EN Official Journal of the European Union C 401/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 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 401/01

— 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 29.10.2012 Clopidogrel Teva Generics B.V. Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/650/001-015 31.10.2012 29.10.2012 Desloratadine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/732/001-013 31.10.2012 29.10.2012 Docetaxel Accord Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom EU/1/12/769/001-003 31.10.2012 29.10.2012 Docetaxel Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom EU/1/12/770/001-005 31.10.2012 29.10.2012 Esmya Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/12/750/001-002 31.10.2012 29.10.2012 Galvus Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414/001-010 EU/1/07/414/018 31.10.2012 29.10.2012 Jalra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485/001-011 31.10.2012 29.10.2012 JEVTANA Sanofi-aventis groupe 54, rue de la Boétie, F-75008 France EU/1/11/676/001 31.10.2012 29.10.2012 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland EU/1/10/637/001-009 31.10.2012 29.10.2012 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311/001-003 31.10.2012 29.10.2012 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703/001-003 31.10.2012 29.10.2012 Xiliarx Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486/001-011 31.10.2012 29.10.2012 Zoely Theramex S.r.l. Via Messina 38, 20154 Milano, Italia EU/1/11/690/001-004 9.11.2012 31.10.2012 Clopidogrel Teva Pharma B.V. Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/649/001-016 6.11.2012 31.10.2012 Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/11/685/001-005 6.11.2012 31.10.2012 Lamivudine/Zidovudine Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/663/001-002 6.11.2012 31.10.2012 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/741/001 6.11.2012 31.10.2012 Levetiracetam Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/701/001-032 6.11.2012 31.10.2012 PecFent Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom EU/1/10/644/001-006 6.11.2012 31.10.2012 Rivastigmine Actavis Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/693/001-016 6.11.2012





— 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 29.10.2012 Naxcel Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/05/053/001-003 31.10.2012 29.10.2012 Zuprevo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/124/001-004 31.10.2012

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