Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2011-02-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, pharmaceutical industry, pharmaceutical legislation








C_2011061EN.01000101.xml










25.2.2011   


EN


Official Journal of the European Union


C 61/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010

(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 61/01
—   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




29.11.2010


Aflunov


Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/658/001-002


suspension for injection in prefilled syringe


J07BB02


3.12.2010




29.11.2010


Leflunomide ratiopharm


leflunomide







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/10/654/001-004


Film-coated tablet


L04AA13


6.12.2010




29.11.2010


Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic


Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/657/001-002


suspension for injection in prefilled syringe


J07BB02


3.12.2010




3.12.2010


Brilique


ticagrelor







AstraZeneca AB




Södertälje S 151 85,




Sverige






EU/1/10/655/001-006


Film-coated tablet


B01AC24


7.12.2010




3.12.2010


Possia


ticagrelor







AstraZeneca AB




Södertälje S 151 85,




Sverige






EU/1/10/656/001-006


Film-coated tablet


B01AC24


7.12.2010







—   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




3.11.2010


Actraphane







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd,




Danmark






EU/1/02/229/001-037


8.11.2010




3.11.2010


Adcirca







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA,




Houten,




Nederland






EU/1/08/476/005-006


9.11.2010




3.11.2010


Bridion







N.V. Organon




Kloosterstraat 6, 5349 AB Oss,




Nederland






EU/1/08/466/001-002


9.11.2010




3.11.2010


Combivir







ViiV Healthcare UK Ltd




980 Great West Road, Brentford,




Middlesex, TW8 9GS,




United Kingdom






EU/1/98/058/001-002


9.11.2010




3.11.2010


Doribax







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/467/001-002


9.11.2010




3.11.2010


Effentora







Cephalon Europe




5 Rue Charles Martigny,




Maisons-Alfort 94700,




France






EU/1/08/441/001-010


9.11.2010




3.11.2010


Efficib







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/457/001-016


5.11.2010




3.11.2010


Enyglid







KRKA, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/580/001-021


9.11.2010




3.11.2010


Filgrastim Hexal







HEXAL AG




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/08/496/001-016


9.11.2010




3.11.2010


Janumet







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/455/001-016


5.11.2010




3.11.2010


Januvia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/383/001-018


8.11.2010




3.11.2010


Norvir







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road,




Maidenhead,




Berkshire SL6 4XE,




United Kingdom






EU/1/96/016/001
EU/1/96/016/003-007


8.11.2010




3.11.2010


Olanzapine Mylan







Generics [UK] Limited




Station Close, Potters Bar,




Hertfordshire, EN6 1TL,




United Kingdom






EU/1/08/475/001-034


9.11.2010




3.11.2010


Rasilez







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/405/001-040


9.11.2010




3.11.2010


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/491/001-080


5.11.2010




3.11.2010


Riprazo







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/409/001-020


9.11.2010




3.11.2010


Ristaben







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/10/621/001-018


9.11.2010




3.11.2010


Ristfor







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/10/620/001-016


9.11.2010




3.11.2010


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/05/330/001-011


8.11.2010




3.11.2010


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


9.11.2010




3.11.2010


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


9.11.2010




3.11.2010


Tesavel







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/435/001-018


8.11.2010




3.11.2010


Velmetia







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/456/001-016


9.11.2010




3.11.2010


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/382/001-018


8.11.2010




3.11.2010


Zarzio







Sandoz GmbH




Biochemiestrasse 10,




A-6250 Kundl,




Österreich






