FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Jorveza (which may affect up to 3 in 10 people) are fungal infections in the mouth, pharynx (throat) and oesophagus.
Portuguese: Os efeitos secundários mais frequentes associados ao Jorveza (que podem afetar até 3 em cada 10 pessoas) são infeções por fungos na boca, faringe (garganta) e esófago.
English: Corticosteroids help reduce inflammation by attaching to receptors of immune cells and reducing the release of substances that are involved in the inflammation process.
Portuguese: Os corticosteroides reduzem a inflamação ligando-se a recetores das células imunitárias e reduzindo a libertação de substâncias envolvidas no processo inflamatório.
English: What is Jorveza and what is it used for?
Portuguese: O que é o Jorveza e para que é utilizado?
English: For more information about treatment with Jorveza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Portuguese: Para mais informações sobre o tratamento com o Jorveza, leia o Folheto Informativo (também parte do EPAR) ou contacte o seu médico ou farmacêutico.
English: What benefits of Jorveza have been shown in studies?
Portuguese: Quais os benefícios demonstrados pelo Jorveza durante os estudos?
English: The active substance in Jorveza, budesonide, is a corticosteroid medicine.
Portuguese: A substância ativa do Jorveza, a budesonida, é um corticosteroide.
English: Because the number of patients with eosinophilic oesophagitis is low, the disease is considered ‘rare', and Jorveza was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 August
Portuguese: Dado o número de doentes afetados por esofagite eosinofílica ser reduzido, a doença é considerada rara, pelo que o Jorveza foi designado medicamento órfão (medicamento utilizado em doenças raras) em 5 de agosto de 2013.
English: The full EPAR for Jorveza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Portuguese: O EPAR completo relativo ao Jorveza pode ser consultado no sítio Internet da Agência em: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Jorveza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Portuguese: O resumo do parecer emitido pelo Comité dos Medicamentos Órfãos para o Jorveza pode ser consultado no sítio Internet da Agência em: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Jorveza approved?
Portuguese: Por que foi aprovado o Jorveza?
English: Jorveza contains the active substance budesonide.
Portuguese: O Jorveza contém a substância ativa budesonida.
English: For the full list of all side effects and restrictions with Jorveza, see the package leaflet.
Portuguese: Para a lista completa dos efeitos secundários e das restrições de utilização relativos ao Jorveza, consulte o Folheto Informativo.
English: For practical information about using Jorveza, patients should read the package leaflet or contact their doctor or pharmacist.
Portuguese: Para obter informações práticas sobre a utilização do Jorveza, os doentes devem ler o folheto informativo ou contactar o seu médico ou farmacêutico.
English: The main measure of effectiveness was the level of eosinophils in the oesophagus and improvement in symptoms.
Portuguese: O principal parâmetro de eficácia foi o nível de eosinófilos no esófago e o alívio dos sintomas.
English: Jorveza was shown to be effective in one main study involving 88 adults with eosinophilic oesophagitis.
Portuguese: O Jorveza demonstrou eficácia num estudo principal que incluiu 88 adultos com esofagite eosinofílica.
English: Eosinophilic oesophagitis is inflammation of the oesophagus (the food-pipe that leads from the mouth to the stomach), which causes symptoms including dysphagia (difficulty swallowing) and obstruction of the oesophagus.
Portuguese: A esofagite eosinofílica é uma inflamação do esófago (o canal que leva os alimentos da boca até ao estômago) que causa sintomas, nomeadamente disfagia (dificuldades na deglutição) e obstrução do esófago.
English: Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.
Portuguese: O Jorveza só pode ser obtido mediante receita médica e o tratamento deve ser iniciado por um médico com experiência no diagnóstico e tratamento da esofagite eosinofílica.
English: After Jorveza dissolves in the mouth, the saliva carries it to the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis.
Portuguese: Depois de o Jorveza se ter dissolvido na boca, a saliva transporta-o para o esófago, onde reduz a inflamação e alivia os sintomas da esofagite eosinofílica.
English: Jorveza benefits patients with eosinophilic oesophagitis by improving the symptoms of the disease and reducing the excess of eosinophils.
Portuguese: O Jorveza é benéfico para os doentes com esofagite eosinofílica ao melhorar os sintomas da doença e reduzir o excesso de eosinófilos.
