natgillin/translations-raw huggingface dataset:
UK - England WINTHROP Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom 
Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom
NL - Holland Mylan B.V. 
Mylan B.V.
CZ - Tjekkiet Ingers Industrial Solutions s.r.o. 
Ingers Industrial Solutions s.r.o.
IT - Italien Actavis Italy Spa Viale Luigi Pasteur 10 - Nerviano - 20014 
IT - Italy Actavis Italy Spa Viale Luigi Pasteur 10 - Nerviano - 20014 MILANO
SISlovenien 
SISlovenia
Guildford, Surrey GU1 4YS United Kingdom 
One Onslow Street Guildford, Surrey GU1 4YS United Kingdom
CZ - Tjekkiet sanofi-aventis s.r.o. 
CZ - Czech Republic sanofi-aventis s.r.o.
FENOFIBRAT LPH 200 mg 200 mg kapsler (med mikroniseret pulver) 
FENOFIBRAT LPH 200 mg 200 mg capsules (micronised powder)
28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex France 
Laboratoires Fournier SA 28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex France
FR - Frankrig Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine France 
FR - France Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine France
CY - Cypern Varnavas Hadjipanayis Ltd, 7 Androcleous street 
CY - Cyprus Varnavas Hadjipanayis Ltd, 7 Androcleous street
FR - Frankrig Arrow 26, avenue Tony Garnier 69007 Lyon 
FR - France Arrow 26, avenue Tony Garnier 69007 Lyon
FR - Frankrig ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon 
FR - France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
FR - Frankrig ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE 
FR - France ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
FR - Frankrig ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France 
FR - France ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Hyperlipen kapsler, hårde 
Hyperlipen capsule, hard
Katalip 250 mg trde kapsule kapsler, hårde 
Katalip 250 mg trde kapsule capsule, hard
ES - Spanien QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 
ES - Spain QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 08210 BARCELONA
LACROMID 200 FC TABLETS 200mg 
LACROMID 200 FC TABLETS 200mg tablets
Kallithea 176 74 Attiki 
Kallithea 176 74
NL - Holland Sandoz B.V. 
Sandoz B.V.
UK - England PFIZER LIMITED. 
PFIZER LIMITED.
LT - Litauen UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2 
UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania
FR - Frankrig CRISTERS 22 quai Gallieni 92150 Suresnes FRANCE 
FR - France CRISTERS 22 quai Gallieni 92150 Suresnes France
DE - Tyskland TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven 
TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven Germany
DE - Tyskland Hennig Arzneimittel GmbH & Co.KG 
Hennig Arzneimittel GmbH & Co.KG
PL - Polen ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079 
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
DETyskland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany 
DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
RORumænien 
RORomania
PL - Polen Apotex Europe B.V. 
PL - Poland Apotex Europe B.V. Darwinweg 20
FENOGAL 267 MG LIDOSE 267 mg kapsler hårde 
FENOGAL 267 MG LIDOSE 267 mg capsule hard
LV - Letland Laboratoires Fournier S.A. Boulevard Clemenceau 28 
LV - Latvia Laboratoires Fournier S.A. Boulevard Clemenceau 28
BE - Belgien SANDOZ N.V. 
SANDOZ N.V.
GEMLIPID-MEDICHROM 600 MG/TAB Filmovertrukne tabletter 
GEMLIPID-MEDICHROM 600 MG/TAB Film coated tablet
PL - Polen Laboratoires Fournier S.A. Bd Clemenceau 28 
PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
Fenardin kapsler, hårde 
Fenardin capsules, hard
Lipsin 100 mg - Kapseln 100 mg kapsler, hårde 
Lipsin 100 mg - Kapseln 100 mg capsule, hard
TABLETTER 
tablets
FENOGAL 200 LIDOSE 200 mg kapsler, hårde 
FENOGAL 200 LIDOSE 200 mg capsule, hard
FENOSUP LIDOSE 160 MG 160 mg kapsler hårde 
FENOSUP LIDOSE 160 MG 160 mg capsule hard
NL - Holland Pfizer B.V. 
