Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-06-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012190EN.01000101.xml










29.6.2012   


EN


Official Journal of the European Union


C 190/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 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 190/01
—   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




7.5.2012


Riluzole Zentiva


Riluzole







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/12/768/001


Film-coated tablet


N07XX02


10.5.2012




10.5.2012


Pixuvri


pixantrone







CTI Life Sciences Ltd




Biopark, Broadwater Road,




Welwyn Garden City,




Hertfordshire AL73AX,




United Kingdom






EU/1/12/764/001


powder for concentrate for solution for infusion


L01DB11


14.5.2012




22.5.2012


Docetaxel Accord


Docetaxel







Accord Healthcare Limited




Sage house, 319 Pinner road,




North Harrow,




Middlesex HA1 4HF




United Kingdom






EU/1/12/769/001-003


Concentrate for solution for infusion


L01CD02


25.5.2012




22.5.2012


Docetaxel Kabi


Docetaxel







Fresenius Kabi Oncology Plc.




Lion Court, Farnham Road,




Bordon,




Hampshire,




GU35 0NF,




United Kingdom






EU/1/12/770/001-004


Concentrate for solution for infusion


L01CD02


25.5.2012







—   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




7.5.2012


Intanza







Sanofi Pasteur MSD SNC




8, rue Jonas Salk,




Lyon 69007,




France






EU/1/08/505/001-003


9.5.2012




7.5.2012


Ovitrelle







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/00/165/001-003


9.5.2012




10.5.2012


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


14.5.2012




10.5.2012


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris,




France






EU/1/98/086/001-034


14.5.2012




10.5.2012


Ibandronic Acid Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/642/001-004


14.5.2012




10.5.2012


Irbesartan / Hydrochlorothiazide Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/583/001-072


14.5.2012




10.5.2012


Siklos







ADDMEDICA




101, rue Saint Lazare,




Paris 75009,




France






EU/1/07/397/001-004


14.5.2012




10.5.2012


Telmisartan Actavis







Actavis Group PTC ehf.




Reykjavíkurvegi 76 78,




220 Hafnarfjörður,




Iceland






EU/1/10/639/001-030


14.5.2012




10.5.2012


Telmisartan Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/610/001-060


14.5.2012




10.5.2012


Trobalt







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/11/681/001-013


14.5.2012




14.5.2012


Brilique







AstraZeneca AB




Södertälje S 151 85,




Sverige






EU/1/10/655/001-006


16.5.2012




14.5.2012


Invega







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse –




België






EU/1/07/395/001-095


16.5.2012




14.5.2012


JEVTANA







SANOFI




174, avenue de France,




F-75013 Paris,




France






EU/1/11/676/001


16.5.2012




14.5.2012


Luveris







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/00/155/001-003


16.5.2012




14.5.2012


Possia







AstraZeneca AB




Södertälje S 151 85,




Sverige






EU/1/10/656/001-006


16.5.2012




14.5.2012


TOBI Podhaler







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/10/652/001-003


16.5.2012




15.5.2012


Mircera







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/07/400/008-013
EU/1/07/400/017-024


