Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2012-11-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012371EN.01000701.xml










30.11.2012   


EN


Official Journal of the European Union


C 371/7





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012

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

2012/C 371/03
—   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




23.10.2012


XALKORI


crizotinib







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/1/12/793/001-004


Capsule, hard


L01XE16


26.10.2012




25.10.2012


Adcetris


Brentuximab vedotin







Takeda Global Research and Development Centre (Europe) Ltd.




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/12/794/001


powder for concentrate for solution for infusion


L01XC12


30.10.2012




25.10.2012


Glybera


Alipogene tiparvovec







uniQure biopharma B.V.




Meibergdreef 61, 1105 BA Amsterdam, Nederland






EU/1/12/791/001


Solution for injection


C10AX10


29.10.2012







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










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




25.10.2012


Elelyso







Pfizer Limited




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






—


29.10.2012







—   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




1.10.2012


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/02/237/001-009


3.10.2012




1.10.2012


Conbriza







Pfizer Limited




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






EU/1/09/511/001-005


3.10.2012




1.10.2012


Olanzapine Neopharma







Neopharma Limited




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






EU/1/07/426/001-011


3.10.2012




1.10.2012


Tamiflu







Roche Registration Limited




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






EU/1/02/222/001-005


3.10.2012




4.10.2012


Cimzia







UCB Pharma SA.




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






EU/1/09/544/001-002


8.10.2012




4.10.2012


Orencia







Bristol-Myers Squibb Pharma EEIG




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






EU/1/07/389/001-009


8.10.2012




4.10.2012


Soliris







Alexion Europe S.A.S.




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






EU/1/07/393/001


8.10.2012




4.10.2012


Topotecan Eagle







Eagle Laboratories Limited




The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM






EU/1/11/744/002


8.10.2012




4.10.2012


Vepacel







Baxter Innovations GmbH




Industriestrasse 67, A – 1221 Vienna, Österreich






EU/1/12/752/001-002


8.10.2012




8.10.2012


Biograstim







CT Arzneimittel GmbH




Graf-Arco-Strasse 3, 89079 Ulm, Deutschland






EU/1/08/450/001-010


11.10.2012




8.10.2012


Comtan







Novartis Europharm Ltd




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






EU/1/98/081/001-004


10.10.2012




8.10.2012


DuoTrav







Alcon Laboratories (UK) Ltd.




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






EU/1/06/338/001-003


10.10.2012




8.10.2012


Vidaza







Celgene Europe Ltd




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






EU/1/08/488/001


10.10.2012




8.10.2012


Zavesca







Actelion Registration Ltd.




Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom






EU/1/02/238/001


10.10.2012




10.10.2012


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




54, rue La Boétie, 75008 Paris, France






EU/1/97/046/001-039


12.10.2012




10.10.2012


Biopoin







CT Arzneimittel GmbH




Graf-Arco-Strasse 3, 89079 Ulm, Deutschland






EU/1/09/565/001-028


12.10.2012




10.10.2012


Dynastat







Pfizer Ltd




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






EU/1/02/209/001-008


12.10.2012




10.10.2012


Emend







Merck Sharp & Dohme Ltd




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






EU/1/03/262/001-010


15.10.2012




10.10.2012


Karvea







Bristol-Myers Squibb Pharma EEIG




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






EU/1/97/049/034-039


12.10.2012




10.10.2012


Pylobactell







Torbet Laboratories Limited




Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom






EU/1/98/064/001


12.10.2012




10.10.2012


Rapamune







Pfizer Limited




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






EU/1/01/171/007-010


12.10.2012




10.10.2012


Synagis







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/99/117/001-002


12.10.2012




15.10.2012


Ceplene







Meda AB




Box 906, SE 170 09 Solna, Sverige






EU/1/08/477/001


17.10.2012




15.10.2012


Clopidogrel Apotex







Apotex Europe B.V.




