# Official Journal C 190/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.190.eng |
| --- | --- |
| Official Journal
  of the European Union | C 190 |
| | |
| English edition | Information and Notices | Volume 5529 June 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.190.eng

Official Journal

of the European Union

C 190

English edition

Information and Notices

Volume 5529 June 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 190/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2012/C 190/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 12 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 190/01

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

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

1

2012/C 190/02

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

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

12

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.6.2012 | EN | Official Journal of the European Union | C 190/1 |
| --- | --- | --- | --- |

29.6.2012

EN

Official Journal of the European Union

C 190/1

---

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

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

2012/C 190/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.5.2012 | Riluzole Zentiva | Riluzole | Aventis Pharma S.A. |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.5.2012

Riluzole Zentiva

Riluzole

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/12/768/001

Film-coated tablet

N07XX02

10.5.2012

10.5.2012

Pixuvri

pixantrone

| CTI Life Sciences Ltd |
| --- |
| Biopark, Broadwater Road, |
| Welwyn Garden City, |
| Hertfordshire AL73AX, |
| United Kingdom |

CTI Life Sciences Ltd

Biopark, Broadwater Road,

Welwyn Garden City,

Hertfordshire AL73AX,

United Kingdom

EU/1/12/764/001

powder for concentrate for solution for infusion

L01DB11

14.5.2012

22.5.2012

Docetaxel Accord

Docetaxel

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

Accord Healthcare Limited

Sage house, 319 Pinner road,

North Harrow,

Middlesex HA1 4HF

United Kingdom

EU/1/12/769/001-003

Concentrate for solution for infusion

L01CD02

25.5.2012

22.5.2012

Docetaxel Kabi

Docetaxel

| Fresenius Kabi Oncology Plc. |
| --- |
| Lion Court, Farnham Road, |
| Bordon, |
| Hampshire, |
| GU35 0NF, |
| United Kingdom |

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road,

Bordon,

Hampshire,

GU35 0NF,

United Kingdom

EU/1/12/770/001-004

Concentrate for solution for infusion

L01CD02

25.5.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.5.2012 | Intanza | Sanofi Pasteur MSD SNC |
| 8, rue Jonas Salk, |
| Lyon 69007, |
| France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

7.5.2012

Intanza

Sanofi Pasteur MSD SNC

8, rue Jonas Salk,

Lyon 69007,

France

EU/1/08/505/001-003

9.5.2012

7.5.2012

Ovitrelle

| 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/1/00/165/001-003

9.5.2012

10.5.2012

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, |
| Oxford Road, |
| Uxbridge, |
| Middlesex UB8 1HU, |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park,

Oxford Road,

Uxbridge,

Middlesex UB8 1HU,

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

14.5.2012

10.5.2012

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - |
| 75013 Paris, |
| France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris,

France

EU/1/98/086/001-034

14.5.2012

10.5.2012

Ibandronic Acid Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/642/001-004

14.5.2012

10.5.2012

Irbesartan / Hydrochlorothiazide Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/583/001-072

14.5.2012

10.5.2012

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, |
| Paris 75009, |
| France |

ADDMEDICA

101, rue Saint Lazare,

Paris 75009,

France

EU/1/07/397/001-004

14.5.2012

10.5.2012

Telmisartan Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78,

220 Hafnarfjörður,

Iceland

EU/1/10/639/001-030

14.5.2012

10.5.2012

Telmisartan Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/610/001-060

14.5.2012

10.5.2012

Trobalt

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

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/11/681/001-013

14.5.2012

14.5.2012

Brilique

| AstraZeneca AB |
| --- |
| Södertälje S 151 85, |
| Sverige |

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/655/001-006

16.5.2012

14.5.2012

Invega

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

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse –

België

EU/1/07/395/001-095

16.5.2012

14.5.2012

JEVTANA

| SANOFI |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

SANOFI

174, avenue de France,

F-75013 Paris,

France

EU/1/11/676/001

16.5.2012

14.5.2012

Luveris

| 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/1/00/155/001-003

16.5.2012

14.5.2012

Possia

| AstraZeneca AB |
| --- |
| Södertälje S 151 85, |
| Sverige |

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/656/001-006

16.5.2012

14.5.2012

TOBI Podhaler

| 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/1/10/652/001-003

16.5.2012

15.5.2012

Mircera

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/07/400/008-013

EU/1/07/400/017-024

17.5.2012

15.5.2012

Topotecan Hospira

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

Hospira UK Limited

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/633/001-002

17.5.2012

15.5.2012

Vizarsin

| KRKA, d.d., Novo mesto |
| --- |
| Šmarješka cesta 6, |
| 8501 Novo mesto, |
| Slovenija |

