natgillin/translations-raw huggingface dataset:
IT - Italy Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene
Via Fratelli Cervi, 8 - Valle Salimbene
FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
FENOFIBRATE EG 160 mg, comprimé pelliculé tablett
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3
DE - Saksamaa ratiopharm GmbH Graf-Arco-Str. 3
FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
49, avenue Georges Pompidou 92300 Levallois-Perret PRANTSUSMAA
FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
49, avenue Georges Pompidou 92300 Levallois-Perret Prantsusmaa
LIPILFEN 160 mg, comprimé tablet
LIPILFEN 160 mg, comprimé tablett
LIPANTHYL 267 M capsule 267 mg capsules
LIPANTHYL 267 M capsule 267 mg kapslid
FENOFIBRAT TERAPIA 200 mg capsules
FENOFIBRAT TERAPIA 200 mg kapslid
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
PL - Poola ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
FENOFIBRATE QUALIMED 145 mg, comprimé tablet
FENOFIBRATE QUALIMED 145 mg, comprimé tablett
Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
Bezafibraati sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
D-64295 Darmstadt Germany durafenat retard
D-64295 Darmstadt Saksamaa durafenat retard toimeainet prolongeeritult vabastav kõvakapsel
CY - Cyprus REMEDICA LTD Aharnon street P.O.Box 51706
REMEDICA LTD Aharnon street P.O.Box 51706 3508 Lemesos Küpros
EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Kreeka
LIPOFOR CAPSULES 600mg 600mg capsules
LIPOFOR CAPSULES 600mg 600mg kapslid
Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Iceland
Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Island
FENOFIBRATE EG 145 mg, comprimé tablet
FENOFIBRATE EG 145 mg, comprimé tablett
LIPOFIB 200 mg capsules
LIPOFIB 200 mg kapslid
EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Kreeka
Lipantil Micro 200 mg capsules, hard hard capsules
Lipantil Micro 200 mg capsules, hard kõvakapslid
FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
FENOFIBRATE RATIOPHARM 160 mg, comprimé tablett
FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette PRANTSUSMAA
Lipanthyl 200 mg hard capsules
Lipanthyl 200 mg hard capsules kõvakapslid
Apteor modified released tablet
toimeainet modifitseeritult vabastavad tabletid
FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
49, av. Pompidou 92300 Levallois-Perret Prantsusmaa
FENOFIBRATE ALTER 160 mg, comprimé tablet
FENOFIBRATE ALTER 160 mg, comprimé tablett
LIPOFIB 267 mg capsules
LIPOFIB 267 mg kapslid
Supralip 160 mg modified released tablet
Supralip 160 mg toimeainet modifitseeritult vabastav tablett
Grofibrat capsules
Grofibrat kapslid
IPOLIPID CAPSULES 600mg 600mg capsules
IPOLIPID CAPSULES 600mg 600mg kapslid
LIPOFIB 67 mg capsules
LIPOFIB 67 mg kapslid
S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
S.A. 26-28 rue de la Pastsuukaudnee B-1080 Bruxelles
CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
CY - Küpros Varnavas Hadjipanayis Ltd 7 Androcleous street
ES - Spain ACTAVIS SPAIN S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid Spain
46 - Bussines Centre Regus Office 525 Madrid
Via dei Pestagalli, 7
Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7
FENOFIBRATE CRISTERS 160 mg, comprimé tablet
FENOFIBRATE CRISTERS 160 mg, comprimé tablett
FR - France TEVA SANTE Le Palatin 1
Le Palatin 1
FENOFIBRATE SANDOZ 145 mg, comprimé tablet
FENOFIBRATE SANDOZ 145 mg, comprimé tablett
FENOFIBRATE WINTHROP 145 mg, comprimé tablet
FENOFIBRATE WINTHROP 145 mg, comprimé tablett
Lipantil Micro 267 mg capsules, hard hard capsules
Lipantil Micro 267 mg capsules, hard kõvakapslid
FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
