EN Official Journal of the European Union C 104/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 2015

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2015/C 104/01)

— Issuing of a marketing authorisation (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 17.2.2015 Holoclar Ex vivo expanded autologous human corneal epithelial cells containing stem cells Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 Living tissue equivalent S01XA19 19.2.2015 17.2.2015 Tyverb lapatinib Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/440 Film-coated tablet L01XE07 19.2.2015 19.2.2015 Clopidogrel ratiopharm clopidogrel Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/975 Film-coated tablet B01AC04 24.2.2015 19.2.2015 Xydalba Dalbavancin Durata Therapeutics International B.V. Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland EU/1/14/986 Powder for concentrate for solution for infusion J01XA04 23.2.2015 24.2.2015 Xadago safinamide Zambon S.p.A. Via Lillo del Duca 10, 20091 Bresso (MI), Italia EU/1/14/984 Film-coated tablet Pending 26.2.2015 26.2.2015 Tasermity sevelamer hydrochloride Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/953 Film-coated tablet V03AE02 2.3.2015

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 3.2.2015 Levetiracetam Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/701 5.2.2015 3.2.2015 Pergoveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/07/396 6.2.2015 6.2.2015 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 10.2.2015 6.2.2015 Bridion Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/466 10.2.2015 6.2.2015 Ceplene Meda AB Box 906, SE-170 09 Solna, Sverige EU/1/08/477 10.2.2015 6.2.2015 Filgrastim Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/08/496 10.2.2015 6.2.2015 Firazyr Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland EU/1/08/461 10.2.2015 6.2.2015 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 10.2.2015 6.2.2015 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654 10.2.2015 6.2.2015 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/741 10.2.2015 6.2.2015 Opgenra Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland EU/1/08/489 10.2.2015 6.2.2015 Raloxifene Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/627 11.2.2015 6.2.2015 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 10.2.2015 6.2.2015 Zarzio Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/08/495 10.2.2015 10.2.2015 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/01/189 12.2.2015 10.2.2015 Telmisartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/610 12.2.2015 10.2.2015 Telmisartan Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/719 12.2.2015 10.2.2015 Tybost Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/872 12.2.2015 11.2.2015 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 13.2.2015 11.2.2015 HBVAXPRO Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/01/183 13.2.2015 11.2.2015 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/251 13.2.2015 11.2.2015 Olanzapine Apotex Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/10/635 16.2.2015 11.2.2015 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634 13.2.2015 11.2.2015 Somavert Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/240 13.2.2015 11.2.2015 Tyverb Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/440 13.2.2015 11.2.2015 Vitekta Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/883 13.2.2015 11.2.2015 Zoledronic acid Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/12/800 13.2.2015 12.2.2015 Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/11/667 16.2.2015 17.2.2015 Arzerra Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/625 19.2.2015 17.2.2015 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 19.2.2015 17.2.2015 Oprymea Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 19.2.2015 17.2.2015 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 19.2.2015 17.2.2015 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123 19.2.2015 17.2.2015 Sutent Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/347 19.2.2015 17.2.2015 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/488 19.2.2015 19.2.2015 Abilify Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/04/276 23.2.2015 19.2.2015 EVARREST Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/13/868 23.2.2015 19.2.2015 Fertavid Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/510 23.2.2015 19.2.2015 Memantine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/880 23.2.2015 19.2.2015 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231 23.2.2015 19.2.2015 NeuroBloc Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/166 23.2.2015 19.2.2015 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 23.2.2015 19.2.2015 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 23.2.2015 19.2.2015 RotaTeq Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/348 23.2.2015 19.2.2015 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 23.2.2015 24.2.2015 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/04/306 26.2.2015 24.2.2015 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 26.2.2015 24.2.2015 Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/13/828 26.2.2015 24.2.2015 Hexyon Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/13/829 26.2.2015 26.2.2015 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 2.3.2015 26.2.2015 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 2.3.2015 26.2.2015 Brimica Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/14/963 2.3.2015 26.2.2015 Duaklir Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/14/964 2.3.2015 26.2.2015 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 2.3.2015 26.2.2015 Lysodren Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/04/273 2.3.2015 26.2.2015 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 2.3.2015 26.2.2015 Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/11/692 2.3.2015 26.2.2015 Ziagen ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/99/112 2.3.2015

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 11.2.2015 Pumarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/10/664 13.2.2015

— Issuing of a marketing authorisation (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 INN (International Non-Proprietary Name) Holder of the marketing authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 6.2.2015 Zulvac SBV Inactivated Schmallenberg virus, strain BH80/11-4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/178 Suspension for injection QI02AA 10.2.2015

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 17.2.2015 BTVPUR AlSap 1 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/112 19.2.2015 17.2.2015 BTVPUR AlSap 1-8 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/113 19.2.2015 19.2.2015 Nobivac Myxo-RHD Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/132 23.2.2015 26.2.2015 CERTIFECT Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/11/125 2.3.2015 26.2.2015 ECOPORC SHIGA IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland EU/2/13/149 2.3.2015

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 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

(1) OJ L 136, 30.4.2004, p. 1.