# Official Journal C 78/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.078.eng |
| --- | --- |
| Official Journal
  of the European Union | C 78 |
| | |
| English edition | Information and Notices | Volume 5516 March 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.078.eng

Official Journal

of the European Union

C 78

English edition

Information and Notices

Volume 5516 March 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 078/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2012/C 078/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 078/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2012/C 078/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

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

10

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 16.3.2012 | EN | Official Journal of the European Union | C 78/1 |
| --- | --- | --- | --- |

16.3.2012

EN

Official Journal of the European Union

C 78/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012

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

2012/C 78/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2012 | Efavirenz Teva | efavirenz | Teva Pharma BV |
| Computerweg 10, |
| 3542 DR Utrecht, |
| 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

9.1.2012

Efavirenz Teva

efavirenz

Teva Pharma BV

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/742/001-010

Film-coated tablet

J05AG03

11.1.2012

13.1.2012

Desloratadine Actavis

desloratadine

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/11/745/001-009

Film-coated tablet

R06AX27

17.1.2012

13.1.2012

Desloratadine ratiopharm

desloratadine

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, |
| D-89079 Ulm, |
| Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/11/746/001-012

Film-coated tablet

R06AX27

17.1.2012

31.1.2012

Docetaxel Mylan

Docetaxel

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, |
| 69 800 Saint Priest, |
| France |

Mylan S.A.S

117 allée des Parcs,

69 800 Saint Priest,

France

EU/1/11/748/001-006

Concentrate for solution for infusion

L01CD02

2.2.2012

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

| 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 |
| --- | --- | --- | --- | --- |
| 20.1.2012 | Luveniq | Lux Biosciences GmbH |
| MlawGroup, |
| Maximilianstr. 31, |
| D-80539 Munich, |
| 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

20.1.2012

Luveniq

Lux Biosciences GmbH

MlawGroup,

Maximilianstr. 31,

D-80539 Munich,

Deutschland.

24.1.2012

—   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 |
| --- | --- | --- | --- | --- |
| 9.1.2012 | Inovelon | Eisai Limited |
| European Knowledge Centre, |
| Mosquito Way, Hatfield, |
| Hertfordshire, |
| AL10 9SN, |
| 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

9.1.2012

Inovelon

Eisai Limited

European Knowledge Centre,

Mosquito Way, Hatfield,

Hertfordshire,

AL10 9SN,

United Kingdom

EU/1/06/378/001-017

11.1.2012

9.1.2012

Leganto

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, |
| Co, Clare, |
| Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate,

Co, Clare,

Ireland

EU/1/11/695/001-055

11.1.2012

9.1.2012

Pumarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/10/664/001

11.1.2012

9.1.2012

Revlimid

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, |
| Stockley Park, Uxbridge, |
| Middlesex, |
| UB11 1BD, |
| United Kingdom |

Celgene Europe Limited

1 Longwalk Road,

Stockley Park, Uxbridge,

Middlesex,

UB11 1BD,

United Kingdom

EU/1/07/391/001-004

11.1.2012

9.1.2012

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/347/001-008

11.1.2012

13.1.2012

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, |
| 94250 Gentilly, |
| France |

Biocodex

7 avenue Gallieni,

94250 Gentilly,

France

EU/1/06/367/001-012

17.1.2012

13.1.2012

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250, |
| 64271 Darmstadt, |
| Deutschland |

Merck KGaA

Frankfurter Straße 250,

64271 Darmstadt,

Deutschland

EU/1/04/281/001-005

17.1.2012

13.1.2012

Ilaris

| 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/1/09/564/001-003

18.1.2012

13.1.2012

NovoSeven

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/96/006/001-007

17.1.2012

13.1.2012

Olanzapine Mylan

| Generics [UK] Limited |
| --- |
| Station Close, Potters Bar, |
| Hertfordshire, |
| EN6 1TL, |
| United Kingdom |

Generics [UK] Limited

Station Close, Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

EU/1/08/475/001-060

18.1.2012

13.1.2012

Revlimid

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, |
| Stockley Park, Uxbridge, |
| Middlesex, |
| UB11 1BD, |
| United Kingdom |

Celgene Europe Limited

1 Longwalk Road,

Stockley Park, Uxbridge,

Middlesex,

UB11 1BD,

United Kingdom

EU/1/07/391/001-004

18.1.2012

13.1.2012

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg,

30 - 2340 Beerse –

België

EU/1/08/494/001-004

17.1.2012

13.1.2012

Temodal

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/98/096/001-025

18.1.2012

13.1.2012

Twinrix Adult

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

GlaxoSmithKline Biologicals S.A

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/96/020/001-009

17.1.2012

13.1.2012

Twinrix Paediatric

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/97/029/001-010

17.1.2012

20.1.2012

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

25.1.2012

20.1.2012

ChondroCelect

| TiGenix NV |
| --- |
| Romeinse straat 12/2, |
| B-3001 LEUVEN, |
| België |

TiGenix NV

Romeinse straat 12/2,

B-3001 LEUVEN,

België

EU/1/09/563/001

24.1.2012

20.1.2012

Clopidogrel Acino Pharma

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/549/001-007

24.1.2012

20.1.2012

Clopidogrel ratiopharm GmbH

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/541/001-008

24.1.2012

20.1.2012

Glivec

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/01/198/001-013

25.1.2012

20.1.2012

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, |
| Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead,

Berkshire

SL6 4XE,

United Kingdom

EU/1/03/256/001-010

24.1.2012

20.1.2012

Irbesartan Zentiva

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/06/376/001-033

24.1.2012

20.1.2012

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/1/98/063/001-019

25.1.2012

20.1.2012

Sprycel

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/06/363/001-015

24.1.2012

20.1.2012

Vectibix

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/07/423/001-003

24.1.2012

20.1.2012

Xelevia

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/382/001-018

25.1.2012

20.1.2012

Zostavax

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

24.1.2012

24.1.2012

Adenuric

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, |
| L-1611 Luxembourg, |
| Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare,

L-1611 Luxembourg,

Luxembourg

EU/1/08/447/001-012

26.1.2012

24.1.2012

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, |
| A - 1221 Wien, |
| Österreich |

Baxter AG

Industriestraße 67,

A - 1221 Wien,

Österreich

EU/1/08/506/001

26.1.2012

24.1.2012

Cerezyme

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

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/97/053/001-005

26.1.2012

24.1.2012

Dynastat

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/209/001-008

26.1.2012

30.1.2012

alli

| Glaxo Group Limited |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/401/007-016

1.2.2012

30.1.2012

Galvus

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

1.2.2012

30.1.2012

IDflu

| Sanofi Pasteur SA |
| --- |
| 2, avenue Pont Pasteur, |
| F-69007 Lyon, |
| France |

Sanofi Pasteur SA

2, avenue Pont Pasteur,

F-69007 Lyon,

France

EU/1/08/507/001-006

1.2.2012

30.1.2012

Jalra

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/485/001-011

1.2.2012

30.1.2012

Leflunomide medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, |
| D-20354 Hamburg – |
| Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3,

D-20354 Hamburg –

Deutschland

EU/1/10/637/001-009

1.2.2012

30.1.2012

Mimpara

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/04/292/001-012

1.2.2012

30.1.2012

Resolor

| Shire-Movetis NV |
| --- |
| Veedjik 58, |
| B-2300 Turnhout, |
| België |

Shire-Movetis NV

Veedjik 58,

B-2300 Turnhout,

België

EU/1/09/581/001-008

1.2.2012

30.1.2012

Simulect

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/98/084/001-002

1.2.2012

30.1.2012

Xiliarx

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/486/001-011

1.2.2012

31.1.2012

Docetaxel Winthrop

| 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/1/07/384/001-005

2.2.2012

31.1.2012

InductOs

| Medtronic Biopharma BV |
| --- |
| Earl Bakkenstraat 10, |
| 6422 PJ Heerlen, |
| Nederland |

Medtronic Biopharma BV

Earl Bakkenstraat 10,

6422 PJ Heerlen,

Nederland

EU/1/02/226/001

3.2.2012

31.1.2012

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/1/09/508/001-011

2.2.2012

31.1.2012

Temodal

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/98/096/001-025

2.2.2012

31.1.2012

Teysuno

| Nordic Group BV |
| --- |
| Siriusdreef 22, |
| 2132 WT Hoofddorp, |
| Nederland |

Nordic Group BV

Siriusdreef 22,

2132 WT Hoofddorp,

Nederland

EU/1/11/669/001-004

2.2.2012

31.1.2012

Tyverb

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/440/001-006

2.2.2012

31.1.2012

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge

CB21 6GT

United Kingdom

EU/1/01/200/001-002

2.2.2012

31.1.2012

Xgeva

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

Amgen Europe B.V.

Minervum 7061,

4817 ZK Breda,

Nederland

EU/1/11/703/001-003

2.2.2012

31.1.2012

Xyrem

| UCB Pharma Ltd. |
| --- |
| 208 Bath Road, Slough, |
| Berkshire |
| SL1 3WE, |
| United Kingdom |

UCB Pharma Ltd.

208 Bath Road, Slough,

Berkshire

SL1 3WE,

United Kingdom

EU/1/05/312/001

2.2.2012

31.1.2012

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1, |
| Polígono Industrial La Mina, |
| 28770 Colmenar Viejo |
| (Madrid), |
| Espana |

Pharma Mar, S.A.

Avda. de los Reyes 1,

Polígono Industrial La Mina,

28770 Colmenar Viejo

(Madrid),

Espana

EU/1/07/417/001-002

2.2.2012

—   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 Décision | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2012 | Activyl Tick Plus | Indoxacarb + permethrin | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Date of the Décision

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

9.1.2012

Activyl Tick Plus

Indoxacarb + permethrin

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/11/137/001-015

Spot-on solution

QP53AC54

11.1.2012

—   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 |
| --- | --- | --- | --- | --- |
| 9.1.2012 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, |
| 17170- Amer (Girona), |
| España |

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

9.1.2012

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

Avda. La Selva, 135,

17170- Amer (Girona),

España

EU/2/10/114/001-003

11.1.2012

20.1.2012

Posatex

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/08/081/001-003

24.1.2012

24.1.2012

Rheumocam

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, |
| Co. Galway, |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND

EU/2/07/078/001-017

26.1.2012

31.1.2012

Metacam

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/97/004/001

EU/2/97/004/003-015

EU/2/97/004/026-040

EU/2/97/004/043-049

2.2.2012

31.1.2012

Procox

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

Bayer Animal Health GmbH

51368 Leverkusen,

Deutschland

EU/2/11/123/001-002

2.2.2012

31.1.2012

Suvaxyn Aujeszky 783 +O/W

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/98/009/001-006

3.2.2012

31.1.2012

Zubrin

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/00/028/002-008

2.2.2012

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.

---

| 16.3.2012 | EN | Official Journal of the European Union | C 78/10 |
| --- | --- | --- | --- |

16.3.2012

EN

Official Journal of the European Union

C 78/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012

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

2012/C 78/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 13.1.2012 | Cephalosporins | See Annex I | See Annex I | 18.1.2012 |
| 20.1.2012 | Nimesulide | See Annex II | See Annex II | 23.1.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.1.2012

Cephalosporins

See Annex I

See Annex I

18.1.2012

20.1.2012

Nimesulide

See Annex II

See Annex II

23.1.2012

---

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

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, ACTIVE SUBSTANCE, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, APPLICANTS/ MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Applicant/Marketing Authorisation Holder | Name | Active substance | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GmbH |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Member State EU/EEA

Applicant/Marketing Authorisation Holder

Name

Active substance

Strength

Pharmaceutical form

Animal species

Austria

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

Cobactan 2,5 % w/v Injektionssuspension für Rinder und Schweine

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Intervet GmbH |
| --- |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

COBACTAN LA 7,5 % - Injektionssupension für Rinder

Cefquinome

75 mg/ml

Suspension for injection

Cattle

Austria

| Intervet GmbH |
| --- |
| Siemensstraße 107 |
| 1210 Wien |
| AUSTRIA |

Intervet GmbH

Siemensstraße 107

1210 Wien

AUSTRIA

Cobactan 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde und Rinder

Cefquinome

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

Austria

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Austria

| Vetoquinol Österreich GmbH |
| --- |
| Zehetnergasse 24 |
| 1140 Wien |
| AUSTRIA |

Vetoquinol Österreich GmbH

Zehetnergasse 24

1140 Wien

AUSTRIA

Ceftiocyl 50 mg/ml, Injektionssuspension für Rinder und Schweine

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Austria

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU 50 mg/ml Injektionssuspensiuon für Rinder und Schweine

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

AUSTRIA

Excenel - Pulver zur Herstellung einer Injektionslösung für Tiere

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Austria

| Pfizer Corporation Austria GmbH |
| --- |
| Floridsdorfer Hauptstraße 1 |
| 1210 Wien |
| AUSTRIA |

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

AUSTRIA

Excenel RTU 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Austria

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Pulver zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 %

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection

Cattle, Horses (adult and foal) and (adult and calf)

Belgium

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Belgium

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Belgium

| VETOQUINOL N.V./S.A. |
| --- |
| Kontichsesteenweg 42 |
| 2630 Aartselaar |
| BELGIUM |

VETOQUINOL N.V./S.A.

