Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2009 to 31 May 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-06-26
Institutions: European Commission
Subjects: France, Netherlands, Slovenia, United Kingdom, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009146EN.01000601.xml










26.6.2009   


EN


Official Journal of the European Union


C 146/6





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2009 to 31 May 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 146/03
—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code
(Anatomical Therapeutic Chemical Code)


Date of notification




11.5.2009


Nimvastid


Rivastigmine







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/09/525/001-025
EU/1/09/525/026-046


Capsule, hard
Orodispersible tablet


N06DA03


13.5.2009




15.5.2009


Modigraf


Tacrolimus







Astellas Pharma Europe B.V.




Elisabethhof 19




2353 EW Leiderdorp




NEDERLAND






EU/1/09/523/001-002


Granules for oral suspension


L04AD02


20.5.2009




15.5.2009


Ellaone


Ulipristal acetate







Laboratoire HRA Pharma




15 rue Béranger




75003 Paris




FRANCE






EU/1/09/522/001


Tablet


Non applicable


20.5.2009




15.5.2009


Qutenza


Capsaicin







NeurogesX UK Limited




265 Strand




London




WC2R 1BH




UNITED KINGDOM






EU/1/09/524/001-002


Cutaneous patch


N01BX04


20.5.2009




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




5.5.2009


Kinzalkomb







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/214/001-015


8.5.2009




5.5.2009


Kinzalmono







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/98/091/001-014


7.5.2009




6.5.2009


Pritorplus







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/215/001-021


8.5.2009




6.5.2009


Pritor







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/98/089/001-022


8.5.2009




7.5.2009


Viramune







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/97/055/001-004


11.5.2009




7.5.2009


Privigen







CSL Behring GmbH




Emil von Behring Strasse 76




35041 Marburg




DEUTSCHLAND






EU/1/08/446/001-004


11.5.2009




7.5.2009


Adenuric







Beaufour Ipsen Pharma




24, rue Erlanger




75781 Paris Cedex 16




FRANCE






EU/1/08/447/001-004


11.5.2009




11.5.2009


Tamiflu







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/02/222/001
EU/1/02/222/003-004


13.5.2009




15.5.2009


REYATAZ







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/03/267/001-010


20.5.2009




15.5.2009


Oprymea







KRKA, d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/08/469/001-025


20.5.2009




15.5.2009


Telzir







Glaxo Group Ltd.




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/04/282/001-002


20.5.2009




15.5.2009


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/459/001-014


20.5.2009




15.5.2009


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/460/001-014


20.5.2009




15.5.2009


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/458/001-014


20.5.2009




19.5.2009


Adenuric







Ipsen Pharma




65 quai Georges Gorse




92100 Boulogne-Billancourt




FRANCE









Beaufour Ipsen Pharma




24, rue Erlanger




75781 Paris Cedex 16




FRANCE






EU/1/08/447/001-004


26.5.2009




20.5.2009


Pramipexole Teva







Teva Pharma B.V.




Computerweg 10




DR Utrecht 3542




NEDERLAND






EU/1/08/490/001-016


26.5.2009




26.5.2009


TORISEL







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/07/424/001


28.5.2009




26.5.2009


Luveris







Serono Europe Limited




56, Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/00/155/001-006


28.5.2009




26.5.2009


Tysabri







Elan Pharma International Ltd.




Monksland, Athlone




County Westmeath




IRELAND






EU/1/06/346/001


28.5.2009




26.5.2009


Pritor







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/98/089/001-022


28.5.2009




26.5.2009


Zavesca







Actelion Registration Ltd




BSI Building 13th Floor




389 Chiswick High Road




London




W4 4AL




UNITED KINGDOM






EU/1/02/238/001


28.5.2009




27.5.2009


TRIZIVIR







Glaxo Group Ltd.




Greenford Road




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/00/156/002-003


29.5.2009




27.5.2009


Ventavis







Bayer Schering Pharma AG




Müllerstrasse 170-178




13342 Berlin




DEUTSCHLAND






EU/1/03/255/001-008


29.5.2009




27.5.2009


Rilutek







Aventis Pharma S.A.




