# Den Europæiske Unions C 78/2012

| | ISSN 1977-0871
  doi:10.3000/19770871.C_2012.078.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 78 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 55. årgang16. marts 2012 |

ISSN 1977-0871

doi:10.3000/19770871.C_2012.078.dan

Den Europæiske Unions

Tidende

C 78

Dansk udgave

Meddelelser og oplysninger

55. årgang16. marts 2012

---

| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2012/C 078/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2012/C 078/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 10 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2012/C 078/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2012/C 078/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

10

| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 16.3.2012 | DA | Den Europæiske Unions Tidende | C 78/1 |
| --- | --- | --- | --- |

16.3.2012

DA

Den Europæiske Unions Tidende

C 78/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1)
  )

2012/C 78/01

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2012 | Efavirenz Teva | efavirenz | Teva Pharma BV |
| Computerweg 10, |
| 3542 DR Utrecht, |
| Nederland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

9.1.2012

Efavirenz Teva

efavirenz

Teva Pharma BV

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/742/001-010

Filmovertrukket tablet

J05AG03

11.1.2012

13.1.2012

Desloratadine Actavis

desloratadin

| 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

Filmovertrukket tablet

R06AX27

17.1.2012

13.1.2012

Desloratadine ratiopharm

desloratadin

| 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

Filmovertrukket 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

Koncentrat till infusionsvaeske, opløsning

L01CD02

2.2.2012

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Afslået

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 20.1.2012 | Luveniq | Lux Biosciences GmbH |
| MlawGroup, |
| Maximilianstr. 31, |
| D-80539 Munich, |
| Deutschland. |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

20.1.2012

Luveniq

Lux Biosciences GmbH

MlawGroup,

Maximilianstr. 31,

D-80539 Munich,

Deutschland.

24.1.2012

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 9.1.2012 | Inovelon | Eisai Limited |
| European Knowledge Centre, |
| Mosquito Way, Hatfield, |
| Hertfordshire, |
| AL10 9SN, |
| United Kingdom |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (2)
  ): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2012 | Activyl Tick Plus | Indoxacarb + permethrin | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

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, opløsning

QP53AC54

11.1.2012

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 9.1.2012 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, |
| 17170- Amer (Girona), |
| España |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.2004, s. 1.

(2)  EUT L 136 af 30.4.2004, s. 1.

---

| 16.3.2012 | DA | Den Europæiske Unions Tidende | C 78/10 |
| --- | --- | --- | --- |

16.3.2012

DA

Den Europæiske Unions Tidende

C 78/10

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. januar 2012 til 31. januar 2012

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
   (1)
  eller artikel 38 i direktiv 2001/82/EF
   (2)
  )

2012/C 78/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 13.1.2012 | Cephalosporins | Se bilaget I | Se bilaget I | 18.1.2012 |
| 20.1.2012 | Nimesulide | Se bilaget II | Se bilaget II | 23.1.2012 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

13.1.2012

Cephalosporins

Se bilaget I

Se bilaget I

18.1.2012

20.1.2012

Nimesulide

Se bilaget II

Se bilaget II

23.1.2012

---

(1)  EUT L 311 af 28.11.2001, s. 67.

(2)  EUT L 311 af 28.11.2001, s. 1.

---

BILAG I

LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, AKTIVE STOFFER, STYRKER, DYREARTER, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat EU/EØS | Ansøger/indehaver af markedsføringstilladelse | Navn | Aktivt stof | Styrke | Lægemiddelform | Dyreart |
| --- | --- | --- | --- | --- | --- | --- |
| Østrig | Intervet GmbH |
| Siemensstraße 107 |
| 1210 Wien |
| ØSTRIG |

Medlemsstat EU/EØS

Ansøger/indehaver af markedsføringstilladelse

Navn

Aktivt stof

Styrke

Lægemiddelform

Dyreart

Østrig

Intervet GmbH

Siemensstraße 107

1210 Wien

ØSTRIG

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

Cefquinome

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Intervet GmbH

Siemensstraße 107

1210 Wien

ØSTRIG

COBACTAN LA 7,5 % - Injektionssupension für Rinder

Cefquinome

75 mg/ml

Injektionsvæske, suspension

Kvæg

Østrig

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

Intervet GmbH

Siemensstraße 107

1210 Wien

ØSTRIG

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

Cefquinome

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste

Østrig

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Østrig

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

Vetoquinol Österreich GmbH

Zehetnergasse 24

1140 Wien

ØSTRIG

Ceftiocyl 50 mg/ml, Injektionssuspension für Rinder und Schweine

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Østrig

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL RTU 50 mg/ml Injektionssuspensiuon für Rinder und Schweine

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

ØSTRIG

Excenel - Pulver zur Herstellung einer Injektionslösung für Tiere

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Østrig

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

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

ØSTRIG

Excenel RTU 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

READYCEF 50 mg/ml Injektionssuspension für Schweine und Rinder

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Østrig

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef Pulver zur Herstellung einer Injektionslösung für Rinder und Schweine

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Belgien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 4,5 %

Cefquinome (as sulfate)

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste (voksne og føl) og (voksne og kalve)

Belgien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Belgien

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

ACTIONIS 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Belgien

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

VETOQUINOL N.V./S.A.

Kontichsesteenweg 42

2630 Aartselaar

BELGIEN

CEFTIOCYL 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

CEFTIOSAN

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Svin, der vejer op til 125 kg.

Kvæg

Belgien

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

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIEN

CEVAXEL 50MG/ML

Ceftiofur (as sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Belgien

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

CEVA Santé Animale NV/SA

Metrologielaan 6

1130 Brussel

BELGIEN

CEVAXEL-RTU 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50 MG/ML

Ceftiofur (as sodium)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIEN

EXCENEL

Ceftiofur (as sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Belgien

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

Pfizer Animal Health s.a.

