FrancophonIA/ELRC3.0 huggingface dataset:
English: Peseri Trading Limited 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus
Portuguese: Peseri Trading Limited 20 Queen Frederica Street
English: Pioglitazone 45mg Tablets 45 mg
Portuguese: Pioglitazone 45mg Tablets 45 mg Comprimido
English: Alendronic acid Acide Alendronique Ranbaxy 70 mg, comprimé
Portuguese: Ácido alendrónico Acide Alendronique Ranbaxy 70 mg, comprimé
English: 200 mg Capsule
Portuguese: 200 mg Cápsula
English: Slovak Republic Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
Portuguese: Reino Unido Generics (UK) Ltd Station Close, Potters Bar Hertfordshire, EN6 1TL United Kingdom
English: Desmopressin DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Portuguese: Desmopressina DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
English: Alendronic acid Alendronic Acid Once Weekly 70 mg Tablets
Portuguese: Ácido alendrónico Alendronic Acid Once Weekly 70 mg Tablets
English: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Portuguese: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
English: Desmopressin DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Portuguese: Desmopressina DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
English: 2,5 mg Tablet
Portuguese: 2,5 mg Comprimido
English: Pioglitazone 15mg Tablets 15 mg
Portuguese: Pioglitazone 15mg Tablets 15 mg Comprimido
English: Amlodipine 10mg Tablets 10 mg
Portuguese: Amlodipine 10mg Tablets 10 mg Comprimido
English: Alendronic acid alendronic acid 70mg Once Daily Tablets
Portuguese: Ácido alendrónico alendronic acid 70mg Once Daily Tablets
English: Valsartan/Hydrochlorothiaz ide Fair-Med 160 mg/12.5 mg film-coated tablets.
Portuguese: Valsartan/Hydrochlorothia zide Fair-Med 160 mg/12.5 mg film-coated tablets.
English: Alendronic acid ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Portuguese: Ácido alendrónico ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
English: 750 mg Tablet
Portuguese: 750 mg Comprimido
English: Laboratórios Anova - Produtos Farmacêuticos, Lda.
Portuguese: Laboratórios AnovaProdutos Farmacêuticos, Lda.
English: 250 mg Tablet
Portuguese: 250 mg Comprimido
English: Alendronic acid Alendran 70
Portuguese: Ácido alendrónico Alendran 70
English: Alendronic acid Alendronat Ranbaxy Veckotablett 70 mg tabletter
Portuguese: Ácido alendrónico Alendronat Ranbaxy Veckotablett 70 mg tabletter
English: 0,06 mg Orodispersible tablet
Portuguese: 0,06 mg Comprimido orodispersível
English: 2,5 mg Orodispersible tablet
Portuguese: 2,5 mg Comprimido orodispersível
English: Laboratorios Ranbaxy, S. L U. Paseig de Gracia 9
Portuguese: Laboratorios Ranbaxy, S. L U.
English: 0,24 mg Orodispersible tablet
Portuguese: 0,24 mg Comprimido orodispersível
English: Irbesartanas/Hidrochlorotia zidas Torrent mg/12,5 mg
Portuguese: Irbesartanas/Hidrochloroti azidas Torrent mg/12,5 mg
English: Generics Pharma Hellas Ltd 577a Vouliagmenis Avenue Argyroupoli
Portuguese: 577a Vouliagmenis Avenue
English: Alendronic acid alendronic acid 10mg Tablets
