FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: Por consiguiente, el PRAC recomienda la modificación de las condiciones de la autorización de comercialización de los medicamentos que contienen valproato y sustancias relacionadas a los que se hace referencia en el anexo I, cuyas secciones relevantes del resumen de las características del producto y del prospecto se incluyen en el anexo III de la recomendación del PRAC.
Croatian: Stoga, PRAC je preporučio izmjenu uvjeta za izdavanje odobrenja za stavljanje u promet lijekova koji sadrže valproat i povezane tvari navedene u Dodatku I., za koje su relevantni dijelovi sažetka opisa svojstava lijeka i uputa o lijeku navedeni u Dodatku III. preporuke PRAC-a.
Spanish: Conclusiones científicas y explicación pormenorizada de las bases científicas de las diferencias con respecto a la recomendación del PRAC
Croatian: Znanstveni zaključci i detaljno pojašnjenje za znanstvene razloge za razlike u odnosu na preporuku PRAC-a
Spanish: • El PRAC ha llegado a la conclusión de que el valproato y las sustancias relacionadas no deben utilizarse en niñas, mujeres en edad fértil y mujeres embarazadas, a menos que las alternativas de tratamiento sean ineficaces o no se toleren, en las indicaciones siguientes:
Croatian: • je PRAC zaključio da se valproat i povezane tvari ne smiju koristiti u ženske djece, žena reproduktivne dobi i trudnica osim ako alternativne terapije nisu nedjelotvorne ili se ne podnose, i to u sljedećim indikacijama:
Spanish: Esto incluye las respuestas de los titulares de las autorizaciones de comercialización, por escrito y en exposiciones orales, y las conclusiones del grupo asesor de expertos en neurología.
Croatian: Ovaj je postupak obuhvatio odgovore dostavljene od strane nositelja odobrenja za stavljanje lijeka u promet pisanim putem i usmenim putem, kao i ishode znanstvene savjetodavne grupe na području neurologije.
Spanish: Por tanto, el PRAC llegó a la conclusión de que el valproato y las sustancias relacionadas no deben utilizarse en niñas, mujeres en edad fértil y mujeres embarazadas para el tratamiento de la epilepsia y de los episodios maníacos en el trastorno bipolar, a menos que las alternativas de tratamiento sean ineficaces o no se toleren.
Croatian: Stoga, PRAC je zaključio da se valproat i povezane tvari ne smiju primjenjivati u ženske djece, žena reproduktivne dobi i trudnica za potrebe liječenja epilepsije i maničnih epizoda u bipolarnom poremećaju, osim ako su alternativne terapije nedjelotvorne ili se ne podnose.
Spanish: Además, en la recomendación se tuvieron en cuenta también los puntos de vista de las pacientes, familiares y cuidadores, así como las opiniones de los profesionales sanitarios, respecto a las implicaciones, la comprensión y la concienciación de los riesgos asociados a la exposición intrauterina a valproato.
Croatian: Nadalje, u preporuci su u obzir uzeta mišljenja bolesnika, obitelji i skrbnika, te mišljenja zdravstvenih djelatnika u vezi s implikacijama, razumijevanjem i svjesnošću rizika povezanih s in-utero izlaganjem valproatu.
Spanish: Además, el PRAC ha tenido en cuenta los puntos de vista de las pacientes, familiares y cuidadores, así como las opiniones de los profesionales sanitarios, para la comprensión y la concienciación de los riesgos asociados a la exposición intrauterina a valproato.
Croatian: Nadalje, PRAC je razmotrio mišljenja bolesnika, obitelji i skrbnika kao i mišljenja zdravstvenih djelatnika i vezi s razumijevanjem i upoznatošću s rizicima povezanima s in-utero izlaganju valproatu.
Spanish: • El PRAC ha llegado a la conclusión de que el valproato y las sustancias relacionadas deben estar contraindicados en la profilaxis de las crisis de migraña durante el embarazo y en mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces durante el tratamiento.
Croatian: • je PRAC zaključio da valproat i povezane tvari treba kontraindicirati u profilaksi migrenskih napadaja u trudnica i žena reproduktivne dobi koje ne koriste djelotvorne metode kontracepcije tijekom liječenja valproatom.
Spanish: Entre ellos, una guía para el médico y un folleto informativo para la paciente que garanticen la comprensión y concienciación sobre los riesgos por parte de los médicos y las pacientes.