English: How does Jorveza work?
Portuguese: Como funciona o Jorveza?
English: It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus.
Portuguese: Esta doença é causada pela forte acumulação de um tipo de glóbulos brancos, os eosinófilos, na parede do esófago.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.
Portuguese: No Resumo das Características do Medicamento e no Folheto Informativo foram incluídas recomendações e precauções a observar pelos profissionais de saúde e pelos doentes para a utilização segura e eficaz do Jorveza.
English: Jorveza is a medicine used to treat adults with eosinophilic oesophagitis.
Portuguese: O Jorveza é um medicamento utilizado no tratamento da esofagite eosinofílica em adultos.
English: How is Jorveza used?
Portuguese: Como se utiliza o Jorveza?
English: 50000 IU Powder and solvent for solution for injection
Portuguese: Pó e solvente para solução injetável
English: Solution 5000 IU/ml)
Portuguese: Solvente: 10 ml (solução reconstituída 5000 UI/ml)
English: Subcutaneous or intravenous use powder: multidose vial (glass); solvent: ampoule (glass)
Portuguese: Pó: frasco multidose (vidro)
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Portuguese: Anexo I Lista das denominações, formas farmacêuticas, dosagens, vias de administração dos medicamentos, dos requerentes titulares das autorizações de introdução no mercado nos estados membros
English: Germany Hexal Aktiengesellschaft Industriestr.
Portuguese: Alemanha Hexal Aktiengesellschaft Industriestr.
English: Norton Healthcare Limited Ridings Point, Whistler Drive
Portuguese: Reino Unido Norton Healthcare Limited Ridings Point, Whistler Drive
English: Teva UK Limited Brampton Road, Hampden Park
Portuguese: Reino Unido Teva UK Limited Brampton Road, Hampden Park
English: Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
Portuguese: Dinamarca Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
Portuguese: Roménia S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu nr.
English: Luxembourg Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
Portuguese: Luxemburgo Hexal AG Industriestrasse 25 83067 Holzkirchen Germany
English: Germany IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
Portuguese: Alemanha IIP - Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft mbH
English: Finland Sanofi Oy Huopalahdentie 24 PL 22
Portuguese: Finlândia Sanofi Oy Huopalahdentie 24 PL 22
English: Finland Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Portuguese: Finlândia Sandoz A/S C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
English: Luxembourg Eurogenerics SA Esplanade Heysel b22
Portuguese: Luxemburgo Eurogenerics SA Esplanade Heysel b22
English: Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
Portuguese: Letónia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 Riga LV1010
English: Romania GEROT PHARMAZEUTIKA Ges.m.b.H.
Portuguese: Roménia GEROT PHARMAZEUTIKA Ges.m.b.H.
English: Sweden Sanofi AB Box 30052
Portuguese: Sanofi AB Box 30052
English: Luxembourg Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
Portuguese: Luxemburgo Takeda Belgium Chaussée de Gand 615 1080 Bruxelles
English: Winthrop Pharmaceuticals UK Limited
Portuguese: Reino Unido Winthrop Pharmaceuticals UK Limited
English: Austria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
Portuguese: Áustria sanofi-aventis GmbH SATURN Tower, Vienna DC Leonard-Bernstein-Straße
English: Denmark Sanofi-aventis Denmark A/S
Portuguese: Dinamarca Sanofi-aventis Denmark A/S
English: Germany Mylan dura GmbH Wittichstr.
Portuguese: Alemanha Mylan dura GmbH Wittichstr.
