# C_2013024EN.01000101.xml

| 25.1.2013 | EN | Official Journal of the European Union | C 24/1 |
| --------- | -- | -------------------------------------- | ------ |

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

(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 24/01

—   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 |
| ---------------------------------------------- | ----------------------------- | -------------------------------------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------- | ----------------------------------------------- | ------------------------ |
| 18.12.2012 | NexoBrid | Concentrate of proteolytic enzymes enriched in bromelain | TEVA Pharma GmbH Graf-Arco-Str. 3, 89079 Ulm, Deutschland | TEVA Pharma GmbH | Graf-Arco-Str. 3, 89079 Ulm, Deutschland | EU/1/12/803 | Powder and gel for gel |
| TEVA Pharma GmbH | | | | | | | |
| Graf-Arco-Str. 3, 89079 Ulm, Deutschland | | | | | | | |
| 20.12.2012 | Betmiga | mirabegron | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, 2353 EW Leiderdorp, Nederland | EU/1/12/809 | Prolonged-release tablet |
| Astellas Pharma Europe B.V. | | | | | | | |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland | | | | | | | |

—   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 |
| ----------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | ----------------------------------------------------------------------------------- |
| 10.12.2012 | Olanzapine Glenmark | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 10.12.2012 | Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 10.12.2012 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 17.12.2012 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 17.12.2012 | Clopidogrel Zentiva | sanofi-aventis groupe 54, rue La Boétie, 75008 Paris | sanofi-aventis groupe | 54, rue La Boétie, 75008 Paris |
| sanofi-aventis groupe | | | | |
| 54, rue La Boétie, 75008 Paris | | | | |
| 17.12.2012 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | Actos | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 18.12.2012 | Afinitor | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.12.2012 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 18.12.2012 | Efficib | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | Glubrava | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 18.12.2012 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 18.12.2012 | Janumet | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | 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 | | | | |
| 18.12.2012 | Pritor | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 18.12.2012 | Ristaben | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | Ristfor | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | TachoSil | Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich | Nycomed Austria GmbH | St.-Peter-Strasse 25, A-4020 Linz, Österreich |
| Nycomed Austria GmbH | | | | |
| St.-Peter-Strasse 25, A-4020 Linz, Österreich | | | | |
| 18.12.2012 | Thalidomide Celgene | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | | | | |
| 18.12.2012 | Velmetia | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.12.2012 | Zytiga | 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 | | | | |
| 20.12.2012 | Adenuric | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | | | | |
| 20.12.2012 | Competact | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 20.12.2012 | Effentora | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 20.12.2012 | Exjade | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 20.12.2012 | Extavia | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 20.12.2012 | Kinzalmono | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, Deutschland |
| Bayer Pharma AG | | | | |
| Berlin 13342, Deutschland | | | | |
| 20.12.2012 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 20.12.2012 | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 20.12.2012 | Prevenar 13 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 20.12.2012 | Tesavel | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 20.12.2012 | Viramune | 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 | | | | |
| 20.12.2012 | Zelboraf | 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 | | | | |

—   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 |
| ------------------------------------------ | ----------------------------- | ----------------------------------------------------------- | --------------------------------------------- | ------------------------------------------ |
| 6.12.2012 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 6.12.2012 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 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 Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------------------------------------- | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- | ----------------------------------------------- | ---------------------- |
| 6.12.2012 | Contacera | Meloxicam | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | EU/2/12/144 | Solution for injection |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | | | | | | | |

—   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 |
| --------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------- | --------------------------------------------------- |
| 6.12.2012 | Coxevac | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, 33500 Libourne, France |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, 33500 Libourne, France | | | | |
| 10.12.2012 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, Deutschland | | | | |
| 10.12.2012 | Nobilis Influenza H5N2 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | | | | |
| 10.12.2012 | Procox | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen, Deutschland | | | | |
| 18.12.2012 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, IRELAND | | | | |

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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