FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten
Spanish: Ibuprofeno lisina Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten
English: Ibuprofen Lysine Mylan 200 mg
Spanish: Ibuprofeno lisina Ibuprofen Lysine Mylan 200 mg
English: IBUPROFEN TABLETS BP 600MG
Spanish: WAYMADE IBUPROFEN TABLETS BP 600MG
English: Schmelztabletten
Spanish: DUEXIS TABLETS
English: 200 mg Orodispersible tablet Oral use
Spanish: 200 mg Comprimido dispersable Vía oral
English: 300 mg Prolonged-realease capsule
Spanish: 300 mg Cápsula dura de liberación prolongada
English: Deltaran 200 mg Filmtabletten
Spanish: Dexibuprofeno Deltaran 200 mg Filmtabletten
English: 400 mg Tablet
Spanish: 400 mg Comprimido
English: ATRISCAL 400 mg comprimidos recubiertos con película
Spanish: Dexibuprofeno ATRISCAL 400 mg comprimidos recubiertos con película
English: 400 mg Powder for oral solution
Spanish: 400 mg Polvo para solución oral Vía oral
English: Chelonia Healthcare Limited Boumpoulinas 11
Spanish: Reino Unido Chelonia Healthcare Limited
English: 400 mg Capsule, hard
Spanish: 400 mg Cápsula dura
English: LABORATORIOS JUVENTUS, S.A.
Spanish: LABORATORIOS NORMON, S.A.
English: Deltaran 400 mg Filmtabletten
Spanish: Dexibuprofeno Deltaran 400 mg Filmtabletten
English: Hadovka Office Park Czech Republic
Spanish: 160 00 Praha 6 - Hadovka Office Park
English: Brufen 400 mg šumivé granule
Spanish: Brufedol 400 mg šumivé granule
English: Brufen 400mg filmcoated tablets
Spanish: Brufen 400mg film-coated tablets
English: Abbott Laboratories Poland Sp. z o.o.
Spanish: BGP Products Poland Sp. z o.o.
English: IBUPROFENE ANGENERICO
Spanish: Ibuprofeno Generis
English: Nurofen 400 mg obložene tablete
Spanish: Nurofen Forte 400 mg obložene tablete
English: Ibuprofen 200mg film-coated tablets
Spanish: Ibuprofen 200mg filmcoated tablets
English: Brufen Retard 800 mg
Spanish: Brufen retard 800
English: 400 mg Powder for oral suspension
Spanish: 400 mg Polvo para suspensión oral
English: IBUPROFENO FARLINE 400 mg comprimidos bucodispersables
Spanish: IBUPROFENO ASTREL 400 mg comprimidos bucodispersables
English: Brufen 400 mg filmcoated tablets
Spanish: Brufen 400 mg film-coated tablets
English: SERACTIL 400 mg comprimidos recubiertos con película
Spanish: Dexibuprofeno SERACTIL 400 mg comprimidos recubiertos con película
English: Athlone Laboratories Limited, Ballymurray,
Spanish: Ballymurray,
English: Ibumax 600 mg filmcoated tablets
Spanish: Ibumax 600 mg film-coated tablets
English: Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten
Spanish: Ibuprofeno lisina Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten
English: IBUPROFENO ABEX 600 MG GRANULADO EFERVESCENTE EFG
Spanish: IBUKERN 600 MG GRANULADO EFERVESCENTE EFG
English: IBUPROFEN ARGININE
Spanish: Ibuprofeno arginina
English: Tradil
Spanish: Perivale
English: IBUPROFENRATIOPHARM 200 mg filmtabletta
Spanish: IBUPROFEN-RATIOPHARM 200 mg filmtabletta
English: Ibuprofen arginine 600 mg Granules for oral solution
Spanish: IBUPROFENE ANGELINI 600 mg Granulado para solución oral
English: Dignoflex 400mg retard