English: Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
Portuguese: Sandoz Farmacêutica, Lda. Avenida Professor Doutor Cavaco Silva, 10 E 2740-255 Porto Salvo Portugal
English: Sandoz B.V. Veluwezoom 22 1327 AH ALMERE The Netherlands
Portuguese: Veluwezoom 22 1327 AH ALMERE The Netherlands
English: Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
Portuguese: Nieuwe Donk 3 4879 AC ETTEN LEUR The Netherlands
English: Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
Portuguese: Alemanha Heumann Pharma GmbH & Co. Generica KG Südwestpark 50
English: Germany 1 A Pharma GmbH Keltenring 1 + 3
Portuguese: Alemanha 1 A Pharma GmbH Keltenring 1 + 3
English: Ireland Sanofi-aventis Ireland Ltd. T/A SANOFI
Portuguese: Sanofi-aventis Ireland Ltd. T/A SANOFI
English: Germany Sanofi-Aventis Deutschland GmbH
Portuguese: Alemanha Sanofi-Aventis Deutschland GmbH
English: Luxembourg Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Portuguese: Luxemburgo Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
English: Luxembourg Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Portuguese: Luxemburgo Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
English: Lithuania UAB „SANOFI-AVENTIS LIETUVA“
Portuguese: UAB „SANOFI-AVENTIS LIETUVA“
English: Germany Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
Portuguese: Alemanha Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1
English: Valproic acid Convulex gelule gastro résistante
Portuguese: Convulex gelule gastro résistante
English: Generics UK Limited Station Close, Potter's Bar Hertfordshire EN6 1TL
Portuguese: Reino Unido Generics UK Limited Station Close, Potter's Bar Hertfordshire
English: Germany Stadapharm GmbH Stadastr 2-18
Portuguese: Alemanha Stadapharm GmbH Stadastr 2-18
English: Finland Orion Pharma Orionintie 1
Portuguese: Finlândia Orion Pharma Orionintie 1
English: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Portuguese: Darwinweg 20 2333 CR LEIDEN The Netherlands
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem
Portuguese: Sanofi Belgium Leonardo Da Vincilaan 19 1831 Diegem Belgium
English: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Portuguese: Roménia Sanofi-Aventis France 1-13 Boulevard Romain Rolland
English: Sandoz Pharmaceuticals d.d
Portuguese: Eslováquia Sandoz Pharmaceuticals d.d
English: 500-1000 mg Modified-release granules
Portuguese: 500-1000 mg Granulado de libertação modificada
English: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
Portuguese: Wrexham Industrial Estate Wrexham, LL13 9UF United Kingdom
English: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Portuguese: Swensweg 5 2031 GA HAARLEM The Netherlands
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart
Portuguese: Mylan BVBA/SPRL Terhulpsesteenweg 6 box A 1560 Hoeilaart Belgium
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Portuguese: Alemanha ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
English: Germany Neuraxpharm Arzneimittel GmbH
Portuguese: Alemanha Neuraxpharm Arzneimittel GmbH
English: Germany betapharm Arzneimittel GmbH
Portuguese: Alemanha betapharm Arzneimittel GmbH
English: Valproic acid Ácido Valpróico Generis
Portuguese: Ácido valpróico Generis
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Portuguese: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Granulado revestido em saquetas
English: Coated granules in sachet
Portuguese: Granulado revestido em saquetas
English: Sanofi-Aventis Slovakia s r.o.
Portuguese: Eslováquia Sanofi-Aventis Slovakia s r.o.
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Portuguese: Alemanha TAD Pharma GmbH Heinz-Lohmann-Str. 5
English: Modified-release granules
Portuguese: Granulado de libertação modificada
English: Solution for injection/concentra te for solution for infusion
Portuguese: Solução injetável/concentra do para solução para perfusão
English: Germany Winthrop Arzneimittel GmbH
Portuguese: Alemanha Winthrop Arzneimittel GmbH
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Portuguese: Dunajska cesta 151
English: Germany G.L.
Portuguese: Alemanha G.L.
English: Valproic acid VALPROATE SODIUM SANDOZ 500MG
Portuguese: VALPROATE SODIUM SANDOZ 500MG
English: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Portuguese: Valpromida Depamide 300 mg comprimidos gastrorresistentes
English: Germany TEVA GmbH Graf-Arco-Str. 3
Portuguese: Alemanha TEVA GmbH Graf-Arco-Str. 3
English: Germany AbZ-Pharma GmbH Graf-Arco-Str. 3
Portuguese: Alemanha AbZ-Pharma GmbH Graf-Arco-Str. 3
English: SI-1000 Ljubljana Slovenia
Portuguese: 1000 Ljubljana
English: LT-09310 Vilnius
Portuguese: A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania
English: Valproic acid CONVULEX 100 mg/ml oldatos injekció
Portuguese: CONVULEX 100 mg/ml oldatos injekció
English: One Onslow Street Guildford, Surrey GU1 4YS
Portuguese: Guildford, Surrey
English: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Portuguese: Valpromida DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
English: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4SY
Portuguese: Reino Unido Aventis Pharma Limited One Onslow Street
English: Valproic acid CONVULEX 50 mg/ml szirup gyermekeknek
Portuguese: CONVULEX 50 mg/ml szirup gyermekeknek
English: Epilim Syrup 200mg/5ml Oral Solution.
