EN Official Journal of the European Union C 328/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 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 328/01

— 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 3.9.2012 Inlyta Axitinib Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/12/777/001-006 Film-coated tablet L01XE17 5.9.2012 3.9.2012 NovoThirteen catridecacog Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/775/001 Powder and solvent for solution for injection B02BD11 5.9.2012 20.9.2012 Dacogen Decitabine Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792/001 powder for concentrate for solution for infusion L01BC08 24.9.2012 28.9.2012 Enurev Breezhaler glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/12/789/001-006 Inhalation powder, hard capsule R03BB06 3.10.2012 28.9.2012 Seebri Breezhaler glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/12/788/001-006 Inhalation powder, hard capsule R03BB06 3.10.2012 28.9.2012 Tovanor Breezhaler glycopyrronium bromide Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/12/790/001-006 Inhalation powder, hard capsule R03BB06 3.10.2012





— 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 10.9.2012 Advate Baxter AG Industriesstrasse 67, 1221 Wien, Österreich EU/1/03/271/007-010 12.9.2012 10.9.2012 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/237/001-009 12.9.2012 10.9.2012 Entacapone Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/665/001-004 12.9.2012 10.9.2012 JEVTANA Sanofi-aventis groupe 54, rue de la Boétie, F-75008 France EU/1/11/676/001 12.9.2012 10.9.2012 Levetiracetam ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/702/001-031 12.9.2012 10.9.2012 Norvir Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-008 12.9.2012 10.9.2012 Orgalutran N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/00/130/001-002 12.9.2012 10.9.2012 Ozurdex Allergan Pharmaceuticals (Ireland) Ltd Castlebar Road, Westport, Co. Mayo, Ireland EU/1/10/638/001 12.9.2012 10.9.2012 Rasilamlo Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/686/001-056 12.9.2012 10.9.2012 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/730/001-060 12.9.2012 10.9.2012 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom EU/1/07/391/001-006 12.9.2012 10.9.2012 Sildenafil Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/584/002-006 EU/1/09/584/008-012 EU/1/09/584/014-018 12.9.2012 10.9.2012 Simponi Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland EU/1/09/546/001-004 12.9.2012 10.9.2012 Somavert Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/240/001-004 12.9.2012 10.9.2012 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-005 12.9.2012 10.9.2012 Trobalt Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/681/001-013 12.9.2012 10.9.2012 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 12.9.2012 11.9.2012 Clopidogrel ratiopharm Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/554/001-008 13.9.2012 11.9.2012 Docetaxel Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/611/001-002 13.9.2012 12.9.2012 Clopidogrel Krka KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556/001-011 14.9.2012 12.9.2012 Clopidogrel Krka d.d. KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562/001-009 14.9.2012 12.9.2012 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland EU/1/09/555/001-009 14.9.2012 17.9.2012 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430/001-002 19.9.2012 17.9.2012 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419/001-012 19.9.2012 17.9.2012 Clopidogrel ratiopharm GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/541/001-008 19.9.2012 17.9.2012 Glubrava Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/07/421/001-009 19.9.2012 17.9.2012 Levetiracetam Accord Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/712/001-040 19.9.2012 17.9.2012 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/01/189/001-006 19.9.2012 20.9.2012 Azarga Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/08/482/001-002 24.9.2012 20.9.2012 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654/001-004 24.9.2012 20.9.2012 Mircera 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 24.9.2012 20.9.2012 Olanzapine Apotex Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/10/635/001-018 24.9.2012 20.9.2012 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland EU/1/07/394/001-009 24.9.2012 20.9.2012 Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom EU/1/04/302/001-004 24.9.2012 20.9.2012 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 24.9.2012 20.9.2012 Tasigna Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422/001-012 24.9.2012 20.9.2012 Tesavel Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435/001-018 24.9.2012 20.9.2012 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/07/424/001 24.9.2012 20.9.2012 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274/001-002 24.10.2012 20.9.2012 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163/001-002 24.9.2012 24.9.2012 alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-016 26.9.2012 24.9.2012 Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige EU/1/06/365/001-003 26.9.2012 24.9.2012 Komboglyze Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/731/004-005 EU/1/11/731/010-011 EU/1/11/731/013-014 24.9.2012 24.9.2012 Nevanac Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/07/433/001 26.9.2012 24.9.2012 PecFent Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-006 27.9.2012 24.9.2012 Pramipexole Accord Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/728/001-010 24.9.2012 24.9.2012 Revasc Canyon Pharmaceuticals Ltd 7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom EU/1/97/043/001-003 26.9.2012 24.9.2012 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/07/424/001 26.9.2012 24.9.2012 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071/001-006 26.9.2012 28.9.2012 Irbesartan Zentiva Sanofi 54, rue La Boétie, 75008 Paris, France EU/1/06/376/001-039 3.10.2012 28.9.2012 Matever Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/11/711/001-030 3.10.2012 28.9.2012 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221/001-016 3.10.2012





— Modification 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 28.9.2012 Libertek Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland – 4.10.2012





— 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 10.9.2012 Rivastigmine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/513/001-020 12.9.2012





— 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 3.9.2012 BTVPUR AlSap 8 MERIAL 29 avenue Tony Garnier, 69007 LYON, France EU/2/09/094/001-005 5.9.2012 10.9.2012 TruScient Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/2/11/136/001 12.9.2012 10.9.2012 Veraflox Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/10/107/001-014 12.9.2012 11.9.2012 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/091/001-010 13.9.2012 28.9.2012 SevoFlo Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM EU/2/02/035/007 5.10.2012

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.