Kontichsesteenweg 42

2630 Aartselaar

BELGIUM

CEFTIOCYL 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

Belgium

| CEVA Santé Animale NV/SA |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| BELGIUM |

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIUM

CEVAXEL 50MG/ML

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Belgium

| CEVA Santé Animale NV/SA |
| --- |
| Metrologielaan 6 |
| 1130 Brussel |
| BELGIUM |

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIUM

CEVAXEL-RTU 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 Louvain La Neuve |
| BELGIUM |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIUM

EXCENEL

Ceftiofur (as sodium)

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Belgium

| Pfizer Animal Health s.a. |
| --- |
| Rue Laid Burniat 1 |
| B-1348 Louvain La Neuve |
| BELGIUM |

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIUM

EXCENEL RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Belgium

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF Poudre pour solution injectable pour bovins et porcins

Ceftiofur (as sodium)

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Bulgaria

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Цефтиомакс 50 mg/ml инжекционна суспензия за едри преживни животни и свине

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Ceva Animal Health Bulgaria EOOD |
| --- |
| 26 Elemag Str., ent. B, app. 1 |
| 1113 Sofia |
| BULGARIA |

Ceva Animal Health Bulgaria EOOD

26 Elemag Str., ent. B, app. 1

1113 Sofia

BULGARIA

Севаксел-РТУ 50 мг/мл, суспенсия за инжектиране при говеда и свине

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Ефикур 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Цефтиозан 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50mg/ml

Suspension for injection

Cattle, pigs

Bulgaria

| Interchemie werken "De Adelaar" BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| THE NETHERLANDS |

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

THE NETHERLANDS

Цефтионел-50-ceftiofur base(50mg/ml), инжекционна суспензия за говеда и свине

Ceftiofur

50mg/kg

Suspension for injection

Cattle, pigs

Bulgaria

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Кобактан ЛА 7,5 % инжективна суспензия за говеда

Cefquinome

75mg/ml

Suspension for injection

Cattle

Bulgaria

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Кобактан 2,5 %

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Cyprus

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50mg/ml Σκόνη και διαλύτης για ενέσιμο διάλυμα για βοοειδή και χοίρους

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Cyprus

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50mg/ml ενέσιμο διάλυμα για χοίρους και βοοειδή

Ceftiofur (as hydrochloride)

50 mg/ml

Injectable suspension

Cattle, pigs

Cyprus

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Injectable suspension

Cattle

Cyprus

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Czech Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml powder and solvent for solution for njection for cattle and pigs.

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Czech Republic

| Vetoquinol s.r.o. |
| --- |
| Zámečnická 411 |
| CZ - 288 02 Nymburk |
| CZECH REPUBLIC |

Vetoquinol s.r.o.

Zámečnická 411

CZ - 288 02 Nymburk

CZECH REPUBLIC

Ceftiocyl 50 mg/ml suspension for injection for cattle and pigs

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml suspension for injection for pigs and cattle

Ceftiofurum (ut Ceftiofuri hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml powder and solvent for solution for njection for cattle and pigs.

Ceftiofurum (ut natricum)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Czech Republic

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

50 mg/ml suspension for injection for pigs and cattle

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| CZECH REPUBLIC |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

CZECH REPUBLIC

Excenel 50 mg/ml freeze-dried powder for solution for injection

Ceftiofurum (ut natricum)

50 mg/ml

Freeze-dried powder for solution for injection

Cattle, pigs, horses

Czech Republic

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| CZECH REPUBLIC |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

CZECH REPUBLIC

EXCENEL RTU inj

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Suspension for injection

Cattle, pigs

Czech Republic

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef powder for solution for injection for cattle and pigs

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Czech Republic

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 % inj

Cefquinomum (ut sulfas)

25 mg/ml

Injection

Cattle, pigs

Czech Republic

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinomum (ut sulfas)

75 mg/ml

Suspension for injection

Cattle

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

75 mg/ml

Solution for injection, suspension

Cattle

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

25mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan Vet.

cefquinome

45 mg/ml

Powder and solvent for injections for solution

Horses

Denmark

| Vetoquinol scandinavia AB |
| --- |
| Torggatan 2 |
| Box 9 |
| SE-26521 Åstorp |
| SWEDEN |

Vetoquinol scandinavia AB

Torggatan 2

Box 9

SE-26521 Åstorp

SWEDEN

Ceftiocyl

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Denmark

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur Vet.

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

ceftiofur

50 mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan

Ceftiofur

50 mg/ml

Solution for injection, suspension

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Denmark

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel Vet.

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Estonia

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan 50mg/ml

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Estonia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel-RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Estonia

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Estonia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel RTU

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Estonia

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

Ceftiocyl

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Finland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL VET 50 mg/ml

Ceftiofurum natricum

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL 1 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, horses, pigs

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL 4 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, horses, pigs

France

| INTERVET |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49070 Beaucouze |
| FRANCE |

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANCE

COBACTAN 2,5 %

Cefquinome (sous forme de sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs, calves

France

| PFIZER HOLDING France |
| --- |
| 23/25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| FRANCE |

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANCE

EXCENEL RTU

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome (sous forme de sulfate)

75 mg/ml

Suspension for injection

Cattle

France

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN IV IM 4,5 %

Cefquinome (sous forme de sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Horses

France

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

France

| INTERVET |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49070 Beaucouze |
| FRANCE |

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANCE

COBACTAN 4,5 % PS

Cefquinome (sous forme de sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Cattle, horses

France

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

France

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF POUDRE POUR SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Powder for solution for injection.

Cattle, pigs

France

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

CEFTIOCYL 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL-RTU 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA RTU 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection.

Cattle, pigs

France

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Cattle, pigs

France

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 MG/ML SUSPENSION INJECTABLE POUR PORCS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Suspension for injection

Pigs

Germany

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml Injektionssuspension

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| CEVA Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| D-40472 Düsseldorf |
| GERMANY |

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

GERMANY

CEVAXEL-RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan LA 7,5 %

cefquinome sulfate

75 mg/ml

Suspension for injection

Cattle

Germany

| Laboratorios Maymó S.A. |
| --- |
| Calle Ferro 9, Poligono Industrial Can Pelegri |
| E-08755 Castellbisbal (Barcelona) |
| SPAIN |

Laboratorios Maymó S.A.

Calle Ferro 9, Poligono Industrial Can Pelegri

E-08755 Castellbisbal (Barcelona)

SPAIN

CEMAY 50 mg/ml

ceftiofur HCl

50 mg/ml

Suspension for injection

Pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan 2,5 %

cefquinome sulfate

25 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, injectable suspension for cattle and pigs

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Vetoquinol GmbH |
| --- |
| Parkstr. 10 |
| D-88212 Ravensburg |
| GERMANY |

Vetoquinol GmbH

Parkstr. 10

D-88212 Ravensburg

GERMANY

CEFTIOCYL

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml

ceftiofur sodium

50 mg/ml

Powder and solvent for reconstitution

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan 4,5 %

cefquinome sulfate

45 mg/ml

Powder and solvent for reconstitution

Cattle, horses

Germany

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Readycef 50 mg/ml Injektionssuspension für Schweine und Rinder

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| CEVA Tiergesundheit GmbH |
| --- |
| Kanzlerstr. 4 |
| D-40472 Düsseldorf |
| GERMANY |

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

GERMANY

CEVAXEL 50 mg/ml

ceftiofur sodium

50 mg/ml

Powder and solvent for reconstitution

Cattle, pigs

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Cobactan IV 4,5 % Pulver und Lösungsmittel zur Herstellung einer Injektionslösung für Pferde

cefquinome sulfate

45 mg/ml

Powder and solvent for reconstitution

Horses

Germany

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel 1g Pulver zur Herstellung einer Injektionslösung für Schweine und Rinder

ceftiofur sodium

50 mg/ml

Powder

Cattle, pigs

Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel 4g

ceftiofur sodium

50 mg/ml

Powder

Cattle, pigs

Germany

| Pfizer GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| GERMANY |

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

GERMANY

Excenel RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Germany

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

Truleva RTU

ceftiofur HCl

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| INTERVET HELLAS AE |
| --- |
| Ag Dimitriou Str 63, Alimos |
| 174 55 Athens |
| GREECE |

INTERVET HELLAS AE

Ag Dimitriou Str 63, Alimos

174 55 Athens

GREECE

COBACTAN

Cefquinome sulphate

25 mg/ml

Inj.sol.

Cattle, pigs

Greece

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 %

Cefquinome sulphate

45 mg/ml

Powder and solvent for solution for injection

Horses, foals, cattle, calves

Greece

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA

Cefquinome sulphate

75 mg/ml

Suspension for injection

Cattle

Greece

| CEVA HELLAS |
| --- |
| Ag. Nikolaou 15 |
| 17455 Alimos |
| GREECE |

CEVA HELLAS

Ag. Nikolaou 15

17455 Alimos

GREECE

CEVAXEL

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Greece

| CEVA HELLAS |
| --- |
| Ag. Nikolaou 15 |
| 17455 Alimos |
| GREECE |

CEVA HELLAS

Ag. Nikolaou 15

17455 Alimos

GREECE

CEVAXEL-RTU, for cattle and pigs

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Greece

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

VIRBACEF σκόνη για ενέσιμο διάλυμα για βοοειδή και χοίρους

Ceftiofur

50 mg/ml

Powder for Solution for Injection

Cattle, pigs

Greece

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| PFIZER HELLAS AE |
| --- |
| Messogeion Ave 243. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS AE

Messogeion Ave 243.

Neo Psychiko

GR-154 51

GREECE

EXCENEL

CEFTIOFUR

50 mg/ml

Ppowder for injection

Cattle, pigs

Greece

| PFIZER HELLAS AE |
| --- |
| Messogeion Ave 243. |
| Neo Psychiko |
| GR-154 51 |
| GREECE |

PFIZER HELLAS AE

Messogeion Ave 243.

Neo Psychiko

GR-154 51

GREECE

EXCENEL PTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Greece

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Hungary

| Pfizer Co. Ltd. |
| --- |
| Budapest |
| Alkotás u. 54. |
| H-1123 |
| HUNGARY |

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

HUNGARY

Excenel SP injekció

Ceftiofur Sodium

50 mg/ml

Sterile powder for injection

Water for parenteral use

Cattle, pigs

Hungary

| Pfizer Co. Ltd. |
| --- |
| Budapest |
| Alkotás u. 54. |
| H-1123 |
| HUNGARY |

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

HUNGARY

Excenel RTU injekció

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 % injekció

Cefquinom sulphate

25 mg/ml

Injection

Cattle, pigs

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan IV 4,5 % injekció

Cefquinom sulphate

45 mg/ml

Injection

Cattle, horses

Hungary

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % injekció

Cefquinom sulphate

75 mg/ml

Injection

Cattle

Hungary

| Ceva Phylaxia Co. Ltd. |
| --- |
| Budapest |
| Szállás u. 5. |
| H-1107 |
| HUNGARY |

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

HUNGARY

Cevaxel RTU 50 mg/ml szuszpenziós injekció szarvasmarha és sertés részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Ceva Phylaxia Co. Ltd. |
| --- |
| Budapest |
| Szállás u. 5. |
| H-1107 |
| HUNGARY |

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

HUNGARY

Cevaxel 50 mg/ml por és oldószer injekcióhoz szarvasmarha és sertés részére

Ceftiofur Sodium

50 mg/ml

Sterile powder for injection

Water for parenteral use

Cattle, pigs

Hungary

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml injekció sertés és szarvasmarha részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

Ceftiocyl 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Hungary

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injection

Cattle, pigs

Iceland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur vet.