Darwingweg 20, 2333 CR Leiden, Nederland






EU/1/09/568/001-018


17.10.2012




15.10.2012


Olazax







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/597/001-005


16.10.2012




23.10.2012


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/290/001-002


26.10.2012




23.10.2012


Glivec







Novartis Europharm Ltd




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






EU/1/01/198/001-013


26.10.2012




23.10.2012


Helixate NexGen







Bayer Schering Pharma AG




13342 Berlin, Deutschland






EU/1/00/144/001-005


26.10.2012




23.10.2012


Humira







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/03/256/001-010


26.10.2012




23.10.2012


Kogenate Bayer







Bayer Pharma AG




13342 Berlin, Deutschland






EU/1/00/143/004-013


26.10.2012




23.10.2012


Nplate







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/08/497/001-008


26.10.2012




23.10.2012


NULOJIX







Bristol-Myers Squibb Pharma EEIG




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






EU/1/11/694/001-002


26.10.2012




23.10.2012


Osseor







Les Laboratoires Servier




50, rue Carnot, 92284 Suresnes cedex, France






EU/1/04/287/001-006


26.10.2012




23.10.2012


Prolia







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/10/618/001-004


26.10.2012




23.10.2012


Protelos







Les Laboratoires Servier




50, rue Carnot, 92284 Suresnes cedex, France






EU/1/04/288/001-006


26.10.2012




23.10.2012


Telzir







ViiV Healthcare UK Ltd




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






EU/1/04/282/001-002


26.10.2012




23.10.2012


Victoza







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/09/529/001-005


26.10.2012




23.10.2012


Visudyne







Novartis Europharm Ltd




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






EU/1/00/140/001


26.10.2012




24.10.2012


Adenuric







Menarini International Operations Luxembourg S.A.