Rue Laid Burniat 1

B-1348 Louvain La Neuve

BELGIEN

EXCENEL RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

READYCEF 50 MG/ML

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

TRULEVA RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Belgien

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

VIRBACEF Poudre pour solution injectable pour bovins et porcins

Ceftiofur (as sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Bulgarien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Bulgarien

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

Ceva Animal Health Bulgaria EOOD

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

1113 Sofia

BULGARIEN

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Bulgarien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Ефикур 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Bulgarien

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

Цефтиозан 50 мг/мл инжекционна суспензия за свине и говеда

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Bulgarien

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

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

NEDERLANDENE

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

Ceftiofur

50 mg/kg

Injektionsvæske, suspension

Kvæg, svin

Bulgarien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Кобактан ЛА 7,5 % инжективна суспензия за говеда

Cefquinome

75 mg/ml

Injektionsvæske, suspension

Kvæg

Bulgarien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Кобактан 2,5 %

Cefquinome

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Cypern

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Cypern

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Eficur 50 mg/ml ενέσιμο διάλυμα για χοίρους και βοοειδή

Ceftiofur (as hydrochloride)

50 mg/ml

Suspension til injektion

Kvæg, svin

Cypern

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Suspension til injektion

Kvæg

Cypern

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Den Tjekkiske Republik

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Den Tjekkiske Republik

| Vetoquinol s.r.o. |
| --- |
| Zámečnická 411 |
| CZ - 288 02 Nymburk |
| DEN TJEKKISKE REPUBLIK |

Vetoquinol s.r.o.

Zámečnická 411

CZ - 288 02 Nymburk

DEN TJEKKISKE REPUBLIK

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

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Den Tjekkiske Republik

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

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

Ceftiofurum (ut Ceftiofuri hydrochloridum)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Den Tjekkiske Republik

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

Ceftiofurum (ut natricum)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Den Tjekkiske Republik

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

50 mg/ml suspension for injection for pigs and cattle

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Den Tjekkiske Republik

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| DEN TJEKKISKE REPUBLIK |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

DEN TJEKKISKE REPUBLIK

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

Ceftiofurum (ut natricum)

50 mg/ml

Frysetørret pulver til injektionsvæske, opløsning

Kvæg, svin og heste

Den Tjekkiske Republik

| Pfizer s.r.o. |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| DEN TJEKKISKE REPUBLIK |

Pfizer s.r.o.

Stroupežnického 17

150 00 Praha 5

DEN TJEKKISKE REPUBLIK

EXCENEL RTU inj

Ceftiofurum (ut hydrochloridum)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Den Tjekkiske Republik

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef powder for solution for injection for cattle and pigs

Ceftiofurum (ut Ceftiofurum natricum)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Den Tjekkiske Republik

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 2,5 % inj

Cefquinomum (ut sulfas)

25 mg/ml

Injektionsvæske

Kvæg, svin

Den Tjekkiske Republik

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinomum (ut sulfas)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Danmark

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan Vet.

cefquinome

75 mg/ml

Injektionsvæske, opløsning, suspension

Kvæg

Danmark

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan Vet.

cefquinome

25 mg/ml

Injektionsvæske, opløsning, suspension

Kvæg, svin

Danmark

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan Vet.

cefquinome

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste

Danmark

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

Vetoquinol scandinavia AB

Torggatan 2

Box 9

SE-26521 Åstorp

SVERIGE

Ceftiocyl

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Danmark

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Eficur Vet.

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Danmark

| 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

Injektionsvæske, opløsning, suspension

Kvæg, svin

Danmark

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

Ceftiosan

Ceftiofur

50 mg/ml

Injektionsvæske, opløsning, suspension

Kvæg, svin

Danmark

| 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

Pulver til injektionsvæske, opløsning

Kvæg, svin

Danmark

| 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

Pulver til injektionsvæske, opløsning

Kvæg, svin

Estland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

Ceftiosan 50mg/ml

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

Cevaxel

Ceftiofur (as sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Estland

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

Cevaxel-RTU

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 2,5 %

Cefquinome (as sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 %

Cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Estland

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

Ceftiomax

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Eficur

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

Cefenil

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Estland

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

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

Rijksweg 12

B-2870 Puurs

BELGIEN

Excenel RTU

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Estland

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

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANKRIG

Ceftiocyl

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Finland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL VET 50 mg/ml

Ceftiofurum natricum

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Frankrig

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

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANKRIG

EXCENEL 1 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

Frankrig

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

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANKRIG

EXCENEL 4 G

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

Frankrig

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

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANKRIG

COBACTAN 2,5 %

Cefquinome (sous forme de sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin og kalve

Frankrig

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

PFIZER HOLDING France

23/25 Avenue du Docteur Lannelongue

75014 Paris

FRANKRIG

EXCENEL RTU

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 %

Cefquinome (sous forme de sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Frankrig

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN IV IM 4,5 %

Cefquinome (sous forme de sulfate)

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste

Frankrig

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Frankrig

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

INTERVET

Rue Olivier De Serres

Angers Technopole

49070 Beaucouze

FRANKRIG

COBACTAN 4,5 % PS

Cefquinome (sous forme de sulfate)

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste

Frankrig

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL 50 MG/ML

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Frankrig

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

VIRBACEF POUDRE POUR SOLUTION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de sel de sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Frankrig

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

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANKRIG

CEFTIOCYL 50 MG/ML SUSPENSION INJECTABLE POUR BOVINS ET PORCINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

READYCEF 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

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

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

CEFTIOSAN 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

ACTIONIS 50 MG/ML SUSPENSION INJECTABLE POUR PORCINS ET BOVINS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Frankrig

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

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPANIEN

CEMAY 50 MG/ML SUSPENSION INJECTABLE POUR PORCS

Ceftiofur (sous forme de chlorhydrate)

50 mg/ml

Injektionsvæske, suspension

Svin

Tyskland

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

Actionis 50 mg/ml Injektionssuspension

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

TYSKLAND

CEVAXEL-RTU

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

TYSKLAND

Cobactan LA 7,5 %

cefquinome sulfate

75 mg/ml

Injektionsvæske, suspension

Kvæg

Tyskland

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

Laboratorios Maymó S.A.