Portuguese: Ácido alendrónico alendronic acid 10mg Tablets
English: 15 mg Gastro - resistant tablet
Portuguese: 15 mg Comprimido gastrorresistente
English: Rizatriptan benzoate
Portuguese: Benzoato de rizatriptano
English: 7a Pl
Portuguese: Paseig de Gracia 9 7a Pl
English: 800 mg Tablet
Portuguese: 800 mg Comprimido
English: 01-919 Warszawa Poland
Portuguese: Wólczyńska 232 01-919 Warszawa Poland
English: Pantoprazole 40mg GastroResistant tablets
Portuguese: Pantoprazole 40mg Gastro-Resistant tablets
English: Valsartan/hydrochl orothiazide
Portuguese: Valsartan/hidroclor otiazida
English: 200 mg Tablet
Portuguese: 200 mg Comprimido
English: 500 mg Tablet
Portuguese: 500 mg Comprimido
English: Amlodipine besilate Amlodipine Niche 5mg tablets
Portuguese: Amlodipine Niche 5mg tablets
English: Alvotadin 5 mg filmtabletta 5 mg
Portuguese: Alvotadin 5 mg filmtabletta
English: Pantoprazole 20mg GastroResistant tablets
Portuguese: Pantoprazole 20mg Gastro-Resistant tablets
English: Alendronic acid Alendroninezuur Accord 10mg Tabletten
Portuguese: Ácido alendrónico Alendroninezuur Accord 10mg Tabletten
English: Alendronic acid Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Portuguese: Ácido alendrónico Alendroninezuur 70 Ranbaxy, tabletten 70 mg
English: Irbesartan/Hydrochlorothia zid Heumann 300 mg/25 mg Filmtabletten
Portuguese: Irbesartan/Hydrochlorothi azid Heumann 300 mg/25 mg Filmtabletten
English: Cefpodoxime
Portuguese: Cefpodoxima
English: Amlodipine besilate Amlodipine Niche 10mg Tablets
Portuguese: Amlodipine Niche 10mg Tablets
English: Fluconazole 50mg capsules 50 mg
Portuguese: Fluconazole 50mg capsules
English: Clindamycin hydrochloride
Portuguese: Cloridrato de clindamicina
English: Teva UK Limited Brampton Road Hampden Park Sussex BN22 9AG United Kingdom
Portuguese: Sussex BN22 9AG United Kingdom
English: Rua Doutor António Loureiro Borges
Portuguese: Parque Industrial Manuel Lourenço Ferreira, Lote
English: Levocetirizine
Portuguese: Levocetirizina
English: Clonazepam Clonazepam 2mg Tablet
Portuguese: Clonazepam Clonazepam 2mg Tablet 2 mg
English: 0,12 mg Orodispersible tablet
Portuguese: 0,12 mg Comprimido orodispersível
English: Metoclopramide hydrochloride
Portuguese: Cloridrato de metoclopramida
English: 37,5 mg Prolongedrelease tablet
Portuguese: 37,5 mg Comprimido de libertação prolongada
English: Desloratadina Labesfal OD 2,5 mg Orodispersible tablet
Portuguese: Desloratadina Labesfal OD 2,5 mg Comprimido orodispersível
English: Teva Nederland B.V. Swensweg 5
Portuguese: Teva Nederland B.V.
English: Telmisartan/Hydrochlorothi azide 40mg/12.5mg Tablets
Portuguese: Telmisartan/Hydrochloroth iazide 40mg/12.5mg Tablets
English: Levetiracetam Levetiracetam 500mg filmcoated tablets
Portuguese: Levetiracetam Levetiracetam 500mg film-coated tablets
English: Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/25 mg film-coated tablets
Portuguese: Valsartan/Hydrochlorothia zide Fair-Med 320 mg/25 mg film-coated tablets
English: Glenmark Pharmaceuticals s.r.o.
Portuguese: Pharmaceuticals s.r.o.
