PT Jornal Oficial da União Europeia C 76/1

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de janeiro de 2016 a 31 de janeiro de 2016

[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (1)]

(2016/C 076/01)

— Concessão de uma autorização de introdução no mercado [Artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 11.1.2016 Eptifibatide Accord eptifibatida Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1065 Solução injetável Solução para perfusão B01AC16 13.1.2016 14.1.2016 Benepali Etanercept Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom EU/1/15/1074 Solução injetável L04AB01 18.1.2016 14.1.2016 Briviact brivaracetam UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 Comprimido revestido por película Solução oral Solução para injecção ou perfusão N03AX23 18.1.2016 14.1.2016 Episalvan extrato de casca de bétula Birken AG Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 Gele Pending 18.1.2016 14.1.2016 Lopinavir/Ritonavir Mylan lopinavir/ritonavir Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1067 Comprimido revestido por película J05AR10 18.1.2016 14.1.2016 Oncaspar pegaspargase Baxalta Innovations GmbH Industriestrasse 67, A-1221 Vienna, Österreich EU/1/15/1070 Pó e solvente para solução para injeção ou para perfusão L01XX24 18.1.2016 14.1.2016 Spectrila asparaginase medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/15/1072 Pó para concentrado para solução para perfusão L01XX02 18.1.2016 18.1.2016 Pemetrexedo Accord pemetrexedo Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1071 Pó para concentrado para solução para perfusão L01BA04 20.1.2016 18.1.2016 Pemetrexedo Actavis pemetrexedo Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/15/1063 Concentrado para solução para perfusão L01BA04 21.1.2016

— Alteração de uma autorização de introdução no mercado [Artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 7.1.2016 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 11.1.2016 7.1.2016 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 11.1.2016 7.1.2016 Sildenafil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/584 11.1.2016 7.1.2016 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 11.1.2016 11.1.2016 Cometriq TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/13/890 13.1.2016 11.1.2016 Latuda Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/913 13.1.2016 11.1.2016 Sivextro Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/991 13.1.2016 11.1.2016 Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/11/692 13.1.2016 11.1.2016 Zinforo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/785 13.1.2016 12.1.2016 Atriance Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/403 14.1.2016 12.1.2016 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 14.1.2016 12.1.2016 Gardasil Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 14.1.2016 12.1.2016 Gardasil 9 Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/15/1007 14.1.2016 12.1.2016 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 14.1.2016 14.1.2016 Bronchitol Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom. EU/1/12/760 18.1.2016 14.1.2016 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 18.1.2016 14.1.2016 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 18.1.2016 14.1.2016 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 18.1.2016 14.1.2016 Glivec Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/198 18.1.2016 14.1.2016 Leganto UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 19.1.2016 14.1.2016 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 18.1.2016 14.1.2016 Pravafenix LABORATOIRES SMB SA 26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België EU/1/11/679 18.1.2016 14.1.2016 Rotarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/05/330 18.1.2016 14.1.2016 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 18.1.2016 14.1.2016 Trobalt Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 18.1.2016 14.1.2016 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 18.1.2016 14.1.2016 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 18.1.2016 18.1.2016 Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/674 20.1.2016 18.1.2016 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 20.1.2016 18.1.2016 Xiapex Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/11/671 20.1.2016 22.1.2016 Clopidogrel Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/561 26.1.2016 22.1.2016 Kadcyla Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/885 26.1.2016 22.1.2016 Levitra Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/248 26.1.2016 22.1.2016 Levodopa/Carbidopa/Entacapona Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706 26.1.2016 22.1.2016 Neupro UCB Manufacturing Ireland Ltd Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 26.1.2016 22.1.2016 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 26.1.2016 22.1.2016 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 26.1.2016 22.1.2016 Optaflu Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 26.1.2016 22.1.2016 Topotecan Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/09/536 27.1.2016 22.1.2016 Ulunar Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/917 26.1.2016 22.1.2016 Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/98/077 26.1.2016 22.1.2016 Vivanza Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/249 26.1.2016 25.1.2016 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 27.1.2016 25.1.2016 Cyramza Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/14/957 27.1.2016 25.1.2016 Entacapona Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/708 27.1.2016 25.1.2016 Exviera AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/983 27.1.2016 25.1.2016 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 27.1.2016 25.1.2016 NovoRapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/99/119 27.1.2016 25.1.2016 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 27.1.2016 25.1.2016 SANCUSO ProStrakan Limited Galabank Business Park, Galashiels TD1 1QH, United Kingdom EU/1/12/766 27.1.2016 25.1.2016 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland EU/1/09/595 27.1.2016 25.1.2016 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603 28.1.2016 25.1.2016 Stalevo Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/03/260 27.1.2016 25.1.2016 Tarceva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/05/311 27.1.2016 25.1.2016 Travatan Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/01/199 27.1.2016 25.1.2016 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 27.1.2016 25.1.2016 Viekirax AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/14/982 27.1.2016 28.1.2016 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 1.2.2016 28.1.2016 Clopidogrel Acino Acino AG Am Windfeld 35, 83714 D-Miesbach, Deutschland EU/1/09/532 1.2.2016 28.1.2016 Comtess Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/98/082 1.2.2016 28.1.2016 Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/14/939 1.2.2016 28.1.2016 Defitelio Gentium S.p.A. Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia EU/1/13/878 1.2.2016 28.1.2016 Nonafact Sanquin Plasma Products B.V. Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland EU/1/01/186 1.2.2016 28.1.2016 Relistor PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/08/463 1.2.2016 28.1.2016 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 1.2.2016 28.1.2016 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 1.2.2016 28.1.2016 Ultibro Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/862 1.2.2016 28.1.2016 Voriconazol Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/15/1004 1.2.2016 28.1.2016 Xoterna Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/863 1.2.2016

— Alteração de uma autorização de introdução no mercado [Artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 7.1.2016 Activyl Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/10/118 11.1.2016 7.1.2016 CaniLeish VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France EU/2/11/121 11.1.2016 7.1.2016 Cimalgex Vétoquinol SA Magny-Vernois, F-70200 Lure, France EU/2/10/119 11.1.2016 7.1.2016 Comfortis Eli Lilly and Company Ltd, Elanco Animal Health Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/10/115 11.1.2016 7.1.2016 Melosus CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/10/116 11.1.2016 7.1.2016 Neocolipor Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/98/008 11.1.2016 7.1.2016 Veraflox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/10/107 11.1.2016 7.1.2016 Zulvac 1 + 8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/120 11.1.2016 14.1.2016 Procox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/11/123 18.1.2016 22.1.2016 ERYSENG PARVO Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/14/167 26.1.2016 22.1.2016 Purevax RCPCh FeLV Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/047 26.1.2016

Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:

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

(1) JO L 136 de 30.4.2004, p. 1.