FrancophonIA/ELRC3.0 huggingface dataset:
English: Lipanthyl Nanopartikel 145 mg - Filmtabletten
Romanian: Lipanthyl Nanopartikel 145 mg - Filmcomprimatten 145 mg
English: Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Romanian: Ciprofibrate produselor medicamentoase care conţin cu autorizaţiei de introducere pe piaţă în Uniunea Europeană
English: Box 42
Romanian: Boulevard 40
English: Fenofanton 250 mg Hartkapseln, retardiert
Romanian: Fenofanton 250 mg Hartkapseln, retardiert capsulă cu eliberare prelungită
English: LIPIPHARM 145 mg, comprimé tablet
Romanian: LIPIPHARM 145 mg, comprimé comprimat
English: modified release tablets
Romanian: Apteor comprimat cu eliberare modificată
English: 68-88, rue Louis Ampère ZI des Chanoux
Romanian: Laboratoires LEURQUIN MEDIOLANUM 68-88, rue Louis Ampère ZI des Chanoux 93330 Neuilly-sur-Marne Franţa
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Romanian: FR - Franţa Actavis Group PTC ehf Reykjavikurvegi 76-78
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Romanian: FENOFIBRATE QUALIMED 145 mg, comprimé comprimat
English: Fenofibrat AL 250 retard 250 mg
Romanian: Fenofibrat AL 250 retard 250 mg capsulă cu eliberare prelungită
English: Bezabeta 400 retard
Romanian: Bezabeta 400 retard comprimat cu eliberare prelungită
English: 3 Howard Road, Eaton Socon St. Neots, Cambridgeshire PE19 8ET
Romanian: 3 Howard Road, Eaton Socon St.
English: IPOLIPID CAPSULES 600mg 600mg capsules
Romanian: IPOLIPID CAPSULES 600mg 600mg
English: Supralip 160 mg modified released tablet
Romanian: Supralip 160 mg comprimat cu eliberare modificată
English: BEZAFIBRAT SLAVIA 200 mg tablets
Romanian: BEZAFIBRAT SLAVIA 200 mg comprimat
English: Via dei Pestagalli, 7
Romanian: Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli, 7
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Romanian: FENOFIBRATE ALTER 160 mg, comprimé comprimat
English: Eulitop tablet
Romanian: Eulitop comprimat
English: S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
Romanian: Laboratoires SMB S.A. Rue de la Pastoralăe 26-28 1080 Brussels Belgium
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Romanian: FENOFIBRATE SANDOZ 145 mg, comprimé comprimat
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Romanian: FENOFIBRATE WINTHROP 145 mg, comprimé comprimat
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Romanian: FENOGAL 267 MG LIDOSE 267 mg
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Romanian: Lipantil Supra 145mg filmcoated tablets
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Romanian: FENOFIBRATE RANBAXY 160 mg, comprimé comprimat
English: FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
Romanian: LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette Franţa
English: SOLVAY PHARMA S.A.-N.V. Blue Planet Building Av. Brg.
Romanian: SOLVAY PHARMA S.A.-N.V. Blue Planet Building Av. Brg. E. Demunterlaan 3 1090 Bruxelles Belgium
English: FENOFIBRATE EG 145 mg, comprimé tablet
Romanian: FENOFIBRATE EG 145 mg, comprimé comprimat
English: 900 MG/TAB Film coated tablet
Romanian: 900 MG/TAB comprimat filmat
English: ES - Spain KERN PHARMA S.L.
Romanian: KERN PHARMA S.L. Venus, 72.