Calle Ferro 9, Poligono Industrial Can Pelegri

E-08755 Castellbisbal (Barcelona)

SPANIEN

CEMAY 50 mg/ml

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Svin

Tyskland

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

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

TYSKLAND

Cobactan 2,5 %

cefquinome sulfate

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

Vetoquinol GmbH

Parkstr. 10

D-88212 Ravensburg

TYSKLAND

CEFTIOCYL

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

Cefenil 50 mg/ml

ceftiofur sodium

50 mg/ml

Pulver og solvens til rekonstitution

Kvæg, svin

Tyskland

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

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

TYSKLAND

Cobactan 4,5 %

cefquinome sulfate

45 mg/ml

Pulver og solvens til rekonstitution

Kvæg, heste

Tyskland

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

Readycef 50 mg/ml Injektionssuspension für Schweine und Rinder

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

CEVA Tiergesundheit GmbH

Kanzlerstr. 4

D-40472 Düsseldorf

TYSKLAND

CEVAXEL 50 mg/ml

ceftiofur sodium

50 mg/ml

Pulver og solvens til rekonstitution

Kvæg, svin

Tyskland

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

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

TYSKLAND

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

cefquinome sulfate

45 mg/ml

Pulver og solvens til rekonstitution

Heste

Tyskland

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

TYSKLAND

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

ceftiofur sodium

50 mg/ml

Pulver

Kvæg, svin

Tyskland

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

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

TYSKLAND

Excenel 4g

ceftiofur sodium

50 mg/ml

Pulver

Kvæg, svin

Tyskland

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

Pfizer GmbH

Linkstr. 10

D-10785 Berlin

TYSKLAND

Excenel RTU

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Tyskland

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

Truleva RTU

ceftiofur HCl

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Grækenland

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

INTERVET HELLAS AE

63 Ag Dimitriou Str, Alimos

174 55 Athens

GRÆKENLAND

COBACTAN

Cefquinome sulphate

25 mg/ml

Opløsning til injektion

Kvæg, svin

Grækenland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 4,5 %

Cefquinome sulphate

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste, føl, kvæg og kalve

Grækenland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA

Cefquinome sulphate

75 mg/ml

Injektionsvæske, suspension

Kvæg

Grækenland

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

CEVA HELLAS

15 Ag. Nikolaou

17455 Alimos

GRÆKENLAND

CEVAXEL

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Grækenland

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

CEVA HELLAS

15 Ag. Nikolaou

17455 Alimos

GRÆKENLAND

CEVAXEL-RTU, for cattle and pigs

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Grækenland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Grækenland

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

VIRBACEF σκόνη για ενέσιμο διάλυμα για βοοειδή και χοίρους

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Grækenland

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

READYCEF

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Grækenland

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

PFIZER HELLAS AE

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GRÆKENLAND

EXCENEL

CEFTIOFUR

50 mg/ml

Pulver til injektionsvæske

Kvæg, svin

Grækenland

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

PFIZER HELLAS AE

243 Messogeion Ave.

Neo Psychiko

GR-154 51

GRÆKENLAND

EXCENEL PTU

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Grækenland

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Ungarn

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

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

UNGARN

Excenel SP injekció

Ceftiofur Sodium

50 mg/ml

Sterilt pulver til injektionsvæske

Vand til parenteral brug

Kvæg, svin

Ungarn

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

Pfizer Co. Ltd.

Budapest

Alkotás u. 54.

H-1123

UNGARN

Excenel RTU injekció

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske

Kvæg, svin

Ungarn

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 2,5 % injekció

Cefquinom sulphate

25 mg/ml

Injektionsvæske

Kvæg, svin

Ungarn

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan IV 4,5 % injekció

Cefquinom sulphate

45 mg/ml

Injektionsvæske

Kvæg, heste

Ungarn

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 % injekció

Cefquinom sulphate

75 mg/ml

Injektionsvæske

Kvæg

Ungarn

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

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

UNGARN

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske

Kvæg, svin

Ungarn

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

Ceva Phylaxia Co. Ltd.

Budapest

Szállás u. 5.

H-1107

UNGARN

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

Ceftiofur Sodium

50 mg/ml

Sterilt pulver til injektionsvæske

Vand til parenteral brug

Kvæg, svin

Ungarn

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

Ceftiomax 50 mg/ml injekció sertés és szarvasmarha részére

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske

Kvæg, svin

Ungarn

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

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANKRIG

Ceftiocyl 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske

Kvæg, svin

Ungarn

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Eficur 50 mg/ml injekció szarvasmarhák és sertések részére

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske

Kvæg, svin

Island

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

Eficur vet.

Ceftiofurum INN

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Irland

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

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRLAND

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

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Irland

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

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRLAND

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Irland

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

Pfizer Healthcare Ireland (Trading as Pfizer Animal Health)

Ringaskiddy Co. Cork

IRLAND

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Irland

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Svin, kvæg

Irland

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef Powder for Solution for Injection for cattle and pigs.

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Irland

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| DET FORENEDE KONGERIGE |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

DET FORENEDE KONGERIGE

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

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Irland

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Irland

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

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRLAND

Cobactan 2,5 % w/v Suspension for Injection

Cefquinome sulfate

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Irland

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

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRLAND

Cobactan LA 7,5 % suspension for injection for cattle

Cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Irland

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

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

IRLAND

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

Cefquinome (as sulfate)

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste (voksne og føl), kvæg (voksne og kalve)

Irland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Svin, der vejer op til 125 kg.

Kvæg

Irland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Italien

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Vetoquinol S.A.

Magny-Vernois

70200 Lure

FRANKRIG

CEFTIOCYL

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

CEFTIOMAX

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

CEFTIOSAN

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPANIEN

CEMAY

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Svin

Italien

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

ACTIONIS

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Ceva Vetem SpA

Via Colleoni 15

20041 Agrate Brianza (MB)

ITALIEN

CEVAXEL

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL RTU

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALIEN

EXCENEL

Sodium ceftiofur

50 mg/ml

Pulver til injektionsvæske

Kvæg, svin, heste

Italien

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

PFIZER ITALIA SRL

Via Valbondione, 113

00188 Roma

ITALIEN

EXCENEL RTU

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Fatro Spa

Via Emilia 285

40064 Ozzano Dell'Emilia (BO)

ITALIEN

WONDERCEF

Ceftiofur sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Italien

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

TRULEVA

Ceftiofur chlorhidrate

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

INTERVET ITALIA SRL

Via Nettunense Km 20,300.

