Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-10-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product, withdrawal from the market








C_2009260EN.01000601.xml










30.10.2009   


EN


Official Journal of the European Union


C 260/6





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 September 2009 to 30 September 2009

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

2009/C 260/04
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




21.9.2009


Cayston


Aztreonam







Gilead Sciences International Limited




Granta Park




Abington




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/09/543/001


Powder and solvent for nebuliser solution


J01DF01


23.9.2009




21.9.2009


Clopidogrel Sandoz


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/547/001-007


Film-coated tablet


B01AC-04


23.9.2009




21.9.2009


Vizarsin


Sildenafil







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/551/001-012


Film-coated tablet


G04B E03


23.9.2009




21.9.2009


Clopidogrel DURA


Clopidogrel







Mylan dura GmbH




Wittichstraße 6




64295 Darmstadt




DEUTSCHLAND






EU/1/09/560/001-009


Film-coated tablet


B01AC-04


23.9.2009




21.9.2009


Clopidogrel HCS


Clopidogrel







HCS bvba




H. Kennisstraat 53




2650 Edegem




BELGÏE






EU/1/09/561/001-009


Film-coated tablet


V03AC02


23.9.2009




21.9.2009


Topotecan Teva


Topotecan







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/552/001-004


Concentrate for solution for infusion


L01XX17


23.9.2009




21.9.2009


Zopya


Clopidogrel







Norpharm Regulatory Services Ltd.




26 Laurence Street




Drogheda




Co. Louth




IRELAND






EU/1/09/562/001-009


Film-coated tablet


B01AC-04


23.9.2009




21.9.2009


Zylagren


Clopidogrel







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/558/001-010


Film-coated tablet


B01AC-04


23.9.2009




21.9.2009


Clopidogrel Mylan


Clopidogrel







Mylan S.A.S




117 Allée des Parcs




69800 Saint Priest




FRANCE






EU/1/09/559/001-009


Film-coated tablet


B01AC-04


23.9.2009




21.9.2009


Javlor


Vinflunine ditartrate







Pierre Fabre Médicament




45 place Abel Gance




92100 Boulogne




FRANCE






EU/1/09/550/001-012


Concentrate for solution for infusion


L01CA05


23.9.2009




21.9.2009


Clopidogrel Acino Pharma GmbH


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/548/001-007


Film-coated tablet


B01AC-04


23.9.2009




23.9.2009


Clopidogrel TAD


Clopidogrel







TAD Pharma GmbH




Heinz-Lohmann-Straße 5




27472 Cuxhaven




DEUTSCHLAND






EU/1/09/555/001-009


Film-coated tablet


B01AC-04


25.9.2009




23.9.2009


Clopidogrel Krka


Clopidogrel







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/556/001-009


Film-coated tablet


B01AC-04


25.9.2009




23.9.2009


Clopidogrel Qualimed


Clopidogrel







Qualimed




117 Allée des Parcs




69800 Saint Priest




FRANCE






EU/1/09/557/001-009


Film-coated tablet


B01AC-04


25.9.2009




23.9.2009


Clopidogrel ratiopharm


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/554/001-007


Film-coated tablet


B01AC-04


25.9.2009




28.9.2009


Clopidogrel Acino Pharma


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/549/001-007


Film-coated tablet


B01AC-04


30.9.2009




28.9.2009


Zyllt


Clopidogrel







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/553/001-010


Film-coated tablet


B01AC-04


30.9.2009




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




2.9.2009


Zomarist







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/08/483/001-018


7.9.2009




2.9.2009


Keppra







UCB Pharma SA.




Allée de la Recherche/Researchdreef 60




1070 Bruxelles/Brussel




BELGIQUE/BELGIË






EU/1/00/146/001-032


7.9.2009




2.9.2009


Inovelon







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Herts




AL10 9SN




UNITED KINGDOM






EU/1/06/378/001-016


7.9.2009




2.9.2009


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road




Westport




Co. Mayo




IRELAND






EU/1/02/205/001-002


7.9.2009




2.9.2009


Norvir







Abbott Laboratories Ltd.




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






EU/1/96/016/001
EU/1/96/016/003-004


7.9.2009




2.9.2009


Silgard







Merck Sharp & Dohme Ltd.




