Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 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.01000301.xml










25.9.2009   


EN


Official Journal of the European Union


C 231/3





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 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 231/03
—   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




1.7.2009


Ribavirin Teva Pharma BV


Ribavirin







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/527/001-016


Film-coated tablet


J05A B04


3.7.2009




2.7.2009


Nymusa


Caffeine citrate







CHIESI FARMACEUTICI SpA




Via Palermo 26/A




43100 Parma PR




ITALIA






EU/1/09/528/001


Solution for infusion and oral solution


N06BC01


6.7.2009




20.7.2009


Instanyl


Fentanyl







Nycomed Danmark ApS




Langebjerg 1




4000 Roskilde




DANMARK






EU/1/09/531/001-009


Nasal spray, solution


N02AB03


23.7.2009




24.7.2009


Vedrop


Tocofersolan







Orphan Europe SARL




Immeuble Le Wilson




70 Avenue du Général de Gaulle




92800 Puteaux




FRANCE






EU/1/09/533/001-003


Oral solution


A11HA08


30.7.2009




24.7.2009


Topotecan Actavis


Topotecan







Actavis Group PTC ehf.




Reykjavikurvegi 76-78




220 Hafnarfjordur




ICELAND






EU/1/09/536/001-002


Powder for concentrate for solution for infusion


L01XX17


30.7.2009




28.7.2009


Clopidogrel Acino


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/532/001-007


Film-coated tablet


BO1AC04


31.7.2009




28.7.2009


Clopidogrel ratiopharm GmbH


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/541/001-007


Film-coated tablet


BO1AC04


31.7.2009




28.7.2009


Clopidogrel 1A Pharma


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/542/001-007


Film-coated tablet


BO1AC04


31.7.2009




28.7.2009


Clopidogrel Hexal


Clopidogrel







Acino Pharma GmbH




Am Windfeld 35




83714 Miesbach




DEUTSCHLAND






EU/1/09/534/001-007


Film-coated tablet


BO1AC04


31.7.2009




28.7.2009


Grepid


Clopidogrel







Pharmathen S.A.




6 Dervenakion




15351 Pallini Attiki




ΕΛΛAΔΑ






EU/1/09/535/001-014


Film-coated tablet


B01AC-04


31.7.2009




28.7.2009


Clopidogrel Teva


Clopidogrel







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/540/001-009


Film-coated tablet


B01AC04


31.7.2009




31.7.2009


Mozobil


Plerixafor







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/09/537/001


Solution for injection


L03AX16


4.8.2009




—   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




1.7.2009


ReFacto AF







Wyeth Europa Ltd




Huntercombe Lane




South Taplow




Maidenhead Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/99/103/001-004


2.7.2009




1.7.2009


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/296/001-009


3.7.2009




1.7.2009


Cancidas







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/01/196/001
EU/1/01/196/003


3.7.2009




1.7.2009


Naglazyme







BioMarin Europe Ltd




164 Shaftesbury Avenue




London




WC2H 8HL




UNITED KINGDOM






EU/1/05/324/001-002


3.7.2009




1.7.2009


Integrilin







Glaxo Group Ltd




Greenford




Middlesex




UB6 ONN




UNITED KINGDOM






EU/1/99/109/001-002


3.7.2009




1.7.2009


Rebif







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/98/063/008-010


3.7.2009




1.7.2009


ProQuad







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/05/323/001-013


3.7.2009




1.7.2009


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/01/195/001-027


3.7.2009




1.7.2009


Norvir







Abbott Laboratories Ltd




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






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


3.7.2009




1.7.2009


Humalog







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/96/007/002
EU/1/96/007/004-006
EU/1/96/007/008
EU/1/96/007/010
EU/1/96/007/015-021
EU/1/96/007/023-038


3.7.2009




1.7.2009


Xeristar







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/04/297/001-008


3.7.2009




1.7.2009


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor




389 Chiswick High Road




London




W4 4AL




UNITED KINGDOM






EU/1/02/220/006


3.7.2009




1.7.2009


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor




389 Chiswick High Road




London




W4 4AL




UNITED KINGDOM






EU/1/02/220/001-006


3.7.2009




1.7.2009


Arava







Sanofi-Aventis Deutschland GmbH




65926 Frankfurt am Main




DEUTSCHLAND






EU/1/99/118/001-010


3.7.2009




2.7.2009


Remicade







Centocor B.V.




Einsteinweg 101




2333 CB Leiden




NEDERLAND






EU/1/99/116/001-005


7.7.2009




2.7.2009


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/290/001-002


7.7.2009




2.7.2009


Mimpara







Amgen Europe B.V.




