EN Official Journal of the European Union C 285/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 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 285/01)

— 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 3.7.2015 Hetlioz tasimelteon Vanda Pharmaceuticals Limited 222 Regent Street, London W1B 5TR, United Kingdom EU/1/15/1008 Capsule, hard N05CH03 7.7.2015 13.7.2015 EVOTAZ atazanavir/cobicistat Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1025 Film-coated tablet J05AR15 15.7.2015 17.7.2015 KEYTRUDA pembrolizumab Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 Powder for concentrate for solution for infusion L01XC18 21.7.2015 17.7.2015 Pregabalin Zentiva pregabalin Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1021 Capsule, hard N03AX16 21.7.2015 17.7.2015 Repatha evolocumab Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1016 Solution for injection in a pre-filled syringe C10AX13 21.7.2015 20.7.2015 Bortezomib Accord bortezomib Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1019 Powder for solution for injection L01XX32 23.7.2015 20.7.2015 Nivolumab BMS nivolumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1026 Concentrate for solution for infusion L01XC17 23.7.2015 28.7.2015 Omidria phenylephrine/ketorolac Omeros London Limited Berkeley Square, London, W1J 6BD, United Kingdom EU/1/15/1018 Concentrate for solution for intraocular irrigation Pending 30.7.2015

— Issuing of a marketing authorization (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 authorization Number of the entry in the Community Register Date of notification 3.7.2015 Lympreva Biovest Europe Limited Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom — 7.7.2015

