Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2011-08-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011250EN.01000101.xml










26.8.2011   


EN


Official Journal of the European Union


C 250/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (1)
)

2011/C 250/01
—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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




6.5.2011


Methylthioninium chloride Proveblue


methylthioninium chloride







Provepharm S.A.S.




Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille






EU/1/11/682/001


Solution for injection


V03AB17


12.5.2011




18.5.2011


Eliquis


apixaban







Bristol-Myers Squibb/Pfizer EEIG




Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom






EU/1/11/691/001-005


Film-coated tablet


B01A


20.5.2011




18.5.2011


Yellox


bromfenac







Croma-Pharma GmbH




Industriezeile 6, A-2100 Leobendorf, Österreich






EU/1/11/692/001


Eye drops, solution


S01BC11


23.5.2011




15.6.2011


Cinryze


c1 inhibitor, human







ViroPharma SPRL-BVBA




rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België






EU/1/11/688/001


Powder and solvent for solution for injection


B02AB03


20.6.2011




16.6.2011


Clopidogrel Teva Pharma B.V.


Clopidogrel







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/649/001-016


Film-coated tablet


B01AC04


21.6.2011




16.6.2011


Leganto


Rotigotine







Schwarz Pharma Ltd




Shannon, Industrial Estate, Co.Clare, Ireland






EU/1/11/695/001-055


Transdermal patch


N04BC09


22.6.2011




16.6.2011


Rivastigmine Actavis


Rivastigmine







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland






EU/1/11/693/001-016


Capsule, hard


N06DA03


21.6.2011




17.6.2011


BYDUREON


exenatide







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/11/696/001-002


powder and solvent for prolonged release suspension for injection


A10BX04


23.6.2011




17.6.2011


NULOJIX


belatacept







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/11/694/001-002


powder for concentrate for solution for infusion


L04AA28


23.6.2011




23.6.2011


Sprimeo HCT


aliskiren hemifumarate / hydrochlorothiazide







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom






EU/1/11/683/001-080


Film-coated tablet


C09XA52


28.6.2011







—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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




17.6.2011


Movectro







Merck Serono Europe Limited




56, Marsh Wall, London E14 9TP, United Kingdom






 


23.6.2011







—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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




2.5.2011


Combivir







ViiV Healthcare UK Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/98/058/001-002


4.5.2011




2.5.2011


Kepivance







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/05/314/001


4.5.2011




2.5.2011


Kinzalkomb







Bayer Schering Pharma AG




D-13342 Berlin, Deutschland






EU/1/02/214/001-015


4.5.2011




2.5.2011


Kinzalmono







Bayer Schering Pharma AG




D-13342 Berlin, Deutschland






EU/1/98/091/001-014


4.5.2011




2.5.2011


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/98/090/001-020


4.5.2011




2.5.2011


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/02/213/001-023


4.5.2011




2.5.2011


Nexavar







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/06/342/001


4.5.2011




2.5.2011


Osigraft







Howmedica International S. de R.L.




Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland






EU/1/01/179/001


4.5.2011




2.5.2011


Pritor







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/98/089/001-022


4.5.2011




2.5.2011


PritorPlus







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/02/215/001-021


4.5.2011




2.5.2011


Revatio







Pfizer Limited




Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/05/318/001-002


4.5.2011




2.5.2011


Revolade







GlaxoSmithKline Trading Services Limited




6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland






EU/1/10/612/001-006


4.5.2011




2.5.2011


Votrient







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/628/001-004


4.5.2011




5.5.2011


M-M-RVAXPRO







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/06/337/001-013


9.5.2011




6.5.2011


Foclivia







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/09/577/001-004


12.5.2011




6.5.2011


Kivexa







ViiV Healthcare UK Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/04/298/001-003


12.5.2011




6.5.2011


Rasilez HCT







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/491/001-080


12.5.2011




6.5.2011


ReFacto AF







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/103/001-008


12.5.2011




6.5.2011


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/05/330/001-011


12.5.2011




6.5.2011


Tygacil







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/06/336/001


12.5.2011




6.5.2011


Vimpat







UCB Pharma SA.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België






EU/1/08/470/001-017


12.5.2011




6.5.2011


Votrient







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/628/001-004


12.5.2011




6.5.2011


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom






EU/1/04/295/001


12.5.2011




12.5.2011


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/06/343/001-007


16.5.2011




12.5.2011


Extavia







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/454/001-002
EU/1/08/454/005-007


16.5.2011




12.5.2011


Ketek







Aventis Pharma S.A.




