EN Official Journal of the European Union C 337/4

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014

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

2014/C 337/02

— 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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 22.8.2014 Daklinza daclatasvir Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 Film-coated tablet J05AX 26.8.2014 22.8.2014 Vizamyl flutemetamol (18F) GE Healthcare Ltd Amersham Place Little Chalfont Buckinghamshire HP7 9NA UNITED KINGDOM EU/1/14/941 Solution for injection V09AX04 26.8.2014 26.8.2014 Velphoro mixture of polynuclear iron (iii)-oxyhydroxide, sucrose and starches Vifor Fresenius Medical Care Renal Pharma France 7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France EU/1/14/943 Chewable tablet V03AE05 28.8.2014

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 5.8.2014 Folcepri Endocyte Europe B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland — 7.8.2014 5.8.2014 Neocepri Endocyte Europe B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland — 7.8.2014 5.8.2014 Reasanz Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom — 20.8.2014 5.8.2014 Vynfinit Endocyte Europe B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland — 7.8.2014 19.8.2014 Nerventra Teva Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland — 21.8.2014

— 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 6.8.2014 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/05/315 8.8.2014 6.8.2014 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 8.8.2014 6.8.2014 Fluenz Tetra MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/13/887 8.8.2014 6.8.2014 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 8.8.2014 6.8.2014 Intanza Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/08/505 8.8.2014 6.8.2014 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika EU/1/09/592 8.8.2014 6.8.2014 Optaflu Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 8.8.2014 6.8.2014 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 8.8.2014 19.8.2014 Aerius Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/160 21.8.2014 19.8.2014 Azomyr Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/157 21.8.2014 19.8.2014 Capecitabine SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/831 21.8.2014 19.8.2014 Neoclarityn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/161 21.8.2014 19.8.2014 Olanzapine Glenmark Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom EU/1/09/587 21.8.2014 19.8.2014 Olanzapine Glenmark Europe Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom EU/1/09/588 21.8.2014 19.8.2014 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475 21.8.2014 19.8.2014 Panretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/149 21.8.2014 19.8.2014 Retacrit Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/07/431 21.8.2014 19.8.2014 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 21.8.2014 19.8.2014 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland EU/1/09/585 21.8.2014 22.8.2014 ADCETRIS Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/12/794 26.8.2014 22.8.2014 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343 26.8.2014 22.8.2014 ChondroCelect TiGenix NV Romeinse straat 12/2, B-3001 Leuven, België EU/1/09/563 26.8.2014 22.8.2014 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B-2650 Edegem, België EU/1/10/651 27.8.2014 22.8.2014 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 26.8.2014 22.8.2014 Dasselta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739 26.8.2014 22.8.2014 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 26.8.2014 22.8.2014 Enyglid Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580 26.8.2014 22.8.2014 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/855 26.8.2014 22.8.2014 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 26.8.2014 22.8.2014 Olazax Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597 26.8.2014 22.8.2014 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 26.8.2014 22.8.2014 Repaglinide Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/579 26.8.2014 22.8.2014 Synagis AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/99/117 26.8.2014 22.8.2014 Teysuno Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/11/669 26.8.2014 22.8.2014 Victrelis Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/11/704 26.8.2014 22.8.2014 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 26.8.2014 26.8.2014 Aerinaze Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399 28.8.2014 26.8.2014 Arixtra Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland EU/1/02/206 28.8.2014 26.8.2014 Avonex Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033 28.8.2014 26.8.2014 BeneFIX Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/97/047 28.8.2014 26.8.2014 Betaferon Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/95/003 28.8.2014 26.8.2014 Biopoin Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/565 28.8.2014 26.8.2014 Busilvex Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France EU/1/03/254 28.8.2014 26.8.2014 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416 28.8.2014 26.8.2014 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 28.8.2014 26.8.2014 Fareston Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/96/004 28.8.2014 26.8.2014 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 28.8.2014 26.8.2014 MACI Aastrom Biosciences DK ApS Oliefabriksvej 45, 2770 Kastrup, Danmark EU/1/13/847 28.8.2014 26.8.2014 Marixino Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland EU/1/13/820 28.8.2014 26.8.2014 Nevirapine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/598 28.8.2014 26.8.2014 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 28.8.2014 26.8.2014 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 28.8.2014 26.8.2014 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063 28.8.2014 26.8.2014 Scintimun CIS bio international Boîte postale 32, F-91192 Gif-sur-Yvette, France EU/1/09/602 28.8.2014 26.8.2014 Temozolomide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/606 28.8.2014 26.8.2014 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071 28.8.2014 26.8.2014 Zalasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415 28.8.2014 27.8.2014 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 29.8.2014

— 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 19.8.2014 Rivastigmine 3M Health Care Ltd. 3M Health Care Limited 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom EU/1/14/911 21.8.2014 22.8.2014 Vistide Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/97/037 26.8.2014

— 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 5.8.2014 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/137 7.8.2014 19.8.2014 Zolvix Novartis Healthcare A/S Edvard Thomsens Vej 14, DK-2300 København S, Danmark EU/2/09/101 21.8.2014 26.8.2014 Cortavance VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France EU/2/06/069 28.8.2014 26.8.2014 Naxcel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/05/053 28.8.2014 26.8.2014 Procox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/11/123 28.8.2014 26.8.2014 Slentrol Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/07/071 28.8.2014 26.8.2014 Stronghold Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/99/014 28.8.2014 27.8.2014 Convenia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/059 29.8.2014

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, 30.4.04, p. 1.