PT Jornal Oficial da União Europeia C 211/1

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de maio de 2015 a 31 de maio de 2015

[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)]

(2015/C 211/01)

— Concessão de uma autorização de introdução no mercado (Artigo 13 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 6.5.2015 Zykadia ceritinib Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 Cápsula L01XE 8.5.2015 27.5.2015 Akynzeo Netupitant/Palonossetrom Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/15/1001 Cápsula A04AA55 29.5.2015 27.5.2015 Jinarc tolvaptano Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/15/1000 Comprimido Pending 29.5.2015 27.5.2015 Synjardy empagliflozina/metformina Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 Comprimido revestido por película A10BD20 29.5.2015 27.5.2015 Voriconazol Hospira Voriconazol Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/15/1004 Pó para solução para perfusão J02AC03 29.5.2015 28.5.2015 Lenvima lenvatinib Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/15/1002 Cápsula L01XE29 1.6.2015

— Alteração de uma autorização de introdução no mercado (Artigo 13 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 5.5.2015 Ácido Zoledrónico Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/772 7.5.2015 5.5.2015 Copalia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/372 7.5.2015 5.5.2015 Copalia HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/575 7.5.2015 5.5.2015 Dafiro Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/371 7.5.2015 5.5.2015 Dafiro HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/574 7.5.2015 5.5.2015 Erivedge Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 8.5.2015 5.5.2015 Exforge Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/370 7.5.2015 5.5.2015 Exforge HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/569 7.5.2015 5.5.2015 Imprida Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/373 7.5.2015 5.5.2015 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 7.5.2015 5.5.2015 Irbesartan + Hidroclorotiazida Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/583 8.5.2015 5.5.2015 Orfadin Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/04/303 8.5.2015 5.5.2015 Sycrest Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/10/640 7.5.2015 5.5.2015 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222 8.5.2015 5.5.2015 Telzir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/282 7.5.2015 5.5.2015 Tyverb Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/440 7.5.2015 5.5.2015 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/13/857 7.5.2015 5.5.2015 Votrient Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/628 7.5.2015 5.5.2015 Zypadhera Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/479 7.5.2015 6.5.2015 Arzerra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/625 8.5.2015 6.5.2015 Celsentri ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/07/418 8.5.2015 6.5.2015 Celvapan Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/08/506 8.5.2015 6.5.2015 Clopidogrel Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 8.5.2015 6.5.2015 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 8.5.2015 6.5.2015 Optaflu Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/07/394 8.5.2015 6.5.2015 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 8.5.2015 6.5.2015 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 8.5.2015 13.5.2015 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543 19.5.2015 13.5.2015 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 19.5.2015 13.5.2015 Granupas Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/896 19.5.2015 13.5.2015 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 19.5.2015 13.5.2015 Leflunomida ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654 19.5.2015 13.5.2015 Luminity Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom EU/1/06/361 19.5.2015 13.5.2015 Memantine Merz Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/12/799 19.5.2015 13.5.2015 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165 19.5.2015 13.5.2015 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/156 19.5.2015 13.5.2015 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 19.5.2015 13.5.2015 Vyndaqel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/11/717 19.5.2015 27.5.2015 Aflunov Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658 29.5.2015 27.5.2015 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/283 29.5.2015 27.5.2015 Brinavess Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom EU/1/10/645 29.5.2015 27.5.2015 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland EU/1/09/555 29.5.2015 27.5.2015 Cometriq TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/13/890 29.5.2015 27.5.2015 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/296 29.5.2015 27.5.2015 Erivedge Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 29.5.2015 27.5.2015 Esmya Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/12/750 29.5.2015 27.5.2015 Foclivia Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/09/577 29.5.2015 27.5.2015 Gardasil Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 29.5.2015 27.5.2015 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 29.5.2015 27.5.2015 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 29.5.2015 27.5.2015 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 29.5.2015 27.5.2015 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278 29.5.2015 27.5.2015 Levetiracetam Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/712 29.5.2015 27.5.2015 Myclausen Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, D-14167 Berlin, Deutschland EU/1/10/647 29.5.2015 27.5.2015 Nexium Control Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/13/860 29.5.2015 27.5.2015 Nivestim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631 29.5.2015 27.5.2015 Prepandrix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/08/453 29.5.2015 27.5.2015 Raloxifene Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/627 29.6.2015 27.5.2015 Relistor TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom EU/1/08/463 29.5.2015 27.5.2015 Resolor Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/09/581 29.5.2015 27.5.2015 Selincro H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/12/815 29.5.2015 27.5.2015 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 29.5.2015 27.5.2015 Sonata Meda AB Pipers väg 2A, S-170 09 Solna, Sverige EU/1/99/102 29.5.2015 27.5.2015 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 29.5.2015 27.5.2015 Targretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/01/178 29.5.2015 27.5.2015 Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/98/096 29.5.2015 27.5.2015 Temozolomide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/10/615 29.5.2015 27.5.2015 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 29.5.2015 27.5.2015 Tolucombi Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 29.5.2015 27.5.2015 Volibris Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/08/451 29.5.2015 27.5.2015 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/297 29.5.2015 27.5.2015 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 29.5.2015 27.5.2015 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/280 29.5.2015 27.5.2015 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 29.5.2015 28.5.2015 Aclasta Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/308 1.6.2015 28.5.2015 alli Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/401 1.6.2015 28.5.2015 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/11/733 1.6.2015 28.5.2015 Invega Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/07/395 1.6.2015 28.5.2015 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 1.6.2015 28.5.2015 Lonquex UAB «Sicor Biotech» Molėtų pl. 5, LT-08409 Vilnius, Lietuva EU/1/13/856 1.6.2015 28.5.2015 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 1.6.2015 28.5.2015 Topotecano Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633 1.6.2015 28.5.2015 Tygacil Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/336 1.6.2015

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

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 5.5.2015 Clopidogrel DURA Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland EU/1/09/560 7.5.2015 6.5.2015 Provenge Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom EU/1/13/867 8.5.2015

— Alteração de uma autorização de introdução no mercado (Artigo 38 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 5.5.2015 Purevax RCP Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/052 7.5.2015 5.5.2015 Vacina MS-H Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom EU/2/11/126 7.5.2015 13.5.2015 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/98/006 19.5.2015 13.5.2015 Rheumocam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/07/078 19.5.2015 27.5.2015 Meloxivet Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/07/077 29.5.2015 27.5.2015 Purevax FeLV Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/00/019 29.5.2015 27.5.2015 Purevax RCPCh Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/04/050 29.5.2015 27.5.2015 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France EU/2/07/072 29.5.2015

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

The European Medicines Agency 30, Churchill Place, Canary Wharf UK — LONDON E14 5EU

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