FrancophonIA/ELRC3.0 huggingface dataset:
English: Lipanthyl Supra 215 mg 215 mg film-coated tablets oral
Spanish: Lipanthyl Supra 215 mg 215 mg comprimidos recubiertos de película
English: Fenolip 160 mg hard capsules
Spanish: Fenolip 160 mg cápsula duraS
English: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
Spanish: S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Bélgica
English: FENOFIBRATE QUALIMED 145 mg, comprimé tablet
Spanish: FENOFIBRATE QUALIMED 145 mg, comprimé comprimido
English: 145 MG/TAB Film-coated tablet
Spanish: 145 MG/TAB Comprimidos recubiertos de película
English: RORomania
Spanish: RORumanía
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Spanish: Lipsin 100 mg - Kapseln 100 mg
English: LIPANTHYL PENTA 145 mg 145 mg film-coated tablets oral use
Spanish: LIPANTHYL PENTA 145 mg 145 mg comprimidos recubiertos de película
English: FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
Spanish: FR - Francia Actavis Group PTC ehf Reykjavikurvegi 76-78
English: FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
Spanish: FR - Francia Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Islandia
English: Sandoz A/S C.F.Tietgens Boulevard 40
Spanish: SE - Suecia Sandoz A/S C.F.Tietgens
English: Box 42
Spanish: Boulevard 40
English: FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
Spanish: FENOFIBRATE RATIOPHARM 160 mg, comprimé comprimido
English: S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
Spanish: Laboratoires SMB S.A. Rue de la Pastorale 26-28 1080 Brussels Bélgica
English: Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Spanish: Productos que contienen Gemfibrozil con Autorización de Comercialización en la Unión Europea
English: Lipantil Micro 200 mg capsules, hard hard capsules
Spanish: Lipantil Micro 200 mg CÁPSULAS, hard cápsulas duraS
English: LIPOFOR CAPSULES 600mg 600mg capsules
Spanish: LIPOFOR CÁPSULAS 600mg 600mg
English: FENOFIBRATE EG 145 mg, comprimé tablet
Spanish: FENOFIBRATE EG 145 mg, comprimé comprimido
English: LIPANTIL NANO 145 mg 145 mg film-coated tablets oral use
Spanish: LIPANTIL NANO 145 mg 145 mg comprimido recubierto de películas
English: 900 MG/TAB Film coated tablet
Spanish: 900 MG/TAB Comprimido recubierto de película
English: CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
Spanish: CY - Chipre Varnavas Hadjipanayis Ltd 7 Androcleous street
English: FENOFIBRATE TEVA 160 mg, comprimé tablet
Spanish: FENOFIBRATE TEVA 160 mg, comprimé comprimido
English: film-coated tablets oral
Spanish: Comprimido depo oral
English: LIPILFEN 160 mg, comprimé tablet
Spanish: LIPILFEN 160 mg, comprimé comprimido
English: FENOGAL 267 MG LIDOSE 267 mg capsule hard
Spanish: FENOGAL 267 MG LIDOSE 267 mg
English: FENOFIBRATE SANDOZ 145 mg, comprimé tablet
Spanish: FENOFIBRATE SANDOZ 145 mg, comprimé comprimido
English: CAPSULES
Spanish: CÁPSULAS
English: FENOFIBRATE RANBAXY 160 mg, comprimé tablet
Spanish: FENOFIBRATE RANBAXY 160 mg, comprimé comprimido
English: FENOFIBRATE WINTHROP 145 mg, comprimé tablet
Spanish: FENOFIBRATE WINTHROP 145 mg, comprimé comprimido
English: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Spanish: Bezafibrat "ratiopharm" retard 400 mgFilmtabletten
English: Lopid 300 mg capsules hard capsules
Spanish: Lopid 300 mg CÁPSULAS 300 mg cápsula duras
English: Lipantil Micro 67 mg capsules, hard hard capsules
Spanish: Lipantil Micro 67 mg CÁPSULAS, hard cápsulas duras
English: Lipantil Micro 267 mg capsules, hard hard capsules
Spanish: Lipantil Micro 267 mg CÁPSULAS, hard cápsulas duras
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Spanish: FENOFIBRATO RANBAXY 160mg comprimidos recubiertos de película
