FrancophonIA/ELRC3.0 huggingface dataset:
English: MODALIM TABLETS 100mg 100mg tablets
Portuguese: MODALIM TABLETS 100mg 100mg
English: Floridsdorfer Hauptstraße 1 A-1210 Wien
Portuguese: Pfizer Corporation Austria GmbH Floridsdorfer Hauptstraße 1 A-1210 Wien
English: CY - Cyprus REMEDICA LTD Aharnon street P.O.Box 51706
Portuguese: REMEDICA LTD Aharnon street P.O.Box 51706 3508 Lemesos Cyprus
English: Lopid 600 mg film-coated tablets film-coated tablets oral use
Portuguese: Lopid 600 mg Film Coated Tablets
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124, Cluj-Napoca România
Portuguese: TERAPIA S.A. Str. Fabricii Nr. 124, Cluj-Napoca România
English: LIPIDIL MICRONISED HARD CAPSULES 267mg capsules
Portuguese: LIPIDIL MICRONISED HARD CÁPSULAS 267mg
English: ES - Spain SOLVAY PHARMA S.A. Avda.
Portuguese: SOLVAY PHARMA S.A. Avda.
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
Portuguese: TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
English: SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1C
Portuguese: SANOFI-AVENTIS BELGIUM N.V.
English: ET - Estonia Pharmaswiss Eesti OÜ Tammsaare tee 47
Portuguese: Pharmaswiss Eesti OÜ Tammsaare tee 47 11316 Tallinn ESTONIA
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca Romania
Portuguese: TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca Romania
English: IT - Italy C.T.
Portuguese: IT - Itália
English: FENOGAL 200MG CAPSULES
Portuguese: FENOGAL 200MG CÁPSULAS
English: IT - Italy Pfizer Italia Srl Via Isonzo, 71
Portuguese: Pfizer Italia Srl Via Isonzo, 71 04100 - LATINA Italy
English: FENOFIBRATE RATIOPHARM 145 mg, comprimé tablet
Portuguese: FENOFIBRATE RATIOPHARM 145 mg, comprimé
English: IT - Italy Teva Italia Srl Via Messina, 38
Portuguese: Teva Italia Srl Via Messina, 38 20154 MILANO Italy
English: 00-308 Warsaw Poland
Portuguese: 8 Kruczkowskiego st. 00-308 Warsaw Poland
English: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée
Portuguese: 400 mg, comprimé enrobé à libération prolongée
English: IT - Italy Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene
Portuguese: Via Fratelli Cervi, 8 - Valle Salimbene
English: 33127 Saint Jean d'Illac France
Portuguese: GALENIX DEVELOPPEMENT Les Palanques 33127 Saint Jean d'Illac FRANCE
English: 33127 Saint Jean d'Illac FRANCE
Portuguese: GALENIX DEVELOPPEMENT Les Palanques 33127 Saint Jean d'Illac France
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Portuguese: ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Greece
English: PFIZER LIMITED.
Portuguese: UK - Reino Unido PFIZER LIMITED.
