EN Official Journal of the European Union C 386/3

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 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 386/02

— 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 1.9.2014 Clopidogrel/Acetylsalicylic acid Teva clopidogrel/acetylsalicylic acid Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/14/942 Film-coated tablet B01AC30 3.9.2014 1.9.2014 Triumeq dolutegravir/abacavir/lamivudine ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/14/940 Film-coated tablet J05AR13 3.9.2014 9.9.2014 ABASRIA Insulin glargine Eli Lilly Regional Operations GmbH. Kölblgasse 8-10, 1030 Wien, Österreich EU/1/14/944 Solution for injection A10AE04 11.9.2014 18.9.2014 Accofil Filgrastim Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/14/946 Solution for injection or infusion L03AA02 22.9.2014 18.9.2014 Xultophy insulin degludec/liraglutide Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/14/947 Solution for injection in pre-filled pen Pending 22.9.2014 18.9.2014 Zydelig idelalisib Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 Film-coated tablet L01XX47 19.9.2014 22.9.2014 Busulfan Fresenius Kabi busulfan Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/14/951 Concentrate for solution for infusion L01AB01 24.9.2014

— 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 1.9.2014 Daliresp Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/668 3.9.2014 1.9.2014 Daxas Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/10/636 3.9.2014 1.9.2014 Desloratadine ratiopharm Ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/746 4.9.2014 1.9.2014 DuoCover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 3.9.2014 1.9.2014 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736 3.9.2014 1.9.2014 Humira AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/03/256 3.9.2014 1.9.2014 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 3.9.2014 1.9.2014 Libertek Takeda GmbH Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland EU/1/11/666 3.9.2014 1.9.2014 Macugen PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Czech Republic EU/1/05/325 3.9.2014 1.9.2014 PHEBURANE Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/822 3.9.2014 1.9.2014 Pixuvri CTI Life Sciences Ltd Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 3.9.2014 1.9.2014 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 3.9.2014 1.9.2014 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 3.9.2014 1.9.2014 Zoely Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/690 4.9.2014 4.9.2014 Actelsar HCT Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/13/817 8.9.2014 4.9.2014 Aprovel Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/97/046 8.9.2014 4.9.2014 CoAprovel Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/086 8.9.2014 4.9.2014 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372 8.9.2014 4.9.2014 Copalia HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575 8.9.2014 4.9.2014 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371 8.9.2014 4.9.2014 Dafiro HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574 8.9.2014 4.9.2014 Exforge Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370 8.9.2014 4.9.2014 Exforge HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569 8.9.2014 4.9.2014 Exjade Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356 8.9.2014 4.9.2014 Extavia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454 8.9.2014 4.9.2014 Ifirmacombi Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 8.9.2014 4.9.2014 Ifirmasta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 8.9.2014 4.9.2014 Imprida Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373 8.9.2014 4.9.2014 Irbesartan HCT Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/377 8.9.2014 4.9.2014 Irbesartan/Hydrochlorothiazide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/583 8.9.2014 4.9.2014 Irbesartan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/576 8.9.2014 4.9.2014 Irbesartan Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/376 8.9.2014 4.9.2014 Karvea Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/97/049 8.9.2014 4.9.2014 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/085 8.9.2014 4.9.2014 Kinzalkomb Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/214 8.9.2014 4.9.2014 Kinzalmono Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/98/091 8.9.2014 4.9.2014 Lucentis Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374 8.9.2014 4.9.2014 Micardis Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/98/090 8.9.2014 4.9.2014 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/02/213 8.9.2014 4.9.2014 Pritor Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/98/089 8.9.2014 4.9.2014 PritorPlus Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/215 8.9.2014 4.9.2014 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 8.9.2014 4.9.2014 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 8.9.2014 4.9.2014 Sabervel Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/12/765 8.9.2014 4.9.2014 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/09/595 8.9.2014 4.9.2014 Simulect Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/084 8.9.2014 4.9.2014 Telmisartan Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland EU/1/10/639 8.9.2014 4.9.2014 Telmisartan Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/610 8.9.2014 4.9.2014 