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Spanish: Lipcor 200 mg - Kapseln 200 mg
English: Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Spanish: Productos que contienen Ciprofibrato con Autorización de Comercialización en la Unión Europea
English: FENOFIBRATE SANDOZ 160 mg, comprimé tablet
Spanish: FENOFIBRATE SANDOZ 160 mg, comprimé comprimido
English: FENOFIBRATE EG 160 mg, comprimé pelliculé tablet
Spanish: FENOFIBRATE EG 160 mg, comprimé pelliculé comprimido
English: IPOLIPID CAPSULES 600mg 600mg capsules
Spanish: IPOLIPID CÁPSULAS 600mg 600mg
English: 600 MG/TAB Film coated tablet
Spanish: 600 MG/TAB Comprimido recubierto de película
English: Capsules, hard
Spanish: Cápsulas, duras
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Spanish: CY - Chipre MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Spanish: Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Islandia
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Spanish: FENOFIBRATE ALTER 160 mg, comprimé comprimido
English: GEMFIBROZILO STADA 900mg film coated tablets oral
Spanish: GEMFIBROZILO STADA 900mg comprimidos recubiertos de película
English: FENOFIBRATE CRISTERS 160 mg, comprimé tablet
Spanish: FENOFIBRATE CRISTERS 160 mg, comprimé comprimido
English: Prolonged-release capsule, hard
Spanish: Cápsula de liberación prolongada, dura
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Spanish: CY - Chipre MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
Spanish: DEAlemania ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
English: FENOFIBRAT TERAPIA 200 mg capsules
Spanish: FENOFIBRAT TERAPIA 200 mg
English: FENOFIBRATE 267MG CAPSULES
Spanish: FENOFIBRATE 267MG CÁPSULAS
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Spanish: FENOFIBRATE ACTAVIS 160 mg, comprimé comprimido
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Spanish: FENOFIBRATE ALMUS 160 mg, comprimé comprimido
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Spanish: CY - Chipre MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOFIBRATE MYLAN 145 mg, comprimé tablet
Spanish: FENOFIBRATE MYLAN 145 mg, comprimé comprimido
English: GEMFIBROZILO STADA 600 mg film coated tablets oral
Spanish: GEMFIBROZILO STADA 600 mg comprimidos recubiertos de película
English: ES - Spain SOLVAY PHARMA S.A. Avda.
Spanish: ES - España SOLVAY PHARMA S.A. Avda. Diagonal
English: modified release tablets
Spanish: comprimidos de liberación modificada
English: LIPIDIL MICRONISED HARD CAPSULES 267mg capsules
Spanish: LIPIDIL MICRONISED CÁPSULA DURAS 267mg
English: FENOFIBRAT TERAPIA 160 mg film-coated tablets oral use
Spanish: FENOFIBRAT TERAPIA 160 mg comprimido recubierto de películas
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Spanish: FENOFIBRATE BIOGARAN 145 mg, comprimé comprimido
English: FENOFIBRATE ZYDUS 160 mg, comprimé tablet
Spanish: FENOFIBRATE ZYDUS 160 mg, comprimé comprimido
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Spanish: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Islandia
English: FENOFIBRATE 67MG CAPSULES
Spanish: FENOFIBRATE 67MG CÁPSULAS
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Spanish: FENOFIBRATE WINTHROP 160 mg, comprimé comprimido
English: Lopid 600 mg film-coated tablets film-coated tablets oral use
Spanish: Lopid 600 mg comprimido recubierto de películas comprimidos recubiertos de película
English: LIPIDIL MICRONISED HARD CAPSULES 200mg capsules
Spanish: LIPIDIL MICRONISED CÁPSULA DURAS 200mg
English: filmcoated tablets
Spanish: COMPRIMIDO RECUBIERTO DE PELÍCULAS
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Spanish: FENOFIBRATE ARROW 160 mg, comprimé comprimido
English: Centrafarm Services B.V. Postbus 289
Spanish: Centrafarm Services B.V.