Croatian: Isti uključuju smjernice za propisivače, knjižicu za bolesnike i informacije koje osiguravaju razumijevanje i upoznatost propisivača i bolesnika s rizicima.
Spanish: 9Cohen M.J et al. Fetal Antiepileptic Drug Exposure: Motor, Adaptive and Emotional/Behavioural Functioning at age 3 years.
Croatian: Drug Exposure: Motor, Adaptive and Emotional/Behavioural Functioning at age 3
Spanish: El protocolo se presentará conforme al artículo 107 quindecies, apartado 1 de la Directiva 2001/83/CE:
Croatian: Protokol će biti dostavljen u skladu sa člankom 107n (1.) Direktive 2001/83/EZ:
Spanish: Para el 12 de enero de
Croatian: Do 12. siječnja 2015.
Spanish: El estudio deberá llevarse a cabo en más de un Estado miembro.
Croatian: Ispitivanje treba provesti u više od jedne države članice.
Spanish: El resto de los informes provisionales se presentarán al PRAC en adelante cada 6 meses durante los primeros 2 años.
Croatian: Daljnja privremena izvješća trebaju se dostaviti PRAC-u svakih 6 mjeseci tijekom prve 2 godine.
Spanish: El informe final del estudio se presentará al PRAC:
Croatian: Konačno završno izvješće dostavit će se PRAC-u:
Spanish: El primer informe provisional se presentará al PRAC:
Croatian: Prvo privremeno izvješće dostavit će se PRAC-u:
Spanish: Deberán presentarse a las autoridades nacionales competentes:
Croatian: Isti se trebaju dostaviti nacionalnim nadležnim tijelima:
Spanish: El diseño del estudio estará encaminado a evaluar y cuantificar la eficacia de las medidas de minimización del riesgo e incluirá una evaluación y un análisis antes y después de su implementación.
Croatian: Cilj dizajna ispitivanja treba biti ocjena i kvantificiranje djelotvornosti mjera za smanjivanje rizika, te isti treba uključivati analizu i ocjenu prije i nakon implementacije.
Spanish: En los 6 meses siguientes al acuerdo del grupo de Coordinación.
Croatian: U roku od 6 mjeseci u dogovoru s
Spanish: Los titulares de las autorizaciones de comercialización de valproato y sustancias relacionadas deberán editar y presentar materiales formativos de acuerdo con los elementos centrales acordados.
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari razvit i dostavit će edukacijske materijale sukladno dogovorenim ključnim elementima.
Spanish: Las autoridades nacionales competentes de los Estados miembros o los Estados miembros de referencia, si procede, garantizarán que los titulares de las autorizaciones de comercialización cumplan las condiciones siguientes:
Croatian: Nadležna državna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), gdje je to primjenjivo, osigurati će ispunjavanje sljedećih uvjeta od strane nositelja odobrenja:
Spanish: Dichos materiales deberán garantizar que el médico que realiza la prescripción esté informado y que las pacientes entiendan y tomen conciencia de los riesgos asociados a la exposición intrauterina a valproato.
Croatian: Ovi materijali trebaju osigurati informiranost propisivača te razumijevanje i prepoznavanje od strane bolesnika rizika povezanih s in-utero izlaganju valproatu.
Spanish: Los titulares de las autorizaciones de comercialización de valproato y sustancias relacionadas deberán realizar un estudio de utilización del fármaco para evaluar la eficacia de las medidas de minimización del riesgo y caracterizar con más exactitud los patrones de prescripción de valproato.
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari provest će ispitivanje iskoristivosti lijeka kako bi ocijenili djelotvornost mjera za smanjivanje rizika i dalje okarakterizirali obrasce propisivanja za valproat.
