FrancophonIA/ELRC3.0 huggingface dataset:
English: LIPANTHYL 267 M capsule 267 mg capsules
Estonian: LIPANTHYL 267 M capsule 267 mg kapslid
English: FENOFIBRAT TERAPIA 200 mg capsules
Estonian: FENOFIBRAT TERAPIA 200 mg kapslid
English: PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Estonian: PL - Poola ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Estonian: FENOFIBRATE QUALIMED 145 mg, comprimé tablett
English: Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
Estonian: Bezafibraati sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
English: D-64295 Darmstadt Germany durafenat retard
Estonian: D-64295 Darmstadt Saksamaa durafenat retard toimeainet prolongeeritult vabastav kõvakapsel
English: CY - Cyprus REMEDICA LTD Aharnon street P.O.Box 51706
Estonian: REMEDICA LTD Aharnon street P.O.Box 51706 3508 Lemesos Küpros
English: EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
Estonian: PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Kreeka
English: LIPOFOR CAPSULES 600mg 600mg capsules
Estonian: LIPOFOR CAPSULES 600mg 600mg kapslid
English: Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Iceland
Estonian: Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Island
English: FENOFIBRATE EG 145 mg, comprimé tablet
Estonian: FENOFIBRATE EG 145 mg, comprimé tablett
English: LIPOFIB 200 mg capsules
Estonian: LIPOFIB 200 mg kapslid
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Estonian: ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Kreeka
English: Lipantil Micro 200 mg capsules, hard hard capsules
Estonian: Lipantil Micro 200 mg capsules, hard kõvakapslid
English: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
Estonian: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablett
English: FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
Estonian: LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette PRANTSUSMAA
English: Lipanthyl 200 mg hard capsules
Estonian: Lipanthyl 200 mg hard capsules kõvakapslid
English: Apteor modified released tablet
Estonian: toimeainet modifitseeritult vabastavad tabletid
English: FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
Estonian: 49, av. Pompidou 92300 Levallois-Perret Prantsusmaa
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Estonian: FENOFIBRATE ALTER 160 mg, comprimé tablett
English: LIPOFIB 267 mg capsules
Estonian: LIPOFIB 267 mg kapslid
English: Supralip 160 mg modified released tablet
Estonian: Supralip 160 mg toimeainet modifitseeritult vabastav tablett
English: Grofibrat capsules
Estonian: Grofibrat kapslid
English: IPOLIPID CAPSULES 600mg 600mg capsules
Estonian: IPOLIPID CAPSULES 600mg 600mg kapslid
English: LIPOFIB 67 mg capsules
Estonian: LIPOFIB 67 mg kapslid
English: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
Estonian: S.A. 26-28 rue de la Pastsuukaudnee B-1080 Bruxelles
English: CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
Estonian: CY - Küpros Varnavas Hadjipanayis Ltd 7 Androcleous street
English: ES - Spain ACTAVIS SPAIN S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid Spain
Estonian: 46 - Bussines Centre Regus Office 525 Madrid
English: Via dei Pestagalli, 7
Estonian: Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Estonian: FENOFIBRATE CRISTERS 160 mg, comprimé tablett
English: FR - France TEVA SANTE Le Palatin 1
Estonian: Le Palatin 1
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Estonian: FENOFIBRATE SANDOZ 145 mg, comprimé tablett
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Estonian: FENOFIBRATE WINTHROP 145 mg, comprimé tablett
English: Lipantil Micro 267 mg capsules, hard hard capsules
Estonian: Lipantil Micro 267 mg capsules, hard kõvakapslid
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Estonian: FENOFIBRATE ACTAVIS 160 mg, comprimé tablett
English: Fenofibrat STADA 250 mg Hartkapseln, retardiert
Estonian: Fenofibrat STADA 250 mg Hartkapseln, retardiert toimeainet prolongeeritult vabastav kapsel
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Estonian: Lipantil Supra 215mg filmcoated tablets õhukese polümeerikattega tabletid
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Estonian: CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Estonian: CY - Küpros MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Estonian: Lipantil Supra 145mg filmcoated tablets õhukese polümeerikattega tabletid
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Estonian: FENOFIBRATE RANBAXY 160 mg, comprimé tablett
English: FENOFIBRATO RANBAXY 200mg capsules
Estonian: FENOFIBRATO RANBAXY 200mg kapslid
English: PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Estonian: Sanofi-Aventis Prantsusmaa boulevard Romain Rolland 1-13, F-75014 Paris,
English: 26-28 rue de la Pastorale B-1080, Brussels
Estonian: 26-28 rue de la Pastsuukaudnee B-1080, Brussels Belgia
English: Lipantil Micro 67 mg capsules, hard hard capsules
Estonian: Lipantil Micro 67 mg capsules, hard kõvakapslid
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Estonian: Lipantil Supra 160mg filmcoated tablets õhukese polümeerikattega tabletid
English: Fenolip retard 250 mgKapseln prolonged release capsule, hard
Estonian: Fenolip retard 250 mgKapseln toimeainet prolongeeritult vabastav kõvakapsel
