Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-07-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012224EN.01000101.xml










27.7.2012   


EN


Official Journal of the European Union


C 224/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2012 to 30 June 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 224/01
—   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




15.06.2012


Rienso


Ferumoxytol







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London WC2B 4AE,




United Kingdom






EU/1/12/774/001-002


Solution for injection


Pending


20.06.2012







—   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




21.06.2012


Folotyn







Allos Therapeutics Limited




71 Knowl Piece,




Wilbury Way,




Hitchin, Hertfordshire SG4 0TY,




United Kingdom






—


25.06.2012







—   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




01.06.2012


Osigraft







Olympus Biotech International Limited




Raheen Business Park,




Limerick,




Ireland






EU/1/01/179/001


05.06.2012




11.06.2012


Levetiracetam Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/701/001-032


13.06.2012




11.06.2012


Mycophenolate mofetil Teva







Teva Pharma B.V.




Computerweg 10,




DR Utrecht 3542,




Nederland






EU/1/07/439/001-006


13.06.2012




11.06.2012


Myfenax







Teva Pharma B.V.




Computerweg 10,




DR Utrecht 3542,




Nederland






EU/1/07/438/001-006


13.06.2012




14.06.2012


Nivestim







Hospira UK Limited Queensway,




Royal Leamington Spa,




Warwickshire CV31 3RW,




United Kingdom






EU/1/10/631/001-009


18.06.2012




14.06.2012


Quadramet







CIS bio international Boite Postale




32 - F-91192 Gif-sur-Yvette -




France






EU/1/97/057/001


18.06.2012




15.06.2012


Abseamed







Medice Arzneimittel Pütter GmbH & Co KG




Kuhloweg 37,




D-58638 Iserlohn,




Deutschland






EU/1/07/412/001-052


19.06.2012




15.06.2012


Azopt







Alcon Laboratories (UK) Ltd.




Pentagon Park,




Boundary Way,




Hemel Hempstead,




Herts HP2 7UD,




United Kingdom






EU/1/00/129/001-003


20.06.2012




15.06.2012


Epivir







ViiV Healthcare UK Ltd




980 Great West Road,




Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/96/015/002


20.06.2012




15.06.2012


Evra







Janssen-Cilag International NV Turnhoutseweg,




30 - 2340 Beerse -




België






EU/1/02/223/001-003


19.06.2012




15.06.2012


Optimark







Covidien Deutschland GmbH




Gewerbepark 1,




Neustadt/Donau 93333,




Deutschland






EU/1/07/398/001-014


19.06.2012




15.06.2012


Prevenar







Wyeth-Lederle Vaccines S.A.




Pleainlaan 17 Boulevard de la Plaine,




1050 Brussels - Bruxelles,




Belgium






EU/1/00/167/001-008


20.06.2012




15.06.2012


Temozolomide HEXAL







HEXAL AG




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/10/616/001-036


20.06.2012




15.06.2012


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


20.06.2012




18.06.2012


Atriance







Glaxo Group Limited




Berkeley Avenue, Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/07/403/001


21.06.2012




18.06.2012


Binocrit







Sandoz GmbH




Biochemiestrasse 10,




Kundl 6250,




Österreich






EU/1/07/410/001-052


21.06.2012




18.06.2012


Epoetin alfa Hexal







Hexal AG.




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/07/411/001-052


21.06.2012




18.06.2012


GILENYA







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/11/677/001-005


20.06.2012




18.06.2012


GILENYA







Novartis Europharm Ltd




Wimblehurst Road,




Horsham, West Sussex RH12 5AB,




United Kingdom






EU/1/11/677/001-005


22.06.2012




18.06.2012


Soliris







Alexion Europe S.A.S.




25, boulevard




de l'Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


20.06.2012




18.06.2012


Soliris







Alexion Europe S.A.S.




