FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyperlipen capsule, hard
Danish: Hyperlipen kapsler, hårde
English: Katalip 250 mg trde kapsule capsule, hard
Danish: Katalip 250 mg trde kapsule kapsler, hårde
English: ES - Spain QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 08210 BARCELONA
Danish: ES - Spanien QUIMIFAR, S.A.Comadran, 37 Barbera del Valles
English: EL - Greece HRISPA ALFA PHARMACEUTICALS S.A.
Danish: HRISPA ALFA PHARMACEUTICALS S.A.
English: LACROMID 200 FC TABLETS 200mg tablets
Danish: LACROMID 200 FC TABLETS 200mg
English: Kallithea 176 74
Danish: Kallithea 176 74 Attiki
English: Sandoz B.V.
Danish: NL - Holland Sandoz B.V.
English: PFIZER LIMITED.
Danish: UK - England PFIZER LIMITED.
English: UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania
Danish: LT - Litauen UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2
English: FR - France CRISTERS 22 quai Gallieni 92150 Suresnes France
Danish: FR - Frankrig CRISTERS 22 quai Gallieni 92150 Suresnes FRANCE
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven Germany
Danish: DE - Tyskland TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven
English: Hennig Arzneimittel GmbH & Co.KG
Danish: DE - Tyskland Hennig Arzneimittel GmbH & Co.KG
English: PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Danish: PL - Polen ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
English: EL - Greece SOLVAY PHARMA Μ.Ε.Π.Ε Agiou DIMITRIOU 63
Danish: SOLVAY PHARMA Μ.Ε.Π.Ε Agiou DIMITRIOU 63 Alimos
English: Veluwezoom 22 1327 AH Almere The Netherlands
Danish: 1327 AH Almere The Netherlands
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Danish: DETyskland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: RORomania
Danish: RORumænien
English: PL - Poland Apotex Europe B.V. Darwinweg 20
Danish: PL - Polen Apotex Europe B.V.
English: DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
Danish: Ambachtenlaan 13H 3001 Leuven
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Danish: FENOGAL 267 MG LIDOSE 267 mg kapsler hårde
English: LV - Latvia Laboratoires Fournier S.A. Boulevard Clemenceau 28
Danish: LV - Letland Laboratoires Fournier S.A. Boulevard Clemenceau 28
English: SANDOZ N.V.
Danish: BE - Belgien SANDOZ N.V.
English: GEMLIPID-MEDICHROM 600 MG/TAB Film coated tablet
Danish: GEMLIPID-MEDICHROM 600 MG/TAB Filmovertrukne tabletter
English: PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
Danish: PL - Polen Laboratoires Fournier S.A. Bd Clemenceau 28
English: Fenardin capsules, hard
Danish: Fenardin kapsler, hårde
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Danish: Lipsin 100 mg - Kapseln 100 mg kapsler, hårde
English: Fenofibrato KernPharma 160 mg capsules
Danish: Fenofibrato KernPharma 160 mg
English: tablets
Danish: TABLETTER
English: FENOGAL 200 LIDOSE 200 mg capsule, hard
Danish: FENOGAL 200 LIDOSE 200 mg kapsler, hårde
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Danish: FENOSUP LIDOSE 160 MG 160 mg kapsler hårde
English: Pfizer B.V.
Danish: NL - Holland Pfizer B.V.
English: FR - France Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
Danish: FR - Frankrig Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
English: FR - France LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
Danish: FR - Frankrig LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
English: Lipanthyl 200 Micronised 200mg capsule, hard
Danish: Lipanthyl 200 Micronised 200mg kapsler, hårde
English: ZAFIBRAL FC TABLETS 200mg tablets
Danish: ZAFIBRAL FC TABLETS 200mg
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Danish: Lipcor 200 mg - Kapseln 200 mg kapsler, hårde
English: Pfizer Pharma GmbH Linkstr.
Danish: DE - Tyskland Pfizer Pharma GmbH Linkstr.
English: 3 Howard Road Eaton Socon
Danish: Eaton Socon
English: LIPIDIL MICRONISED HARD CAPSULES 267mg capsules
Danish: LIPIDIL MICRONISED HARD CAPSULES 267mg
English: ES - Spain SOLVAY PHARMA S.A. Avda.