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/551/001-027

17.5.2012

22.5.2012

Aerinaze

| 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/1/07/399/001-006

25.5.2012

22.5.2012

Fampyra

| Biogen Idec Limited |
| --- |
| Innovation House, |
| 70 Norden Road, |
| Maidenhead, |
| Berkshire SL6 4AY, |
| United Kingdom |

Biogen Idec Limited

Innovation House,

70 Norden Road,

Maidenhead,

Berkshire SL6 4AY,

United Kingdom

EU/1/11/699/001-004

25.5.2012

22.5.2012

Gardasil

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/357/001-008

EU/1/06/357/018-021

25.5.2012

22.5.2012

HALAVEN

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

Eisai Europe Limited

European Knowledge Centre,

Mosquito Way,

Hatfield,

Hertsforshire AL10 9SN,

United Kingdom

EU/1/11/678/001-002

25.5.2012

22.5.2012

Hizentra

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Strasse 76, |
| 35041 Marburg, |
| Deutschland |

CSL Behring GmbH

Emil-von-Behring-Strasse 76,

35041 Marburg,

Deutschland

EU/1/11/687/001-012

25.5.2012

22.5.2012

IDflu

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

Sanofi Pasteur SA

2, avenue Pont Pasteur,

F-69007 Lyon,

France

EU/1/08/507/001-003

25.5.2012

22.5.2012

Pergoveris

| 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/1/07/396/001-003

25.5.2012

22.5.2012

Silgard

| 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/1/06/358/001-008

EU/1/06/358/018-021

25.5.2012

22.5.2012

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/02/222/001-005

24.5.2012

22.5.2012

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/02/222/001-005

25.5.2012

22.5.2012

Votrient

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

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/10/628/001-004

25.5.2012

25.5.2012

Benlysta

| 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/1/11/700/001-002

30.5.2012

25.5.2012

Betaferon

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

Bayer Pharma AG

D - 13342 Berlin,

Deutschland

EU/1/95/003/003-012

30.5.2012

25.5.2012

Busilvex

| Pierre Fabre Médicament |
| --- |
| 45, Place Abel Gance, |
| 92654 Boulogne Billancourt Cedex, |
| France |

Pierre Fabre Médicament

45, Place Abel Gance,

92654 Boulogne Billancourt Cedex,

France

EU/1/03/254/002

31.5.2012

25.5.2012

Clopidogrel Teva Pharma B.V.

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/649/001-016

30.5.2012

25.5.2012

Conbriza

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/09/511/001-005

31.5.2012

25.5.2012

DuoCover

| 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/1/10/623/001-015

30.5.2012

25.5.2012

Ecalta

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/07/416/001-002

31.5.2012

25.5.2012

Fosavance

| 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/1/05/310/001-009

30.5.2012

25.5.2012

Irbesartan Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/576/001-039

30.5.2012

25.5.2012

Ixiaro

| Intercell AG |
| --- |
| Campus Vienna Biocenter 3 |
| A-1030 Wien, |
| Österreich |

Intercell AG

Campus Vienna Biocenter 3

A-1030 Wien,

Österreich

EU/1/08/501/001-002

31.5.2012

25.5.2012

Keppra

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/Researchdreef, 60, |
| Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/00/146/001-032

1.6.2012

25.5.2012

Kinzalkomb

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

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/02/214/001-015

31.5.2012

25.5.2012

Kinzalmono

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

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/98/091/001-014

31.5.2012

25.5.2012

Kuvan

| 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/1/08/481/001-003

30.5.2012

25.5.2012

Lamivudine / Zidovudine Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/663/001-002

1.6.2012

25.5.2012

Micardis

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

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/98/090/001-022

31.5.2012

25.5.2012

MicardisPlus

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

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/02/213/001-023

31.5.2012

25.5.2012

Neulasta

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/02/227/001-002

EU/1/02/227/004

1.6.2012

25.5.2012

Nevirapine Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/598/001-004

30.5.2012

25.5.2012

Onduarp

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

Boehringer Ingelheim International GmbH

Binger Str. 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729/001-006

30.5.2012

25.5.2012

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, |
| D-35041 Marburg, |
| Deutschland |