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Spanish: FENOFIBRATE BIOGARAN 160 mg, comprimé comprimido
English: SKSlovakia
Spanish: SKEslovaquia
English: SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1C
Spanish: BE - Bélgica SANOFI-AVENTIS BÉLGICA N.V.
English: Lipantil Supra 215mg filmcoated tablets film-coated tablets oral use
Spanish: Supra 215mg comprimido recubierto de películas comprimidos recubierto de película
English: Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Spanish: Supra 145mg comprimido recubierto de películas comprimido recubierto de películas
English: FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
Spanish: FR - Francia Biogaran15 bd Charles de Gaulle 92700 Colombes Francia
English: LIPOFOR CAPSULES 300mg 300mg capsules
Spanish: LIPOFOR CÁPSULAS 300mg 300mg
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Spanish: FENOSUP LIDOSE 160 MG 160 mg
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Spanish: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Islandia
English: FENOFIBRATO RANBAXY 200mg capsules
Spanish: FENOFIBRATO RANBAXY 200mg cápsulas
English: Lipantil Supra 160mg filmcoated tablets film-coated tablets oral use
Spanish: Supra 160mg comprimido recubierto de películas comprimidos recubierto de película
English: Modified-release capsule, hard
Spanish: Comprimido de liberación modificada, duro
English: Gemfibrozil Sandoz filmcoated tablet
Spanish: Gemfibrozil Sandoz
English: FENOFIBRATE 200MG CAPSULES
Spanish: FENOFIBRATE 200MG CÁPSULAS
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Spanish: DEAlemania ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Alemania
English: Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Iceland
Spanish: Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Islandia
English: coated tablets
Spanish: comprimidos recubiertos
English: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Spanish: Actavis Group PTC ehf Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Islandia
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Spanish: RORumanía sanofi-aventis Francia 1-13, boulevard Romain Rolland 75014 Paris
English: Ireland
Spanish: Rep. de Irlanda
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Spanish: FR - Francia Sanofi Aventis Francia 1-13 Bd Romain Rolland 75014 Paris
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Spanish: Productos que contienen Fenofibrato con Autorización de Comercialización en la Unión Europea
English: Prolonged-released tablet
Spanish: Comprimido de liberación prolongada
English: Prolonged-release capsules
Spanish: Cápsulas, de liberación prolongada
English: IPOLIPID CAPSULES 300mg 300mg capsules
Spanish: IPOLIPID CÁPSULAS 300mg 300mg
English: FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
Spanish: FR - Francia Biogaran 15, bd Charles de Gaulle 92700 Colombes Francia
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Spanish: FR - Francia BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes Francia
English: TABLET
Spanish: comprimido
English: 1-10 Constantinoupoleos St. P.O.
Spanish: 1-10 Constantinoupoleos St. P.O. Box: 51409
English: Av. du Bourg.
Spanish: Av. Brg.