17.5.2012




15.5.2012


Topotecan Hospira







Hospira UK Limited




Queensway,




Royal Leamington Spa,




Warwickshire CV31 3RW,




United Kingdom






EU/1/10/633/001-002


17.5.2012




15.5.2012


Vizarsin







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/551/001-027


17.5.2012




22.5.2012


Aerinaze







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/07/399/001-006


25.5.2012




22.5.2012


Fampyra







Biogen Idec Limited




Innovation House,




70 Norden Road,




Maidenhead,




Berkshire SL6 4AY,




United Kingdom






EU/1/11/699/001-004


25.5.2012




22.5.2012


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






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


25.5.2012




22.5.2012


HALAVEN







Eisai Europe Limited




European Knowledge Centre,




Mosquito Way,




Hatfield,




Hertsforshire AL10 9SN,




United Kingdom






EU/1/11/678/001-002


25.5.2012




22.5.2012


Hizentra







CSL Behring GmbH




Emil-von-Behring-Strasse 76,




35041 Marburg,




Deutschland






EU/1/11/687/001-012


25.5.2012




22.5.2012


IDflu







Sanofi Pasteur SA




2, avenue Pont Pasteur,




F-69007 Lyon,




France






EU/1/08/507/001-003


25.5.2012




22.5.2012


Pergoveris







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/07/396/001-003


25.5.2012




22.5.2012


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


25.5.2012




22.5.2012


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/222/001-005


24.5.2012




22.5.2012


Tamiflu







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/222/001-005


25.5.2012




22.5.2012


Votrient







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/10/628/001-004


25.5.2012




25.5.2012


Benlysta







Glaxo Group Limited




Glaxo Wellcome House,




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/11/700/001-002


30.5.2012




25.5.2012


Betaferon







Bayer Pharma AG




D - 13342 Berlin,




Deutschland






EU/1/95/003/003-012


30.5.2012




25.5.2012


Busilvex







Pierre Fabre Médicament




45, Place Abel Gance,




92654 Boulogne Billancourt Cedex,




France






EU/1/03/254/002


31.5.2012




25.5.2012


Clopidogrel Teva Pharma B.V.







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/649/001-016


30.5.2012




25.5.2012


Conbriza







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/09/511/001-005


31.5.2012




25.5.2012


DuoCover







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/10/623/001-015


30.5.2012




25.5.2012


Ecalta







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/07/416/001-002


31.5.2012




25.5.2012


Fosavance







Merck Sharp & Dohme Ltd




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/05/310/001-009


30.5.2012




25.5.2012


Irbesartan Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/576/001-039


30.5.2012




25.5.2012


Ixiaro







Intercell AG




Campus Vienna Biocenter 3




A-1030 Wien,




Österreich






EU/1/08/501/001-002


31.5.2012




25.5.2012


Keppra







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef, 60,




Brussel 1070,




België






EU/1/00/146/001-032


1.6.2012




25.5.2012


Kinzalkomb







Bayer Pharma AG




Berlin 13342,




Deutschland






EU/1/02/214/001-015


31.5.2012




25.5.2012


Kinzalmono







Bayer Pharma AG




Berlin 13342,




Deutschland






EU/1/98/091/001-014


31.5.2012




25.5.2012


Kuvan







Merck Serono Europe Limited




56 Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/08/481/001-003


30.5.2012




25.5.2012


Lamivudine / Zidovudine Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/663/001-002


1.6.2012




25.5.2012


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/98/090/001-022


31.5.2012




25.5.2012


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/02/213/001-023


31.5.2012




25.5.2012


Neulasta







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/02/227/001-002
EU/1/02/227/004


1.6.2012




25.5.2012


Nevirapine Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/598/001-004


30.5.2012




25.5.2012


Onduarp







Boehringer Ingelheim International GmbH




Binger Str. 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/11/729/001-006


30.5.2012




25.5.2012


Optaflu







Novartis Vaccines and Diagnostics GmbH




Emil-von-Behring-Strasse 76,




D-35041 Marburg,




Deutschland






EU/1/07/394/001-009


31.5.2012




25.5.2012


Osseor







Les Laboratoires Servier




50, rue Carnot,




92284 Suresnes cedex,




France






EU/1/04/287/001-006


30.5.2012




25.5.2012


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-014


1.6.2012




25.5.2012


Pritor







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/98/089/001-022


30.5.2012




25.5.2012


PritorPlus







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/02/215/001-021


30.5.2012




25.5.2012


Protelos







Les Laboratoires Servier




50, rue Carnot,




92284 Suresnes cedex,




France






EU/1/04/288/001-006


 




25.5.2012


Rasilamlo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/686/001-056


30.5.2012




25.5.2012


Rasilez







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/405/001-040


30.5.2012




25.5.2012


Rasilez HCT







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/491/001-080


31.5.2012




25.5.2012


Rasitrio







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/730/001-060


31.5.2012




25.5.2012


Riprazo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/409/001-040


30.5.2012




25.5.2012


Riprazo HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/680/001-080


1.6.2012




25.5.2012


Rivastigmine Actavis







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78,




Hafnarfjörður 220,




Iceland






EU/1/11/693/001-016


1.6.2012




25.5.2012


RoActemra







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/08/492/001-006


31.5.2012




25.5.2012


Sprimeo







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/07/407/001-040


31.5.2012




25.5.2012


Sprimeo HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex, RH12 5AB,




United Kingdom






EU/1/11/683/001-080


1.6.2012




25.5.2012


Temozolomide Hospira







Hospira UK Ltd.