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76,

D-35041 Marburg,

Deutschland

EU/1/07/394/001-009

31.5.2012

25.5.2012

Osseor

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, |
| 92284 Suresnes cedex, |
| France |

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/287/001-006

30.5.2012

25.5.2012

Pradaxa

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

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442/001-014

1.6.2012

25.5.2012

Pritor

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/98/089/001-022

30.5.2012

25.5.2012

PritorPlus

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/02/215/001-021

30.5.2012

25.5.2012

Protelos

| Les Laboratoires Servier |
| --- |
| 50, rue Carnot, |
| 92284 Suresnes cedex, |
| France |

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex,

France

EU/1/04/288/001-006

25.5.2012

Rasilamlo

| 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/1/11/686/001-056

30.5.2012

25.5.2012

Rasilez

| 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/1/07/405/001-040

30.5.2012

25.5.2012

Rasilez HCT

| 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/1/08/491/001-080

31.5.2012

25.5.2012

Rasitrio

| 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/1/11/730/001-060

31.5.2012

25.5.2012

Riprazo

| 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/1/07/409/001-040

30.5.2012

25.5.2012

Riprazo HCT

| 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/1/11/680/001-080

1.6.2012

25.5.2012

Rivastigmine Actavis

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/11/693/001-016

1.6.2012

25.5.2012

RoActemra

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/08/492/001-006

31.5.2012

25.5.2012

Sprimeo

| 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/1/07/407/001-040

31.5.2012

25.5.2012

Sprimeo HCT

| 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/1/11/683/001-080

1.6.2012

25.5.2012

Temozolomide Hospira

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

Hospira UK Ltd.

Queensway,

Royal Leamington Spa,

Warwickshire CV31 3RW,

United Kingdom

EU/1/10/615/001-002

EU/1/10/615/005-006

EU/1/10/615/009-010

EU/1/10/615/013-014

EU/1/10/615/017-018

EU/1/10/615/021-022

31.5.2012

25.5.2012

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Treasury Building, |
| Lower Grand Canal Street, |
| Dublin 2, |
| IRELAND |

Elan Pharma International Ltd.

Treasury Building,

Lower Grand Canal Street,

Dublin 2,

IRELAND

EU/1/06/346/001

31.5.2012

25.5.2012

Vantavo

| 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/1/09/572/001-004

EU/1/09/572/006-008

30.5.2012

25.5.2012

Victoza

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

31.5.2012

25.5.2012

Vistide

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

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/97/037/001

31.5.2012

25.5.2012

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

Glaxo Group Ltd

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/08/451/001-004

30.5.2012

25.5.2012

Votrient

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

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/10/628/001-004

31.5.2012

25.5.2012

Xolair

| 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/1/05/319/001-010

30.5.2012

31.5.2012

Lamivudine Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/566/001-005

4.6.2012

31.5.2012

Peyona

| CHIESI FARMACEUTICI SpA |
| --- |
| Via Palermo 26/A, |
| I-43100 Parma, |
| ITALIA |

CHIESI FARMACEUTICI SpA

Via Palermo 26/A,

I-43100 Parma,

ITALIA

EU/1/09/528/001-002

4.6.2012

31.5.2012

Temozolomide Teva

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

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/09/606/001-012

4.6.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.5.2012 | Valtropin | BioPartners GmbH |
| Kaiserpassage 11 - |
| D-72764 Reutlingen, |
| Deutschland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.5.2012

Valtropin

BioPartners GmbH

Kaiserpassage 11 -

D-72764 Reutlingen,

Deutschland

EU/1/06/335/001

14.5.2012

25.5.2012

Docefrez

| Sun Pharmaceuticals Industries Europe B.V. |
| --- |
| Polarisavenue 87, |
| 2132 JH Hoofddorp, |
| Nederland |

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87,

2132 JH Hoofddorp,

Nederland

EU/1/10/630/001-002

31.5.2012

25.5.2012

Intrinsa

| Warner Chilcott UK Ltd |
| --- |
| Old Belfast Road, |
| Millbrook, Larne, |
| County Antrim BT40 2SH, |
| United Kingdom |