20 avenue Raymond Aron, F-92160 Antony, France






EU/1/01/191/001-005


16.5.2011




12.5.2011


MabCampath







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/01/193/001-002


16.5.2011




12.5.2011


Olanzapine Apotex







Apotex Europe B.V.




Darwingweg 20, 2333 CR Leiden, Nederland






EU/1/10/635/001-014


16.5.2011




16.5.2011


Elonva







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/09/609/001-002


18.5.2011




16.5.2011


Pramipexole Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/08/490/001-024


18.5.2011




16.5.2011


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana






EU/1/07/417/001-002


18.5.2011




16.5.2011


Zavesca







Actelion Registration Ltd




BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom






EU/1/02/238/001


18.5.2011




18.5.2011


Arixtra







Glaxo Group Ltd.




Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/02/206/001-035


20.5.2011




18.5.2011


Celvapan







Baxter AG




Industriestraße 67, A - 1221 Wien, Österreich






EU/1/08/506/001


20.5.2011




18.5.2011


DepoCyte







Pacira Limited




3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom






EU/1/01/187/001


20.5.2011




18.5.2011


Hepsera







Gilead Sciences International Limited




Cambridge, CB21 6GT, United Kingdom






EU/1/03/251/001-002


20.5.2011




18.5.2011


Karvea







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/97/049/001-039


23.5.2011




18.5.2011


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/98/085/001-034


23.5.2011




18.5.2011


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/460/001-014


23.5.2011




18.5.2011


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse – België






EU/1/06/380/001-005


23.5.2011




18.5.2011


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/05/330/001-011


20.5.2011




18.5.2011


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


23.5.2011




18.5.2011


Sprimeo







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/407/001-020


23.5.2011




18.5.2011


Tarceva







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/05/311/001-003


20.5.2011




18.5.2011


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200/001-002


23.5.2011




23.5.2011


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/97/046/001-039


26.5.2011




23.5.2011


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/98/086/001-034


30.5.2011




23.5.2011


Emtriva







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/03/261/001-003


26.5.2011




23.5.2011


Exalief







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal






EU/1/09/520/001-020


26.5.2011




23.5.2011


Exelon







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/98/066/001-026


26.5.2011




23.5.2011


Glivec







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/01/198/001-013


26.5.2011




23.5.2011


GONAL-f







Merck Serono Europe Ltd.




56, Marsh Wall, London E14 9TP, United Kingdom






EU/1/95/001/033-035


26.5.2011




23.5.2011


Luveris







Merck Serono Europe Limited




56, Marsh Wall, London E14 9TP, United Kingdom






EU/1/00/155/007


25.5.2011




23.5.2011


Prometax







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/98/092/001-028


25.5.2011




23.5.2011


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
EU/1/01/171/013


26.5.2011




23.5.2011


Rasilez







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/405/001-040


25.5.2011




23.5.2011


Riprazo







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/409/001-040


26.5.2011




23.5.2011


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/06/363/001-015


26.5.2011




23.5.2011


Tasigna







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/422/001-006


25.5.2011




23.5.2011


Telzir







ViiV Healthcare UK Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/04/282/001-002


26.5.2011




23.5.2011


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/459/001-014


25.5.2011




23.5.2011


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/08/458/001-014


25.5.2011




23.5.2011


Tygacil







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/06/336/001


26.5.2011




23.5.2011


Tyverb







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/440/001-006


27.5.2011




23.5.2011


Vectibix







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/07/423/001-003


26.5.2011




27.5.2011


Avonex







Biogen Idec Ltd




Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom






EU/1/97/033/002-006


1.6.2011




27.5.2011


Carbaglu







Orphan Europe SARL




Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France






EU/1/02/246/001-003


1.6.2011




27.5.2011


CellCept







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/96/005/001-006


31.5.2011




27.5.2011


Competact







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/06/354/001-012


1.6.2011




27.5.2011


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/126/001-021


31.5.2011




27.5.2011


Forsteo







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/03/247/001-002


1.6.2011




27.5.2011


Levemir







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/04/278/001-016


1.6.2011




27.5.2011


Lucentis







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/06/374/001


31.5.2011




27.5.2011


Mycophenolate mofetil Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/439/001-006


31.5.2011




27.5.2011


Myfenax







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/438/001-006


31.5.2011




27.5.2011


Neulasta







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/02/227/001-002
EU/1/02/227/004


1.6.2011




27.5.2011


Olanzapine Neopharma







Neopharma Limited




57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom






EU/1/07/426/001-011


31.5.2011




27.5.2011


Simponi







Janssen Biologics B.V.




