Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2011-06-24
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011184EN.01000101.xml










24.6.2011   


EN


Official Journal of the European Union


C 184/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 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 184/01
—   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




4.3.2011


Ifirmacombi


Irbesartan/hydrochlorothiazide







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/11/673/001-024


Film-coated tablet


C09DA04


8.3.2011




4.3.2011


Pumarix


Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)







GlaxoSmithKline Biologicals S.A.




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






EU/1/10/664/001


Suspension and emulsion for emulsion for injection


J07BB02


8.3.2011




4.3.2011


Xeplion


paliperidone







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/672/001-006


Prolonged release suspension for injection


N05AX13


8.3.2011




10.3.2011


Leflunomide Teva


leflunomide







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/675/001-010


Film-coated tablet


L04AA13


14.3.2011




14.3.2011


Repso


leflunomide







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/674/001-010


Film-coated tablet


L04AA13


17.3.2011




14.3.2011


Teysuno


Tegafur/gimeracil/oteracil







Taiho Pharma Europe, Limited




55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom






EU/1/11/669/001-004


Capsule, hard


L01BC53


17.3.2011




17.3.2011


GILENYA


Fingolimod







Novartis Europharm Limited




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






EU/1/11/677/001-004


Capsule, hard


L04AA27


22.3.2011




17.3.2011


HALAVEN


eribulin







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom






EU/1/11/678/001-002


Solution for injection


L01XX41


22.3.2011




17.3.2011


JEVTANA


cabazitaxel







Sanofi-Aventis




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






EU/1/11/676/001


Concentrate and solvent for solution for infusion


Pending


22.3.2011




28.3.2011


Trobalt


retigabine







Glaxo Group Limited




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






EU/1/11/681/001-013


Film-coated tablet


N03AX21


31.3.2011




13.4.2011


Riprazo HCT


aliskiren hemifumarate / hydrochlorothiazide







Novartis Europharm Limited




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






EU/1/11/680/001-080


Film-coated tablet


C09XA52


15.4.2011




14.4.2011


Hizentra


human normal immunoglobulin







CSL Behring GmbH




Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland






EU/1/11/687/001-012


Solution for injection


J06BA01


18.4.2011




14.4.2011


Pravafenix


fenofibrate / pravastatin







LABORATOIRES SMB SA




26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe






EU/1/11/679/001-006


Capsule, hard


C10BA03


19.4.2011




14.4.2011


Rasilamlo


aliskiren / amlodipine







Novartis Europharm Ltd




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






EU/1/11/686/001-056


Film-coated tablet


C09XA53


18.4.2011







—   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




4.3.2011


Silgard







Merck Sharp & Dohme Ltd




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






EU/1/06/358/001-021


8.3.2011




4.3.2011


Vaniqa







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/01/173/001-003


8.3.2011




8.3.2011


Clopidogrel DURA







Mylan dura GmbH




Wittichstraße 6, D-64295 Darmstadt, Deutschland






EU/1/09/560/001-009


10.3.2011




8.3.2011


Clopidogrel Mylan







Mylan S.A.S




117 allée des Parcs, 69 800 Saint Priest, France






EU/1/09/559/001-016


10.3.2011




8.3.2011


Rebetol







Schering Plough Europe




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






EU/1/99/107/001-005


21.3.2011




8.3.2011


Tarceva







Roche Registration Limited




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






EU/1/05/311/001-003


10.3.2011




10.3.2011


Abraxane







Abraxis BioScience Limited




Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom






EU/1/07/428/001


22.3.2011




10.3.2011


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37, D-58638 Iserlohn, Deutschland






EU/1/07/412/001-052


11.3.2011




10.3.2011


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37, D-58638 Iserlohn, Deutschland






EU/1/07/412/001-052


14.3.2011




10.3.2011


Clopidogrel Teva Pharma







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/561/001-010


14.3.2011




14.3.2011


Actrapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/230/001-017


17.3.2011




14.3.2011


BeneFIX







Wyeth Europa Ltd.