25, boulevard




de l'Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


20.06.2012




21.06.2012


alli







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue,




Greenford, Middlesex UB6 0NN,




United Kingdom






EU/1/07/401/007-016


25.06.2012




21.06.2012


Cimzia







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef,




60, Brussel 1070,




België






EU/1/09/544/001-002


20.06.2012




21.06.2012


Ketek







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92160 Antony,




France






EU/1/01/191/001-005


25.06.2012




21.06.2012


Tarceva







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/05/311/001-003


25.06.2012




21.06.2012


Yervoy







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/11/698/001-002


25.06.2012




27.06.2012


Abraxane







Celgene Europe Limited




1 Longwalk Road,




Stockley Park, Uxbridge,




Middlesex, UB11 1DB,




United Kingdom






EU/1/07/428/001


02.07.2012




27.06.2012


Actraphane







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/229/001-004
EU/1/02/229/036-037


29.06.2012




27.06.2012


Actrapid







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/230/001-004
EU/1/02/230/016-017


29.06.2012




27.06.2012


Avastin







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/04/300/001-002


02.07.2012




27.06.2012


Cimzia







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef,




60, Brussel 1070,




België






EU/1/09/544/001-002


29.06.2012




27.06.2012


Dificlir







Astellas Pharma Europe B.V.




Elisabethhof 19,




2353 EW Leiderdorp,




Nederland






EU/1/11/733/001-004


29.06.2012




27.06.2012


Humira







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead,




Berkshire SL6 4XE,




United Kingdom






EU/1/03/256/001-010


02.07.2012




27.06.2012


Insulatard







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/233/003-004
EU/1/02/233/017


02.07.2012




27.06.2012


Invanz







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/02/216/001-002


29.06.2012




27.06.2012


Invega







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse -




België






EU/1/07/395/001-095


02.07.2012




27.06.2012


Invirase







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/96/026/001-002


29.06.2012




27.06.2012


Irbesartan HCT Zentiva (Ex-Winthrop)







Sanofi




54, rue La Boétie,




75008 Paris,




France






EU/1/06/377/001-034


03.07.2012




27.06.2012


Javlor







Pierre Fabre Médicament




45, place Abel Gance,




F-92100 Boulogne,




France






EU/1/09/550/001-012


02.07.2012




27.06.2012


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/98/085/001-034


29.06.2012




27.06.2012


Lucentis







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/06/374/001


29.06.2012




27.06.2012


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/614/001-003


29.06.2012




27.06.2012


Mixtard







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/231/001-004
EU/1/02/231/036-037


02.07.2012




27.06.2012


Nexavar







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/06/342/001


02.07.2012




27.06.2012


Osseor







Les Laboratoires Servier




50, rue Carnot,




92284 Suresnes cedex,




France






EU/1/04/287/001-006


02.07.2012




27.06.2012


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse -




België






EU/1/06/380/001-005


02.07.2012




27.06.2012


Protaphane







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/234/003-004
EU/1/02/234/017


02.07.2012




27.06.2012


Protelos







Les Laboratoires Servier




50, rue Carnot,




92284 Suresnes cedex,




France






EU/1/04/288/001-006


02.07.2012




27.06.2012


Rebif







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/98/063/001-019


29.06.2012




27.06.2012


Revolade







GlaxoSmithKline Trading Services Limited




6900 Cork Airport Business Park,




Kinsale Road,




Cork,




Ireland






EU/1/10/612/001-006


02.07.2012




27.06.2012


Stocrin







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/99/111/001-005
EU/1/99/111/008
EU/1/99/111/010-011


02.07.2012




27.06.2012


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


02.07.2012




27.06.2012


Sycrest







N.V. Organon




Kloosterstraat 6, 5349 AB Oss,




Nederland






EU/1/10/640/001-006


02.07.2012




27.06.2012


Synagis







Abbott Laboratories Ltd




Abbott House,




Vanwall Business Park,




Vanwall Road,




Maidenhead,




Berkshire SL6 4XE,




United Kingdom






EU/1/99/117/001-002


29.06.2012




27.06.2012


Tasigna







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/422/001-012


02.07.2012




27.06.2012


Temodal







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon,




Hertfordshire, EN11 9BU,




United Kingdom






EU/1/98/096/001-025


02.07.2012




27.06.2012


Trisenox







Cephalon Europe




5 Rue Charles Martigny,




94700 Maisons Alfort,




Cedex,




France






EU/1/02/204/001


02.07.2012




27.06.2012


Viracept







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






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


29.06.2012




27.06.2012


VPRIV







Shire Pharmaceuticals Ireland Limited




5 Riverwalk,




Citywest Business Campus,




Dublin 24,




Ireland






EU/1/10/646/001-006


02.07.2012




27.06.2012


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/672/001-006


02.07.2012




27.06.2012


Zeffix







Glaxo Group Ltd.