04011 Aprilia (LT)

ITALIEN

COBACTAN

Cefquinome sulphate

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Italien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN IV IM 4,5 %

Cefquinome sulphate

Ingen tilgængelige oplysninger

Injektionsvæske, suspension

Kvæg, heste

Italien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 %

Cefquinome sulphate

Ingen tilgængelige oplysninger

Injektionsvæske, suspension

Kvæg

Letland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

Cefenil

ceftiofur sodium

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Letland

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL

ceftiofur sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Letland

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

Ceftiomax

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Letland

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

Cevaxel-RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Letland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 2,5 %

cefquinome

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Letland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 %

cefquinome

75 mg/ml

Injektionsvæske, suspension

Kvæg

Letland

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

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIEN

Excenel RTU

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Letland

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

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIEN

Excenel Sterile Powder

ceftiofur sodium

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Letland

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Letland

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

Ceftiosan

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 2,5 %, injekcinė suspensija

Cefquinome (as sulphate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 %, injekcinė suspensija

Cefquinome (as sulphate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Litauen

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

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

Rijksweg 12

B-2870 Puurs

BELGIEN

EXCENEL, milteliai injekciniam tirpalui ruošti

Ceftiofur (as sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin, en dag gamle kyllinger

Litauen

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

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

Rijksweg 12

B-2870 Puurs

BELGIEN

EXCENEL RTU, injekcinė suspensija

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50 mg/ml injekcinė ceftiofuro suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

Ceftiofur (as sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Litauen

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL RTU, injekcinė suspensija

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur (as sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Litauen

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

Ceftiomax 50 mg/ml injekcinė suspensija kiaulėms ir galvijams

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

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

Interchemie werken "De Adelaar" BV

Horsterweg 26A

5811 AC Castenray

NEDERLANDENE

CEFTIONEL-50, injekcinė suspensija galvijams ir kiaulėms

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Litauen

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Svin, der vejer op til 125 kg, kvæg

Polen

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

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLEN

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

Ceftiofurum

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

Polen

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

Pfizer Trading Polska Sp. z o.o.

ul. Rzymowskiego 34

02-697 Warszawa

POLEN

Excenel RTU

Ceftiofurum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Polen

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

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

Ceftiofuri hydrochloridum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Polen

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

Ceva Animal Health Polska Sp. z o.o.

ul. Okrzei 1A

03-715 Warszawa

POLEN

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

Ceftiofurum

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Polen

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

Ceftiofurum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Polen

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofurum natricum

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Polen

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

Vetoquinol Biowet Sp. z o.o

ul. Kosynierów Gdyńskich 13-14

66-400 Gorzów Wielkopolski

POLEN

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

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Polen

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

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

Cefquinomum

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Polen

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

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

Cefquinomum

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste

Polen

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan LA 7,5 % zawiesina do wstrzykiwań dla bydła

Cefquinomum

75 mg/ml

Injektionsvæske, suspension

Kvæg

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Portugal

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef Pó para solução injectável para bovinos e suínos

Ceftiofur (as ceftiofur sodium)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

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

Injektionsvæske, suspension

Kvæg, svin

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

Injektionsvæske, suspension.

Kvæg, svin

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

Injektionsvæske, suspension

Kvæg, svin

Portugal

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50 mg/ml suspensão injectável para suínos e bovinos

Ceftiofur (as Ceftiofur Hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

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

Injektionsvæske, suspension

Kvæg

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

Pulver og solvens til injektionsvæske, opløsning

Heste (voksne og føl), kvæg (voksne og kalve)

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

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

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

Injektionsvæske, suspension

Kvæg, svin

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

Injektionsvæske, suspension

Kvæg, svin

Portugal

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

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

Ceftiofur (as ceftiofur hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Portugal

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

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPANIEN

CEMAY 50 mg/ml, suspension for injection for pigs

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske suspension

Svin

Portugal

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

Ceftiofur (as hydrochloride)

50 mg/ml

Injektionsvæske, suspension

Svin, der vejer op til 125 kg. Kvæg

Rumænien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 2,5 %

Cefquinome

25 mg/ml

Suspension til injektion

Kvæg, malkekøer, kalve, svin, smågrise

Rumænien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 7,5 % L.A.

Cefquinome

75 mg/ml

Suspension til injektion

Kvæg

Rumænien

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

DET FORENEDE KONGERIGE

EXCENEL RTU

Ceftiofur

50 mg/ml

Suspension til injektion

Kvæg, svin

Rumænien

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

Pfizer Animal Health

Boulevard de la Paine 17

B-1050 Brussels

BELGIEN

EXCENEL

Ceftiofur

50 mg/ml.

Sterilt pulver

Kvæg, svin

Rumænien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR 50mg/ml

Ceftiofur

50 mg/ml

Oliesuspension

Kvæg, svin

Rumænien

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

CEFENIL 50 m

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Rumænien

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

CEVAXEL 50mg/ml

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste, svin

Rumænien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

CEFTIOMAX 50mg/ml

Ceftiofur

50 mg/ml

Suspension til injektion

Kvæg, svin

Slovakiet

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6J |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6J

DET FORENEDE KONGERIGE

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

ceftiofurum

50 mg/ml

Pulver + fortyndingsmiddel

Kvæg, svin

Slovakiet

| Vetoquinol s.r.o. |
| --- |
| Zámečnícka 411 |
| CZ-288 02 Nymburk |
| DEN TJEKKISKE REPUBLIK |

Vetoquinol s.r.o.