Ceftiofurum INN

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel RTU, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for Injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Pfizer Healthcare Ireland (Trading as Pfizer Animal Health) |
| --- |
| Ringaskiddy Co. Cork |
| IRELAND |

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRELAND

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspension for injection for pigs and cattle

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Pigs, cattle

Ireland

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Powder for Solution for Injection for cattle and pigs.

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Ireland

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| UNITED KINGDOM |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

UNITED KINGDOM

Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs.

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL-RTU 50 mg/ml, suspension for injection for cattle and pigs

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan 2,5 % w/v Suspension for Injection

Cefquinome sulfate

25 mg/ml

Suspension for injection

Cattle, pigs

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRELAND

Cobactan 4,5 % powder and solvent for solution for injection for horse and cattle

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal), cattle (adult and calf)

Ireland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan 50 mg/ml suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs.

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Italy

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Vetoquinol S.A. |
| --- |
| Magny-Vernois |
| 70200 Lure |
| FRANCE |

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANCE

CEFTIOCYL

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

CEFTIOSAN

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Pigs

Italy

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Ceva Vetem SpA |
| --- |
| Via Colleoni 15 |
| 20041 Agrate Brianza (MB) |
| ITALY |

Ceva Vetem SpA

Via Colleoni 15

20041 Agrate Brianza (MB)

ITALY

CEVAXEL

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| PFIZER ITALIA SRL |
| --- |
| Via Valbondione, 113 |
| 00188 Roma |
| ITALY |

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALY

EXCENEL

Sodium ceftiofur

50 mg/ml

Powder for injection

Cattle, pigs, horses

Italy

| PFIZER ITALIA SRL |
| --- |
| Via Valbondione, 113 |
| 00188 Roma |
| ITALY |

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALY

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Fatro Spa |
| --- |
| Via Emilia 285 |
| 40064 Ozzano Dell'Emilia (BO) |
| ITALY |

Fatro Spa

Via Emilia 285

40064 Ozzano Dell'Emilia (BO)

ITALY

WONDERCEF

Ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Italy

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Suspension for injection

Cattle, pigs

Italy

| INTERVET ITALIA SRL |
| --- |
| Via Nettunense Km 20,300. |
| 04011 Aprilia (LT) |
| ITALY |

INTERVET ITALIA SRL

Via Nettunense Km 20,300.

04011 Aprilia (LT)

ITALY

COBACTAN

Cefquinome sulphate

25 mg/ml

Suspension for injection

Cattle, pigs

Italy

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN IV IM 4,5 %

Cefquinome sulphate

No information available

Suspension for injection

Cattle, horses

Italy

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

Cefquinome sulphate

No information available

Suspension for injection

Cattle

Latvia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil

ceftiofur sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

Latvia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL

ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Latvia

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel-RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 2,5 %

cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

cefquinome

75 mg/ml

Suspension for injection

Cattle

Latvia

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

Excenel RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

Excenel Sterile Powder

ceftiofur sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

Latvia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Latvia

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %, injekcinė suspensija

Cefquinome (as sulphate)

25 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %, injekcinė suspensija

Cefquinome (as sulphate)

75 mg/ml

Suspension for injection

Cattle

Lithuania

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

EXCENEL, milteliai injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs, one-day-old chickens

Lithuania

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

EXCENEL RTU, injekcinė suspensija

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml injekcinė ceftiofuro suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Lithuania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL RTU, injekcinė suspensija

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 mg/ml, milteliai ir tirpiklis injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Lithuania

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml injekcinė suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Interchemie werken "De Adelaar" BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| THE NETHERLANDS |

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

THE NETHERLANDS

CEFTIONEL-50, injekcinė suspensija galvijams ir kiaulėms

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Lithuania

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg, cattle

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

Excenel Ceftiofur (w postaci Ceftiofuru sodowego) 50 mg/ml, proszek do sporządzania roztworu do wstrzykiwań

Ceftiofurum

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

Poland

| Pfizer Trading Polska Sp. z o.o. |
| --- |
| ul. Rzymowskiego 34 |
| 02-697 Warszawa |
| POLAND |

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLAND

Excenel RTU

Ceftiofurum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Ceftiomax 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła

Ceftiofuri hydrochloridum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Ceva Animal Health Polska Sp. z o.o. |
| --- |
| ul. Okrzei 1A |
| 03-715 Warszawa |
| POLAND |

Ceva Animal Health Polska Sp. z o.o.

ul. Okrzei 1A

03-715 Warszawa

POLAND

Cevaxel 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń

Ceftiofurum

50 mg/ml

Powder and solution for solution for injection

Cattle, pigs

Poland

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml zawiesina do wstrzykiwań dla świń i bydła

Ceftiofurum

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefur 50 mg/ml proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla bydła i świń

Ceftiofurum natricum

50 mg/ml

Powder and solution for solution for injection

Cattle, pigs

Poland

| Vetoquinol Biowet Sp. z o.o |
| --- |
| ul. Kosynierów Gdyńskich 13-14 |
| 66-400 Gorzów Wielkopolski |
| POLAND |

Vetoquinol Biowet Sp. z o.o

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

POLAND

Ceftiocyl 50 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

Ceftiofur as hydrochloride

50 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan, 25 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

Cefquinomum

25 mg/ml

Suspention for injection

Cattle, pigs

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 4,5 % proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań dla koni i bydła

Cefquinomum

45 mg/ml

Powder and solution for solution for injection

Cattle, horses

Poland

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % zawiesina do wstrzykiwań dla bydła

Cefquinomum

75 mg/ml

Suspention for injection

Cattle

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml pó e solvente para solução injectável para bovinos e suínos

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Portugal

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Pó para solução injectável para bovinos e suínos

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Powder for solution for injection.

Cattle, pigs

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

COBACTAN 2,5 % p/v suspensão injectável para bovinos e suínos

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratórios Pfizer, Lda |
| --- |
| Lagoas Park – Edifício 10 |
| 2740-244 Porto Salvo |
| PORTUGAL |

Laboratórios Pfizer, Lda

Lagoas Park – Edifício 10

2740-244 Porto Salvo

PORTUGAL

EXCENEL RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection.

Cattle, pigs

Portugal

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

CALIER PORTUGAL, S.A.

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 - 335 Sintra

PORTUGAL

CEFTIOMAX 50 mg/ml suspensão injectável para bovinos e suínos

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspensão injectável para suínos e bovinos

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

COBACTAN LA 7,5 %, suspensão injectável para bovinos

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém

PORTUGAL

Cobactan 4,5 % pó e solvente para solução injectável para equinos e bovinos

cefquinome (as sulphate)

45 mg/ml

Powder and solvent for solution for injection

Horses (adult and foal), cattle (adult and calf)

Portugal

| Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, no 9/9A, 9oA |
| Miraflores- 1495-131 Algés |
| PORTUGAL |

Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges, no 9/9A, 9oA

Miraflores- 1495-131 Algés

PORTUGAL

CEVAXEL 50 mg/ml pó e solvente para solução injectável para bovinos e suínos

Ceftiofur (as sodium)

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

Portugal

| VÉTOQUINOL, Lda |
| --- |
| Rua Consiglieri Pedroso, no 123, Edifício H |
| Queluz de Baixo |
| 2730-056 BARCARENA |
| PORTUGAL |

VÉTOQUINOL, Lda

Rua Consiglieri Pedroso, no 123, Edifício H

Queluz de Baixo

2730-056 BARCARENA

PORTUGAL

Ceftiocyl 50 mg/ml, suspensão injectável para Bovinos e Suínos

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, no 9/9A, 9oA |
| Miraflores- 1495-131 Algés |
| PORTUGAL |

Ceva Saúde Animal - Produtos Farmacêuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges, no 9/9A, 9oA

Miraflores- 1495-131 Algés

PORTUGAL

CEVAXEL -RTU 50 mg/ml, suspensão injectável para bovinos e suínos

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml, suspensão injectável para suínos e bovinos

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Portugal

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 mg/ml, suspension for injection for pigs

Ceftiofur (as hydrochloride)

50 mg/ml

Supension for injection

Pigs

Portugal

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg. Cattle.

Romania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

Cefquinome

25 mg/ml

Injectable suspension

Cattle, dairy cows, calves, pigs, piglets

Romania

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 7,5 % L.A.

Cefquinome

75 mg/ml

Injectable suspension

Cattle

Romania

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

EXCENEL RTU

Ceftiofur

50 mg/ml

Injectable suspension

Cattle, pigs

Romania

| Pfizer Animal Health |
| --- |
| Boulevard de la Paine 17 |
| B-1050 Brussels |
| BELGIUM |

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIUM

EXCENEL

Ceftiofur

50 mg/ml.

Sterile powder

Cattle, pigs

Romania

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50mg/ml

Ceftiofur

50 mg/ml

Oily suspension

Cattle, pigs

Romania

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 m

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Romania

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

CEVAXEL 50mg/ml

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, horses, pigs

Romania

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50mg/ml

Ceftiofur

50 mg/ml

Injectable suspension

Cattle, pigs

Slovakia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6J |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6J

UNITED KINGDOM

Cefenil 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

powder+ diluent

Cattle, pigs

Slovakia

| Vetoquinol s.r.o. |
| --- |
| Zámečnícka 411 |
| CZ-288 02 Nymburk |
| CZECH REPUBLIC |

Vetoquinol s.r.o.

Zámečnícka 411

CZ-288 02 Nymburk

CZECH REPUBLIC

Ceftiocyl 50 mg/ml injekčná suspenzia

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel 50 mg/ml prášok a riedidlo na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

powder+ diluent

Cattle, pigs

Slovakia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Efficur 50 mg/ml injekčná suspenzia pre ošípané a hovädzí dobytok

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel 50 mg/ml lyofilizát na prípravu injekčného roztoku

ceftiofurum

50 mg/ml

lyophilisate

Cattle, pigs, one day old chicken, horses.

Slovakia

| Pfizer Manufacturing Belgium N,V./S.A. |
| --- |
| Rijksweg 12 |
| B-2870 Puurs |
| BELGIUM |

Pfizer Manufacturing Belgium N,V./S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Excenel RTU 50 mg/ml injekčná suspenzia

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 25 mg/ ml injekčná suspenzia

cefquinomum

25 mg/ml

Suspension for injection

Cattle, pigs

Slovakia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 % inj.susp. pre hovädzí dobytok

cefquinomum

75 mg/ml

Suspension for injection

Cattle

Slovakia

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef prášok na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

Ceftiofurum (ut natricum)

50 mg/ml

Powder for solution for injection

Cattle, pigs

Slovakia

| Ceva Sante Animale |
| --- |
| 10 avenue de la Ballastiere |
| 33500 Libourne |
| FRANCE |

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANCE

Cevaxel RTU 50 mg/ml injekčná suspnzia pre hovädzí dobytok a ošípané

ceftiofurum

50 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 2,5 %

cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 % suspenzija za injiciranje za govedo

cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

Slovenia

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspenzija za injiciranje za prašiče in govedo

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51 Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| LUXEMBOURG |

Pfizer Luxembourg SARL

51 Avenue J.F.Kennedy

L-1855 Luxembourg

LUXEMBOURG

EXCENEL 50 mg/ml prašek za raztopino za injiciranje za govedo in prašiče

ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, pigs

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| 51 Avenue J.F.Kennedy |
| L-1855 Luxembourg |
| LUXEMBOURG |

Pfizer Luxembourg SARL

51 Avenue J.F.Kennedy

L-1855 Luxembourg

LUXEMBOURG

EXCENEL RTU suspenzija za injiciranje za prašiče in govedo

ceftiofur (as hydrochloride)

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPAIN

EXCENEL

Ceftiofur

50 mg/ml

Sterile powder to dissolve into sterile bacteriostatic water

Cattle, pigs

Spain

| CEVA SALUD ANIMAL, S.A. |
| --- |
| Carabela La Niña no 12 |
| 5a planta |
| 08017 Barcelona |
| SPAIN |

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPAIN

CEVAXEL 50 mg/ml

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

CEFENIL 50 mg/ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE PARA BOVINO Y PORCINO

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Spain

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPAIN

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y VACUNO

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Vetoquinol Especialidades Veterinarias, S.A. |
| --- |
| Autovia Fuencarral-Alcobendas km 15 |
| 700-Edificio Europa I, Portal 3, 2o5 |
| 28108 Alcobendas. |
| SPAIN |

Vetoquinol Especialidades Veterinarias, S.A.

