Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2011-10-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011316EN.01000101.xml










28.10.2011   


EN


Official Journal of the European Union


C 316/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 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 316/01
—   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




13.7.2011


Benlysta


belimumab







Glaxo Group Limited




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






EU/1/11/700/001-002


powder for concentrate for solution for infusion


L04AA26


15.7.2011




13.7.2011


Temozolomide Sun


temozolomide







Sun Pharmaceuticals Industries Europe B.V.




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/11/697/001-012


Capsule, hard


L01AX03


18.7.2011




13.7.2011


Xgeva


denosumab







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/11/703/001-002


Solution for injection


M05BX04


15.7.2011




13.7.2011


Yervoy


ipilimumab







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/698/001-002


Concentrate for solution for infusion


L01XC11


15.7.2011




18.7.2011


Victrelis


boceprevir







Merck Sharp & Dohme Limited




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






EU/1/11/704/001


Capsule, hard


J05AE


20.7.2011




20.7.2011


Fampyra


fampridine







Biogen Idec Limited




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






EU/1/11/699/001-002


Prolonged-release tablet


N07XX07


25.7.2011




20.7.2011


TOBI Podhaler


Tobramycin







Novartis Europharm Limited




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






EU/1/10/652/001-003


Inhalation powder, hard capsule


J01GB01


25.7.2011




26.7.2011


Ibandronic acid Sandoz


Ibandronic acid







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland






EU/1/11/685/001-005


Film-coated tablet


M05BA06


28.7.2011




27.7.2011


Zoely


nomegestrol/estradiol







Merck Serono Europe Limited




56 Marsh Wall, London E14 9TP, United Kingdom






EU/1/11/690/001-002


Film-coated tablet


G03AA14


1.8.2011




18.8.2011


Entacapone Orion


entacapone







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/11/708/001-004


Film-coated tablet


N04BX02


22.8.2011




24.8.2011


Levodopa/Carbidopa/Entacapone Orion


Levodopa, carbidopa, entacapone







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/11/706/001-033


Film-coated tablet


N04BA03


29.8.2011




24.8.2011


Trajenta


linagliptin







Boehringer Ingelheim International GmbH




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






EU/1/11/707/001-011


Film-coated tablet


A10BH05


30.8.2011




26.8.2011


Levetiracetam ratiopharm


levetiracetam







ratiopharm GmbH




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






EU/1/11/702/001-031


Film-coated tablet
Oral solution


N03AX14


31.8.2011




26.8.2011


Levetiracetam Teva


levetiracetam







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/701/001-028


Film-coated tablet


N03AX14


31.8.2011







—   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




5.7.2011


Irbesartan Winthrop







Sanofi-Aventis




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






EU/1/06/376/001-033


7.7.2011




5.7.2011


Relistor







Wyeth Europa Limited




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






EU/1/08/463/001-011


7.7.2011




7.7.2011


Adrovance







Merck Sharp & Dohme Ltd




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






EU/1/06/364/005
EU/1/06/364/009


11.7.2011




7.7.2011


Ammonaps







Swedish Orphan Biovitrum International AB




SE-112 76 Stockholm, Sverige






EU/1/99/120/001-004


12.7.2011




7.7.2011


Hirobriz Breezhaler







Novartis Europharm Limited




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






EU/1/09/594/001-010


11.7.2011




7.7.2011


Modigraf







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/09/523/001-002


11.7.2011




7.7.2011


Removab







Fresenius Biotech GmbH




Am Haag 6-7, D-82166 Graefelfing, Deutschland






EU/1/09/512/001-002


11.7.2011




11.7.2011


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/1/99/119/017-023


13.7.2011




11.7.2011


Onbrez Breezhaler







Novartis Europharm Ltd




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






EU/1/09/593/001-010


13.7.2011




11.7.2011


Optaflu







Novartis Vaccines and Diagnostics GmbH




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






EU/1/07/394/001-009


13.7.2011




13.7.2011


Sildenafil ratiopharm







ratiopharm GmbH




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






EU/1/09/603/001-015


18.7.2011




13.7.2011


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


18.7.2011




13.7.2011


Sustiva







Bristol-Myers Squibb Pharma EEIG




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






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


18.7.2011




13.7.2011


ViraferonPeg







Schering Plough Europe




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






EU/1/00/132/001-050


18.7.2011




13.7.2011


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200/001-002


18.7.2011




18.7.2011


Crixivan







Merck Sharp & Dohme Ltd




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






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


20.7.2011




18.7.2011


Intrinsa







Warner Chilcott UK Ltd




Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom






EU/1/06/352/001-003


20.7.2011




18.7.2011


Livensa







Warner Chilcott Deutschland Gmbh




Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland






EU/1/06/351/001-003


20.7.2011




18.7.2011


Multaq







Sanofi-Aventis




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






EU/1/09/591/001-004


20.7.2011




18.7.2011


ReFacto AF







Wyeth Europa Ltd.