Spanish: Dignoflex 400mg retard 400 mg Comprimido de liberación prolongada
English: SAETIL 400 mg GRANULADO PARA SOLUCION ORAL
Spanish: MOMENTACT ANALGESICO 400 mg Granulado para solución oral
English: Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten
Spanish: Ibuprofeno lisina Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten
English: Guglgasse 17
Spanish: Boumpoulinas 11
English: Ibugesic 400 mg film-coated tablets
Spanish: Ibugesic 400 mg filmcoated tablets
English: Ibuprofeno Farmoz Ibuprofen
Spanish: Ibuprofeno Farmoz
English: 200 mg Dispersible tablet
Spanish: 200 mg Comprimido orodispersable
English: Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom
Spanish: Regulatory Department Wellcroft House, Wellcroft Road,
English: Seractil forte 400 mg - Filmtabletten
Spanish: Dexibuprofeno Seractil forte 400 mgFilmtabletten
English: Ibuprofeno Zentiva Ibuprofen
Spanish: Ibuprofeno Zentiva
English: IBUPROFEN TABLETS BP 400MG
Spanish: WAYMADE IBUPROFEN TABLETS BP 400MG
English: Ibumax 200 mg filmcoated tablets
Spanish: Ibumax 200 mg film-coated tablets
English: Ibumetin 200 mg film-coated tablets
Spanish: Ibumetin 200 mg filmcoated tablets
English: Nurofen Immedia 400 mg Pulver zur Herstellung einer Lösung zum Einnehmen
Spanish: Ibuprofeno lisina Nurofen Immedia 400 mg Pulver zur Herstellung einer Lösung zum Einnehmen
English: Seractil 200 mgFilmtabletten
Spanish: Dexibuprofeno Seractil 200 mgFilmtabletten
English: 400 mg Prolonged-release capsule, hard
Spanish: 400 mg Cápsula dura de liberación prolongada
English: Ibuprofen 200 mg film-coated tablets
Spanish: IBUPROFEN 200 MG FILMCOATED TABLETS
English: Nurofen Expres 200 mg
Spanish: Nurofen 200 mg
English: Ibu-acis 800 mg retard
Spanish: Ibu-acis 800 mg retard 800 mg Comprimido de liberación prolongada
English: Ibustar 400 mg filmcoated tablets
Spanish: Ibustar 400 mg film-coated tablets
English: Movone 400 mgFilmtabletten
Spanish: 400 mgFilmtabletten
English: Ibumetin 400 mg film-coated tablets
Spanish: Ibumetin 400 mg filmcoated tablets
English: Wealworth Industrial Estate Andover, Hampshire SP10 5AZ
Spanish: Andover, Hampshire
English: Nurofen Migraine Pain
Spanish: Spalt Kopfschmerz
English: 400 mg Dispersible tablet
Spanish: 400 mg Comprimido orodispersable
English: Ibumax 400 mg filmcoated tablets
Spanish: Ibumax 400 mg film-coated tablets
English: Ibuprofen Wrafton 400 mg, filmomhulde tabletten
Spanish: Ibuprofeno lisina Ibuprofen Wrafton 400 mg, filmomhulde tabletten
English: 123ratio Sp. z o.o.
Spanish: SEQUOIA Sp. z o.o.
English: Aharnon str, Limassol Industrial Estate, Limassol
Spanish: Limassol Industrial Estate Limassol 3508
English: Medphano Arzneimittel GmbH Maienbergstr.
Spanish: Medphano Arzneimittel GmbH
English: Ibumetin forte 400 mg - Filmtabletten
Spanish: Ibumetin forte 400 mgFilmtabletten
English: Schmerztabletten 500 mg
Spanish: 500 mg Comprimido
English: Avenida do Forte, 3 - Edificio Suécia III, Piso 1
Spanish: Avenida do Forte, 3Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal
English: Ibuprofen Teva 600mg
Spanish: Ibuprofen Teva 600mg 600 mg Comprimido
English: APOTEX ESPAÑA, S.L.