Minervum 7061




4817 ZK Breda




NEDERLAND






EU/1/04/292/001-012


7.7.2009




2.7.2009


ADROVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/364/001-009


7.7.2009




2.7.2009


Bonviva







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/03/265/003-006


7.7.2009




2.7.2009


Bondenza







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/03/266/003-006


7.7.2009




2.7.2009


Aldurazyme







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/03/253/001-003


7.7.2009




2.7.2009


Angiox







The Medicines Company UK Ltd




115 L Milton Park




Abingdon




Oxfordshire




OX14 4SA




UNITED KINGDOM






EU/1/04/289/001-002


8.7.2009




3.7.2009


Prevenar







Wyeth-Lederle Vaccines S.A.




Rue du Bosquet 15




1348 Louvain-La-Neuve




BELGIQUE






EU/1/00/167/001-008


7.7.2009




3.7.2009


Remicade







Centocor B.V.




Einsteinweg 101




2333 CB Leiden




NEDERLAND






EU/1/99/116/001-005


7.7.2009




3.7.2009


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


7.7.2009




3.7.2009


RELISTOR







Wyeth Europa Limited




Huntercombe Lane South, Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/08/463/001-003


7.7.2009




7.7.2009


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor




389 Chiswick High Road




London




W4 4AL




UNITED KINGDOM






EU/1/02/220/001-006


9.7.2009




7.7.2009


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/99/125/001-016


9.7.2009




7.7.2009


Prepandrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/453/001


9.7.2009




7.7.2009


Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/478/001


9.7.2009




7.7.2009


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/343/005


9.7.2009




7.7.2009


YENTREVE







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/280/001-008


9.7.2009




7.7.2009


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


9.7.2009




7.7.2009


Zonegran







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Hertfordshire




AL10 9SN




UNITED KINGDOM






EU/1/04/307/001-013


9.7.2009




7.7.2009


CELSENTRI







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/418/001-010


9.7.2009




7.7.2009


Invega







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/07/395/001-095


9.7.2009




7.7.2009


Tygacil







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/06/336/001


9.7.2009




7.7.2009


FOSAVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/05/310/001-009


9.7.2009




7.7.2009


REYATAZ







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/03/267/001-010


9.7.2009




7.7.2009


Revatio







Pfizer Limited




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/05/318/001


9.7.2009




10.7.2009


Binocrit







Sandoz GmbH




Biochemiestrasse 10




6250 Kundl




ÖSTERREICH






EU/1/07/410/001-020


14.7.2009




10.7.2009


Pandemrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/08/452/001


14.7.2009




10.7.2009


Epoetin alfa Hexal







Hexal AG.




Industriestrasse 25




83607 Holzkirchen




DEUTSCHLAND






EU/1/07/411/001-020


14.7.2009




14.7.2009


INCRELEX







Ipsen Pharma




65 quai Georges Gorse




92100 Boulogne-Billancourt




FRANCE









Tercica Europe Limited




Riverside One, Sir John Rogerson's Quay




Dublin 2




IRELAND






EU/1/07/402/001


16.7.2009




14.7.2009


Zometa







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/01/176/001-006


16.7.2009




14.7.2009


Exjade







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/06/356/001-009


16.7.2009




14.7.2009


ISENTRESS







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/436/001-002


16.7.2009




14.7.2009


Thelin







Encysive (UK) Limited




Alder Castle House




10 Noble Street




London




EC2V 7QJ




UNITED KINGDOM






EU/1/06/353/001-005


16.7.2009




14.7.2009


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37




58638 Iserlohn




DEUTSCHLAND






EU/1/07/412/001-020


16.7.2009




14.7.2009


Dynastat







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/02/209/001-008


16.7.2009




14.7.2009


DULOXETINE BOEHRINGER INGELHEIM







Boehringer Ingelheim International GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/08/471/001-012


16.7.2009




14.7.2009


Doribax







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/08/467/001


16.7.2009




14.7.2009


Crixivan







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/96/024/001-005
EU/1/96/024/008
EU/1/96/024/010


16.7.2009




14.7.2009


Paxene







Norton Healthcare Limited




Albert Basin




Royal Docks




London




E16 2QJ




UNITED KINGDOM






EU/1/99/113/001-004


16.7.2009




16.7.2009


Neupro







Schwarz Pharma Ltd




Shannon




Industrial Estate




Co. Clare




IRELAND






EU/1/05/331/001-055


21.7.2009




16.7.2009


Opgenra







Howmedica International S. de R. L.