English: Apo-trimetazidin 35 mg 35 mg
Portuguese: Apo-trimetazidin 35 mg 35 mg Comprimido de libertação prolongada
English: 100 mg Tablet
Portuguese: 100 mg Comprimido
English: 30 mg Gastro - resistant tablet
Portuguese: 30 mg Comprimido gastrorresistente
English: Telmisartan/Hydrochlorothi azide 80mg/25mg Tablets
Portuguese: Telmisartan/Hydrochloroth iazide 80mg/25mg Tablets
English: Alendronic acid Alendronic Acid 70mg Tablets
Portuguese: Ácido alendrónico Alendronic Acid 70mg Tablets
English: Valsartan/Hydrochlorothiaz ide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
Portuguese: Valsartan/Hydrochlorothia zide Fair-Med 320 mg/12.5 mg film-coated tablets mg/12,5 mg
English: Irbesartan/Hydrochlorothia zide Fairmed 300mg/25mg film-coated tablets
Portuguese: Irbesartan/Hydrochlorothi azide Fairmed 300mg/25mg film-coated tablets
English: Levetiracetam Levetiracetam 750mg filmcoated tablets
Portuguese: Levetiracetam Levetiracetam 750mg film-coated tablets
English: Clopidogrel hydrochloride
Portuguese: Cloridrato de clopidogrel
English: Telmisartan/Hydrochlorothi azide 80mg/12.5mg Tablets
Portuguese: Telmisartan/Hydrochloroth iazide 80mg/12.5mg Tablets
English: Daquimed - Comércio de Produtos Farmacêuticos, S.A. Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha
Portuguese: Av. Associação Comercial e Industrial de Gondomar, 330 - Zona Industrial da Portelinha 4510-688 Fânzeres Portugal
English: Irbesartan/Hydrochlorothia zide 300mg/25mg filmcoated tablets
Portuguese: Irbesartan/Hydrochlorothi azide 300mg/25mg filmcoated tablets
English: Fexofenadine hydrochloride
Portuguese: Cloridrato de fexofenadina
English: Ropinirole 1mg film-coated tablets
Portuguese: Ropinirole 1mg filmcoated tablets
English: Alendronic acid Alendroninezuur Accord 70mg Tabletten
Portuguese: Ácido alendrónico Alendroninezuur Accord 70mg Tabletten
English: Levetiracetam Levetiracetam-Hormosan 1000 mg Filmtabletten
Portuguese: Levetiracetam LevetiracetamHormosan 1000 mg Filmtabletten
English: Venlagamma 37,50 mg 37,5 mg Prolongedreleased capsule, hard
Portuguese: Venlagamma 37,50 mg 37,5 mg Cápsula dura de libertação prolongada
English: Metformin hydrochloride
Portuguese: Cloridrato de metformina
English: Levetiracetam Levetiracetam 250mg filmcoated tablets
Portuguese: Levetiracetam Levetiracetam 250mg film-coated tablets
English: Ulica Danica 5
Portuguese: Swensweg 5
English: 4510-688 Fânzeres Portugal
Portuguese: 3450-232 Mortágua Portugal
English: Ropinirole 5mg film-coated tablets
Portuguese: Ropinirole 5mg filmcoated tablets
English: Ropinirole 2mg film-coated tablets
Portuguese: Ropinirole 2mg filmcoated tablets
English: Labormed Pharma SA Bd. Theodor Pallady nr. 44 B 032266, sector 3, Bucureşti România
Portuguese: Labormed Pharma SA Bd. Theodor Pallady nr. 44 B
English: Desloratadina Labormed 2,5 mg Orodispersible tablet
Portuguese: Desloratadina Labormed 2,5 mg Comprimido orodispersível
English: VENLAFAXINA PENSA 150 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXINA PENSA 150 mg Cápsula dura de libertação prolongada
English: Alendronic acid Ácido alendrónico Accord 70 mg tablet
Portuguese: Ácido alendrónico Ácido alendrónico Accord 70 mg Comprimido
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Portuguese: Daquimed - Comércio de Produtos Farmacêuticos, S.A.