Danish: ES - Spanien SOLVAY PHARMA S.A. Avda.
English: FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
Danish: FR - Frankrig Sandoz 49, av. Pompidou 92300 Levallois-Perret France
English: EL - Greece SPECIFAR ABEE 28th October str 1
Danish: SPECIFAR ABEE 28th October str 1 Agia Barbara 123 51 Greece
English: LIPANTHYL 67 M capsule 67 mg capsules
Danish: LIPANTHYL 67 M capsule 67 mg
English: Fenolip capsule, hard
Danish: Fenolip kapsler, hårde
English: Box 313, 3740 AH Baarn, The Netherlands
Danish: NL - Holland Actavis BV P.O. Box 313, 3740 AH Baarn, The Netherlands
English: MODALIM TABLETS 100mg 100mg tablets
Danish: MODALIM TABLETS 100mg 100mg
English: Box 313, 3740 AH Baarn The Netherlands
Danish: NL - Holland Actavis BV P.O. Box 313, 3740 AH Baarn The Netherlands
English: LIPANTHYL 267 M capsule 267 mg capsules
Danish: LIPANTHYL 267 M capsule 267 mg
English: 6D 64295 Darmstadt Germany
Danish: 64295 Darmstadt Germany
English: 145 MG/TAB Film-coated tablet
Danish: 145 MG/TAB Filmovertrukne tabletter
English: Lipanor capsule, hard
Danish: Lipanor kapsler, hårde
English: modified release tablets
Danish: Tabletter med modificeret udløsning
English: Lipanthyl 267 Micronised 267mg capsule, hard
Danish: Lipanthyl 267 Micronised 267mg kapsler, hårde
English: Pharmachemie BV P.O.Box 552, 2003 RN Haarlem The Netherlands
Danish: NL - Holland Pharmachemie BV P.O.Box 552,
English: FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Danish: FR - Frankrig Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
English: TECHNOLOGY S.A. Rue du Parc Industriel 39 6900 Marche-en-Famenne Belgium
Danish: TECHNOLOGY S.A. Rue du Parc Industriel 39
English: PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Danish: PL - Polen Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
English: Lipanthyl 67 Micronised 67mg capsule, hard
Danish: Lipanthyl 67 Micronised 67mg kapsler, hårde
English: FENOFIBRATE RATIOPHARM 145 mg, comprimé tablet
Danish: FENOFIBRATE RATIOPHARM 145 mg, comprimé
English: Lopid 600 mg film-coated tablets film-coated tablets oral use
Danish: Lopid 600 mg film-coated tablets
English: FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Danish: FR - Frankrig SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: LIPIDIL MICRONISED HARD CAPSULES 200mg capsules
Danish: LIPIDIL MICRONISED HARD CAPSULES 200mg
English: 300,00 mg capsule
Danish: 300,00 mg Kapsler
English: ES - Spain SOLVAY PHARMA, S.A.Avda.
Danish: ES - Spanien SOLVAY PHARMA, S.A.Avda.