Spanish: Aurovitas Spain, S.A.U.
English: Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Hungría ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Perdofemina 400mg Ibuprofen lysine 684 mg Film-coated tablet
Spanish: Ibuprofeno lisina Ibuprofen Perrigo 400 mg 684 mg Comprimido recubierto con película
English: Denk Pharma GmbH & Co. KG Prinzregentenstr.
Spanish: Denk Pharma GmbH & Co. KG
English: Farmoz - Sociedade Técnico Medicinal, S.A.
Spanish: Distrifarma - Companhia de Distribuição Farmacêutica, S.A.
English: 400 mg Effervescent granules Oral use
Spanish: 400 mg Granulado efervescente Vía oral
English: Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Noruega ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Francia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Brufen Granules 600 Ibuprofen
Spanish: Brufen Granules 600
English: Pharmaceutical Works Polfa in Pabianice Joint-Stock Co. Marszałka J. Piłsudskiego St. 5 95-200 Pabianice Poland
Spanish: Pharmaceutical Works Polfa in Pabianice JointStock Co.
English: Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Italia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Perdotensio 200mg Ibuprofen lysine 342 mg Film-coated tablet
Spanish: Ibuprofeno lisina Nurofen Lysine 200 mg 342 mg Comprimido recubierto con película
English: Reckitt Benckiser Healthcare (UK) Ltd. Dansom Lane Hull HU8 7DS
Spanish: Reino Unido Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House
English: Ibu 600 - 1 A Pharma Ibuprofen
Spanish: Ibu 600 - 1 A Pharma
English: Ibuprofeno Generis Ibuprofen
Spanish: Ibuprofeno lisina Ibuzin
English: Ibuberl 400 mg
Spanish: IBUFLUX 400 MG
English: Lithuania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Lituania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Suecia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Ibum200 mg Capsule, soft
Spanish: Ibum200 mg Cápsula blanda
English: IBUPROFENRATIOPHARM 400 mg filmtabletta
Spanish: IBUPROFEN-RATIOPHARM 400 mg filmtabletta
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Alemania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Movone 200 mgFilmtabletten
Spanish: Dexibuprofeno Movone 200 mgFilmtabletten
English: Ibuprofen Wrafton 200 mg, filmomhulde tabletten
Spanish: Ibuprofeno lisina Ibuprofen Wrafton 200 mg, filmomhulde tabletten
English: IBALGIN RAPID IBUPROFEN
Spanish: Ibuprofeno lisina Ibalgin Rapid
English: 200 mg Effervescent granules Oral use
Spanish: 200 mg Granulado efervescente Vía oral
English: IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
Spanish: IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG
English: Ibuprofen codeine
Spanish: Ibuprofeno codeina
English: 600 mg Effervescent granules Oral use
Spanish: 600 mg Granulado efervescente Vía oral
English: Ibuprofen EG 400 mg Ibuprofen sodium hydrate
Spanish: Ibuprofen EG 400 mg 512 mg Comprimido efervescente
English: 200 mg Effervescent tablet
Spanish: 200 mg Comprimido efervescente
English: Str. Calea Rahovei nr. 266-268 Corp 60, Etaj 2, Sector 5 Bucuresti
Spanish: corp 63, anexele B-C, stâlpii 3-4, etaj 3, cam.
English: Ibuprofen Lysine Mylan
Spanish: Ibuprofeno lisina Nurofen lysine
English: SPIFEN 200 mg, comprimé
Spanish: SPIFEN 200 mg, comprimé 200 mg Comprimido
English: 200 mg Modified-release capsule, hard
Spanish: 200 mg Cápsula dura de liberación modificada
English: Nurofen Express 200 mg meke kapsule
Spanish: Nurofen Rapid 200 mg meke kapsule
English: Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom
Spanish: Reino Unido Relonchem Limited Cheshire House
English: de Bruselas, 13, 3º D.Edificio América.