EU/1/08/495/001-016


9.11.2010




5.11.2010


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park,




Oxford Road, Uxbridge,




Middlesex UB8 1HU,




United Kingdom






EU/1/04/276/001-020
EU/1/04/276/024-036


9.11.2010




5.11.2010


Diacomit







Biocodex




7 avenue Gallieni,




94250 Gentilly,




France






EU/1/06/367/001-012


9.11.2010




5.11.2010


Erbitux







Merck KGaA




Frankfurter Straße 250,




64271 Darmstadt,




Deutschland






EU/1/04/281/001-005


9.11.2010




5.11.2010


Irbesartan Winthrop







SANOFI PHARMA BRISTOL MYERS SQUIBB SNC




174 avenue de France,




F- 75013 Paris,




France






EU/1/06/376/001-033


9.11.2010




5.11.2010


Torisel







Wyeth Europa Ltd




Huntercombe Lane South, Taplow,




Maidenhead,




Berkshire SL6 0PH,




United Kingdom






EU/1/07/424/001


9.11.2010




5.11.2010


Twinrix Paediatric







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/97/029/001-010


9.11.2010




12.11.2010


Kentera







Nicobrand Limited




189 Castleroe Road,




Coleraine,




Northern Ireland BT51 3 RP






EU/1/03/270/001-003


16.11.2010




12.11.2010


Xolair







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/05/319/001-010


16.11.2010




19.11.2010


Qutenza







Astellas Pharma Europe B.V.




Elisabethhof 19,




2353 EW Leiderdorp,




Nederland






EU/1/09/524/001-002


23.11.2010




26.11.2010


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330 Belgique






EU/1/02/224/001-005


1.12.2010




26.11.2010


Avastin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/04/300/001-002


1.12.2010




26.11.2010


Cancidas







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






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


1.12.2010




26.11.2010


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury,




Reading,




Berkshire RG1 3EB,




United Kingdom






EU/1/07/392/001-002


2.12.2010




26.11.2010


Efficib







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/457/001-016


1.12.2010




26.11.2010


Enbrel







Wyeth Europa Limited




Huntercombe Lane South, Taplow,




Maidenhead,




Berkshire, SL6 0PH,




United Kingdom






EU/1/99/126/001-021


1.12.2010




26.11.2010


Iressa







AstraZeneca AB




Sodertalje S 151 85,




Sverige






EU/1/09/526/001-002


1.12.2010




26.11.2010


Janumet







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/455/001-016


1.12.2010




26.11.2010


Januvia







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/383/001-018


1.12.2010




26.11.2010


Livensa







Warner Chilcott Deutschland Gmbh




Dr.-Otto-Röhm-Strasse 2-4,




Weiterstadt 64331,




Deutschland






EU/1/06/351/001-003


1.12.2010




26.11.2010


Nexavar







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/06/342/001


1.12.2010




26.11.2010


Nplate







Amgen Europe B.V.




Minervum 7061,




4817 ZK Breda,




Nederland






EU/1/08/497/001-008


1.12.2010




26.11.2010


Prevenar 13







Wyeth Lederle Vaccines S.A.




Rue du Bosquet, 15,




B-1348 Louvain-la-Neuve,




Belgium






EU/1/09/590/001-006


1.12.2010




26.11.2010


Ristaben







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/10/621/001-018


1.12.2010




26.11.2010


Ristfor







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/10/620/001-016


1.12.2010




26.11.2010


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/02/222/001-004


1.12.2010




26.11.2010


Temozolomide Teva







Teva Pharma B.V.




Computerweg 10,




DR Utrecht 3542,




Nederland






EU/1/09/606/001-012


1.12.2010




26.11.2010


Thalidomide Celgene







Celgene Europe Limited




Riverside House, Riverside Walk,




Windsor SL4 1NA,




United Kingdom






EU/1/08/443/001


1.12.2010




26.11.2010


Truvada







Gilead Sciences International Limited




Cambridge CB21 6GT




United Kingdom






EU/1/04/305/001-002


1.12.2010




26.11.2010


Velmetia







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/456/001-016


1.12.2010




26.11.2010


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham,




Basingstoke,




Hampshire RG24 8EP,




United Kingdom






EU/1/04/295/001


1.12.2010




26.11.2010


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/382/001-018


1.12.2010




26.11.2010


Zeffix







Glaxo Group Ltd.