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






EU/1/08/447/001-012


26.10.2012




24.10.2012


Avastin







Roche Registration Limited




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






EU/1/04/300/001-002


26.10.2012




24.10.2012


Baraclude







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/343/001-007


26.10.2012




24.10.2012


Benlysta







Glaxo Group Limited




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






EU/1/11/700/001-002


26.10.2012




24.10.2012


Brilique







AstraZeneca AB




Södertälje S 151 85, Sverige






EU/1/10/655/001-006


26.10.2012




24.10.2012


ChondroCelect







TiGenix NV




Romeinse straat 12/2, B-3001 LEUVEN, België






EU/1/09/563/001


26.10.2012




24.10.2012


Cialis







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/02/237/007-008


26.10.2012




24.10.2012


Clopidogrel HCS







HCS bvba




H. Kennisstraat 53, B 2650 Edegem, Belgïe






EU/1/10/651/001-015


26.10.2012




24.10.2012


Daliresp







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/668/001-003


26.10.2012




24.10.2012


Daxas







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/10/636/001-007


26.10.2012




24.10.2012


Dynastat







Pfizer Ltd




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






EU/1/02/209/005-008


26.10.2012




24.10.2012


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/736/001


26.10.2012




24.10.2012


Enbrel







Pfizer Limited




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






EU/1/99/126/001-022


26.10.2012




24.10.2012


Eviplera







Gilead Sciences International Limited




Cambridge, CB21 6GT, United Kingdom






EU/1/11/737/001-002


26.10.2012




24.10.2012


Exjade







Novartis Europharm Ltd




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






EU/1/06/356/001-009


26.10.2012




24.10.2012


Ganfort







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/06/340/001-002


26.10.2012




24.10.2012


Humira







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/03/256/001-010


26.10.2012




24.10.2012


Invirase







Roche Registration Limited




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






EU/1/96/026/001-002


26.10.2012




24.10.2012


Kinzalkomb







Bayer Pharma AG




Berlin 13342, Deutschland






EU/1/02/214/001-015


26.10.2012




24.10.2012


Komboglyze







Bristol Myers Squibb/AstraZeneca EEIG




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






EU/1/11/731/001-014


26.10.2012




24.10.2012


Libertek







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/11/666/001-003


26.10.2012




24.10.2012


MicardisPlus







Boehringer Ingelheim International GmbH




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






EU/1/02/213/001-023


26.10.2012




24.10.2012


Multaq







Sanofi




54, rue La Boétie, 75008 Paris, France






EU/1/09/591/001-004


26.10.2012




24.10.2012


Norvir







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






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


26.10.2012




24.10.2012


NovoSeven







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/96/006/001-011


26.10.2012




24.10.2012


Onduarp







Boehringer Ingelheim International GmbH




Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/11/729/001-006


26.10.2012




24.10.2012


Pandemrix







GlaxoSmithKline Biologicals S.A.




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






EU/1/08/452/001


26.10.2012




24.10.2012


Possia







AstraZeneca AB




Södertälje S 151 85, Sverige






EU/1/10/656/001-006


26.10.2012




24.10.2012


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, B - 2340 Beerse, België






EU/1/06/380/001-006


26.10.2012




24.10.2012


PritorPlus







Bayer Pharma AG




13342 Berlin, Deutschland






EU/1/02/215/001-021


26.10.2012




24.10.2012


ReFacto AF







Pfizer Limited




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






EU/1/99/103/001-009


26.10.2012




24.10.2012


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/06/348/001-002


26.10.2012




24.10.2012


SonoVue







Bracco International B.V.




Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland






EU/1/01/177/002


26.10.2012




24.10.2012


Thymanax







Servier (Ireland) Industries Limited




Gorey Road, Arklow, Co. Wicklow, Ireland






EU/1/08/498/001-008


26.10.2012




24.10.2012


Trajenta







Boehringer Ingelheim International GmbH




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






EU/1/11/707/001-011


26.10.2012




24.10.2012


Valdoxan







Les Laboratoires Servier




50, rue Carnot, 92284 Suresnes cedex, France






EU/1/08/499/001-008


26.10.2012




24.10.2012


Vimpat







UCB Pharma SA.




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






EU/1/08/470/001-013
EU/1/08/470/016-019


29.10.2012




24.10.2012


Votrient







Glaxo Group Limited




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






EU/1/10/628/001-004


26.10.2012




24.10.2012


Zometa







Novartis Europharm Ltd




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






EU/1/01/176/001-009


26.10.2012




25.10.2012


Bridion







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/08/466/001-002


29.10.2012




25.10.2012


Capecitabine Krka







KRKA, d.d




Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/12/763/001-018


30.10.2012




25.10.2012


Cinryze







ViroPharma SPRL-BVBA




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






EU/1/11/688/001


29.10.2012




25.10.2012


Clopidogrel Teva Pharma







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/561/001-011


29.10.2012




25.10.2012


Copalia







Novartis Europharm Ltd




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






EU/1/06/372/001-039


29.10.2012




25.10.2012


Corlentor







Les Laboratoires Servier




50 rue Carnot, 92284 Suresnes, Cedex, France






EU/1/05/317/001-014


29.10.2012




25.10.2012


Dafiro







Novartis Europharm Ltd




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






EU/1/06/371/001-039


29.10.2012




25.10.2012


Efavirenz Teva







Teva Pharma BV




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/742/001-010


30.10.2012




25.10.2012


Eucreas







Novartis Europharm Ltd




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






EU/1/07/425/001-018


29.10.2012




25.10.2012


Exforge HCT







Novartis Europharm Ltd




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






EU/1/09/569/001-060


29.10.2012




25.10.2012


Fasturtec







Sanofi-aventis groupe




54, rue La Boétie, 75008 Paris, France






EU/1/00/170/001-002


26.10.2012




25.10.2012


Ferriprox







Apotex Europe B.V.




