Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 April 2009 to 30 April 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-05-29
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009121EN.01000301.xml










29.5.2009   


EN


Official Journal of the European Union


C 121/3





Summary of Community decisions on marketing authorisations in respect of medicinal products
from 1 April 2009 to 30 April 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 121/03
—   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




17.4.2009


Rivastigmine Teva


Rivastigmine







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/513/001-020


Capsule, hard


N06DA03


21.4.2009




17.4.2009


CONBRIZA


Bazedoxifene







Wyeth Europa Limited




Huntercombe Lane




South Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/09/511/001-004


Film-coated tablet


G03XC02


21.4.2009




20.4.2009


Removab


Catumaxomab







Fresenius Biotech GmbH




Am Haag 6-7




82166 Graefelfing




DEUTSCHLAND






EU/1/09/512/001-002


Concentrate for solution for infusion


L01XC09


22.4.2009




21.4.2009


Exalief


Eslicarbazepine acetate







BIAL - Portela & Ca, SA, A




Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado




PORTUGAL






EU/1/09/520/001-020


Tablet


N03AF04


23.4.2009




21.4.2009


Zebinix


Eslicarbazepine acetate







BIAL - Portela & Ca, SA, A




Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado




PORTUGAL






EU/1/09/514/001-020


Tablet


N03AF04


23.4.2009




—   Issuing 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




27.4.2009


Sovrima







Santhera Pharmaceuticals (Deutschland) GmbH




Wallbrunnstr. 24




79539 Lörrach




DEUTSCHLAND






—


29.4.2009




—   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




2.4.2009


Xarelto







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND




Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/08/472/001-008


6.4.2009




2.4.2009


Altargo







Glaxo Group Limited Glaxo Wellcome House




Berkely Avenue Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/390/001-004


4.4.2009




2.4.2009


Neupro







Schwarz Pharma Ltd




Shannon Industrial Estate




Co. Clare




IRELAND






EU/1/05/331/001-055


6.4.2009




2.4.2009


Abraxane







Abraxis BioScience Limited




Hatfield




AL10 9NA




UNITED KINGDOM






EU/1/07/428/001


6.4.2009




2.4.2009


Combivir







Glaxo Group Ltd




Greenford Road Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/98/058/001-002


4.4.2009




3.4.2009


Optimark







Covidien Deutschland GmbH




Gewerbepark 1




93333 Neustadt/Donau




DEUTSCHLAND






EU/1/07/398/001-014


8.4.2008




3.4.2009


Intrinsa







Procter & Gamble Pharmaceuticals UK Ltd




Rusham Park Technical Centre




Whitehall Lane




Egham Surrey




TW20 9NW




UNITED KINGDOM






EU/1/06/352/001-003


8.4.2009




3.4.2009


Livensa







Procter & Gamble Pharmaceuticals — Germany GmbH




Dr Otto-Röhm-Strasse 2-4




64331 Weiterstadt




DEUTSCHLAND






EU/1/06/351/001-003


8.4.2009




3.4.2009


Riprazo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/409/001-020


8.4.2009




3.4.2009


Enviage







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/406/001-020


8.4.2009




3.4.2009


Sprimeo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/407/001-020


8.4.2009




3.4.2009


Tekturna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/408/001-020


8.4.2009




3.4.2009


Rasilez







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/405/001-020


8.4.2009




3.4.2009


YENTREVE







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/280/001-008


8.4.2009




3.4.2009


DULOXETINE BOEHRINGER INGELHEIM







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/471/001-012


8.4.2009




7.4.2009


Vectibix







Amgen Europe B.V.




Minervum 7061




4817 ZK Breda




NEDERLAND






EU/1/07/423/001-003


9.4.2009




7.4.2009


ADROVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/364/001-009


14.4.2009




7.4.2009


FOSAVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/05/310/001-009


14.4.2009




7.4.2009


Champix







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT 13 9NJ




UNITED KINGDOM






EU/1/06/360/001-012


9.4.2009




7.4.2009


Volibris







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/08/451/001-004


9.4.2009




7.4.2009


Irbesartan







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/375/001-033


9.4.2009




7.4.2009


PritorPlus







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/215/001-021


9.4.2009




7.4.2009


KOGENATE Bayer







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND




Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/00/143/001-011


9.4.2009




7.4.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


9.4.2009




7.4.2009


Irbesartan HCT BMS







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/369/001-028


9.4.2009




7.4.2009


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND




Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/00/144/001-004


9.4.2009




7.4.2009


Kinzalkomb







Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/02/214/001-015


9.4.2009




7.4.2009


Nexavar







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND




Bayer HealthCare AG




51368 Leverkusen




DEUTSCHLAND






EU/1/06/342/001


9.4.2009




7.4.2009


Fluticasone furoate GSK







Glaxo Group Ltd




Greenford




Middlesex




UB6 ONN




UNITED KINGDOM






EU/1/08/474/001-003


9.4.2009




7.4.2009


Protopic







Astellas Pharma Europe B.V.




