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)
Date: 2013-01-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013024EN.01000101.xml










25.1.2013   


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.