Autovia Fuencarral-Alcobendas km 15

700-Edificio Europa I, Portal 3, 2o5

28108 Alcobendas.

SPAIN

CEFTIOCYL 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| CEVA SALUD ANIMAL, S.A. |
| --- |
| Carabela La Niña no 12 |
| 5a planta |
| 08017 Barcelona |
| SPAIN |

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPAIN

CEVAXEL RTU 50 MG/ML SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil HCL Injection for Cattle and Swine (Name proposed in ES: Cefenil RTU)

Procedure curretly ongoing

ceftiofur

50 mg/ml

Solution for injection

Cattle, pigs

Spain

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspension for injection for pigs and cattle

ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

ACTIONIS 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Laboratorios Maymó, S.A. |
| --- |
| Vía Augusta, 302 |
| 08017. Barcelona |
| SPAIN |

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPAIN

CEMAY 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios E Industrias Iven, S.A. |
| --- |
| Luis I, 56. |
| Polígono Industrial Vallecas |
| 28031 Madrid |
| SPAIN |

Laboratorios E Industrias Iven, S.A.

Luis I, 56.

Polígono Industrial Vallecas

28031 Madrid

SPAIN

CEFTIONIL 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Suspension for injection

Pigs

Spain

| Laboratorios Intervet, S.A. |
| --- |
| Polígono Industrial El Montalvo I |
| C/ Zeppelín no 6, parcela 39 |
| 37188- Carbajosa de la Sagrada (Salamanca) |
| SPAIN |

Laboratorios Intervet, S.A.

Polígono Industrial El Montalvo I

C/ Zeppelín no 6, parcela 39

37188- Carbajosa de la Sagrada (Salamanca)

SPAIN

COBACTAN 2,5 % P/V SUSPENSIÓN INYECTABLE PARA BOVINO Y PORCINO

cefquinoma

25 mg/ml

Suspension for injection

Cattle, pigs

Spain

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN LA 7,5 %

cefquinoma

75 mg/ml

Suspension for injection

Cattle

Spain

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

COBACTAN 4,5 % INYECTABLE PARA EQUINO Y BOVINO

Cefquinoma

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

Sweden

| Pfizer Oy, Animal Health |
| --- |
| Tietokuja 4 |
| FI-00330 Helsinki |
| FINLAND |

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel vet.®

ceftiofur sodium

1g and 4g

Powder for injection

Cattle

Sweden

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Ceftiofur N-vet

ceftiofur sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

Sweden

| Vetoquinol scandinavia AB |
| --- |
| Box 9 |
| SE-26521 Åstorp |
| SWEDEN |

Vetoquinol scandinavia AB

Box 9

SE-26521 Åstorp

SWEDEN

Ceftiocyl

ceftiofur hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Ceva Santé Animale B.V. |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

CEVAXEL 50 mg/ml poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

The Netherlands

Vétoquinol BV

Postbus 3191

NL-5203 DD

’s-Hertogenbosch

THE NETHERLANDS

CEFTIOCYL 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur as hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

READYCEF 50 mg/ml suspensie voor injectie voor varkens en runderen

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Ceva Santé Animale B.V. |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

CEVAXEL-RTU 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

THE NETHERLANDS

Ceftiosan, 50 mg/ml, suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Pigs weighing up to 125 kg.

Cattle

The Netherlands

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

EFICUR 50 mg/ml suspensie voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 Ld Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 Ld Capelle a/d Ijssel

THE NETHERLANDS

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| D-Vett. B.V. |
| --- |
| Gebroek 37 |
| 6043 GP Roermond |
| THE NETHERLANDS |

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

THE NETHERLANDS

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan LA 7,5 %

Cefquinome

75 mg/ml

Suspension for injection

Cattle

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan 4,5 %, poeder en oplosmiddel voor oplssing voor injectie.

Cefquinome

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal) and cattle (adult and calf)

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan IV 4,5 %

Cefquinome

45 mg/ml

Powder and solvent for solution for injection.

Horses (adult and foal)

The Netherlands

| Intervet Nederland B.V. |
| --- |
| Postbus 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

THE NETHERLANDS

Cobactan 2,5 % suspensie voor injectie voor rund en varken

Cefquinome

25 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| D-Vett. B.V. |
| --- |
| Gebroek 37 |
| 6043 GP Roermond |
| THE NETHERLANDS |

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

THE NETHERLANDS

Cobactan 2,5 % suspensie voor injectie voor rund en varken

Cefquinome

26 mg/ml

Suspension for injection

Cattle, pigs

The Netherlands

| Pfizer Animal Health B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

THE NETHERLANDS

Excenel

Ceftiofur

50 mg/ml

Powder for solution for injection.

Cattle, pigs

The Netherlands

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml, poeder en oplosmiddel voor oplossing voor injectie voor runderen en varkens

Ceftiofur

50 mg/ml

Powder and solvent for solution for injection.

Cattle, pigs

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan 2,5 % w/v suspension for injection for cattle and pigs

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan 25 mg/ml Suspension for Injection

Cefquinome (as sulfate)

25 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| THE NETHERLANDS |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

THE NETHERLANDS

Cobactan 4,5 % Powder and Solvent for Solution for Injection for Horse and Cattle

Cefquinome (as sulfate)

45 mg/ml

Powder and solvent for solution for injection

Cattle, horses

United Kingdom

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| UNITED KINGDOM |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

UNITED KINGDOM

Cobactan LA 7,5 % Suspension for Injection for Cattle

Cefquinome (as sulfate)

75 mg/ml

Suspension for injection

Cattle

United Kingdom

| Laboratorios SYVA S.A.U. |
| --- |
| Avda. Párroco Pablo Díez 49-57 |
| 24010 León |
| SPAIN |

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPAIN

Actionis 50 mg/ml Suspension for Injection for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| UNITED KINGDOM |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

UNITED KINGDOM

Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for Cattle, Pigs and Horses

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, horses, pigs

United Kingdom

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| UNITED KINGDOM |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

UNITED KINGDOM

Ceftiocyl 50 mg/ml Suspension for Injection for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| The Netherlands |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

The Netherlands

Ceftiosan 50 mg/ml Injectable Suspension for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| UNITED KINGDOM |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Cevaxel 50 mg/ml Powder and Solvent for Solution for Injection for Cattle and Pigs

Ceftiofur Sodium

50 mg/ml

Powder and solvent for solution for injection

Cattle, pigs

United Kingdom

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| UNITED KINGDOM |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Cevaxel - RTU

Ceftiofur Hydrochloride

No information provided

Suspension for injection

Cattle, pigs

United Kingdom

| Laboratorios Hipra S.A. |
| --- |
| Avenida la Selva 135 |
| 17 170, Amer (Girona) |
| SPAIN |

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPAIN

Eficur 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UNITED KINGDOM

Excenel RTU 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Laboratorios Calier S.A. |
| --- |
| Barcelones 26 (Pla del Ramassa) |
| ES 08520, Les Franqueses del Valles |
| SPAIN |

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPAIN

Readycef 50 mg/ml Suspension for Injection for Swine and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Continental Farmaceutica, S.L. |
| --- |
| Parque Empresarial La Moraleja |
| Avenida de Europa 20-B |
| E-28108 Madrid, Alcobendas |
| SPAIN |

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPAIN

Truleva RTU 50 mg/ml Suspension for Injection for Pigs and Cattle

Ceftiofur Hydrochloride

50 mg/ml

Suspension for injection

Cattle, pigs

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Powder for Solution for Injection for Cattle and Pigs

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Powder for solution for injection

Cattle, pigs

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| FR 06 516 Carros cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANCE

Virbacef Sterile Powder for Cattle, Pigs and Horses

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Powder for solution for injection

Cattle, horses, pigs

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | CSC Pharmaceuticals Handels GmbH |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Granulat

100 mg

Granules for oral suspension

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Suppositorien

100 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 200 mg - Suppositorien

200 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Tabletten

100 mg

Tablet

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 100 mg - Granulat

100 mg

Granules for oral suspension

Oral use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Mesulid 100 mg - Suppositorien

100 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 200 mg - Suppositorien

200 mg

Suppository

Rectal use

AT - Austria

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstädter Straße 395 b |
| A-1190 Wien |
| Austria |

CSC Pharmaceuticals Handels GmbH

Heiligenstädter Straße 395 b

A-1190 Wien

Austria

Mesulid 100 mg - Tabletten

100 mg

Tablet

Oral use

BG - Bulgaria

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 |
| 56010 PISA La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897

56010 PISA La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

BG - Bulgaria

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Coxtral

100 mg

Tablet

Oral use

BG - Bulgaria

| Actavis EAD |
| --- |
| 29 Atanas Dukov str. |
| 1407 Sofia |
| Bulgaria |

Actavis EAD

29 Atanas Dukov str.

1407 Sofia

Bulgaria

Enetra

100 mg

Tablet

Oral use

BG - Bulgaria

| Inbiotech Ltd |
| --- |
| 5A Triaditza str. |
| 1000 Sofia |
| Bulgaria |

Inbiotech Ltd

5A Triaditza str.

1000 Sofia

Bulgaria

Biolin

100 mg

Tablet

Oral use

BG - Bulgaria

| Sopharma AD |
| --- |
| 16 Iliensko shosse str. |
| 1220 Sofia |
| Bulgaria |

Sopharma AD

16 Iliensko shosse str.

1220 Sofia

Bulgaria

Ameolin

100 mg

Tablet

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Aulin

100 mg

Tablet

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Aulin

100 mg

Granules for oral suspension

Oral use

BG - Bulgaria

| CSC Pharmaceuticals Ltd-Bulgaria EOOD, |
| --- |
| 10 Assen Jordanov str., |
| 1592 Sofia, |
| Bulgaria |

CSC Pharmaceuticals Ltd-Bulgaria EOOD,

10 Assen Jordanov str.,

1592 Sofia,

Bulgaria

Nimed

100 mg

Tablet

Oral use

BG - Bulgaria

| Chaikapharma – Highquality medicines AD, |
| --- |
| 1 G.M.Dimitrov Blvd |
| 1172 Sofia, |
| Bulgaria |

Chaikapharma – Highquality medicines AD,

1 G.M.Dimitrov Blvd

1172 Sofia,

Bulgaria

AllGone

100 mg

Effervescent tablet

Oral use

CY - Cyprus

| CDL PHARMACEUTICAL LTD |
| --- |
| 5 Diomedous str. |
| P.O.Box 40981 |
| 6308 Larnaca |
| Cyprus |

CDL PHARMACEUTICAL LTD

5 Diomedous str.

P.O.Box 40981

6308 Larnaca

Cyprus

ELINAP TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| CHR. K. UNIMED LTD |
| --- |
| 21 Davlou |
| 2114 Aglantzia |
| Lefkosia |
| Cyprus |

CHR. K. UNIMED LTD

21 Davlou

2114 Aglantzia

Lefkosia

Cyprus

FLOGOSTOP TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| CODAL SYNTO LTD |
| --- |
| 33 Thekla Lysioti str. |
| Dorothea Building, 6th floor |
| P.O.Box 51785 |
| 3508 Lemessos |
| Cyprus |

CODAL SYNTO LTD

33 Thekla Lysioti str.

Dorothea Building, 6th floor

P.O.Box 51785

3508 Lemessos

Cyprus

NIMM TABLETS 100 mg

100 mg

Tablet

Oral use

CY - Cyprus

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos str. |
| P.O.Box 51409 |
| 3505 Lemessos |
| Cyprus |

MEDOCHEMIE LTD

1-10 Constantinoupoleos str.

P.O.Box 51409

3505 Lemessos

Cyprus

APONIL TABLETS 100 mg

100 mg

Tablet

Oral use

CZ - Czech Republic

| Laboratori Guidotti S.p.A (Menarini Group). |
| --- |
| Via Livornese 897 |
| 560 10 San Piero a Grado Pisa |
| Italy |

Laboratori Guidotti S.p.A (Menarini Group).

Via Livornese 897

560 10 San Piero a Grado Pisa

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Aulin

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Aulin

100 mg

Tablet

Oral use

CZ - Czech Republic

| Zentiva k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Prague |
| Czech Republic |

Zentiva k.s.

Evropská 846/176a

160 00 Prague

Czech Republic

COXTRAL 100 MG TABLETY

100 mg

Tablet

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

MESULID

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

MESULID

100 mg

Tablet

Oral use

CZ - Czech Republic

| Medicom International, s.r.o. |
| --- |
| Páteřní 1216/7 |
| 635 00 Brno |
| Czech Republic |

Medicom International, s.r.o.