Zámečnícka 411

CZ-288 02 Nymburk

DEN TJEKKISKE REPUBLIK

Ceftiocyl 50 mg/ml injekčná suspenzia

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovakiet

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

ceftiofurum

50 mg/ml

Pulver + fortyndingsmiddel

Kvæg, svin

Slovakiet

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

ceftiofurum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovakiet

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

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

Rijksweg 12

B-2870 Puurs

BELGIEN

Excenel 50 mg/ml lyofilizát na prípravu injekčného roztoku

ceftiofurum

50 mg/ml

Lyofilisat

Kvæg, svin, en dag gamle kyllinger, heste

Slovakiet

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

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

Rijksweg 12

B-2870 Puurs

BELGIEN

Excenel RTU 50 mg/ml injekčná suspenzia

ceftiofurum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovakiet

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

Cobactan 25 mg/ ml injekčná suspenzia

cefquinomum

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovakiet

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

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

cefquinomum

75 mg/ml

Injektionsvæske, suspension

Kvæg

Slovakiet

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef prášok na prípravu injekčného roztoku pre hovädzí dobytok a ošípané

Ceftiofurum (ut natricum)

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Slovakiet

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

Ceva Sante Animale

10 avenue de la Ballastiere

33500 Libourne

FRANKRIG

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

ceftiofurum

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovenien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 2,5 %

cefquinome (as sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovenien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 % suspenzija za injiciranje za govedo

cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Slovenien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Slovenien

| 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

Pulver til injektionsvæske, opløsning

Kvæg, svin

Slovenien

| 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

Injektionsvæske, suspension

Kvæg, svin

Spanien

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPANIEN

EXCENEL

Ceftiofur

50 mg/ml

Sterilt pulver til opløsning i sterilt bakteriostatisk vand

Kvæg, svin

Spanien

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

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPANIEN

CEVAXEL 50 mg/ml

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Spanien

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Spanien

PFIZER, S.A.

Avda. de Europa, 20 B.

Parque Empresarial

28108 La Moraleja

SPANIEN

EXCENEL RTU

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Svin

Spanien

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

EFICUR

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

CEFTIOMAX 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y VACUNO

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Vetoquinol Especialidades Veterinarias, S.A.

Autovia Fuencarral-Alcobendas km 15

700-Edificio Europa I, Portal 3, 2o5

28108 Alcobendas.

SPANIEN

CEFTIOCYL 50 mg/ml SUSPENSION INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12

5a planta

08017 Barcelona

SPANIEN

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

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Procedure curretly ongoing

ceftiofur

50 mg/ml

Injektionsvæske, opløsning

Kvæg, svin

Spanien

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

ACTIONIS 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO Y BOVINO

ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Laboratorios Maymó, S.A.

Vía Augusta, 302

08017. Barcelona

SPANIEN

CEMAY 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Svin

Spanien

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

Laboratorios E Industrias Iven, S.A.

Luis I, 56.

Polígono Industrial Vallecas

28031 Madrid

SPANIEN

CEFTIONIL 50 mg/ml SUSPENSIÓN INYECTABLE PARA PORCINO

ceftiofur

50 mg/ml

Injektionsvæske, suspension

Svin

Spanien

| Laboratorios Intervet, S.A. |
| --- |
| Polígono Industrial El Montalvo I |
| C/ Zeppelín no6, parcela 39 |
| 37188- Carbajosa de la Sagrada (Salamanca) |
| SPANIEN |

Laboratorios Intervet, S.A.

Polígono Industrial El Montalvo I

C/ Zeppelín no6, parcela 39

37188- Carbajosa de la Sagrada (Salamanca)

SPANIEN

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

cefquinoma

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Spanien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN LA 7,5 %

cefquinoma

75 mg/ml

Injektionsvæske, suspension

Kvæg

Spanien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

COBACTAN 4,5 % INYECTABLE PARA EQUINO Y BOVINO

Cefquinoma

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste

Sverige

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

Pfizer Oy, Animal Health

Tietokuja 4

FI-00330 Helsinki

FINLAND

Excenel vet.®

ceftiofur sodium

1 g og 4 g

Pulver til injektionsvæske

Kvæg

Sverige

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

Ceftiofur N-vet

ceftiofur sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Sverige

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

Vetoquinol scandinavia AB

Box 9

SE-26521 Åstorp

SVERIGE

Ceftiocyl

ceftiofur hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

NEDERLANDENE

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

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Nederlandene

Vétoquinol BV

Postbus 3191

NL-5203 DD

’s-Hertogenbosch

NEDERLANDENE

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

Ceftiofur as hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Ceva Santé Animale B.V.

Tiendweg 8c

2671 SB Naaldwijk

NEDERLANDENE

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| NEDERLANDENE |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

NEDERLANDENE

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Svin, der vejer op til 125 kg.

Kvæg

Nederlandene

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 Ld Capelle a/d Ijssel

NEDERLANDENE

EXCENEL RTU

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

NEDERLANDENE

EXCENEL RTU

Ceftiofur

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

NEDERLANDENE

Cobactan LA 7,5 %

Cefquinome

75 mg/ml

Injektionsvæske, suspension

Kvæg

Nederlandene

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

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

NEDERLANDENE

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

Cefquinome

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste (voksne og føl) og kvæg (voksne og kalve)

Nederlandene

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

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

NEDERLANDENE

Cobactan IV 4,5 %

Cefquinome

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Heste (voksne og føl)

Nederlandene

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

Intervet Nederland B.V.

Postbus 50

5830 AB Boxmeer

NEDERLANDENE

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

Cefquinome

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

D-Vett. B.V.

Gebroek 37

6043 GP Roermond

NEDERLANDENE

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

Cefquinome

26 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Nederlandene

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

Pfizer Animal Health B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

NEDERLANDENE

Excenel

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Nederlandene

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Det Forenede Kongerige

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| DET FORENEDE KONGERIGE |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

DET FORENEDE KONGERIGE

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

Cefquinome (as sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| DET FORENEDE KONGERIGE |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

DET FORENEDE KONGERIGE

Cobactan 25 mg/ml Suspension for Injection

Cefquinome (as sulfate)

25 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLANDENE

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

Cefquinome (as sulfate)

45 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste

Det Forenede Kongerige

| Intervet UK |
| --- |
| Walton Manor, Walton |
| Milton Keynes |
| Buckinghamshire |
| MK7 7AJ |
| DET FORENEDE KONGERIGE |

Intervet UK

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

DET FORENEDE KONGERIGE

Cobactan LA 7,5 % Suspension for Injection for Cattle

Cefquinome (as sulfate)

75 mg/ml

Injektionsvæske, suspension

Kvæg

Det Forenede Kongerige

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

Laboratorios SYVA S.A.U.