FENOFIBRATE ACTAVIS 160 mg, comprimé tablett
Fenofibrat STADA 250 mg Hartkapseln, retardiert
Fenofibrat STADA 250 mg Hartkapseln, retardiert toimeainet prolongeeritult vabastav kapsel
Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Lipantil Supra 215mg filmcoated tablets õhukese polümeerikattega tabletid
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
CY - Küpros MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Lipantil Supra 145mg filmcoated tablets õhukese polümeerikattega tabletid
FENOFIBRATE RANBAXY 160 mg, comprimé tablet
FENOFIBRATE RANBAXY 160 mg, comprimé tablett
FENOFIBRATO RANBAXY 200mg capsules
FENOFIBRATO RANBAXY 200mg kapslid
PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Sanofi-Aventis Prantsusmaa boulevard Romain Rolland 1-13, F-75014 Paris,
26-28 rue de la Pastorale B-1080, Brussels
26-28 rue de la Pastsuukaudnee B-1080, Brussels Belgia
Lipantil Micro 67 mg capsules, hard hard capsules
Lipantil Micro 67 mg capsules, hard kõvakapslid
Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Lipantil Supra 160mg filmcoated tablets õhukese polümeerikattega tabletid
Fenolip retard 250 mgKapseln prolonged release capsule, hard
Fenolip retard 250 mgKapseln toimeainet prolongeeritult vabastav kõvakapsel
FENOGAL 267 MG LIDOSE 267 mg capsule hard
FENOGAL 267 MG LIDOSE 267 mg
FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
FENOFIBRATE BIOGARAN 145 mg, comprimé tablett
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
FENOFIBRATE SANDOZ 160 mg, comprimé tablet
FENOFIBRATE SANDOZ 160 mg, comprimé tablett
Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Island
tablets
TABLETID
LIPANTHYL SUPRA 160 mg 160 mg modified-release filmcoated tablets
LIPANTHYL SUPRA 160 mg 160 mg toimeainet modifitseeritult vabastavad õhukese polümeerikattega tabletid
Fenofibrat-ratiopharm 250 mg Retardkapseln
Fenofibrat-ratiopharm 250 mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
LT-09200 Vilnius
FENOFIBRATE ALMUS 160 mg, comprimé tablet
FENOFIBRATE ALMUS 160 mg, comprimé tablett
FENOX 160 mg modified-release filmcoated tablets
FENOX 160 mg toimeainet modifitseeritult vabastavad õhukese polümeerikattega tabletid
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Island
S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
Rue de la Pastsuukaudnee 26-28 1080 Brussels
FENOFIBRATE ZYDUS 160 mg, comprimé tablet
FENOFIBRATE ZYDUS 160 mg, comprimé tablett
Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Gemfibrosiili sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
COATED TABLET
KAETUD TABLET
FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
DE - Saksamaa Actavis Group PTC ehf Reykjavikurvegur 76-78
LIPOFOR CAPSULES 300mg 300mg capsules
LIPOFOR CAPSULES 300mg 300mg kapslid
Fenofibrat AL 250 retard 250 mg
Fenofibrat AL 250 retard 250 mg toimeainet prolongeeritult vabastav kõvakapsel
Lipsin 100 mg - Kapseln 100 mg capsule, hard
Lipsin 100 mg - Kapseln 100 mg
FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Biogaran15 bd Charles de Gaulle 92700 Colombes Prantsusmaa
FENOFIBRATE MYLAN 145 mg, comprimé tablet
FENOFIBRATE MYLAN 145 mg, comprimé tablett
MT - Malta Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2
KG Liebigstrasse 1-2
Fenofanton 250 mg Hartkapseln, retardiert
Fenofanton 250 mg Hartkapseln, retardiert toimeainet prolongeeritult vabastav kõvakapsel
FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
FENOFIBRATE BIOGARAN 160 mg, comprimé tablett
Lipcor 200 mg - Kapseln 200 mg capsule, hard
Lipcor 200 mg - Kapseln 200 mg
FENOFIBRATE ARROW 160 mg, comprimé tablet
FENOFIBRATE ARROW 160 mg, comprimé tablett
FENOFIBRATE WINTHROP 160 mg, comprimé tablet