English: Irbesartan/Hydrochlorothia zid Heumann 300 mg/12.5 mg Filmtabletten mg/12,5 mg
Portuguese: Irbesartan/Hydrochlorothi azid Heumann 300 mg/12.5 mg Filmtabletten mg/12,5 mg
English: 1080 Brussels
Portuguese: 1140 Wien Austria
English: Nebivolol Generis tablet
Portuguese: Nebivolol Generis
English: Fexofenadine 120 mg filmcoated tablets
Portuguese: Fexofenadine 120 mg film-coated tablets
English: Esomeprazole/ Generics 40 mg
Portuguese: Esomeprazole/ Generics 40 mg Cápsula de libertação prolongada
English: Desloratadine Ratiopharm 2,5 mg Orodispersible tablet
Portuguese: Desloratadine Ratiopharm 2,5 mg Comprimido orodispersível
English: Irbesartan/Hydrochlorothia zid Heumann 150 mg/12.5 mg Filmtabletten mg/12,5 mg
Portuguese: Irbesartan/Hydrochlorothi azid Heumann 150 mg/12.5 mg Filmtabletten mg/12,5 mg
English: Fexofenadine 180 mg filmcoated tablets
Portuguese: Fexofenadine 180 mg film-coated tablets
English: BOSENTAN SANDOZ 62,5 mg Film - coated tablet
Portuguese: BOSENTAN SANDOZ 62,5 mg Comprimido revestido por película
English: Czech Republic SVUS Pharma a.s. Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic
Portuguese: 500 02 Hradec Králové Czech Republic
English: Irbesartan/Hydrochlorothia zide 300mg/12.5mg filmcoated tablets mg/12,5 mg
Portuguese: Irbesartan/Hydrochlorothi azide 300mg/12.5mg filmcoated tablets mg/12,5 mg
English: VENLAFAXINA PENSA 75 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXINA PENSA 75 mg Cápsula dura de libertação prolongada
English: Venlafaxina Eurogenus 37,5 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Eurogenus 37,5 mg Cápsula dura de libertação prolongada
English: Trimetazidine hydrochloride
Portuguese: Cloridrato de trimetazidina
English: Venlafaxine hydrochloride
Portuguese: Cloridrato de venlafaxina
English: 04-790 Warszawa Poland
Portuguese: Trakt Lubelski 135 04-790 Warszawa Poland
English: Irbesartan/Hydrochlorothia zide 150mg/12.5mg filmcoated tablets mg/12,5 mg
Portuguese: Irbesartan/Hydrochlorothi azide 150mg/12.5mg filmcoated tablets mg/12,5 mg
English: BOSENTAN SANDOZ 125 mg Film - coated tablet
Portuguese: BOSENTAN SANDOZ 125 mg Comprimido revestido por película
English: 75 mg Prolongedrelease tablet
Portuguese: 75 mg Comprimido de libertação prolongada
English: Desloratadin Ratiopharm 2,5 mg Orodispersible tablet
Portuguese: Desloratadin Ratiopharm 2,5 mg Comprimido orodispersível
English: 1000 mg Prolongedrelease tablet
Portuguese: 1000 mg Comprimido de libertação prolongada
English: Alendronic acid ALENDRONIC ACID ACCORD 70mg
Portuguese: Ácido alendrónico ALENDRONIC ACID ACCORD 70mg
English: Alendronic acid ALENDRONIC ACID ACCORD 70MG
Portuguese: Ácido alendrónico ALENDRONIC ACID ACCORD 70MG
English: Venlafaxine Bluefish 150 mg Prolongedrelease capsule
Portuguese: Venlafaxine Bluefish 150 mg Cápsula de libertação prolongada
English: 750 mg Prolongedrelease tablet
Portuguese: 750 mg Comprimido de libertação prolongada
English: France ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Portuguese: França ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: Wałbrzyska 13
Portuguese: Torsgatan 11
English: Venlafaxina Eurogenus 150 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Eurogenus 150 mg Cápsula dura de libertação prolongada
English: Desloratadine Labormed 2,5 mg Orodispersible tablet
Portuguese: Desloratadine Labormed 2,5 mg Comprimido orodispersível
English: Venlafaxine Bluefish 75 mg Prolongedrelease capsule
Portuguese: Venlafaxine Bluefish 75 mg Cápsula de libertação prolongada
English: 37,5 mg Prolongedrelease capsule
Portuguese: 37,5 mg Cápsula de libertação prolongada
English: Koprivnica 48000
Portuguese: Ulica Danica 5 Koprivnica 48000 Croatia
English: 150 mg Prolongedrelease capsule
Portuguese: 150 mg Cápsula de libertação prolongada
English: Iceland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Portuguese: Islândia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: Fexofenadina Mylan 120 mg Film - coated tablet
Portuguese: Fexofenadina Mylan 120 mg Comprimido revestido por película
English: Tacpan 0.5 mg Hartkapseln 0,5 mg Capsule, hard Oral use
Portuguese: Tacpan 0.5 mg Hartkapseln
English: VENLAFAXIN ORION 37,5 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXIN ORION 37,5 mg Cápsula dura de libertação prolongada
English: Levetiracetam Levetiracetam-Hormosan 250 mg Filmtabletten
Portuguese: Levetiracetam LevetiracetamHormosan 250 mg
English: Venlafaxina Bluepharma 37,5 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Bluepharma 37,5 mg Cápsula dura de libertação prolongada