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






EU/1/99/103/001-008


20.7.2011




18.7.2011


Savene







SpePharm Holding BV




Kingsfordweg 151, GR Amsterdam 1043, Nederland






EU/1/06/350/001


20.7.2011




20.7.2011


Atriance







Glaxo Group Limited




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






EU/1/07/403/001


25.7.2011




20.7.2011


Betaferon







Bayer Schering Pharma AG




Müllerstrasse 170-178, D - 13342 Berlin, Deutschland






EU/1/95/003/003-012


25.7.2011




20.7.2011


Esbriet







InterMune UK Ltd




4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom






EU/1/11/667/001-003


26.7.2011




20.7.2011


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/468/001


25.7.2011




20.7.2011


Ratiograstim







ratiopharm GmbH




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






EU/1/08/444/001-012


25.7.2011




20.7.2011


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Keltenring 1+3, Oberhaching 82041, Deutschland






EU/1/09/585/001-018


25.7.2011




20.7.2011


Rivastigmine Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland






EU/1/09/599/001-018


25.7.2011




20.7.2011


Silgard







Merck Sharp & Dohme Ltd




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






EU/1/06/358/001-008
EU/1/06/358/018-021


25.7.2011




20.7.2011


Zalasta







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/07/415/001-056


25.7.2011




26.7.2011


Avaglim







SmithKline Beecham Ltd.




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






EU/1/06/349/001-010


28.7.2011




26.7.2011


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


28.7.2011




26.7.2011


Busilvex







Pierre Fabre Médicament




45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France






EU/1/03/254/002


28.7.2011




26.7.2011


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/296/001-009


28.7.2011




26.7.2011


Forsteo







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/03/247/001-002


28.7.2011




26.7.2011


Infanrix hexa







GlaxoSmithKline Biologicals S.A.




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






EU/1/00/152/001-008
EU/1/00/152/019-020


28.7.2011




26.7.2011


Kuvan







Merck Serono Europe Limited




56 Marsh Wall, London E14 9TP, United Kingdom






EU/1/08/481/001-003


28.7.2011




26.7.2011


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/10/614/001-003


28.7.2011




26.7.2011


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116/001-005


28.7.2011




26.7.2011


Retacrit







Hospira UK Limited




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






EU/1/07/431/001-025


28.7.2011




26.7.2011


Stelara







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/494/001-004


28.7.2011




26.7.2011


Xeristar







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/297/001-008


28.7.2011




27.7.2011


Avastin







Roche Registration Limited




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






EU/1/04/300/001-002


2.8.2011




27.7.2011


Beromun







Boehringer Ingelheim International GmbH




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






EU/1/99/097/001


1.8.2011




27.7.2011


Bondenza







Roche Registration Limited




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






EU/1/03/266/003-006


29.7.2011




27.7.2011


Bonviva







Roche Registration Limited




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






EU/1/03/265/003-006


29.7.2011




27.7.2011


Copalia







Novartis Europharm Ltd




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






EU/1/06/372/001-039


1.8.2011




27.7.2011


Dafiro







Novartis Europharm Ltd




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






EU/1/06/371/001-039


1.8.2011




27.7.2011


Ecalta







Pfizer Limited




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






EU/1/07/416/001-002


29.7.2011




27.7.2011


Emtriva







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/03/261/001-003


3.8.2011




27.7.2011


Eporatio







ratiopharm GmbH




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






EU/1/09/573/001-028


29.7.2011




27.7.2011


Exforge







Novartis Europharm Ltd




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






EU/1/06/370/001-039


29.7.2011




27.7.2011


Exjade







Novartis Europharm Ltd




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






EU/1/06/356/001-009


1.8.2011




27.7.2011


Faslodex







AstraZeneca UK Limited




Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom






EU/1/03/269/001-002


1.8.2011




27.7.2011


Fosavance







Merck Sharp & Dohme Ltd




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






EU/1/05/310/005
EU/1/05/310/009


29.7.2011




27.7.2011


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/06/357/001-008
EU/1/06/357/018-021


29.7.2011




27.7.2011


Imprida







Novartis Europharm Ltd




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






EU/1/06/373/001-039


29.7.2011




27.7.2011


Integrilin







Glaxo Group Ltd




Greenford, Middlesex, UB6 ONN, United Kingdom






EU/1/99/109/001-002


1.8.2011




27.7.2011


Kiovig







Baxter AG




Industriestraße 67, A - 1221 Wien, Österreich






EU/1/05/329/001-006


29.7.2011




27.7.2011


Leflunomide Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/09/604/001-010


2.8.2011




27.7.2011


Nevanac







Alcon Laboratories (UK) Ltd.