Portuguese: Epilim Xarope 200mg/5ml Oral Solution.
English: Oral drops, solution Oral Use
Portuguese: Gotas orais, solução
English: Solution for injection
Portuguese: Pó para injeção
English: Lithuania G.L.
Portuguese: Eslováquia G.L.
English: Prolonged-release granules
Portuguese: Granulado de libertação prolongada
English: Epilim Enteric 200 mg gastroresistant coated tablets
Portuguese: Epilim Enteric 200 gastroresistant coated tablets
English: Valproic acid Convulex 50 mg/ml - Sirup für Kinder
Portuguese: Convulex 50 mg/ml - Sirup für Kinder
English: Valproic acid Diplexil 1000
Portuguese: Diplexil 1000
English: Magnesium Valproate
Portuguese: Valproato de magnésio
English: 500 mg - Retardtabletten
Portuguese: 500 mg - RetardComprimidoten
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Portuguese: Convulex 300 mg/mlLösung zum Einnehmen
English: Germany Orion Corporation Orionintie 1 A
Portuguese: Alemanha Orion Corporation Orionintie 1 A
English: Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Portuguese: DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
English: Valproic acid Convulex 300 mg - Kapseln 300 mg
Portuguese: Convulex 300 mg - Kapseln 300 mg
English: 300 mg - Retardtabletten
Portuguese: 300 mg - RetardComprimidoten
English: Orfiril CR 150 mg, capsules met gereguleerde afgifte
Portuguese: Orfiril CR 150 mg, Cápsulas met gereguleerde afgifte
English: Valproic acid Convulex 500 mg - Kapseln 500 mg
Portuguese: Convulex 500 mg - Kapseln 500 mg
English: Convulex 500 mgRetardtabletten
Portuguese: Convulex 500 mgRetardComprimidoten
English: Convulex 300 mgRetardtabletten
Portuguese: Convulex 300 mgRetardComprimidoten
English: Denmark Orion Corporation Orionintie 1 A
Portuguese: Dinamarca Orion Corporation Orionintie 1 A
English: Valproic acid Convulex 150 mg - Kapseln 150 mg
Portuguese: Convulex 150 mg - Kapseln 150 mg
English: Valproic acid Convulex 100 mg/mlInjektionslösung
Portuguese: Convulex 100 mg/mlInjektionslösung
English: Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Portuguese: CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
English: Valproid acid, Sodium valproate
Portuguese: Ácido valpróico, Valproato de sódio
English: Valproic acid Convulex Capsules 150mg 150 mg
Portuguese: Convulex Capsules 150mg 150 mg
English: Valproic acid DEPAKINE 50 mg/ml szirup 50 mg/ml
Portuguese: DEPAKINE 50 mg/ml szirup 50 mg/ml
English: Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Portuguese: CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Convulex 300 mg gastroresistant capsules, soft
Portuguese: Convulex 300 mg gastroresistant capsules, soft
English: Valproic acid Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
Portuguese: Ácido valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
English: Valproic acid Convulex 150 mg gastroresistant capsules, soft
Portuguese: Convulex 150 mg gastroresistant capsules, soft
English: Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Portuguese: CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
English: Lithuania Orion Corporation Orionintie 1 A
Portuguese: Eslováquia Orion Corporation Orionintie 1 A
English: Gastro-resistant capsule, hard
Portuguese: Cápsula dura gastrorresistente
English: Valproic acid Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
Portuguese: Ácido valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
English: Valproic acid Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
Portuguese: Ácido valpróico Sandoz 500 mg Comprimidos de libertação prolongada
English: Valpromide Depamide
Portuguese: Valpromida Depamide
English: Valproic acid Depakine 400 mg/4 ml
Portuguese: Depakine 400 mg/4 ml
English: Valproic acid Convulex 500 mg gastroresistant capsules, soft
Portuguese: Convulex 500 mg gastroresistant capsules, soft
English: Valproic acid CONVULEX RETARD 500MG 500 mg
Portuguese: CONVULEX RETARD 500MG 500 mg
English: Valproic acid Absenor 300 mg tablety s predĺženým uvoľňovaním
Portuguese: Absenor 300 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Convulex Capsules 300mg 500 mg
Portuguese: Convulex Capsules 300mg 500 mg
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Portuguese: Alemanha Ratiopharm GmbH Graf-Arco-Strasse 3
English: Valproic acid Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
