PT Jornal Oficial da União Europeia C 371/7

Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de outubro de 2012 a 31 de outubro de 2012

[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) ]

2012/C 371/03

— 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 23.10.2012 XALKORI crizotinib Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/1/12/793/001-004 Cápsula L01XE16 26.10.2012 25.10.2012 Adcetris Brentuximab vedotina Takeda Global Research and Development Centre (Europe) Ltd. 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/12/794/001 Pó para concentrado para solução para perfusão L01XC12 30.10.2012 25.10.2012 Glybera Alipogene tiparvovec uniQure biopharma B.V. Meibergdreef 61, 1105 BA Amsterdam, Nederland EU/1/12/791/001 Solução injectável C10AX10 29.10.2012





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

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 25.10.2012 Elelyso Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom — 29.10.2012





— 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 1.10.2012 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/237/001-009 3.10.2012 1.10.2012 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511/001-005 3.10.2012 1.10.2012 Olanzapine Neopharma Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom EU/1/07/426/001-011 3.10.2012 1.10.2012 Tamiflu Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/02/222/001-005 3.10.2012 4.10.2012 Cimzia UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België EU/1/09/544/001-002 8.10.2012 4.10.2012 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389/001-009 8.10.2012 4.10.2012 Soliris Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France EU/1/07/393/001 8.10.2012 4.10.2012 Topotecan Eagle Eagle Laboratories Limited The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM EU/1/11/744/002 8.10.2012 4.10.2012 Vepacel Baxter Innovations GmbH Industriestrasse 67, A – 1221 Vienna, Österreich EU/1/12/752/001-002 8.10.2012 8.10.2012 Biograstim CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland EU/1/08/450/001-010 11.10.2012 8.10.2012 Comtan Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/98/081/001-004 10.10.2012 8.10.2012 DuoTrav Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom EU/1/06/338/001-003 10.10.2012 8.10.2012 Vidaza Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom EU/1/08/488/001 10.10.2012 8.10.2012 Zavesca Actelion Registration Ltd. Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom EU/1/02/238/001 10.10.2012 10.10.2012 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 54, rue La Boétie, 75008 Paris, France EU/1/97/046/001-039 12.10.2012 10.10.2012 Biopoin CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland EU/1/09/565/001-028 12.10.2012 10.10.2012 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/001-008 12.10.2012 10.10.2012 Emend Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/03/262/001-010 15.10.2012 10.10.2012 Karvea Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/97/049/034-039 12.10.2012 10.10.2012 Pylobactell Torbet Laboratories Limited Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom EU/1/98/064/001 12.10.2012 10.10.2012 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/01/171/007-010 12.10.2012 10.10.2012 Synagis AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/99/117/001-002 12.10.2012 15.10.2012 Ceplene Meda AB Box 906, SE 170 09 Solna, Sverige EU/1/08/477/001 17.10.2012 15.10.2012 Clopidogrel Apotex Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/09/568/001-018 17.10.2012 15.10.2012 Olazax Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/597/001-005 16.10.2012 23.10.2012 Alimta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/04/290/001-002 26.10.2012 23.10.2012 Glivec Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198/001-013 26.10.2012 23.10.2012 Helixate NexGen Bayer Schering Pharma AG 13342 Berlin, Deutschland EU/1/00/144/001-005 26.10.2012 23.10.2012 Humira AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/03/256/001-010 26.10.2012 23.10.2012 Kogenate Bayer Bayer Pharma AG 13342 Berlin, Deutschland EU/1/00/143/004-013 26.10.2012 23.10.2012 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497/001-008 26.10.2012 23.10.2012 NULOJIX Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/694/001-002 26.10.2012 23.10.2012 Osseor Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/04/287/001-006 26.10.2012 23.10.2012 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618/001-004 26.10.2012 23.10.2012 Protelos Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/04/288/001-006 26.10.2012 23.10.2012 Telzir ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/04/282/001-002 26.10.2012 23.10.2012 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529/001-005 26.10.2012 23.10.2012 Visudyne Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/00/140/001 26.10.2012 24.10.2012 Adenuric Menarini International Operations France S.A. 1, Avenue de la Gare, L-1611 France, France EU/1/08/447/001-012 26.10.2012 24.10.2012 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300/001-002 26.10.2012 24.10.2012 Baraclude Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/343/001-007 26.10.2012 24.10.2012 Benlysta Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700/001-002 26.10.2012 24.10.2012 Brilique AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/655/001-006 26.10.2012 24.10.2012 ChondroCelect