Raheen Business Park




Limerick




IRELAND






EU/1/08/489/001-002


21.7.2009




16.7.2009


ADROVANCE







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/364/001-009


21.7.2009




16.7.2009


ECALTA







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/416/001


21.7.2009




16.7.2009


ISENTRESS







Merck Sharp & Dohme Limited




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/436/001-002


21.7.2009




16.7.2009


CUBICIN







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/05/328/001-002


21.7.2009




16.7.2009


Olanzapine Neopharma







Neopharma Limited




57 High Street




Odiham




Hampshire




RG29 1LF




UNITED KINGDOM






EU/1/07/426/001-011


21.7.2009




16.7.2009


Enbrel







Wyeth Europa Limited




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/99/126/001-021


21.7.2009




17.7.2009


Zalasta







Krka d.d.




Novo mesto




Šmarješka cesta 6




SI-8501 Novo mesto




SLOVENIJA






EU/1/07/415/001-056


21.7.2009




17.7.2009


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


21.7.2009




17.7.2009


Olanzapine Mylan







Generics (UK) Limited




Station Close




Potters Bar




Hertfordshire




EN6 1TL




UNITED KINGDOM






EU/1/08/475/001-034


21.7.2009




20.7.2009


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/07/427/001-057


23.7.2009




23.7.2009


Dynastat







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/02/209/001-008


28.7.2009




23.7.2009


NeuroBloc







Eisai Limited




European Knowledge Centre




Mosquito Way




Hatfield




Hertfordshire




AL10 9SN




UNITED KINGDOM






EU/1/00/166/001-003


28.7.2009




23.7.2009


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/382/001-018


28.7.2009




23.7.2009


Cancidas







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/01/196/001
EU/1/01/196/003


28.7.2009




23.7.2009


Invanz







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/02/216/001-002


28.7.2009




23.7.2009


ATryn







GTC Biotherapeutics UK Limited




10 Norwich Street




London




EC4A 1BD




UNITED KINGDOM









LEO Pharma A/S




Industriparken 55




2750 Ballerup




DANMARK






EU/1/06/355/001-003


28.7.2009




23.7.2009


Avastin







Roche Registration Limited




6 Falcon Way




Shire Park




Welwyn Garden City




AL7 1TW




UNITED KINGDOM






EU/1/04/300/001-002


28.7.2009




23.7.2009


Vistide







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/97/037/001


28.7.2009




23.7.2009


ECALTA







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/416/002


28.7.2009




24.7.2009


Vimpat







UCB Pharma S.A.




Allée de la Recherche 60




1070 Bruxelles




BELGIQUE






EU/1/08/470/001-017


31.7.2009




24.7.2009


Humira







Abbott Laboratories Ltd




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






EU/1/03/256/001-010


30.7.2009




24.7.2009


ZYPADHERA







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/08/479/001-003


30.7.2009




24.7.2009


Macugen







Pfizer Ltd




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/05/325/002


30.7.2009




24.7.2009


Silgard







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/358/001-021


30.7.2009




24.7.2009


Flebogammadif







Instituto Grifols S.A.




Can Guasch




Parets del Vallès




08150 Barcelona




ESPAÑA






EU/1/07/404/001-005


30.7.2009




24.7.2009


FABLYN







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/08/500/001-004


30.7.2009




24.7.2009


Nexavar







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/06/342/001


30.7.2009




24.7.2009


FIRMAGON







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11




2300 København S




DANMARK






EU/1/08/504/001-002


30.7.2009




24.7.2009


GONAL-f







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035


30.7.2009




24.7.2009


Cervarix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89




1330 Rixensart




BELGIQUE






EU/1/07/419/001-012


30.7.2009




24.7.2009


Kuvan







Merck KGaA




Frankfurter Straße 250




64293 Darmstadt




DEUTSCHLAND






EU/1/08/481/001-003


30.7.2009




24.7.2009


Gardasil







Sanofi Pasteur MSD SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/357/001-021


30.7.2009




24.7.2009


Pedea







Orphan Europe SARL




Immeuble Le Wilson




70 Avenue du Général de Gaulle




92800 Puteaux




FRANCE






EU/1/04/284/001


30.7.2009




27.7.2009


Synagis







Abbott Laboratories Ltd




Queenborough




Kent




ME11 5EL




UNITED KINGDOM






EU/1/99/117/001-002


30.7.2009




27.7.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


30.7.2009




27.7.2009


Luminity







Lantheus MI UK Limited




One South Place




London




EC2M 2WG




UNITED KINGDOM









Bristol-Myers Squibb Pharma Belgium Sprl




Chaussée de la Hulpe/Terhulpsesteenweg 185




1170 Brussels/Brussel




BELGIQUE/BELGIË






EU/1/06/361/001-002


30.7.2009




27.7.2009


NovoRapid







Novo Nordisk A/S




Novo Allé




2880 Bagsværd




DANMARK






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


30.7.2009




27.7.2009


Xolair







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/05/319/001-010


30.7.2009




27.7.2009


Prevenar







Wyeth-Lederle Vaccines S.A.