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Estonian: FENOGAL 267 MG LIDOSE 267 mg
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Estonian: FENOFIBRATE BIOGARAN 145 mg, comprimé tablett
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Estonian: CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Estonian: FENOFIBRATE SANDOZ 160 mg, comprimé tablett
English: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Estonian: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Island
English: tablets
Estonian: TABLETID
English: LIPANTHYL SUPRA 160 mg 160 mg modified-release filmcoated tablets
Estonian: LIPANTHYL SUPRA 160 mg 160 mg toimeainet modifitseeritult vabastavad õhukese polümeerikattega tabletid
English: Fenofibrat-ratiopharm 250 mg Retardkapseln
Estonian: Fenofibrat-ratiopharm 250 mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
English: UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
Estonian: LT-09200 Vilnius
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Estonian: FENOFIBRATE ALMUS 160 mg, comprimé tablett
English: FENOX 160 mg modified-release filmcoated tablets
Estonian: FENOX 160 mg toimeainet modifitseeritult vabastavad õhukese polümeerikattega tabletid
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Estonian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Island
English: S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
Estonian: Rue de la Pastsuukaudnee 26-28 1080 Brussels
English: FENOFIBRATE ZYDUS 160 mg, comprimé tablet
Estonian: FENOFIBRATE ZYDUS 160 mg, comprimé tablett
English: Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Estonian: Gemfibrosiili sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
English: COATED TABLET
Estonian: KAETUD TABLET
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Estonian: DE - Saksamaa Actavis Group PTC ehf Reykjavikurvegur 76-78
English: LIPOFOR CAPSULES 300mg 300mg capsules
Estonian: LIPOFOR CAPSULES 300mg 300mg kapslid
English: Fenofibrat AL 250 retard 250 mg
Estonian: Fenofibrat AL 250 retard 250 mg toimeainet prolongeeritult vabastav kõvakapsel
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Estonian: Lipsin 100 mg - Kapseln 100 mg
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Estonian: Biogaran15 bd Charles de Gaulle 92700 Colombes Prantsusmaa
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Estonian: FENOFIBRATE MYLAN 145 mg, comprimé tablett
English: MT - Malta Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2
Estonian: KG Liebigstrasse 1-2
English: Fenofanton 250 mg Hartkapseln, retardiert
Estonian: Fenofanton 250 mg Hartkapseln, retardiert toimeainet prolongeeritult vabastav kõvakapsel
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Estonian: FENOFIBRATE BIOGARAN 160 mg, comprimé tablett
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Estonian: Lipcor 200 mg - Kapseln 200 mg
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Estonian: FENOFIBRATE ARROW 160 mg, comprimé tablett
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Estonian: FENOFIBRATE WINTHROP 160 mg, comprimé tablett
English: S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
Estonian: RO - Rumeenia S.C. TERAPIA S.A. Str. Fabricii Nr. 124
English: Prolonged-released tablet
Estonian: toimeainet prolongeeritult vabastav tablett
English: LTLithuania
Estonian: Leedu
English: Bezafibrat Sandoz 400mg Retardtabletten
Estonian: Bezafibrat Sandoz 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: LIPANTIL NANO 145 mg 145 mg film-coated tablets oral use
Estonian: LIPANTIL NANO 145 mg 145 mg õhukese polümeerikattega tabletid
English: LIPANTHYL PENTA 145 mg 145 mg film-coated tablets oral use
Estonian: LIPANTHYL PENTA 145 mg 145 mg õhukese polümeerikattega tabletid
English: coated tablets
Estonian: kaetud tabletid
English: IT - Italy Doc Generici Srl Via Manuzio, 7
Estonian: Doc Generici Srl Via Manuzio, 7 20124 MILANO Itaalia
English: Bezafibrat-ratiopharm 400 mg Retardtabletten
Estonian: Bezafibrat-ratiopharm 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Estonian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Island
English: Lopid 300 mg capsules hard capsules
Estonian: Lopid 300 mg capsules kõvakapslid
English: Tablet
Estonian: TABLETT
English: TABLET
Estonian: tablett
English: PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
Estonian: Laboratoires Fournier S.A. Bd Clemenceau 28
English: IPOLIPID CAPSULES 300mg 300mg capsules
Estonian: IPOLIPID CAPSULES 300mg 300mg kapslid
English: DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
Estonian: DE - Saksamaa DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA
English: Lipsin retard 250 mgKapseln prolonged release capsule, hard
Estonian: Lipsin retard 250 mgKapseln toimeianet prolongeeritult vabastav kõvakapsel
English: 145 MG/TAB Film-coated tablet
Estonian: 145 MG/TAB õhukese polümeerikattega tablett
English: Bezafibrat HEXAL 400mg retard Retardtabletten
Estonian: Bezafibrat HEXAL 400mg retard Retardtabletten toimeainet prolongeeritult vabastav tablett
English: FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Estonian: Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
English: Centrafarm Services B.V. Postbus 289
Estonian: NL - Holland Centrafarm Services B.V.
