EN Official Journal of the European Union C 396/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2015 to 31 October 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 396/01)

— 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 15.10.2015 Cresemba isavuconazole Basilea Medical Ltd c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom EU/1/15/1036 Powder for concentrate for solution for infusion J02AC05 19.10.2015

— 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 5.10.2015 Kanuma Synageva BioPharma Ltd 1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom EU/1/15/1033 7.10.2015 5.10.2015 Potactasol Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/10/660 7.10.2015 8.10.2015 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 12.10.2015 8.10.2015 Invanz Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/02/216 12.10.2015 8.10.2015 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/051 12.10.2015 8.10.2015 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 12.10.2015 15.10.2015 Adempas Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/907 19.10.2015 15.10.2015 Betaferon Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/95/003 19.10.2015 15.10.2015 ChondroCelect TiGenix NV Romeinse straat 12/2, B-3001 Leuven, België EU/1/09/563 19.10.2015 15.10.2015 Dynastat Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/209 19.10.2015 15.10.2015 Fortacin Plethora Solutions Limited Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom EU/1/13/881 19.10.2015 15.10.2015 Iressa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/526 19.10.2015 15.10.2015 Kadcyla Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/885 19.10.2015 15.10.2015 Lyxumia Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/811 19.10.2015 15.10.2015 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 19.10.2015 15.10.2015 Onbrez Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/593 19.10.2015 15.10.2015 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 19.10.2015 15.10.2015 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 19.10.2015 16.10.2015 Corbilta Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/13/859 20.10.2015 16.10.2015 Silapo STADA Arzneimittel AG Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland EU/1/07/432 20.10.2015 22.10.2015 Procysbi Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland EU/1/13/861 26.10.2015 22.10.2015 Zalasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415 26.10.2015 28.10.2015 Cerezyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/97/053 30.10.2015 28.10.2015 Daliresp Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668 30.10.2015 28.10.2015 Daxas Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636 30.10.2015 28.10.2015 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 30.10.2015 28.10.2015 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 30.10.2015 28.10.2015 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 30.10.2015 28.10.2015 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/00/152 30.10.2015 28.10.2015 Libertek Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666 30.10.2015 28.10.2015 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 30.10.2015 28.10.2015 Rebetol Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/107 30.10.2015 28.10.2015 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 30.10.2015 28.10.2015 Sycrest Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/10/640 30.10.2015 28.10.2015 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/488 30.10.2015 28.10.2015 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 30.10.2015

— 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 5.10.2015 RevitaCAM Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/138 7.10.2015 8.10.2015 NexGard Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/159 12.10.2015 8.10.2015 SevoFlo Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 12.10.2015 15.10.2015 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 19.10.2015 15.10.2015 Zulvac SBV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/178 19.10.2015 22.10.2015 MS-H vaccine Pharmsure Ltd Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom EU/2/11/126 26.10.2015

— Withdrawal of a marketing authorization (Article 38 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 28.10.2015 Dicural Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/97/003 30.10.2015

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 7, Westferry Circus, Canary Wharf UK — LONDON E14 4H

(1) OJ L 136, 30.4.04, p. 1.