Spanish: Avda. de Bruselas, 13
English: Fibraflex 600 mg Ibuprofen
Spanish: Fibraflex 600 mg
English: 1505 Sofia
Spanish: SP10 5AZ
English: Ibumyl Rapid 400 mg Ibuprofen lysine 400 mg Film-coated tablet
Spanish: Ibuprofeno lisina Ibumyl Rapid 400 mg 684 mg Comprimido recubierto con película
English: Strathmann GmbH & Co. KG Sellhopsweg 1
Spanish: Strathmann GmbH & Co. KG
English: Pharmamatch B.V. Egelenburg 2
Spanish: Países Bajos Abbott B.V Wegalaan 9
English: Ibuprofen 600mg Effervescent Granules
Spanish: Brufen 600mg Effervescent Granules
English: IBUPROFENE CARLO ERBA
Spanish: Ibuprofeno lisina ARFEN
English: Ibuklaph 800 mg Ibuprofen
Spanish: Ibuklaph 800 mg
English: IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Spanish: IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
English: 800 mg Modified-release tablet Oral use
Spanish: 800 mg Comprimido de liberación modificada
English: EUDORLIN Migräne Ibuprofen
Spanish: EUDORLIN Migräne
English: Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Finlandia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Ibuprofen Perrigo 200 mg potahované tablety
Spanish: Ibuprofeno lisina Ibuprofen Perrigo 200 mg potahované tablety
English: IBUPROFENO CINFA 40 MG/ML
Spanish: IBUPROFEN FARMALIDER 40 mg/ml
English: Nurofen 400 fasttabs Ibuprofen lysine 684 mg Film-coated tablet
Spanish: Ibuprofeno lisina Nurofen Lysine 400 mg 684 mg Comprimido recubierto con película
English: INFLANOR FORTE 400 mg
Spanish: Jenaprofen 400 mg
English: GELUFENE 200 mg, gélule
Spanish: GELUFENE 200 mg, gélule 200 mg Cápsula dura
English: 800 mg Prolonged-release tablet
Spanish: 800 mg Comprimido de liberación prolongada
English: Nurofen Express 400 mg meke kapsule
Spanish: Nurofen Rapid Forte 400 mg meke kapsule
English: ANADIN LIQUIFAST 200 MG
Spanish: ANADIN LIQUIFAST 200 MG EFFERVESCENT TABLETS
English: Nurofen-Ibuprofen 200 mg
Spanish: CUFEN-EF IBUPROFEN TABLETS 200 MG
English: Ibuprofen lysinate 400 mg Powder for oral solution
Spanish: Ibuprofen Temmler 400 mg 400 mg Comprimido soluble Vía oral
English: Perdophen
Spanish: Harpenden
English: Nurofen 200 fastsodium200 mg Coated tablet
Spanish: Nurofen 200 fastsodium 200 mg Comprimido recubierto Vía oral
English: Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Spanish: Letonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: EFISEN M 200 mg IBUPROFEN
Spanish: EFISEN M 200 mg
English: Horizon Pharma Gmbh Joseph Meyer Strasse 13-15 68167 Mannheim Germany
Spanish: Reino Unido Horizon Pharma Gmbh Joseph Meyer Strasse 13
English: Remedica Ltd.
Spanish: Pharmaceutical plants Milve Ltd.
English: Esprenit 800 mg retard
Spanish: Esprenit 800 mg retard Retardtabletten
English: IBUPROFEN TABLETS 200MG
Spanish: WAYMADE IBUPROFEN TABLETS 200MG
English: IBUPROFEN TABLETS 400MG
Spanish: WAYMADE IBUPROFEN TABLETS 400MG
English: Furthermore, the MAH has adapted the study design.
Spanish: Además de eso, adaptó el diseño del estudio.