Elisabethhof 19




2353 EW Leiderdorp




NEDERLAND




Astellas Pharma GmbH




Neumarkter Str. 61




81673 München




DEUTSCHLAND






EU/1/02/201/001-006


9.4.2009




7.4.2009


MIRCERA







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/07/400/001-021


9.4.2009




7.4.2009


Integrilin







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/109/001-002


9.4.2009




7.4.2009


Ziagen







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/112/001-002


9.4.2009




7.4.2009


Avamys







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/434/001-003


9.4.2009




7.4.2009


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/02/213/001-023


9.4.2009




7.4.2009


Thyrogen







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/122/001-002


9.4.2009




8.4.2009


Irbesartan Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/06/376/001-033


15.4.2009




8.4.2009


PEGASYS







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/02/221/001-010


15.4.2009




16.4.2009


ReFacto AF







Wyeth Europa Ltd




Huntercombe Lane South Taplow




Maidenhead Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/99/103/001-004


20.4.2009




16.4.2009


Levemir







Novo Nordisk A/S




Novo Allé




2880 Bagsvaerd




DANMARK






EU/1/04/278/001-009


20.4.2009




16.4.2009


Thelin







Encysive (UK) Limited




Alder Castle House




10 Noble Street




London




EC2V 7QJ




UNITED KINGDOM






EU/1/06/353/001-005


21.4.2009




17.4.2009


CUBICIN







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/05/328/001-002


21.4.2009




17.4.2009


Mirapexin







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/97/051/001-006
EU/1/97/051/009-012


21.4.2009




17.4.2009


Irbesartan HCT Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France




75013 Paris




FRANCE






EU/1/06/377/001-028


21.4.2009




17.4.2009


Sifrol







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/97/050/001-006
EU/1/97/050/009-012


21.4.2009




21.4.2009


Trisenox







Cephalon Europe




5 Rue Charles Martigny




94700 Maisons Alfort




Cedex




FRANCE






EU/1/02/204/001


23.4.2009




21.4.2009


Kivexa







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/04/298/001-003


23.4.2009




21.4.2009


Prepandrix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/453/001


23.4.2009




21.4.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


23.4.2009




21.4.2009


Pandemrix







GlaxoSmithKline Biologicals s.a.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


23.4.2009




21.4.2009


Angiox







The Medicines Company UK Ltd




115 L Milton Park




Abingdon




Oxfordshire




OX14 4SA




UNITED KINGDOM






EU/1/04/289/001-002


23.4.2009




21.4.2009


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


23.4.2009




21.4.2009


ISENTRESS







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/436/001-002


23.4.2009




21.4.2009


Renagel







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/123/005-012


23.4.2009




22.4.2009


Viread







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/01/200/001-002


24.4.2009




22.4.2009


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/01/195/022-027


24.4.2009




22.4.2009


Sustiva







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/99/110/001-005
EU/1/99/110/008-010


24.4.2009




22.4.2009


Stocrin







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/99/111/001-005
EU/1/99/111/008-011


24.4.2009




22.4.2009


BeneFIX







Wyeth Europa Ltd




Huntercombe Lane




South Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/97/047/001-007


24.4.2009




22.4.2009


Rebif







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/98/063/001-010


24.4.2009




22.4.2009


Cervarix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/07/419/001-012


24.4.2009




22.4.2009


Enviage







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/406/001-020


24.4.2009




22.4.2009


Riprazo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/409/001-020


24.4.2009




22.4.2009


Tekturna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/408/001-020


24.4.2009




22.4.2009


Rasilez







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/405/001-020


24.4.2009




22.4.2009


Sprimeo







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/407/001-020


27.4.2009




23.4.2009


Rebetol







Schering Plough Europe




Rue de Stalle 73/Stallestraat 73




1180 Bruxelles/Brussel




BELGIQUE/BELGIË






EU/1/99/107/001-005


28.4.2009




23.4.2009


Corlentor







Les Laboratoires Servier




22, rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/05/317/001-014


7.5.2009




23.4.2009


Procoralan







Les Laboratoires Servier




22, rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/05/316/001-014


7.5.2009




23.4.2009


INTELENCE







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/08/468/001


28.4.2009




23.4.2009


EVICEL







OMRIX biopharmaceuticals S.A./N.V.




200 Chaussée de Waterloo/Waterloosesteenweg 200




1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode




BELGIQUE/BELGIË






EU/1/08/473/001-003


28.4.2009




24.4.2009


KOGENATE Bayer







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/00/143/001-011


28.4.2009




24.4.2009


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/00/144/001-004


28.4.2009




27.4.2009


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19




2353 EW Leiderdorp




NEDERLAND






EU/1/07/387/001-013


29.4.2009




29.4.2009


Glivec







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/01/198/001-013


5.5.2009




29.4.2009


Evoltra







Genzyme Europe BV




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/06/334/001-004


5.5.2009




29.4.2009


Rapamune







Wyeth Europa Limited




Huntercombe Lane




South Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/01/171/001
EU/1/01/171/007-010


5.5.2009




30.4.2009


NovoRapid







Novo Nordisk A/S Novo Allé




2880 Bagsvaerd




DANMARK






EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-015


5.5.2009




30.4.2009


TachoSil







Nycomed Austria GmbH




St.-Peter-Strasse 25




4020 Linz




ÖSTERREICH






EU/1/04/277/001-004


5.5.2009




30.4.2009


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park




Chineham




Basingstoke




Hampshire




RG24 8EP




UNITED KINGDOM






EU/1/04/295/001


5.5.2009




30.4.2009


Kentera







Nicobrand Limited




189 Castleroe Road




Coleraine




Northern Ireland




BT51 3 RP




UNITED KINGDOM






EU/1/03/270/001-003


5.5.2009




—   Suspension of a marketing authorisation (Article 20 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




17.4.2009


Raptiva







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/04/291/001-003


21.4.2009




—   Issuing of a marketing 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




16.4.2009


Netvax


Clostridium perfringens type A toxoid







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/09/093/001-002


Emulsion for injection


QI01A08


20.4.2009




—   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




27.4.2009


Equilis StrepE







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/04/043/001


29.4.2009




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.