Páteřní 1216/7

635 00 Brno

Czech Republic

Nimed

100 mg

Tablet

Oral use

EL - Greece

| ALET PHARMACEUTICALS |
| --- |
| M. Alexander 121 |
| Agia Varvara 12351 |
| Greece |

ALET PHARMACEUTICALS

M. Alexander 121

Agia Varvara 12351

Greece

SPECILID

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| Gerakas Attikis 153 44 |
| Greece |

ANFARM HELLAS S.A.

Perikleous 53-57

Gerakas Attikis 153 44

Greece

LEMESILIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANTONIOS POLYCHRONIS OF MARINOU |
| --- |
| Ethnikis Antistaseos 6A |
| Holargos 15562 |
| Greece |

ANTONIOS POLYCHRONIS OF MARINOU

Ethnikis Antistaseos 6A

Holargos 15562

Greece

OMNIBUS

100 MG/TAB

Tablet

Oral use

EL - Greece

| ANTOR EPE |
| --- |
| P. Mavromihali 1 |
| Vrilissia 15235 |
| Greece |

ANTOR EPE

P. Mavromihali 1

Vrilissia 15235

Greece

MELIMONT

100 MG/TAB

Tablet

Oral use

EL - Greece

| ARMEDICA A.E. |
| --- |
| Agias Markellis 17 |
| Athens 11855 |
| Greece |

ARMEDICA A.E.

Agias Markellis 17

Athens 11855

Greece

ALENCAST

100 MG/TAB

Tablet

Oral use

EL - Greece

| B.I. FARMA A.E. |
| --- |
| Aristotelous 73 |
| Athens 10434 |
| Greece |

B.I. FARMA A.E.

Aristotelous 73

Athens 10434

Greece

NIMESULIDE / B.I. FARMA

100 MG/TAB

Tablet

Oral use

EL - Greece

| BALU EPE |
| --- |
| 30 Km Athens-Lavrion |
| Markopoulo 19003 |
| Greece |

BALU EPE

30 Km Athens-Lavrion

Markopoulo 19003

Greece

NIBERAN

100 MG/TAB

Tablet

Oral use

EL - Greece

| BIOMEDICA-CHEMICA A.E. |
| --- |
| G. Lyra 25 |
| Kato Kifissia 14564 |
| Greece |

BIOMEDICA-CHEMICA A.E.

G. Lyra 25

Kato Kifissia 14564

Greece

NIMESULIDE / BIOMEDICA CHEMICA

100 MG/TAB

Tablet

Oral use

EL - Greece

| BIOSPRAY ABEE |
| --- |
| 18TH Km Marathonos Avenue |
| Pallini 15344 |
| Greece |

BIOSPRAY ABEE

18TH Km Marathonos Avenue

Pallini 15344

Greece

FLOGOSTOP

100 MG/TAB

Tablet

Oral use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

100 MG/TAB

Tablet

Oral use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| Ellinikou 2 |
| 167 77 Elliniko |
| Greece |

BOEHRINGER INGELHEIM HELLAS S.A.

Ellinikou 2

167 77 Elliniko

Greece

MESULID

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| BROS EPE |
| --- |
| Avgis & Gallinis 15 |
| N. Kifissia 14564 |
| Greece |

BROS EPE

Avgis & Gallinis 15

N. Kifissia 14564

Greece

DISCORID

100 MG/TAB

Tablet

Oral use

EL - Greece

| COUP ABEE |
| --- |
| Agias Varvaras 53-55 |
| Dafni, Athens 17235 |
| Greece |

COUP ABEE

Agias Varvaras 53-55

Dafni, Athens 17235

Greece

MELICAT

100 MG/TAB

Tablet

Oral use

EL - Greece

| DEMO ABEE |
| --- |
| 21ST Km National Highway Athens-Lamia 14565 |
| Greece |

DEMO ABEE

21ST Km National Highway Athens-Lamia 14565

Greece

RITAMINE

100 MG/TAB

Tablet

Oral use

EL - Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| Marathonos Avenue 95 |
| Pikermi 19009 |
| Greece |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

Marathonos Avenue 95

Pikermi 19009

Greece

ROLAKET

100 MG/TAB

Tablet

Oral use

EL - Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| Marathonos Avenue 95 |
| Pikermi 19009 |
| Greece |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

Marathonos Avenue 95

Pikermi 19009

Greece

ROLAKET

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| EVAGGELOS KALOFOLIAS & SIA O.E. |
| --- |
| Menandrou 54 |
| Athens 10431 |
| Greece |

EVAGGELOS KALOFOLIAS & SIA O.E.

Menandrou 54

Athens 10431

Greece

ALGOVER

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMANIC CHEMIPHARMA S.A. |
| --- |
| Fylis 137 |
| Kamatero Attikis 13451 |
| Greece |

FARMANIC CHEMIPHARMA S.A.

Fylis 137

Kamatero Attikis 13451

Greece

CHEMISULIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMEDIA A.E. |
| --- |
| Athinas 22 & Apollonos |
| Gerakas Attikis 15344 |
| Greece |

FARMEDIA A.E.

Athinas 22 & Apollonos

Gerakas Attikis 15344

Greece

MULTIFORMIL

100 MG/TAB

Tablet

Oral use

EL - Greece

| FARMILIA E.E. |
| --- |
| Favierou 48 |
| Athens 10438 |
| Greece |

FARMILIA E.E.

Favierou 48

Athens 10438

Greece

AUROMELID

100 MG/TAB

Tablet

Oral use

EL - Greece

| FINIXFARM EPE |
| --- |
| Dervenakion 38 & Sahini |
| Gerakas 15344 |
| Greece |

FINIXFARM EPE

Dervenakion 38 & Sahini

Gerakas 15344

Greece

KARTAL

100 MG/TAB

Tablet

Oral use

EL - Greece

| GENEPHARM A.E. |
| --- |
| 18th Km Marathonos Avenue |
| Pallini Attikis 15351 |
| Greece |

GENEPHARM A.E.

18th Km Marathonos Avenue

Pallini Attikis 15351

Greece

NIMELIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| HELP ABEE |
| --- |
| Valaoritou 10 |
| Metamorfosi Attikis 14452 |
| Greece |

HELP ABEE

Valaoritou 10

Metamorfosi Attikis 14452

Greece

MOSUOLIT

100 MG/TAB

Tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Effervescent tablet

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| INTERMED ABEE |
| --- |
| Kalyftaki 27 |
| Athens 14564 |
| Greece |

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

200 MG/SUPP

Suppository

Rectal use

EL - Greece

| KLEVA EPE |
| --- |
| Parnithos Avenue 189 |
| Aharnai Attikis 13671 |
| Greece |

KLEVA EPE

Parnithos Avenue 189

Aharnai Attikis 13671

Greece

ELINAP

100 MG/TAB

Tablet

Oral use

EL - Greece

| LAVIPHARM HELLAS A.E. |
| --- |
| Agias Marinas |
| Paiania Attikis 19002 |
| Greece |

LAVIPHARM HELLAS A.E.

Agias Marinas

Paiania Attikis 19002

Greece

AULIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| LEOVAN, M. LEWN & SIA EE |
| --- |
| Argonafton 22 |
| Argyroupoli 16452 |
| Greece |

LEOVAN, M. LEWN & SIA EE

Argonafton 22

Argyroupoli 16452

Greece

RISTOLZIT

100 MG/TAB

Tablet

Oral use

EL - Greece

| MEDARTE PHARMACEUTICLS ABEE |
| --- |
| Spyrou Vretou 10 |
| Metamorfosi 14452 |
| Greece |

MEDARTE PHARMACEUTICLS ABEE

Spyrou Vretou 10

Metamorfosi 14452

Greece

MESILEX

100 MG/TAB

Tablet

Oral use

EL - Greece

| MEDICHROM A.E. |
| --- |
| 6 Km Markopoulou-Koropi Avenue |
| Markopoulo Mesogeion 19003 |
| Greece |

MEDICHROM A.E.

6 Km Markopoulou-Koropi Avenue

Markopoulo Mesogeion 19003

Greece

NIMESUL

100 MG/TAB

Tablet

Oral use

EL - Greece

| MED-ONE S.A., HELLAS |
| --- |
| Parnithos Avenue 211 |
| Aharnai 13671 |
| Greece |

MED-ONE S.A., HELLAS

Parnithos Avenue 211

Aharnai 13671

Greece

ALGOSULID

100 MG/TAB

Tablet

Oral use

EL - Greece

| MINERVA PHARMAKEFTIKI A.E. |
| --- |
| Kifissou Avenue 132 |
| Peristeri 12131 |
| Greece |

MINERVA PHARMAKEFTIKI A.E.

Kifissou Avenue 132

Peristeri 12131

Greece

MIN-A-PON

100 MG/TAB

Tablet

Oral use

EL - Greece

| NORMA HELLAS A.E. |
| --- |
| Menandrou 54 |
| Athens 10431 |
| Greece |

NORMA HELLAS A.E.

Menandrou 54

Athens 10431

Greece

MYXINA

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| Dilou 9 |
| Peristeri Attikis 12134 |
| Greece |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

Dilou 9

Peristeri Attikis 12134

Greece

FLADALGIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| Paster 6 |
| Ampelokipoi 11521 |
| Greece |

PHARMACYPRIA HELLAS A.E.

Paster 6

Ampelokipoi 11521

Greece

LALIDE

100 MG/TAB

Tablet

Oral use

EL - Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| Paster 6 |
| Ampelokipoi 11521 |
| Greece |

PHARMACYPRIA HELLAS A.E.

Paster 6

Ampelokipoi 11521

Greece

LALIDE

50 MG/5ML

Oral suspension

Oral use

EL - Greece

| PHARMATHEN INTERNATIONAL S.A. GREECE, |
| --- |
| Dervenakion 4 |
| Pallini Attikis 15351 |
| Greece |

PHARMATHEN INTERNATIONAL S.A. GREECE,

Dervenakion 4

Pallini Attikis 15351

Greece

BIOXIDOL

100 MG/TAB

Tablet

Oral use

EL - Greece

| RAFARM AEBE |
| --- |
| Korintou 12 |
| N. Psychiko 15451 |
| Greece |

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/TAB

Tablet

Oral use

EL - Greece

| RAFARM AEBE |
| --- |
| Korintou 12 |
| N. Psychiko 15451 |
| Greece |

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/SACHET

Granules for oral solution

Oral use

EL - Greece

| REMEDINA ABEE |
| --- |
| Gounari 25 & Areos |
| Kamatero Attikis 13451 |
| Greece |

REMEDINA ABEE

Gounari 25 & Areos

Kamatero Attikis 13451

Greece

AMOCETIN

100 MG/TAB

Tablet

Oral use

EL - Greece

| REMEK PHARMACEUTICALS ABEE |
| --- |
| Pentelis 34 |
| Palaio Faliro Attikis 17564 |
| Greece |

REMEK PHARMACEUTICALS ABEE

Pentelis 34

Palaio Faliro Attikis 17564

Greece

MESUPON

100 MG/TAB

Tablet

Oral use

EL - Greece

| S.J.A. PHARM O.E. |
| --- |
| Arkoleon 11 |
| Kato Patissia 10445 |
| Greece |

S.J.A. PHARM O.E.

Arkoleon 11

Kato Patissia 10445

Greece

CLIOVYL

100 MG/TAB

Tablet

Oral use

EL - Greece

| VELKA HELLAS AEBE |
| --- |
| Kapodistriou & Korinthou 12 |
| Neo Psychiko 15451 |
| Greece |

VELKA HELLAS AEBE

Kapodistriou & Korinthou 12

Neo Psychiko 15451

Greece

NAOFID

100 MG/TAB

Tablet

Oral use

EL - Greece

| VIOFAR EPE |
| --- |
| Ethnikis Antistaseos & Trifyllias |
| Aharnai 13671 |
| Greece |

VIOFAR EPE

Ethnikis Antistaseos & Trifyllias

Aharnai 13671

Greece

VOLONTEN

100 MG/TAB

Tablet

Oral use

EL - Greece

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| Gounari 150 |
| Glyfada 16674 |
| Greece |

VOCATE PHARMAKEFTIKI A.E.

Gounari 150

Glyfada 16674

Greece

TRANZICALM

100 MG/TAB

Tablet

Oral use

ES - Spain

| HELSINN BIREX PHARMACEUTICALS LTD. |
| --- |
| Damastown Mulhuddart |
| County Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS LTD.

