Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2012-09-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012293EN.01000101.xml










28.9.2012   


EN


Official Journal of the European Union


C 293/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 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 293/01
—   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




03.08.2012


Zoledronic acid medac


zoledronic acid







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstr. 6, D-22880 Wedel, Deutschland






EU/1/12/779/001-006


Concentrate for solution for infusion


M05BA08


07.08.2012




16.08.2012


Zoledronic acid Teva


zoledronic acid







TEVA Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/12/771/001-006


Concentrate for solution for infusion


M05BA08


20.08.2012




16.08.2012


Zoledronic acid Teva Pharma


zoledronic acid







TEVA Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/12/772/001-004


Solution for infusion


M05BA08


20.08.2012




23.08.2012


Cuprymina


Copper 64Cu chloride







SPARKLE S.r.l.




Contrada Calò snc, 73042 Casarano (LE) - Italia






EU/1/12/784/001


Radiopharmaceutical precursor, solution


Pending


29.08.2012




23.08.2012


Jakavi


ruxolitinib







Novartis Europharm Limited




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






EU/1/12/773/001-003


Tablet


L01XE18


28.08.2012




23.08.2012


Zinforo


ceftaroline fosamil







AstraZeneca AB




S-151 85 Södertälje, Sverige






EU/1/12/785/001


powder for concentrate for solution for infusion


J01DI02


27.08.2012




23.08.2012


Zoledronic acid Mylan


zoledronic acid







Mylan S.A.S




117 allée des Parcs,F-69 800 Saint Priest, France






EU/1/12/786/001-003


Concentrate for solution for infusion


M05BA08


27.08.2012




23.08.2012


Zyclara


imiquimod







Meda AB




Pipers väg 2A, 170 73 Solna, Svërige






EU/1/12/783/001-003


Cream


D06BB10


27.08.2012




30.08.2012


Revestive


teduglutide







Nycomed Danmark ApS




Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/12/787/001


Powder and solvent for solution for injection


A16AX08


04.09.2012







—   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




03.08.2012


Hirobriz Breezhaler







Novartis Europharm Limited




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






EU/1/09/594/001-010


07.08.2012




03.08.2012


INCRELEX







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402/001


07.08.2012




03.08.2012


Mabthera







Roche Registration Limited




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






EU/1/98/067/001-002


07.08.2012




03.08.2012


Olanzapine Mylan







Generics [UK] Limited




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






EU/1/08/475/001-060


07.08.2012




03.08.2012


Volibris







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/08/451/001-004


07.08.2012




03.08.2012


Votrient







Glaxo Group Limited




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






EU/1/10/628/001-004


07.08.2012




03.08.2012


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana






EU/1/07/417/001-002


07.08.2012




08.08.2012


Kivexa







ViiV Healthcare UK Ltd




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






EU/1/04/298/001-003


10.08.2012




08.08.2012


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/427/001-057


10.08.2012




22.08.2012


IDflu







Sanofi Pasteur SA




2, avenue Pont Pasteur, F-69007 Lyon, France






EU/1/08/507/001-006


23.08.2012




22.08.2012


Intanza







Sanofi Pasteur MSD SNC




8, rue Jonas Salk, Lyon 69007, France






EU/1/08/505/001-006


23.08.2012




23.08.2012


Adcirca







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/08/476/005-006


27.08.2012




23.08.2012


BeneFIX







Pfizer Limited




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






EU/1/97/047/004-008


28.08.2012




23.08.2012


Brinavess







Merck Sharp & Dohme Limited




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






EU/1/10/645/001-002


28.08.2012




23.08.2012


Copalia







Novartis Europharm Ltd




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






EU/1/06/372/001-039


28.08.2012




23.08.2012


Dafiro







Novartis Europharm Ltd




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






EU/1/06/371/001-039


28.08.2012




23.08.2012


Docetaxel Teva Pharma







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/10/662/001-002


27.08.2012




23.08.2012


Doribax







Janssen-Cilag International NV




Turnhoutseweg 30, B - 2340 Beerse, België






EU/1/08/467/001-002


27.08.2012




23.08.2012


Ecalta







Pfizer Limited




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






EU/1/07/416/002


28.08.2012




23.08.2012


Efficib







Merck Sharp & Dohme Ltd.