English: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée
Danish: 400 mg, comprimé enrobé à libération prolongée
English: FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Danish: FR - Frankrig Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
English: 160 MG/CAP HARD CAPSULES ORAL
Danish: 160 MG/CAP HÅRDE KAPSLER oral anvendelse
English: 100,00 mg capsule
Danish: 100,00 mg Kapsler
English: Reykjavikurvegur 76-78, 220, Hafnarfjordur
Danish: Reykjavikurvegur 76-78, 220, Hafnarfjordur Iceland
English: LIPOFOR CAPSULES 600mg 600mg capsules
Danish: LIPOFOR CAPSULES 600mg 600mg
English: PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3
Danish: PL - Polen ratiopharm GmbH Graf-Arco-Strasse 3
English: UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
Danish: LT - Litauen UAB PharmaSwiss Šeimyniškių 21B
English: 100 MG/CAP HARD CAPSULES ORAL
Danish: 100 MG/CAP HÅRDE KAPSLER oral anvendelse
English: EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
Danish: PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Greece
English: 200 MG/CAP HARD CAPSULES ORAL
Danish: 200 MG/CAP HÅRDE KAPSLER oral anvendelse
English: Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
Danish: Eastbourne, E Sussex BN22 9AG United Kingdom
English: 26-28 rue de la Pastorale B-1080, Brussels
Danish: 26-28 rue de la Pastorale B-1080, Brussels Belgium
English: Lipantil Micro 200 mg capsules, hard hard capsules
Danish: Lipantil Micro 200 mg capsules, hard hårde kapsler
English: FENOFIBRATE EXPANPHARM 67 mg, comprimé tablet
Danish: FENOFIBRATE EXPANPHARM 67 mg, comprimé
English: Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany
Danish: DE - Tyskland Berlin-Chemie AG Glienicker Weg 125
English: Modified-release capsule,hard
Danish: Kapsler med modificeret udløsning, hårde
English: FENOFIBRATE EXPANPHARM 200 mg, comprimé tablet
Danish: FENOFIBRATE EXPANPHARM 200 mg, comprimé
English: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
Danish: FENOFIBRATE RATIOPHARM 160 mg, comprimé
English: LIPIPHARM 145 mg, comprimé tablet
Danish: LIPIPHARM 145 mg, comprimé
English: BEZAFIBRAT ARENA 200 mg 200 mg tablets
Danish: BEZAFIBRAT ARENA 200 mg 200 mg
English: 400 MG/TAB PROLONGED RELEASE TABLETS
Danish: 400 MG/TAB Depottabletter
English: ES - Spain SOLVAY PHARMA S.A.Avda.
Danish: ES - Spanien SOLVAY PHARMA S.A.Avda.
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Danish: ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Greece
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Danish: CY - Cypern MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Danish: FENOFIBRATE QUALIMED 145 mg, comprimé
English: IPOLIPID CAPSULES 600mg 600mg capsules
Danish: IPOLIPID CAPSULES 600mg 600mg
English: Lipantil Micro 267 mg capsules, hard hard capsules
Danish: Lipantil Micro 267 mg capsules, hard hårde kapsler
English: AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
Danish: AT - Østrig Actavis Group PTC ehf Reykjavikurvegur 76-78
English: Lipantil Micro 67 mg capsules, hard hard capsules
Danish: Lipantil Micro 67 mg capsules, hard hårde kapsler
English: 160,0 mg film-coated tablet
Danish: 160,0 mg filmovertrukne tabletter
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Danish: FENOFIBRATE ALTER 160 mg, comprimé
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Danish: CY - Cypern MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: FENOFIBRATE TEVA 160 mg, comprimé tablet
Danish: FENOFIBRATE TEVA 160 mg, comprimé
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Danish: FENOFIBRATE SANDOZ 145 mg, comprimé
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Danish: FR - Frankrig Actavis Group PTC ehf Reykjavikurvegi 76-78
English: CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
Danish: CY - Cypern Varnavas Hadjipanayis Ltd 7 Androcleous street
English: 100MG capsule, hard
Danish: 100MG kapsler, hårde
English: Fegenor capsule, hard
Danish: Fegenor kapsler, hårde
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Danish: Lipantil Supra 145mg filmcoated tablets
English: BEZAFIBRAT SLAVIA 200 mg tablets
Danish: BEZAFIBRAT SLAVIA 200 mg
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Danish: CY - Cypern MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: IT - Italy Ratiopharm GmbH Graf-Arco Strasse 3
Danish: IT - Italien Ratiopharm GmbH Graf-Arco Strasse 3
English: IT - Italy Ratiopharm Gmbh Graf-Arco Strasse 3
Danish: IT - Italien Ratiopharm Gmbh Graf-Arco Strasse 3
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Danish: FENOFIBRATE CRISTERS 160 mg, comprimé
English: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Danish: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten
English: Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler der indeholder ciprofibrat med markedføringstilladelses i EU.
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Danish: FENOFIBRATE WINTHROP 145 mg, comprimé
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Danish: ET - Estland Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Danish: FENOFIBRATE ACTAVIS 160 mg, comprimé
English: Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler der indeholder gemfibrozil med markedføringstilladelses i EU.
English: Fenolip retard 250 mgKapseln prolonged release capsule, hard
Danish: Fenolip retard 250 mgKapseln depotkapsler, hårde oral anvendelse
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Danish: FENOFIBRATE BIOGARAN 145 mg, comprimé
English: SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1C
Danish: BE - Belgien SANOFI-AVENTIS BELGIUM N.V.