Damastown Mulhuddart

County Dublin 15

Ireland

GUAXAN 100 mg comprimidos

100 mg

Tablet

Oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arenas |
| 455, promenade des Anglais |
| 06299 NICE Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arenas

455, promenade des Anglais

06299 NICE Cedex 03

France

NIMESULIDE CEHEL PHARMA

100 mg

Tablet

Oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| "Le Quintet" - Bâtiment A |
| 12, rue Danjou |
| 92517 BOULOGNE BILLANCOURT Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - Bâtiment A

12, rue Danjou

92517 BOULOGNE BILLANCOURT Cedex

France

NIMESULIDE EG

100 mg

Tablet

Oral use

FR - France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Tablet

Oral use

FR - France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Granules for oral solution in sachet

Oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 PARIS LA DEFENSE Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 PARIS LA DEFENSE Cedex

France

NIMESULIDE TEVA

100 mg

Tablet

Oral use

FR - France

| THERABEL LUCIEN PHARMA |
| --- |
| 19 rue Alphonse de Neuville |
| 75017 PARIS |
| France |

THERABEL LUCIEN PHARMA

19 rue Alphonse de Neuville

75017 PARIS

France

NEXEN

100 mg

Tablet

Oral use

FR - France

| THERABEL LUCIEN PHARMA |
| --- |
| 19 rue Alphonse de Neuville |
| 75017 PARIS |
| France |

THERABEL LUCIEN PHARMA

19 rue Alphonse de Neuville

75017 PARIS

France

NEXEN

100 mg

Granules for oral solution in sachet

Oral use

HU - Hungary

| Eurodrug Lab. BV |
| --- |
| Laan Copes van Cattenbruch 74. |
| 2585 GD, The Hague, |
| The Netherlands |

Eurodrug Lab. BV

Laan Copes van Cattenbruch 74.

2585 GD, The Hague,

The Netherlands

Nidol

100mg

Tablet

Oral use

HU - Hungary

| Lab. Guidotti S.p.A. |
| --- |
| Via Livornese 897 |
| 56010 San Piero a Grado, PISA |
| Italy |

Lab. Guidotti S.p.A.

Via Livornese 897

56010 San Piero a Grado, PISA

Italy

Xilox

50 mg/g

Granules for oral suspension

Oral use

HU - Hungary

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720, Pécsvárad |
| Hungary |

PannonPharma Kft.

Pannonpharma út 1.

7720, Pécsvárad

Hungary

Nimelid

100 mg

Tablet

Oral use

HU - Hungary

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

100 mg

Tablet

Oral use

HU - Hungary

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

50 mg/g

Granules

Oral use

IT - Italy

| Actavis Group PTC EHF |
| --- |
| Reykjavikurvegi 76-78 |
| Hafnarf Joerdur |
| Iceland |

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Granules

Oral use

IT - Italy

| Actavis Group PTC EHF |
| --- |
| Reykjavikurvegi 76-78 |
| Hafnarf Joerdur |
| Iceland |

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Tablet

Oral use

IT - Italy

| Aesculapius Farmaceutici Srl |
| --- |
| Via Cozzaglio, 24 |
| 25125 Brescia |
| Italy |

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Tablet

Oral use

IT - Italy

| Aesculapius Farmaceutici Srl |
| --- |
| Via Cozzaglio, 24 |
| 25125 Brescia |
| Italy |

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Agips Farmaceutici Srl |
| --- |
| Via Amendola, 4 |
| 16035 Rapallo (GE) |
| Italy |

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Agips Farmaceutici Srl |
| --- |
| Via Amendola, 4 |
| 16035 Rapallo (GE) |
| Italy |

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Tablet

Oral use

IT - Italy

| Almus Srl |
| --- |
| Via Cesarea, 11/10 |
| 16121 Genova |
| Italy |

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Tablet

Oral use

IT - Italy

| Almus Srl |
| --- |
| Via Cesarea, 11/10 |
| 16121 Genova |
| Italy |

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Angenerico Spa |
| --- |
| Via Nocera Umbra, 75 |
| 00181 Roma |
| Italy |

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Angenerico Spa |
| --- |
| Via Nocera Umbra, 75 |
| 00181 Roma |
| Italy |

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

200 mg

Suppository

Rectal use

IT - Italy

| Aurobindo Pharma Italia Srl |
| --- |
| Vicolo San Giovanni sul Muro, 9 |
| 20121 Milano |
| Italy |

Aurobindo Pharma Italia Srl

Vicolo San Giovanni sul Muro, 9

20121 Milano

Italy

ORONIME

100 mg

Orodispersible tablet

Oral use

IT - Italy

| C.T.Laboratorio Farmaceutico Srl |
| --- |
| Villa Sayonara - Strada Solaro, 75/77 |
| 18038 Sanremo (IM) |
| Italy |

C.T.Laboratorio Farmaceutico Srl

Villa Sayonara - Strada Solaro, 75/77

18038 Sanremo (IM)

Italy

FLOLID

100 mg

Tablet

Oral use

IT - Italy

| C.T.Laboratorio Farmaceutico Srl |
| --- |
| Villa Sayonara - Strada Solaro, 75/77 |
| 18038 Sanremo (IM) |
| Italy |

C.T.Laboratorio Farmaceutico Srl

Villa Sayonara - Strada Solaro, 75/77

18038 Sanremo (IM)

Italy

FLOLID

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 Milano |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 Milano |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Tablet

Oral use

IT - Italy

| Dorom Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Dorom Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE DOROM

100 mg

Powder for oral solution

Oral use

IT - Italy

| Dr Reddy's Srl |
| --- |
| Via Fernanda Wittengs, 3 |
| 20123 Milano |
| Italy |

Dr Reddy's Srl

Via Fernanda Wittengs, 3

20123 Milano

Italy

NIMESULIDE DR REDDY'S

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

100 mg

Tablet

Oral use

IT - Italy

| Ecobi Farmaceutici sas |
| --- |
| Via E. Bazzano, 26 |
| 16019 Ronco Scrivia (GE) |
| Italy |

Ecobi Farmaceutici sas

Via E. Bazzano, 26

16019 Ronco Scrivia (GE)

Italy

AREUMA

200 mg

Suppository

Rectal use

IT - Italy

| Eg S.p.A. |
| --- |
| Via Domenico Scarlatti, 31 |
| 20124 Milano |
| Italy |

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italy

NIMESULIDE EG

100 mg

Tablet

Oral use

IT - Italy

| Eg S.p.A. |
| --- |
| Via Domenico Scarlatti, 31 |
| 20124 Milano |
| Italy |

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italy

NIMESULIDE EG

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Farmac.Caber Spa |
| --- |
| Viale Città D'Europa, 681 |
| 00144 Roma |
| Italy |

Farmac.Caber Spa

Viale Città D'Europa, 681

00144 Roma

Italy

NIMS

100 mg

Granules

Oral use

IT - Italy

| Farmac.Damor Spa |
| --- |
| Via Emilio Scaglione, 27 |
| 80145 Napoli |
| Italy |

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Powder for oral suspension

Oral use

IT - Italy

| Farmac.Damor Spa |
| --- |
| Via Emilio Scaglione, 27 |
| 80145 Napoli |
| Italy |

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Tablet

Oral use

IT - Italy

| Benedetti & Co spa |
| --- |
| Via Bolognese, 250 |
| 51020 Pistoia |
| Italy |

Benedetti & Co spa

Via Bolognese, 250

51020 Pistoia

Italy

NIMESULIDE Benedetti & Co

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Francia Farmac.Ind.Far.Bio.Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 Milano |
| Italy |

Francia Farmac.Ind.Far.Bio.Srl

Via dei Pestagalli, 7

20138 Milano

Italy

ALGIMESIL

100 mg

Tablet

Oral use

IT - Italy

| Francia Farmac.Ind.Far.Bio.Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 Milano |
| Italy |

Francia Farmac.Ind.Far.Bio.Srl

Via dei Pestagalli, 7

20138 Milano

Italy

ALGIMESIL

100 mg

Granules

Oral use

IT - Italy

| Germed Pharma Spa |
| --- |
| Via Cesare Cantù, 11 |
| 20092 Cinisello Balsamo (Milano) |
| Italy |

Germed Pharma Spa

Via Cesare Cantù, 11

20092 Cinisello Balsamo (Milano)

Italy

NIMESULIDE GERMED

100 mg

Tablet

Oral use

IT - Italy

| Germed Pharma Spa |
| --- |
| Via Cesare Cantù, 11 |
| 20092 Cinisello Balsamo (Milano) |
| Italy |

Germed Pharma Spa

Via Cesare Cantù, 11

20092 Cinisello Balsamo (Milano)

Italy

NIMESULIDE GERMED

100 mg

Granules

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Tablet

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

200 mg

Suppository

Rectal use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID FAST

400 mg

Granules

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Tablet

Oral use

IT - Italy

| Helsinn Birex Pharmac.Ltd |
| --- |
| Mulhuddart, 15 |
| Damastown - Dublin |
| Ireland |

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

200 mg

Suppository

Rectal use

IT - Italy

| Hexal Spa |
| --- |
| Largo Boccioni 1 |
| 21040 Origgio Varese |
| Italy |

Hexal Spa

Largo Boccioni 1

21040 Origgio Varese

Italy

NIMESULIDE HEXAL

100 mg

Tablet

Oral use

IT - Italy

| I.B.N. Savio Srl |
| --- |
| Via E. Bazzano, 14 |
| 16019 Ronco Scrivia (GE) |
| Italy |

I.B.N. Savio Srl

Via E. Bazzano, 14

16019 Ronco Scrivia (GE)

Italy

EUDOLENE

100 mg

Granules

Oral use

IT - Italy

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italy |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

NIMEDEX

400 mg

Granules for oral suspension

Oral use

IT - Italy

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italy |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

NIMEDEX

400 mg

Tablet

Oral use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

200 mg

Suppository

Rectal use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Lab.Guidotti Spa |
| --- |
| Via Livornese, 897 |
| 56010 La Vettola - Pisa |
| Italy |

Lab.Guidotti Spa

Via Livornese, 897

56010 La Vettola - Pisa

Italy

NIMESULENE

100 mg

Tablet

Oral use

IT - Italy

| Laboratori Alter Srl |
| --- |
| Via Egadi, 7 |
| 20144 Milano |
| Italy |

Laboratori Alter Srl

Via Egadi, 7

20144 Milano

Italy

NIMESULIDE ALTER

100 mg

Granules

Oral use

IT - Italy

| Crinos spa |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Tablet

Oral use

IT - Italy

| Crinos spa |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Levofarma Srl |
| --- |
| Via Conforti, 42 |
| 84083 Castel San Giorgio (Salerno) |
| Italy |

Levofarma Srl

Via Conforti, 42

84083 Castel San Giorgio (Salerno)

Italy

NOALGOS

100 mg

Granules

Oral use

IT - Italy

| Magis Farmaceutici Spa |
| --- |
| Via Cacciamali, 34-36-38/B |
| 25125 Brescia |
| Italy |

Magis Farmaceutici Spa

Via Cacciamali, 34-36-38/B

25125 Brescia

Italy

ISODOL

100 mg

Tablet

Oral use

IT - Italy

| Magis Farmaceutici Spa |
| --- |
| Via Cacciamali, 34-36-38/B |
| 25125 Brescia |
| Italy |

Magis Farmaceutici Spa

Via Cacciamali, 34-36-38/B

25125 Brescia

Italy

ISODOL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| MDM Spa |
| --- |
| Viale Papiniano, 22/B |
| 20100 Milano |
| Italy |

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Granules for oral suspension

Oral use

IT - Italy

| MDM Spa |
| --- |
| Viale Papiniano, 22/B |
| 20100 Milano |
| Italy |

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Tablet

Oral use

IT - Italy

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D-83607 Holzkirchen – |
| Germany |

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D-83607 Holzkirchen – |
| Germany |

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Tablet

Oral use

IT - Italy

| Mylan Spa |
| --- |
| Via Vittor Pisani, 20 |
| 20124 Milano |
| Italy |

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Mylan Spa |
| --- |
| Via Vittor Pisani, 20 |
| 20124 Milano |
| Italy |

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Tablet

Oral use

IT - Italy

| New Research Srl |
| --- |
| Via della Tenuta di Torrenova, 142 |
| 00133 Roma |
| Italy |