Greenford Road,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/99/114/003


02.07.2012




27.06.2012


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/479/001-003


29.06.2012




27.06.2012


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


29.06.2012




27.06.2012


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/99/125/001-020


29.06.2012




28.06.2012


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




54, rue La Boétie,




75008 Paris,




France






EU/1/98/086/001-034


03.07.2012




28.06.2012


Copalia HCT







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/09/575/001-060


03.07.2012




28.06.2012


Dafiro HCT







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/09/574/001-060


03.07.2012




28.06.2012


Ecalta







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/07/416/001-002


03.07.2012




28.06.2012


ellaOne







Laboratoire HRA Pharma




15, rue Béranger,




75003 Paris,




France






EU/1/09/522/001


03.07.2012




28.06.2012


Exforge







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/06/370/001-039


03.07.2012




28.06.2012


Firmagon







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11,




Copenhagen S 2300,




Danmark






EU/1/08/504/001-003


07.07.2012




28.06.2012


GONAL-f







Merck Serono Europe Ltd.




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035


03.07.2012




28.06.2012


Icandra







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/484/001-018


03.07.2012




28.06.2012


Imprida







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/06/373/001-039


03.07.2012




28.06.2012


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/06/368/001-015
EU/1/06/368/020-024
EU/1/06/368/029-033
EU/1/06/368/037-042
EU/1/06/368/047-051
EU/1/06/368/056-057
EU/1/06/368/088-102
EU/1/06/368/113-150
EU/1/06/368/163-174


04.07.2012




28.06.2012


Jalra







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/485/001-011


03.07.2012




28.06.2012


Lamivudine Teva Pharma B.V.







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/596/001-014


03.07.2012




28.06.2012


Myclausen







Herbert J. Passauer GmbH & Co. KG




Stubenrauchstrasse 33,




14167 Berlin,




Deutschland






EU/1/10/647/001-004


03.07.2012




28.06.2012


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-014


03.07.2012




28.06.2012


PritorPlus







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/02/215/001-021


04.07.2012




28.06.2012


Rasilez HCT







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/491/001-080


03.07.2012




28.06.2012


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street,




E14 5DS London,




United Kingdom






EU/1/09/582/001


04.07.2012




28.06.2012


Riprazo HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/680/001-080


03.07.2012




28.06.2012


Siklos







ADDMEDICA




101, rue Saint Lazare,




Paris 75009,




France






EU/1/07/397/001-004


03.07.2012




28.06.2012


Siklos







ADDMEDICA




101, rue Saint Lazare,




Paris 75009,




France






EU/1/07/397/001-004


03.07.2012




28.06.2012


Sprimeo HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/683/001-080


02.07.2012




28.06.2012


Vfend







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT 13 9NJ,




United Kingdom






EU/1/02/212/001-026


03.07.2012




28.06.2012


Votubia







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/710/001-007


04.07.2012




28.06.2012


Votubia







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/710/001-007


04.07.2012




28.06.2012


Vyndaqel







Pfizer Specialty UK Limited




Ramsgate Road,




Sandwich,




Kent CT 13 9NJ,




United Kingdom






EU/1/11/717/001


04.07.2012




28.06.2012


Xiliarx







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/08/486/001-011


03.07.2012




28.06.2012


Zomarist







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/08/483/001-018


03.07.2012







—   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




28.06.2012


Hexavac







Aventis Pasteur MSD




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/00/147/001-012


04.07.2012







—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (2)
): Accepted













Date of the Décision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




14.06.2012


Porcilis ColiClos


—







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/12/141/001-009


Suspension for injection


QI09AB08


17.06.2012




15.06.2012


Poulvac E. coli


—







Pfizer Limited




Ramsgate Road,




Sandwich, Kent,




CT13 9NJ,




United Kingdom






EU/2/12/140/001-008


Lyophilisate for suspension for spray vaccination


QI01AE04


20.06.2012







—   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




11.06.2012


Activyl







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/10/118/001-021


13.06.2012




14.06.2012


Emdocam







Emdoka bvba




J. Lijsenstraat 16,




B-2321 Hoogstraten,




Belgïe






EU/2/11/128/001-003


18.06.2012




27.06.2012


Bovilis BTV8







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/10/106/001-014


02.07.2012




28.06.2012


Nobilis IB 4-91







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/98/006/001-010


04.07.2012




28.06.2012


Oxyglobin







OPK Biotech Netherlands BV




Teleportboulevard 140,




1043EJ Amsterdam,




Nederland






EU/2/99/015/001-002


04.07.2012




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, 30.4.04, p. 1.

(2)  OJ L 136, 30.4.04, p. 1.