Einsteinweg 101, CB Leiden 2333, Nederland






EU/1/09/546/001-004


1.6.2011




27.5.2011


Temozolomide Hospira







Hospira UK Ltd.




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/10/615/001-024


31.5.2011




27.5.2011


Truvada







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/04/305/001-002


31.5.2011




27.5.2011


Viracept







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/97/054/001
EU/1/97/054/004-005


1.6.2011




7.6.2011


Caelyx







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/96/011/001-004


9.6.2011




7.6.2011


Champix







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/06/360/001-013


9.6.2011




7.6.2011


Fabrazyme







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/01/188/001-006


9.6.2011




7.6.2011


Irbesartan Winthrop







Sanofi-Aventis




174, avenue de France, F-75013 Paris, France






EU/1/06/376/001-033


9.6.2011




7.6.2011


Multaq







Sanofi-Aventis




174, avenue de France, F-75013 Paris, France






EU/1/09/591/001-004


9.6.2011




7.6.2011


Norvir







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom






EU/1/96/016/001
EU/1/96/016/003-004
EU/1/96/016/008


9.6.2011




7.6.2011


Tractocile







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11, Copenhagen S 2300, Danmark






EU/1/99/124/001-002


9.6.2011




7.6.2011


Trizivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/00/156/002-004


9.6.2011




14.6.2011


Afinitor







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/538/001-008


16.6.2011




14.6.2011


Doribax







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse – België






EU/1/08/467/001-002


16.6.2011




14.6.2011


Ivemend







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/07/437/001-004


16.6.2011




14.6.2011


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/427/001-057


16.6.2011




14.6.2011


Opgenra







Howmedica International S. de R. L.




Raheen Business Park, Limerick, Ireland






EU/1/08/489/001-002


16.6.2011




14.6.2011


PecFent







Archimedes Development Ltd




Nottingham, NGT7 2TN, United Kingdom






EU/1/10/644/001-006


16.6.2011




14.6.2011


Ribavirin BioPartners







BioPartners GmbH




Kaiserpassage 11 - D-72764 Reutlingen, Deutschland






EU/1/10/626/001-004


16.6.2011




14.6.2011


Temodal







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/98/096/001-025


16.6.2011




14.6.2011


Twynsta







Boehringer Ingelheim International GmbH




Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland






EU/1/10/648/001-028


16.6.2011




14.6.2011


Vidaza







Celgene Europe Ltd




Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom






EU/1/08/488/001


16.6.2011




15.6.2011


InductOs







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/02/226/001


20.6.2011




15.6.2011


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/00/152/009-018


17.6.2011




15.6.2011


PegIntron







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/00/131/001-050


17.6.2011




15.6.2011


Ziagen







ViiV Healthcare UK Ltd




980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom






EU/1/99/112/001-002


17.6.2011




16.6.2011


INCRELEX







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402/001


21.6.2011




16.6.2011


IntronA







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/99/127/011-039
EU/1/99/127/041-044


22.6.2011




16.6.2011


Irbesartan HCT Winthrop







Sanofi-Aventis




174, avenue de France, F-75013 Paris, France






EU/1/06/377/001-028


21.6.2011




16.6.2011


Macugen







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/05/325/002


21.6.2011




16.6.2011


Olanzapine Mylan







Generics [UK] Limited




Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom






EU/1/08/475/001-034


21.6.2011




16.6.2011


Omnitrope







Sandoz GmbH




Biochemiestrasse 10, Kundl 6250, Österreich






EU/1/06/332/001-012


21.6.2011




16.6.2011


Ozurdex







Allergan Pharmaceuticals (Ireland) Ltd,




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/10/638/001


21.6.2011




16.6.2011


Samsca







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom






EU/1/09/539/001-004


21.6.2011




16.6.2011


Tysabri







Elan Pharma International Ltd.




