Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-05-01
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009101EN.01000301.xml










1.5.2009   


EN


Official Journal of the European Union


C 101/3





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 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 101/03
—   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




4.3.2009


CELVAPAN


Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)







Baxter AG




Industriestraße 67




A - 1221 Wien




ÖSTERREICH






EU/1/08/506/001


Suspension for injection


J07BB01


6.3.2009




6.3.2009


MEPACT


mifamurtide







IDM Pharma S.A.




47 rue de Chaillot




75116 Paris




FRANCE






EU/1/08/502/001


Powder for suspension for infusion


L03AX15


23.3.2009




19.3.2009


Fertavid


follitropin beta







SP Europe




Rue de Stalle




73 B-1180 Bruxelles




BELGIQUE






EU/1/09/510/001-019


Solution for injection


G03G A06


23.3.2009




30.3.2009


Synflorix


Pneumococcal polysaccharide conjugate vaccine (adsorbed)







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/09/508/001-009


Suspension for injection


J07AL52


31.3.2009




31.3.2009


Ribavirin Teva


Ribavirin







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/509/001-004


Capsule, hard


J05A B04


2.4.2009




31.3.2009


IXIARO


Japanese Encephalitis vaccine (inactivated, adsorbed)







Intercell AG




Campus Vienna Biocenter 3




A-1030 Wien




ÖSTERREICH






EU/1/08/501/001-002


Suspension for injection


J07BA02


2.4.2009




—   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




2.3.2009


Fendrix







GlaxoSmithKline Biologicals s.a.




rue de l'Institut 89




Rixensart, B-1330




BELGIQUE






EU/1/04/299/001-003


4.3.2009




2.3.2009


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/296/001-009


4.3.2009




2.3.2009


Fareston







Orion Corporation




Orionintie 1




FIN-02200 Espoo




SUOMI






EU/1/96/004/001-002


4.3.2009




2.3.2009


Nexavar







Bayer HealthCare AG




D-51368 Leverkusen




DEUTSCHLAND






EU/1/06/342/001


4.3.2009




2.3.2009


Irbesartan BMS







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/06/375/001-033


4.3.2009




2.3.2009


Aptivus







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/05/315/001


4.3.2009




2.3.2009


Ganfort







Allergan Pharmaceuticals Ireland




Castlebar Road




Westport, Co. Mayo




IRELAND






EU/1/06/340/001-002


5.3.2009




4.3.2009


KOGENATE Bayer







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/00/143/001-011


6.3.2009




4.3.2009


Helixate NexGen







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/00/144/001-004


6.3.2009




4.3.2009


Gardasil







Sanofi Pasteur MSD




SNC, 8, rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/357/001-021


6.3.2009




4.3.2009


Cystadane







Orphan Europe S.a.r.l.




Immeuble Le Wilson




70 Avenue du Général de Gaulle




92800 Puteaux




FRANCE






EU/1/06/379/001


6.3.2009




4.3.2009


Photobarr







Axcan Pharma International BV




Engelenkampstraat 72




6131 JJ Sittard




NEDERLAND






EU/1/04/272/001-002


6.3.2009




6.3.2009


Silgard







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon




Hertfordshire EN11 9BU




UNITED KINGDOM






EU/1/06/358/001-021


10.3.2009




6.3.2009


BYETTA







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/06/362/001-004


10.3.2009




6.3.2009


IntronA







Schering Plough Europe




Rue de Stalle, 73




1180 Bruxelles




BELGIQUE






EU/1/99/127/001-044


10.3.2009




6.3.2009


Remicade







Centocor B.V.




Einsteinweg 101




2333 CB Leiden




NEDERLAND






EU/1/99/116/001-005


10.3.2009




6.3.2009


Protelos







Les Laboratoires Servier




22, rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/288/001-006


10.3.2009




6.3.2009


ATryn







LEO Pharma A/S




Industriparken 55




DK-2750 Ballerup




DANMARK






EU/1/06/355/001-003


10.3.2009




6.3.2009


Irbesartan Hydrochlorothiazide Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




F- 75013 Paris




FRANCE






EU/1/06/377/001-028


10.3.2009




9.3.2009


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main




DEUTSCHLAND






EU/1/00/133/001-032


11.3.2009




9.3.2009


Osseor







Les Laboratoires Servier




22, rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/287/001-006


11.3.2009




9.3.2009


Sustiva







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/99/110/001-009


11.3.2009




10.3.2009


DULOXETINE BOEHRINGER INGELHEIM







Boehringer Ingelheim International GmbH




Binger Strasse 173 - D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/471/001-012