20 avenue Raymond Aron




92165 Antony Cedex




FRANCE






EU/1/96/010/001


29.5.2009




27.5.2009


PritorPlus







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/02/215/001-021


29.5.2009




28.5.2009


TESAVEL







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/435/001-018


1.6.2009




28.5.2009


ISENTRESS







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/436/001-002


1.6.2009




28.5.2009


NovoSeven







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DANMARK






EU/1/96/006/001-006


2.6.2009




28.5.2009


AVANDIA







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/00/137/002-018


1.6.2009




28.5.2009


Soliris







Alexion Europe SAS




54-56 Avenue Hoche




75008 Paris




FRANCE






EU/1/07/393/001


2.6.2009




28.5.2009


Tarceva







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/05/311/001-003


1.6.2009




28.5.2009


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/06/368/163-168


2.6.2009




28.5.2009


DepoCyte







Pacira Limited




West Forest Gate




Wellington Road




Wokingham




Berkshire




RG40 2AQ




UNITED KINGDOM






EU/1/01/187/001


1.6.2009




28.5.2009


Gardasil







Sanofi Pasteur MSD SNC




8, rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/357/001-021


2.6.2009




29.5.2009


Ebixa







H. Lundbeck A/S




Ottiliavej 9




2500 Valby




DANMARK






EU/1/02/219/001-049


3.6.2009




29.5.2009


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/98/090/001-020


3.6.2009




29.5.2009


SUTENT







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT 13 9NJ




UNITED KINGDOM






EU/1/06/347/007-008


3.6.2009




29.5.2009


Lyrica







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT 13 9NJ




UNITED KINGDOM






EU/1/04/279/001-043


3.6.2009




29.5.2009


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/02/213/001-023


3.6.2009




29.5.2009


Ziagen







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/112/001-002


3.6.2009




29.5.2009


CellCept







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/96/005/001-006


3.6.2009




29.5.2009


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/382/001-018


3.6.2009




29.5.2009


Viramune







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/97/055/001-004


3.6.2009




29.5.2009


Zostavax







Sanofi Pasteur MSD SNC




8, rue Jonas Salk




Lyon 69007




FRANCE






EU/1/06/341/001-013


3.6.2009




29.5.2009


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D




SE-182 33 Danderyd




SVERIGE






EU/1/01/189/001-006


3.6.2009




29.5.2009


Velcade







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/04/274/001-002


3.6.2009




29.5.2009


Aptivus







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/05/315/001


3.6.2009




29.5.2009


Kinzalkomb







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/02/214/001-015


3.6.2009




29.5.2009


ORENCIA







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/07/389/001-003


3.6.2009




29.5.2009


Avastin







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/04/300/001-002


3.6.2009




29.5.2009


Advate







Baxter AG




Industriesstrasse 67




1220 Vienna




ÖSTERREICH






EU/1/03/271/001-006


3.6.2009




29.5.2009


Kinzalmono







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/98/091/001-014


3.6.2009




29.5.2009


Enbrel







Wyeth Europa Limited




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/99/126/001-018


3.6.2009




29.5.2009


Insuman







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/97/030/028-195


3.6.2009




—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (2)
): 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




11.5.2009


Improvac


Synthetic peptide analogue of GnRF conjugated to a carrier protein of min. 300 μg per 2 ml dose







PFIZER Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/2/09/095/001-003


Solution for injection


QI09AX


13.5.2009




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




8.5.2009


Econor







Novartis Animal Health Austria GmbH




Biochemiestrasse 10




6250 Kundl




ÖSTERREICH






EU/2/98/010/004-006
EU/2/98/010/017-018
EU/2/98/010/021-024


12.5.2009




11.5.2009


Aivlosin







ECO Animal Health Ltd




78 Coombe Road




New Malden




Surrey




KT3 4QS




UNITED KINGDOM






EU/2/04/044/009-010


13.5.2009




19.5.2009


Onsior







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley/Camberley




Surrey




GU16 7SR




UNITED KINGDOM






EU/2/08/089/001-020


21.5.2009




25.5.2009


Advocate







Bayer Animal Health GmbH




51368 Leverkusen




DEUTSCHLAND






EU/2/03/039/001-002
EU/2/03/039/013
EU/2/03/039/019-020


27.5.2009




29.5.2009


Previcox







Merial




29 Avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/04/045/001-007


3.6.2009




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




7.5.2009


Porcilis Porcoli







Intervet International B.V. (NL)




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/96/001/003-008


11.5.2009




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.

(2)  OJ L 136 of 30.4.2004, p. 1.