Monksland, Athlone, County Westmeath, Ireland






EU/1/06/346/001


21.6.2011




16.6.2011


ViraferonPeg







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/00/132/001-050


24.6.2011




16.6.2011


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal






EU/1/09/514/001-020


21.6.2011




17.6.2011


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France - 75013 Paris, France






EU/1/97/046/001-039


23.6.2011




17.6.2011


Champix







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/06/360/001-013


23.6.2011




17.6.2011


INCRELEX







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402/001


23.6.2011




17.6.2011


Lyrica







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/04/279/001-044


23.6.2011




17.6.2011


Mirapexin







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/97/051/001-006
EU/1/97/051/009-033


24.6.2011




17.6.2011


Mircera







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/07/400/008-013
EU/1/07/400/017-024


23.6.2011




17.6.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/08/452/001


23.6.2011




17.6.2011


Ranexa







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg






EU/1/08/462/001-012


21.6.2011




17.6.2011


Relistor







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/08/463/001-011


21.6.2011




17.6.2011


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116/001-005


21.6.2011




17.6.2011


Sifrol







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/97/050/001-006
EU/1/97/050/009-033


24.6.2011




17.6.2011


Tasigna







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/07/422/001-008


23.6.2011




17.6.2011


Tygacil







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/06/336/001


23.6.2011




17.6.2011


Tysabri







Elan Pharma International Ltd.




Monksland, Athlone, County Westmeath, Ireland






EU/1/06/346/001


23.6.2011




17.6.2011


Xeloda







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/00/163/001-002


21.6.2011




17.6.2011


Xolair







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/05/319/001-010


23.6.2011




23.6.2011


BeneFIX







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/97/047/001-007


28.6.2011




23.6.2011


Docefrez







Sun Pharmaceuticals Industries Europe B.V.




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/10/630/001-002


28.6.2011




23.6.2011


Dynastat







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/02/209/001-008


28.6.2011




23.6.2011


Erbitux







Merck KGaA




Frankfurter Straße 250, 64271 Darmstadt, Deutschland






EU/1/04/281/001-005


27.6.2011




23.6.2011


Ganfort







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/06/340/001-002


28.7.2011




23.6.2011


Herceptin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/00/145/001


27.6.2011




23.6.2011


Invirase







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/96/026/001-002


28.6.2011




23.6.2011


Mabthera







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/98/067/001-002


27.6.2011




23.6.2011


NovoSeven







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/96/006/001-007


27.6.2011




23.6.2011


Orencia







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/07/389/001-003


28.6.2011




23.6.2011


Ovitrelle







Merck Serono Europe Limited




56, Marsh Wall, London E14 9TP, United Kingdom






EU/1/00/165/001-008


27.6.2011




23.6.2011


Protopic







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/02/201/001-006


27.6.2011




23.6.2011


Tamiflu







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/02/222/001-004


28.6.2011




23.6.2011


Temozolomide HEXAL







HEXAL AG




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/10/616/001-024


27.6.2011




23.6.2011


Temozolomide Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland






EU/1/10/617/001-024


27.6.2011




23.6.2011


Tevagrastim







Teva GmbH




Wasastraße 50, 01445 Radebeul, Deutschland






EU/1/08/445/001-014


27.6.2011




23.6.2011


Torisel







Wyeth Europa Ltd




Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom






EU/1/07/424/001


27.6.2011




23.6.2011


Twinrix Adult







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, Rixensart, B-1330 Belgique






EU/1/96/020/001-009


27.6.2011




23.6.2011


Viramune







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/97/055/001-004


28.6.2011




29.6.2011


Abraxane







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom






EU/1/07/428/001


5.7.2011




29.6.2011


Aclasta







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/05/308/001-002


4.7.2011




29.6.2011


Adrovance







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/06/364/001-009


1.7.2011




29.6.2011


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/07/387/001-026


5.7.2011




29.6.2011


Advate







Baxter AG




Industriesstrasse 67, 1220 Vienna, Österreich






EU/1/03/271/001-006


4.7.2011




29.6.2011


APTIVUS







Boehringer Ingelheim International GmbH




Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland






EU/1/05/315/001-002


4.7.2011




29.6.2011


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/04/300/001-002


4.7.2011




29.6.2011


Bondenza







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/03/266/003-006


1.7.2011




29.6.2011


Bondronat







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/96/012/004
EU/1/96/012/009-013