Darwingweg 20, 2333 CR Leiden, Nederland






EU/1/99/108/001-006


29.10.2012




25.10.2012


Firazyr







Shire Orphan Therapies GmbH




Friedrichstrasse 149, D-10117 Berlin, Deutschland






EU/1/08/461/001-002


29.10.2012




25.10.2012


Glidipion







Actavis Group PTC ehf.




Reykjavíkurvegi 76 - 78, 220 Hafnarfjörður, Iceland






EU/1/12/756/001-027


29.10.2012




25.10.2012


Helicobacter test INFAI







INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH




Universitätsstrasse 142, D - 44799 Bochum, Deutschland






EU/1/97/045/001-005


29.10.2012




25.10.2012


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


30.10.2012




25.10.2012


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/720/001-002


29.10.2012




25.10.2012


Instanyl







Nycomed Danmark ApS




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/09/531/001-021


29.10.2012




25.10.2012


Irbesartan Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/576/001-042


30.10.2012




25.10.2012


Isentress







Merck Sharp & Dohme Limited




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






EU/1/07/436/001-002


30.10.2012




25.10.2012


Jentadueto







Boehringer Ingelheim International GmbH




Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/12/780/029-034


30.10.2012




25.10.2012


Kaletra







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/01/172/001-008


30.10.2012




25.10.2012


Kepivance







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/05/314/001


29.10.2012




25.10.2012


Kineret







Swedish Orphan Biovitrum AB (publ)




SE-112 76, Stockholm, Sverige






EU/1/02/203/001-004


30.10.2012




25.10.2012


Liprolog







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/01/195/001-027


29.10.2012




25.10.2012


Olanzapine Glenmark







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom






EU/1/09/587/001-017


29.10.2012




25.10.2012


Olanzapine Glenmark Europe







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom






EU/1/09/588/001-012


29.10.2012




25.10.2012


Olanzapine Mylan







Generics [UK] Limited




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






EU/1/08/475/001-060


29.10.2012




25.10.2012


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/592/001-005


29.10.2012




25.10.2012


Procoralan







Les Laboratoires Servier




50, rue Carnot, 92284 Suresnes cedex, France






EU/1/05/316/001-014


29.10.2012




25.10.2012


Ranexa







Menarini International Operations Luxembourg S.A.




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






EU/1/08/462/001-012


30.10.2012




25.10.2012


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/508/001-011


29.10.2012




25.10.2012


Temomedac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3, D-20354 Hamburg - Deutschland






EU/1/09/605/001-012


29.10.2012




25.10.2012


Temozolomide HEXAL







HEXAL AG




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/10/616/001-002
EU/1/10/616/005-006
EU/1/10/616/009-010
EU/1/10/616/013-014
EU/1/10/616/017-018
EU/1/10/616/021-022
EU/1/10/616/025-036


30.10.2012




25.10.2012


Temozolomide Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland






EU/1/10/617/001-002
EU/1/10/617/005-006
EU/1/10/617/009-010
EU/1/10/617/013-014
EU/1/10/617/017-018
EU/1/10/617/021-022
EU/1/10/617/025-036


30.10.2012




25.10.2012


Temozolomide SUN







Sun Pharmaceuticals Industries Europe B.V.




Polarisavenue 87, 2132 JH Hoofddorp, Nederland






EU/1/11/697/001-024


30.10.2012




25.10.2012


Temozolomide Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/09/606/001-012


29.10.2012




25.10.2012


Topotecan Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/09/552/001-004


29.10.2012




25.10.2012


Toviaz







Pfizer Limited




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






EU/1/07/386/019-020


29.10.2012




25.10.2012


Tracleer







Actelion Registration Ltd




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






EU/1/02/220/001-006


30.10.2012




25.10.2012


Tredaptive







Merck Sharp & Dohme Ltd




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






EU/1/08/459/001-014


29.10.2012




25.10.2012


Trevaclyn







Merck Sharp & Dohme Ltd




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






EU/1/08/458/001-014


29.10.2012




25.10.2012


Twynsta







Boehringer Ingelheim International GmbH




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






EU/1/10/648/001-028


29.10.2012




25.10.2012


Vectibix







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/07/423/001-003


29.10.2012




29.10.2012


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/07/387/009-010
EU/1/07/387/016
EU/1/07/387/026