English: PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Portuguese: PL - Polónia ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
English: Reykjavikurvegur 76-78, 220, Hafnarfjordur
Portuguese: Reykjavikurvegur 76-78, 220, Hafnarfjordur Iceland
English: FENOFIBRATE MICRO 267MG CAPSULES
Portuguese: FENOFIBRATE MICRO 267MG CÁPSULAS
English: Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
Portuguese: Eastbourne, E Sussex BN22 9AG United Kingdom
English: 68-88, rue Louis Ampère ZI des Chanoux
Portuguese: Laboratoires LEURQUIN MEDIOLANUM 68-88, rue Louis Ampère ZI des Chanoux 93330 Neuilly-sur-Marne FRANCE
English: 160,0 mg film-coated tablet
Portuguese: 160,0 mg Comprimidos revestidos por película
English: EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
Portuguese: PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Greece
English: FENOFIBRATE EXPANPHARM 67 mg, comprimé tablet
Portuguese: FENOFIBRATE EXPANPHARM 67 mg, comprimé
English: FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
Portuguese: 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
English: FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Portuguese: 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: FENOFIBRATE EXPANPHARM 200 mg, comprimé tablet
Portuguese: FENOFIBRATE EXPANPHARM 200 mg, comprimé
English: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
Portuguese: FENOFIBRATE RATIOPHARM 160 mg, comprimé
English: LIPIPHARM 145 mg, comprimé tablet
Portuguese: LIPIPHARM 145 mg, comprimé
English: BEZAFIBRAT ARENA 200 mg 200 mg tablets
Portuguese: BEZAFIBRAT ARENA 200 mg 200 mg
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Portuguese: Lipcor 200 mg - Kapseln 200 mg
English: LIPANOR® 100 mg capsules
Portuguese: Lipanor 100 mg CAPSULES 100 mg Cápsulas
English: coated tablets
Portuguese: Comprimidos revestidos
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Portuguese: Lipsin 100 mg - Kapseln 100 mg
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Portuguese: FENOFIBRATE QUALIMED 145 mg, comprimé
English: CENCARAN 140 mg, gélule 140 mg
Portuguese: CENCARAN 140 mg, gélule
English: 100,00 mg capsule
Portuguese: 100,00 mg Cápsulas
English: PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
Portuguese: Laboratoires Fournier S.A. Bd Clemenceau 28
English: FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
Portuguese: LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette France
English: FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
Portuguese: 49, av. Pompidou 92300 Levallois-Perret France
English: AT - Austria Arcana Arzneimittel GmbH Hütteldorfer Straße 299
Portuguese: Arcana Arzneimittel GmbH Hütteldorfer Straße 299 A-1140 Wien
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Portuguese: FENOFIBRATE ALTER 160 mg, comprimé
English: FR - France TEVA SANTE Le Palatin 1
Portuguese: Le Palatin 1
English: FENOFIBRATE TEVA 160 mg, comprimé tablet
Portuguese: FENOFIBRATE TEVA 160 mg, comprimé
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Portuguese: FENOFIBRATE SANDOZ 145 mg, comprimé
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Portuguese: FENOGAL 267 MG LIDOSE 267 mg
English: 145 MG/TAB Film-coated tablet
Portuguese: 145 MG/TAB Comprimidos revestidos por película
English: Via dei Pestagalli, 7
Portuguese: Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7
English: 26-28 rue de la Pastorale B-1080, Brussels
Portuguese: 26-28 rue de la Pastorale B-1080, Brussels Belgium
English: BEZAFIBRAT SLAVIA 200 mg tablets
Portuguese: BEZAFIBRAT SLAVIA 200 mg
English: PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Portuguese: Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Portuguese: FENOFIBRATE CRISTERS 160 mg, comprimé
English: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Portuguese: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Portuguese: MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: FENOFIBRAT TERAPIA 200 mg capsules
Portuguese: FENOFIBRAT TERAPIA 200 mg
English: 900 MG/TAB Film coated tablet
Portuguese: 900 MG/TAB Comprimidos revestidos por película
English: 300,00 mg capsule
Portuguese: 300,00 mg Cápsulas
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Portuguese: FENOFIBRATE WINTHROP 145 mg, comprimé
English: Genus Pharmaceuticals Limited Park View House 65 London Road NEWBURY, BERKS RG14 1JN United Kingdom