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






EU/1/97/047/001-007


18.3.2011




14.3.2011


Binocrit







Sandoz GmbH




Biochemiestrasse 10, Kundl 6250, Österreich






EU/1/07/410/001-052


17.3.2011




14.3.2011


Binocrit







Sandoz GmbH




Biochemiestrasse 10, Kundl 6250, Österreich






EU/1/07/410/001-052


16.3.2011




14.3.2011


Clopidogrel Acino







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/532/001-007


16.3.2011




14.3.2011


Clopidogrel Hexal







Acino Pharma GmbH




Am Windfeld 35, Miesbach 83714, Deutschland






EU/1/09/534/001-007


21.3.2011




14.3.2011


Epoetin alfa Hexal







Hexal AG.




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/07/411/001-052


17.3.2011




14.3.2011


Epoetin alfa Hexal







Hexal AG.




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/07/411/001-052


18.3.2011




14.3.2011


Prometax







Novartis Europharm Limited




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






EU/1/98/092/001-026


16.3.2011




14.3.2011


Rivastigmine HEXAL







HEXAL AG




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/09/589/001-018


21.3.2011




14.3.2011


Visudyne







Novartis Europharm Limited




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






EU/1/00/140/001


21.3.2011




17.3.2011


Actraphane







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/229/001-004
EU/1/02/229/011-019
EU/1/02/229/024-037


22.3.2011




17.3.2011


Clopidogrel Sandoz







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/547/001-007


22.3.2011




17.3.2011


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575/001-060


22.3.2011




17.3.2011


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574/001-060


22.3.2011




17.3.2011


Exelon







Novartis Europharm Limited




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






EU/1/98/066/001-026


22.3.2011




17.3.2011


HBVAXPRO







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-032


22.3.2011




17.3.2011


INOmax







INO Therapeutics AB




SE-181 81 Lidingö, Sverige






EU/1/01/194/001-002


22.3.2011




17.3.2011


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/01/195/001-027


22.3.2011




17.3.2011


Mixtard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/231/001-037


22.3.2011




17.3.2011


NovoMix







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/00/142/004-005
EU/1/00/142/009-025


22.3.2011




17.3.2011


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/05/323/001-013


22.3.2011




17.3.2011


Protaphane







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/234/001-017


22.3.2011




18.3.2011


Adrovance







Merck Sharp & Dohme Ltd




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






EU/1/06/364/001-009


23.3.2011




18.3.2011


Fosavance







Merck Sharp & Dohme Ltd




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






EU/1/05/310/001-009


23.3.2011




18.3.2011


Humira







Abbott Laboratories Ltd




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






EU/1/03/256/001-010


23.3.2011




18.3.2011


INOmax







INO Therapeutics AB




SE-181 81 Lidingö, Sverige






EU/1/01/194/001-004


22.3.2011




18.3.2011


Ivemend







Merck Sharp & Dohme Limited




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






EU/1/07/437/001-004


23.3.2011




18.3.2011


Kaletra







Abbott Laboratories




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






EU/1/01/172/001-008


23.3.2011




18.3.2011


Kivexa







ViiV Healthcare UK Ltd




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






EU/1/04/298/001-003


23.3.2011




18.3.2011


Luveris







Merck Serono Europe Limited




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






EU/1/00/155/001-007


23.3.2011




18.3.2011


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/10/614/001-002


23.3.2011




18.3.2011


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


23.3.2011




18.3.2011


Rasilez







Novartis Europharm Limited




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






EU/1/07/405/001-040


23.3.2011




18.3.2011


Rasilez HCT







Novartis Europharm Limited




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






EU/1/08/491/001-080


23.3.2011




18.3.2011


Riprazo







Novartis Europharm Limited




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






EU/1/07/409/001-040


23.3.2011




18.3.2011


RoActemra







Roche Registration Limited




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






EU/1/08/492/001-006


23.3.2011




18.3.2011


Sifrol







Boehringer Ingelheim International GmbH




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






EU/1/97/050/013-033


23.3.2011




18.3.2011


Simulect







Novartis Europharm Limited




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






EU/1/98/084/001-002


23.3.2011




18.3.2011


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200/001-002


23.3.2011




18.3.2011


Xyrem







UCB Pharma Ltd.




