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.