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)
Date: 2012-12-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012401EN.01000101.xml










28.12.2012   


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.