English: Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183
Spanish: Gemfibrozil Sandoz comprimido 900, omhulde tabletten 900 mg, RVG
English: FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
Spanish: FR - Francia Qualimed 117, allée des Parcs 69800 Saint Priest Francia
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Spanish: FR - Francia Mylan SAS 117, allée des Parcs 69800 Saint Priest Francia
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Spanish: FR - Francia MYLAN SAS 117, allée des Parcs 69800 Saint-Priest FRANCIA
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest FRANCE
Spanish: FR - Francia MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francia
English: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
Spanish: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islandia
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Spanish: FR - Francia QUALIMED 117, allée des Parcs 69800 Saint-Priest Francia
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Spanish: GEMFIBROZILO FERMON 900 mg comprimidos recubiertos de película
English: Apteor modified released tablet
Spanish: Apteor comprimido de liberación modificada
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
Spanish: FR - Francia SANOFI AVENTIS FRANCIA 1-13, boulevard Romain Rolland 75014 Paris FRANCIA
English: FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland 75014 Paris
Spanish: FR - Francia SANOFI AVENTIS FRANCIA 1-13, boulevard Romain Rolland 75014 Paris
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
Spanish: FR - Francia SANOFI AVENTIS Francia 1-13, boulevard Romain Rolland 75014 Paris
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Spanish: GEMFIBROZILO FERMON 600 mg comprimidos recubiertos de película
English: LIPOFIB 160 mg capsules
Spanish: LIPOFIB 160 mg
English: Retard coated tablets Oral
Spanish: Comprimidos recubiertos de efecto retardado
English: LIPANOR® 100 mg capsules
Spanish: LIPANOR® 100 mg
English: Gemfibrozil Sandoz tablet 600, omhulde tabletten 600 mg, RVG 25182
Spanish: Gemfibrozil Sandoz comprimido 600, omhulde tabletten 600 mg, RVG
English: TRICOR 145 mg film-coated tablets oral use
Spanish: TRICOR 145 mg comprimidos recubiertos de película
English: LIPOFIB 67 mg capsules
Spanish: LIPOFIB 67 mg
English: MODIFIED-RELEASE TABLET
Spanish: COMPRIMIDO DE LIBERACIÓN MODIFICADA
English: Coated tablet
Spanish: COMPRIMIDO RECUBIERTO
English: COATED TABLET
Spanish: Comprimido recubierto
English: Lipanthyl 67 Micronised 67mg capsule, hard
Spanish: Lipanthyl 67 Micronised 67mg
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Spanish: Resultado de un procedimiento realizado de conformidad con el artículo 29 de la Directiva 2001/83/EC, modificada
English: The European Commission issued a decision on 11 September 2012.
Spanish: La Comisión Europea adoptó una decisión el 11 de septiembre de 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Spanish: deseaba que la autorización se reconociese en Francia y el Reino Unido (los «Estados miembros afectados»).
English: EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
Spanish: 11 de septiembre de 2012 EMA/410788/2012 Rev. 1 EMEA/H/A-29/1331
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Spanish: Además, los datos disponibles sobre la seguridad y la eficacia del medicamento no eran suficientes para compensar la falta de bioequivalencia.
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.
Spanish: Sin embargo, los Estados miembros no pudieron alcanzar un acuerdo y la agencia reguladora de medicamentos de Francia remitió el asunto al CHMP para un procedimiento de arbitraje el 23 de febrero de 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.
Spanish: El 21 de junio de 2012, la Agencia Europea de Medicamentos finalizó un procedimiento de arbitraje con motivo del desacuerdo entre Estados miembros de la Unión Europea (UE) relativo a la autorización del medicamento Mifepristone Linepharma.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Spanish: Esto significa que es similar a un «medicamento de referencia» llamado Mifegyne que contiene el mismo principio activo.
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.
Spanish: Contiene el principio activo mifepristona, que actúa bloqueando los efectos de la hormona progesterona, la cual desempeña una importante función en el mantenimiento del embarazo.
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.
Spanish: Linepharma France presentó una solicitud de reconocimiento mutuo para Mifepristone Linepharma sobre la base de la autorización inicial concedida por Suecia el 3 de diciembre de 2010.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Spanish: Además, el Comité ha recomendado que se realice un estudio prospectivo observacional para el seguimiento de la forma en que se prescribe Mifepristone Linepharma.
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Spanish: El CHMP también llegó a la conclusión de que la información sobre el producto debe incluir la declaración de que no deben administrarse dosis superiores a 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.