TiGenix NV Romeinse straat 12/2, B-3001 LEUVEN, België EU/1/09/563/001 26.10.2012 24.10.2012 Cialis Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/02/237/007-008 26.10.2012 24.10.2012 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe EU/1/10/651/001-015 26.10.2012 24.10.2012 Daliresp Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/668/001-003 26.10.2012 24.10.2012 Daxas Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/10/636/001-007 26.10.2012 24.10.2012 Dynastat Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/209/005-008 26.10.2012 24.10.2012 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736/001 26.10.2012 24.10.2012 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/99/126/001-022 26.10.2012 24.10.2012 Eviplera Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom EU/1/11/737/001-002 26.10.2012 24.10.2012 Exjade Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/356/001-009 26.10.2012 24.10.2012 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland EU/1/06/340/001-002 26.10.2012 24.10.2012 Humira AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/03/256/001-010 26.10.2012 24.10.2012 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026/001-002 26.10.2012 24.10.2012 Kinzalkomb Bayer Pharma AG Berlin 13342, Deutschland EU/1/02/214/001-015 26.10.2012 24.10.2012 Komboglyze Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/731/001-014 26.10.2012 24.10.2012 Libertek Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/11/666/001-003 26.10.2012 24.10.2012 MicardisPlus Boehringer Ingelheim International GmbH Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland EU/1/02/213/001-023 26.10.2012 24.10.2012 Multaq Sanofi 54, rue La Boétie, 75008 Paris, France EU/1/09/591/001-004 26.10.2012 24.10.2012 Norvir AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/96/016/001 EU/1/96/016/003-008 26.10.2012 24.10.2012 NovoSeven Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/96/006/001-011 26.10.2012 24.10.2012 Onduarp Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/729/001-006 26.10.2012 24.10.2012 Pandemrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 France EU/1/08/452/001 26.10.2012 24.10.2012 Possia AstraZeneca AB Södertälje S 151 85, Sverige EU/1/10/656/001-006 26.10.2012 24.10.2012 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B – 2340 Beerse, België EU/1/06/380/001-006 26.10.2012 24.10.2012 PritorPlus Bayer Pharma AG 13342 Berlin, Deutschland EU/1/02/215/001-021 26.10.2012 24.10.2012 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/99/103/001-009 26.10.2012 24.10.2012 RotaTeq Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France EU/1/06/348/001-002 26.10.2012 24.10.2012 SonoVue Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland EU/1/01/177/002 26.10.2012 24.10.2012 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498/001-008 26.10.2012 24.10.2012 Trajenta Boehringer Ingelheim International GmbH Binger Strasse 173- D – 55216 Ingelheim am Rhein, Deutschland EU/1/11/707/001-011 26.10.2012 24.10.2012 Valdoxan Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/08/499/001-008 26.10.2012 24.10.2012 Vimpat UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, France/Researchdreef, 60, Brussel 1070, België EU/1/08/470/001-013 EU/1/08/470/016-019 29.10.2012 24.10.2012 Votrient Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/10/628/001-004 26.10.2012 24.10.2012 Zometa Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/176/001-009 26.10.2012 25.10.2012 Bridion N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/08/466/001-002 29.10.2012 25.10.2012 Capecitabina Krka KRKA, d.d Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763/001-018 30.10.2012 25.10.2012 Cinryze ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688/001 29.10.2012 25.10.2012 Clopidogrel Teva Pharma Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/561/001-011 29.10.2012 25.10.2012 Copalia Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372/001-039 29.10.2012 25.10.2012 Corlentor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes, Cedex, France EU/1/05/317/001-014 29.10.2012 25.10.2012 Dafiro Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371/001-039 29.10.2012 25.10.2012 Efavirenz Teva Teva Pharma BV Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/742/001-010 30.10.2012 25.10.2012 Eucreas Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425/001-018 29.10.2012 25.10.2012 Exforge HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569/001-060 29.10.2012 25.10.2012 Fasturtec Sanofi-aventis groupe 54, rue La Boétie, 75008 Paris, France EU/1/00/170/001-002 26.10.2012 25.10.2012 Ferriprox Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland EU/1/99/108/001-006 29.10.2012 25.10.2012 Firazyr Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland EU/1/08/461/001-002 29.10.2012 25.10.2012 Glidipion Actavis Group PTC ehf. Reykjavíkurvegi 76 – 78, 220 Hafnarfjörður, Iceland EU/1/12/756/001-027 29.10.2012 25.10.2012 Helicobacter test INFAI INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH Universitätsstrasse 142, D – 44799 Bochum, Deutschland EU/1/97/045/001-005 29.10.2012 25.10.2012 Humalog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010 EU/1/96/007/015-021 EU/1/96/007/023-038 30.10.2012 25.10.2012 Incivo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/720/001-002 29.10.2012 25.10.2012 Instanyl Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/09/531/001-021 