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Danish: FENOFIBRATE MYLAN 145 mg, comprimé
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Danish: FENOFIBRATE BIOGARAN 160 mg, comprimé
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Danish: Lipantil Supra 215mg filmcoated tablets
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Danish: FENOFIBRATE RANBAXY 160 mg, comprimé
English: 20154 MILANO Italy
Danish: 20154 MILANO
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Danish: Lipantil Supra 160mg filmcoated tablets
English: Lopid 300 mg capsules hard capsules
Danish: Lopid 300 mg capsules
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Danish: FENOFIBRATE ARROW 160 mg, comprimé
English: FENOFIBRAT TERAPIA 200 mg capsules
Danish: FENOFIBRAT TERAPIA 200 mg
English: Genus Pharmaceuticals Limited Park View House 65 London Road NEWBURY, BERKS RG14 1JN United Kingdom
Danish: NEWBURY, BERKS RG14 1JN United Kingdom
English: MT - Malta Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2
Danish: KG Liebigstrasse 1-2
English: 2333 CR Leiden The Netherlands
Danish: 2333 CR Leiden
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Danish: FENOFIBRATE ALMUS 160 mg, comprimé
English: FILM-COATED TABLET oral use
Danish: Overtrukne tabletter oral anvendelse
English: EL - Greece COSMOPHARM EPE P.O.
Danish: COSMOPHARM EPE P.O. Box 42
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Danish: FENOFIBRATE SANDOZ 160 mg, comprimé
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler der indeholder fenofibrat med markedføringstilladelses i EU.
English: Liparison Retard capsules
Danish: Tabletter med forsinket udløsning
English: LIPOFOR CAPSULES 300mg 300mg capsules
Danish: LIPOFOR CAPSULES 300mg 300mg
English: FENOFIBRATE ZYDUS 160 mg, comprimé tablet
Danish: FENOFIBRATE ZYDUS 160 mg, comprimé
English: 900 MG/TAB Film coated tablet
Danish: 900 MG/TAB Filmovertrukne tabletter
English: PTPortugal
Danish: Petersfield
English: ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE DEVON EX32 8NS United Kingdom
Danish: UK - England ACTAVIS UK LIMITED WHIDDON VALLEY
English: FENOFIBRATE EG 145 mg, comprimé tablet
Danish: FENOFIBRATE EG 145 mg, comprimé
English: UK - United Kingdom
Danish: United Kingdom
English: FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
Danish: FENOFIBRATE EG 160 mg, comprimé pelliculé
English: Archimedes Pharma Uk Limited Bishops Weald House Albion Way, Horsham, West Sussex RH12 1AH United Kingdom
Danish: UK - England Archimedes Pharma Uk Limited Bishops Weald House
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Danish: FR - Frankrig Biogaran15 bd Charles de Gaulle 92700 Colombes France
English: DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
Danish: DE - Tyskland DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA
English: Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
Danish: DE - Tyskland Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
English: IPOLIPID CAPSULES 300mg 300mg capsules
Danish: IPOLIPID CAPSULES 300mg 300mg
English: LIPILFEN 160 mg, comprimé tablet
Danish: LIPILFEN 160 mg, comprimé
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Danish: RORumænien sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
English: Lipsin retard 250 mgKapseln prolonged release capsule, hard
Danish: Lipsin retard 250 mgKapseln depotkapsler, hårde oral anvendelse
English: Centrafarm Services B.V. Postbus 289
Danish: NL - Holland Centrafarm Services B.V.
English: SESweden
Danish: SESverige
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Danish: FENOFIBRATE WINTHROP 160 mg, comprimé
English: Apteor modified released tablet
Danish: Tabletter, med modificeret udløsning
English: 1-10 Constantinoupoleos St. P.O.
Danish: 1-10 Constantinoupoleos St. P.O. Box: 51409
English: 600 MG/TAB Film coated tablet
Danish: 600 MG/TAB Filmovertrukne tabletter
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Danish: FR - Frankrig Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
English: Actavis BV P.O.
Danish: BEZAFIBRATE ACTAVIS L.P.
