EN Official Journal of the European Union C 350/26

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013

(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

2013/C 350/02

— 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 18.10.2013 Defitelio defibrotide Gentium S.p.A. Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia EU/1/13/878 Concentrate for solution for infusion B01AX01 22.10.2013 18.10.2013 Grastofil filgrastim Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/13/877 Solution for injection or infusion L03AA02 22.10.2013





— 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 2.10.2013 Myocet Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/00/141 4.10.2013 2.10.2013 Spedra Menarini International Operations Luxembourg S.A. 1, avenue de la Gare - L-1611 Luxembourg EU/1/13/841 4.10.2013 2.10.2013 Zonegran Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/04/307 4.10.2013 4.10.2013 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355 8.10.2013 4.10.2013 Ganfort Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland EU/1/06/340 8.10.2013 9.10.2013 Biograstim AbZ-Pharma GmbH Graf -Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/450 11.10.2013 9.10.2013 Biopoin Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/565 11.10.2013 9.10.2013 Bridion Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/466 18.10.2013 9.10.2013 Revestive NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland EU/1/12/787 11.10.2013 11.10.2013 Foscan Biolitec Pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland EU/1/01/197 14.10.2013 18.10.2013 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 22.10.2013 18.10.2013 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 22.10.2013 24.10.2013 ADCETRIS Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/12/794 28.10.2013 24.10.2013 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 28.10.2013 31.10.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 17.10.2013 31.10.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 4.11.2013 31.10.2013 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 5.11.2013





— 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 25.10.2013 Clopidogrel ratiopharm Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika EU/1/09/554 28.10.2013





— 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 11.10.2013 Equip WNV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/08/086 15.10.2013 18.10.2013 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 22.10.2013

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.