English: Norway ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Portuguese: Noruega ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: Tablet
Portuguese: Filmtabletten
English: 75 mg Prolongedrelease capsule
Portuguese: 75 mg Cápsula de libertação prolongada
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex
Portuguese: North Harrow HA1 4HF Middlesex
English: Germany ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Portuguese: Alemanha ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: VENLAGAMMA 150 MG 150 mg Prolongedreleased capsule, hard
Portuguese: VENLAGAMMA 150 mg 150 mg Cápsula dura de libertação prolongada
English: Venlafaxina Eurogenus 75 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Eurogenus 75 mg Cápsula dura de libertação prolongada
English: Wólczyńska 232
Portuguese: Darwinweg 20
English: Levetiracetam Levetiracetam-Generics 750 mg Film - coated tablet
Portuguese: Levetiracetam Levetiracetam-Generics 750 mg Comprimido revestido por película
English: VENLAFAXIN ORION 150 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXIN ORION 150 mg Cápsula dura de libertação prolongada
English: Ropinirole hydrochloride
Portuguese: Cloridrato de ropinirol
English: Venlafaxina Bluepharma 150 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Bluepharma 150 mg Cápsula dura de libertação prolongada
English: Scored tablet
Portuguese: Comprimido com incisões
English: Fexofenadina Mylan 180 mg Film - coated tablet
Portuguese: Fexofenadina Mylan 180 mg Comprimido revestido por película
English: Trimetazidina Pharmakern 35 mg
Portuguese: Trimetazidina Pharmakern 35 mg Comprimido de libertação modificada
English: VENLAFAXIN ORION 75 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXIN ORION 75 mg Cápsula dura de libertação prolongada
English: Venlafaxina Bluepharma 75 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Bluepharma 75 mg Cápsula dura de libertação prolongada
English: Pharmachemie B.V. Swensweg 5
Portuguese: Países Baixos Pharmachemie B.V.
English: Finland ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Portuguese: Finlândia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
English: VENLAFAXINE ORION 37,5 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXINE ORION 37,5 mg Cápsula dura de libertação prolongada
English: Levetiracetam Levetiracetam-Generics 250 mg Film - coated tablet
Portuguese: Levetiracetam Levetiracetam-Generics 250 mg Comprimido revestido por película
English: ACCORD HEALTHCARE France SAS
Portuguese: Accord Healthcare Limited
English: Venlafaxine Bluefish XL 75 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxine Bluefish XL 75 mg Cápsula dura de libertação prolongada
English: Ciprofloxacin Fair-Med 250 mg Film - coated tablet
Portuguese: Ciprofloxacin Fair-Med 250 mg Comprimido revestido por película
English: Venlafaxine Bluefish XL 150 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxine Bluefish XL 150 mg Cápsula dura de libertação prolongada
English: Donepezil Mylan 10 mg 10 mg
Portuguese: Donepezil Mylan 10 mg 10 mg Comprimido orodispersível
English: Levocetirizine hydrochloride
Portuguese: Irbesartan/hidrocl orotiazida
English: Desloratadina Ratiopharm 2,5 mg Orodispersible tablet
Portuguese: Desloratadina Ratiopharm 2,5 mg Comprimido orodispersível
English: Levetiracetam Levetiracetam-Generics 500 mg Film - coated tablet
Portuguese: Levetiracetam Levetiracetam-Generics 500 mg Comprimido revestido por película
English: Ciprofloxacin Fair-Med 500 mg Film - coated tablet
Portuguese: Ciprofloxacin Fair-Med 500 mg Comprimido revestido por película
English: VENLAFAXINE ORION 75 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXINE ORION 75 mg Cápsula dura de libertação prolongada
English: VENLAFAXINE ORION 150 mg Prolongedreleased capsule, hard
Portuguese: VENLAFAXINE ORION 150 mg Cápsula dura de libertação prolongada
English: Venlafaxine Bluefish 37,5 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxine Bluefish 37,5 mg Cápsula dura de libertação prolongada
English: 500 mg Prolongedrelease tablet
Portuguese: 500 mg Comprimido de libertação prolongada
English: Donepezil Odis Mylan
Portuguese: Donepezil Odis Mylan 5 mg
English: Venlafaxina Bluefish XR 75 mg Prolongedreleased capsule, hard
Portuguese: Venlafaxina Bluefish XR 75 mg Cápsula dura de libertação prolongada
English: It is used after at least one other treatment has failed;
Portuguese: É utilizado após insucesso de, pelo menos, um outro tratamento;
English: Potactasol topotecan
Portuguese: Potactasol topotecano
English: This is a summary of the European public assessment report (EPAR) for Potactasol.