English: The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Spanish: El nuevo diseño ha sido remitido a la Autoridad Competente alemana (BfArM) para que emita una opinión y en la actualidad está siendo objeto de una revisión.
English: Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Spanish: Resumen general de la evaluación científica de Novimp 3,6 mg Implantat y denominaciones asociadas (Ver Anexo I)
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormonedepending prostate carcinoma.
Spanish: Se trata de un agonista de la hormona LHRH (un análogo de la hormona liberadora de hormona luteinizante natural) que reduce las concentraciones séricas de testosterona hasta el nivel de castración para inhibir el crecimiento del carcinoma de próstata hormonodependiente.
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novimp 3,6 mg Implantat and associated names as listed in Annex I.
Spanish: • que el Comité ha examinado el procedimiento de arbitraje realizado de conformidad con el artículo 36 de la Directiva 2001/83/CE para Novimp 3,6 mg Implantat y denominaciones asociadas que figuran en el Anexo I;
English: In spite of the fact that patient safety and product efficacy was always ensured, the MAH decided to clinically reinvestigate the current goserelin 1-month product.
Spanish: A pesar de que la seguridad del paciente y la eficacia del producto estuvieron siempre aseguradas, el TAC decidió volver a investigar clínicamente la formulación actual de liberación prolongada durante 1 mes de goserelina.
English: Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCP-compliant studies in support of a MAA.
Spanish: Por consiguiente, ni el diseño comparativo del estudio ni los resultados del mismo pueden compensar el incumplimiento de los requisitos legales que exigen la presentación de estudios realizados conforme a la BPC en apoyo de una solicitud de autorización de comercialización.
English: Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Spanish: Las deficiencias analíticas habrían afectado por igual al fármaco de comparación y al producto del TAC: Puesto que la eficacia clínica se basó en una comparación entre dos productos, cabría esperar que los errores analíticos afectaran por igual a ambos.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Spanish: Se descubrieron infracciones críticas de normas fundamentales de la BPC del ICH y de normas de laboratorio aceptadas internacionalmente durante los análisis bioanalíticos de las muestras de sangre, tanto en el estudio GOS/001 (formulación de liberación prolongada durante 1 mes) como en el estudio GOS/002 (formulación de liberación prolongada durante 1 y 3 meses).
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Spanish: La temperatura exterior durante el tratamiento con Dany's BienenWohl debe ser de 3 °C como mínimo.
English: The active substance in Dany's BienenWohl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Spanish: La sustancia activa de Dany's BienenWohl es una sustancia permitida según se indica en el cuadro 1 del anexo del Reglamento (UE) nº 37/2010 de la Comisión:
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Spanish: Los IPS se deberán sincronizar presentar con la misma frecuencia establecida para el producto de referencia.
English: The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Spanish: El uso de Dany's BienenWohl con el mencionado régimen posológico se aplica únicamente a las colmenas con tableros verticales a los que se pueda acceder por la parte superior, puesto que no se ha investigado el tratamiento de las abejas en otro tipo de colmenas.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Spanish: <Fecha de la primera autorización:> <14/06/2018>
English: Mix with Dany's BienenWohl solution before use.
Spanish: Mezclar con la solución Dany's BienenWohl antes de usar.
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Spanish: Dany's BienenWohl tiene efectos corrosivos sobre las partes sensibles a la corrosión de los equipos de apicultura.
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Spanish: Dany's BienenWohl no se deberá verter en cursos de agua puesto que podría resultar peligroso para los peces y otros organismos acuáticos.
English: Mix with Dany's BienenWohl powder as instructed, before use.
Spanish: Mezclar con el polvo Dany's BienenWohl según las instrucciones antes de usar.
English: Dany's BienenWohl should not be used when honey supers are present.
Spanish: Dany's BienenWohl no debe utilizarse cuando haya bastidores con miel.