Greenford Road,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/99/114/001-003


1.12.2010




29.11.2010


Adrovance







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/06/364/001-009


6.12.2010




29.11.2010


alli







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/07/401/007-015


3.12.2010




29.11.2010


Atriance







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/07/403/001


3.12.2010




29.11.2010


Cimzia







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/09/544/001-002


2.12.2010




29.11.2010


Corlentor







Les Laboratoires Servier




22, rue Garnier,




92200 Neuilly-sur-Seine,




France






EU/1/05/317/001-014


2.12.2010




29.11.2010


Cubicin







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/05/328/001-004


6.12.2010




29.11.2010


DepoCyte







Pacira Limited




3 Glory Park Avenue, Wooburn Green,




High Wycombe,




Buckinghamshire, HP10 0DF,




United Kingdom






EU/1/01/187/001


18.1.2011




29.11.2010


Exalief







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado - Portugal






EU/1/09/520/001-020


2.12.2010




29.11.2010


Fertavid







SP Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique - Stallestraat,




73 - 1180 Brussel,




België






EU/1/09/510/001-019


6.12.2010




29.11.2010


Fosavance







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/05/310/001-009


1.12.2010




29.11.2010


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/468/001


2.12.2010




29.11.2010


Intelence







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/468/001


2.12.2010




29.11.2010


Neupro







Schwarz Pharma Ltd




Shannon, Industrial Estate,




Co.Clare,




Ireland






EU/1/05/331/001-055


2.12.2010




29.11.2010


NeuroBloc







Eisai Limited




European Knowledge Centre, Mosquito Way,




Hatfield,




Hertfordshire, AL10 9SN,




United Kingdom






EU/1/00/166/001-003


2.12.2010




29.11.2010


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/06/380/001-005


2.12.2010




29.11.2010


Procoralan







Les Laboratoires Servier




22, rue Garnier,




92200 Neuilly-sur-Seine,




France






EU/1/05/316/001-014


2.12.2010




29.11.2010


Puregon







Organon N.V.




Kloosterstraat 6, Postbus 20,




5340 BH Oss,




Nederland






EU/1/96/008/001-041


6.12.2010




29.11.2010


Remicade







Centocor B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/99/116/001-005


6.12.2010




29.11.2010


Sebivo







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/388/001-003


6.12.2010




29.11.2010


Sildenafil Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/584/001-018


2.12.2010




29.11.2010


Sutent







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/06/347/001-008


3.12.2010




29.11.2010


Travatan







Alcon Laboratories (UK) Ltd.




Boundary Way,




Hemel Hempstead,




Herts HP2 7UD,




United Kingdom






EU/1/01/199/001-002


2.12.2010




29.11.2010


Trizivir







ViiV Healthcare UK Limited




980 Great West Road,




Brentford,




Middlesex, TW8 9GS,




United Kingdom






EU/1/00/156/002-004


2.12.2010




29.11.2010


Tysabri







Elan Pharma International Ltd.




Monksland,




Athlone,




County Westmeath,




Ireland






EU/1/06/346/001


2.12.2010




29.11.2010


Vantavo







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/09/572/001-009


2.12.2010




29.11.2010


Vfend







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/02/212/001-026


6.12.2010




29.11.2010


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado - Portugal






EU/1/09/514/001-020


2.12.2010




3.12.2010


Aranesp







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/01/185/001-022
EU/1/01/185/031-099


7.12.2010




3.12.2010


Orencia







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/07/389/001-003


7.12.2010




3.12.2010


Tesavel







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/435/001-018


7.12.2010




3.12.2010


Zerit







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/96/009/001-009


7.12.2010




6.12.2010


Ilaris







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/09/564/001-002


8.12.2010




6.12.2010


Kiovig







Baxter AG




Industriestraße 67,




A - 1221 Wien,




Österreich






EU/1/05/329/001-006


9.12.2010




6.12.2010


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/06/363/001-015


8.12.2010




13.12.2010


Diacomit







Biocodex




7 avenue Gallieni,




94250 Gentilly,




France






EU/1/06/367/001-012


15.12.2010




13.12.2010


Flebogamma DIF







Instituto Grifols, S.A.