Warner Chilcott UK Ltd

Old Belfast Road,

Millbrook, Larne,

County Antrim BT40 2SH,

United Kingdom

EU/1/06/352/001-003

31.5.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 25.5.2012 | Angiox | The Medicines Company UK Ltd |
| 115 L Milton Park, |
| Abingdon, |
| Oxfordshire, OX14 4SA, |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

25.5.2012

Angiox

The Medicines Company UK Ltd

115 L Milton Park,

Abingdon,

Oxfordshire, OX14 4SA,

United Kingdom

EU/1/04/289/001

31.5.2012

25.5.2012

Caelyx

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/96/011/001-004

31.5.2012

25.5.2012

Luminity

| Lantheus MI UK Limited |
| --- |
| Festival House - |
| 39 Oxford Street - |
| Newbury - |
| Berkshire RG14 1JG - |
| United Kingdom |

Lantheus MI UK Limited

Festival House -

39 Oxford Street -

Newbury -

Berkshire RG14 1JG -

United Kingdom

EU/1/06/361/001-002

31.5.2012

25.5.2012

Mepact

| IDM PHARMA SAS |
| --- |
| 11-15 quai De Dion Bouton, |
| 92816 Puteaux Cedex, |
| France |

IDM PHARMA SAS

11-15 quai De Dion Bouton,

92816 Puteaux Cedex,

France

EU/1/08/502/001

1.6.2012

25.5.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l’Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard de l’Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

31.5.2012

25.5.2012

Torisel

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

EU/1/07/424/001

30.5.2012

25.5.2012

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

31.5.2012

31.5.2012

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, |
| D-80336 München, |
| Deutschland |

EpiCept GmbH

Goethestrasse 4,

D-80336 München,

Deutschland

EU/1/08/477/001

4.6.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.5.2012 | Circovac | Merial |
| 29 Avenue Tony Garnier, |
| 69007 Lyon, |
| France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.5.2012

Circovac

Merial

29 Avenue Tony Garnier,

69007 Lyon,

France

EU/2/07/075/001-004

14.5.2012

10.5.2012

Netvax

| 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/2/09/093/001-002

14.5.2012

22.5.2012

Convenia

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/06/059/001-002

30.5.2012

22.5.2012

Equip WNV

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/08/086/001-003

25.5.2012

22.5.2012

PRILACTONE

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| 33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/07/074/001-006

25.5.2012

25.5.2012

Onsior

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park, |
| Frimley/Camberley, |
| Surrey, GU16 7SR, |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park,

Frimley/Camberley,

Surrey, GU16 7SR,

United Kingdom

EU/2/08/089/001-021

1.6.2012

25.5.2012

Suprelorin

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

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. -

06516 Carros –

France

EU/2/07/072/001-004

1.6.2012

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

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

---

| 29.6.2012 | EN | Official Journal of the European Union | C 190/12 |
| --- | --- | --- | --- |

29.6.2012

EN

Official Journal of the European Union

C 190/12

---

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

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

2012/C 190/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 7.5.2012 | Vivaglobin and associated names | See Annex I | See Annex I | 8.5.2012 |
| 22.5.2012 | Femara and associated names | See Annex II | See Annex II | 23.5.2012 |
| 25.5.2012 | Priorix and associated names | See Annex III | See Annex III | 30.5.2012 |
| 25.5.2012 | Prontax 5 Mg/ml | See Annex IV | See Annex IV | 30.5.2012 |
| 25.5.2012 | Prontax 10 Mg/ml | See Annex V | See Annex V | 29.5.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

7.5.2012

Vivaglobin and associated names

See Annex I

See Annex I

8.5.2012

22.5.2012

Femara and associated names

See Annex II

See Annex II

23.5.2012

25.5.2012

Priorix and associated names

See Annex III

See Annex III

30.5.2012

25.5.2012

Prontax 5 Mg/ml

See Annex IV

See Annex IV

30.5.2012

25.5.2012

Prontax 10 Mg/ml

See Annex V

See Annex V

29.5.2012

---

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

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

---

ANNEX I

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

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | CSL Behring GmbH |
| Emil-von-Behring-Straße 76 |
| 35041 Marburg an der Lahn |
| Germany |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

CSL Behring GmbH

Emil-von-Behring-Straße 76

35041 Marburg an der Lahn

Germany

Vivaglobin 160 mg/ml Injektionslösung (subkutane Anwendung)