29.10.2012 25.10.2012 Irbesartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/576/001-042 30.10.2012 25.10.2012 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436/001-002 30.10.2012 25.10.2012 Jentadueto Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780/029-034 30.10.2012 25.10.2012 Kaletra AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/01/172/001-008 30.10.2012 25.10.2012 Kepivance Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/05/314/001 29.10.2012 25.10.2012 Kineret Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige EU/1/02/203/001-004 30.10.2012 25.10.2012 Liprolog Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/01/195/001-027 29.10.2012 25.10.2012 Olanzapina Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475/001-060 29.10.2012 25.10.2012 Olanzapine Glenmark Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HÁ3 OBU, United Kingdom EU/1/09/587/001-017 29.10.2012 25.10.2012 Olanzapine Glenmark Europe Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HÁ3 OBU, United Kingdom EU/1/09/588/001-012 29.10.2012 25.10.2012 Olazax Disperzi Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika EU/1/09/592/001-005 29.10.2012 25.10.2012 Procoralan Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France EU/1/05/316/001-014 29.10.2012 25.10.2012 Ranexa Menarini International Operations France S.A. 1, Avenue de la Gare, L-1611 France, France EU/1/08/462/001-012 30.10.2012 25.10.2012 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, France EU/1/09/508/001-011 29.10.2012 25.10.2012 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg – Deutschland EU/1/09/605/001-012 29.10.2012 25.10.2012 Temozolomide HEXAL HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616/001-002 EU/1/10/616/005-006 EU/1/10/616/009-010 EU/1/10/616/013-014 EU/1/10/616/017-018 EU/1/10/616/021-022 EU/1/10/616/025-036 30.10.2012 25.10.2012 Temozolomide Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/10/617/001-002 EU/1/10/617/005-006 EU/1/10/617/009-010 EU/1/10/617/013-014 EU/1/10/617/017-018 EU/1/10/617/021-022 EU/1/10/617/025-036 30.10.2012 25.10.2012 Temozolomide SUN Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/11/697/001-024 30.10.2012 25.10.2012 Temozolomide Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/606/001-012 29.10.2012 25.10.2012 Topotecan Teva Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland EU/1/09/552/001-004 29.10.2012 25.10.2012 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386/019-020 29.10.2012 25.10.2012 Tracleer Actelion Registration Ltd Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220/001-006 30.10.2012 25.10.2012 Tredaptive Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/459/001-014 29.10.2012 25.10.2012 Trevaclyn Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/458/001-014 29.10.2012 25.10.2012 Twynsta Boehringer Ingelheim International GmbH Binger Strasse 173 – D – 55216 Ingelheim am Rhein, Deutschland EU/1/10/648/001-028 29.10.2012 25.10.2012 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423/001-003 29.10.2012 29.10.2012 Advagraf Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland EU/1/07/387/009-010 EU/1/07/387/016 EU/1/07/387/026 1.11.2012 29.10.2012 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185/001-022 EU/1/01/185/031-111 1.11.2012 29.10.2012 Atryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355/001-003 6.11.2012 29.10.2012 Biograstim CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland EU/1/08/450/001-010 5.11.2012 29.10.2012 Bronchitol Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom EU/1/12/760/001-002 1.11.2012 29.10.2012 Byetta Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland EU/1/06/362/001-004 1.11.2012 29.10.2012 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011/001-004 5.11.2012 29.10.2012 CANCIDAS Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/01/196/001 EU/1/01/196/003 6.11.2012 29.10.2012 Dificlir Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland EU/1/11/733/001-004 31.10.2012 29.10.2012 Docetaxel Mylan Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France EU/1/11/748/001-006 6.11.2012 29.10.2012 Esbriet InterMune UK Ltd Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom EU/1/11/667/001-004 1.11.2012 29.10.2012 Exforge Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370/001-039 31.10.2012 29.10.2012 Firdapse BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom EU/1/09/601/001 1.11.2012 29.10.2012 Foscan Biolitec pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland EU/1/01/197/001-002 31.10.2012 29.10.2012 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom EU/1/12/776/001-023 31.10.2012 29.10.2012 Ibandronic Acid Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/642/001-004 31.10.2012 29.10.2012 Icandra Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484/001-018 1.11.2012 29.10.2012 Imprida Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373/001-039 31.10.2012 29.10.2012 INOmax INO Therapeutics AB SE-181 81 Lidingö, Sverige EU/1/01/194/001-004 1.11.2012 29.10.2012 Irbesartan + Hidroclorotiazida Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/583/001-075 1.11.2012 29.10.2012 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550/001-012 31.10.2012 29.10.2012 Leflunomida Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/675/001-010 6.11.2012 29.10.2012 Levetiracetam Actavis