English: Lipantil Micro 200 mg capsules, hard hard capsules
Romanian: Lipantil Micro 200 mg capsules, hard
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Romanian: FENOFIBRATE SANDOZ 160 mg, comprimé comprimat
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Romanian: FENOFIBRATE CRISTERS 160 mg, comprimé comprimat
English: LIPILFEN 160 mg, comprimé tablet
Romanian: LIPILFEN 160 mg, comprimé comprimat
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Romanian: FENOFIBRATE ACTAVIS 160 mg, comprimé comprimat
English: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Romanian: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Islanda
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Romanian: FR - Franţa Biogaran15 bd Charles de Gaulle 92700 Colombes Franţa
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Romanian: CY - Cipru MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Romanian: Lipantil Supra 215mg filmcoated tablets
English: Lopid 300 mg capsules hard capsules
Romanian: Lopid 300 mg capsules
English: Fenofibrat AbZ 250 mg Retardkapseln
Romanian: Fenofibrat AbZ 250 mg Retardkapseln capsulă cu eliberare prelungită
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Romanian: CY - Cipru MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Romanian: Lipantil Supra 160mg filmcoated tablets
English: MT - Malta Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2
Romanian: KG Liebigstrasse 1-2
English: IT - Italy Francia Farmaceutici Industria Farmaco Biologica Srl
Romanian: IT - Italia C.T. Laboratorio Farmaceutico Srl
English: FENOFIBRAT TERAPIA 200 mg capsules
Romanian: FENOFIBRAT TERAPIA 200 mg
English: Lipanthyl supra 160 mgFilmtabletten
Romanian: Lipanthyl supra 160 mgFilmcomprimatten
English: Bezafibrat Sandoz 400mg Retardtabletten
Romanian: Bezafibrat Sandoz 400mg Retardtabletten comprimat cu eliberare prelungită
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Romanian: FENOFIBRATE ALMUS 160 mg, comprimé comprimat
English: CZ - Czech Republic
Romanian: CY - Cipru
English: FENOX 160 mg modified-release filmcoated tablets
Romanian: FENOX 160 mg comprimat cu eliberare modificată
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Romanian: CY - Cipru MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOFIBRATE DCI PHARMA 200 mg, gélule
Romanian: FENOFIBRATE DCI PHARMA 200 mg, gélule 200 mg
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Romanian: FENOFIBRATE MYLAN 145 mg, comprimé comprimat
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Romanian: FENOFIBRATE BIOGARAN 145 mg, comprimé comprimat
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Romanian: FENOFIBRATE ARROW 160 mg, comprimé comprimat
English: FENOFIBRATE ZYDUS 160 mg, comprimé tablet
Romanian: FENOFIBRATE ZYDUS 160 mg, comprimé comprimat
English: Lipantil Micro 267 mg capsules, hard hard capsules
Romanian: Lipantil Micro 267 mg capsules, hard
English: Lipantil Micro 67 mg capsules, hard hard capsules
Romanian: Lipantil Micro 67 mg capsules, hard
English: Bezafibrat-ratiopharm 400 mg Retardtabletten
Romanian: Bezafibrat-ratiopharm 400 mg Retardtabletten comprimat cu eliberare prelungită
English: FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
Romanian: FR - Franţa Biogaran 15, bd Charles de Gaulle 92700 Colombes Franţa
English: LIPOFOR CAPSULES 300mg 300mg capsules
Romanian: LIPOFOR CAPSULES 300mg 300mg
English: PharmaSwiss Ćeská republika s.r.o.
Romanian: PharmaSwiss Magyarország Kft.
English: Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Romanian: Gemfibrozil produselor medicamentoase care conţin cu autorizaţiei de introducere pe piaţă în Uniunea Europeană
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Romanian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Islanda
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Romanian: FENOFIBRATE BIOGARAN 160 mg, comprimé comprimat
English: Elipsia 145 mg Filmtabletten
Romanian: Elipsia 145 mg Filmtablette 145 mg
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Romanian: Fenofibrate produselor medicamentoase care conţin cu autorizaţiei de introducere pe piaţă în Uniunea Europeană
English: FENOFIBRATE WYVERN MEDICAL 67 mg, gélule
Romanian: FENOFIBRATE WYVERN MEDICAL 67 mg, gélule 67 mg
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Romanian: FR - Franţa Sanofi Aventis Franţa 1-13 Bd Romain Rolland 75014 Paris
English: Bezafibrat HEXAL 400mg retard Retardtabletten
Romanian: Bezafibrat HEXAL 400mg retard Retardtabletten comprimat cu eliberare prelungită
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Romanian: Lipcor 200 mg - Kapseln 200 mg
English: FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
Romanian: FENOFIBRATE EG 160 mg, comprimé pelliculé comprimat
English: ES - Spain SOLVAY PHARMA, S.A.Avda.