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






EU/1/08/457/001-016


28.08.2012




23.08.2012


Exforge HCT







Novartis Europharm Ltd




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






EU/1/09/569/001-060


28.08.2012




23.08.2012


Firazyr







Shire Orphan Therapies GmbH




Friedrichstrasse 149, D-10117 Berlin, Deutschland






EU/1/08/461/001-002


27.08.2012




23.08.2012


Hepsera







Gilead Sciences International Limited




Cambridge, CB21 6GT, United Kingdom






EU/1/03/251/001-002


28.08.2012




23.08.2012


Humira







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom






EU/1/03/256/001-010


28.08.2012




23.08.2012


Imprida HCT







Novartis Europharm Ltd




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






EU/1/09/570/001-060


28.08.2012




23.08.2012


Janumet







Merck Sharp & Dohme Ltd.




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






EU/1/08/455/001-016


28.08.2012




23.08.2012


Lysodren







Laboratoire HRA Pharma




15, rue Béranger, 75003 Paris, France






EU/1/04/273/001


27.08.2012




23.08.2012


Macugen







Pfizer Ltd




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






EU/1/05/325/002


29.08.2012




23.08.2012


Mepact







IDM PHARMA SAS




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






EU/1/08/502/001


27.08.2012




23.08.2012


Neupro







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/05/331/001-055


27.08.2012




23.08.2012


Noxafil







Merck Sharp & Dohme Ltd.




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






EU/1/05/320/001


28.08.2012




23.08.2012


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




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






EU/1/09/592/001-005


27.08.2012




23.08.2012


Panretin







Eisai Limited




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






EU/1/00/149/001


28.08.2012




23.08.2012


Rasilez







Novartis Europharm Ltd




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






EU/1/07/405/001-040


28.08.2012




23.08.2012


Reyataz







Bristol-Myers Squibb Pharma EEIG




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






EU/1/03/267/001-006
EU/1/03/267/008-010


28.08.2012




23.08.2012


Riprazo







Novartis Europharm Ltd




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






EU/1/07/409/001-040


28.08.2012




23.08.2012


Thalidomide Celgene







Celgene Europe Limited




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






EU/1/08/443/001


28.08.2012




23.08.2012


Vectibix







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/07/423/001-003


27.08.2012




23.08.2012


Velmetia







Merck Sharp & Dohme Ltd.




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






EU/1/08/456/001-016


28.08.2012




23.08.2012


Vfend







Pfizer Ltd




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






EU/1/02/212/001-026


28.08.2012




23.08.2012


Vfend







Pfizer Ltd




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






EU/1/02/212/001-026


28.08.2012




23.08.2012


Viramune







Boehringer Ingelheim International GmbH




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






EU/1/97/055/001-009


27.08.2012




23.08.2012


Xgeva







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/11/703/001-003


27.08.2012




23.08.2012


Zavesca







Actelion Registration Ltd




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






EU/1/02/238/001


27.08.2012




23.08.2012


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal






EU/1/09/514/001-023


27.08.2012




23.08.2012


Zebinix







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal






EU/1/09/514/001-020


27.08.2012




23.08.2012


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, F-69007 Lyon, France






EU/1/06/341/001-013


27.08.2012




24.08.2012


FLUENZ







MedImmune, LLC




Lagelandseweg 78, 6545 CG Nijmegen, Nederland






EU/1/10/661/001-002


28.08.2012




27.08.2012


FLUENZ







MedImmune, LLC




Lagelandseweg 78, 6545 CG Nijmegen, Nederland






EU/1/10/661/002


29.08.2012




30.08.2012


Avastin







Roche Registration Limited




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






EU/1/04/300/001-002


04.09.2012




30.08.2012


Copalia HCT







Novartis Europharm Ltd




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






EU/1/09/575/001-060


03.09.2012




30.08.2012


Crixivan







Merck Sharp & Dohme Ltd




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






EU/1/96/024/010


03.09.2012




30.08.2012


Dafiro HCT







Novartis Europharm Ltd




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






EU/1/09/574/001-060


03.09.2012




30.08.2012


Enbrel







Pfizer Limited




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






EU/1/99/126/001-022


03.09.2012




30.08.2012


Evista







DAIICHI SANKYO EUROPE GmbH




Zielstattstrasse 48, 81379 München, Deutschland






EU/1/98/073/001-004


03.09.2012




30.08.2012


Exforge







Novartis Europharm Ltd




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






EU/1/06/370/001-039


03.09.2012




30.08.2012


Flebogamma DIF







Instituto Grifols, S.A.




Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa






EU/1/07/404/001-008


04.09.2012




30.08.2012


Gliolan







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3, D-20354 Hamburg - Deutschland






EU/1/07/413/001-003


04.09.2012




30.08.2012


Imprida







Novartis Europharm Ltd




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






EU/1/06/373/001-039


03.09.2012




30.08.2012


INCRELEX







Ipsen Pharma




65, quai Georges Gorse, 92100 Boulogne-Billancourt, France






EU/1/07/402/001


04.09.2012




30.08.2012


Irbesartan Zentiva







Sanofi




54, rue La Boétie, 75008 Paris, France






EU/1/06/376/001-039


03.09.2012




30.08.2012


Januvia







Merck Sharp & Dohme Ltd




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






EU/1/07/383/001-018


03.09.2012




30.08.2012


Kaletra







Abbott Laboratories




Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom






EU/1/01/172/001-008


03.09.2012




30.08.2012


Leganto







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/11/695/001-055


04.09.2012




30.08.2012


Methylthioninium chloride Proveblue







Provepharm S.A.S.




Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille






EU/1/11/682/001


04.09.2012




30.08.2012


Modigraf







Astellas Pharma Europe B.V.




Elisabethhof 19, 2353 EW Leiderdorp, Nederland






EU/1/09/523/001-002


03.09.2012




30.08.2012


Multaq







Sanofi




54, rue La Boétie, 75008 Paris, France






EU/1/09/591/001-004


03.09.2012




30.08.2012


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


03.09.2012




30.08.2012


Optruma







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/98/074/001-004


03.09.2012




30.08.2012


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442/001-014
EU/1/08/442/017-019


05.09.2012




30.08.2012


Pravafenix







LABORATOIRES SMB SA




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






EU/1/11/679/001-006


04.09.2012




30.08.2012


Protopic







Astellas Pharma Europe B.V.




Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland






EU/1/02/201/001-006


03.09.2012




30.08.2012


ReFacto AF







Pfizer Limited




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






EU/1/99/103/001-008


03.09.2012




30.08.2012


Ristaben







Merck Sharp & Dohme Ltd.




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






EU/1/10/621/001-018


04.09.2012




30.08.2012


Ristfor







Merck Sharp & Dohme Ltd.




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






EU/1/10/620/001-016


04.09.2012




30.08.2012


Sprycel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/363/001-015


03.09.2012




30.08.2012


Telmisartan Teva







Teva Pharma B.V.




Computerweg 10, 3542 DR Utrecht, Nederland






EU/1/09/610/061-062


03.09.2012




30.08.2012


Tygacil







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/1/06/336/001


03.09.2012




30.08.2012


Vedrop







Orphan Europe SARL




Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux - France






EU/1/09/533/001-003


04.09.2012




30.08.2012


Votrient







Glaxo Group Limited




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






EU/1/10/628/001-004


04.09.2012




30.08.2012


Zytiga







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/714/001


04.09.2012







—   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




08.08.2012


MabCampath







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/01/193/001-002


10.08.2012




23.08.2012


Zerene







Meda AB




Pipers väg 2A, Solna 170 09, Sverige






EU/1/99/099/001-006


27.08.2012




30.08.2012


Riprazo HCT







Novartis Europharm Limited




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






EU/1/11/680/001-080


03.09.2012







—   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




16.08.2012


Inflacam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, IRELAND






EU/2/11/134/001-017


20.08.2012




30.08.2012


Dexdomitor







Orion Corporation




Orionintie 1, FIN-02200 Espoo, Suomi






EU/2/02/033/001-004


03.09.2012




30.08.2012


Nobivac Bb







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/02/034/001


03.09.2012




30.08.2012


Suvaxyn Aujeszky 783 +O/W







Pfizer Limited




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






EU/2/98/009/001-006


03.09.2012




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.