FENOFIBRATE WINTHROP 160 mg, comprimé tablett
S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
RO - Rumeenia S.C. TERAPIA S.A. Str. Fabricii Nr. 124
Prolonged-released tablet
toimeainet prolongeeritult vabastav tablett
LTLithuania
Leedu
Bezafibrat Sandoz 400mg Retardtabletten
Bezafibrat Sandoz 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
LIPANTIL NANO 145 mg 145 mg film-coated tablets oral use
LIPANTIL NANO 145 mg 145 mg õhukese polümeerikattega tabletid
LIPANTHYL PENTA 145 mg 145 mg film-coated tablets oral use
LIPANTHYL PENTA 145 mg 145 mg õhukese polümeerikattega tabletid
coated tablets
kaetud tabletid
IT - Italy Doc Generici Srl Via Manuzio, 7
Doc Generici Srl Via Manuzio, 7 20124 MILANO Itaalia
Bezafibrat-ratiopharm 400 mg Retardtabletten
Bezafibrat-ratiopharm 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Island
Lopid 300 mg capsules hard capsules
Lopid 300 mg capsules kõvakapslid
Tablet
TABLETT
TABLET
tablett
PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
Laboratoires Fournier S.A. Bd Clemenceau 28
IPOLIPID CAPSULES 300mg 300mg capsules
IPOLIPID CAPSULES 300mg 300mg kapslid
DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
DE - Saksamaa DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA
Lipsin retard 250 mgKapseln prolonged release capsule, hard
Lipsin retard 250 mgKapseln toimeianet prolongeeritult vabastav kõvakapsel
145 MG/TAB Film-coated tablet
145 MG/TAB õhukese polümeerikattega tablett
Bezafibrat HEXAL 400mg retard Retardtabletten
Bezafibrat HEXAL 400mg retard Retardtabletten toimeainet prolongeeritult vabastav tablett
FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Centrafarm Services B.V. Postbus 289
NL - Holland Centrafarm Services B.V.
160,0 mg film-coated tablet
160,0 mg õhukese polümeerikattega tablett
Prolonged release coated tablet
Bezalip toimeainet prolongeeritult vabastav kaetud tablett
FENOSUP LIDOSE 160 MG 160 mg capsule hard
FENOSUP LIDOSE 160 MG 160 mg
Fenofibrat-CT 250mg Retardkapseln
Fenofibrat-CT 250mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Island
FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Sanofi Aventis Prantsusmaa 1-13 Bd Romain Rolland 75014 Paris
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
DE - Saksamaa ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
400 mg Prolonged release coated tablet
400 mg, comprimé enrobé à libération prolongée toimeainet prolongeeritult vabastav tablett
Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
DE - Saksamaa Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Fenofibraati sisaldavate ravimite müügiloa hoidjad Euroopa Liidus
FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
QUALIMED 117, allée des Parcs 69800 Saint-Priest PRANTSUSMAA
Lipanthyl Supra 215 mg 215 mg film-coated tablets oral
Lipanthyl Supra 215 mg 215 mg õhukese polümeerikattega tabletid
100 95 Grugliasco Italy
Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Itaalia
Fenofibrat 250 retard Heumann
Fenofibrat 250 retard Heumann toimeainet prolongeeritult vabastav kõvakapsel
GEMFIBROZILO STADA 900mg film coated tablets oral
GEMFIBROZILO STADA 900mg õhukese polümeerikattega tabletid
Retard coated tablets Oral
Befibrat kaetud retardtabletid suukaudne
FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Mylan SAS 117, allée des Parcs 69800 Saint Priest Prantsusmaa
Gemfibrozil Sandoz filmcoated tablet
Gemfibrozil Sandoz
Laboratoires Fournier S.A. 28 boulevard Clemenceau Dijon
SI - Sloveenia Laboratoires Fournier S.A. 28 boulevard Clemenceau Dijon
Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland
Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Island
Bezafibrat-CT 400mg Retardtabletten
