Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-09-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009231EN.01002001.xml










25.9.2009   


EN


Official Journal of the European Union


C 231/20





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 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 231/05
—   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




3.8.2009


Afinitor


Everolimus







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/09/538/001-006


Tablet


L01XE10


5.8.2009




3.8.2009


Samsca


Tolvaptan







Otsuka Pharmaceutical Europe Ltd




Hunton House Highbridge




Business Park




Oxford Road




Uxbridge




Middlesex




UB8 1HU




UNITED KINGDOM






EU/1/09/539/001-004


Tablet


C03XA01


5.8.2009




—   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




3.8.2009


SUTENT







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/06/347/001-008


5.8.2009




3.8.2009


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/343/001-007


5.8.2009




3.8.2009


INTELENCE







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/08/468/001


5.8.2009




3.8.2009


Revatio







Pfizer Limited




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/05/318/001


5.8.2009




3.8.2009


PegIntron







Schering Plough Europe




Rue de Stalle 73




1180 Bruxelles




BELGIQUE




Stallestraat 73




1180 Brussel




BELGIË






EU/1/00/131/001-050


5.8.2009




3.8.2009


Champix







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/06/360/001-012


5.8.2009




3.8.2009


FOSAVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/05/310/001-009


5.8.2009




6.8.2009


Lucentis







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/06/374/001


10.8.2009




6.8.2009


TESAVEL







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/435/001-018


10.8.2009




6.8.2009


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/458/001-014


10.8.2009




6.8.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


10.8.2009




6.8.2009


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/460/001-014


10.8.2009




6.8.2009


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/459/001-014


10.8.2009




7.8.2009


CELSENTRI







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/418/001-010


11.8.2009




7.8.2009


Prepandrix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/453/002


11.8.2009




7.8.2009


Lyrica







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/04/279/001-043


11.8.2009




7.8.2009


Revlimid







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




Berkshire




SL4 1NA




UNITED KINGDOM






EU/1/07/391/001-004


11.8.2009




13.8.2009


Oprymea







KRKA, d. d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/08/469/001-025


17.8.2009




13.8.2008


Clopidogrel BMS







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/08/464/001-019


17.8.2009




13.8.2008


Clopidogrel Winthrop







Sanofi Pharma Bristol-Myers Squibb SNC




174 Avenue de France




75013 Paris




FRANCE






EU/1/08/465/001-019


17.8.2009




18.8.2009


Nobilis Influenza H5N6







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/07/076/001-004


20.8.2009




20.8.2009


Lyrica







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/04/279/001-043


24.8.2009




20.8.2009


SUTENT







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/06/347/001-008


24.8.2009




20.8.2009


TESAVEL







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/435/001-018


24.8.2009




20.8.2009


Pramipexole Teva







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/08/490/001-016


24.8.2009




20.8.2009


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/442/001-008


24.8.2009




20.8.2009


Apidra







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/04/285/001-036


24.8.2009




21.8.2009


PEGASYS







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/02/221/001-010


25.8.2009




21.8.2009


Galvus







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/414/001-010
EU/1/07/414/018


25.8.2009




21.8.2009


TORISEL







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/07/424/001


25.8.2009




21.8.2009


Jalra







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/08/485/001-011


25.8.2009




21.8.2009


Mycophenolate mofetil Teva







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/07/439/001-004


25.8.2009




21.8.2009


TARGRETIN







Eisai Limited, European Knowledge Centre




Mosquito Way




Hatfield




Hertfordshire




AL10 9SN




UNITED KINGDOM






EU/1/01/178/001


25.8.2009




21.8.2009


AVANDIA







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/00/137/002-018


25.8.2009




21.8.2009


Myfenax







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/07/438/001-004


25.8.2009




21.8.2009


Kaletra







Abbott Laboratories Ltd




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






EU/1/01/172/001-006


25.8.2009




21.8.2009


Myozyme







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/06/333/001-003


25.8.2009




21.8.2009


Luminity







Lantheus MI UK Limited




One South Place




London




EC2M 2WG




UNITED KINGDOM






EU/1/06/361/001-002


25.8.2009




21.8.2009


Januvia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/383/001-018


25.8.2009




21.8.2009


Rotarix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/05/330/001-011


25.8.2009




21.8.2009


Privigen







CSL Behring GmbH




Emil von Behring Strasse 76




35041 Marburg




DEUTSCHLAND






EU/1/08/446/001-006


25.8.2009




21.8.2009


Competact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




UNITED KINGDOM






EU/1/06/354/001-009


25.8.2009




21.8.2009


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House




Highbridge Business Park




Oxford Road




Uxbridge




Middlesex




UB8 1HU




UNITED KINGDOM






EU/1/04/276/001-020
EU/1/04/276/024-036


25.8.2009




21.8.2009


Mabthera







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/98/067/001-002


25.8.2009




25.8.2009


Epoetin alfa Hexal







Hexal AG.