1.7.2011




29.6.2011


Bonviva







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/03/265/003-006


1.7.2011




29.6.2011


Byetta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/06/362/001-004


5.7.2011




29.6.2011


Ecalta







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/1/07/416/001-002


1.7.2011




29.6.2011


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/126/001-022


1.7.2011




29.6.2011


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom






EU/1/99/126/001-022


5.7.2011




29.6.2011


Fosavance







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/05/310/001-009


1.7.2011




29.6.2011


Ibandronic Acid Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/642/001-004


1.7.2011




29.6.2011


Instanyl







Nycomed Danmark ApS




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/09/531/001-021


5.7.2011




29.6.2011


IntronA







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/99/127/011-039
EU/1/99/127/041-044


4.7.2011




29.6.2011


Karvea







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/97/049/001-039


5.7.2011




29.6.2011


Keppra







UCB Pharma SA.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België






EU/1/00/146/001-032


4.7.2011




29.6.2011


Nexavar







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/06/342/001


5.7.2011




29.6.2011


Pegasys







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/02/221/001-016


1.7.2011




29.6.2011


PegIntron







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/00/131/001-050


1.7.2011




29.6.2011


Prevenar 13







Wyeth Lederle Vaccines S.A.




Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium






EU/1/09/590/001-006


5.7.2011




29.6.2011


Rasilez HCT







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/08/491/001-080


1.7.2011




29.6.2011


Rebetol







Schering Plough Europe




Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België






EU/1/99/107/001-005


1.7.2011




29.6.2011


Siklos







ADDMEDICA




101, rue Saint Lazare, Paris 75009, France






EU/1/07/397/001-004


4.7.2011




29.6.2011


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/508/001-011


5.7.2011




29.6.2011


Telmisartan Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/610/031-060


5.7.2011




29.6.2011


Vantavo







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/09/572/001-009


1.7.2011




29.6.2011


Velcade







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/04/274/001-002


5.7.2011




29.6.2011


VPRIV







Shire Pharmaceuticals Ireland Limited




5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland






EU/1/10/646/003-006


5.7.2011




29.6.2011


Zometa







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/01/176/001-006


1.7.2011







—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)










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




14.6.2011


Humenza







Sanofi Pasteur SA




2, avenue Pont Pasteur, F-69007 Lyon, France






EU/1/10/629/001


16.6.2011







—   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 Décision


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




6.5.2011


CERTIFECT


(S)-Methoprene, Fipronil, Amitraz







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/11/125/001-008


Spot-on solution


QP53AX65


12.5.2011




6.5.2011


Zuprevo


Tildipirosin







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/124/001-008


Solution for injection


QJ01FA96


12.5.2011




14.6.2011


MS-H vaccine


Mycoplasma synoviae
Strain MS-H live attenuated thermosensitive







Pharmsure Ltd




Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom






EU/2/11/126/001


Eye drops, suspension


QI01AE03


16.6.2011







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




16.5.2011


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, IRELAND






EU/2/07/078/001-014


18.5.2011




18.5.2011


Aivlosin







ECO Animal Health Ltd




78 Coombe Road New Malden Surrey KT3 4QS United Kingdom






EU/2/04/044/001-006
EU/2/04/044/013


23.5.2011




18.5.2011


Previcox







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/04/045/001-007


20.5.2011




18.5.2011


ProteqFlu







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/03/037/005


20.5.2011




18.5.2011


ProteqFlu-Te







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/03/038/005


20.5.2011




23.5.2011


Suvaxyn PCV







Fort Dodge Animal Health Ltd




Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom






EU/2/09/099/001-006


25.5.2011




7.6.2011


Fevaxyn Pentofel







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom






EU/2/96/002/001-003


9.6.2011




14.6.2011


Advocate







Bayer Animal Health GmbH




51368 Leverkusen, Deutschland






EU/2/03/039/031-054


16.6.2011




14.6.2011


Naxcel







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/2/05/053/003


16.6.2011




15.6.2011


Convenia







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/2/06/059/001


17.6.2011




23.6.2011


Metacam







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/97/004/026
EU/2/97/004/033-034
EU/2/97/004/039-040
EU/2/97/004/043-048


28.6.2011




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




UK - LONDON E14 4H






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.