EN Official Journal of the European Union C 24/1

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 EU/1/12/803 Powder and gel for gel Pending 20.12.2012 20.12.2012 Betmiga mirabegron Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/12/809 Prolonged-release tablet G04BD12 7.1.2013





— 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 EU/1/09/587 12.12.2012 10.12.2012 Olanzapine Glenmark Europe Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom EU/1/09/588 12.12.2012 10.12.2012 Sifrol Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/050 12.12.2012 17.12.2012 Avamys Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/434 19.12.2012 17.12.2012 Clopidogrel Zentiva sanofi-aventis groupe 54, rue La Boétie, 75008 Paris EU/1/08/465 19.12.2012 17.12.2012 Januvia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 19.12.2012 18.12.2012 Actos Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/150 20.12.2012 18.12.2012 Afinitor Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538 21.12.2012 18.12.2012 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118 20.12.2012 18.12.2012 Efficib Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 20.12.2012 18.12.2012 Glubrava Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/07/421 20.12.2012 18.12.2012 Glustin Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/00/151 20.12.2012 18.12.2012 Janumet Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 20.12.2012 18.12.2012 Leganto UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 20.12.2012 18.12.2012 Pritor Bayer Pharma AG 13342 Berlin, Deutschland EU/1/98/089 20.12.2012 18.12.2012 Ristaben Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 20.12.2012 18.12.2012 Ristfor Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 20.12.2012 18.12.2012 TachoSil Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277 20.12.2012 18.12.2012 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/443 20.12.2012 18.12.2012 Velmetia Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 20.12.2012 18.12.2012 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 20.12.2012 18.12.2012 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 20.12.2012 20.12.2012 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447 24.12.2012 20.12.2012 Competact Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/06/354 24.12.2012 20.12.2012 Effentora Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/08/441 27.12.2012 20.12.2012 Exjade Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356 2.1.2013 20.12.2012 Extavia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454 21.12.2012 20.12.2012 Kinzalmono Bayer Pharma AG Berlin 13342, Deutschland EU/1/98/091 2.1.2013 20.12.2012 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604 27.12.2012 20.12.2012 Micardis Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/98/090 27.12.2012 20.12.2012 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 2.1.2012 20.12.2012 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 2.1.2013 20.12.2012 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland EU/1/97/055 27.12.2012 20.12.2012 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 2.1.2013





— 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 EU/1/09/509 11.12.2012 6.12.2012 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/527 11.12.2012





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

Date of the Décision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 6.12.2012 Contacera Meloxicam Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/12/144 Solution for injection QM01AC06 11.12.2012





— 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 6.12.2012 Coxevac CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/10/110 11.12.2012 10.12.2012 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004 12.12.2012 10.12.2012 Nobilis Influenza H5N2 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/06/061 12.12.2012 10.12.2012 Procox Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/11/123 12.12.2012 18.12.2012 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/07/078 20.12.2012

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

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

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