Group Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland EU/1/11/738/001-003 1.11.2012 29.10.2012 Lucentis Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374/001 1.11.2012 29.10.2012 Myclausen Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland EU/1/10/647/001-004 31.10.2012 29.10.2012 Myocet Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France EU/1/00/141/001-002 5.11.2012 29.10.2012 Nimvastid KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525/001-050 5.11.2012 29.10.2012 Pelzont Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/460/001-014 31.10.2012 29.10.2012 Pixuvri CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom EU/1/12/764/001 6.11.2012 29.10.2012 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 54, rue La Boétie, 75008 Paris, France EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b EU/1/98/069/012 2.11.2012 29.10.2012 Plenadren ViroPharma SPRL Rue Montoyer 47, 1000 Bruxelles/Brussel, France/België EU/1/11/715/001-002 6.11.2012 29.10.2012 Pravafenix LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Bruxelles, France/26-28 Herdersliedstraat, 1080 Brussel, België EU/1/11/679/007 6.11.2012 29.10.2012 Pumarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 France EU/1/10/664/001 6.11.2012 29.10.2012 Raloxifene Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/10/627/001-003 6.11.2012 29.10.2012 Ranexa Menarini International Operations France S.A. 1, Avenue de la Gare, L-1611 France, France EU/1/08/462/001-012 2.11.2012 29.10.2012 Rapiscan Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, UK EU/1/10/643/001 6.11.2012 29.10.2012 Repaglinide Krka KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/579/001-018 5.11.2012 29.10.2012 Repaglinide Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/530/001-015 6.11.2012 29.10.2012 Repso Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/674/001-010 1.11.2012 29.10.2012 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634/001-011 1.11.2012 29.10.2012 Rienso Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom EU/1/12/774/001-004 31.10.2012 29.10.2012 Sabervel Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/12/765/001-009 31.10.2012 29.10.2012 Samsca Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom EU/1/09/539/001-004 31.10.2012 29.10.2012 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B – 2340 Beerse, België EU/1/08/494/001-002 5.11.2012 29.10.2012 Sycrest N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640/001-006 6.11.2012 29.10.2012 Tasmar Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige EU/1/97/044/001-009 1.11.2012 29.10.2012 Telmisartan Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland EU/1/10/639/001-030 31.10.2012 29.10.2012 Telmisartan Teva Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/09/610/001-062 31.10.2012 29.10.2012 Telmisartan Teva Pharma Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland EU/1/11/719/001-062 31.10.2012 29.10.2012 Teysuno Nordic Group BV Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/11/669/001-005 6.11.2012 29.10.2012 Topotecano Hospira Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom EU/1/10/633/001-002 31.10.2012 29.10.2012 Vfend Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/1/02/212/001-027 1.11.2012 29.10.2012 Xarelto Bayer Pharma AG 13342 Berlin, Deutschland EU/1/08/472/011-021 31.10.2012 29.10.2012 Zalasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415/001-056 6.11.2012 29.10.2012 Zomarist Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483/001-018 1.11.2012 31.10.2012 Adjupanrix GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89, 1330 Rixensart, France EU/1/09/578/001 6.11.2012 31.10.2012 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main – Deutschland EU/1/02/218/001-003 EU/1/02/218/005-030 6.11.2012 31.10.2012 Copalia HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575/001-060 6.11.2012 31.10.2012 Dafiro HCT Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574/001-060 6.11.2012 31.10.2012 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France EU/1/07/384/003-005 6.11.2012 31.10.2012 Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/02/219/001-003 EU/1/02/219/005-049 6.11.2012 31.10.2012 Ifirmasta KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480/001-024 6.11.2012 31.10.2012 Kaletra AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom EU/1/01/172/001-008 6.11.2012 31.10.2012 Kiovig Baxter AG Industriestraße 67, A – 1221 Wien, Österreich EU/1/05/329/001-006 6.11.2012 31.10.2012 Levetiracetam Accord Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom EU/1/11/712/001-040 6.11.2012 31.10.2012 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland EU/1/11/713/001-040 6.11.2012 31.10.2012 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444/001-012 7.11.2012 31.10.2012 Repaglinida Accord Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom EU/1/11/743/001-015 6.11.2012 31.10.2012 Rivastigmine Sandoz Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland EU/1/09/599/001-018 6.11.2012 31.10.2012 Siklos ADDMEDICA 101, rue Saint Lazare, Paris 75009, France EU/1/07/397/001-004 6.11.2012 31.10.2012 Tevagrastim Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/445/001-014 6.11.2012 31.10.2012 Tolura KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/10/632/001-021 6.11.2012 31.10.2012 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom EU/1/11/710/001-007 6.11.2012