Can Guasch, 2 - Parets del Vallès,




08150 Barcelona - Espaňa






EU/1/07/404/001-008


15.12.2010




13.12.2010


Invega







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/07/395/001-095


15.12.2010




13.12.2010


Kaletra







Abbott Laboratories




Abbott House, Vanwall Business Park, Vanwall Road,




SL6 4XE Maidenhead,




Berks,




United Kingdom






EU/1/01/172/001-008


15.12.2010




13.12.2010


Revlimid







Celgene Europe Limited




Riverside House, Riverside Walk, Windsor,




Berkshire SL4 1NA,




United Kingdom






EU/1/07/391/001-004


15.12.2010




13.12.2010


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


15.12.2010




13.12.2010


Vectibix







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/07/423/001-003


15.12.2010




13.12.2010


Velcade







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/04/274/001-002


15.12.2010




17.12.2010


Revlimid







Celgene Europe Limited




Riverside House, Riverside Walk,




Windsor,




Berkshire SL4 1NA,




United Kingdom






EU/1/07/391/001-004


22.12.2010




20.12.2010


Aloxi







Helsinn Birex Pharmaceuticals Ltd




Damastown,




Mulhuddart, Dublin 15,




Republic of Ireland






EU/1/04/306/001-003


4.1.2011




20.12.2010


Aranesp







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/01/185/001-022
EU/1/01/185/031-099


23.12.2010




20.12.2010


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




IDA Business & Technology Park,




Carrigtohill, Co. Cork,




Ireland






EU/1/07/430/001-002


23.12.2010




20.12.2010


Avastin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/04/300/001-002


23.12.2010




20.12.2010


Celsentri







ViiV Healthcare UK Ltd




980 Great West Road,




Brentford,




Middlesex, TW8 9GS,




United Kingdom






EU/1/07/418/001-010


23.12.2010




20.12.2010


Champix







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/06/360/001-013


23.12.2010




20.12.2010


Conbriza







Wyeth Europa Limited




Huntercombe Lane South, Taplow,




Maidenhead,




Berkshire, SL6 0PH,




United Kingdom






EU/1/09/511/001-004


23.12.2010




20.12.2010


DuoCover







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/10/623/001-015


23.12.2010




20.12.2010


DuoPlavin







Sanofi Pharma Bristol-Myers Squibb SNC




174 Avenue de France,




F-75013 Paris,




France






EU/1/10/619/001-015


23.12.2010




20.12.2010


Emselex







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/04/294/001-028


23.12.2010




20.12.2010


Exjade







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/06/356/001-009


23.12.2010




20.12.2010


Glivec







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/01/198/001-013


23.12.2010




20.12.2010


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/00/144/001-005


23.12.2010




20.12.2010


Javlor







Pierre Fabre Médicament




45, place Abel Gance,




F-92100 Boulogne,




France






EU/1/09/550/001-012


23.12.2010




20.12.2010


Kogenate Bayer







Bayer Schering Pharma AG




13342 Berlin,




Deutschland






EU/1/00/143/004-013


23.12.2010




20.12.2010


Mabthera







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/98/067/001-002


23.12.2010




20.12.2010


Macugen







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/05/325/002


23.12.2010




20.12.2010


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


23.12.2010




20.12.2010


Mycamine







Astellas Pharma Europe B.V.




