EN Official Journal of the European Union C 362/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

(2016/C 362/01)

— 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 16.8.2016 Cinqaero reslizumab Teva Pharmaceuticals Limited Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom EU/1/16/1125 Concentrate for solution for infusion R03DX08 18.8.2016 18.8.2016 Aerivio Spiromax salmeterol/fluticasone propionate Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1122 Inhalation powder R03AK06 22.8.2016 18.8.2016 Airexar Spiromax salmeterol/fluticasone propionate Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1123 Inhalation powder R03AK06 22.8.2016 18.8.2016 Nordimet methotrexate Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/16/1124 Solution for injection L01BA01 22.8.2016 18.8.2016 Zalmoxis Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2) MolMed S.p.A. Via Olgettina 58, I-20132 Milano, Italia EU/1/16/1121 Dispersion for infusion Pending 23.8.2016 22.8.2016 Atazanavir Mylan atazanavir Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1091 Capsule, hard J05AE08 24.8.2016 25.8.2016 Kisplyx lenvatinib Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom EU/1/16/1128 Capsule, hard L01XE29 30.8.2016

— 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 1.8.2016 Aripiprazole Mylan Pharma Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1005 3.8.2016 1.8.2016 Ilaris Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/564 3.8.2016 1.8.2016 Pegasys Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/221 3.8.2016 1.8.2016 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 3.8.2016 1.8.2016 Rasagiline ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/977 3.8.2016 1.8.2016 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 3.8.2016 8.8.2016 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/11/746 10.8.2016 8.8.2016 Desloratadine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/732 10.8.2016 8.8.2016 Levetiracetam Actavis Group Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/11/738 10.8.2016 8.8.2016 Plenadren Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/715 10.8.2016 8.8.2016 Zavesca Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238 10.8.2016 9.8.2016 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/08/507 11.8.2016 9.8.2016 Intanza Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/08/505 11.8.2016 9.8.2016 Kaletra AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/01/172 11.8.2016 9.8.2016 Memantine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/13/836 11.8.2016 12.8.2016 Ibandronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/12/798 17.8.2016 12.8.2016 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/855 17.8.2016 12.8.2016 Myclausen Passauer Pharma GmbH Eiderstedter Weg 3, 14129 Berlin, Deutschland EU/1/10/647 17.8.2016 12.8.2016 Scenesse Clinuvel UK Limited Devonshire House, 60 Goswell Road, London EC1M 7AD, United Kingdom EU/1/14/969 17.8.2016 16.8.2016 Aflunov Seqirus S.r.l. Via Fiorentina, 1, Siena, Italia EU/1/10/658 18.8.2016 16.8.2016 Dasselta Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739 18.8.2016 16.8.2016 Eylea Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/12/797 18.8.2016 16.8.2016 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 18.8.2016 16.8.2016 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 18.8.2016 18.8.2016 Kaletra AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/01/172 22.8.2016 18.8.2016 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 22.8.2016 18.8.2016 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/924 22.8.2016 18.8.2016 Sevelamer carbonate Zentiva Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/952 22.8.2016 18.8.2016 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 22.8.2016 18.8.2016 Truvada Gilead Sciences International Ltd. Cambridge, CB21 6GT, United Kingdom EU/1/04/305 22.8.2016 18.8.2016 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/954 22.8.2016 18.8.2016 Viekirax AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/982 22.8.2016 22.8.2016 Brimica Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/963 24.8.2016 22.8.2016 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/11/733 24.8.2016 22.8.2016 Duaklir Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/964 24.8.2016 22.8.2016 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 24.8.2016 22.8.2016 Nimenrix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/767 24.8.2016 22.8.2016 Tasmar Meda AB Pipers väg 2A, S-170 09 Solna, Sverige EU/1/97/044 24.8.2016 25.8.2016 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 30.8.2016 25.8.2016 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 29.8.2016 25.8.2016 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 30.8.2016 25.8.2016 Renvela Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/521 29.8.2016 25.8.2016 Revestive Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/12/787 29.8.2016 25.8.2016 Tasermity Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/953 29.8.2016 25.8.2016 VPRIV Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 29.8.2016 25.8.2016 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 30.8.2016 25.8.2016 Zurampic Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland EU/1/15/1080 29.8.2016 31.8.2016 Ketoconazole HRA Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/14/965 2.9.2016 31.8.2016 Renagel Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/123 2.9.2016

— 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 12.8.2016 Sedadex dexmedetomidine Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/16/198 Solution for injection QN05CM18 17.8.2016

— 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 9.8.2016 Recocam Cross Vetpharm Group, Ltd Broomhill Road, Tallaght Dublin 24, Ireland EU/2/11/133 11.8.2016 12.8.2016 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 17.8.2016 26.8.2016 Panacur AquaSol Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/135 30.8.2016

— 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 22.8.2016 Velactis Ceva Santé Animale 10 av. de La Ballastière, 33500 Libourne, France EU/2/15/192 24.8.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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