1.11.2012




29.10.2012


Aranesp







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/01/185/001-022
EU/1/01/185/031-111


1.11.2012




29.10.2012


ATryn







GTC Biotherapeutics UK Limited




10 Norwich Street, London EC4A 1BD, United Kingdom






EU/1/06/355/001-003


6.11.2012




29.10.2012


Biograstim







CT Arzneimittel GmbH




Graf-Arco-Strasse 3, 89079 Ulm, Deutschland






EU/1/08/450/001-010


5.11.2012




29.10.2012


Bronchitol







Pharmaxis Pharmaceuticals Limited




The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom






EU/1/12/760/001-002


1.11.2012




29.10.2012


Byetta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/06/362/001-004


1.11.2012




29.10.2012


Caelyx







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/96/011/001-004


5.11.2012




29.10.2012


CANCIDAS







Merck Sharp & Dohme Ltd




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






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


6.11.2012




29.10.2012


Dificlir







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/11/733/001-004


31.10.2012




29.10.2012


Docetaxel Mylan







Mylan S.A.S




117 allée des Parcs, 69 800 Saint Priest, France






EU/1/11/748/001-006


6.11.2012




29.10.2012


Esbriet







InterMune UK Ltd




Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom






EU/1/11/667/001-004


1.11.2012




29.10.2012


Exforge







Novartis Europharm Ltd




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






EU/1/06/370/001-039


31.10.2012




29.10.2012


Firdapse







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/09/601/001


1.11.2012




29.10.2012


Foscan







Biolitec pharma Ltd




United Drug House, Magna Drive, Dublin 24, Ireland






EU/1/01/197/001-002


31.10.2012




29.10.2012


Fycompa







Eisai Europe Limited




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






EU/1/12/776/001-023


31.10.2012




29.10.2012


Ibandronic Acid Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/642/001-004


31.10.2012




29.10.2012


Icandra







Novartis Europharm Ltd




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






EU/1/08/484/001-018


1.11.2012




29.10.2012


Imprida







Novartis Europharm Ltd




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






EU/1/06/373/001-039


31.10.2012




29.10.2012


INOmax







INO Therapeutics AB




SE-181 81 Lidingö, Sverige






EU/1/01/194/001-004


1.11.2012




29.10.2012


Irbesartan/Hydrochlorothiazide Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/583/001-075


1.11.2012




29.10.2012


Javlor







Pierre Fabre Médicament




45, place Abel Gance, F-92100 Boulogne, France






EU/1/09/550/001-012


31.10.2012




29.10.2012


Leflunomide Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/675/001-010


6.11.2012




29.10.2012


Levetiracetam Actavis Group







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland






EU/1/11/738/001-003


1.11.2012




29.10.2012


Lucentis







Novartis Europharm Ltd




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






EU/1/06/374/001


1.11.2012




29.10.2012


Myclausen







Herbert J. Passauer GmbH & Co. KG




Stubenrauchstrasse 33, 14167 Berlin, Deutschland






EU/1/10/647/001-004


31.10.2012




29.10.2012


Myocet







Cephalon Europe




5 Rue Charles Martigny, Maisons Alfort 94700, France






EU/1/00/141/001-002


5.11.2012




29.10.2012


Nimvastid







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/525/001-050


5.11.2012




29.10.2012


Pelzont







Merck Sharp & Dohme Ltd




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






EU/1/08/460/001-014


31.10.2012




29.10.2012


Pixuvri







CTI Life Sciences Ltd




Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom






EU/1/12/764/001


6.11.2012




29.10.2012


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




54, rue La Boétie, 75008 Paris, France






EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b
EU/1/98/069/005a-005b
EU/1/98/069/006a-006b
EU/1/98/069/007a-007b
EU/1/98/069/008-010
EU/1/98/069/011a-011b
EU/1/98/069/012


