EN Official Journal of the European Union C 78/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 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 78/01

— 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 9.1.2012 Efavirenz Teva efavirenz Teva Pharma BV Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/742/001-010 Film-coated tablet J05AG03 11.1.2012 13.1.2012 Desloratadine Actavis desloratadine Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/745/001-009 Film-coated tablet R06AX27 17.1.2012 13.1.2012 Desloratadine ratiopharm desloratadine ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/746/001-012 Film-coated tablet R06AX27 17.1.2012 31.1.2012 Docetaxel Mylan Docetaxel Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France EU/1/11/748/001-006 Concentrate for solution for infusion L01CD02 2.2.2012





— 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 20.1.2012 Luveniq Lux Biosciences GmbH MlawGroup, Maximilianstr. 31, D-80539 Munich, Deutschland. 24.1.2012





— 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 9.1.2012 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/06/378/001-017 11.1.2012 9.1.2012 Leganto UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695/001-055 11.1.2012 9.1.2012 Pumarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/10/664/001 11.1.2012 9.1.2012 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/07/391/001-004 11.1.2012 9.1.2012 Sutent Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/347/001-008 11.1.2012 13.1.2012 Diacomit Biocodex 7 avenue Gallieni, 94250 Gentilly, France EU/1/06/367/001-012 17.1.2012 13.1.2012 Erbitux Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland EU/1/04/281/001-005 17.1.2012 13.1.2012 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/09/564/001-003 18.1.2012 13.1.2012 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006/001-007 17.1.2012 13.1.2012 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-060 18.1.2012 13.1.2012 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/07/391/001-004 18.1.2012 13.1.2012 Stelara Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België EU/1/08/494/001-004 17.1.2012 13.1.2012 Temodal Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/98/096/001-025 18.1.2012 13.1.2012 Twinrix Adult GlaxoSmithKline Biologicals S.A rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/96/020/001-009 17.1.2012 13.1.2012 Twinrix Paediatric GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique EU/1/97/029/001-010 17.1.2012 20.1.2012 Champix Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/06/360/001-013 25.1.2012 20.1.2012 ChondroCelect TiGenix NV Romeinse straat 12/2, B-3001 LEUVEN, België EU/1/09/563/001 24.1.2012 20.1.2012 Clopidogrel Acino Pharma Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/549/001-007 24.1.2012 20.1.2012 Clopidogrel ratiopharm GmbH Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland EU/1/09/541/001-008 24.1.2012 20.1.2012 Glivec Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 25.1.2012 20.1.2012 Humira Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom EU/1/03/256/001-010 24.1.2012 20.1.2012 Irbesartan Zentiva Sanofi-Aventis 174, avenue de France, F-75013 Paris, France EU/1/06/376/001-033 24.1.2012 20.1.2012 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063/001-019 25.1.2012 20.1.2012 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363/001-015 24.1.2012 20.1.2012 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 24.1.2012 20.1.2012 Xelevia Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382/001-018 25.1.2012 20.1.2012 Zostavax Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France EU/1/06/341/001-013 24.1.2012 24.1.2012 Adenuric Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg EU/1/08/447/001-012 26.1.2012 24.1.2012 Celvapan Baxter AG Industriestraße 67, A - 1221 Wien, Österreich EU/1/08/506/001 26.1.2012 24.1.2012 Cerezyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/97/053/001-005 26.1.2012 24.1.2012 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 26.1.2012 30.1.2012 alli Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/401/007-016 1.2.2012 30.1.2012 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 1.2.2012 30.1.2012 IDflu Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507/001-006 1.2.2012 30.1.2012 Jalra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 1.2.2012 30.1.2012 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg – Deutschland EU/1/10/637/001-009 1.2.2012 30.1.2012 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292/001-012 1.2.2012 30.1.2012 Resolor Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België EU/1/09/581/001-008 1.2.2012 30.1.2012 Simulect Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084/001-002 1.2.2012 30.1.2012 Xiliarx Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 1.2.2012 31.1.2012 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/001-005 2.2.2012 31.1.2012 InductOs Medtronic Biopharma BV Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland EU/1/02/226/001 3.2.2012 31.1.2012 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508/001-011 2.2.2012 31.1.2012 Temodal Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België EU/1/98/096/001-025 2.2.2012 31.1.2012 Teysuno Nordic Group BV Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/11/669/001-004 2.2.2012 31.1.2012 Tyverb Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/07/440/001-006 2.2.2012 31.1.2012 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200/001-002 2.2.2012 31.1.2012 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703/001-003 2.2.2012 31.1.2012 Xyrem UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312/001 2.2.2012 31.1.2012 Yondelis Pharma Mar, S.A. Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana EU/1/07/417/001-002 2.2.2012





— 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 9.1.2012 Activyl Tick Plus Indoxacarb + permethrin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/137/001-015 Spot-on solution QP53AC54 11.1.2012





— 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 9.1.2012 Hiprabovis IBR Marker Live Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España EU/2/10/114/001-003 11.1.2012 20.1.2012 Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/001-003 24.1.2012 24.1.2012 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND EU/2/07/078/001-017 26.1.2012 31.1.2012 Metacam Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland EU/2/97/004/001 EU/2/97/004/003-015 EU/2/97/004/026-040 EU/2/97/004/043-049 2.2.2012 31.1.2012 Procox Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/11/123/001-002 2.2.2012 31.1.2012 Suvaxyn Aujeszky 783 +O/W Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/98/009/001-006 3.2.2012 31.1.2012 Zubrin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/00/028/002-008 2.2.2012

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.