Avda. Párroco Pablo Díez 49-57

24010 León

SPANIEN

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur Sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Det Forenede Kongerige

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry |
| Co Down, |
| BT35 6JP |
| DET FORENEDE KONGERIGE |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co Down,

BT35 6JP

DET FORENEDE KONGERIGE

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

Ceftiofur Sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, heste, svin

Det Forenede Kongerige

| Vetoquinol UK Limited |
| --- |
| Vetoquinol House |
| Great Slade |
| Buckingham Industrial Park |
| Buckingham |
| MK18 1PA |
| DET FORENEDE KONGERIGE |

Vetoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

DET FORENEDE KONGERIGE

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

| Alfasan Nederland BV |
| --- |
| Kuipersweg 9 |
| 3449 JA Woerden |
| Nederlandene |

Alfasan Nederland BV

Kuipersweg 9

3449 JA Woerden

Nederlandene

Ceftiosan 50 mg/ml Injectable Suspension for Cattle and Pigs

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| DET FORENEDE KONGERIGE |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

DET FORENEDE KONGERIGE

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

Ceftiofur Sodium

50 mg/ml

Pulver og solvens til injektionsvæske, opløsning

Kvæg, svin

Det Forenede Kongerige

| Ceva Animal Health Ltd |
| --- |
| 90 The Broadway |
| Chesham |
| Buckinghamshire |
| HP5 1EG |
| DET FORENEDE KONGERIGE |

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

DET FORENEDE KONGERIGE

Cevaxel - RTU

Ceftiofur Hydrochloride

Oplysninger ikke fremlagt

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

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

Laboratorios Hipra S.A.

Avenida la Selva 135

17 170, Amer (Girona)

SPANIEN

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

DET FORENEDE KONGERIGE

Excenel 1 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

Det Forenede Kongerige

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

DET FORENEDE KONGERIGE

Excenel 4 g Sterile Powder for Solution for Injection

Ceftiofur

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

Det Forenede Kongerige

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich, Kent |
| CT13 9NJ |
| DET FORENEDE KONGERIGE |

Pfizer Ltd

Ramsgate Road

Sandwich, Kent

CT13 9NJ

DET FORENEDE KONGERIGE

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

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

Laboratorios Calier S.A.

Barcelones 26 (Pla del Ramassa)

ES 08520, Les Franqueses del Valles

SPANIEN

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

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

Continental Farmaceutica, S.L.

Parque Empresarial La Moraleja

Avenida de Europa 20-B

E-28108 Madrid, Alcobendas

SPANIEN

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

Ceftiofur Hydrochloride

50 mg/ml

Injektionsvæske, suspension

Kvæg, svin

Det Forenede Kongerige

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef Powder for Solution for Injection for Cattle and Pigs

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, svin

Det Forenede Kongerige

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

Virbac S.A.

1ère avenue 2065 m L.I.D

FR 06 516 Carros cedex

FRANKRIG

Virbacef Sterile Powder for Cattle, Pigs and Horses

Ceftiofur as Ceftiofur Sodium

50 mg/ml

Pulver til injektionsvæske, opløsning

Kvæg, heste, svin

---

BILAG II

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsland EU/EEA | Indehaver af markedsføringstilladelsen | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| AT - Østrig | CSC Pharmaceuticals Handels GmbH |
| Gewerbestraße 18-20 |
| A-2102 Bisamberg |
| Austria |

Medlemsland EU/EEA

Indehaver af markedsføringstilladelsen

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

AT - Østrig

CSC Pharmaceuticals Handels GmbH

Gewerbestraße 18-20

A-2102 Bisamberg

Austria

Aulin 100 mg - Granulat

100 mg

Granulat til oral suspension

Oral anvendelse

AT - Østrig

| 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

Suppositorier

Rektal anvendelse

AT - Østrig

| 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

Suppositorier

Rektal anvendelse

AT - Østrig

| 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

Tabletter

Oral anvendelse

AT - Østrig

| 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

Granulat til oral suspension

Oral anvendelse

AT - Østrig

| 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

Suppositorier

Rektal anvendelse

AT - Østrig

| 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

Suppositorier

Rektal anvendelse

AT - Østrig

| 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

Tabletter

Oral anvendelse

BG - Bulgarien

| 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

Granulat til oral suspension

Oral anvendelse

BG - Bulgarien

| 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

Tabletter

Oral anvendelse

BG - Bulgarien

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

Actavis EAD

29 Atanas Dukov str.

Sofia 1407

Bulgaria

Enetra

100 mg

Tabletter

Oral anvendelse

BG - Bulgarien

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

Inbiotech Ltd

5A Triaditza str.

1000 Sofia

Bulgaria

Biolin

100 mg

Tabletter

Oral anvendelse

BG - Bulgarien

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

Sopharma AD

16 Iliensko shosse str.

1220 Sofia

Bulgaria

Ameolin

100 mg

Tabletter

Oral anvendelse

BG - Bulgarien

| 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

Tabletter

Oral anvendelse

BG - Bulgarien

| 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

Granulat til oral suspension

Oral anvendelse

BG - Bulgarien

| 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

Tabletter

Oral anvendelse

BG - Bulgarien

| 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

Brusetabletter

Oral anvendelse

CY - Kypern

| 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

Tabletter

Oral anvendelse

CY - Kypern

| 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

Tabletter

Oral anvendelse

CY - Kypern

| 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

Tabletter

Oral anvendelse

CY - Kypern

| 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

Tabletter

Oral anvendelse

CZ - Tjekkiet

| 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

Granulat til oral suspension

Oral anvendelse

CZ - Tjekkiet

| 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

Granulat til oral opløsning

Oral anvendelse

CZ - Tjekkiet

| 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

Tabletter

Oral anvendelse

CZ - Tjekkiet

| 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

Tabletter

Oral anvendelse

CZ - Tjekkiet

| 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

Granulat til oral opløsning

Oral anvendelse

CZ - Tjekkiet

| 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

Tabletter

Oral anvendelse

CZ - Tjekkiet

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

ALET PHARMACEUTICALS

M. Alexander 121

Agia Varvara 12351

Greece

SPECILID

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

ANTONIOS POLYCHRONIS OF MARINOU

Ethnikis Antistaseos 6A

Holargos 15562

Greece

OMNIBUS

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

ANTOR EPE

P. Mavromihali 1

Vrilissia 15235

Greece

MELIMONT

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

ARMEDICA A.E.