English: 160,0 mg film-coated tablet
Estonian: 160,0 mg õhukese polümeerikattega tablett
English: Prolonged release coated tablet
Estonian: Bezalip toimeainet prolongeeritult vabastav kaetud tablett
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Estonian: FENOSUP LIDOSE 160 MG 160 mg
English: Fenofibrat-CT 250mg Retardkapseln
Estonian: Fenofibrat-CT 250mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
English: FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Estonian: Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Island
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Estonian: Sanofi Aventis Prantsusmaa 1-13 Bd Romain Rolland 75014 Paris
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Estonian: DE - Saksamaa ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
English: 400 mg Prolonged release coated tablet
Estonian: 400 mg, comprimé enrobé à libération prolongée toimeainet prolongeeritult vabastav tablett
English: Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
Estonian: DE - Saksamaa Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Estonian: Fenofibraati sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Estonian: QUALIMED 117, allée des Parcs 69800 Saint-Priest PRANTSUSMAA
English: Lipanthyl Supra 215 mg 215 mg film-coated tablets oral
Estonian: Lipanthyl Supra 215 mg 215 mg õhukese polümeerikattega tabletid
English: 100 95 Grugliasco Italy
Estonian: Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Itaalia
English: Fenofibrat 250 retard Heumann
Estonian: Fenofibrat 250 retard Heumann toimeainet prolongeeritult vabastav kõvakapsel
English: GEMFIBROZILO STADA 900mg film coated tablets oral
Estonian: GEMFIBROZILO STADA 900mg õhukese polümeerikattega tabletid
English: Retard coated tablets Oral
Estonian: Befibrat kaetud retardtabletid suukaudne
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Estonian: Mylan SAS 117, allée des Parcs 69800 Saint Priest Prantsusmaa
English: Gemfibrozil Sandoz filmcoated tablet
Estonian: Gemfibrozil Sandoz
English: Laboratoires Fournier S.A. 28 boulevard Clemenceau Dijon
Estonian: SI - Sloveenia Laboratoires Fournier S.A. 28 boulevard Clemenceau Dijon
English: Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland
Estonian: Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Island
English: Bezafibrat-CT 400mg Retardtabletten
Estonian: Bezafibrat-CT 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
Estonian: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Island
English: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78220 Hafnarfjordur Iceland
Estonian: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78220 Hafnarfjordur Island
English: 900 MG/TAB Film coated tablet
Estonian: 900 MG/TAB õhukese polümeerikattega tablett
English: Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur , Iceland
Estonian: Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur , Island
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest FRANCE
Estonian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Prantsusmaa
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Estonian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest PRANTSUSMAA
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Estonian: 15, boulevard Charles de Gaulle 92700 Colombes Prantsusmaa
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Estonian: GEMFIBROZILO FERMON 900 mg õhukese polümeerikattega tabletid
English: Attiki
Estonian: Taani
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Estonian: GEMFIBROZILO FERMON 600 mg õhukese polümeerikattega tabletid
English: Lipox Bezafibrat 400mg Retardtabletten
Estonian: Lipox Bezafibrat 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: filmcoated tablets
Estonian: Fibrocit tablett
English: 100 MG/CAP HARD CAPSULES ORAL
Estonian: 100 MG/CAP KÕVAKAPSLID SUUKAUDNE
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Estonian: LT - Leedu Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon
English: PTPortugal
Estonian: PT - Portugal
English: DKDenmark
Estonian: SANDOZ
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Estonian: RO - Rumeenia sanofi-aventis Prantsusmaa 1-13, boulevard Romain Rolland 75014 Paris
English: 1-10 Constantinoupoleos St. P.O.