208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom






EU/1/05/312/001


23.3.2011




18.3.2011


Zerit







Bristol-Myers Squibb Pharma EEIG




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






EU/1/96/009/001-009


23.3.2011




24.3.2011


Avastin







Roche Registration Limited




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






EU/1/04/300/001-002


29.3.2011




24.3.2011


Cayston







Gilead Sciences International Limited




Granta Park, Abington, Cambridge CB21 6GT, United Kingdom






EU/1/09/543/001-002


29.3.2011




24.3.2011


Clopidogrel ratiopharm







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/554/001-008


28.3.2011




24.3.2011


DuoTrav







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/06/338/001-003


29.3.2011




24.3.2011


Evoltra







Genzyme Europe BV




Gooimeer 10, 1411 DD Naarden, Nederland






EU/1/06/334/001-005


30.3.2011




24.3.2011


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569/001-060


30.3.2011




24.3.2011


Forsteo







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/03/247/001-002


30.3.2011




24.3.2011


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535/001-016


29.3.2011




24.3.2011


HBVAXPRO







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/01/183/001
EU/1/01/183/004-005
EU/1/01/183/007-008
EU/1/01/183/011
EU/1/01/183/013
EU/1/01/183/015
EU/1/01/183/018-032


28.3.2011




24.3.2011


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


28.3.2011




24.3.2011


Imprida HCT







Novartis Europharm Limited




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






EU/1/09/570/001-060


30.3.2011




24.3.2011


Insulatard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/233/001-017


28.3.2011




24.3.2011


Levitra







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/03/248/001-020


30.3.2011




24.3.2011


Myocet







Cephalon Europe




5 Rue Charles Martigny, Maisons Alfort 94700, France






EU/1/00/141/001


29.3.2011




24.3.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




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






EU/1/08/452/001


31.3.2011




24.3.2011


Revatio







Pfizer Limited




Sandwich, Kent, CT13 9NJ, United Kingdom






EU/1/05/318/001-002


30.3.2011




24.3.2011


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267/001-010


30.3.2011




24.3.2011


Scintimun







CIS bio international




Boite Postale 32 - F-91192 Gif-sur-Yvette - France






EU/1/09/602/001-002


29.3.2011




24.3.2011


Silodyx







Recordati Ireland Ltd.




Raheens East, Ringaskiddy Co. Cork, Ireland






EU/1/09/607/001-014


29.3.2011




24.3.2011


Soliris







Alexion Europe S.A.S.




25, boulevard de l'Amiral Bruix, 75016 Paris, France






EU/1/07/393/001


28.3.2011




24.3.2011


Sprimeo







Novartis Europharm Limited




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






EU/1/07/407/001-040


28.3.2011




24.3.2011


Toviaz







Pfizer Limited




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






EU/1/07/386/001-018


30.3.2011




24.3.2011


Urorec







Recordati Ireland Ltd.




Raheens East, Ringaskiddy Co. Cork, Ireland






EU/1/09/608/001-014


29.3.2011




24.3.2011


Vantavo







Merck Sharp & Dohme Ltd.




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






EU/1/09/572/001-009


28.3.2011




24.3.2011


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200/001-002


29.3.2011




24.3.2011


Zopya







Norpharm Regulatory Services Ltd




26 Laurence Street, Drogheda, Co. Louth, Ireland






EU/1/09/562/001-009


29.3.2011




24.3.2011


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/06/341/001-013


30.3.2011




28.3.2011


Adenuric







Menarini International Operations Luxembourg S.A.




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






EU/1/08/447/001-012


30.3.2011




28.3.2011


Afinitor







Novartis Europharm Limited




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






EU/1/09/538/001-008


30.3.2011




28.3.2011


Evicel







OMRIX biopharmaceuticals S.A. / N.V.