12.3.2009




17.3.2009


Pritor Plus







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/215/001-021


19.3.2009




17.3.2009


Irbesartan Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




F- 75013 Paris




FRANCE






EU/1/06/376/001-033


19.3.2009




17.3.2009


Pritor







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/98/089/001-022


19.3.2009




17.3.2009


Hycamtin







SmithKline Beecham plc




980 Great West Road, Brentford




Middlesex,TW8 9GS




UNITED KINGDOM






EU/1/96/027/001
EU/1/96/027/003-007


19.3.2009




17.3.2009


Onsenal







Pfizer Limited




Ramsgate Road, Sandwich




Kent CT13 9NJ




UNITED KINGDOM






EU/1/03/259/001-006


19.3.2009




18.3.2009


Irbesartan HCT BMS







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/06/369/001-028


20.3.2009




18.3.2009


Atriance







Glaxo Group Limited




Berkeley Avenue, Greenford




Middlesex UB6 0NN




UNITED KINGDOM






EU/1/07/403/001


20.3.2009




18.3.2009


Kinzalkomb







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/214/001-015


20.3.2009




18.3.2009


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/02/213/001-023


20.3.2009




18.3.2009


Kinzalmono







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/98/091/001-014


20.3.2009




19.3.2009


Regranex







Janssen-Cilag International NV




Turnhoutseweg




30 - 2340 Beerse –




BELGIË






EU/1/99/101/001


23.3.2009




19.3.2009


Stalevo







Orion Corporation




Orionintie 1




FIN-02200 Espoo




SUOMI






EU/1/03/260/001-023


23.3.2009




19.3.2009


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/98/090/001-020


23.3.2009




19.3.2009


Vectibix







Amgen Europe B.V.




Minervum 7061




NL-4817 ZK Breda




NEDERLAND






EU/1/07/423/001-003


23.3.2009




23.3.2009


NovoSeven







Novo Nordisk A/S




Novo Allé




DK-2880 Bagsvaerd




DANMARK






EU/1/96/006/001-003


25.3.2009




23.3.2009


Irbesartan BMS







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/06/375/001-033


25.3.2009




25.3.2009


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park




Welwyn Garden City, AL7 1TW




UNITED KINGDOM






EU/1/04/300/001-002


27.3.2009




25.3.2009


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow




Maidenhead, Berkshire, SL6 0PH




UNITED KINGDOM






EU/1/99/126/001-018


27.3.2009




25.3.2009


Telzir







Glaxo Group Ltd.




Greenford Road, Greenford




Middlesex UB6 0NN




UNITED KINGDOM






EU/1/04/282/001-002


27.3.2009




25.3.2009


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/283/001-012


27.3.2009




25.3.2009


Exjade







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/06/356/001-009


27.3.2009




25.3.2009


Arixtra







Glaxo Group Ltd.




Greenford Road, Greenford




Middlesex UB6 0NN




UNITED KINGDOM






EU/1/02/206/001-035


27.3.2009




25.3.2009


Xenical







Roche Registration Limited




6 Falcon Way, Shire Park




Welwyn Garden City, AL7 1TW




UNITED KINGDOM






EU/1/98/071/001-006


27.3.2009




25.3.2009


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/296/001-009


27.3.2009




25.3.2009


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19




NL-2353 EW Leiderdorp




NEDERLAND






EU/1/07/387/001-010


27.3.2009




25.3.2009


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173




D-55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/442/001-008


27.3.2009




25.3.2009


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/008-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-034


27.3.2009




25.3.2009


ProQuad







Sanofi Pasteur MSD




SNC, 8, rue Jonas Salk




69007 Lyon




FRANCE






EU/1/05/323/001-013


27.3.2009




25.3.2009


Cetrotide







Serono Europe Limited




56, Marsh Wall




London E14 9TP




UNITED KINGDOM






EU/1/99/100/001-003


27.3.2009




25.3.2009


Tyverb







Glaxo Group Limited




Berkeley Avenue, Greenford




Middlesex UB6 0NN




UNITED KINGDOM






EU/1/07/440/001-002


27.3.2009




25.3.2009


Lysodren







Laboratoire HRA Pharma




15, rue Béranger




75003 Paris




FRANCE






EU/1/04/273/001


27.3.2009




25.3.2009


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/99/125/001-016


27.3.2009




25.3.2009


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes 1




Polígono Industrial La Mina




28770 Colmenar Viejo (Madrid)




ESPAÑA






EU/1/07/417/001-002


27.3.2009




25.3.2009


Extavia







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/08/454/001-002
EU/1/08/454/005