Pfizer B.V.
FR - Frankrig Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier 
FR - France Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
FR - Frankrig LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier 
FR - France LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
Lipanthyl 200 Micronised 200mg kapsler, hårde 
Lipanthyl 200 Micronised 200mg capsule, hard
ZAFIBRAL FC TABLETS 200mg 
ZAFIBRAL FC TABLETS 200mg tablets
Lipcor 200 mg - Kapseln 200 mg kapsler, hårde 
Lipcor 200 mg - Kapseln 200 mg capsule, hard
DE - Tyskland Pfizer Pharma GmbH Linkstr. 
Pfizer Pharma GmbH Linkstr.
Eaton Socon 
3 Howard Road Eaton Socon
ES - Spanien SOLVAY PHARMA S.A. Avda. 
ES - Spain SOLVAY PHARMA S.A. Avda.
FR - Frankrig Sandoz 49, av. Pompidou 92300 Levallois-Perret France 
FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
SPECIFAR ABEE 28th October str 1 Agia Barbara 123 51 Greece 
EL - Greece SPECIFAR ABEE 28th October str 1
Fenolip kapsler, hårde 
Fenolip capsule, hard
NL - Holland Actavis BV P.O. Box 313, 3740 AH Baarn, The Netherlands 
Box 313, 3740 AH Baarn, The Netherlands
MODALIM TABLETS 100mg 100mg 
MODALIM TABLETS 100mg 100mg tablets
NL - Holland Actavis BV P.O. Box 313, 3740 AH Baarn The Netherlands 
Box 313, 3740 AH Baarn The Netherlands
64295 Darmstadt Germany 
6D 64295 Darmstadt Germany
145 MG/TAB Filmovertrukne tabletter 
145 MG/TAB Film-coated tablet
Lipanor kapsler, hårde 
Lipanor capsule, hard
Tabletter med modificeret udløsning 
modified release tablets
Lipanthyl 267 Micronised 267mg kapsler, hårde 
Lipanthyl 267 Micronised 267mg capsule, hard
NL - Holland Pharmachemie BV P.O.Box 552, 
Pharmachemie BV P.O.Box 552, 2003 RN Haarlem The Netherlands
FR - Frankrig Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland 
FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
PL - Polen Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris, 
PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
Lipanthyl 67 Micronised 67mg kapsler, hårde 
Lipanthyl 67 Micronised 67mg capsule, hard
FENOFIBRATE RATIOPHARM 145 mg, comprimé 
FENOFIBRATE RATIOPHARM 145 mg, comprimé tablet
FR - Frankrig SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France 
FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
300,00 mg Kapsler 
300,00 mg capsule
ES - Spanien SOLVAY PHARMA, S.A.Avda. 
ES - Spain SOLVAY PHARMA, S.A.Avda.