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






EU/1/07/433/001


29.7.2011




27.7.2011


PhotoBarr







Axcan Pharma International BV




Engelenkampstraat 72, 6131 JJ Sittard, Nederland






EU/1/04/272/001-002


2.8.2011




27.7.2011


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/06/380/001-005


2.8.2011




27.7.2011


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/1/01/171/013-014


1.8.2011




27.7.2011


Relistor







TMC Pharma Services Ltd.




Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom






EU/1/08/463/001-011


1.8.2011




27.7.2011


Silgard







Merck Sharp & Dohme Ltd




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






EU/1/06/358/001-021


2.8.2011




27.7.2011


Sycrest







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/10/640/001-006


2.8.2011




27.7.2011


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498/001-008


29.7.2011




27.7.2011


Truvada







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/04/305/001-002


3.8.2011




27.7.2011


Valdoxan







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/08/499/001-008


1.8.2011




27.7.2011


Vantavo







Merck Sharp & Dohme Ltd.




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






EU/1/09/572/005
EU/1/09/572/009


1.8.2011




27.7.2011


Yentreve







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/280/001-008


29.7.2011




1.8.2011


alli







Glaxo Group Limited




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






EU/1/07/401/007-016


3.8.2011




1.8.2011


Doribax







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/467/001-002


3.8.2011




1.8.2011


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/06/357/001-021


3.8.2011




1.8.2011


Iressa







AstraZeneca AB




Sodertalje S 151 85, Sverige






EU/1/09/526/001-002


3.8.2011




1.8.2011


Nexavar







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/06/342/001


2.8.2011




1.8.2011


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442/001-014


3.8.2011




1.8.2011


Rivastigmine Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/513/001-020


3.8.2011




1.8.2011


RoActemra







Roche Registration Limited




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






EU/1/08/492/001-006


3.8.2011




5.8.2011


ATryn







GTC Biotherapeutics UK Limited




10 Norwich Street, London EC4A 1BD, United Kingdom






EU/1/06/355/001-003


10.8.2011




5.8.2011


Biograstim







CT Arzneimittel GmbH




Lengeder Straße 42a, D-13407 Berlin, Deutschland






EU/1/08/450/001-010


10.8.2011




5.8.2011


Biopoin







CT Arzneimittel GmbH




Lengeder Straße 42a, D-13407 Berlin, Deutschland






EU/1/09/565/001-028


10.8.2011




5.8.2011


Enbrel







Wyeth Europa Limited




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






EU/1/99/126/001-022


10.8.2011




5.8.2011


Focetria







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/07/385/001-002
EU/1/07/385/004


10.8.2011




5.8.2011


Hepsera







Gilead Sciences International Limited




Cambridge, CB21 6GT, United Kingdom






EU/1/03/251/001-002


10.8.2011




5.8.2011


Hycamtin







SmithKline Beecham Ltd.




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






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


10.8.2011




5.8.2011


InductOs







Wyeth Europa Ltd.




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






EU/1/02/226/001


10.8.2011




5.8.2011


Silapo







STADA Arzneimittel AG




Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland






EU/1/07/432/001-022


10.8.2011




5.8.2011


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89, 1330 Rixensart, Belgique