Spanish: Oficina D 28230 Las Rozas (Madrid) Spain
Croatian: 28230 Las Rozas (Madrid) Spain
Spanish: 11-15 Quai Dion Bouton 92800 Puteaux France
Croatian: 11-15 Quai Dion Bouton 92800 Puteaux
Spanish: Desitin Arzneimittel GmbH Postfach 630164
Croatian: Norveška Desitin Arzneimittel GmbH Postfach 630164
Spanish: Reino Unido Norton Healthcare Limited Ridings Point, Whistler Drive
Croatian: Norton Healthcare Limited Ridings Point, Whistler Drive
Spanish: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Croatian: Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
Spanish: Reino Unido Teva UK Limited Brampton Road, Hampden Park
Croatian: Teva UK Limited Brampton Road, Hampden Park
Spanish: Luxemburgo Eurogenerics SA Esplanade Heysel b22
Croatian: Luksemburg Eurogenerics SA Esplanade Heysel b22
Spanish: Luxemburgo Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Croatian: Luksemburg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Spanish: DK-2970 Hørsholm
Croatian: DK-2970 Hørsholm Denmark
Spanish: Alemania IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Croatian: Njemačka IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Spanish: PSC 170 00 Holesovice Czech Republic
Croatian: PSC 170 00 Holesovice Czech Republic magnezijev valproat
Spanish: Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Croatian: Francuska Arrow Generiques 26, avenue Tony Garnier 69007 Lyon
Spanish: 110, Esplanade du Général de Gaulle
Croatian: Francuska TEVA SANTE 110, Esplanade du Général de Gaulle
Spanish: Finlandia Sanofi Oy Huopalahdentie 24 PL 22
Croatian: Sanofi Oy Huopalahdentie 24 PL 22
Spanish: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Croatian: Francuska Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 Lyon
Spanish: Letonia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Croatian: Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Spanish: SANOFI AVENTIS, S.A. Josep Plá, 2
Croatian: Španjolska SANOFI AVENTIS, S.A. Josep Plá, 2
Spanish: Reino Unido Winthrop Pharmaceuticals UK Limited
Croatian: Winthrop Pharmaceuticals UK Limited
Spanish: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Croatian: Austrija sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Spanish: Convulsofin Tabletten
Croatian: Convulsofin Tabletten tablet
Spanish: 85101 Bratislava
Croatian: 85101 Bratislava Slovak Republic
Spanish: Finlandia Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Croatian: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Spanish: Alemania Mylan dura GmbH Wittichstr.
Croatian: Njemačka Mylan dura GmbH Wittichstr.
Spanish: Luxemburgo Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Croatian: Luksemburg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Spanish: Alemania Stadapharm GmbH Stadastr 2-18
Croatian: Njemačka Stadapharm GmbH Stadastr 2-18
Spanish: Dinamarca Sanofi-aventis Denmark A/S
Croatian: Sanofi-aventis Denmark A/S
Spanish: Evropská 846/176a 160 00 Prague 6
Croatian: Sanofi-Aventis, s.r.o. Evropská 846/176a 160 00 Prague 6
Spanish: Luxemburgo Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Croatian: Luksemburg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Spanish: Reino Unido Generics UK Limited Station Close, Potter's Bar Hertfordshire
Croatian: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Spanish: Ranbaxy Pharmacie Génériques
Croatian: Francuska Ranbaxy Pharmacie Génériques
Spanish: Alemania Orion Corporation Orionintie 1 A
Croatian: Njemačka Orion Corporation Orionintie 1 A
Spanish: Países Bajos Apotex Europe B.V.
Croatian: Nizozemska Apotex Europe B.V.
Spanish: Luxemburgo Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Croatian: Luksemburg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Spanish: D-22311 HAMBURG Deutschland
Croatian: D-22311 HAMBURG
Spanish: Alemania 1 A Pharma GmbH Keltenring 1 + 3
Croatian: Njemačka 1 A Pharma GmbH Keltenring 1 + 3
Spanish: Alemania Sanofi-Aventis Deutschland GmbH
Croatian: Njemačka Sanofi-Aventis Deutschland GmbH
Spanish: 02101 Espoo
Croatian: 02101 Espoo Finland
Spanish: Dinamarca Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Croatian: Edvard Thomsens Vej 14 DK-2300 København
Spanish: Eslovaquia Sandoz Pharmaceuticals d.d
Croatian: Sandoz Pharmaceuticals d.d
Spanish: Depakine sirop
Croatian: Depakine sirup
Spanish: Alemania Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Croatian: Njemačka Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
Spanish: Sanofi-Aventis Bulgaria EOOD
Croatian: Bugarska Sanofi-Aventis Bulgaria EOOD
Spanish: Via Scarlatti Domenico, 31 20124 Milano Italy
Croatian: Via Scarlatti Domenico, 31 20124 Milano Italy valproatna kiselina, natrijev valproat
Spanish: Alemania ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Croatian: Njemačka ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Spanish: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution
Croatian: Orlept (SF) Liquid or Sodium Valproate 40mg/ml oral solution oralna otopina
Spanish: 500-1000 mg Granulado de liberación modificada
Croatian: 500-1000 mg granule s prilagođenim oslobađanjem
Spanish: Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Croatian: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Spanish: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml
Croatian: Depakine vloeistof voor kinderen, vloeistof voor oraal gebruik 300 mg/ml oralna tekućina
Spanish: Sanofi-Aventis zrt.