2.11.2012




29.10.2012


Plenadren







ViroPharma SPRL




Rue Montoyer 47, 1000 Bruxelles/Brussel, Belgique/België






EU/1/11/715/001-002


6.11.2012




29.10.2012


Pravafenix







LABORATOIRES SMB SA




26-28 rue de la Pastorale, 1080 Bruxelles, Belgique/26-28 Herdersliedstraat, 1080 Brussel, België






EU/1/11/679/007


6.11.2012




29.10.2012


Pumarix







GlaxoSmithKline Biologicals S.A.




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






EU/1/10/664/001


6.11.2012




29.10.2012


Raloxifene Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/10/627/001-003


6.11.2012




29.10.2012


Ranexa







Menarini International Operations Luxembourg S.A.




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






EU/1/08/462/001-012


2.11.2012




29.10.2012


Rapiscan







Rapidscan Pharma Solutions EU Ltd.




Regent's Place, 338 Euston Road, London NW1 3BT, UK






EU/1/10/643/001


6.11.2012




29.10.2012


Repaglinide Krka







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/579/001-018


5.11.2012




29.10.2012


Repaglinide Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/530/001-015


6.11.2012




29.10.2012


Repso







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/674/001-010


1.11.2012




29.10.2012


Ribavirin Mylan







Generics [UK] Limited




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






EU/1/10/634/001-011


1.11.2012




29.10.2012


Rienso







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/12/774/001-004


31.10.2012




29.10.2012


Sabervel







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/12/765/001-009


31.10.2012




29.10.2012


Samsca







Otsuka Pharmaceutical Europe Ltd




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






EU/1/09/539/001-004


31.10.2012




29.10.2012


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, B - 2340 Beerse, België






EU/1/08/494/001-002


5.11.2012




29.10.2012


Sycrest







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/10/640/001-006


6.11.2012




29.10.2012


Tasmar







Meda AB




Pipers väg 2A, SE-170 73 Solna, Sverige






EU/1/97/044/001-009


1.11.2012




29.10.2012


Telmisartan Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland






EU/1/10/639/001-030


31.10.2012




29.10.2012


Telmisartan Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/610/001-062


31.10.2012




29.10.2012


Telmisartan Teva Pharma







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/11/719/001-062


31.10.2012




29.10.2012


Teysuno







Nordic Group BV




Siriusdreef 22, 2132 WT Hoofddorp, Nederland






EU/1/11/669/001-005


6.11.2012




29.10.2012


Topotecan Hospira







Hospira UK Limited




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






EU/1/10/633/001-002


31.10.2012




29.10.2012


Vfend







Pfizer Ltd




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






EU/1/02/212/001-027


1.11.2012




29.10.2012


Xarelto







Bayer Pharma AG




13342 Berlin, Deutschland






EU/1/08/472/011-021


31.10.2012




29.10.2012


Zalasta







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/07/415/001-056


6.11.2012




29.10.2012


Zomarist







Novartis Europharm Ltd




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






EU/1/08/483/001-018


1.11.2012




31.10.2012


Adjupanrix







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/09/578/001


6.11.2012




31.10.2012


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland






EU/1/02/218/001-003
EU/1/02/218/005-030


6.11.2012




31.10.2012


Copalia HCT







Novartis Europharm Ltd




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






EU/1/09/575/001-060


6.11.2012




31.10.2012


Dafiro HCT







Novartis Europharm Ltd




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






EU/1/09/574/001-060


6.11.2012




31.10.2012


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron, F-92165 Antony Cedex, France