EU/1/09/508/001-010


10.8.2011




5.8.2011


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200/001-002


10.8.2011




10.8.2011


Arava







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/99/118/001-010


12.8.2011




10.8.2011


Cholestagel







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/03/268/001-004


12.8.2011




10.8.2011


Filgrastim Hexal







HEXAL AG




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/08/496/001-016


12.8.2011




10.8.2011


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/134/001-037


12.8.2011




10.8.2011


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/133/001-032


12.8.2011




10.8.2011


Oslif Breezhaler







Novartis Europharm Limited




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






EU/1/09/586/001-010


12.8.2011




10.8.2011


Vidaza







Celgene Europe Ltd




1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom






EU/1/08/488/001


12.8.2011




10.8.2011


Zarzio







Sandoz GmbH




Biochemiestrasse 10, A-6250 Kundl, Österreich






EU/1/08/495/001-016


12.8.2011




18.8.2011


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/283/008-012


22.8.2011




18.8.2011


Karvezide







Bristol-Myers Squibb Pharma EEIG




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






EU/1/98/085/001-034


22.8.2011




18.8.2011


Osseor







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/04/287/001-006


22.8.2011




18.8.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




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






EU/1/08/452/001


22.8.2011




18.8.2011


Protelos







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/04/288/001-006


22.8.2011




18.8.2011


Sutent







Pfizer Ltd




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






EU/1/06/347/001-008


22.8.2011




18.8.2011


Volibris







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/08/451/001-004


22.8.2011




19.8.2011


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland






EU/1/07/430/001-002


23.8.2011




24.8.2011


Afinitor







Novartis Europharm Ltd




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






EU/1/09/538/001-008


30.8.2011




24.8.2011


Efficib







Merck Sharp & Dohme Ltd.




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






EU/1/08/457/001-016


30.8.2011




24.8.2011


Enbrel







Pfizer Limited




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






EU/1/99/126/001-022


9.9.2011




24.8.2011


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/468/001


30.8.2011




24.8.2011


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


30.8.2011




24.8.2011


Janumet







Merck Sharp & Dohme Ltd.




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






EU/1/08/455/001-016


30.8.2011




24.8.2011


Januvia







Merck Sharp & Dohme Ltd




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






EU/1/07/383/001-018


30.8.2011




24.8.2011


Kentera







Nicobrand Limited




189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP






EU/1/03/270/001-005


30.8.2011




24.8.2011


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/134/001-037


30.8.2011




24.8.2011


Mepact







IDM PHARMA SAS




11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France






EU/1/08/502/001


30.8.2011




24.8.2011


Micardis







Boehringer Ingelheim International GmbH




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






EU/1/98/090/017-022


29.8.2011




24.8.2011


Modigraf







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/09/523/001-002


29.8.2011




24.8.2011


Multaq







Sanofi-Aventis




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






EU/1/09/591/001-004


26.8.2011




24.8.2011


Mycamine







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/08/448/001-002


26.8.2011




24.8.2011


Neupro







Schwarz Pharma Ltd




Shannon, Industrial Estate, Co.Clare, Ireland






EU/1/05/331/001-055


26.8.2011




24.8.2011


Nplate







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/08/497/001-008


30.8.2011




24.8.2011


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/00/133/001-032


29.8.2011




24.8.2011


Osigraft







Howmedica International S. de R.L.




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






EU/1/01/179/001


30.8.2011




24.8.2011


PegIntron







Schering Plough Europe




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






EU/1/00/131/001-050


26.8.2011




24.8.2011


Pelzont







Merck Sharp & Dohme Ltd




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






EU/1/08/460/001-014


26.8.2011




24.8.2011


Rebetol







Schering Plough Europe




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






EU/1/99/107/001-005


29.8.2011




24.8.2011


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267/001-010


30.8.2011




24.8.2011


Ristaben







Merck Sharp & Dohme Ltd.




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






EU/1/10/621/001-018


30.8.2011




24.8.2011


Ristfor







Merck Sharp & Dohme Ltd.




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






EU/1/10/620/001-016


30.8.2011




24.8.2011


Stalevo







Orion Corporation




Orionintie 1, FIN-02200 Espoo, Suomi






EU/1/03/260/001-038


30.8.2011




24.8.2011


Starlix







Novartis Europharm Ltd




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






EU/1/01/174/001-021


30.8.2011




24.8.2011


Tarceva







Roche Registration Limited




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






EU/1/05/311/001-003


26.8.2011




24.8.2011


Tesavel







Merck Sharp & Dohme Ltd




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






EU/1/07/435/001-018


30.8.2011




24.8.2011


Thyrogen







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/99/122/001-002


30.8.2011




24.8.2011


Tredaptive







Merck Sharp & Dohme Ltd




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






EU/1/08/459/001-014


30.8.2011




24.8.2011


Trevaclyn







Merck Sharp & Dohme Ltd




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






EU/1/08/458/001-014


30.8.2011




24.8.2011


Tygacil







Wyeth Europa Ltd.




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






EU/1/06/336/001


30.8.2011




24.8.2011


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/04/274/001-002


30.8.2011




24.8.2011


Velmetia







Merck Sharp & Dohme Ltd.