Croatian: Mađarska Sanofi-Aventis zrt.
Spanish: Alemania Neuraxpharm Arzneimittel GmbH
Croatian: Njemačka Neuraxpharm Arzneimittel GmbH
Spanish: Valproinsäure- ratiopharm Lösung
Croatian: Valproinsäure- ratiopharm Lösung oralna otopina
Spanish: Eslovaquia Sanofi-Aventis Slovakia s r.o.
Croatian: Sanofi-Aventis Slovakia s r.o.
Spanish: DEMO ABEE 21st Km Athens-Lamias National Highway 14568 Kryoneri Greece
Croatian: National Highway 14568 Kryoneri Greece
Spanish: Depakine suikervrije stroop, drank 200 mg/5 ml
Croatian: Depakine suikervrije stroop, drank 200 mg/5 ml oralna otopina
Spanish: Alemania TAD Pharma GmbH Heinz-Lohmann-Str. 5
Croatian: Njemačka TAD Pharma GmbH Heinz-Lohmann-Str.
Spanish: Finlandia Orion Pharma Orionintie 1
Croatian: Orion Pharma Orionintie 1 PL 65
Spanish: 17 Bonifraterska Str. 00-203 Warsaw Poland
Croatian: Sanofi-Aventis Sp. z o.o. 17 Bonifraterska Str. 00-203 Warsaw Poland
Spanish: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette France
Croatian: Francuska LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf
Spanish: DEPAKINE 57,64 mg/ml, sirop 57,64 mg
Croatian: DEPAKINE 57,64 mg/ml, sirop 57,64 mg sirup
Spanish: Valpro TAD Lösung
Croatian: Valpro TAD Lösung oralna otopina
Spanish: Rumanía Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Croatian: Rumunjska Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Spanish: Slovak Republic
Croatian: Slovačka Republika
Spanish: Sanofi-Aventis Croatia d.o.o.
Croatian: Hrvatska Sanofi-Aventis Croatia d.o.o.
Spanish: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable
Croatian: VALPROATE DE SODIUM AGUETTANT 400 mg/4 ml, solution injectable otopina za injekciju u venu
Spanish: Epilim 100 mg Crushable Tablets
Croatian: Epilim 100 mg Crushable Tablets tableta
Spanish: Alemania Winthrop Arzneimittel GmbH
Croatian: Njemačka Winthrop Arzneimittel GmbH
Spanish: Depakine Chronosphere 250 166,76 mg 72,61 mg
Croatian: Depakine Chronosphere 250 166,76 mg + 72,61 mg granule s produljenim oslobađanjem
Spanish: Epilim 400mg Powder & solvent for solution for injection
Croatian: Epilim 400mg Powder & solvent for solution for injection prašak za injekciju u venu
Spanish: Sodium Valproate Oral solution BP 200mg/5ml
Croatian: Sodium Valproate Oral solution BP 200mg/5ml oralna otopina
Spanish: Comprimido recubierto con película
Croatian: Dipromal filmom obložena tableta
Spanish: Denmark
Croatian: S Denmark
Spanish: Granulado de liberación porlongada
Croatian: granule s produljenim oslobađanjem
Spanish: Depakine Chronosphere 750 500,06 mg 217,75 mg
Croatian: Depakine Chronosphere 750 500,06 mg + 217,75 mg granule s produljenim oslobađanjem
Spanish: Sodium valproate liquid 200mg/5ml
Croatian: Sodium valproate liquid 200mg/5ml oralna otopina
Spanish: Epilim 100mg Crushable Tablet comprimido
Croatian: Epilim 100mg Crushable Tablet tableta
Spanish: Convulex 50 mg/ml - Sirup für Kinder
Croatian: Convulex 50 mg/ml - Sirup für Kinder sirup
Spanish: Depakine 57,64 mg/ml syrup 57,64 mg/ml
Croatian: Depakine 57,64 mg/ml syrup 57,64 mg/ml sirup
Spanish: Depakine Chronosphere 100 66,66 mg 29,03 mg
Croatian: Depakine Chronosphere 100 66,66 mg + 29,03 mg granule s produljenim oslobađanjem
Spanish: Convulex gelule gastro résistante
Croatian: Convulex gelule gastro résistante želučanootporna kapsula
Spanish: Convulex Tropflösung
Croatian: Convulex Tropflösung oralna otopina
Spanish: Depakine Enteric 150 mg 150 mg
Croatian: Depakine Enteric 150 mg 150 mg tablet
Spanish: Depakine Chronosphere 1000 666,60 mg 290,27 mg
Croatian: Depakine Chronosphere 1000 666,60 mg + 290,27 mg granule s produljenim oslobađanjem