160 mg/ml

solution for injection

subcutaneous use

Belgium

| CSL Behring GMBH |
| --- |
| Emil-von-Behring-Str. 76 |
| 35041 Marburg |
| Germany |

CSL Behring GMBH

Emil-von-Behring-Str. 76

35041 Marburg

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Denmark

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76, |
| 35041 Marburg, |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76,

35041 Marburg,

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Finland

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76, |
| 35041 Marburg, |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76,

35041 Marburg,

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

France

| CSL BEHRING SA - PARIS |
| --- |
| 44 rue Cambronne |
| 75015 Paris, |
| France |

CSL BEHRING SA - PARIS

44 rue Cambronne

75015 Paris,

France

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Germany

| CSL Behring GmbH, |
| --- |
| Emil von Behring Strasse 76, |
| 35041 Marburg |

CSL Behring GmbH,

Emil von Behring Strasse 76,

35041 Marburg

Vivaglobin

Solution for infusion, 160 mg/ml

solution for infusion

subcutaneous use

Greece

| CSL BEHRING ΜΕΠΕ |
| --- |
| XATZHGIANNI MEKSI 5 |
| ATHENS 11528 |

CSL BEHRING ΜΕΠΕ

XATZHGIANNI MEKSI 5

ATHENS 11528

VIVAGLOBIN

16 % (W/V)

[150-170 MG]

solution for injection

subcutaneous use

Hungary

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-str. 76. |
| 35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-str. 76.

35041 Marburg

Germany

Vivaglobin 160 mg/ml oldatos injekció szubkután alkalmazásra

160 mg/ml solution for injection (subcutaneous use)

solution for injection

subcutaneous use

Italy

| CSL BEHRING GmbH |
| --- |
| Emil von Behring Str 76 |
| D-35041 Marburg-Germany |

CSL BEHRING GmbH

Emil von Behring Str 76

D-35041 Marburg-Germany

VIVAGLOBIN

160 MG/ML

solution for injection

subcutaneous use

Luxembourg

| CSL BEHRING GMBH 76 |
| --- |
| EMIL-VON-BEHRING-STRASSED |
| 35041 MARBURG |

CSL BEHRING GMBH 76

EMIL-VON-BEHRING-STRASSED

35041 MARBURG

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

The Netherlands

| CSL Behring GmbH, |
| --- |
| Emil v. Behring Str. 76, |
| 35041 Marburg, |
| Germany |

CSL Behring GmbH,

Emil v. Behring Str. 76,

35041 Marburg,

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Norway

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Str. 76, |
| 35041 Marburg, |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Str. 76,

35041 Marburg,

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Poland

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Str. 76, |
| 35041 Marburg, |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Str. 76,

35041 Marburg,

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Portugal

| CSL Behring GmbH |
| --- |
| Emil-von-Behring Strasse, 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring Strasse, 76

D-35041 Marburg

Germany

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

Spain

| CSL BEHRING, GMBH |
| --- |
| Emil von Bhering Strasse, 76 |
| 35041 Marburg, |
| Germany |

CSL BEHRING, GMBH

Emil von Bhering Strasse, 76

35041 Marburg,

Germany

VIVAGLOBIN 160 mg/ml para inyección (uso subcutáneo)

160 mg/ml

solution for injection

subcutaneous use

Sweden

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg, |
| Tyskland |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg,

Tyskland

Vivaglobin

160 mg/ml

solution for injection

subcutaneous use

---

ANNEX II

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

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Stella-Klein Loew-Weg 17 |
| 1020 Vienna |
| Austria |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH

Stella-Klein Loew-Weg 17

1020 Vienna

Austria

Femara 2,5 mg – Filmtabletten

2,5 mg

film-coated tablet

Oral

Belgium

| Novartis Pharma N.V. |
| --- |
| Medialaan, 40 bus 1, 1800 Vilvoorde |
| Belgium |

Novartis Pharma N.V.