200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België






EU/1/08/473/001-003


5.4.2011




28.3.2011


Levemir







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/04/278/001-011


30.3.2011




28.3.2011


Oprymea







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/469/001-025


30.3.2011




28.3.2011


Vizarsin







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/551/001-012


30.3.2011




31.3.2011


Ilaris







Novartis Europharm Limited




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






EU/1/09/564/001-002


4.4.2011




31.3.2011


Temozolomide Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/09/606/001-012


4.4.2011




8.4.2011


Copalia







Novartis Europharm Limited




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






EU/1/06/372/001-039


12.4.2011




8.4.2011


Dafiro







Novartis Europharm Limited




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






EU/1/06/371/001-039


12.4.2011




8.4.2011


Invega







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/07/395/001-095


12.4.2011




8.4.2011


Neulasta







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/02/227/001-004


12.4.2011




8.4.2011


NovoRapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-015
EU/1/99/119/017-018


12.4.2011




8.4.2011


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


12.4.2011




8.4.2011


Tyverb







Glaxo Group Limited




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






EU/1/07/440/001-003


12.4.2011




12.4.2011


Aclasta







Novartis Europharm Limited




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






EU/1/05/308/001-002


14.4.2011




12.4.2011


Emtriva







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/03/261/001-003


14.4.2011




12.4.2011


Firdapse







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/09/601/001


14.4.2011




12.4.2011


Kineret







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/02/203/001-004


14.4.2011




12.4.2011


Nexavar







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/06/342/001


14.4.2011




12.4.2011


Sildenafil ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/09/603/001-015


14.4.2011




14.4.2011


Bondenza







Roche Registration Limited




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






EU/1/03/266/003-006


19.4.2011




14.4.2011


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


18.4.2011




14.4.2011


Bonviva







Roche Registration Limited




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






EU/1/03/265/003-006


19.4.2011




14.4.2011


Brinavess







Merck Sharp & Dohme Limited




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






EU/1/10/645/001-002


18.4.2011




14.4.2011


Ceplene







EpiCept GmbH




Goethestrasse 4, D-80336 München, Deutschland






EU/1/08/477/001


18.4.2011




14.4.2011


Integrilin







Glaxo Group Ltd




Greenford, Middlesex, UB6 ONN, United Kingdom






EU/1/99/109/001-002


20.4.2011




14.4.2011


NutropinAq







Ipsen Pharma




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






EU/1/00/164/003-005


19.4.2011




14.4.2011


Preotact







Nycomed Danmark ApS




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/06/339/001-002


18.4.2011




14.4.2011


Rotarix







GlaxoSmithKline Biologicals S.A.




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






EU/1/05/330/001-011


18.4.2011




14.4.2011


Travatan







Alcon Laboratories (UK) Ltd.




Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom






EU/1/01/199/001-002


18.4.2011




14.4.2011


Zopya







Norpharm Regulatory Services Ltd




26 Laurence Street, Drogheda, Co. Louth, Ireland






EU/1/09/562/001-009


19.4.2011




18.4.2011


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/99/118/001-010


21.4.2011




18.4.2011


DaTSCAN







GE Healthcare Limited




Little Chalfont, Bucks HP7 9NA, United Kingdom






EU/1/00/135/001-002


21.4.2011




18.4.2011


Erbitux







Merck KGaA




Frankfurter Straße 250, 64271 Darmstadt, Deutschland






EU/1/04/281/001-005


21.4.2011




18.4.2011


Firazyr







Jerini AG




Invalidenstr. 130, D-10115 Berlin, Deutschland






EU/1/08/461/001-002


21.4.2011




18.4.2011


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


21.4.2011




18.4.2011


Kaletra







Abbott Laboratories




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






EU/1/01/172/001-008


21.4.2011




18.4.2011


Leflunomide Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/09/604/001-010


21.4.2011




18.4.2011


Modigraf







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/09/523/001-002


21.4.2011




18.4.2011


Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/578/001


21.4.2011




18.4.2011


Pegasys







Roche Registration Limited




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






EU/1/02/221/001-010


21.4.2011




18.4.2011


Rasilez







Novartis Europharm Limited




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






EU/1/07/405/001-040


21.4.2011




18.4.2011


Somavert







Pfizer Ltd




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






EU/1/02/240/001-004


21.4.2011




18.4.2011


Telzir







ViiV Healthcare UK Ltd




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






EU/1/04/282/001-002


21.4.2011




18.4.2011


Thalidomide Celgene







Celgene Europe Limited




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






EU/1/08/443/001


18.4.2011




18.4.2011


Valtropin







BioPartners GmbH




Kaiserpassage 11 - D-72764 Reutlingen, Deutschland






EU/1/06/335/001


21.4.2011




18.4.2011


Xyrem







UCB Pharma Ltd.