New Research Srl

Via della Tenuta di Torrenova, 142

00133 Roma

Italy

NERELID

100 mg

Capsule

Oral use

IT - Italy

| New Research Srl |
| --- |
| Via della Tenuta di Torrenova, 142 |
| 00133 Roma |
| Italy |

New Research Srl

Via della Tenuta di Torrenova, 142

00133 Roma

Italy

NERELID

100 mg

Granules

Oral use

IT - Italy

| Pantafarm Srl |
| --- |
| Via Palestro, 14 |
| 00185 Roma |
| Italy |

Pantafarm Srl

Via Palestro, 14

00185 Roma

Italy

PANTAMES

100 mg

Orodispersible tablet

Oral use

IT - Italy

| Pensa Pharma Spa |
| --- |
| Via Rosellini Ippolito, 12 |
| 20124 Milano |
| Italy |

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Pensa Pharma Spa |
| --- |
| Via Rosellini Ippolito, 12 |
| 20124 Milano |
| Italy |

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Tablet

Oral use

IT - Italy

| Ranbaxy Italia Spa |
| --- |
| Piazza Filippo Meda, 3 |
| 20121 Milano |
| Italy |

Ranbaxy Italia Spa

Piazza Filippo Meda, 3

20121 Milano

Italy

NIMESULIDE RANBAXY

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Tablet

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arcostrasse, 2 |
| ULM D-89070 |
| Germany |

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Effervescent tablet

Oral use

IT - Italy

| Sandoz Spa |
| --- |
| Largo U. Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Capsule

Oral use

IT - Italy

| Sandoz Spa |
| --- |
| Largo U. Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Granules

Oral use

IT - Italy

| Sarda Pharmaceutica Srl |
| --- |
| Via Castiglione, 92/B |
| 09100 Cagliari |
| Italy |

Sarda Pharmaceutica Srl

Via Castiglione, 92/B

09100 Cagliari

Italy

DIMESUL

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Selvi Laboratorio Bioterapico Spa |
| --- |
| Via Procoio, 28 |
| 0065 Fiano Romano (Roma) |
| Italy |

Selvi Laboratorio Bioterapico Spa

Via Procoio, 28

0065 Fiano Romano (Roma)

Italy

ANTALGO

100 mg

Granules

Oral use

IT - Italy

| SIAR Pharma Srl |
| --- |
| Via Verdi, 33 |
| 20060 Bussero (MI) |
| Italy |

SIAR Pharma Srl

Via Verdi, 33

20060 Bussero (MI)

Italy

ALGOLIDER

100 mg

Granules for oral suspension

Oral use

IT - Italy

| So.Se.Pharm Srl |
| --- |
| Via dei Castelli Romani, 22 |
| 00040 Pomezia (Roma) |
| Italy |

So.Se.Pharm Srl

Via dei Castelli Romani, 22

00040 Pomezia (Roma)

Italy

DOMES

100 mg

Granules for oral suspension

Oral use

IT - Italy

| So.Se.Pharm Srl |
| --- |
| Via dei Castelli Romani, 22 |
| 00040 Pomezia (Roma) |
| Italy |

So.Se.Pharm Srl

Via dei Castelli Romani, 22

00040 Pomezia (Roma)

Italy

DOMES

100 mg

Orodispersible tablet

Oral use

IT - Italy

| Sofar Spa |
| --- |
| Via Isonzo, 8 |
| 20100 Milano |
| Italy |

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Tablet

Oral use

IT - Italy

| Sofar Spa |
| --- |
| Via Isonzo, 8 |
| 20100 Milano |
| Italy |

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Tablet

Oral use

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Union Health Srl |
| --- |
| Via Roccamandolfi, 1 |
| 00156 Roma |
| Italy |

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Tablet

Oral use

IT - Italy

| Union Health Srl |
| --- |
| Via Roccamandolfi, 1 |
| 00156 Roma |
| Italy |

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Granules for oral suspension

Oral use

IT - Italy

| Piam Farmaceutici Spa |
| --- |
| Via Padre G. Semeria, 5 |
| 16131 Genova |
| Italy |

Piam Farmaceutici Spa

Via Padre G. Semeria, 5

16131 Genova

Italy

REMOV

100 mg

Tablet

Oral use

IT - Italy

| Piam Farmaceutici Spa |
| --- |
| Via Padre G. Semeria, 5 |
| 16131 Genova |
| Italy |

Piam Farmaceutici Spa

Via Padre G. Semeria, 5

16131 Genova

Italy

REMOV

100 mg

Granules

Oral use

LT - Lithuania

| Helsinn Birex Pharmaceuticals Ltd. |
| --- |
| Damastown Mulhuddart |
| Dublin 15 |
| Ireland |

Helsinn Birex Pharmaceuticals Ltd.

Damastown Mulhuddart

Dublin 15

Ireland

Mesulid

100 mg

Tablet

Oral use

LT - Lithuania

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 |
| Pisa-La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897

Pisa-La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

LT - Lithuania

| Medochemie Ltd. |
| --- |
| P.O. Box 51409 |
| Limassol, CY-3505 |
| Cyprus |

Medochemie Ltd.

P.O. Box 51409

Limassol, CY-3505

Cyprus

Apronil

100 mg

Tablet

Oral use

LT - Lithuania

| Zentiva k.s. |
| --- |
| U Kabelovny 130, |
| 102 37, Prague 10, |
| Dolni Mecholupy |
| Czech Republic |

Zentiva k.s.

U Kabelovny 130,

102 37, Prague 10,

Dolni Mecholupy

Czech Republic

Coxtral

100 mg

Tablet

Oral use

LV - Latvia

| Helsinn Birex Pharmaceutical Ltd. |
| --- |
| Damastown, Mulhuddart |
| Dublin-15 |
| Ireland |

Helsinn Birex Pharmaceutical Ltd.

Damastown, Mulhuddart

Dublin-15

Ireland

Mesulid 100 mg tabletes

100 mg

Tablet

Oral use

LV - Latvia

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 – |
| 56010 Pisa – La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 –

56010 Pisa – La Vettola

Italy

Nimesil 100 mg granulas iekšķīgi lietojamās suspensijas pagatavošanai

100 mg

Granules for oral suspension

Oral use

LV - Latvia

| Medochemie Ltd. |
| --- |
| Constantinoupoleos Str. 1-10 |
| Limassol, CY–3011 |
| Cyprus |

Medochemie Ltd.

Constantinoupoleos Str. 1-10

Limassol, CY–3011

Cyprus

Aponil 100 mg tabletes

100 mg

Tablet

Oral use

LV - Latvia

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| Dolni Mecholupy |
| Praha 10, CZ-10237 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

Dolni Mecholupy

Praha 10, CZ-10237

Czech Republic

Coxtral 100 mg tabletes

100 mg

Tablet

Oral use

MT - Malta

| VECCHI & C. PIAM s.a.p.a. |
| --- |
| Via Padre G. Semeria, |
| 5 - 16131 Genova |
| Italy |

VECCHI & C. PIAM s.a.p.a.

Via Padre G. Semeria,

5 - 16131 Genova

Italy

Remov

100 mg

Tablet

Oral use

MT - Malta

| VECCHI & C. PIAM s.a.p.a. |
| --- |
| Via Padre G. Semeria, |
| 5 - 16131 Genova |
| Italy |

VECCHI & C. PIAM s.a.p.a.

Via Padre G. Semeria,

5 - 16131 Genova

Italy

Remov

100 mg/sachet

Granules for oral suspension

Oral use

PL - Poland

| Laboratori Guidotti S.p.A. (Menarini Group) |
| --- |
| Via Livornese 897 |
| I-56010, Piza |
| Italy |

Laboratori Guidotti S.p.A. (Menarini Group)

Via Livornese 897

I-56010, Piza

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

PL - Poland

| Medicom International s.r.o. |
| --- |
| Paterni 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Paterni 7

635 00, Brno

Czech Republic

Aulin

100 mg

Granules for oral suspension

Oral use

PL - Poland

| Medicom International s.r.o. |
| --- |
| Paterni 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Paterni 7

635 00, Brno

Czech Republic

Aulin

100 mg

Tablet

Oral use

PL - Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| Marszałka J. Piłsudskiego 5, |
| 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Marszałka J. Piłsudskiego 5,

95-200 Pabianice

Poland

Minesulin

100 mg

Powder for oral suspension

Oral use

PL - Poland

| Pabianickie Zakłady Farmaceutyczne Polfa S.A. |
| --- |
| Marszałka J. Piłsudskiego 5, |
| 95-200 Pabianice |
| Poland |

Pabianickie Zakłady Farmaceutyczne Polfa S.A.

Marszałka J. Piłsudskiego 5,

95-200 Pabianice

Poland

Minesulin

100 mg

Tablet

Oral use

PL - Poland

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva a.s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

Coxtral

100 mg

Tablet

Oral use

PT - Portugal

| Alter, S.A. |
| --- |
| Estrada Marco do Grilo - Zemouto |
| 2830-000 Coina |
| Portugal |

Alter, S.A.

Estrada Marco do Grilo - Zemouto

2830-000 Coina

Portugal

Nimesulida Alter

100 mg

Tablet

Oral use

PT - Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1499-040 Cruz Quebrada – Dafundo |
| Portugal |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1499-040 Cruz Quebrada – Dafundo

Portugal

Aulin

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1499-040 Cruz Quebrada – Dafundo |
| Portugal |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1499-040 Cruz Quebrada – Dafundo

Portugal

Aulin

100 mg

Tablet

Oral use

PT - Portugal

| Arrowblue Produtos Farmacêuticos S.A. |
| --- |
| Av. D. João II, |
| 10 Esqo - Torre Fernão de Magalhães |
| 1998-025 Lisboa |
| Portugal |

Arrowblue Produtos Farmacêuticos S.A.

Av. D. João II,

10 Esqo - Torre Fernão de Magalhães

1998-025 Lisboa

Portugal

Nimesulida Arrowblue

100 mg

Tablet

Oral use

PT - Portugal

| Baldacci - Portugal, S.A. |
| --- |
| Rua Cândido de Figueiredo, 84-B |
| 1549-005 Lisboa |
| Portugal |

Baldacci - Portugal, S.A.

Rua Cândido de Figueiredo, 84-B

1549-005 Lisboa

Portugal

Nimesulida Baldacci

100 mg

Tablet

Oral use

PT - Portugal

| Bluepharma Genéricos - Comércio de Medicamentos, S.A. |
| --- |
| São Martinho do Bispo |
| 3045-016 Coimbra |
| Portugal |

Bluepharma Genéricos - Comércio de Medicamentos, S.A.

São Martinho do Bispo

3045-016 Coimbra

Portugal

Nimesulida Bluepharma

100 mg

Tablet

Oral use

PT - Portugal

| Ciclum Farma Unipessoal, Lda. Quinta da Fonte, |
| --- |
| Rua Vitor Câmara, 2 – |
| Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda. Quinta da Fonte,

Rua Vitor Câmara, 2 –

Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Nimesulida Ciclum

100 mg

Tablet

Oral use

PT - Portugal

| Cinfa Portugal, Lda. |
| --- |
| Av. Tomás Ribeiro, 43 - Bloco 1, 4o B – |
| Edifício Neopark |
| 2790-221 Carnaxide |
| Portugal |

Cinfa Portugal, Lda.

Av. Tomás Ribeiro, 43 - Bloco 1, 4o B –

Edifício Neopark

2790-221 Carnaxide

Portugal

Nimesulida Cinfa

100 mg

Tablet

Oral use

PT - Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, |
| --- |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2,

Abrunheira

2710-089 Sintra

Portugal

Nimesulida Farmoz

100 mg

Coated tablet

Oral use

PT - Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| PORTUGAL |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

PORTUGAL

Nimesulida Generis

100 mg

Tablet

Oral use

PT - Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Rua João de Deus, 19 |
| 2700-487 Amadora |
| PORTUGAL |

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

PORTUGAL

Nimesulida Generis

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 – 1o Dto – |
| Edifício Monsanto |
| 2790-012 Portela de Carnaxide |
| Portugal |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 – 1o Dto –

Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Nimesulida Germed

100 mg

Tablet

Oral use

PT - Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 – 1o Dto – |
| Edifício Monsanto |
| 2790-012 Portela de Carnaxide |
| Portugal |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 – 1o Dto –

Edifício Monsanto

2790-012 Portela de Carnaxide

Portugal

Nimesulida Germed

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| GP - genéricos portugueses, Lda. |
| --- |
| Rua Henrique Paiva Couceiro, 29 – |
| Venda Nova |
| 2700-451 Amadora |
| Portugal |

GP - genéricos portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 –

Venda Nova

2700-451 Amadora

Portugal

Nimesulida GP

100 mg

Tablet

Oral use

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 32 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 32

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Tablet

Oral use

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 32 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 32

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Nimesulida Labesfal

100 mg

Tablet

Oral use

PT - Portugal

| Labesfal - Laboratórios Almiro, S.A. |
| --- |
| Zona Industrial do Lagedo |
| 3465-157 Santiago de Besteiros |
| Portugal |

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Nimesulida Labesfal

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratori Guidotti, S.p.A. |
| --- |
| Via Livornese, 897 |
| I-56010 La Vettola – Pisa |
| Italy |

Laboratori Guidotti, S.p.A.