Romanian: SOLVAY PHARMA, S.A.Avda.
English: 00-308 Warsaw Poland
Romanian: z o.o. 8 Kruczkowskiego st. 00-308 Warsaw Polonia
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Romanian: RORomania sanofi-aventis Franţa 1-13, boulevard Romain Rolland 75014 Paris
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Romanian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Islanda
English: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
Romanian: LABORATOIRES S.M.B. S.A. 26-28 rue de la Pastoralăe B-1080 Bruxelles Belgium
English: IT - Italy Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene
Romanian: Via Fratelli Cervi, 8 - Valle Salimbene
English: 600 MG/TAB Film coated tablet
Romanian: 600 MG/TAB comprimat filmat
English: Bezadoc PB retard 400 mg 400 mg
Romanian: Bezadoc PB retard 400 mg 400 mg comprimat cu eliberare prelungită
English: FENOFIBRATE ENIREX 160 mg, comprimé pelliculé
Romanian: FENOFIBRATE ENIREX 160 mg, comprimé pelliculé 160 mg
English: AT - Austria G.L.
Romanian: AT - Austria
English: IPOLIPID CAPSULES 300mg 300mg capsules
Romanian: IPOLIPID CAPSULES 300mg 300mg
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Romanian: FENOFIBRATE WINTHROP 160 mg, comprimé comprimat
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Romanian: Lipsin 100 mg - Kapseln 100 mg
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Romanian: FENOSUP LIDOSE 160 MG 160 mg
English: 100 MG/CAP HARD CAPSULES ORAL
Romanian: 100 MG/CAP capsulă
English: 200 MG/CAP HARD CAPSULES ORAL
Romanian: 200 MG/CAP capsulă
English: 160 MG/CAP HARD CAPSULES ORAL
Romanian: 160 MG/CAP capsulă
English: Bezafibrat 400 retard Heumann
Romanian: Bezafibrat 400 retard Heumann comprimat cu eliberare prelungită
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Romanian: Pfizer Pharma GmbH Linkstr. 10D D- 10785 Berlin Germania
English: FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Romanian: Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
English: FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
Romanian: FR - Franţa Qualimed 117, allée des Parcs 69800 Saint Priest Franţa
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Romanian: FR - Franţa Mylan SAS 117, allée des Parcs 69800 Saint Priest Franţa
English: ES - Spain SOLVAY PHARMA S.A.Avda.
Romanian: SOLVAY PHARMA S.A.Avda.
English: Befibrat 200mg Dragees 200 mg
Romanian: Befibrat 200mg Dragees 200 mg comprimat cu eliberare prelungită
English: Wörwag Pharma GmbH & Co. KG Calwer Str. 7
Romanian: Wörwag Pharma GmbH & Co.