Bezafibrat-CT 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Island
ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78220 Hafnarfjordur Iceland
ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78220 Hafnarfjordur Island
900 MG/TAB Film coated tablet
900 MG/TAB õhukese polümeerikattega tablett
Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur , Iceland
Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur , Island
FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest FRANCE
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Prantsusmaa
FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest PRANTSUSMAA
FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
15, boulevard Charles de Gaulle 92700 Colombes Prantsusmaa
GEMFIBROZILO FERMON 900 mg film coated tablets oral
GEMFIBROZILO FERMON 900 mg õhukese polümeerikattega tabletid
Attiki
Taani
GEMFIBROZILO FERMON 600 mg film coated tablets oral
GEMFIBROZILO FERMON 600 mg õhukese polümeerikattega tabletid
Lipox Bezafibrat 400mg Retardtabletten
Lipox Bezafibrat 400mg Retardtabletten toimeainet prolongeeritult vabastav tablett
filmcoated tablets
Fibrocit tablett
100 MG/CAP HARD CAPSULES ORAL
100 MG/CAP KÕVAKAPSLID SUUKAUDNE
ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
LT - Leedu Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon
PTPortugal
PT - Portugal
DKDenmark
SANDOZ
RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
RO - Rumeenia sanofi-aventis Prantsusmaa 1-13, boulevard Romain Rolland 75014 Paris
1-10 Constantinoupoleos St. P.O.
SK - Slovakkia Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée
Bezadoc PB retard 400 mg 400 mg toimeainet prolongeeritult vabastav tablett
FENOFIBRAT TERAPIA 160 mg film-coated tablets oral use
FENOFIBRAT TERAPIA 160 mg õhukese polümeerikattega tabletid
Bezafibrat Stada 400 mg Retardtabletten
Bezafibrat Stada 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
160 MG/CAP HARD CAPSULES ORAL
160 MG/CAP KÕVAKAPSLID
Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Island
modified release tablets
TOIMEAINET MODIFITSEERITULT VABASTAV TABLETT
FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
SANOFI AVENTIS Prantsusmaa 1-13, boulevard Romain Rolland 75014 Paris
FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
SANOFI AVENTIS PRANTSUSMAA 1-13, boulevard Romain Rolland 75014 Paris
DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
Ratiopharm GmbH Graf-Arco Strasse 3 D-89079 ULMSaksamaa
GEMFIBROZILO STADA 600 mg film coated tablets oral
GEMFIBROZILO STADA 600 mg õhukese polümeerikattega tabletid
Lipox Bezafibrat 400 mg Retardtabletten
Lipox Bezafibrat 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
TRICOR 145 mg film-coated tablets oral use
TRICOR 145 mg õhukese polümeerikattega tabletid
FENOFIBRATO RANBAXY 160mg film coated tablets oral
FENOFIBRATO RANBAXY 160mg
DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM Saksamaa
600 MG/TAB Film coated tablet
600 MG/TAB õhukese polümeerikattega tablett
Befibrat 200mg Dragees 200 mg
FENOGAL 200 LIDOSE 200 mg
Prolonged-release tablet
Bezalip Retard toimeainet prolongeeritult vabastav tablett
Fenofibrat AbZ 250 mg Retardkapseln
Fenofibrat AbZ 250 mg Retardkapseln toimeainet prolongeeritult vabastav kõvakapsel
The European Commission issued a decision on 11 September 2012.
Euroopa Komisjon tegi otsuse 11. septembril 2012.
The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Ettevõte soovis, et müügiluba tunnustataks Prantsusmaal ja Ühendkuningriigis (asjaomased liikmesriigid).
In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Samuti ei olnud ravimi ohutuse ja efektiivsuse andmed piisavad, et kompenseerida puuduvat bioekvivalentsust.
Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Mifepristone Linepharma on saanud müügiloa detsentraliseeritud menetlusega Islandil, Norras, Rootsis, Soomes ja Taanis.
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.
Liikmesriigid ei jõudnud kokkuleppele ning Prantsusmaa ravimiamet tegi 23. veebruaril 2012 inimravimite komiteele vahekohtumenetluse alustamise esildise.
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.
Linepharma France esitas Mifepristone Linepharma vastastikuse tunnustamise taotluse, võttes aluseks 3. detsembril 2010 Rootsis antud esmase müügiloa.
In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Komitee soovitas korraldada prospektiivse vaatlusuuringu, et jälgida Mifepristone Linepharma määramist.
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.
Euroopa Ravimiamet (EMA) lõpetas 21. juunil 2012 vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Mifepristone Linepharma heakskiitmises.
Mifepristone Linepharma is a medicine used for terminating pregnancy.
Mifepristone Linepharma on ravim, mida kasutatakse raseduse katkestamiseks.
This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
See tähendab, et ta sarnaneb võrdlusravimiga Mifegyne, mis sisaldab sama toimeainet.
What is Mifepristone Linepharma?
Mis on Mifepristone Linepharma?
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.
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.
Why was Mifepristone Linepharma reviewed?
Miks Mifepristone Linepharma andmed uuesti läbi vaadati?
The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Komitee järeldas ka, et ravimi infolehele peab lisama märkuse, et annuseid üle 200 mg ei tohi manustada.
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.
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.
Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Mifepristone Linepharmat manustatakse ühekordse 200 mg annusena, 36-48 tunni pärast manustatakse teise ravimi gemeprosti annus.
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.
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.
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.
See sisaldab toimeainena mifepristooni, mis blokeerib hormooni progesterooni toime.
Mifepristone Linepharma is a ‘hybrid medicine'.
Mifepristone Linepharma on hübriidravim.
The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg.
Inimravimite komitee märkis, et ettevõtte esitatud andmed näitasid Mifepristone Linepharma ja võrdlusravimi bioekvivalentsust mõneti väljaspool vastuvõetavat vahemikku, sest Mifepristone Linepharma 200 mg tekitas organismis veidi suurema toimeainesisalduse kui Mifegyne 200 mg.
The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Esildise alus oli see, et Mifepristone Linepharma bioekvivalentsus võrdlusravimiga Mifegyne 200 mg ei ole tõendatud.
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.
Mifegyne müügiluba on 600 mg ja 200 mg annusele, kuid Mifepristone Linepharma ainus vorm on 200 mg annusega.
The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 28. veebruaril 2014.
The referral started on 7 November 2012.
Esildise menetlemine algas 7. novembril 2012.
Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Müügiloa taotlejad ja hoidjad esitasid kirjalikud selgitused 15. veebruaril 2013 ja 9. septembril 2013.
Veterinary Medicines
Veterinaarravimite komitee
The condition on the marketing authorisations is in Annex IV.
Müügilubade tingimused on esitatud IV lisas.
International non-proprietary name (INN): enrofloxacin
Rahvusvaheline mittekaubanduslik nimetus (INN): enrofloksatsiin
The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Komitee määras hindajaks H. Jukesi ja kaashindajaks E.-M. Vestergaardi.
Enrofloxacin is for veterinary use only.
Enrofloksatsiin on ette nähtud ainult veterinaarseks kasutamiseks.
The CVMP was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Veterinaarravimite komiteel paluti üle vaadata näidustused, annustamine ja keeluajad kanadel ning kalkunitel, et tagada tarbijate ohutus, kanade ja kalkunite efektiivne ravi ning samuti väiksem risk, et haigustekitajatel tekib enrofloksatsiini suhtes resistentsus.
Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Enrofloksatsiin on sünteetiline kemoterapeutikum, mis kuulub fluorokinolooni karboksüülhappe derivaatide klassi.