Agias Markellis 17

Athens 11855

Greece

ALENCAST

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

BALU EPE

30 Km Athens-Lavrion

Markopoulo 19003

Greece

NIBERAN

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

BIOSPRAY ABEE

18TH Km Marathonos Avenue

Pallini 15344

Greece

FLOGOSTOP

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Suppositorier

Rektal anvendelse

EL - Grækenland

| 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/BREV

Granulat til oral opløsning

Oral anvendelse

EL - Grækenland

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

BROS EPE

Avgis & Gallinis 15

N. Kifissia 14564

Greece

DISCORID

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

COUP ABEE

Agias Varvaras 53-55

Dafni, Athens 17235

Greece

MELICAT

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

DEMO ABEE

21ST Km National Highway Athens-Lamia 14565

Greece

RITAMINE

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Suppositorier

Rektal anvendelse

EL - Grækenland

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

EVAGGELOS KALOFOLIAS & SIA O.E.

Menandrou 54

Athens 10431

Greece

ALGOVER

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

FARMANIC CHEMIPHARMA S.A.

Fylis 137

Kamatero Attikis 13451

Greece

CHEMISULIDE

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

FARMEDIA A.E.

Athinas 22 & Apollonos

Gerakas Attikis 15344

Greece

MULTIFORMIL

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

FARMILIA E.E.

Favierou 48

Athens 10438

Greece

AUROMELID

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

FINIXFARM EPE

Dervenakion 38 & Sahini

Gerakas 15344

Greece

KARTAL

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

HELP ABEE

Valaoritou 10

Metamorfosi Attikis 14452

Greece

MOSUOLIT

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/TAB

Brusetabletter

Oral anvendelse

EL - Grækenland

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

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

100 MG/BREV

Granulat til oral opløsning

Oral anvendelse

EL - Grækenland

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

INTERMED ABEE

Kalyftaki 27

Athens 14564

Greece

DOLOSTOP

200 MG/SUPP

Suppositorier

Rektal anvendelse

EL - Grækenland

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

KLEVA EPE

Parnithos Avenue 189

Aharnai Attikis 13671

Greece

ELINAP

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

LAVIPHARM HELLAS A.E.

Agias Marinas

Paiania Attikis 19002

Greece

AULIN

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

LEOVAN, M. LEWN & SIA EE

Argonafton 22

Argyroupoli 16452

Greece

RISTOLZIT

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

MEDARTE PHARMACEUTICLS ABEE

Spyrou Vretou 10

Metamorfosi 14452

Greece

MESILEX

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

NORMA HELLAS A.E.

Menandrou 54

Athens 10431

Greece

MYXINA

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

PHARMACYPRIA HELLAS A.E.

Paster 6

Ampelokipoi 11521

Greece

LALIDE

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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 anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

RAFARM AEBE

Korintou 12

N. Psychiko 15451

Greece

VENTOR

100 MG/BREV

Granulat til oral opløsning

Oral anvendelse

EL - Grækenland

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

REMEDINA ABEE

Gounari 25 & Areos

Kamatero Attikis 13451

Greece

AMOCETIN

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

REMEK PHARMACEUTICALS ABEE

Pentelis 34

Palaio Faliro Attikis 17564

Greece

MESUPON

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

| 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

Tabletter

Oral anvendelse

EL - Grækenland

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

VELKA HELLAS AEBE

Kapodistriou & Korinthou 12

Neo Psychiko 15451

Greece

NAOFID

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

VIOFAR EPE

Ethnikis Antistaseos & Trifyllias

Aharnai 13671

Greece

VOLONTEN

100 MG/TAB

Tabletter

Oral anvendelse

EL - Grækenland

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

VOCATE PHARMAKEFTIKI A.E.

Gounari 150

Glyfada 16674

Greece

TRANZICALM

100 MG/TAB

Tabletter

Oral anvendelse

ES - Spanien

| 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

Tabletter

Oral anvendelse

FR - Frankrig

| 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

Tabletter

Oral anvendelse

FR - Frankrig

| 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

Tabletter

Oral anvendelse

FR - Frankrig

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

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Tabletter

Oral anvendelse

FR - Frankrig

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

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

Dublin 15

Ireland

OXETIAN

100 mg

Granulat til oral opløsning i brev

Oral anvendelse

FR - Frankrig

| 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

Tabletter

Oral anvendelse

FR - Frankrig

| 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

Tabletter

Oral anvendelse

FR - Frankrig

| 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

Granulat til oral opløsning i brev

Oral anvendelse

HU - Ungarn

| 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

Tabletter

Oral anvendelse

HU - Ungarn

| 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

Granulat til oral suspension

Oral anvendelse

HU - Ungarn

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

PannonPharma Kft.

Pannonpharma út 1.

7720, Pécsvárad

Hungary

Nimelid

100 mg

Tabletter

Oral anvendelse

HU - Ungarn

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

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

100 mg

Tabletter

Oral anvendelse

HU - Ungarn

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

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Mesulid

50 mg/g

Granulat

Oral anvendelse

IT - Italien

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

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Granulat

Oral anvendelse

IT - Italien

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

Actavis Group PTC EHF

Reykjavikurvegi 76-78

Hafnarf Joerdur

Iceland

NIMESULIDE ACTAVIS

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24

25125 Brescia

Italy

EFRIDOL

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Agips Farmaceutici Srl

Via Amendola, 4

16035 Rapallo (GE)

Italy

DELFOS

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

NIMESULIDE ALMUS

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Angenerico Spa

Via Nocera Umbra, 75

00181 Roma

Italy

NIMESULIDE ANGENERICO

200 mg

Suppositorier

Rektal anvendelse

IT - Italien

| 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

Smeltetabletter

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Doc Generici Srl

Via Manuzio, 7

20124 Milano

Italy

NIMESULIDE DOC GENERICI

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Dorom Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE DOROM