Telmisartan Teva Pharma Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/11/719 8.9.2014 4.9.2014 Tolucombi Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 8.9.2014 4.9.2014 Tolura Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632 8.9.2014 4.9.2014 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/10/648 8.9.2014 9.9.2014 Edarbi Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/734 11.9.2014 9.9.2014 Ipreziv Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/735 11.9.2014 9.9.2014 Lamivudine Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/566 12.9.2014 9.9.2014 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 11.9.2014 9.9.2014 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603 11.9.2014 9.9.2014 Sildenafil Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/584 12.9.2014 9.9.2014 Stribild Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/830 10.9.2014 11.9.2014 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011 15.9.2014 11.9.2014 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 15.9.2014 11.9.2014 Insulin Human Winthrop Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/06/368 16.9.2014 11.9.2014 Kolbam ASK Pharmaceuticals GmbH Heimeranstraße 35, D-80339 München, Deutschland EU/1/13/895 15.9.2014 11.9.2014 Lamivudine Teva Pharma B.V. Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/596 15.9.2014 11.9.2014 Relistor TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/08/463 15.9.2014 16.9.2014 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185 19.9.2014 16.9.2014 Ovaleap Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/871 18.9.2014 16.9.2014 Zutectra Biotest Pharma GmbH Landsteinerstrasse 5, D-63303 Dreieich, Deutschland EU/1/09/600 18.9.2014 18.9.2014 Clopidogrel Apotex Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/09/568 22.9.2014 18.9.2014 Clopidogrel Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/08/465 22.9.2014 18.9.2014 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 22.9.2014 18.9.2014 Hirobriz Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/594 22.9.2014 18.9.2014 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 22.9.2014 18.9.2014 Ilaris Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/564 22.9.2014 18.9.2014 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 22.9.2014 18.9.2014 Noxafil Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320 22.9.2014 18.9.2014 Onbrez Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/593 22.9.2014 18.9.2014 Oslif Breezhaler Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/586 22.9.2014 18.9.2014 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 22.9.2014 18.9.2014 Prialt Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/04/302 22.9.2014 18.9.2014 Rienso Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/12/774 22.9.2014 18.9.2014 Silodyx Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/607 22.9.2014 18.9.2014 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 22.9.2014 18.9.2014 Urorec Recordati Ireland Ltd Raheens East, Ringaskiddy Co. Cork, Ireland EU/1/09/608 22.9.2014 18.9.2014 Vantavo Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572 22.9.2014 22.9.2014 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537 24.9.2014 22.9.2014 Multaq Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/09/591 24.9.2014 30.9.2014 Cinryze ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 2.10.2014 30.9.2014 Humalog Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/96/007 2.10.2014 30.9.2014 Infanrix hexa GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/00/152 6.10.2014 30.9.2014 Inflectra Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/13/854 2.10.2014 30.9.2014 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 2.10.2014 30.9.2014 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 2.10.2014

— 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 1.9.2014 Clopidogrel Qualimed Qualimed 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/557 3.9.2014 16.9.2014 Pioglitazone Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/723 18.9.2014

— Issuing of a marketing authorization (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 4.9.2014 Nobilis IB Primo QX Live avian infectious bronchitis virus, strain D388 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/14/174 Lyophilisate and solvent for oculonasal suspension Lyophilisate for suspension for spray QI01AD07 8.9.2014

— 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 1.9.2014 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 3.9.2014 1.9.2014 Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/98/009 3.9.2014 9.9.2014 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 11.9.2014 9.9.2014 Fevaxyn Pentofel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/96/002 11.9.2014 9.9.2014 Pirsue Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/00/027 11.9.2014 9.9.2014 Zulvac 1 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/130 11.9.2014 9.9.2014 Zulvac 1 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/131 11.9.2014 16.9.2014 Zulvac 1+8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/120 18.9.2014 30.9.2014 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 2.10.2014 30.9.2014 Meloxoral Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/10/111 2.10.2014

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.

(2) OJ L 136, 30.4.04, p. 1.