Medialaan, 40 bus 1, 1800 Vilvoorde

Belgium

Femara

2,5 mg

film-coated tablet

Oral

Bulgaria

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nuernberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuernberg

Germany

Femara

2,5 mg

film-coated tablet

Oral

Cyprus

| Novartis Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey GU16 7SR

United Kingdom

Femara

2,5 mg

film-coated tablet

Oral

Czech Republic

| Novartis s.r.o., |
| --- |
| Gemini, budova B |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 |
| Czech Republic |

Novartis s.r.o.,

Gemini, budova B

Na Pankráci 1724/129

140 00 Prague 4

Czech Republic

Femara

2,5 mg

film-coated tablet

Oral

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172, |
| 2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø

Denmark

Femar

2,5 mg

film-coated tablet

Oral

Estonia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| 02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Femara

2,5 mg

film-coated tablet

Oral

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| 02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

02130 Espoo

Finland

Femar

2,5 mg

film-coated tablet

Oral

France

| Novartis Pharma S.A.S. |
| --- |
| 2 & 4, rue Lionel Terray, |
| 92500 Rueil Malmaison Cédex |
| France |

Novartis Pharma S.A.S.

2 & 4, rue Lionel Terray,

92500 Rueil Malmaison Cédex

France

Fémara 2,5 mg comprimé pelliculé

2,5 mg

film-coated tablet

Oral

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| 90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstraße 25

90429 Nürnberg

Germany

Femara 2,5 mg Filmtabletten

2,5 mg

film-coated tablet

Oral

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12 km of National Road Athens, |
| Lamia No 1, |
| 14451 Metamorphosis, |
| Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

12 km of National Road Athens,

Lamia No 1,

14451 Metamorphosis,

Athens

Greece

FEMARA

2,5 mg

film-coated tablet

Oral

Hungary

| Novartis Hungária Kft. Pharma |
| --- |
| 1114 Budapest, |
| Bartók Béla út 43-47 |
| Hungary |

Novartis Hungária Kft. Pharma

1114 Budapest,

Bartók Béla út 43-47

Hungary

Femara 2,5 mg filmtabletta

2,5 mg

film-coated tablet

Oral

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172, |
| 2100 København Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø

Denmark

Femar

2,5 mg

film-coated tablet

Oral

Ireland

| Novartis Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey GU16 7SR

United Kingdom

Femara 2,5 mg Film-coated Tablets

2,5 mg

film-coated tablet

Oral

Italy

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road |
| RH12 5 Ab - Horsham (West Sussex) |
| United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road

RH12 5 Ab - Horsham (West Sussex)

United Kingdom

Femara

2,5 mg

film-coated tablet

Oral

Latvia

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10, |
| 02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10,

02130 Espoo

Finland

Femara 2,5 mg apvalkotās tabletes

2,5 mg

film-coated tablet

Oral

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10, |
| 02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10,

02130 Espoo

Finland

Femara

2,5 mg

film-coated tablet

Oral

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| 90429 Nürnberg, |
| Germany |

Novartis Pharma GmbH

Roonstraße 25

90429 Nürnberg,

Germany

Femara

2,5 mg

film-coated tablet

Oral

Malta

| Novartis Pharmaceuticals UK Limited |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley,

Camberley,

Surrey GU16 7SR

United Kingdom

Femara

2,5 mg

film-coated tablet

Oral

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1, |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1,

6824 DP Arnhem

The Netherlands

Femara

2,5 mg

film-coated tablet

Oral

Norway

| Novartis Norge AS |
| --- |
| Postboks 4284 Nydalen, |
| 0401 Oslo |
| Norway |

Novartis Norge AS

Postboks 4284 Nydalen,

0401 Oslo

Norway

Femar

2,5 mg

film-coated tablet

Oral

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| 90429 Nürnberg, |
| Germany |

Novartis Pharma GmbH

Roonstraße 25

90429 Nürnberg,

Germany

Femara

2,5 mg

film-coated tablet

Oral

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, |
| Edif. 8, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial,

Edif. 8, Quinta da Beloura

2710-444 Sintra

Portugal

Femara

2,5 mg

film-coated tablet

Oral

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| 90429 Nürnberg, |
| Germany |

Novartis Pharma GmbH

Roonstraße 25

90429 Nürnberg,

Germany

Femara 2,5 mg comprimate filmate

2,5 mg

film-coated tablet

Oral

Slovak Republic

| Novartis, s.r.o. |
| --- |
| Gemini, budova B |
| Na Pankráci 1724,/129 |
| 14000 Prague 4, |
| Czech Republic |

Novartis, s.r.o.