Portuguese: NEWBURY, BERKS RG14 1JN United Kingdom
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm fenofibrato com Autorização de Introdução no Mercado na União Europeia
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Portuguese: FENOFIBRATE ACTAVIS 160 mg, comprimé
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Portuguese: MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm ciprofibrato e com Autorização de Introdução no Mercado na União Europeia
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Portuguese: FENOFIBRATE BIOGARAN 145 mg, comprimé
English: FENOFIBRAAT JUBILANT 200 MG CAPSULES
Portuguese: FENOFIBRAAT JUBILANT 200 MG CÁPSULAS
English: LIPANTHYL SUPRA 160 MG 160 mg
Portuguese: LIPANTHYL SUPRA 160 MG
English: LIPANTHYL SUPRA 160 mg 160 mg
Portuguese: LIPANTHYL SUPRA 160 mg
English: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
Portuguese: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Portuguese: FENOFIBRATE MYLAN 145 mg, comprimé
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Portuguese: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Portuguese: FENOFIBRATE BIOGARAN 160 mg, comprimé
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Portuguese: UK - Reino Unido Actavis Group Ptc Ehf, Reykjavikurvegi 76-78
English: LIPOFOR CAPSULES 600mg 600mg capsules
Portuguese: LIPOFOR CÁPSULAS 600mg 600mg
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Portuguese: FENOFIBRATE RANBAXY 160 mg, comprimé
English: Sanofi-Synthélabo SA Twin Squares, Navona Building B- 1831 Diegem
Portuguese: LU - Luxembourgo Sanofi-Synthélabo SA Twin Squares,
English: LIPIDIL MICRONISED HARD CAPSULES 200mg capsules
Portuguese: LIPIDIL MICRONISED HARD CÁPSULAS 200mg
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Portuguese: FENOFIBRATE ARROW 160 mg, comprimé
English: Lipanthyl Supra 215 mg 215 mg film-coated tablets oral
Portuguese: LIPANTHYL S 215 MG 215 MG Comprimidos revestidos por película
English: Modified-release tablet
Portuguese: Comprimidos de libertação modificado
English: Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm Gemfibrozil e com Autorização de Introdução no Mercado na União Europeia
English: FENOFIBRATE 267MG CAPSULES
Portuguese: FENOFIBRATE 267MG CÁPSULAS
English: Prolonged release tablet
Portuguese: Comprimidos de libertação prolongada
English: Box 313, 3740 AH Baarn The Netherlands
Portuguese: 3740 AH Baarn
English: IT - Italy Doc Generici Srl Via Manuzio, 7
Portuguese: Doc Generici Srl Via Manuzio, 7 20124 MILANO Italy
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Portuguese: FENOFIBRATE ALMUS 160 mg, comprimé
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Portuguese: Biogaran15 bd Charles de Gaulle 92700 Colombes France
English: 160 MG/CAP HARD CAPSULES ORAL
Portuguese: 160 MG/CAP Cápsulas
English: Solvay Pharma S.A.
Portuguese: SOLVAY PHARMA S.A.Avda.
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Portuguese: FENOFIBRATE SANDOZ 160 mg, comprimé
English: PTPortugal
Portuguese: Petersfield
English: FENOFIBRATE WYVERN MEDICAL 200 mg, gélule
Portuguese: FENOFIBRATE WYVERN MEDICAL 200 mg, gélule capsule
English: FENOFIBRATE ZYDUS 160 mg, comprimé tablet
Portuguese: FENOFIBRATE ZYDUS 160 mg, comprimé
English: 1080 Brussels
Portuguese: B- 1020 Bruxelles
English: FENOFIBRATE 67MG CAPSULES
Portuguese: FENOFIBRATE 67MG CÁPSULAS
English: 600 MG/TAB Film coated tablet
Portuguese: 600 MG/TAB Comprimidos revestidos por película
English: Gemfibrozil Sandoz filmcoated tablet
Portuguese: Gemfibrozil Sandoz
English: 100 MG/CAP HARD CAPSULES ORAL
Portuguese: 100 MG/CAP Cápsulas
English: 200 MG/CAP HARD CAPSULES ORAL
Portuguese: 200 MG/CAP Cápsulas
English: IPOLIPID CAPSULES 600mg 600mg capsules
Portuguese: IPOLIPID CÁPSULAS 600mg 600mg
English: FENOFIBRATE EG 145 mg, comprimé tablet
Portuguese: FENOFIBRATE EG 145 mg, comprimé
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Portuguese: DE - Alemanha ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: ES - Spain SOLVAY PHARMA, S.A.Avda.
Portuguese: SOLVAY PHARMA, S.A.Avda.
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Portuguese: Supra 215mg Comprimidos revestidos por películas
English: Lopid 300 mg capsules hard capsules
Portuguese: Lopid 300 mg CAPSULES 300 mg Cápsulas
English: Centrafarm Services B.V. Postbus 289
Portuguese: Centrafarm Services B.V.