Spanish: Sin embargo, tales diferencias no se consideraron motivo de preocupación, ya que la seguridad y eficacia de la mifepristona en dosis muy superiores, hasta de 600 mg, han sido bien establecidas y confirmadas por los estudios de apoyo con Mifepristone Linepharma.
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.
Spanish: Mifepristone Linepharma se administra en una dosis única de 200 mg, seguida, de 36 a 48 horas después, por una dosis de otro medicamento denominado gemeprost.
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Spanish: Mifepristone Linepharma es un medicamento utilizado para la interrupción del embarazo.
English: The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Spanish: Los motivos de la remisión fueron que Mifepristone Linepharma no había demostrado ser bioequivalente al medicamento de referencia, Mifegyne 200 mg.
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.
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia concluyó que los beneficios de Mifepristone Linepharma son mayores que sus riesgos y recomendó que la autorización de comercialización concedida en Suecia se reconociera en los demás Estados miembros de la UE.
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.
Spanish: Por consiguiente, tras la evaluación de los datos actualmente disponibles y el debate científico en el seno del Comité, el CHMP consideró que los beneficios de Mifepristone Linepharma superan a los riesgos y recomendó que se concediera la autorización de comercialización para Mifepristone Linepharma en todos los Estados miembros afectados.
English: Why was Mifepristone Linepharma reviewed?
Spanish: ¿Por qué se ha revisado Mifepristone Linepharma?
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Spanish: Mifepristone Linepharma es un «medicamento híbrido».
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.
Spanish: El CHMP observó que los datos presentados por la empresa mostraban para Mifepristone Linepharma una pequeña desviación del intervalo aceptable de bioequivalencia con respecto al medicamento de referencia, ya que Mifepristone Linepharma 200 mg alcanzaba unos niveles del principio activo en el organismo que eran ligeramente superiores a los de Mifegyne 200 mg.
English: What is Mifepristone Linepharma?
Spanish: ¿Qué es 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.
Spanish: Ambos medicamentos están disponibles en comprimidos de 200 mg, pero mientras Mifegyne se autorizó en dosis de 600 mg y 200 mg, Mifepristone Linepharma solo se autorizó en la dosis de 200 mg. Mifepristone Linepharma ya está autorizado mediante un procedimiento descentralizado en Dinamarca, Finlandia, Islandia, Noruega y Suecia.
English: 28 February 2014
Spanish: 28 de febrero de 2014
English: The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Spanish: El dictamen final se transformó en Decisión de la Comisión Europea el 28 de febrero de 2014.
English: Veterinary Medicines
Spanish: Medicamentos Veterinarios
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Spanish: El Comité nombró a H. Jukes como ponente y a E-M. Vestergaard como ponente adjunto.
English: The condition on the marketing authorisations is in Annex IV.
Spanish: La condición de las autorizaciones de comercialización se encuentra en el Anexo IV.
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Spanish: Los solicitantes y los titulares de las autorizaciones de comercialización presentaron sus explicaciones por escrito el 15 de febrero de 2013 y el 9 de septiembre de 2013.
English: The referral started on 7 November 2012.
Spanish: El procedimiento de arbitraje se inició el 7 de noviembre de 2012.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Spanish: Presenta actividad antibacteriana contra un amplio espectro de bacterias gramnegativas y grampositivas.
English: International non-proprietary name (INN): enrofloxacin
Spanish: Denominación común internacional (DCI): enrofloxacino
English: Enrofloxacin is for veterinary use only.
Spanish: El enrofloxacino está destinado únicamente a uso veterinario.
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.
Spanish: La lista de las denominaciones de los productos afectados se recoge en el Anexo I. Las conclusiones científicas se recogen en el Anexo II, junto con las modificaciones de los resúmenes de las características de los productos, de las etiquetas y de los prospectos en el Anexo III.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Spanish: El enrofloxacino es un agente quimioterapéutico sintético perteneciente a la clase de los derivados de los ácidos carboxílicos de las fluoroquinolonas.