Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2012-10-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012328EN.01000101.xml










26.10.2012   


EN


Official Journal of the European Union


C 328/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 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 328/01
—   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




3.9.2012


Inlyta


Axitinib







Pfizer Limited




Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/12/777/001-006


Film-coated tablet


L01XE17


5.9.2012




3.9.2012


NovoThirteen


catridecacog







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/12/775/001


Powder and solvent for solution for injection


B02BD11


5.9.2012




20.9.2012


Dacogen


Decitabine







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/12/792/001


powder for concentrate for solution for infusion


L01BC08


24.9.2012




28.9.2012


Enurev Breezhaler


glycopyrronium bromide







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/12/789/001-006


Inhalation powder, hard capsule


R03BB06


3.10.2012




28.9.2012


Seebri Breezhaler


glycopyrronium bromide







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/12/788/001-006


Inhalation powder, hard capsule


R03BB06


3.10.2012




28.9.2012


Tovanor Breezhaler


glycopyrronium bromide







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/12/790/001-006


Inhalation powder, hard capsule


R03BB06


3.10.2012







—   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




10.9.2012


Advate







Baxter AG




Industriesstrasse 67, 1221 Wien, Österreich






EU/1/03/271/007-010


12.9.2012




10.9.2012


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/02/237/001-009


12.9.2012




10.9.2012


Entacapone Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/665/001-004


12.9.2012




10.9.2012


JEVTANA







Sanofi-aventis groupe




54, rue de la Boétie, F-75008 France






EU/1/11/676/001


12.9.2012




10.9.2012


Levetiracetam ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/11/702/001-031


12.9.2012




10.9.2012


Norvir







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom






EU/1/96/016/001
EU/1/96/016/003-008


12.9.2012




10.9.2012


Orgalutran







N.V. Organon




P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland






EU/1/00/130/001-002


12.9.2012




10.9.2012


Ozurdex







Allergan Pharmaceuticals (Ireland) Ltd




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/10/638/001


12.9.2012




10.9.2012


Rasilamlo







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/11/686/001-056


12.9.2012




10.9.2012


Rasitrio







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/11/730/001-060


12.9.2012




10.9.2012


Revlimid







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom






EU/1/07/391/001-006


12.9.2012




10.9.2012


Sildenafil Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/584/002-006
EU/1/09/584/008-012
EU/1/09/584/014-018


12.9.2012




10.9.2012


Simponi







Janssen Biologics B.V.




Einsteinweg 101, CB Leiden 2333, Nederland






EU/1/09/546/001-004


12.9.2012




10.9.2012


Somavert







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/02/240/001-004


12.9.2012




10.9.2012


Tamiflu







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/02/222/001-005


12.9.2012




10.9.2012


Trobalt







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/11/681/001-013


12.9.2012




10.9.2012


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/382/001-018


12.9.2012




11.9.2012


Clopidogrel ratiopharm







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/554/001-008


13.9.2012




11.9.2012


Docetaxel Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/611/001-002


13.9.2012




12.9.2012


Clopidogrel Krka







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556/001-011


14.9.2012




12.9.2012


Clopidogrel Krka d.d.







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/562/001-009


14.9.2012




12.9.2012


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555/001-009


14.9.2012




17.9.2012


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland






EU/1/07/430/001-002


19.9.2012




17.9.2012


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/07/419/001-012


19.9.2012




17.9.2012


Clopidogrel ratiopharm GmbH







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/541/001-008


19.9.2012




17.9.2012


Glubrava







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/07/421/001-009


19.9.2012




17.9.2012


Levetiracetam Accord







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom






EU/1/11/712/001-040


19.9.2012




17.9.2012


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D, 182 33 Danderyd, Sverige






EU/1/01/189/001-006


19.9.2012




20.9.2012


Azarga







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/08/482/001-002


24.9.2012




20.9.2012


Leflunomide ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/10/654/001-004


24.9.2012




20.9.2012


Mircera







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/07/400/008-013
EU/1/07/400/017-024


24.9.2012




20.9.2012


Olanzapine Apotex







Apotex Europe B.V.




Darwingweg 20, 2333 CR Leiden, Nederland






EU/1/10/635/001-018


24.9.2012




20.9.2012


Optaflu







Novartis Vaccines and Diagnostics GmbH




Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland






EU/1/07/394/001-009


24.9.2012




20.9.2012


Prialt







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom






EU/1/04/302/001-004


24.9.2012




20.9.2012


Sutent







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/06/347/001-008


24.9.2012




20.9.2012


Tasigna







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/422/001-012


24.9.2012




20.9.2012


Tesavel







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/435/001-018


24.9.2012




20.9.2012


Torisel







Pfizer Limited




Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/07/424/001


24.9.2012




20.9.2012


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/04/274/001-002


24.10.2012




20.9.2012


Xeloda







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/00/163/001-002


24.9.2012




24.9.2012


alli







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/401/007-016


26.9.2012




24.9.2012


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D, 182 33 Danderyd, Sverige






EU/1/06/365/001-003


26.9.2012




24.9.2012


Komboglyze







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/11/731/004-005
EU/1/11/731/010-011
EU/1/11/731/013-014


24.9.2012




24.9.2012


Nevanac







Alcon Laboratories (UK) Ltd.




Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/07/433/001


26.9.2012




24.9.2012


PecFent







Archimedes Development Ltd




Nottingham, NGT7 2TN, United Kingdom






EU/1/10/644/001-006


27.9.2012




24.9.2012


Pramipexole Accord







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom






EU/1/11/728/001-010


24.9.2012




24.9.2012


Revasc







Canyon Pharmaceuticals Ltd




7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom






EU/1/97/043/001-003


26.9.2012




24.9.2012


Torisel







Pfizer Limited




Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/07/424/001


26.9.2012




24.9.2012


Xenical







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/98/071/001-006


26.9.2012




28.9.2012


Irbesartan Zentiva







Sanofi




54, rue La Boétie, 75008 Paris, France






EU/1/06/376/001-039


3.10.2012




28.9.2012


Matever







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/11/711/001-030


3.10.2012




28.9.2012


Pegasys







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/02/221/001-016


3.10.2012







—   Modification 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




28.9.2012


Libertek







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






–


4.10.2012







—   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




10.9.2012


Rivastigmine Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/513/001-020


12.9.2012







—   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




3.9.2012


BTVPUR AlSap 8







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/09/094/001-005


5.9.2012




10.9.2012


TruScient







Pfizer Limited




Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom






EU/2/11/136/001


12.9.2012




10.9.2012


Veraflox







Bayer Animal Health GmbH




51368 Leverkusen, Deutschland






EU/2/10/107/001-014


12.9.2012




11.9.2012


Porcilis PCV







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/091/001-010


13.9.2012




28.9.2012


SevoFlo







Abbott Laboratories Limited




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM






EU/2/02/035/007


5.10.2012




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.