— 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 3.7.2015 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 7.7.2015 3.7.2015 Bemfola FINOX Biotech AG Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein EU/1/13/909 8.7.2015 3.7.2015 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 7.7.2015 3.7.2015 Docetaxel Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/769 7.7.2015 3.7.2015 Docetaxel Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/12/770 7.7.2015 3.7.2015 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699 7.7.2015 3.7.2015 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 7.7.2015 3.7.2015 Hemangiol Pierre Fabre Dermatologie 45 place Abel Gance, F-92100 Boulogne, France EU/1/14/919 7.7.2015 3.7.2015 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 7.7.2015 3.7.2015 Neuraceq Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom EU/1/13/906 7.7.2015 3.7.2015 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 7.7.2015 3.7.2015 Viramune Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/97/055 7.7.2015 3.7.2015 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 7.7.2015 3.7.2015 Zometa Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/176 7.7.2015 8.7.2015 Ambirix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/02/224 10.7.2015 8.7.2015 CONTROLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/515 10.7.2015 8.7.2015 DuoResp Spiromax Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/920 13.7.2015 8.7.2015 Flebogamma DIF Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa EU/1/07/404 10.7.2015 8.7.2015 Foscan biolitec pharma ltd. Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland. EU/1/01/197 10.7.2015 8.7.2015 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659 10.7.2015 8.7.2015 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292 10.7.2015 8.7.2015 PANTECTA Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/518 10.7.2015 8.7.2015 PANTOLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519 10.7.2015 8.7.2015 PANTOZOL Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/517 10.7.2015 8.7.2015 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 10.7.2015 8.7.2015 Pregabalin Pfizer Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/916 10.7.2015 8.7.2015 Ranexa Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/462 10.7.2015 8.7.2015 Remicade Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/99/116 10.7.2015 8.7.2015 SOMAC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/516 10.7.2015 8.7.2015 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 10.7.2015 8.7.2015 Vaniqa Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/01/173 10.7.2015 8.7.2015 Vimizim BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/14/914 10.7.2015 8.7.2015 Yttriga Eckert & Ziegler Radiopharma GmbH Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland EU/1/05/322 10.7.2015 13.7.2015 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 15.7.2015 13.7.2015 Zoledronic acid Teva Generics Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/912 15.7.2015 17.7.2015 Aflunov Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658 22.7.2015 17.7.2015 Brilique AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/655 21.7.2015 17.7.2015 Circadin RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom EU/1/07/392 21.7.2015 17.7.2015 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 21.7.2015 17.7.2015 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 21.7.2015 17.7.2015 JETREA ThromboGenics NV Gaston Geenslaan 1, B-3001 Leuven, België EU/1/13/819 22.7.2015 17.7.2015 Latuda Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/913 21.7.2015 17.7.2015 PecFent Archimedes Development Ltd Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom EU/1/10/644 21.7.2015 17.7.2015 Rapiscan Rapidscan Pharma Solutions EU Ltd Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom EU/1/10/643 21.7.2015 17.7.2015 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 21.7.2015 17.7.2015 Somavert Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/240 21.7.2015 17.7.2015 Sylvant Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/928 22.7.2015 17.7.2015 Votrient Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/628 21.7.2015 17.7.2015 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 21.7.2015 20.7.2015 Lucentis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/374 23.7.2015 20.7.2015 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/01/189 23.7.2015 20.7.2015 Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/07/393 23.7.2015 28.7.2015 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 30.7.2015 28.7.2015 Brinavess Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/10/645 30.7.2015 28.7.2015 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 30.7.2015 28.7.2015 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 30.7.2015 28.7.2015 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278 30.7.2015 28.7.2015 Mycamine Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/08/448 30.7.2015 28.7.2015 Neoclarityn Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/00/161 31.7.2015 28.7.2015 Nimenrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/12/767 31.7.2015 28.7.2015 Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/13/893 30.7.2015 28.7.2015 Osigraft Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland EU/1/01/179 30.7.2015 28.7.2015 Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/813 30.7.2015 28.7.2015 Prepandemic Influenza Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/657 31.7.2015 28.7.2015 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 30.7.2015 28.7.2015 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/09/605 30.7.2015 28.7.2015 Temozolomide SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/697 30.7.2015 28.7.2015 Tivicay ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 30.7.2015 28.7.2015 Translarna PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/13/902 30.7.2015 28.7.2015 Vizarsin Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 31.7.2015 28.7.2015 Votubia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 30.7.2015 28.7.2015 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 30.7.2015 28.7.2015 Zebinix BIAL — Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 30.7.2015 28.7.2015 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 30.7.2015 29.7.2015 Glubrava Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/07/421 31.7.2015 29.7.2015 Ketek Aventis Pharma S.A. 20, Avenue Raymond Aron, F-92160 ANTONY, France EU/1/01/191 31.7.2015 31.7.2015 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412 4.8.2015 31.7.2015 Binocrit Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/07/410 4.8.2015 31.7.2015 Epoetin alfa Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411 4.8.2015 31.7.2015 Picato Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/12/796 4.8.2015 31.7.2015 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/13/857 4.8.2015

— 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 3.7.2015 Sonata Meda AB Pipers väg 2A, S-170 09 Solna, Sverige EU/1/99/102 7.7.2015 13.7.2015 Zoledronic acid Teva Generics Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/912 15.7.2015

— 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 3.7.2015 Canigen L4 Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/15/183 Suspension for injection QI07AB01 7.7.2015 3.7.2015 Innovax-ILT Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/15/182 Suspension and solvent for suspension for injection QI01AD 7.7.2015 31.7.2015 UpCard Torasemide Vétoquinol SA Magny-Vernois, 70200 Lure, France EU/2/15/184 Tablet QC03CA04 4.8.2015

— Issuing of a marketing authorization (Article 38 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 authorization Number of the entry in the Community Register Date of notification 8.7.2015 Lodipressin Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland — 10.7.2015

— 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 13.7.2015 SevoFlo Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom EU/2/02/035 15.7.2015 17.7.2015 Incurin Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/00/018 21.7.2015 20.7.2015 Contacera Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/144 23.7.2015 28.7.2015 Poulvac E. coli Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/140 30.7.2015 31.7.2015 BTVPUR AlSap 2-4 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/10/108 4.8.2015 31.7.2015 Coxevac CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/10/110 4.8.2015

— 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 8.7.2015 ProMeris Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/064 10.7.2015 8.7.2015 ProMeris Duo Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/2/06/065 10.7.2015

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.