Spanish: CONVULEX 50 mg/ml szirup gyermekeknek
Croatian: CONVULEX 50 mg/ml szirup gyermekeknek sirup
Spanish: Convulex 50 mg/ml syrup 50 mg/ml
Croatian: Convulex 50 mg/ml syrup 50 mg/ml sirup
Spanish: Reino Unido Aventis Pharma Limited One Onslow Street
Croatian: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Spanish: DEPAKINE 50 mg/ml szirup 50 mg/ml
Croatian: DEPAKINE 50 mg/ml szirup 50 mg/ml sirup
Spanish: Convulex 100 mg/ml solution for injection/concentrate for solution for infusion
Croatian: Convulex 100 mg/ml solution for injection/concentrate for solution for infusion otopina za injekciju/infuziju u venu
Spanish: Alemania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Croatian: Njemačka Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Spanish: Natriumvalproaat Apotex 300 mg/5 ml, drank
Croatian: Natriumvalproaat Apotex 300 mg/5 ml, drank oralna otopina
Spanish: 13435 Berlin espa-valept 300 mg retard 199,8 mg, 87 mg
Croatian: Germany espa-valept 300 mg retard 199,8 mg, 87 mg
Spanish: Rumanía Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Croatian: Rumunjska Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Spanish: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg
Croatian: Depakine Chrono 500, tabletten met gereguleerde afgifte 500 mg tableta s prilagođenim oslobađanjem
Spanish: Guildford, Surrey
Croatian: One Onslow Street Guildford, Surrey GU1 4YS
Spanish: Cápsula de liberación porlongada
Croatian: kapsula s produljenim oslobađanjem
Spanish: Sodium valproate 100mg/ml solution for injection or infusion
Croatian: Sodium valproate 100mg/ml solution for injection or infusion otopina za injekciju/infuziju u venu
Spanish: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Croatian: Spain valpromid Depamide 300 mg comprimidos gastrorresistentes
Spanish: Valproat HEXAL 300mg/ml Lösung
Croatian: Valproat HEXAL 300mg/ml Lösung oralna otopina
Spanish: Depakine Chronosphere 500 333,30 mg 145,14 mg
Croatian: Depakine Chronosphere 500 333,30 mg + 145,14 mg granule s produljenim oslobađanjem
Spanish: Sanofi-Aventis SpA Viale Luigi Bodio, 37/B 20158 Milano Italy
Croatian: Sanofi-Aventis S.P.A. Viale Luigi Bodio 37/b 20158 Milano Italy
Spanish: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg
Croatian: Depakine Chrono 300, tabletten met gereguleerde afgifte 300 mg tableta s prilagođenim oslobađanjem
Spanish: Episenta solution for injection 100 mg/ml
Croatian: Episenta solution for injection 100 mg/ml otopina za injekciju u venu
Spanish: Depakine 300 mg/ml Tropfen 300 mg/ml
Croatian: Depakine 300 mg/ml Tropfen 300 mg/ml oralna otopina
Spanish: Sanofi-aventis Ireland Ltd. T/A SANOFI
Croatian: Sanofi-aventis Ireland Ltd.
Spanish: Orfiril Injektionslösung
Croatian: Orfiril Injektionslösung otopina za injekciju u venu
Spanish: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Croatian: France valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Spanish: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte
Croatian: Orfiril CR 1000 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Spanish: Cápsula, dura
Croatian: kapsula, meka
Spanish: Convulex 300 mg/ml oral solution
Croatian: Convulex 300 mg/ml oral solution oralna otopina
Spanish: 104 25 Stockholm Sweden
Croatian: 104 25 Stockholm Sweden valproatna kiselina natrijev valproat
Spanish: Depakine 100 mg/ml polvo y disolvente para solución inyectable
Croatian: Depakine 100 mg/ml polvo y disolvente para solución inyectable prašak i otapalo za otopinu za injekciju u venu
Spanish: Alemania TEVA GmbH Graf-Arco-Str. 3
Croatian: Njemačka TEVA GmbH Graf-Arco-Str.