208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom






EU/1/05/312/001


21.4.2011




20.4.2011


Adcirca







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/08/476/005-006


27.4.2011




20.4.2011


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/07/387/001-026


28.4.2011




20.4.2011


Altargo







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/390/001-004


27.4.2011




20.4.2011


Efient







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/08/503/001-016


28.4.2011




20.4.2011


Herceptin







Roche Registration Limited




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






EU/1/00/145/001


27.4.2011




20.4.2011


Levitra







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/03/248/001-015


27.4.2011




20.4.2011


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/01/195/001-027


27.4.2011




20.4.2011


Prepandrix







GlaxoSmithKline Biologicals S.A.




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






EU/1/08/453/002


28.4.2011




20.4.2011


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116/001-005


27.4.2011




20.4.2011


Revasc







Canyon Pharmaceuticals Ltd




20-22 Bedford Row - WC1R 4JS London - United Kingdom






EU/1/97/043/001-003


27.4.2011




20.4.2011


Simponi







Janssen Biologics B.V.




Einsteinweg 101, CB Leiden 2333, Nederland






EU/1/09/546/001-004


27.4.2011




20.4.2011


Tolura







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/10/632/001-021


28.4.2011




20.4.2011


Tysabri







Elan Pharma International Ltd.




Monksland, Athlone, County Westmeath, Ireland






EU/1/06/346/001


27.4.2011




20.4.2011


Vivanza







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/03/249/001-012


27.4.2011




20.4.2011


Zerit







Bristol-Myers Squibb Pharma EEIG




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






EU/1/96/009/001-009


27.4.2011







—   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




24.3.2011


Onsenal







Pfizer Limited




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






EU/1/03/259/001-006


29.3.2011




31.3.2011


Clopidogrel Sandoz







Acino Pharma GmbH




Am Windfeld 35, 83714 Miesbach, Deutschland






EU/1/09/547/001-007


4.4.2011




20.4.2011


Filgrastim ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/08/449/001-008


28.4.2011







—   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




14.3.2011


CaniLeish


Leishmania infantum Excreted Secreted Proteins (ESP)







VIRBAC S.A.




1ère Avenue 2065 m L.I.D. - 06516 Carros - France






EU/2/11/121/001-009


Lyophilisate and solvent for suspension for injection


QI07AO


17.3.2011




14.3.2011


ZULVAC 1+8 Ovis


Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 / Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02







Pfizer Limited




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






EU/2/11/120/001-003


Suspension for injection


QI04AA02


17.3.2011




12.4.2011


Veraflox


Pradofloxacin







Bayer Animal Health GmbH




51368 Leverkusen, Deutschland






EU/2/10/107/001-014


Oral suspension Tablet


QJ01MA


14.4.2011




14.4.2011


BLUEVAC BTV8


Bluetongue virus inactivated, serotype 8







CZ Veterinaria, S.A.




La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA






EU/2/11/122/001-003


Suspension for injection


QI02AA08
QI04AA02


18.4.2011




20.4.2011


Procox


emodepside & toltrazuril







Bayer Animal Health GmbH




51368 Leverkusen, Deutschland






EU/2/11/123/001-002


Oral suspension


QP52AX60


28.4.2011







—   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




10.3.2011


Flexicam







Dechra Veterinary Products A/S




Mekuvej 9, 7171 Uldum, Danmark






EU/2/06/058/004


14.3.2011




14.3.2011


Zulvac 8 Bovis







Pfizer Limited




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






EU/2/09/105/001-002


17.3.2011




18.3.2011


Zubrin







Schering - Plough Limited




Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom






EU/2/00/028/002-008


23.3.2011




28.3.2011


BTVPUR AlSap 8







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/09/094/001-005


31.3.2011




12.4.2011


Zactran







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/08/082/001-007


14.4.2011




14.4.2011


Convenia







Pfizer Ltd




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






EU/2/06/059/001


20.4.2011




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, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.