English: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Romanian: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Islanda
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven Germany
Romanian: 5D 27472 Cuxhaven Germania
English: FENOFIBRATE RPG 160 mg, comprimé pelliculé
Romanian: FENOFIBRATE RPG 160 mg, comprimé pelliculé 160 mg
English: TAD Pharma GmbH Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Romanian: 5 D-27472 Cuxhaven Germania
English: Lipoite Forte coated tablet
Romanian: Lipoite Forte drajeu
English: Gemfibrozil Sandoz filmcoated tablet
Romanian: Gemfibrozil Sandoz
English: Retard coated tablets Oral
Romanian: Lipanthyl Supra comprimat cu eliberare modificată orală
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Romanian: PL - Polonia ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germania
English: Apteor 160 mgFilmtabletten
Romanian: Apteor 160 mgFilmcomprimatten
English: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
Romanian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islanda
English: CY - Cyprus Varnavas Hadjipanayis Ltd, 7 Androcleous street
Romanian: Varnavas Hadjipanayis Ltd, 7 Androcleous street P.O.Box 21229
English: Lipox Bezafibrat 400 mg Retardtabletten
Romanian: Lipox Bezafibrat 400 mg Retardtabletten comprimat cu eliberare prelungită
English: Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183
Romanian: Gemfibrozil Sandoz comprimat 900, omhulde tabletten 900 mg, RVG
English: HUHungary
Romanian: HUUngaria
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Romanian: GEMFIBROZILO FERMON 900 mg
English: Prolonged-released tablet
Romanian: Befibrat comprimat cu eliberare prelungită
English: Lipox Bezafibrat 400mg Retardtabletten
Romanian: Lipox Bezafibrat 400mg Retardtabletten comprimat cu eliberare prelungită
English: Prolonged release coated tablet
Romanian: Hadiel comprimat cu eliberare prelungită
English: MODIFIED-RELEASE TABLET
Romanian: capsulă cu eliberare modificată
English: 400 mg Prolonged release coated tablet
Romanian: Bezafibrat dura 400 mg Retardtabletten comprimat cu eliberare prelungită
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Romanian: QUALIMED 117, allée des Parcs 69800 Saint-Priest FRANŢA
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Romanian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Franţa
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Romanian: GEMFIBROZILO FERMON 600 mg
English: 100 95 Grugliasco Italy
Romanian: Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Italia
English: FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
Romanian: Pompidou 92300 Levallois-Perret Franţa
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Romanian: Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
English: LIPOFIB 160 mg capsules
Romanian: LIPOFIB 160 mg
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Romanian: FENOFIBRATO RANBAXY 160mg
English: Mylan B.V.
Romanian: NL - Olanda Mylan B.V. Dieselweg 25
English: Bezafibrat Stada 400 mg Retardtabletten
Romanian: Bezafibrat Stada 400 mg Retardtabletten comprimat cu eliberare prelungită
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Romanian: SANOFI AVENTIS FRANŢA 1-13, boulevard Romain Rolland 75014 Paris
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Romanian: 15, boulevard Charles de Gaulle 92700 Colombes Franţa
English: 11 September 2012
Romanian: 11 septembrie 2012
English: The European Commission issued a decision on 11 September 2012.
Romanian: Comisia Europeană a emis o decizie la 11 septembrie 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Romanian: Compania dorea ca autorizaţia să fie recunoscută în Franţa şi Regatul Unit („statele membre în cauză”).
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Romanian: În plus, datele disponibile cu privire la siguranţa şi eficacitatea medicamentului nu au fost suficiente pentru a compensa lipsa bioechivalenţei.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Romanian: Mifepristone Linepharma este deja autorizat printr-o procedură descentralizată în Danemarca, Finlanda, Islanda, Norvegia şi Suedia.
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.
Romanian: Cu toate acestea, statele membre nu au putut ajunge la un acord, iar agenţia franceză de reglementare în domeniul medicamentelor a sesizat în acest sens CHMP în vederea unui arbitraj, la 23 februarie 2012.
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.
Romanian: La data de 21 iunie 2012, Agenţia Europeană pentru Medicamente a finalizat o procedură de arbitraj în urma unui dezacord între statele membre ale Uniunii Europene (UE) cu privire la autorizarea medicamentului Mifepristone Linepharma.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Romanian: Aceasta înseamnă că este similar cu un „medicament de referinţă”, numit Mifegyne, care conţine aceeaşi substanţă activă.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Romanian: În plus, comitetul a recomandat efectuarea unui studiu observaţional prospectiv pentru monitorizarea modului în care este prescris Mifepristone Linepharma.
English: EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
Romanian: 1 EMEA/H/A-29/1331
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.
Romanian: Linepharma France a depus o cerere pentru recunoaşterea reciprocă a Mifepristone Linepharma pe baza autorizaţiei iniţiale acordate de Suedia la data de 3 decembrie 2010.
English: It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.
Romanian: Acesta conţine substanţa activă mifepriston, care acţionează prin blocarea efectelor hormonului progesteron, un hormon cu un rol important în menţinerea sarcinii.
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Romanian: De asemenea, CHMP a concluzionat că informaţiile referitoare la produs trebuie să includă o afirmaţie potrivit căreia nu trebuie să se administreze doze mai mari de 200 mg.