27.3.2009




25.3.2009


Mabthera







Roche Registration Limited




6 Falcon Way, Shire Park




Welwyn Garden City, AL7 1TW




UNITED KINGDOM






EU/1/98/067/001-002


27.3.2009




25.3.2009


Beromun







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/99/097/001


27.3.2009




25.3.2009


Dukoral







SBL Vaccin AB




S-105 21 Stockholm




SWEDEN






EU/1/03/263/001-003


30.3.2009




25.3.2009


NeuroBloc







Eisai Limited




3, Shortlands




London W6 8EE




UNITED KINGDOM






EU/1/00/166/001-003


30.3.2009




25.3.2009


Xeristar







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216




Ingelheim am Rhein




DEUTSCHLAND






EU/1/04/297/001-008


27.3.2009




27.3.2009


Aerinaze







SP Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique -




Stallestraat, 73 - 1180 Brussel




BELGIË






EU/1/07/399/001-006


1.4.2009




27.3.2009


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/01/195/001-015
EU/1/01/195/022-025


1.4.2009




27.3.2009


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/98/085/001-034


1.4.2009




27.3.2009


Irbesartan HCT Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




F- 75013 Paris




FRANCE






EU/1/06/377/001-028


1.4.2009




27.3.2009


Litak







Lipomed GmbH




Schönaugasse 11




D-79713 Bad Säckingen




DEUTSCHLAND






EU/1/04/275/001-002


1.4.2009




27.3.2009


Procoralan







Les Laboratoires Servier




22, rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/05/316/001-014


1.4.2009




27.3.2009


Mimpara







Amgen Europe B.V.




Minervum 7061




NL-4817 ZK Breda




NEDERLAND






EU/1/04/292/001-012


1.4.2009




27.3.2009


TRIZIVIR







Glaxo Group Ltd.




Greenford Road, Greenford




Middlesex UB6 0NN




UNITED KINGDOM






EU/1/00/156/002-003


1.4.2009




27.3.2009


Dafiro







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/06/371/001-036


1.4.2009




27.3.2009


Copalia







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/06/372/001-036


1.4.2009




27.3.2009


Imprida







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/06/373/001-036


1.4.2009




27.3.2009


Exforge







Novartis Europharm Limited




Wimblehurst Road, Horsham




West Sussex RH12 5AB




UNITED KINGDOM






EU/1/06/370/001-036


1.4.2009




27.3.2009


Stalevo







Orion Corporation




Orionintie 1




FIN-02200 Espoo




SUOMI






EU/1/03/260/024-033


1.4.2009




30.3.2009


Cholestagel







Genzyme Europe B.V.




Gooimeer 10




NL-1411 DD Naarden




NEDERLAND






EU/1/03/268/001-004


1.4.2009




31.3.2009


Rapilysin







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfjordur




ICELAND






EU/1/96/018/001


2.4.2009




31.3.2009


Velcade







Janssen-Cilag International NV




Turnhoutseweg 30




B-2340 Beerse




BELGIË






EU/1/04/274/001-002


2.4.2009




31.3.2009


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris




FRANCE






EU/1/97/046/001-039


2.4.2009




31.3.2009


Karvea







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road




Uxbridge UB8 1DH




UNITED KINGDOM






EU/1/97/049/001-039


2.4.2009




31.3.2009


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris




FRANCE






EU/1/98/086/001-034


2.4.2009




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










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




17.3.2009


Dynepo







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham, Basingstoke




Hampshire RG24 8EP




UNITED KINGDOM






EU/1/02/211/001-005
EU/1/02/211/010-012


19.3.2009




—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No (2) 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




17.3.2009


BTVPUR Alsap 8


Bluetongue virus Serotype 8 Antigen







MERIAL




29 avenue Tony Garnier




69007 LYON




FRANCE






EU/2/09/094/001-005


Suspension for injection


Q104AA02
Q102AA08


19.3.2009




—   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




6.3.2009


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


10.3.2009




12.3.2009


Novem







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/2/04/042/003-004


16.3.2009




18.3.2009


Aivlosin







ECO Animal Health Ltd




78 Coombe Road New Malden




Surrey KT3 4QS




UNITED KINGDOM






EU/2/04/044/001-008


20.3.2009




23.3.2009


Equilis Prequenza Te







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/05/057/001-004


25.3.2009




23.3.2009


Equilis Prequenza







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/05/056/001-004


25.3.2009




25.3.2009


Quadrisol







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/97/005/002-004
EU/2/97/005/006-009


27.3.2009




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, 30.4.2004, p. 1.