Queensway,




Royal Leamington Spa,




Warwickshire CV31 3RW,




United Kingdom






EU/1/10/615/001-002
EU/1/10/615/005-006
EU/1/10/615/009-010
EU/1/10/615/013-014
EU/1/10/615/017-018
EU/1/10/615/021-022


31.5.2012




25.5.2012


Tysabri







Elan Pharma International Ltd.




Treasury Building,




Lower Grand Canal Street,




Dublin 2,




IRELAND






EU/1/06/346/001


31.5.2012




25.5.2012


Vantavo







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/09/572/001-004
EU/1/09/572/006-008


30.5.2012




25.5.2012


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


31.5.2012




25.5.2012


Vistide







Gilead Sciences International Limited




Cambridge,




CB21 6GT,




United Kingdom






EU/1/97/037/001


31.5.2012




25.5.2012


Volibris







Glaxo Group Ltd




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/08/451/001-004


30.5.2012




25.5.2012


Votrient







Glaxo Group Limited




Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






EU/1/10/628/001-004


31.5.2012




25.5.2012


Xolair







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/05/319/001-010


30.5.2012




31.5.2012


Lamivudine Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/566/001-005


4.6.2012




31.5.2012


Peyona







CHIESI FARMACEUTICI SpA




Via Palermo 26/A,




I-43100 Parma,




ITALIA






EU/1/09/528/001-002


4.6.2012




31.5.2012


Temozolomide Teva







Teva Pharma B.V.




Computerweg 10,




DR Utrecht 3542,




Nederland






EU/1/09/606/001-012


4.6.2012







—   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




10.5.2012


Valtropin







BioPartners GmbH




Kaiserpassage 11 -




D-72764 Reutlingen,




Deutschland






EU/1/06/335/001


14.5.2012




25.5.2012


Docefrez







Sun Pharmaceuticals Industries Europe B.V.




Polarisavenue 87,




2132 JH Hoofddorp,




Nederland






EU/1/10/630/001-002


31.5.2012




25.5.2012


Intrinsa







Warner Chilcott UK Ltd




Old Belfast Road,




Millbrook, Larne,




County Antrim BT40 2SH,




United Kingdom






EU/1/06/352/001-003


31.5.2012







—   Lift of 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




25.5.2012


Angiox







The Medicines Company UK Ltd




115 L Milton Park,




Abingdon,




Oxfordshire, OX14 4SA,




United Kingdom






EU/1/04/289/001


31.5.2012




25.5.2012


Caelyx







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/96/011/001-004


31.5.2012




25.5.2012


Luminity







Lantheus MI UK Limited




Festival House -




39 Oxford Street -




Newbury -




Berkshire RG14 1JG -




United Kingdom






EU/1/06/361/001-002


31.5.2012




25.5.2012


Mepact







IDM PHARMA SAS




11-15 quai De Dion Bouton,




92816 Puteaux Cedex,




France






EU/1/08/502/001


1.6.2012




25.5.2012


Soliris







Alexion Europe S.A.S.




25, boulevard de l’Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


31.5.2012




25.5.2012


Torisel







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






EU/1/07/424/001


30.5.2012




25.5.2012


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/04/274/001-002


31.5.2012




31.5.2012


Ceplene







EpiCept GmbH




Goethestrasse 4,




D-80336 München,




Deutschland






EU/1/08/477/001


4.6.2012







—   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




10.5.2012


Circovac







Merial




29 Avenue Tony Garnier,




69007 Lyon,




France






EU/2/07/075/001-004


14.5.2012




10.5.2012


Netvax







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/09/093/001-002


14.5.2012




22.5.2012


Convenia







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/2/06/059/001-002


30.5.2012




22.5.2012


Equip WNV







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/2/08/086/001-003


25.5.2012




22.5.2012


PRILACTONE







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




33500 Libourne,




France






EU/2/07/074/001-006


25.5.2012




25.5.2012


Onsior







Novartis Animal Health UK Ltd




Frimley Business Park,




Frimley/Camberley,




Surrey, GU16 7SR,




United Kingdom






EU/2/08/089/001-021


1.6.2012




25.5.2012


Suprelorin







VIRBAC S.A.




1ère Avenue 2065 m L.I.D. -




06516 Carros –




France






EU/2/07/072/001-004


1.6.2012




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.