EN Official Journal of the European Union C 467/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 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 467/01)

— 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 17.11.2014 Harvoni ledipasvir/sofosbuvir Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 Film-coated tablet Pending 18.11.2014 19.11.2014 Brimica Genuair aclidinium bromide/formoterol fumarate dihydrate Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/14/963 Inhalation powder R03AL05 21.11.2014 19.11.2014 Budesonide/Formoterol Teva budesonide/formoterol Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/948 Inhalation powder R03AK07 24.11.2014 19.11.2014 Budesonide/Formoterol Teva Pharma B.V. budesonide/formoterol Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/950 Inhalation powder R03AK07 21.11.2014 19.11.2014 Duaklir Genuair aclidinium bromide/formoterol fumarate dihydrate Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/14/964 Inhalation powder R03AL05 21.11.2014 19.11.2014 Ketoconazole HRA ketoconazole Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/14/965 Tablet Pending 21.11.2014 19.11.2014 Lymphoseek tilmanocept Navidea Biopharmaceuticals Limited 30 Upper High Street Thame, OX9 3EZ United Kingdom EU/1/14/955 Kit for radiopharmaceutical preparation V09IA09 21.11.2014 19.11.2014 REZOLSTA DARUNAVIR/COBICISTAT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/967 Film-coated tablet J05AR14 21.11.2014 19.11.2014 Vylaer Spiromax budesonide/formoterol Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/949 Inhalation powder R03AK07 24.11.2014 21.11.2014 Tadalafil Mylan tadalafil Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/14/961 Film-coated tablet G04BE08 25.11.2014 21.11.2014 Trulicity dulaglutide Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/14/956 Solution for injection Pending 25.11.2014 21.11.2014 Vargatef nintedanib Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/954 Capsule, soft Pending 25.11.2014

— 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 authorization Number of the entry in the Community Register Date of notification 7.11.2014 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118 11.11.2014 7.11.2014 Biograstim AbZ-Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/450 11.11.2014 7.11.2014 Inlyta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/777 11.11.2014 7.11.2014 Pioglitazone Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/722 11.11.2014 7.11.2014 Prometax Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/092 11.11.2014 7.11.2014 Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/674 12.11.2014 7.11.2014 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 11.11.2014 11.11.2014 Glidipion Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/12/756 13.11.2014 11.11.2014 Imatinib Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/808 13.11.2014 11.11.2014 Irbesartan/Hydrochlorothiazide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/583 14.11.2014 11.11.2014 Lamivudine/Zidovudine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/663 13.11.2014 11.11.2014 Nemdatine Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/824 13.11.2014 11.11.2014 Pioglitazone Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/12/755 13.11.2014 13.11.2014 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227 17.11.2014 13.11.2014 NovoMix Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142 17.11.2014 13.11.2014 Ribavirin Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/509 17.11.2014 13.11.2014 Ribavirin Teva Pharma BV Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/527 17.11.2014 13.11.2014 Trisenox Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/02/204 17.11.2014 13.11.2014 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 17.11.2014 17.11.2014 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 19.11.2014 17.11.2014 Fendrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/04/299 19.11.2014 17.11.2014 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 19.11.2014 17.11.2014 Lamivudine Teva Pharma B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/596 20.11.2014 17.11.2014 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 19.11.2014 17.11.2014 Tepadina ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 19.11.2014 17.11.2014 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/336 19.11.2014 17.11.2014 Zometa Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176 19.11.2014 19.11.2014 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253 20.11.2014 19.11.2014 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/13/838 21.11.2014 19.11.2014 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 21.11.2014 19.11.2014 Bretaris Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/781 21.11.2014 19.11.2014 DuoCover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 21.11.2014 19.11.2014 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 21.11.2014 19.11.2014 Eklira Genuair Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/12/778 21.11.2014 19.11.2014 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 21.11.2014 19.11.2014 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 21.11.2014 19.11.2014 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 21.11.2014 19.11.2014 Kalydeco Vertex Pharmaceuticals (U.K.) Limited Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom EU/1/12/782 21.11.2014 19.11.2014 Leflunomide Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/09/604 21.11.2014 19.11.2014 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 21.11.2014 19.11.2014 Neupro UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 21.11.2014 19.11.2014 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123 21.11.2014 19.11.2014 Signifor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/753 21.11.2014 19.11.2014 Temozolomide HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616 21.11.2014 19.11.2014 Temozolomide Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/10/617 21.11.2014 19.11.2014 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 21.11.2014 19.11.2014 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/08/499 21.11.2014 19.11.2014 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 21.11.2014 19.11.2014 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/814 21.11.2014 21.11.2014 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 25.11.2014 21.11.2014 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 25.11.2014 21.11.2014 Docetaxel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/611 25.11.2014 21.11.2014 Firmagon Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 København S, Danmark EU/1/08/504 25.11.2014 21.11.2014 Leganto UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 25.11.2014 21.11.2014 Nexavar Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/06/342 25.11.2014 21.11.2014 Repaglinide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/530 25.11.2014 21.11.2014 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 25.11.2014 21.11.2014 Tafinlar GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/13/865 25.11.2014 28.11.2014 Brinavess Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/10/645 2.12.2014 28.11.2014 Cetrotide Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/99/100 2.12.2014 28.11.2014 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601 2.12.2014 28.11.2014 Topotecan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/552 2.12.2014 28.11.2014 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 2.12.2014

— Suspension of a marketing authorisation (Article 20 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 19.11.2014 MACI Aastrom Biosciences DK ApS Oliefabriksvej 45, 2770 Kastrup, Danmark EU/1/13/847 24.11.2014

— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): 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 7.11.2014 Porcilis PCV M Hyo Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated) Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/14/175 Emulsion for injection QI09AL 11.11.2014

— 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 authorization Number of the entry in the Community Register Date of notification 7.11.2014 Zolvix Novartis Healthcare A/S Edvard Thomsens Vej 14, DK-2300 København S, Danmark EU/2/09/101 11.11.2014 7.11.2014 Zulvac 8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/105 12.11.2014 7.11.2014 Zulvac 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/104 12.11.2014 28.11.2014 ProZinc Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/2/13/152 2.12.2014 28.11.2014 Semintra Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 2.12.2014

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, 30.4.2004, p. 1.

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