Via Livornese, 897

I-56010 La Vettola – Pisa

Italy

Nimesulene

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratórios Basi - Indústria Farmacêutica, S.A. |
| --- |
| Rua do Padrão, 98 |
| 3000-312 Coimbra |
| Portugal |

Laboratórios Basi - Indústria Farmacêutica, S.A.

Rua do Padrão, 98

3000-312 Coimbra

Portugal

Nimesulida Basi

100 mg

Tablet

Oral use

PT - Portugal

| Laboratórios Basi - Indústria Farmacêutica, S.A. |
| --- |
| Rua do Padrão, 98 |
| 3000-312 Coimbra |
| Portugal |

Laboratórios Basi - Indústria Farmacêutica, S.A.

Rua do Padrão, 98

3000-312 Coimbra

Portugal

Nimesulida Basi

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira – |
| Edifício 1 - 2o I - Sintra Business Park |
| 2710-089 Sintra |
| Portugal |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira –

Edifício 1 - 2o I - Sintra Business Park

2710-089 Sintra

Portugal

Nimesulida Inibsa

100 mg

Tablet

Oral use

PT - Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira – |
| Edifício 1 - 2o I - Sintra Business Park |
| 2710-089 Sintra |
| Portugal |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira –

Edifício 1 - 2o I - Sintra Business Park

2710-089 Sintra

Portugal

Nimesulida Inibsa

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Mer Medicamentos, Lda. |
| --- |
| Rua João deDeus,19 |
| Venda Nova |
| 2700-487 Amadora |
| Portugal |

Mer Medicamentos, Lda.

Rua João deDeus,19

Venda Nova

2700-487 Amadora

Portugal

Nimesulida Mer

100 mg

Tablet

Oral use

PT - Portugal

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, |
| Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges,

Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés

Portugal

Nimesulida Mylan

100 mg

Tablet

Oral use

PT - Portugal

| Mylan, Lda. |
| --- |
| Rua Doutor António Loureiro Borges, |
| Edíficio Arquiparque 1, R/C Esqo |
| 1499-016 Algés |
| Portugal |

Mylan, Lda.

Rua Doutor António Loureiro Borges,

Edíficio Arquiparque 1, R/C Esqo

1499-016 Algés

Portugal

Nimesulida Mylan

100 mg

Granules for oral solution

Oral use

PT - Portugal

| Almus,Lda. |
| --- |
| Rua Engenheiro Ferreira Dias, |
| 728, 3o Piso Sul |
| 4149-014 Porto |
| Portugal |

Almus,Lda.

Rua Engenheiro Ferreira Dias,

728, 3o Piso Sul

4149-014 Porto

Portugal

Nimesulida Almus

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. |
| --- |
| Edifício Atlas II, |
| Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31 |
| 1495-139 Miraflores – Algés |
| Portugal |

Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda.

Edifício Atlas II,

Av. José Gomes Ferreira, N.o 11 - 3o, Sala 31

1495-139 Miraflores – Algés

Portugal

Nimesulida Pharmakern

100 mg

Tablet

Oral use

PT - Portugal

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Edifício Botânico |
| Rua do Campo Alegre |
| 1306-5o-sala 501 |
| 4150-174 Porto |
| Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Edifício Botânico

Rua do Campo Alegre

1306-5o-sala 501

4150-174 Porto

Portugal

Nimesulida Ranbaxy

100 mg

Tablet

Oral use

PT - Portugal

| Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. |
| --- |
| Edifício Botânico |
| Rua do Campo Alegre |
| 1306-5o-sala 501 |
| 4150-174 Porto |
| Portugal |

Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.

Edifício Botânico

Rua do Campo Alegre

1306-5o-sala 501

4150-174 Porto

Portugal

Nimesulida Ranbaxy

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro – |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro –

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Nimesulida Ratiopharm

100 mg

Tablet

Oral use

PT - Portugal

| Rega Farma - Promoção de Produtos Farmacêuticos, |
| --- |
| S.A. Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |
| Portugal |

Rega Farma - Promoção de Produtos Farmacêuticos,

S.A. Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Portugal

Donulide

100 mg

Tablet

Oral use

PT - Portugal

| Rega Farma - Promoção de Produtos Farmacêuticos, S.A. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |
| Portugal |

Rega Farma - Promoção de Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Portugal

Donulide

100 mg

Granules for oral suspension

Oral use

PT - Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - |
| Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o -

Escritório 15

2710-693 Sintra

Portugal

Nimesulida Sandoz

100 mg

Tablet

Oral use

PT - Portugal

| Helsinn Birex Pharmaceuticals, Ltd |
| --- |
| Damastown-Mulhuddart |
| 15 Dublin |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals, Ltd

Damastown-Mulhuddart

15 Dublin

Republic of Ireland

Nimed

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Helsinn Birex Pharmaceuticals, Ltd |
| --- |
| Damastown-Mulhuddart |
| 15 Dublin |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals, Ltd

Damastown-Mulhuddart

15 Dublin

Republic of Ireland

Nimed

100 mg

Granules for oral solution

Oral use

PT - Portugal

| APceuticals-Farmacêutica, Lda |
| --- |
| Av Aida, Edif. Garden-Bloco 9, Lj 910 |
| 2765-187 Estoril |
| Portugal |

APceuticals-Farmacêutica, Lda

Av Aida, Edif. Garden-Bloco 9, Lj 910

2765-187 Estoril

Portugal

Nimesulida APceuticals

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 – Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2 – Abrunheira

2710-089 Sintra

Portugal

Nimesulida Neuride

100 mg

Film-coated tablet

Oral use

PT - Portugal

| Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso, |
| --- |
| Amoreiras |
| 1070-274 Lisboa |
| Portugal |

Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso,

Amoreiras

1070-274 Lisboa

Portugal

Nimesulida Wynn

100 mg

Tablet

Oral use

RO - Romania

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| 153 44 Gerakas Attikis |
| Greece |

ANFARM HELLAS S.A.

Perikleous 53-57

153 44 Gerakas Attikis

Greece

LEMESIL, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| CSC PHARMACEUTICALS HANDELS GmbH |
| --- |
| Gewerbestrasse 18-20 |
| Gewerbegebiet Klein-Engersdorf |
| A-2102 Bisamberg |
| Austria |

CSC PHARMACEUTICALS HANDELS GmbH

Gewerbestrasse 18-20

Gewerbegebiet Klein-Engersdorf

A-2102 Bisamberg

Austria

AULIN, granule pentru suspensie orală, 100 mg/plic

100 mg/sachet

Granules for oral suspension

oral use

RO - Romania

| CSC PHARMACEUTICALS HANDELS GmbH |
| --- |
| Gewerbestrasse 18-20 |
| Gewerbegebiet Klein-Engersdorf |
| A-2102 Bisamberg |
| Austria |

CSC PHARMACEUTICALS HANDELS GmbH

Gewerbestrasse 18-20

Gewerbegebiet Klein-Engersdorf

A-2102 Bisamberg

Austria

AULIN 100 mg,

100 mg

Tablet

Oral use

RO - Romania

| Dr. REDDY’S LABORATORIES ROMÂNIA S.R.L, |
| --- |
| Str. Nicolae Caramfil nr. 71-73, et. 5 spațiul 10, sector 1, |
| București |
| Romania |

Dr. REDDY’S LABORATORIES ROMÂNIA S.R.L,

Str. Nicolae Caramfil nr. 71-73, et. 5 spațiul 10, sector 1,

București

Romania

NISE 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| LABORATORI GUIDOTTI SpA |
| --- |
| Via Livornese, 897 |
| 56010 Pisa-La Vettola |
| Italy |

LABORATORI GUIDOTTI SpA

Via Livornese, 897

56010 Pisa-La Vettola

Italy

NIMESIL, granule pentru suspensie orală, 100 mg

100 mg/sachet

Granules for oral suspension

oral use

RO - Romania

| MEDOCHEMIE LTD. - CYPRUS, |
| --- |
| P.O. Box 51409 |
| Limassol |
| Cyprus |

MEDOCHEMIE LTD. - CYPRUS,

P.O. Box 51409

Limassol

Cyprus

APONIL, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu, Nr. 31, Sector 2, |
| București, |
| Romania |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu, Nr. 31, Sector 2,

București,

Romania

NIMESULID ARENA 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. FARMEX COMPANY SRL |
| --- |
| Str.Drumul Potcoavei nr. 30, Pipera |
| Voluntari, Jud. Ilfov, |
| Romania |

S.C. FARMEX COMPANY SRL

Str.Drumul Potcoavei nr. 30, Pipera

Voluntari, Jud. Ilfov,

Romania

NIMESULID FARMEX 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. LABORMED PHARMA S.A. |
| --- |
| B-dul Theodor Pallady nr. 44B sector 3, |
| Bucuresti |
| Romania |

S.C. LABORMED PHARMA S.A.

B-dul Theodor Pallady nr. 44B sector 3,

Bucuresti

Romania

NIMESULID LPH 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. MAGISTRA C&C S.R.L. |
| --- |
| B-dul Aurel Vlaicu nr. 82 A, |
| Constanța |
| Romania |

S.C. MAGISTRA C&C S.R.L.

B-dul Aurel Vlaicu nr. 82 A,

Constanța

Romania

NIMESULID 100 mg, comprimate

100 mg

Tablet

Oral use

RO - Romania

| S.C. SLAVIA PHARM SRL |
| --- |
| Str. Știrbei Vodă nr. 53-55 sector 1, |
| București |
| Romania |

S.C. SLAVIA PHARM SRL

Str. Știrbei Vodă nr. 53-55 sector 1,

București

Romania

NIMESULID SLAVIA, comprimate, 100 mg

100 mg

Tablet

Oral use

RO - Romania

| Zentiva k.s., |
| --- |
| U kabelovny 130, |
| Dolní Měcholupy |
| 102 37, Praha 10, |
| Czech Republic |

Zentiva k.s.,

U kabelovny 130,

Dolní Měcholupy

102 37, Praha 10,

Czech Republic

COXTRAL, comprimate, 100 mg

100 mg

Tablet

Oral use

SI - Slovenia

| CSC Pharma d.o.o. |
| --- |
| Jana Husa 1a |
| SI-1000 Ljubljana |
| Slovenia |

CSC Pharma d.o.o.

Jana Husa 1a

SI-1000 Ljubljana

Slovenia

Aulin 100 mg tablete

100 mg

Tablet

Oral use

SI - Slovenia

| CSC Pharma d.o.o. |
| --- |
| Jana Husa 1a |
| SI-1000 Ljubljana |
| Slovenia |

CSC Pharma d.o.o.

Jana Husa 1a

SI-1000 Ljubljana

Slovenia

Aulin 100 mg zrnca za peroralno suspenzijo

100 mg

Granules for oral suspension

oral use

SK - Slovakia

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 |
| 56010 Pisa - La Vettola |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897

56010 Pisa - La Vettola

Italy

Nimesil

100 mg

Granules for oral suspension

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

AULIN 100 mg granulát

100 mg

Granules for oral solution

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

AULIN 100 mg tablety

100 mg

Tablet

Oral use

SK - Slovakia

| Medicom International s.r.o. |
| --- |
| Páteřní 7 |
| 635 00, Brno |
| Czech Republic |

Medicom International s.r.o.

Páteřní 7

635 00, Brno

Czech Republic

NIMED

100 mg

Tablet

Oral use

SK - Slovakia

| Zentiva k.s., |
| --- |
| Evropská 846/176a, |
| 160 00, Praha |
| Czech Republic |

Zentiva k.s.,

Evropská 846/176a,

160 00, Praha

Czech Republic

COXTRAL

100 mg

Tablet

Oral use

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