English: EU/2/18/225/002 (750 g solution)
Spanish: EU/2/18/225/002 (solución de 750 g)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Spanish: NÚMERO(S) DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN EU/2/18/225/001-002
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Spanish: Dany's BienenWohl solo debe aplicarse una única vez en colonias sin cría.
English: Dany's BienenWohl must only be applied once in brood-free colonies.
Spanish: Dany's BienenWohl solo debe aplicarse una vez en colonias sin cría.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Spanish: NÚMERO(S) DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN EU/2/18/225/001 (solución de 375 g)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Spanish: DENOMINACIÓN DEL MEDICAMENTO VETERINARIO Dany's BienenWohl solución para dispersión para colmenas ácido oxálico dihidrato
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Spanish: Dany's BienenWohl polvo y solución para 39,4 mg/ml de dispersión para colmenas de abejas
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Spanish: DENOMINACIÓN DEL MEDICAMENTO VETERINARIO Dany's BienenWohl polvo para dispersión para colmenas sacarosa
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Spanish: DENOMINACIÓN DEL MEDICAMENTO VETERINARIO Dany's BienenWohl polvo y solución para 39,4 mg/ml de dispersión para colmenas ácido oxálico dihidrato
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Spanish: DENOMINACIÓN DEL MEDICAMENTO VETERINARIO Dany's BienenWohl polvo y solución para 39,4 mg/ml de dispersión para colmenas de abejas
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Spanish: La Comisión Europea emitió una autorización de comercialización válida en toda la Unión Europea para el medicamento Clopidogrel DURA a Mylan Dura GmbH el 21 de septiembre de 2009.
English: The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Spanish: La dosis estándar de Clopidogrel DURA es de un comprimido de 75 mg administrado una vez al día con o sin alimentos.
English: Other information about Clopidogrel DURA:
Spanish: Otras informaciones sobre Clopidogrel DURA :
English: The full EPAR for Clopidogrel DURA can be found here.
Spanish: El texto completo del EPAR de Clopidogrel DURA puede encontrarse aquí.
English: It is available as pink, round tablets (75 mg).
Spanish: y se presenta en forma de comprimidos redondos de color rosa (75 mg).
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Spanish: El Comité de Medicamentos de Uso Humano (CHMP) concluyó que, de acuerdo con los requisitos de la Unión Europea, Clopidogrel DURA ha demostrado tener una calidad comparable y ser bioequivalente a Plavix.
English: Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Spanish: Clopidogrel DURA se utiliza en adultos para prevenir los episodios aterotrombóticos (problemas causados por los coágulos de sangre y el endurecimiento de las arterias).
English: Clopidogrel DURA can be given to the following groups of patients:
Spanish: Clopidogrel DURA puede administrarse a los siguientes grupos de pacientes:
English: The Committee recommended that Clopidogrel DURA be given marketing authorisation.
Spanish: En consecuencia, el Comité recomendó que se aprobase la comercialización de Clopidogrel DURA .
English: Because Clopidogrel DURA is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Spanish: Como Clopidogrel DURA es un medicamento genérico y es bioequivalente al medicamento de referencia, sus beneficios y riesgos son los mismos que los de dicho medicamento.
English: This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Spanish: Clopidogrel DURA es un «medicamento genérico», lo que significa que es similar a un medicamento de referencia ya autorizado en la Unión Europea (UE) llamado Plavix.
English: Clopidogrel DURA can be started between seven days and six months after the
Spanish: La administración de Clopidogrel DURA puede iniciarse entre 7 días y seis meses después del infarto;
English: Clopidogrel DURA is a medicine that contains the active substance clopidogrel.
Spanish: Clopidogrel DURA es un medicamento que contiene el principio activo clopidogrel.
English: Because Clopidogrel DURA is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Spanish: Como Clopidogrel DURA es un medicamento genérico, los estudios se han limitado a la realización de ensayos para demostrar que es bioequivalente al medicamento de referencia, Plavix.