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

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 4.10.2012 Daliresp Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland — 8.10.2012 4.10.2012 Daxas Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland — 8.10.2012





— 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 24.10.2012 Rilonacept Regeneron Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom EU/1/09/582/001 26.10.2012





— 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 10.10.2012 Acticam Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe EU/2/08/088/004 12.10.2012 15.10.2012 Oxyglobin OPK Biotech Netherlands BV Teleportboulevard 140, 1043EJ Amsterdam, Nederland EU/2/99/015/001-004 16.10.2012 23.10.2012 ProteqFlu Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/03/037/005 26.10.2012 24.10.2012 Pirsue Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/00/027/001-003 26.10.2012 25.10.2012 Dexdomitor Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi EU/2/02/033/001-004 30.10.2012 25.10.2012 Posatex Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/081/001-003 29.10.2012 25.10.2012 Stronghold Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom EU/2/99/014/001-012 29.10.2012 29.10.2012 Improvac Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/2/09/095/001-006 1.11.2012 29.10.2012 Loxicom Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090/001-028 31.10.2012 29.10.2012 Meloxidyl CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/06/070/009 31.10.2012 29.10.2012 Previcox Merial 29 Avenue Tony Garnier, 69007 Lyon, France EU/2/04/045/001-007 6.11.2012 29.10.2012 Procox Bayer Animal Health GmbH 51368 Leverkusen, Deutschland EU/2/11/123/001-002 2.11.2012 29.10.2012 RevitaCAM Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM EU/2/12/138/001-003 31.10.2012 29.10.2012 Suvaxyn PCV Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/09/099/001-006 1.11.2012 31.10.2012 PRILACTONE CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France EU/2/07/074/001-009 6.11.2012





— Levantamento de uma suspensão de autorização de introdução no mercado (Artigo 45 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 10.10.2012 Suvaxyn PCV Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom EU/2/09/099/001-006 12.10.2012

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.