Rue du Bosquet 15




1348 Louvain-La-Neuve




BELGIQUE






EU/1/00/167/001-008


30.7.2009




27.7.2009


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/00/144/001-004


30.7.2009




27.7.2009


KOGENATE Bayer







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/00/143/001-011


30.7.2009




27.7.2009


ViraferonPeg







Schering Plough Europe




Rue de Stalle 73




1180 Bruxelles




BELGIQUE









Stallestraat 73




1180 Brussel




BELGIË






EU/1/00/132/001-050


30.7.2009




27.7.2009


Renagel







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/99/123/005-013


30.7.2009




28.7.2009


Osseor







Les Laboratoires Servier




22 rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/287/001-006


31.7.2009




28.7.2009


Protelos







Les Laboratoires Servier




22 rue Garnier




92200 Neuilly-sur-Seine




FRANCE






EU/1/04/288/001-006


31.7.2009




28.7.2009


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/363/001-011


31.7.2009




29.7.2009


Ebixa







H.Lundbeck A/S




Ottiliavej 9




2500 Valby




DANMARK






EU/1/02/219/005-006
EU/1/02/219/013


31.7.2009




29.7.2009


Januvia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/383/001-018


31.7.2009




29.7.2009


Firazyr







Jerini AG




Invalidenstr. 130




10115 Berlin




DEUTSCHLAND






EU/1/08/461/001


31.7.2009




29.7.2009


NutropinAq







Ipsen Pharma




65 quai Georges Gorse




92100 Boulogne-Billancourt




FRANCE









IPSEN Limited




190 Bath Road




Slough




Berkshire




SLI 3XE




UNITED KINGDOM






EU/1/00/164/003-005


31.7.2009




29.7.2009


Abraxane







Abraxis BioScience Limited




Hatfield




AL10 9NA




UNITED KINGDOM






EU/1/07/428/001


31.7.2009




29.7.2009


Janumet







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/455/001-016


31.7.2009




29.7.2009


Velmetia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/456/001-016


31.7.2009




29.7.2009


Efficib







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/457/001-016


31.7.2009




29.7.2009


IVEMEND







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/437/001-002


31.7.2009




29.7.2009


TOVIAZ







Pfizer Limited




Ramsgate Road




Sandwich




Kent




CT13 9NJ




UNITED KINGDOM






EU/1/07/386/001-016


31.7.2009




31.7.2009


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100-104




60318 Frankfurt/Main




DEUTSCHLAND






EU/1/02/218/004-006


4.8.2009




31.7.2009


Emselex







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/04/294/001-028


4.8.2009




31.7.2009


Kepivance







Biovitrum AB (publ)




SE-112 76 Stockholm




SVERIGE






EU/1/05/314/001


4.8.2009




31.7.2009


EMEND







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/03/262/001-008


4.8.2009




—   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




7.7.2009


Melovem


Meloxicam







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




NEDERLAND






EU/2/09/098/001


Solution for injection


QM01AC06


9.7.2009




24.7.2009


Suvaxyn PCV


Porcine Circovirus recombinant virus (cPCV) 1-2, inactivated







Fort Dodge Animal Health Ltd




Flanders Road




Hedge End




Southampton




SO30 4QH




UNITED KINGDOM






EU/2/09/099/001-006


Suspension for injection


QI09AA07


30.7.2009




—   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




14.7.2009


Meloxivet







Janssen Pharmaceutica N.V.




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/2/07/077/001-005


16.7.2009




16.7.2009


Nobivac Piro







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/04/046/001-003


21.7.2009




20.7.2009


PRILACTONE







Ceva sante animale




Z.I. la Ballastière




33500 Libourne




FRANCE






EU/2/07/074/001-006


23.7.2009




20.7.2009


ZACTRAN







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/08/082/001-006


23.7.2009




31.7.2009


Nobilis Influenza H7N1







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND






EU/2/07/073/001-004


4.8.2009




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 of 30.4.2004, p. 1.