English: However, the difference was not considered to be of concern as the safety and effectiveness of mifepristone at much higher doses of up to 600 mg is well established and has been confirmed by the supportive studies with Mifepristone Linepharma.
Romanian: Cu toate acestea, diferenţa nu a fost considerată drept un motiv de îngrijorare, întrucât siguranţa şi eficacitatea mifepristonului la doze mult mai mari, de până la 600 mg, este bine stabilită şi a fost confirmată prin studii de susţinere cu Mifepristone 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.
Romanian: Ambele medicamente sunt disponibile sub formă de comprimate de 200 mg, dar în timp ce Mifegyne a fost autorizat pentru a fi administrat în doze de 600 mg şi 200 mg, Mifepristone Linepharma a fost autorizat doar în doza de 200 mg.
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.
Romanian: Prin urmare, pe baza evaluării datelor disponibile în prezent şi a dezbaterii ştiinţifice din cadrul comitetului, CHMP a concluzionat că beneficiile Mifepristone Linepharma sunt mai mari decât riscurile asociate şi a recomandat acordarea autorizaţiei de introducere pe piaţă pentru Mifepristone Linepharma în toate statele membre în cauză.
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.
Romanian: Mifepristone Linepharma se administrează sub formă de doză unică de 200 mg, urmat după 36 până la 48 de ore de administrarea unei doze dintr-un alt medicament, numit gemeprost.
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Romanian: Mifepristone Linepharma este un „medicament hibrid”.
English: What is Mifepristone Linepharma?
Romanian: Ce este Mifepristone Linepharma?
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.
Romanian: Comitetul pentru produse medicamentoase de uz uman (CHMP) al agenţiei a concluzionat că beneficiile Mifepristone Linepharma sunt mai mari decât riscurile asociate şi a recomandat recunoaşterea autorizaţiei de introducere pe piaţă acordate în Suedia în alte state membre ale UE.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Romanian: Mifepristone Linepharma este un medicament utilizat pentru întreruperea sarcinii.
English: 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.
Romanian: CHMP a observat că datele prezentate de companie indică o mică abatere a Mifepristone Linepharma de la intervalul acceptabil pentru bioechivalenţa cu medicamentul de referinţă, Mifepristone Linepharma 200 mg producând niveluri uşor mai crescute de substanţă activă în organism decât Mifegyne 200 mg.
English: Why was Mifepristone Linepharma reviewed?
Romanian: De ce a fost evaluat Mifepristone Linepharma?
English: The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Romanian: Motivele sesizării au constat în faptul că nu se demonstrase că Mifepristone Linepharma era bioechivalent cu medicamentul de referinţă, Mifegyne 200 mg.
English: 28 February 2014
Romanian: 28 februarie 2014
English: The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Romanian: Avizul final a devenit decizie a Comisiei Europene la 28 februarie 2014.
English: The referral started on 7 November 2012.
Romanian: Sesizarea a fost iniţiată la 7 noiembrie 2012.
English: The condition on the marketing authorisations is in Annex IV.
Romanian: Condiţia pentru autorizaţiile de punere pe piaţă se află în anexa IV.
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Romanian: Solicitanţii şi titularii autorizaţiilor de introducere pe piaţă au furnizat explicaţii scrise la 15 februarie 2013 şi la 9 septembrie 2013.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Romanian: Acesta prezintă activitate antibacteriană împotriva unui spectru larg de bacterii gram-negative şi gram-pozitive.
English: Enrofloxacin is for veterinary use only.
Romanian: Enrofloxacina este numai pentru uz veterinar.
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Romanian: Comitetul i-a desemnat pe H. Jukes ca raportor şi pe E-M.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Romanian: Lista denumirilor produselor în cauză este prezentată în anexa I. Concluziile ştiinţifice sunt prevăzute în anexa II, împreună cu rezumatele caracteristicilor produselor, etichetarea şi prospectele modificate în anexa III.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Romanian: Enrofloxacina este un agent chimioterapeutic sintetic din clasa derivaţilor fluorochinolonici ai acidului carboxilic.