Spanish: Orfiril CR 500 mg, granulaat met gereguleerde afgifte
Croatian: Orfiril CR 500 mg, granulaat met gereguleerde afgifte granule s prilagođenim oslobađanjem
Spanish: Depakine 300 mg/5 ml
Croatian: Depakine 300 mg/5 ml sirup
Spanish: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Croatian: 92517 Boulogne Billancourt Cedex
Spanish: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable
Croatian: VALPROATE DE SODIUM ARROW 200 mg/ml, solution buvable oralna otopina
Spanish: Convulex 300 mg/ml - Lösung zum Einnehmen
Croatian: Convulex 300 mg/ml - Lösung zum Einnehmen oralna otopina
Spanish: Convulex 150 mg kapsuly
Croatian: Convulex 150 mg kapsuly kapsula
Spanish: VALPROATE DE SODIUM ZENTIVA 200 mg/ml, solution buvable
Croatian: VALPROATE DE SODIUM ZENTIVA 200 mg/ml, solution buvable oralna otopina
Spanish: Depakine Enteric 300 mg 300 mg
Croatian: Depakine Enteric 300 mg 300 mg tablet
Spanish: Convulex 300 mg kapsuly
Croatian: Convulex 300 mg kapsuly kapsula
Spanish: 12 de enero de 2015
Croatian: 12 siječnja 2015.
Spanish: Los materiales formativos se presentarán al mismo tiempo que la solicitud de modificación de la información sobre el producto.
Croatian: Edukacijski se materijali trebaju dostaviti istovremeni s izmjenama primjene informacija o proizvodu.
Spanish: Aplicación del acuerdo por parte de los Estados miembros (presentación de la modificación para aplicar los cambios en la información sobre el producto por parte del titular de la autorización de comercialización):
Croatian: Implementacija sporazuma od strane država članica (dostavljanje izmjene za implementaciju izmjena u informacijama o proizvodu od strane nositelja odobrenja za stavljanje lijeka u promet):
Spanish: Anexo V Calendario para la aplicación del acuerdo
Croatian: Dodatak V. Raspored provedbe sporazuma
Spanish: 17 de abril de 2019 EMA/248364/2019 Rev1
Croatian: EMA/248364/2019 Rev1
Spanish: 2 Directriz del Consejo Internacional de Armonización de los Requisitos Técnicos para el Registro de Medicamentos de Uso Humano (ICH): M7(R1)
Croatian: 2 Smjernice Međunarodnog vijeća za harmonizaciju tehničkih zahtjeva za farmaceutske proizvode za primjenu u ljudi (ICH): M7(R1)
Spanish: Ensayos que deberán realizarse durante y después del periodo de transición
Croatian: Ispitivanje tijekom i nakon prijelaznog razdoblja
Spanish: La revisión de los medicamentos con valsartán se inició a petición de la Comisión Europea el 5 de julio de 2018 de conformidad con el artículo 31 de la Directiva 2001/83/CE.
Croatian: Ocjenjivanje lijekova koji sadržavaju valsartan pokrenuto je 5. srpnja 2018. na zahtjev Europske komisije u skladu s člankom 31. Direktive 2001/83/EZ.
Spanish: Después realizar los ensayos correspondientes, algunos medicamentos han sido retirados de las farmacias y ya no se utilizan en la UE.
Croatian: Nakon ispitivanja neki su lijekovi povučeni iz ljekarni i više se ne upotrebljavaju u EU-u.
Spanish: Las estimaciones se han extrapolado a partir de estudios en animales y son muy bajas en comparación con el riesgo de cáncer a lo largo de la vida en la UE (1 de cada 2).
Croatian: Procjene su ekstrapolirane iz ispitivanja provedenih na životinjama i vrlo su niske u usporedbi s rizikom od raka tijekom života u EU-u (u 1 na 2 slučaja).
Spanish: Candesartán (32 mg) Irbesartán (300 mg) Losartán (150 mg) Olmesartán (40 mg) Valsartán (320 mg)
Croatian: kandesartan (32 mg) irbesartan (300 mg) losartan (150 mg) olmesartan (40 mg) valsartan (320 mg)
Spanish: Principio activo (dosis máx.
Croatian: Djelatna tvar (maksimalna dnevna doza)