAVEX 100 mg/ml concentrado para solucion oral pollos y pavos

Enrofloxacin

10 % w/v

Concentrate for oral solution

Oral

Chickens and turkeys

Spain

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

FLOXACIN 100 mg/ml concentrado para solucion oral pollos y pavos

Enrofloxacin

100 mg/ml

Concentrate for oral solution

Oral

Chickens and turkeys

Spain

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

AQUAFLOX 100 mg/ml solucion para administracion en agua de bebida

Enrofloxacin

100 mg/ml

Solution for use in drinking water.

Oral

Chickens (broilers, replacement chickens, broiler breeders) and rabbits

Spain

| Laboratorios Syva, s.a.u, |
| --- |
| Avenue Parroco Pablo Diez 49-57, |
| 24010 Leon, |
| Spain |

Laboratorios Syva, s.a.u,

Avenue Parroco Pablo Diez 49-57,

24010 Leon,

Spain

SYVAQUINOL 10 % oral

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (broilers)

Spain

| S.P. VETERINARIA, S.A. |
| --- |
| Ctra. Reus - Vinyols Km 4,1 |
| Riudoms 43330 (Tarragona) |
| Spain |

S.P. VETERINARIA, S.A.

Ctra. Reus - Vinyols Km 4,1

Riudoms 43330 (Tarragona)

Spain

COLMYC-C

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Poultry (broilers and fattened turkeys), rabbits

Spain

| Laboratorios Hipra S.A. |
| --- |
| Avda. La Selva 135, |
| 17170 - Amer (Girona) |
| Spain |

Laboratorios Hipra S.A.

Avda. La Selva 135,

17170 - Amer (Girona)

Spain

HIPRALONA ENRO-S

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Poultry (broilers and fattened turkeys), rabbits

Spain

| Laboratorios Maymo, S.A., |
| --- |
| Via Augusta 302, |
| 08017 Barcelona |
| Spain |

Laboratorios Maymo, S.A.,

Via Augusta 302,

08017 Barcelona

Spain

QUIMIOCOLI

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Poultry (broilers)

Spain

| LABORATORIOS E INDUSTRIAS IVEN, S.A. |
| --- |
| C/Luis I 56 |
| 28031 Madrid |
| Spain |

LABORATORIOS E INDUSTRIAS IVEN, S.A.

C/Luis I 56

28031 Madrid

Spain

FLOXACIVEN

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Poultry (broilers)

Spain

| LABORATORIOS DR ESTEVE |
| --- |
| Avda. Madre de Déu de Montserrat 221 |
| 08041 Barcelona |
| Spain |

LABORATORIOS DR ESTEVE

Avda. Madre de Déu de Montserrat 221

08041 Barcelona

Spain

ALSIR 10 % solucion oral

Enrofloxacin

10 g/100 ml

Oral solution

Oral

Poultry (broilers, replacement chickens, broiler breeders and turkeys)

Spain

| CENAVISA, S.A., |
| --- |
| Cami Pedra Estela s/n, |
| 43205 Reus (Tarragona) |
| Spain |

CENAVISA, S.A.,

Cami Pedra Estela s/n,

43205 Reus (Tarragona)

Spain

FLOXICEN

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (broilers)

Spain

| Laboratorios Serra Pamies, S.A. |
| --- |
| Crta de Castellvell, 24 |
| 43206 Reus (Tarragona) |
| Spain |

Laboratorios Serra Pamies, S.A.

Crta de Castellvell, 24

43206 Reus (Tarragona)

Spain

E-FLOX solucion oral

Enrofloxacin

100 mg/ml

Oral solution to be administered via drinking water

Oral

Poultry (broilers)

Spain

| CEVA SALUD ANIMAL, |
| --- |
| Carabela La Niña 12, 5a |
| 08017 Barcelona |
| Spain |

CEVA SALUD ANIMAL,

Carabela La Niña 12, 5a

08017 Barcelona

Spain

QUINOEX-10

Enrofloxacin

100 mg/ml

Oral solution

Oral

Poultry (broilers and broiler breeders)

Sweden

| Bayer Animal Health GmbH, |
| --- |
| 51368 Leverkusen, |
| Germany |

Bayer Animal Health GmbH,

51368 Leverkusen,

Germany

Baytril vet.

Enrofloxacin

100 mg/ml

Solution for use in water

Oral

Poultry

Sweden

| aniMedica GmbH, |
| --- |
| Im Südfeld 9, |
| 48308 Senden-Bosensell |
| Germany |

aniMedica GmbH,

Im Südfeld 9,

48308 Senden-Bosensell

Germany

Enrotron

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

United Kingdom

| Bayer plc |
| --- |
| Animal Health Division |
| Bayer House |
| Strawberry Hill |
| Newbury RG14 1JA |
| Berkshire |
| United Kingdom |

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury RG14 1JA

Berkshire

United Kingdom

Baytril 10 % Oral Solution

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

United Kingdom

| Krka d.d. Novo mesto, |
| --- |
| Šmarjeska cesta 6 |
| 8501 Novo Mesto |
| Slovenia |

Krka d.d. Novo mesto,

Šmarjeska cesta 6

8501 Novo Mesto

Slovenia

Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

United Kingdom

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Lanflox 100 mg/ml Solution for Use in Drinking Water for Chickens and Turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

United Kingdom

| Global Vet Health S.L. |
| --- |
| C/Capcanes, 12-bajos |
| Poligono Agro-Reus |
| 43206-Reus |
| Tarragona |
| Spain |

Global Vet Health S.L.

C/Capcanes, 12-bajos

Poligono Agro-Reus

43206-Reus

Tarragona

Spain

Quinoflox 100 mg/ml Solution for Use in Drinking Water, Chicken and Rabbits

Enrofloxacin

100 mg/ml

Oral solution

Oral

ChickensRabbits

United Kingdom

| Vetpharma Animal Health S.L., |
| --- |
| Les Corts 23, |
| 08028 Barcelona |
| Spain |

Vetpharma Animal Health S.L.,

Les Corts 23,

08028 Barcelona

Spain

Unisol 100 mg/ml Oral Solution for use in Drinking Water for Chickens and Turkeys

Enrofloxacin

100 mg/ml

Oral solution

Oral

Chickens and turkeys

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