FR - Frankrig Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon 
FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
160 MG/CAP HÅRDE KAPSLER oral anvendelse 
160 MG/CAP HARD CAPSULES ORAL
100,00 mg Kapsler 
100,00 mg capsule
Reykjavikurvegur 76-78, 220, Hafnarfjordur Iceland 
Reykjavikurvegur 76-78, 220, Hafnarfjordur
PL - Polen ratiopharm GmbH Graf-Arco-Strasse 3 
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3
LT - Litauen UAB PharmaSwiss Šeimyniškių 21B 
UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
100 MG/CAP HÅRDE KAPSLER oral anvendelse 
100 MG/CAP HARD CAPSULES ORAL
PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Greece 
EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
200 MG/CAP HÅRDE KAPSLER oral anvendelse 
200 MG/CAP HARD CAPSULES ORAL
Eastbourne, E Sussex BN22 9AG United Kingdom 
Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
26-28 rue de la Pastorale B-1080, Brussels Belgium 
26-28 rue de la Pastorale B-1080, Brussels
Lipantil Micro 200 mg capsules, hard hårde kapsler 
Lipantil Micro 200 mg capsules, hard hard capsules
FENOFIBRATE EXPANPHARM 67 mg, comprimé 
FENOFIBRATE EXPANPHARM 67 mg, comprimé tablet
DE - Tyskland Berlin-Chemie AG Glienicker Weg 125 
Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany
Kapsler med modificeret udløsning, hårde 
Modified-release capsule,hard
FENOFIBRATE EXPANPHARM 200 mg, comprimé 
FENOFIBRATE EXPANPHARM 200 mg, comprimé tablet
FENOFIBRATE RATIOPHARM 160 mg, comprimé 
FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
LIPIPHARM 145 mg, comprimé 
LIPIPHARM 145 mg, comprimé tablet
BEZAFIBRAT ARENA 200 mg 200 mg 
BEZAFIBRAT ARENA 200 mg 200 mg tablets
400 MG/TAB Depottabletter 
400 MG/TAB PROLONGED RELEASE TABLETS
ES - Spanien SOLVAY PHARMA S.A.Avda. 
ES - Spain SOLVAY PHARMA S.A.Avda.
CY - Cypern MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409 
CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
FENOFIBRATE QUALIMED 145 mg, comprimé 
FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Lipantil Micro 267 mg capsules, hard hårde kapsler 
Lipantil Micro 267 mg capsules, hard hard capsules
AT - Østrig Actavis Group PTC ehf Reykjavikurvegur 76-78 
AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
Lipantil Micro 67 mg capsules, hard hårde kapsler 
Lipantil Micro 67 mg capsules, hard hard capsules
160,0 mg filmovertrukne tabletter 
160,0 mg film-coated tablet
FENOFIBRATE ALTER 160 mg, comprimé 
FENOFIBRATE ALTER 160 mg, comprimé tablet
CY - Cypern MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409 
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
FENOFIBRATE TEVA 160 mg, comprimé 
FENOFIBRATE TEVA 160 mg, comprimé tablet
FENOFIBRATE SANDOZ 145 mg, comprimé 
FENOFIBRATE SANDOZ 145 mg, comprimé tablet
FR - Frankrig Actavis Group PTC ehf Reykjavikurvegi 76-78 
FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
CY - Cypern Varnavas Hadjipanayis Ltd 7 Androcleous street 
CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
100MG kapsler, hårde 
100MG capsule, hard
Fegenor kapsler, hårde 
Fegenor capsule, hard
BEZAFIBRAT SLAVIA 200 mg 
BEZAFIBRAT SLAVIA 200 mg tablets
CY - Cypern MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409 
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
IT - Italien Ratiopharm GmbH Graf-Arco Strasse 3 
IT - Italy Ratiopharm GmbH Graf-Arco Strasse 3
IT - Italien Ratiopharm Gmbh Graf-Arco Strasse 3 
IT - Italy Ratiopharm Gmbh Graf-Arco Strasse 3
FENOFIBRATE CRISTERS 160 mg, comprimé 
FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten 
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Lægemidler der indeholder ciprofibrat med markedføringstilladelses i EU. 
Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
FENOFIBRATE WINTHROP 145 mg, comprimé 
FENOFIBRATE WINTHROP 145 mg, comprimé tablet
ET - Estland Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon 
ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
FENOFIBRATE ACTAVIS 160 mg, comprimé 
FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Lægemidler der indeholder gemfibrozil med markedføringstilladelses i EU. 
Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Fenolip retard 250 mgKapseln depotkapsler, hårde oral anvendelse 
Fenolip retard 250 mgKapseln prolonged release capsule, hard
FENOFIBRATE BIOGARAN 145 mg, comprimé 
FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
BE - Belgien SANOFI-AVENTIS BELGIUM N.V. 
SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1C
FENOFIBRATE MYLAN 145 mg, comprimé 
FENOFIBRATE MYLAN 145 mg, comprimé tablet
FENOFIBRATE BIOGARAN 160 mg, comprimé 
FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
FENOFIBRATE RANBAXY 160 mg, comprimé 
FENOFIBRATE RANBAXY 160 mg, comprimé tablet
20154 MILANO 
20154 MILANO Italy
FENOFIBRATE ARROW 160 mg, comprimé 
FENOFIBRATE ARROW 160 mg, comprimé tablet
NEWBURY, BERKS RG14 1JN United Kingdom 
Genus Pharmaceuticals Limited Park View House 65 London Road NEWBURY, BERKS RG14 1JN United Kingdom
FENOFIBRATE ALMUS 160 mg, comprimé 
FENOFIBRATE ALMUS 160 mg, comprimé tablet
Overtrukne tabletter oral anvendelse 
FILM-COATED TABLET oral use
FENOFIBRATE SANDOZ 160 mg, comprimé 
FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Lægemidler der indeholder fenofibrat med markedføringstilladelses i EU. 
Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Tabletter med forsinket udløsning 
Liparison Retard capsules
FENOFIBRATE ZYDUS 160 mg, comprimé 
FENOFIBRATE ZYDUS 160 mg, comprimé tablet
900 MG/TAB Filmovertrukne tabletter 
900 MG/TAB Film coated tablet
Petersfield 
PTPortugal
UK - England ACTAVIS UK LIMITED WHIDDON VALLEY 
ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE DEVON EX32 8NS United Kingdom
FENOFIBRATE EG 145 mg, comprimé 
FENOFIBRATE EG 145 mg, comprimé tablet
United Kingdom 
UK - United Kingdom
FENOFIBRATE EG 160 mg, comprimé pelliculé 
FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
UK - England Archimedes Pharma Uk Limited Bishops Weald House 
Archimedes Pharma Uk Limited Bishops Weald House Albion Way, Horsham, West Sussex RH12 1AH United Kingdom
FR - Frankrig Biogaran15 bd Charles de Gaulle 92700 Colombes France 
FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
DE - Tyskland DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA 
DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
DE - Tyskland Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur 
Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
LIPILFEN 160 mg, comprimé 
LIPILFEN 160 mg, comprimé tablet
RORumænien sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris 
RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Lipsin retard 250 mgKapseln depotkapsler, hårde oral anvendelse 
Lipsin retard 250 mgKapseln prolonged release capsule, hard
NL - Holland Centrafarm Services B.V. 
Centrafarm Services B.V. Postbus 289
SESverige 
SESweden
FENOFIBRATE WINTHROP 160 mg, comprimé 
FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Tabletter, med modificeret udløsning 
Apteor modified released tablet
600 MG/TAB Filmovertrukne tabletter 
600 MG/TAB Film coated tablet
FR - Frankrig Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris 
FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
BEZAFIBRATE ACTAVIS L.P. 
Actavis BV P.O.
FR - Frankrig BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE 
FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
FR - Frankrig BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France 
FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
FR - Frankrig Biogaran 15, bd Charles de Gaulle 92700 Colombes France 
FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
Lægemidler der indeholder bezafibrat med markedføringstilladelses i EU. 
Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
FR - Frankrig Qualimed 117, allée des Parcs 69800 Saint Priest France 
FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
FR - Frankrig Mylan SAS 117, allée des Parcs 69800 Saint Priest France 
FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
FR - Frankrig QUALIMED 117, allée des Parcs 69800 Saint-Priest FRANCE 
FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
FR - Frankrig MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France 
FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Kapsler, hårde 
Capsules, hard
kapsler, hårde 
capsules, hard
FR - Frankrig SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE 
FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
FR - Frankrig SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris 
FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Depotkapsler 
Grofibrat capsules
LT - Litauen Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon 
Laboratoires Fournier S. A. 28 Boulevard Clemenceau 21000 Dijon
Agisilaou 46 
Box 42
SE - Sverige Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur , 
Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur Iceland
Resultat af en procedure i henhold til artikel 29 i direktiv 2001/83/EF, som ændret 
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Europa-Kommissionen traf en afgørelse den 11. september 2012. 