EU/1/07/384/003-005


6.11.2012




31.10.2012


Ebixa







H. Lundbeck A/S




Ottiliavej 9, DK-2500 Valby, Danmark






EU/1/02/219/001-003
EU/1/02/219/005-049


6.11.2012




31.10.2012


Ifirmasta







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/08/480/001-024


6.11.2012




31.10.2012


Kaletra







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/01/172/001-008


6.11.2012




31.10.2012


Kiovig







Baxter AG




Industriestraße 67, A - 1221 Wien, Österreich






EU/1/05/329/001-006


6.11.2012




31.10.2012


Levetiracetam Accord







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom






EU/1/11/712/001-040


6.11.2012




31.10.2012


Levetiracetam Actavis







Actavis Group PTC ehf.




Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland






EU/1/11/713/001-040


6.11.2012




31.10.2012


Ratiograstim







ratiopharm GmbH




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






EU/1/08/444/001-012


7.11.2012




31.10.2012


Repaglinide Accord







Accord Healthcare Limited




Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom






EU/1/11/743/001-015


6.11.2012




31.10.2012


Rivastigmine Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland






EU/1/09/599/001-018


6.11.2012




31.10.2012


Siklos







ADDMEDICA




101, rue Saint Lazare, Paris 75009, France






EU/1/07/397/001-004


6.11.2012




31.10.2012


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3, 89079 Ulm, Deutschland






EU/1/08/445/001-014


6.11.2012




31.10.2012


Tolura







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/10/632/001-021


6.11.2012




31.10.2012


Votubia







Novartis Europharm Limited




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






EU/1/11/710/001-007


6.11.2012







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










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




4.10.2012


Daliresp







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






—


8.10.2012




4.10.2012


Daxas







Nycomed GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






—


8.10.2012







—   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




24.10.2012


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street, E14 5DS London, United Kingdom






EU/1/09/582/001


26.10.2012







—   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




10.10.2012


Acticam







Ecuphar NV




Legeweg 157-I, B-8020 Oostkamp, Belgïe






EU/2/08/088/004


12.10.2012




15.10.2012


Oxyglobin







OPK Biotech Netherlands BV




Teleportboulevard 140, 1043EJ Amsterdam, Nederland






EU/2/99/015/001-004


16.10.2012




23.10.2012


ProteqFlu







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/03/037/005


26.10.2012




24.10.2012


Pirsue







Pfizer Ltd




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






EU/2/00/027/001-003


26.10.2012




25.10.2012


Dexdomitor







Orion Corporation




Orionintie 1, FIN-02200 Espoo, Suomi






EU/2/02/033/001-004


30.10.2012




25.10.2012


Posatex







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/08/081/001-003


29.10.2012




25.10.2012


Stronghold







Pfizer Ltd




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






EU/2/99/014/001-012


29.10.2012




29.10.2012


Improvac







Pfizer Limited




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






EU/2/09/095/001-006


1.11.2012




29.10.2012


Loxicom







Norbrook Laboratories Limited




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






EU/2/08/090/001-028


31.10.2012




29.10.2012


Meloxidyl







CEVA SANTE ANIMALE




10 avenue de la Ballastière, 33500 Libourne, France






EU/2/06/070/009


31.10.2012




29.10.2012


Previcox







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/04/045/001-007


6.11.2012




29.10.2012


Procox







Bayer Animal Health GmbH




51368 Leverkusen, Deutschland






EU/2/11/123/001-002


2.11.2012




29.10.2012


RevitaCAM







Abbott Laboratories Limited




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM






EU/2/12/138/001-003


31.10.2012




29.10.2012


Suvaxyn PCV







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/09/099/001-006


1.11.2012




31.10.2012


PRILACTONE







CEVA SANTE ANIMALE




10 avenue de la Ballastière, 33500 Libourne, France






EU/2/07/074/001-009


6.11.2012







—   Lift of suspension of a marketing authorization (Article 45 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




10.10.2012


Suvaxyn PCV







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/09/099/001-006


12.10.2012




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.