English: FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
Portuguese: FENOFIBRATE EG 160 mg, comprimé pelliculé
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Portuguese: FENOSUP LIDOSE 160 MG 160 mg
English: Archimedes Pharma Uk Limited Bishops Weald House Albion Way, Horsham, West Sussex RH12 1AH United Kingdom
Portuguese: UK - Reino Unido Archimedes Pharma Uk Limited Bishops Weald House
English: ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE DEVON EX32 8NS United Kingdom
Portuguese: UK - Reino Unido ACTAVIS UK LIMITED WHIDDON VALLEY
English: filmcoated tablets
Portuguese: Comprimidos revestidos por películas
English: LIPANTIL NANO 145 mg 145 mg film-coated tablets oral use
Portuguese: LIPANTHYL NT 145 MG 145 MG Comprimidos revestidos por película
English: AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
Portuguese: LU - Luxembourgo Actavis Group PLC Reykjavikurvegur 76-78
English: LIPILFEN 160 mg, comprimé tablet
Portuguese: LIPILFEN 160 mg, comprimé
English: FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Portuguese: Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
English: LIPANTIL MICRO 200
Portuguese: LIPANTIL MICRO 200 200mg
English: FENOFIBRATE 200MG CAPSULES
Portuguese: FENOFIBRATE 200MG CÁPSULAS
English: 100 95 Grugliasco Italy
Portuguese: Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Italy
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
Portuguese: DE - Alemanha ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
English: FENOX 300 mg, gélule
Portuguese: FENOX 300 mg, gélule 300 mg
English: RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079
Portuguese: Ratiopharm GmbH Graf-Arco Strasse 3 D-89079 ULMGermany
English: AT - Austria G.L.
Portuguese: AT - Áustria
English: FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Portuguese: Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
English: CY - Cyprus Varnavas Hadjipanayis Ltd, 7 Androcleous street
Portuguese: Varnavas Hadjipanayis Ltd, 7 Androcleous street P.O.Box 21229
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Portuguese: FENOFIBRATE WINTHROP 160 mg, comprimé
English: LIPANOR 100 mg, gélule 100 mg
Portuguese: LIPANOR 100 mg, gélule 100 mg Cápsulas
English: LIPOFIB 67 mg capsules
Portuguese: Lipantil Micro 67 mg Cápsulas
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Portuguese: Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Portuguese: Supra 145mg Comprimidos revestidos por películas
English: LIPOFOR CAPSULES 300mg 300mg capsules
Portuguese: LIPOFOR CÁPSULAS 300mg 300mg
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Portuguese: Supra 160mg Comprimidos revestidos por películas
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Portuguese: QUALIMED 117, allée des Parcs 69800 Saint-Priest France
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Portuguese: Mylan SAS 117, allée des Parcs 69800 Saint Priest France
English: LIPOFIB 200 mg capsules
Portuguese: Lipantil Micro 200 mg Cápsulas
English: SECALIP 67 mg, gélule
Portuguese: SECALIP 67 mg, gélule 67 mg
English: LIPOFIB 267 mg capsules
Portuguese: Lipantil Micro 267 mg Cápsulas
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Portuguese: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Portuguese: 15, boulevard Charles de Gaulle 92700 Colombes France
English: FENOX 100 mg, gélule
Portuguese: FENOX 100 mg, gélule 100 mg
English: Riga, LV-1011
Portuguese: HERTS EN6 1TL
English: IPOLIPID CAPSULES 300mg 300mg capsules
Portuguese: IPOLIPID CÁPSULAS 300mg 300mg
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Portuguese: RO - Roménia sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
English: LIPOFIB 160 mg capsules
Portuguese: LIPOFIB 160 mg
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
Portuguese: SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
English: DKDenmark
Portuguese: DK - Denmark
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Portuguese: GEMFIBROZILO FERMON 900 mg
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Portuguese: FENOFIBRATO RANBAXY 160mg
English: Attiki
Portuguese: Actavis
English: LV - Latvia Laboratoires Fournier S.A. Boulevard Clemenceau 28
Portuguese: SK - Eslováquia Laboratoires FOURNIER S.A. 28Bd Clemenceau
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Portuguese: SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
Portuguese: SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
English: Lipanthyl 67 Micronised 67mg capsule, hard
Portuguese: Lipanthyl 67 Micronised 67mg
English: Prolonged-released tablet
Portuguese: Comprimidos de libertação retardada
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Portuguese: Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Portuguese: GEMFIBROZILO FERMON 600 mg
English: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Portuguese: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS- 220 Hafnarfjördur Iceland
English: Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
Portuguese: Medicamentos que contêm Bezafibrato e com Autorização de Introdução no Mercado na União Europeia
English: The European Commission issued a decision on 11 September 2012.