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Danish: FR - Frankrig BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
Danish: FR - Frankrig BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
English: Gemfibrozil Sandoz filmcoated tablet
Danish: Gemfibrozil Sandoz
English: FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
Danish: FR - Frankrig Biogaran 15, bd Charles de Gaulle 92700 Colombes France
English: Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
Danish: Lægemidler der indeholder bezafibrat med markedføringstilladelses i EU.
English: FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
Danish: FR - Frankrig Qualimed 117, allée des Parcs 69800 Saint Priest France
English: LIVESAN 67 mg, gélule 67 mg
Danish: LIVESAN 67 mg, gélule
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Danish: FR - Frankrig Mylan SAS 117, allée des Parcs 69800 Saint Priest France
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Danish: FR - Frankrig QUALIMED 117, allée des Parcs 69800 Saint-Priest FRANCE
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Danish: FR - Frankrig MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
English: Capsules, hard
Danish: Kapsler, hårde
English: capsules, hard
Danish: kapsler, hårde
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
Danish: FR - Frankrig SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Danish: GEMFIBROZILO FERMON 900 mg
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Danish: FR - Frankrig SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
English: Grofibrat capsules
Danish: Depotkapsler
English: Av. du Bourg.
Danish: Av. Brg.
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Danish: GEMFIBROZILO FERMON 600 mg
English: Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon
Danish: LT - Litauen Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon
English: Box 42
Danish: Agisilaou 46
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Danish: FENOFIBRATO RANBAXY 160mg
English: LIPOFIB 160 mg capsules
Danish: LIPOFIB 160 mg
English: Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland
Danish: SE - Sverige Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur ,
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultat af en procedure i henhold til artikel 29 i direktiv 2001/83/EF, som ændret
English: The European Commission issued a decision on 11 September 2012.
Danish: Europa-Kommissionen traf en afgørelse den 11. september 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede, at denne godkendelse blev anerkendt i Frankrig og Det Forenede Kongerige (de "berørte medlemsstater").
English: EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
Danish: Den 11. september 2012 EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
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.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den franske lægemiddelstyrelse henviste sagen til CHMP med henblik på voldgift den 23. februar 2012.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Danish: Mifepriston Linepharma er i forvejen godkendt ved en decentral procedure i Danmark, Finland, Island, Norge og Sverige.
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Danish: Desuden var de foreliggende data om lægemidlets sikkerhed og virkning ikke tilstrækkelige til at opveje den manglende bioækvivalens.
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.
Danish: Den 21. juni 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Mifepriston Linepharma.
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.
Danish: Det indeholder det aktive stof mifepriston, der virker ved at blokere virkningerne af hormonet progesteron, som spiller en vigtig rolle i opretholdelsen af svangerskabet.
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.
Danish: Linepharma France indsendte en ansøgning for Mifepriston Linepharma med henblik på gensidig anerkendelse på grundlag af den oprindelige godkendelse, der var udstedt i Sverige den 3. december 2010.
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Danish: CHMP konkluderede desuden, at produktinformationen bør indeholde en angivelse af, at der ikke bør gives højere doser end 200 mg.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Danish: Det vil sige, at det svarer til "referencelægemidlet" Mifegyne, der indeholder samme aktive stof.
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.
Danish: Forskellen blev imidlertid ikke fundet at give anledning til betænkelighed, da sikkerheden og virkningen af mifepriston i langt højere doser på op til 600 mg er veldokumenteret og bekræftes af de støttende undersøgelser med Mifepriston Linepharma.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Danish: Derudover anbefalede udvalget, at der blev udført en prospektiv observationsundersøgelse (dvs. en undersøgelse, hvor udviklingen følges i et stykke tid) til overvågning af, hvordan Mifepriston Linepharma ordineres.
English: Why was Mifepristone Linepharma reviewed?
Danish: Hvorfor blev Mifepriston Linepharma vurderet igen?
English: What is Mifepristone Linepharma?
Danish: Hvad er Mifepriston Linepharma?
English: Both medicines are available as 200 mg tablets but whereas Mifegyne was authorised to be given at doses of 600 mg and 200 mg, Mifepristone Linepharma was only authorised at the 200 mg dose.
Danish: Begge lægemidler fås som 200 mg tabletter, men hvor Mifegyne blev godkendt i doser på 600 mg og 200 mg, blev Mifepriston Linepharma kun godkendt med en dosering på 200 mg.