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






EU/1/08/456/001-016


30.8.2011




24.8.2011


Vfend







Pfizer Ltd




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






EU/1/02/212/001-026


30.8.2011




24.8.2011


ViraferonPeg







Schering Plough Europe




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






EU/1/00/132/001-050


30.8.2011




24.8.2011


Yttriga







Eckert & Ziegler Nuclitec GmbH




Gieselweg 1, Braunschweig 38110, Deutschland






EU/1/05/322/001-002


29.8.2011




24.8.2011


Zevalin







Bayer Schering Pharma AG




D-13342 Berlin, Deutschland






EU/1/03/264/001


30.8.2011




24.8.2011


Zometa







Novartis Europharm Ltd




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






EU/1/01/176/001-009


30.8.2011




26.8.2011


Alisade







Glaxo Group Ltd




Greenford, Middlesex, UB6 ONN, United Kingdom






EU/1/08/474/001-003


31.8.2011




26.8.2011


Avamys







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/434/001-003


31.8.2011




26.8.2011


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89, 1330 Rixensart, Belgique






EU/1/07/419/001-012


31.8.2011




26.8.2011


Corlentor







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/05/317/001-014


31.8.2011




26.8.2011


Fertavid







SP Europe




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






EU/1/09/510/001-019


31.8.2011




26.8.2011


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


31.8.2011




26.8.2011


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/06/368/001-168


31.8.2011




26.8.2011


Procoralan







Les Laboratoires Servier




22, rue Garnier, 92200 Neuilly-sur-Seine, France






EU/1/05/316/001-014


31.8.2011




26.8.2011


Prolia







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/10/618/001-004


31.8.2011




26.8.2011


Sebivo







Novartis Europharm Ltd




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






EU/1/07/388/001-003


31.8.2011




26.8.2011


Tepadina







ADIENNE S.r.l.




via Broseta, 64/B, 24128 Bergamo, Italia






EU/1/10/622/001-002


31.8.2011




26.8.2011


Topotecan Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/09/552/001-004


31.8.2011







—   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




5.8.2011


Proteq West Nile


West Nile recombinant canarypox virus (vCP2017 virus)







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/11/129/001-004


Suspension for injection


QI05AX


10.8.2011




5.8.2011


Zulvac 1 Bovis


Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1







Pfizer Limited




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






EU/2/11/130/001-003


Suspension for injection


QI02AA08


10.8.2011




5.8.2011


Zulvac 1 Ovis


Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1







Pfizer Limited




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






EU/2/11/131/001-006


Suspension for injection


QI04AA02


10.8.2011




18.8.2011


Emdocam


Meloxicam







Emdoka bvba




J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe






EU/2/11/128/001-003


Solution for injection


QM01AC06


22.8.2011







—   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




7.7.2011


Leucofeligen FeLV/RCP







VIRBAC S.A.




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






EU/2/09/097/001-002


11.7.2011




7.7.2011


Palladia







Pfizer Ltd




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






EU/2/09/100/001-003


12.7.2011




7.7.2011


ProMeris Duo







Pfizer Limited




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






EU/2/06/065/001-010


11.7.2011




11.7.2011


Trocoxil







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/08/084/001-005


13.7.2011




13.7.2011


Loxicom







Norbrook Laboratories Limited




Station Works, Newry, Co. Down, BT35 6JP, United Kindgom






EU/2/08/090/001-018


18.7.2011




20.7.2011


Posatex







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/081/001-003


25.7.2011




27.7.2011


Poulvac FluFend H5N3 RG







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/06/060/001-002


1.8.2011




27.7.2011


ProMeris







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/06/064/001-004


1.8.2011




27.7.2011


Slentrol







Pfizer Ltd




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






EU/2/07/071/001-003


2.8.2011




5.8.2011


Cerenia







Pfizer Ltd




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






EU/2/06/062/001-005


10.8.2011




5.8.2011


Virbagen Omega







VIRBAC S.A.




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






EU/2/01/030/001-004


10.8.2011




19.8.2011


Nobilis Influenza H5N2







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/06/061/001-004


23.8.2011




19.8.2011


Zolvix







Novartis Healthcare A/S




Lyngbyvej 172, DK-2100 Copenhagen, Danmark






EU/2/09/101/001-010


23.8.2011




24.8.2011


Suvaxyn Aujeszky 783 +O/W







Fort Dodge Animal Health Holland




C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland






EU/2/98/009/001-006


30.8.2011







—   Withdrawal of a marketing authorization (Article 38 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




10.8.2011


Yarvitan







Janssen Pharmaceutica N.V.




Turnhoutseweg 30, B-2340 Beerse, België






EU/2/06/063/001-003


12.8.2011




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.