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)
Date: 2013-11-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013350EN.01002601.xml










29.11.2013   


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.