EN Official Journal of the European Union C 32/1

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

(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 032/01)

— 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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 5.12.2014 Paliperidone Janssen Paliperidone Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/971 Prolonged release suspension for injection N05AX13 9.12.2014 8.12.2014 Duloxetine Lilly Duloxetine Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/14/972 Gastro-resistant capsule, hard N06AX21 10.12.2014 8.12.2014 Moventig Naloxegol AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/962 Film-coated tablet A06AH03 10.12.2014 16.12.2014 DUAVIVE Oestrogens conjugated/bazedoxifene Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/960 Modified-release tablet G03CX 18.12.2014 16.12.2014 Lynparza Olaparib AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/959 Capsule, hard L01 18.12.2014 19.12.2014 Cyramza Ramucirumab Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/14/957 Concentrate for solution for infusion L01XC 23.12.2014 19.12.2014 Rixubis Nonacog gamma Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich EU/1/14/970 Powder and solvent for solution for injection B02BD04 23.12.2014 22.12.2014 Scenesse Afamelanotide Clinuvel UK Limited c/o — Reed Smith, Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS, United Kingdom EU/1/14/969 Implant D02BB02 29.12.2014

— 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 1.12.2014 Desloratadine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/732 3.12.2014 1.12.2014 Ibandronic Acid Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/10/642 3.12.2014 1.12.2014 Irbesartan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/576 3.12.2014 1.12.2014 Optimark Mallinckrodt Deutschland GmbH Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland EU/1/07/398 3.12.2014 4.12.2014 Menveo Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/614 9.12.2014 4.12.2014 Ratiograstim Ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444 8.12.2014 4.12.2014 Tevagrastim Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/445 8.12.2014 5.12.2014 Cystagon Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/97/039 9.12.2014 5.12.2014 Erbitux Merck KGaA 64271 Darmstadt, Deutschland EU/1/04/281 9.12.2014 5.12.2014 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 9.12.2014 11.12.2014 Bronchitol Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom EU/1/12/760 15.12.2014 11.12.2014 Efavirenz Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/742 15.12.2014 11.12.2014 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 15.12.2014 11.12.2014 Levetiracetam Ratiopharm Ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/702 15.12.2014 11.12.2014 Removab Neovii Biotech GmbH Am Haag 6-7, 82166 Graefelfing, Deutschland EU/1/09/512 15.12.2014 15.12.2014 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 18.12.2014 15.12.2014 Lemtrada Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom EU/1/13/869 17.12.2014 15.12.2014 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/11/738 18.12.2014 15.12.2014 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400 18.12.2014 15.12.2014 Naglazyme BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/05/324 17.12.2014 15.12.2014 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 18.12.2014 15.12.2014 Revestive NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland EU/1/12/787 17.12.2014 15.12.2014 Somatropin Biopartners BioPartners GmbH Kaiserpassage 11, D-72764 Reutlingen, Deutschland EU/1/13/849 17.12.2014 15.12.2014 Tasigna Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/422 18.12.2014 15.12.2014 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 18.12.2014 16.12.2014 Afinitor Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/538 18.12.2014 16.12.2014 Brintellix H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/13/891 18.12.2014 16.12.2014 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 17.12.2014 16.12.2014 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/00/170 18.12.2014 16.12.2014 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/11/687 18.12.2014 16.12.2014 HyQvia Baxter Innovations GmbH Industriestraße 67, A-1221 Wien, Österreich EU/1/13/840 18.12.2014 16.12.2014 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 18.12.2014 16.12.2014 Lamivudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/566 18.12.2014 16.12.2014 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/11/713 18.12.2014 16.12.2014 Methylthioninium chloride Proveblue Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France EU/1/11/682 18.12.2014 16.12.2014 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694 18.12.2014 16.12.2014 Orphacol Laboratoires CTRS 63 rue de l'Est, F-92100 Boulogne-Billancourt, France EU/1/13/870 18.12.2014 16.12.2014 Paglitaz Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/721 18.12.2014 16.12.2014 Pioglitazone Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/757 18.12.2014 16.12.2014 Pioglitazone Teva Pharma Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/12/758 18.12.2014 16.12.2014 Remsima Celltrion Healthcare Hungary Kft. Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország EU/1/13/853 18.12.2014 16.12.2014 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 19.12.2014 16.12.2014 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 17.12.2014 16.12.2014 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 18.12.2014 16.12.2014 Ultibro Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/13/862 18.12.2014 16.12.2014 Ulunar Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/14/917 19.12.2014 16.12.2014 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 18.12.2014 16.12.2014 Xoterna Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/13/863 18.12.2014 16.12.2014 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 19.12.2014 19.12.2014 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005 23.12.2014 19.12.2014 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland EU/1/02/226 23.12.2014 19.12.2014 Puregon Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/008 23.12.2014 19.12.2014 Rilutek Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/96/010 23.12.2014 19.12.2014 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 5.1.2015 19.12.2014 Telmisartan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/610 24.12.2014 19.12.2014 Travatan Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/01/199 23.12.2014 19.12.2014 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 23.12.2014 19.12.2014 Zoledronic acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/771 24.12.2014 19.12.2014 Zoledronic acid Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/772 24.12.2014

— 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 22.12.2014 Bovela Modified live BVDV-1, non-cytopathic parent strain KE-9, Modified live BVDV-2, non-cytopathic parent strain NY-93 Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/2/14/176 Lyophilisate and solvent for suspension for injection QI02AD02 29.12.2014

— 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 4.12.2014 Gripovac 3 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/09/102 8.12.2014 4.12.2014 Porcilis AR-T DF Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/00/026 8.12.2014 4.12.2014 Respiporc Flu3 IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland EU/2/09/103 8.12.2014 11.12.2014 Comfortis Eli Lilly and Company Ltd, Elanco Animal Health Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/10/115 15.12.2014 11.12.2014 Trifexis Eli Lilly and Company Ltd, Elanco Animal Health Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/13/155 15.12.2014 16.12.2014 Pexion Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/147 18.12.2014

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.