Gemini, budova B

Na Pankráci 1724,/129

14000 Prague 4,

Czech Republic

Femara

2,5 mg

film-coated tablet

Oral

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| 90429 Nürnberg, |
| Germany |

Novartis Pharma GmbH

Roonstraße 25

90429 Nürnberg,

Germany

Femara 2,5 mg filmsko obložene tablete

2,5 mg

film-coated tablet

Oral

Spain

| Laboratorios Padró, S.A. |
| --- |
| Gran Via de les Corts Catalanes, No 764 |
| 08013 Barcelona |
| Spain |

Laboratorios Padró, S.A.

Gran Via de les Corts Catalanes, No 764

08013 Barcelona

Spain

Loxifan 2,5 mg comprimidos recubiertos con película

2,5 mg

film-coated tablet

Oral

| Novartis Farmacéutica, S.A. |
| --- |
| Gran Via de les Corts Catalanes, No 764 |
| 08013 Barcelona |
| Spain |

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, No 764

08013 Barcelona

Spain

Femara 2,5 mg comprimidos recubiertos con película

2,5 mg

film-coated tablet

Oral

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B, Box 1150, |
| 18311 Täby, |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B, Box 1150,

18311 Täby,

Sweden

Femar

2,5 mg

film-coated tablet

Oral

United Kingdom

| Novartis Pharmaceuticals UK Limited |
| --- |
| Trading as Ciba Laboratories |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limited

Trading as Ciba Laboratories

Frimley Business Park,

Frimley,

Camberley,

Surrey GU16 7SR

United Kingdom

Femara 2,5 mg Tablets

2,5 mg

film-coated tablet

Oral

---

ANNEX III

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

| Member State EU/EEA | Marketing authorisation holder | (Invented) Name | Strength (1) | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH |
| Albert Schweitzer-Gasse 6 |
| A-1140 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength (1)

Pharmaceutical form

Route of administration

Austria

GlaxoSmithKline Pharma GmbH

Albert Schweitzer-Gasse 6

A-1140 Wien

Austria

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Austria

| GlaxoSmithKline Pharma GmbH |
| --- |
| Albert Schweitzer-Gasse 6 |
| A-1140 Wien |
| Austria |

GlaxoSmithKline Pharma GmbH

Albert Schweitzer-Gasse 6

A-1140 Wien

Austria

Priorix

Powder in vials and solvent in prefilled-syringes for solution for injection

Subcutaneous use

Intramuscular use

Belgium

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Bulgaria

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for suspension for injection

Subcutaneous use

Intramuscular use

Cyprus

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Czech Republic

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68 |
| DK-2605 Brøndby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby

Denmark

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Estonia

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Finland

| GlaxoSmithKline Biologicals SA |
| --- |
| Rue de l’Institut 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi Cedex |
| France |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi Cedex

France

Priorix

powder and solvent for solution for injection in a pre-filled syringe

Measles, mumps, and rubella vaccine (live)

Powder and solvent for solution for injection

Subcutaneous use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| D-80339 München |
| Germany |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

D-80339 München

Germany

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Greece

| GlaxoSmithKline AEBE |
| --- |
| 266 Kifisias avenue |
| 152 32 Halandri |
| Greece |

GlaxoSmithKline AEBE

266 Kifisias avenue

152 32 Halandri

Greece

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Budapest |
| Csörsz u 43 |
| Hungary |

GlaxoSmithKline Kft.

1124 Budapest

Csörsz u 43

Hungary

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavik |
| Iceland |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavik

Iceland

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way |
| Rathfarnham |
| Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Italy

| GlaxoSmithKline S.p.A. |
| --- |
| Via A. Fleming, 2 |
| 37135 Verona |
| Italy |

GlaxoSmithKline S.p.A.

Via A. Fleming, 2

37135 Verona

Italy

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Latvia

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’ |
| --- |
| Goštauto 40A |
| LT-01112, Vilnius |
| Lithuania |

UAB ‘GlaxoSmithKline Lietuva’

Goštauto 40A

LT-01112, Vilnius

Lithuania

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Luxembourg

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Malta

| SmithKline Beecham plc |
| --- |
| Great West Road, |
| Brentford, |
| Middlesex TW8 9GS |

SmithKline Beecham plc

Great West Road,

Brentford,

Middlesex TW8 9GS

Trading as

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| United Kingdom |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Netherlands

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist |
| The Netherlands |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZ Zeist

The Netherlands

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2a |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2a

