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.