100 mg

Pulver til oral opløsning

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Suppositorier

Rektal anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

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

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Pulver til oral suspension

Oral anvendelse

IT - Italien

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

Farmac.Damor Spa

Via Emilio Scaglione, 27

80145 Napoli

Italy

SULIDAMOR

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Benedetti & Co spa

Via Bolognese, 250

51020 Pistoia

Italy

NIMESULIDE Benedetti & Co

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

AULIN

200 mg

Suppositorier

Rektal anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID FAST

400 mg

Granulat

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Helsinn Birex Pharmac.Ltd

Mulhuddart, 15

Damastown - Dublin

Ireland

MESULID

200 mg

Suppositorier

Rektal anvendelse

IT - Italien

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

Hexal Spa

Largo Boccioni 1

21040 Origgio Varese

Italy

NIMESULIDE HEXAL

100 mg

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Suppositorier

Rektal anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

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

Laboratori Alter Srl

Via Egadi, 7

20144 Milano

Italy

NIMESULIDE ALTER

100 mg

Granulat

Oral anvendelse

IT - Italien

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

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Crinos spa

Via Pavia, 6

20136 Milano

Italy

LEDOREN

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

MDM Spa

Viale Papiniano, 22/B

20100 Milano

Italy

SOLVING

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Hexal AG

Industriestrasse, 25

D-83607 Holzkirchen –

Germany

NIMESULIDE HEXAL AG

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Mylan Spa

Via Vittor Pisani, 20

20124 Milano

Italy

NIMESULIDE MYLAN GENERICS

100 mg

Tabletter

Oral anvendelse

IT - Italien

| 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

Kapsler

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

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

Pantafarm Srl

Via Palestro, 14

00185 Roma

Italy

PANTAMES

100 mg

Smeltetabletter

Oral anvendelse

IT - Italien

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

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Pensa Pharma Spa

Via Rosellini Ippolito, 12

20124 Milano

Italy

NIMESULIDE PENSA

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Ranbaxy Italia Spa

Piazza Filippo Meda, 3

20121 Milano

Italy

NIMESULIDE RANBAXY

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Ratiopharm GmbH

Graf-Arcostrasse, 2

ULM D-89070

Germany

NIMESULIDE RATIOPHARM

100 mg

Brusetabletter

Oral anvendelse

IT - Italien

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

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Kapsler

Oral anvendelse

IT - Italien

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

Sandoz Spa

Largo U. Boccioni, 1

21040 Origgio (VA)

Italy

NIMESULIDE SANDOZ

100 mg

Granulat

Oral anvendelse

IT - Italien

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

Sarda Pharmaceutica Srl

Via Castiglione, 92/B

09100 Cagliari

Italy

DIMESUL

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

IT - Italien

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

SIAR Pharma Srl

Via Verdi, 33

20060 Bussero (MI)

Italy

ALGOLIDER

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Smeltetabletter

Oral anvendelse

IT - Italien

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

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Sofar Spa

Via Isonzo, 8

20100 Milano

Italy

FANSULIDE

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

NIMESULIDE TEVA

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

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

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Tabletter

Oral anvendelse

IT - Italien

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

Union Health Srl

Via Roccamandolfi, 1

00156 Roma

Italy

NIMESULIDE UNION HEALTH

100 mg

Granulat til oral suspension

Oral anvendelse

IT - Italien

| 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

Tabletter

Oral anvendelse

IT - Italien

| 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

Granulat

Oral anvendelse

LT - Litauen

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

Helsinn Birex Pharmaceuticals Ltd.

Damastown Mulhuddart

Dublin 15

Ireland

Mesulid

100 mg

Tabletter

Oral anvendelse

LT - Litauen

| 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

Granulat til oral suspension

Oral anvendelse

LT - Litauen

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

Medochemie Ltd.

P.O. Box 51409

Limassol, CY-3505

Cyprus

Apronil

100 mg

Tabletter

Oral anvendelse

LT - Litauen

| 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

Tabletter

Oral anvendelse

LV - Letland

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

Helsinn Birex Pharmaceutical Ltd.

Damastown, Mulhuddart

Dublin-15

Ireland

Mesulid 100 mg tabletes

100 mg

Tabletter

Oral anvendelse

LV - Letland

| 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

Granulat til oral suspension

Oral anvendelse

LV - Letland

| 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

Tabletter

Oral anvendelse

LV - Letland

| 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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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/brev

Granulat til oral suspension

Oral anvendelse

PL - Polen

| 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

Granulat til oral suspension

Oral anvendelse

PL - Polen

| 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

Granulat til oral suspension

Oral anvendelse

PL - Polen

| 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

Tabletter

Oral anvendelse

PL - Polen

| 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

Pulver til oral suspension

Oral anvendelse

PL - Polen

| 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

Tabletter

Oral anvendelse

PL - Polen

| 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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Overtrukne tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral opløsning

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 3 2 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 3 2

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Tabletter

Oral anvendelse

PT - Portugal

| Jaba Recordati, S. A. |
| --- |
| Lagoas Park, Edificio 5, Torre C, |
| Piso 3 2 |
| 2740-298 Porto Salvo |
| Portugal |

Jaba Recordati, S. A.

Lagoas Park, Edificio 5, Torre C,

Piso 3 2

2740-298 Porto Salvo

Portugal

Nimesulida Jabasulide

100 mg

Granulat til oral opløsning

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral opløsning

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Granulat til oral opløsning

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Tabletter

Oral anvendelse

RO - Rumænien

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

ANFARM HELLAS S.A.

Perikleous 53-57

Gerakas Attikis 153 44

Greece

LEMESIL, comprimate, 100 mg

100 mg

Tabletter

Oral anvendelse

RO - Rumænien

| 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/brev

Granulat til oral suspension

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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/brev

Granulat til oral suspension

Oral anvendelse

RO - Rumænien

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

MEDOCHEMIE LTD. - CYPRUS,

P.O. Box 51409

Limassol

Cyprus

APONIL, comprimate, 100 mg

100 mg

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

RO - Rumænien

| 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

Tabletter

Oral anvendelse

SI - Slovenien

| 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

Tabletter

Oral anvendelse

SI - Slovenien

| 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

Granulat til oral suspension

Oral anvendelse

SK - Slovakiet

| 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

Granulat til oral suspension

Oral anvendelse

SK - Slovakiet

| 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

Granulat til oral opløsning

Oral anvendelse

SK - Slovakiet

| 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

Tabletter

Oral anvendelse

SK - Slovakiet

| 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

Tabletter

Oral anvendelse

SK - Slovakiet

| 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

Tabletter

Oral anvendelse

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