EN Official Journal of the European Union C 148/4

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2015 to 31 March 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 148/02)

— 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 18.3.2015 Vantobra Tobramycin PARI Pharma GmbH Moosstrasse 3, D-82319 Starnberg, Deutschland EU/1/14/932 Nebuliser solution J01GB01 20.3.2015 19.3.2015 Ikervis Ciclosporin SANTEN S.A.S. Bâtiment Genavenir IV, 1 rue Pierre Fontaine, F-91058 Evry Cedex, France EU/1/15/990 Eye drops, emulsion S01XA18 23.3.2015 19.3.2015 Orbactiv oritavancin The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/15/989 Powder for concentrate for solution for infusion J01XA05 23.3.2015 19.3.2015 Raplixa human fibrinogen/human thrombin ProFibrix BV Darwinweg 24, 2333 CR Leiden Nederland EU/1/14/985 Sealant powder B02BC30 23.3.2015 23.3.2015 Kengrexal cangrelor The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/15/994 Powder for concentrate for solution for infusion B01AC25 25.3.2015 23.3.2015 Saxenda liraglutide Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/15/992 Solution for injection A10BX07 25.3.2015 23.3.2015 Sivextro tedizolid phosphate Cubist (UK) Ltd Unit 1 Horizon Business Village No 1, Brooklands Road, Weybridge, Surrey KT13 0RU United Kingdom EU/1/15/991 Film-coated tablet Powder for concentrate for solution for infusion Pending 25.3.2015 26.3.2015 DUTREBIS lamivudine/raltegravir Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/995 Film-coated tablet J05AR16 30.3.2015 26.3.2015 Mysimba naltrexone/bupropion Orexigen Therapeutics Ireland Limited 70 Sir John Rogerson's Quay, Dublin 2, Ireland EU/1/14/988 Tablet A08AA62 30.3.2015 26.3.2015 Quinsair levofloxacin Aptalis Pharma SAS Route de Bû, F-78550 Houdan, France EU/1/14/973 Nebuliser solution J01MA12 30.3.2015

— 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 5.3.2015 Bretaris Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/781 9.3.2015 5.3.2015 Buccolam ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 6.3.2015 5.3.2015 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 9.3.2015 5.3.2015 Eklira Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/778 9.3.2015 5.3.2015 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 9.3.2015 5.3.2015 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 9.3.2015 5.3.2015 Norvir AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/96/016 9.3.2015 10.3.2015 Cholib Abbott Healthcare Products Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom EU/1/13/866 12.3.2015 10.3.2015 Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Roma, Italia EU/1/11/716 12.3.2015 10.3.2015 Sildenafil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/584 12.3.2015 10.3.2015 Truvada Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/04/305 12.3.2015 11.3.2015 Busulfan Fresenius Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/14/951 13.3.2015 11.3.2015 Colobreathe Forest Laboratories UK Ltd Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom EU/1/11/747 13.3.2015 11.3.2015 Crixivan Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024 13.3.2015 11.3.2015 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 13.3.2015 11.3.2015 Jakavi Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/12/773 13.3.2015 11.3.2015 Levetiracetam Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/13/889 13.3.2015 16.3.2015 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 18.3.2015 16.3.2015 Desloratadine Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/11/745 18.3.2015 16.3.2015 Emadine Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/98/095 18.3.2015 16.3.2015 Esmya Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/12/750 18.3.2015 16.3.2015 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 18.3.2015 16.3.2015 Omnitrope Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/06/332 18.3.2015 16.3.2015 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009 18.3.2015 19.3.2015 Azarga Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/08/482 23.3.2015 19.3.2015 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 24.3.2015 19.3.2015 Ibandronic acid Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland EU/1/11/685 23.3.2015 19.3.2015 Orphacol Laboratoires CTRS 63 rue de l'Est, F-92100 Boulogne-Billancourt, France EU/1/13/870 24.3.2015 19.3.2015 Rienso Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/774 23.3.2015 19.3.2015 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 23.3.2015 19.3.2015 Tolura Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632 23.3.2015 19.3.2015 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 23.3.2015 19.3.2015 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 23.3.2015 23.3.2015 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229 25.3.2015 23.3.2015 Daliresp Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/668 25.3.2015 23.3.2015 Ibandronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/798 25.3.2015 23.3.2015 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/10/637 25.3.2015 23.3.2015 Libertek Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/666 25.3.2015 23.3.2015 Ozurdex Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/10/638 25.3.2015 23.3.2015 Pixuvri CTI Life Sciences Ltd Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 25.3.2015 23.3.2015 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 25.3.2015 23.3.2015 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 25.3.2015 26.3.2015 Bondronat Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/012 30.3.2015 26.3.2015 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 30.3.2015 26.3.2015 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 30.3.2015 30.3.2015 Kaletra AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/01/172 1.4.2015 30.3.2015 Nevanac Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/07/433 1.4.2015 30.3.2015 Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/07/393 1.4.2015 30.3.2015 Suboxone RB Pharmaceuticals Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom EU/1/06/359 1.4.2015 30.3.2015 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 1.4.2015

— 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 5.3.2015 BindRen Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom EU/1/12/804 9.3.2015

— Issuing 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 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 16.3.2015 Coliprotec F4 Live non-pathogenic Escherichia coli strain O8:K87 Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/14/180 Lyophilisate for oral suspension QI09AE03 18.3.2015

— 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 5.3.2015 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 9.3.2015 5.3.2015 Dexdomitor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/2/02/033 9.3.2015 11.3.2015 Stronghold Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/99/014 13.3.2015 16.3.2015 Zuprevo Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/124 18.3.2015 26.3.2015 Nobivac Myxo-RHD Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/132 30.3.2015

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 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

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