EN Official Journal of the European Union C 116/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016

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

(2016/C 116/01)

— 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 2.2.2016 TAGRISSO osimertinib AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/16/1086 Film-coated tablet L01XE35 4.2.2016 11.2.2016 Caspofungin Accord caspofungin Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1081 Powder for concentrate for solution for infusion J02AX04 15.2.2016 15.2.2016 Portrazza necitumumab Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/15/1084 Concentrate for solution for infusion L01XC22 18.2.2016 15.2.2016 Vaxelis Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1079 Suspension for injection J07CA09 17.2.2016 18.2.2016 Feraccru ferric maltol Iron Therapeutics (UK) Ltd Gateshead Quays, NE8 3DF, United Kingdom EU/1/15/1075 Capsule, hard B03AB10 22.2.2016 18.2.2016 Iblias octocog alfa Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/15/1077 Powder and solvent for solution for injection B02BD02 22.2.2016 18.2.2016 Kovaltry octocog alfa Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/15/1076 Powder and solvent for solution for injection B02BD02 22.2.2016 18.2.2016 Zurampic lesinurad AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1080 Film-coated tablet M04AB05 22.2.2016

— 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 8.2.2016 Hepsera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/251 10.2.2016 8.2.2016 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 10.2.2016 8.2.2016 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 10.2.2016 8.2.2016 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France EU/1/11/682 10.2.2016 8.2.2016 Plavix Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 10.2.2016 8.2.2016 Zoledronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/834 10.2.2016 11.2.2016 Sevelamer carbonate Zentiva Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/952 15.2.2016 11.2.2016 Simbrinza Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/14/933 15.2.2016 11.2.2016 Sutent Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/347 15.2.2016 11.2.2016 Truvada Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/04/305 15.2.2016 11.2.2016 Vitekta Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/883 15.2.2016 11.2.2016 Xigduo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/900 15.2.2016 11.2.2016 Zoledronic acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/771 15.2.2016 11.2.2016 Zostavax Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/341 15.2.2016 11.2.2016 Zydelig Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 15.2.2016 15.2.2016 Latuda Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom EU/1/14/913 17.2.2016 15.2.2016 Rivastigmine Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/11/693 17.2.2016 18.2.2016 Aldara Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige EU/1/98/080 22.2.2016 18.2.2016 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 22.2.2016 18.2.2016 Biopoin Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/565 22.2.2016 18.2.2016 Brilique AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/655 22.2.2016 18.2.2016 BYDUREON AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/696 22.2.2016 18.2.2016 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/11/687 22.2.2016 18.2.2016 Lamivudine Teva Pharma B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/596 22.2.2016 18.2.2016 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 22.2.2016 18.2.2016 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France EU/1/11/682 22.2.2016 18.2.2016 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 22.2.2016 18.2.2016 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 22.2.2016 18.2.2016 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694 22.2.2016 18.2.2016 TOBI Podhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/652 22.2.2016 18.2.2016 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 22.2.2016 18.2.2016 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 22.2.2016 22.2.2016 Azilect Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/04/304 24.2.2016 22.2.2016 Constella Allergan Pharmaceuticals International Ltd Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland EU/1/12/801 24.2.2016 22.2.2016 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 24.2.2016 22.2.2016 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/00/170 24.2.2016 22.2.2016 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 24.2.2016 22.2.2016 Ketoconazole HRA Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/14/965 24.2.2016 22.2.2016 Scintimun CIS bio international Boîte postale 32, F-91192 Gif-sur-Yvette, France EU/1/09/602 24.2.2016 22.2.2016 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/336 24.2.2016 22.2.2016 Vizarsin Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 24.2.2016 22.2.2016 Zoledronic acid Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/12/786 24.2.2016 24.2.2016 Afinitor Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/538 26.2.2016 24.2.2016 Brintellix H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/13/891 26.2.2016 24.2.2016 Firdapse BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/09/601 26.2.2016 24.2.2016 Odomzo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1030 26.2.2016 24.2.2016 Peyona Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/09/528 26.2.2016 24.2.2016 Ravicti Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland EU/1/15/1062 3.3.2016 24.2.2016 Silodyx Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607 26.2.2016 24.2.2016 Stribild Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/830 26.2.2016 24.2.2016 Vylaer Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/949 26.2.2016 24.2.2016 Xultophy Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/14/947 26.2.2016 25.2.2016 Cerdelga Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/974 1.3.2016 26.2.2016 Bridion Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/466 1.3.2016 26.2.2016 Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 1.3.2016 26.2.2016 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 1.3.2016 26.2.2016 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 1.3.2016 26.2.2016 Urorec Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608 1.3.2016 26.2.2016 Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/11/705 2.3.2016 26.2.2016 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 1.3.2016

— 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 24.2.2016 Kepivance Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314 29.2.2016

— 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 10.2.2016 Zactran Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/08/082 12.2.2016 25.2.2016 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/137 29.2.2016 25.2.2016 Vectra 3D CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/13/156 29.2.2016 25.2.2016 Vectra Felis CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/14/165 29.2.2016 26.2.2016 Econor Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/98/010 1.3.2016 26.2.2016 Trifexis Eli Lilly and Company Ltd, Elanco Animal Health Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/13/155 1.3.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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