Estonian: SK - Slovakkia Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
English: BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée
Estonian: Bezadoc PB retard 400 mg 400 mg toimeainet prolongeeritult vabastav tablett
English: FENOFIBRAT TERAPIA 160 mg film-coated tablets oral use
Estonian: FENOFIBRAT TERAPIA 160 mg õhukese polümeerikattega tabletid
English: Bezafibrat Stada 400 mg Retardtabletten
Estonian: Bezafibrat Stada 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: 160 MG/CAP HARD CAPSULES ORAL
Estonian: 160 MG/CAP KÕVAKAPSLID
English: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Estonian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Island
English: modified release tablets
Estonian: TOIMEAINET MODIFITSEERITULT VABASTAV TABLETT
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
Estonian: SANOFI AVENTIS Prantsusmaa 1-13, boulevard Romain Rolland 75014 Paris
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Estonian: SANOFI AVENTIS PRANTSUSMAA 1-13, boulevard Romain Rolland 75014 Paris
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
Estonian: Ratiopharm GmbH Graf-Arco Strasse 3 D-89079 ULMSaksamaa
English: GEMFIBROZILO STADA 600 mg film coated tablets oral
Estonian: GEMFIBROZILO STADA 600 mg õhukese polümeerikattega tabletid
English: Lipox Bezafibrat 400 mg Retardtabletten
Estonian: Lipox Bezafibrat 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: TRICOR 145 mg film-coated tablets oral use
Estonian: TRICOR 145 mg õhukese polümeerikattega tabletid
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Estonian: FENOFIBRATO RANBAXY 160mg
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Estonian: Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM Saksamaa
English: 600 MG/TAB Film coated tablet
Estonian: 600 MG/TAB õhukese polümeerikattega tablett
English: Befibrat 200mg Dragees 200 mg
Estonian: FENOGAL 200 LIDOSE 200 mg
English: Prolonged-release tablet
Estonian: Bezalip Retard toimeainet prolongeeritult vabastav tablett
English: Fenofibrat AbZ 250 mg Retardkapseln
Estonian: Fenofibrat AbZ 250 mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
English: The European Commission issued a decision on 11 September 2012.
Estonian: Euroopa Komisjon tegi otsuse 11. septembril 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Estonian: Ettevõte soovis, et müügiluba tunnustataks Prantsusmaal ja Ühendkuningriigis (asjaomased liikmesriigid).
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Estonian: Samuti ei olnud ravimi ohutuse ja efektiivsuse andmed piisavad, et kompenseerida puuduvat bioekvivalentsust.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Estonian: Mifepristone Linepharma on saanud müügiloa detsentraliseeritud menetlusega Islandil, Norras, Rootsis, Soomes ja Taanis.
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.
Estonian: Liikmesriigid ei jõudnud kokkuleppele ning Prantsusmaa ravimiamet tegi 23. veebruaril 2012 inimravimite komiteele vahekohtumenetluse alustamise esildise.
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.
Estonian: Linepharma France esitas Mifepristone Linepharma vastastikuse tunnustamise taotluse, võttes aluseks 3. detsembril 2010 Rootsis antud esmase müügiloa.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Estonian: Komitee soovitas korraldada prospektiivse vaatlusuuringu, et jälgida Mifepristone Linepharma määramist.
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.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 21. juunil 2012 vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Mifepristone Linepharma heakskiitmises.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Estonian: Mifepristone Linepharma on ravim, mida kasutatakse raseduse katkestamiseks.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Estonian: See tähendab, et ta sarnaneb võrdlusravimiga Mifegyne, mis sisaldab sama toimeainet.
English: What is Mifepristone Linepharma?
Estonian: Mis on Mifepristone Linepharma?
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.
Estonian: Samas ei peetud seda erinevust probleemseks, sest mifepristooni ohutus ja efektiivsus on hästi teada oluliselt suuremate annuste (kuni 600 mg) korral ning seda on kinnitatud Mifepristone Linepharmaga toimunud toetavate uuringutega.
English: Why was Mifepristone Linepharma reviewed?
Estonian: Miks Mifepristone Linepharma andmed uuesti läbi vaadati?
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Estonian: Komitee järeldas ka, et ravimi infolehele peab lisama märkuse, et annuseid üle 200 mg ei tohi manustada.
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.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, järeldas inimravimite komitee, et Mifepristone Linepharma kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda Mifepristone Linepharma müügiloa kõigis asjaomastes liikmesriikides.
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.
Estonian: Mifepristone Linepharmat manustatakse ühekordse 200 mg annusena, 36-48 tunni pärast manustatakse teise ravimi gemeprosti annus.
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.
Estonian: EMA inimravimite komitee järeldas, et Mifepristone Linepharma kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas Rootsis antud müügiluba tunnustada ka teistes Euroopa Liidu liikmesriikides.
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.
Estonian: See sisaldab toimeainena mifepristooni, mis blokeerib hormooni progesterooni toime.
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Estonian: Mifepristone Linepharma on hübriidravim.