Portuguese: Ácido valpróico Sandoz 300 mg Comprimidos de libertação prolongada
English: Valproic acid Convulex Capsules 500mg 300 mg
Portuguese: Convulex Capsules 500mg 300 mg
English: Valproic acid Convulex 300 mg kapsuly
Portuguese: Convulex 300 mg kapsuly
English: Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Portuguese: Propymal Enteric 150 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Portuguese: Propymal Enteric 600 mg, maagsapresistente capsules
English: Valproate semisodium
Portuguese: Valproato semisódico
English: Valproic acid CONVULEX RETARD 300MG 300 mg
Portuguese: CONVULEX RETARD 300MG 300 mg
English: Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Portuguese: Propymal Enteric 450 mg, maagsapresistente capsules
English: Valproic acid Absenor 500 mg tablety s predĺženým uvoľňovaním
Portuguese: Absenor 500 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Convulex 150 mg kapsuly
Portuguese: Convulex 150 mg kapsuly
English: Valproic acid Convulex 500 mg kapsuly
Portuguese: Convulex 500 mg kapsuly
English: Valproat - 1 A Pharma 150 mg magensaftresistente Filmtabletten
Portuguese: Valproat - 1 A Pharma 150 mg magensaftresistente FilmComprimidoten
English: Prolonged-release granules in a sachet
Portuguese: Granulado de libertação prolongada em saqueta
English: Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Portuguese: Propymal Enteric 300 mg, maagsapresistente capsules
English: Sanofi-Aventis d.o.o.
Portuguese: Eslovénia Sanofi-Aventis d.o.o.
English: Valproic acid Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Portuguese: Depakine chrono 300 mg tablete s podaljšanim sproščanjem
English: Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Portuguese: Roménia Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Valproic acid Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Portuguese: Depakine chrono 500 mg tablete s podaljšanim sproščanjem
English: Calcium divalproate
Portuguese: Divalproato de cálcio
English: Modified-release capsule, hard
Portuguese: Cápsula dura de libertação modificada
English: Finland Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Portuguese: Finlândia Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Valproic acid Sodium valproate
Portuguese: Ácido valpróico Valproato de sódio
English: MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose
Portuguese: 750 mg, granulés à libération prolongée en sachet-dose
English: Germany Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Portuguese: Alemanha Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Portuguese: Dinamarca Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
Portuguese: 1000 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose
Portuguese: 250 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose
Portuguese: 500 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid CONVULEX 300 MG/ML
Portuguese: CONVULEX 300 MG/ML
English: MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose
Portuguese: 100 mg, granulés à libération prolongée en sachet-dose
English: Prolonged-release capsule, hard
Portuguese: Cápsula dura de libertação prolongada
English: Depakine Crono 300 mg comprimidos recubiertos
Portuguese: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Depakine Crono 500 mg comprimidos recubiertos
Portuguese: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Valproic acid Valproat "Sandoz"
Portuguese: Valproat "Sandoz"
English: Powder and solvent for solution for injection/infusion
Portuguese: Pó e solvente para Solução injetável para perfusão
English: Valproic acid DEPAKINE CHRONO 300 MG 300 mg
Portuguese: DEPAKINE CHRONO 300 MG 300 mg
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Portuguese: As alterações nas secções relevantes do Resumo das Características do Medicamento e Folheto Informativo estão estabelecidas no Anexo III.
English: The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Portuguese: As Autorizações de Introdução no Mercado dos contracetivos hormonais combinados contendo clormadinona estão sujeitas às condições estabelecidas no Anexo IV.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation
Portuguese: Anexo II Conclusões científicas e fundamentos para a alteração dos termos das Autorizações de Introdução no Mercado e explicação detalhada para as diferenças relativamente à recomendação do PRAC