Industriestrasse 25




83607 Holzkirchen




DEUTSCHLAND






EU/1/07/411/001-020


27.8.2009




25.8.2009


Avandamet







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/03/258/001-022


27.8.2009




25.8.2009


Ranexa







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare




1611 Luxembourg




LUXEMBOURG






EU/1/08/462/001-012


27.8.2009




25.8.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


27.8.2009




25.8.2009


Binocrit







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




ÖSTERREICH






EU/1/07/410/001-020


27.8.2009




25.8.2009


Xiliarx







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/08/486/001-011


27.8.2009




27.8.2009


Thalidomide Celgene







Celgene Europe Limited




Riverside House




Riverside Walk




Windsor




SL4 1NA




UNITED KINGDOM






EU/1/08/443/001


1.9.2009




27.8.2009


CELVAPAN







Baxter AG




Industriestraße 67




1221 Wien




ÖSTERREICH






EU/1/08/506/001


1.9.2009




27.8.2009


Champix







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/06/360/001-012


1.9.2009




27.8.2009


Zeffix







Glaxo Group Ltd.




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/114/001-003


1.9.2009




27.8.2009


Iscover







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/98/070/001a-001b
EU/1/98/070/002a-002b
EU/1/98/070/003a-003b
EU/1/98/070/004a-004b
EU/1/98/070/005a-005b
EU/1/98/070/006a-006b
EU/1/98/070/007a-007b
EU/1/98/070/008-010
EU/1/98/070/011a-011b


1.9.2009




27.8.2009


Xeristar







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/04/297/001-008


31.8.2009




27.8.2009


Vfend







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/02/212/001-026


1.9.2009




28.8.2009


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/460/001-014


1.9.2009




28.8.2009


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/459/001-014


1.9.2009




28.8.2009


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/458/001-014


1.9.2009




28.8.2009


Irbesartan Krka







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/08/480/001-018


1.9.2009




28.8.2009


Volibris







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/08/451/001-004


1.9.2009




28.8.2009


Panretin







Eisai Limited, European Knowledge Centre




Mosquito Way




Hatfield




Hertfordshire




AL10 9SN




UNITED KINGDOM






EU/1/00/149/001


1.9.2009




28.8.2009


Humira







Abbott Laboratories Ltd




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






EU/1/03/256/001-010


1.9.2009




28.8.2009


Forsteo







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/03/247/001-002


1.9.2009




28.8.2009


Invanz







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/02/216/001-002


1.9.2009




28.8.2009


Zerit







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/96/009/001-009


1.9.2009




28.8.2009


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b
EU/1/98/069/005a-005b
EU/1/98/069/006a-006b
EU/1/98/069/007a-007b
EU/1/98/069/008-010
EU/1/98/069/011a-011b


1.9.2009




28.8.2009


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




58638 Iserlohn




DEUTSCHLAND






EU/1/07/412/001-020


1.9.2009




28.8.2009


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/02/213/001-023


1.9.2009




28.8.2009


Eucreas







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/425/001-018


1.9.2009




28.8.2009


Aldara







Meda AB




Pipers väg 2




SE-170 73 Solna




SVËRIGE






EU/1/98/080/001


1.9.2009




28.8.2009


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/382/001-018


1.9.2009




31.8.2009


Betaferon







Bayer Schering Pharma AG




Müllerstrasse 170-178




13342 Berlin




DEUTSCHLAND






EU/1/95/003/009-010


2.9.2009




31.8.2009


Neupro







Schwarz Pharma Ltd




Shannon, Industrial Estate




Co.Clare




IRELAND






EU/1/05/331/001-055


2.9.2009




31.8.2009


Icandra







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/08/484/001-018


2.9.2009




31.8.2009


Mimpara







Amgen Europe B.V.




Minervum 7061




4817 ZK Breda




NEDERLAND






EU/1/04/292/001-012


2.9.2009




31.8.2009


Tandemact







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwich




London




WC2B 4AE




UNITED KINGDOM






EU/1/06/366/005-022


2.9.2009




31.8.2009


Gardasil







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/357/001-021


2.9.2009




31.8.2009


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




Unit 13, Stillorgan Industrial Park




Blackrock, Co.Dublin




IRELAND






EU/1/07/430/001-002


2.9.2009




—   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




27.8.2009


Aivlosin







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey




KT3 4QS




UNITED KINGDOM






EU/2/04/044/001-010


31.8.2009




31.8.2009


Locatim







Biokema Anstalt




Pflugstrasse 12




9490 Vaduz, Fürstentum




LIECHTENSTEIN






EU/2/99/011/001


2.9.2009




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.