# C_2013184EN.01000101.xml

| 28.6.2013 | EN | Official Journal of the European Union | C 184/1 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013

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

2013/C 184/01

—   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 |
| ---------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------------------------------------------------------------- | ----------------------------------------------- | --------------------- |
| 16.5.2013 | HyQvia | human normal immunoglobulin | Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich | Baxter Innovations GmbH | Industriestraße 67, A-1221 Wien, Österreich | EU/1/13/840 | Solution for infusion |
| Baxter Innovations GmbH | | | | | | | |
| Industriestraße 67, A-1221 Wien, Österreich | | | | | | | |
| 16.5.2013 | Voriconazole Accord | voriconazole | 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/1/13/835 | Film-coated tablet |
| Accord Healthcare Limited | | | | | | | |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom | | | | | | | |
| 24.5.2013 | Stribild | elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumarate) | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | Film-coated tablet |
| Gilead Sciences International Limited | | | | | | | |
| Cambridge CB21 6GT, United Kingdom | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------- |
| 14.5.2013 | Qsiva | VIVUS BV Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | VIVUS BV | Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |
| VIVUS BV | | | | |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | | | | |
| 29.5.2013 | Kynamro | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 31.5.2013 | Raxone | Santhera Pharmaceuticals (Deutschland) GmbH Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland | Santhera Pharmaceuticals (Deutschland) GmbH | Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland |
| Santhera Pharmaceuticals (Deutschland) GmbH | | | | |
| Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------------ | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
| 3.5.2013 | Nevanac | Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | Alcon Laboratories (UK) Ltd. | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | | | | |
| 3.5.2013 | Votrient | 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 |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 6.5.2013 | Vibativ | Theravance UK Limited 90 Fetter Lane, London EC4A 1EQ, United Kingdom | Theravance UK Limited | 90 Fetter Lane, London EC4A 1EQ, United Kingdom |
| Theravance UK Limited | | | | |
| 90 Fetter Lane, London EC4A 1EQ, United Kingdom | | | | |
| 14.5.2013 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT, United Kingdom | | | | |
| 14.5.2013 | Olanzapine Cipla | Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom | Cipla (EU) Limited | Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom |
| Cipla (EU) Limited | | | | |
| Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom | | | | |
| 16.5.2013 | Ozurdex | Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland, (514125) | Castlebar Road, Westport, County Mayo, Ireland |
| Allergan Pharmaceuticals Ireland, (514125) | | | | |
| Castlebar Road, Westport, County Mayo, Ireland | | | | |
| 16.5.2013 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | | | | |
| 22.5.2013 | Adcirca | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 22.5.2013 | Aloxi | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland | Helsinn Birex Pharmaceuticals Ltd | Damastown, Mulhuddart, Dublin 15, Ireland |
| Helsinn Birex Pharmaceuticals Ltd | | | | |
| Damastown, Mulhuddart, Dublin 15, Ireland | | | | |
| 22.5.2013 | Leganto | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 22.5.2013 | 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 |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 22.5.2013 | Xarelto | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 23.5.2013 | Trizivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 27.5.2013 | Afinitor | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.5.2013 | Avastin | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 27.5.2013 | Combivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 27.5.2013 | DuoCover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 27.5.2013 | Incivo | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 27.5.2013 | Ixiaro | Intercell Austria AG Campus Vienna Biocenter 3, A-1030 Wien, Österreich | Intercell Austria AG | Campus Vienna Biocenter 3, A-1030 Wien, Österreich |
| Intercell Austria AG | | | | |
| Campus Vienna Biocenter 3, A-1030 Wien, Österreich | | | | |
| 27.5.2013 | Kivexa | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 27.5.2013 | Neupro | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 27.5.2013 | PANTECTA Control | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 27.5.2013 | PANTOLOC Control | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 27.5.2013 | Relistor | TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | TMC Pharma Services Ltd. | Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |
| TMC Pharma Services Ltd. | | | | |
| Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | | | | |
| 27.5.2013 | Samsca | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. | | | | |
| 27.5.2013 | Zometa | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.5.2013 | Zypadhera | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 27.5.2013 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 27.5.2013 | Zyprexa Velotab | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 29.5.2013 | Pritor | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 29.5.2013 | PritorPlus | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 30.5.2013 | Clopidogrel Zentiva | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 30.5.2013 | CONTROLOC Control | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 30.5.2013 | DuoPlavin | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 30.5.2013 | Epivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, | | | | |
| Brentford, Middlesex TW8 9GS, United Kingdom | | | | |
| 30.5.2013 | Iscover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 30.5.2013 | Kinzalkomb | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 30.5.2013 | Kinzalmono | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 30.5.2013 | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 30.5.2013 | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 30.5.2013 | PANTOZOL Control | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 30.5.2013 | PegIntron | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 30.5.2013 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 30.5.2013 | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 30.5.2013 | SOMAC Control | Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Takeda GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Takeda GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |
| 30.5.2013 | ViraferonPeg | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 31.5.2013 | Imatinib Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| -------------------------------------------- | ----------------------------- | ---------------------------------------------------------- | --------------------------------------------------- | --------------------------------------------- | -------------------------------------------- | ----------------------------------------------- | ----------------------------------------------------- |
| 3.5.2013 | Oncept IL-2 | Feline interleukin-2 recombinant canarypox virus (vCP1338) | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/150 | Lyophilisate and solvent for suspension for injection |
| Merial | | | | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 6.5.2013 | BTVPUR AlSap 1 | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 6.5.2013 | BTVPUR AlSap 1-8 | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 14.5.2013 | Cerenia | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 14.5.2013 | Posatex | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |
| 16.5.2013 | Convenia | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 16.5.2013 | Suvaxyn PCV | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 16.5.2013 | Zulvac 1 Ovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 16.5.2013 | Zulvac 8 Ovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Draxxin | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Improvac | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Pirsue | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Poulvac E. coli | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Quadrisol | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Stronghold | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Zulvac 1+8 Bovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Zulvac 1 Bovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 22.5.2013 | Zulvac 8 Bovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 23.5.2013 | Naxcel | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 23.5.2013 | TruScient | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 27.5.2013 | Equip WNV | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 27.5.2013 | Fevaxyn Pentofel | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 27.5.2013 | Palladia | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 27.5.2013 | Slentrol | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 27.5.2013 | Zulvac 1+8 Ovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 30.5.2013 | Trocoxil | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |

—   Withdrawal of a marketing authorization (Article 38 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 |
| -------------------- | ----------------------------- | ---------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 22.5.2013 | Nobivac Piro | Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/04/046 | 24.5.2013 |

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 |

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

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

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