Postboks 180 Vinderen

0319 Oslo

Norway

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Poland

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Portugal

| Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda. |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| Portugal |

Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges, 3

Arquiparque – Miraflores

1495-131 Algés

Portugal

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Romania

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Slovak Republic

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l’Institut, 89 |
| 1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut, 89

1330 Rixensart

Belgium

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Slovenia

| GSK d.o.o., |
| --- |
| Ljubljana, |
| Knezov štradon 90, |
| 1000 Ljubljana |
| Slovenia |

GSK d.o.o.,

Ljubljana,

Knezov štradon 90,

1000 Ljubljana

Slovenia

Priorix

prašek in vehikel za raztopino za injiciranje

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Spain

| GlaxoSmithKline, S.A. |
| --- |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid) |
| Spain |

GlaxoSmithKline, S.A.

C/Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Priorix

polvo y disolvente en jeringa precargada para solución inyectable

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

Sweden

| GlaxoSmithKline AB, |
| --- |
| Box 516, |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB,

Box 516,

169 29 Solna

Sweden

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

United Kingdom

| SmithKline Beecham plc |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex TW8 9GS |
| United Kingdom |

SmithKline Beecham plc

980 Great West Road,

Brentford,

Middlesex TW8 9GS

United Kingdom

Trading as

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex UB11 1BT |
| United Kingdom |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

United Kingdom

Priorix

Powder and solvent for solution for injection

Subcutaneous use

Intramuscular use

---

(1)  Strength applicable for all countries

After reconstitution, 1 dose (0,5 ml) contains:

| Live attenuated measles virus (Schwarz strain) | not less than 103.0 CCID50 |
| --- | --- |
| Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) | not less than 103.7 CCID50 |
| Live attenuated rubella virus (Wistar RA 27/3 strain) | not less than 103.0 CCID50 |

Live attenuated measles virus (Schwarz strain)

not less than 103.0 CCID50

Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain)

not less than 103.7 CCID50

Live attenuated rubella virus (Wistar RA 27/3 strain)

not less than 103.0 CCID50

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Name | Pharmaceutical form | INN/Strength | Animal species | Route of administration | Recommended dose | Withdrawal periods |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Limited Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Member State EU/EEA

Applicant

Name

Pharmaceutical form

INN/Strength

Animal species

Route of administration

Recommended dose

Withdrawal periods

Austria

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Bulgaria

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Denmark

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Spain

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Dectomax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Finland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

France

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml solution pour pour on pour bovins

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Hungary

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Ireland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Dectomax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Iceland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

The Netherlands

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Norway

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Poland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Portugal

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Romania

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Sweden

(Applicant)

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

Slovenia

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Dectomax 5 mg/ml Pour-On Solution for Cattle

Pour-on solution

Doramectin 5 mg/ml

Cattle

topical - on the back of the animal

1 ml per 10 kg bodyweight

CATTLE:

Meat and offal: 35 days.

Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Name | Pharmaceutical form | INN/Strength | Animal species | Route of administration | Recommended dose | Withdrawal periods |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Limited Veterinary Medical Research & Development |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Member State EU/EEA

Applicant

Name

Pharmaceutical form

INN/Strength

Animal species

Route of administration

Recommended dose

Withdrawal periods

Austria

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Bulgaria

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Cyprus

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs – intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Czech Republic

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Denmark

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs – intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Estonia

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Greece

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Spain

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Finland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

France

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution injectable pour bovins, ovins et porcins

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Hungary

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Ireland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Dectomax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Iceland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Latvia

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Lithuania

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Malta

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

The Netherlands

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Norway

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Poland

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Portugal

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

| CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. |
| --- |
| SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. |
| PIGS: Meat and offal: - withdrawal period 56 days. |

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Romania

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Sweden

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Slovenia

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

Slovakia

| Pfizer Limited Veterinary Medical Research & Development |
| --- |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited Veterinary Medical Research & Development

Sandwich

Kent CT13 9NJ

United Kingdom

Prontax 10 mg/ml solution for injection for cattle, sheep and pigs

Solution for injection

Doramectin 10 mg/ml

Cattle, sheep and pigs

Cattle - subcutaneous

Sheep and pigs - intramuscular

Cattle and sheep - 1 ml per 50 kg bodyweight

Pigs - 1 ml per 33 kg bodyweight

CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.

PIGS: Meat and offal: - withdrawal period 56 days.

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