Elisabethhof 19,




2353 EW Leiderdorp,




Nederland






EU/1/08/448/001-002


23.12.2010




20.12.2010


Naglazyme







BioMarin Europe Ltd




164 Shaftesbury Avenue,




London WC2H 8HL,




United Kingdom






EU/1/05/324/001-002


22.12.2010




20.12.2010


Optison







GE Healthcare AS




Nycoveien 1-2, P.O.Box 4220 Nydalen,




N-0401 OSLO,




Norway






EU/1/98/065/001-002


22.12.2010




20.12.2010


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/460/001-014


23.12.2010




20.12.2010


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-008


23.12.2010




20.12.2010


RoActemra







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/08/492/001-006


23.12.2010




20.12.2010


Stelara







Janssen-Cilag International NV




Turnhoutseweg, 30 - 2340 Beerse - België






EU/1/08/494/001-004


23.12.2010




20.12.2010


Sutent







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/06/347/001-008


23.12.2010




20.12.2010


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City, AL7 1TW,




United Kingdom






EU/1/02/222/001-004


23.12.2010




20.12.2010


Tasigna







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/422/001-006


23.12.2010




20.12.2010


Tasigna







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/422/001-006


23.12.2010




20.12.2010


Thalidomide Celgene







Celgene Europe Limited




Riverside House, Riverside Walk,




Windsor SL4 1NA,




United Kingdom






EU/1/08/443/001


23.12.2010




20.12.2010


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/459/001-014


23.12.2010




20.12.2010


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/08/458/001-014


23.12.2010




20.12.2010


Ventavis







Bayer Schering Pharma AG




Müllerstrasse 170-178,




D - 13342 Berlin,




Deutschland






EU/1/03/255/001-008


23.12.2010




20.12.2010


Vfend







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 0NJ,




United Kingdom






EU/1/02/212/001-026


23.12.2010




20.12.2010


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


27.12.2010




20.12.2010


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/341/001-013


22.12.2010




20.12.2010


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/009-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-040


23.12.2010




20.12.2010


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/99/125/017-020


23.12.2010







—   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




13.12.2010


Arepanrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/10/624/001


15.12.2010







—   Suspension of a marketing authorization (Article 20 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




3.12.2010


Avaglim







SmithKline Beecham Ltd.




980 Great West Road,




Brentford,




Middlesex, TW8 9GS




United Kingdom






EU/1/06/349/001-010


7.12.2010




3.12.2010


Avandamet







SmithKline Beecham Ltd.




980 Great West Road,




Brentford,




Middlesex, TW8 9GS




United Kingdom






EU/1/03/258/001-022


7.12.2010




3.12.2010


Avandia







SmithKline Beecham Ltd.




980 Great West Road,




Brentford,




Middlesex, TW8 9GS




United Kingdom






EU/1/00/137/002-018


7.12.2010







—   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 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




5.11.2010


BTVPUR AlSap 2-4


Bluetongue virus serotypes 2-4







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/108/001-005


Suspension for injection


QI02AA08
QI04AA02


9.11.2010




19.11.2010


Meloxoral


Meloxicam







Le Vet B.V.




Wilgenweg 7,




3421 TV Oudewater,




Nederland






EU/2/10/111/001-004


Oral suspension


QM01AC06


23.11.2010




17.12.2010


BTVPUR AlSap 1


Bluetongue Virus Serotype 1 antigen







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/112/001-005


Suspension for injection


QI02AA08
QI04AA02


22.12.2010




17.12.2010


BTVPUR AlSap 1-8


Bluetongue Virus Serotype 1 antigen - Bluetongue Virus Serotype 8 antigen







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/113/001-005


Suspension for injection


QI02AA08
QI04AA02


22.12.2010







—   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




3.11.2010


Melovem







Dopharma Research B.V.




Zalmweg 24,




4941 VX Raamsdonksveer,




Nederland






EU/2/09/098/001


8.11.2010




26.11.2010


ProMeris







Fort Dodge Animal Health Holland




C.J. van Houtenlaan 36,




1381 CP Weesp,




Nederland






EU/2/06/064/001-004


3.12.2010




26.11.2010


ProMeris Duo







Fort Dodge Animal Health Holland




C.J. van Houtenlaan 36,




1381 CP Weesp,




Nederland






EU/2/06/065/001-010


3.12.2010




29.11.2010


Circovac







Merial




29 Avenue Tony Garnier,




69007 Lyon,




France






EU/2/07/075/001-004


3.12.2010




3.12.2010


Masivet







AB Science S.A.




3 avenue George V,




75008 Paris,




France






EU/2/08/087/001-002


7.12.2010




13.12.2010


Poulvac FluFend H5N3 RG







Fort Dodge Animal Health Ltd




Flanders Road, Hedge End,




Southampton SO30 4QH,




United Kingdom






EU/2/06/060/001-002


15.12.2010




20.12.2010


Improvac







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/2/09/095/001-006


23.12.2010




20.12.2010


Metacam







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein,




Deutschland






EU/2/97/004/001
EU/2/97/004/003-048


23.12.2010




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.