The European Commission issued a decision on 11 September 2012.
Virksomheden ønskede, at denne godkendelse blev anerkendt i Frankrig og Det Forenede Kongerige (de "berørte medlemsstater"). 
The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Den 11. september 2012 EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331 
EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
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. 
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.
Mifepriston Linepharma er i forvejen godkendt ved en decentral procedure i Danmark, Finland, Island, Norge og Sverige. 
Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Desuden var de foreliggende data om lægemidlets sikkerhed og virkning ikke tilstrækkelige til at opveje den manglende bioækvivalens. 
In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
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. 
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.
Det indeholder det aktive stof mifepriston, der virker ved at blokere virkningerne af hormonet progesteron, som spiller en vigtig rolle i opretholdelsen af svangerskabet. 
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.
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. 
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.
CHMP konkluderede desuden, at produktinformationen bør indeholde en angivelse af, at der ikke bør gives højere doser end 200 mg. 
The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Det vil sige, at det svarer til "referencelægemidlet" Mifegyne, der indeholder samme aktive stof. 
This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
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. 
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.
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. 
In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Hvorfor blev Mifepriston Linepharma vurderet igen? 
Why was Mifepristone Linepharma reviewed?
Hvad er Mifepriston Linepharma? 
What is Mifepristone Linepharma?
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. 
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.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Mifepriston Linepharma opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Sverige, skal anerkendes i de øvrige EU medlemsstater. 
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.
Mifepriston Linepharma er et lægemiddel, der anvendes til svangerskabsafbrydelse. 
Mifepristone Linepharma is a medicine used for terminating pregnancy.
Begrundelsen for indbringelsen var, at Mifepriston Linepharma ikke var påvist at være bioækvivalent med referencelægemidlet, 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.
Mifepriston Linepharma er et "hybridt lægemiddel". 
Mifepristone Linepharma is a ‘hybrid medicine'.
Efter vurderingen af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP derfor, at fordelene ved Mifepriston Linepharma opvejer risiciene, og at der bør udstedes markedsføringstilladelse for Mifepriston Linepharma i alle berørte medlemsstater. 
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.
CHMP konstaterede, at de af virksomheden forelagte oplysninger viste en lille afvigelse af Mifepriston Linepharma fra det acceptable område for bioækvivalens med referencelægemidlet, idet Mifepriston Linepharma, 200 mg, frembragte lidt højere koncentrationer af det aktive stof i kroppen end Mifegyne, 200 mg. 
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.
Mifepriston Linepharma gives som en enkelt dosis på 200 mg, hvorpå der efter 36-48 timer gives en dosis af et andet lægemiddel, gemeprost. 
Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Den 28. februar 2014 
28 February 2014
Den endelige udtalelse blev den 28. februar 2014 omarbejdet til en beslutning af EuropaKommissionen. 
The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Det har antibakteriel aktivitet mod et bredt spektrum af gramnegative og grampositive bakterier. 
It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Indbringelsesproceduren blev indledt den 7. november 2012. 
The referral started on 7 November 2012.
Ansøgerne og indehaverne af markedsføringstilladelserne afgav skriftlige redegørelser den 15. februar 2013 og den 9. september 
Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Internationalt fællesnavn (INN): enrofloxacin 
International non-proprietary name (INN): enrofloxacin
Afdelingen for veterinærlægemidler 
Veterinary Medicines
Betingelsen for markedsføringstilladelserne fremgår af bilag IV. 
The condition on the marketing authorisations is in Annex IV.
Som rapportør og medrapportør udpegede udvalget henholdsvis H. Jukes og E-M. Vestergaard. 
The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.