Portuguese: A decisão foi emitida pela Comissão Europeia em 11 de setembro de 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Portuguese: A empresa pretendia que a autorização fosse reconhecida em França e no Reino Unido (os “Estados-Membros envolvidos”).
English: EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
Portuguese: 11 de setembro de 2012 EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Portuguese: Além disso, os dados disponíveis relativos à segurança e eficácia do medicamento não eram suficientes para compensar a falta de bioequivalência.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Portuguese: O Mifepristone Linepharma já recebeu autorização na sequência de um procedimento descentralizado na Dinamarca, Finlândia, Islândia, Noruega e Suécia.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Portuguese: Isso significa que é similar a um “medicamento de referência” chamado Mifegyne que contém a mesma substância ativa.
English: On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mifepristone Linepharma.
Portuguese: Em 21 de junho de 2012, a Agência Europeia de Medicamentos terminou um procedimento de arbitragem na sequência de uma divergência entre Estados-Membros da União Europeia (UE) relativa à autorização do medicamento Mifepristone Linepharma.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Portuguese: Além disso, o Comité recomendou a realização de um estudo observacional prospetivo destinado a monitorizar a forma como o Mifepristone Linepharma é prescrito.
English: However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Portuguese: No entanto, os Estados-Membros não chegaram a acordo e, em 23 de fevereiro de 2012, a agência reguladora dos medicamentos da França remeteu a questão para o CHMP para um procedimento de arbitragem.
English: Linepharma France submitted an application for Mifepristone Linepharma for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 December 2010.
Portuguese: A Linepharma France submeteu um pedido relativo ao Mifepristone Linepharma para um procedimento de reconhecimento mútuo com base na autorização inicial concedida pela Suécia em 3 de dezembro de 2010.
English: It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.
Portuguese: Contém a substância ativa mifepristona, cujo mecanismo de ação consiste em bloquear os efeitos da hormona progesterona, a qual desempenha um papel importante na manutenção da gravidez.
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Portuguese: O CHMP concluiu ainda que a informação do medicamento deve incluir uma afirmação no sentido de não serem administradas doses superiores a 200 mg.
English: However, the difference was not considered to be of concern as the safety and effectiveness of mifepristone at much higher doses of up to 600 mg is well established and has been confirmed by the supportive studies with Mifepristone Linepharma.
Portuguese: Contudo, a diferença não foi considerada preocupante porque a segurança e a eficácia da mifepristona em doses substancialmente mais altas até 600 mg estão devidamente estabelecidas e foram confirmadas pelos estudos de suporte com o Mifepristone Linepharma.
English: Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Portuguese: O Mifepristone Linepharma é administrado como uma dose única de 200 mg, seguida, 36 a 48 horas depois, por uma dose de um outro medicamento chamado gemeprost.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Portuguese: O Mifepristone Linepharma é um medicamento utilizado para a interrupção da gravidez.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mifepristone Linepharma outweigh its risks, and recommended that the marketing authorisation granted in Sweden be recognised in other Member States of the EU.
Portuguese: O Comité dos Medicamentos para Uso Humano (CHMP) da Agência concluiu que os benefícios do Mifepristone Linepharma são superiores aos seus riscos e recomendou que a Autorização de Introdução no Mercado concedida na Suécia seja reconhecida noutros Estados-Membros da UE.
English: Why was Mifepristone Linepharma reviewed?
Portuguese: Porque foi revisto o Mifepristone Linepharma?
English: Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States.
Portuguese: Por conseguinte, com base na avaliação dos dados atualmente disponíveis e na discussão científica em sede do Comité, o CHMP concluiu que os benefícios do Mifepristone Linepharma são superiores aos seus riscos e recomendou a concessão de uma Autorização de Introdução no Mercado para o Mifepristone Linepharma nos Estados-Membros envolvidos.