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/358/001-021


7.9.2009




4.9.2009


Zevalin







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/03/264/001


7.9.2009




4.9.2009


Prialt







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Herts




AL10 9SN




UNITED KINGDOM






EU/1/04/302/001-004


7.9.2009




7.9.2009


Sebivo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/388/001-003


9.9.2009




9.9.2009


Isentress







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/436/001-002


15.9.2009




9.9.2009


Tamiflu







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/02/222/001-004


15.9.2009




14.9.2009


Avaglim







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/06/349/001-010


15.9.2009




16.9.2009


Efficib







Merck Sharp & Dohme Ltd.




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/457/001-016


18.9.2009




16.9.2009


Velmetia







Merck Sharp & Dohme Ltd.




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/456/001-016


18.9.2009




16.9.2009


Janumet







Merck Sharp & Dohme Ltd.




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/455/001-016


18.9.2009




17.9.2009


Ribavirin Teva







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/509/001-004


21.9.2009




17.9.2009


Lantus







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/00/134/001-037


21.9.2009




17.9.2009


Actos







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych




London




WC2B 4AE




UNITED KINGDOM






EU/1/00/150/001-024


21.9.2009




17.9.2009


Glustin







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych




London




WC2B 4AE




UNITED KINGDOM






EU/1/00/151/001-024


21.9.2009




17.9.2009


Optisulin







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/00/133/001-032


21.9.2009




17.9.2009


Doribax







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/08/467/001


21.9.2009




17.9.2009


Duloxetine Boehringer Ingelheim







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/471/001-012


21.9.2009




17.9.2009


Glubrava







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych




London




WC2B 4AE




UNITED KINGDOM






EU/1/07/421/001-009


21.9.2009




21.9.2009


Orfadin







Swedish Orphan International AB




Drottninggatan 98




SE-111 60 Stockholm




SVERIGE






EU/1/04/303/001-003


23.9.2009




21.9.2009


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D




SE-182 33 Danderyd




SVERIGE






EU/1/06/365/001-003


23.9.2009




21.9.2009


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/290/001-002


23.9.2009




21.9.2009


Ferriprox







Apotex Europe B.V.




Darwingweg 20




2333 CR Leiden




NEDERLAND






EU/1/99/108/001-003


23.9.2009




21.9.2009


Azilect







Teva Pharma GmbH




Kandelstrasse 10




79199 Kirchzarten




DEUTSCHLAND






EU/1/04/304/001-007


23.9.2009




21.9.2009


Trisenox







Cephalon Europe




5 Rue Charles Martigny




94700 Maisons Alfort, Cedex




FRANCE






EU/1/02/204/001


23.9.2009




23.9.2009


Mimpara







Amgen Europe B.V.




Minervum 7061




4817 ZK Breda




NEDERLAND






EU/1/04/292/001-012


25.9.2009




24.9.2009


Emselex







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/04/294/001-028


28.9.2009




25.9.2009


Qutenza







Astellas Pharma Europe B.V.




Elisabethhof 19




2353 EW Leiderdorp




NEDERLAND









NeurogesX UK Limited




265 Strand




London




WC2R 1BH




UNITED KINGDOM






EU/1/09/524/001-002


29.9.2009




29.9.2009


Focetria







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina 1




Siena SI




ITALIA






EU/1/07/385/001-004


30.9.2009




29.9.2009


Pandemrix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


30.9.2009




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Rejected










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




14.9.2009


Lyrica







Pfizer Ltd.




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/04/279/001-043


16.9.2009




—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004)










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




2.9.2009


Tekturna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/408/001-020


7.9.2009




—   Issuing of a marketing authorisation authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




23.9.2009


Palladia


Toceranib







Pfizer Ltd.




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/2/09/100/001-003


Tablets


QL01XE91


25.9.2009




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




2.9.2009


Cerenia







Pfizer Ltd.




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/2/06/062/001-003
EU/2/06/062/005


7.9.2009




8.9.2009


Posatex







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/08/081/001-003


10.9.2009




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




London




E14 4HB




UNITED KINGDOM






(1)  OJ L 136, 30.4.2004, p. 1.