PT Jornal Oficial da União Europeia C 29/1

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de dezembro de 2013 a 31 de dezembro de 2013

[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) ]

2014/C 29/01

— 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 4.12.2013 Fluenz Tetra Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage) MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/13/887 Suspensão para pulverização nasal J07BB03 6.12.2013 4.12.2013 Memantina Accord memantina Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/880 Comprimido revestido por película N06DX01 6.12.2013 18.12.2013 Brintellix vortioxetina H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/13/891 Comprimido revestido por película Solução oral, gotas N06AX26 20.12.2013 20.12.2013 Opsumit macitentano Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/13/893 Comprimido revestido por película C02KX04 27.12.2013





— 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 3.12.2013 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 6.12.2013 3.12.2013 Ácido zoledrónico medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 6.12.2013 3.12.2013 Bondronat Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/012 6.12.2013 3.12.2013 Cubicin Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/05/328 6.12.2013 3.12.2013 Dynastat Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/209 6.12.2013 3.12.2013 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 6.12.2013 3.12.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 6.12.2013 3.12.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 6.12.2013 3.12.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 6.12.2013 3.12.2013 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/672 6.12.2013 4.12.2013 Synagis AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/99/117 6.12.2013 4.12.2013 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222 6.12.2013 9.12.2013 Sildenafil ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/603 11.12.2013 13.12.2013 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/11/733 16.12.2013 13.12.2013 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/06/378 17.12.2013 13.12.2013 Irbesartan + Hidroclorotiazida Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/583 18.12.2013 13.12.2013 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/11/676 17.12.2013 13.12.2013 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292 17.12.2013 13.12.2013 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 17.12.2013 13.12.2013 Temozolomide HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616 17.12.2013 13.12.2013 Tracleer Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/02/220 17.12.2013 17.12.2013 Benlysta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/700 19.12.2013 17.12.2013 Esbriet InterMune UK Limited Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom EU/1/11/667 19.12.2013 17.12.2013 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 19.12.2013 17.12.2013 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 19.12.2013 17.12.2013 Ovitrelle Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/165 20.12.2013 18.12.2013 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229 20.12.2013 18.12.2013 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230 20.12.2013 18.12.2013 Aflunov Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/10/658 20.12.2013 18.12.2013 Aldurazyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/03/253 23.12.2013 18.12.2013 APTIVUS Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/05/315 2.1.2014 18.12.2013 Bonviva Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/03/265 20.12.2013 18.12.2013 Bronchitol Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire SL1 7LW, United Kingdom EU/1/12/760 23.12.2013 18.12.2013 Buccolam ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 19.12.2013 18.12.2013 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 23.12.2013 18.12.2013 Corlentor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/317 23.12.2013 18.12.2013 Dexdor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/718 23.12.2013 18.12.2013 Efient Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/08/503 23.12.2013 18.12.2013 Emend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262 20.12.2013 18.12.2013 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 20.12.2013 18.12.2013 Erbitux Merck KGaA 64271 Darmstadt EU/1/04/281 23.12.2013 18.12.2013 Esmya Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/12/750 23.12.2013 18.12.2013 Extavia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/454 20.12.2013 18.12.2013 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269 23.12.2013 18.12.2013 GILENYA Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/677 23.12.2013 18.12.2013 Herceptin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/145 23.12.2013 18.12.2013 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/11/687 23.12.2013 18.12.2013 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720 20.12.2013 18.12.2013 Kaletra AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/01/172 23.12.2013 18.12.2013 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/741 23.12.2013 18.12.2013 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 23.12.2013 18.12.2013 Luveris Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/00/155 23.12.2013 18.12.2013 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 23.12.2013 18.12.2013 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333 23.12.2013 18.12.2013 Nivestim Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/631 20.12.2013 18.12.2013 Norvir AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom EU/1/96/016 20.12.2013 18.12.2013 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006 23.12.2013 18.12.2013 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 2.1.2014 18.12.2013 Procoralan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/05/316 23.12.2013 18.12.2013 ProQuad Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/05/323 20.12.2013 18.12.2013 Protopic Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/02/201 23.12.2013 18.12.2013 Removab Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland EU/1/09/512 20.12.2013 18.12.2013 Repaglinide Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/530 24.12.2013 18.12.2013 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634 20.12.2013 18.12.2013 Soliris Alexion Europe SAS 25 boulevard de l'Amiral Bruix, F-75016 Paris, France EU/1/07/393 23.12.2013 18.12.2013 Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/98/096 23.12.2013 18.12.2013 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 23.12.2013 18.12.2013 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 23.12.2013 18.12.2013 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 23.12.2013 18.12.2013 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 23.12.2013 18.12.2013 Yondelis Pharma Mar S.A. Polígono Industrial La Mina, Avda de los Reyes 1, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 23.12.2013 18.12.2013 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 23.12.2013 20.12.2013 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 30.12.2013 20.12.2013 Advate Baxter AG Industriestraße 67, A-1221 Wien, Österreich EU/1/03/271 6.1.2014 20.12.2013 Atriance Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/403 2.1.2014 20.12.2013 Caprelsa AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/749 27.12.2013 20.12.2013 Comtan Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081 2.1.2014 20.12.2013 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 24.12.2013 20.12.2013 Iclusig ARIAD Pharma Ltd Brooklands Business Park, Wellington Way, Weybridge, KT13 0TT, United Kingdom EU/1/13/839 27.12.2013 20.12.2013 Ivemend Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/437 2.1.2014 20.12.2013 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 27.12.2013 20.12.2013 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 2.1.2014 20.12.2013 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231 27.12.2013 20.12.2013 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 24.12.2013 20.12.2013 Optisulin Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/133 27.12.2013 20.12.2013 Pioglitazona Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/722 24.12.2013 20.12.2013 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 24.12.2013 20.12.2013 Sabervel Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/12/765 24.12.2013 20.12.2013 Tasigna Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/422 2.1.2014 20.12.2013 Vizarsin Krka, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 24.12.2013 20.12.2013 VPRIV Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/10/646 24.12.2013 20.12.2013 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 24.12.2013





— Concessão de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (2) ): 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 4.12.2013 BROADLINE Fipronil / S-metopreno / Eprinomectina / Praziquantel Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/157 Solução para unção punctiforme QP54AA54 6.12.2013 4.12.2013 Vectra 3D dinotefurano, piriproxifeno, permetrina CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/13/156 Solução para unção punctiforme QP53AC54 6.12.2013





— 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 3.12.2013 Emdocam Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België EU/2/11/128 6.12.2013 3.12.2013 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/13/148 6.12.2013 4.12.2013 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 6.12.2013 9.12.2013 Acticam Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, België EU/2/08/088 11.12.2013 13.12.2013 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/08/091 17.12.2013 13.12.2013 Prac-Tic Novartis Sanidad Animal S.L. Calle de la Marina, 206, E-08013 Barcelona, España EU/2/06/066 17.12.2013 18.12.2013 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/06/070 20.12.2013

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

The European Medicines Agency 7, Westferry Circus, Canary Wharf UK-LONDON E14 4H

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

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