Portuguese: Este é um resumo do Relatório Público Europeu de Avaliação (EPAR) relativo ao Potactasol.
English: The company has provided data from the published literature on topotecan.
Portuguese: A empresa apresentou informações provenientes da literatura publicada sobre o topotecano.
English: Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects.
Portuguese: As doses de Potactasol poderão ter de ser ajustadas ou o tratamento retardado, dependendo dos efeitos secundários.
English: What are the benefits and risks of Potactasol?
Portuguese: Quais os benefícios e os riscos do Potactasol?
English: Other information about Potactasol
Portuguese: Outras informações sobre o Potactasol
English: The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin.
Portuguese: O CHMP concluiu que, em conformidade com o exigido pela legislação da UE, o Potactasol demonstrou ser comparável ao Hycamtin.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol.
Portuguese: O seu objetivo é explicar o modo como o Comité dos Medicamentos para Uso Humano (CHMP) avaliou o medicamento a fim de emitir um parecer favorável à concessão de uma autorização de introdução no mercado, bem como as suas recomendações sobre as condições de utilização do Potactasol.
English: It is used on its own to treat patients with:
Portuguese: É utilizado em monoterapia (isoladamente) para o tratamento de doentes com:
English: The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height.
Portuguese: A dose de Potactasol utilizada depende do tipo de cancro a tratar e da altura e peso corporal dos doentes.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Portuguese: Por conseguinte, o CHMP considerou que, à semelhança do Hycamtin, os seus benefícios são superiores aos riscos identificados.
English: Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy.
Portuguese: O tratamento com o Potactasol só deve ser administrado sob a supervisão de um médico experiente em quimioterapia.
English: Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Portuguese: Uma vez que o Potactasol é um medicamento genérico bioequivalente ao medicamento de referência, os seus benefícios e riscos são considerados idênticos aos do medicamento de referência.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.
Portuguese: Em 6 de janeiro de 2011, a Comissão Europeia concedeu uma Autorização de Introdução no Mercado, válida para toda a União Europeia, para o medicamento Potactasol.
English: The Committee recommended that Potactasol be given marketing authorisation.
Portuguese: O Comité recomendou a concessão de uma autorização de introdução no mercado para o Potactasol.
English: For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course.
Portuguese: Tanto no cancro do ovário como do pulmão, o Potactasol é administrado diariamente ao longo de cinco dias, com um intervalo de três semanas entre cada ciclo de tratamento.
English: Potactasol is a cancer medicine.
Portuguese: O Potactasol é um medicamento contra o cancro.
English: Potactasol is a medicine that contains the active substance topotecan.
Portuguese: O Potactasol é um medicamento que contém a substância ativa topotecano.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Portuguese: Está disponível na forma de um pó para solução para perfusão (administração gota a gota numa veia).
English: This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin.
Portuguese: O Potactasol é um medicamento genérico, o que significa que é similar a um medicamento de referência já autorizado na União Europeia (UE) denominado Hycamtin.
English: It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix).
Portuguese: O Potactasol também é administrado em associação com cisplatina (outro medicamento contra o cancro) para o tratamento de mulheres com cancro do colo do útero recorrente após radioterapia, ou quando a doença se encontra num estado avançado (o cancro disseminou-se para além do colo do útero).
English: No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Portuguese: Não foram necessários estudos adicionais, uma vez que o Potactasol é um medicamento genérico administrado por perfusão que contém a mesma substância ativa presente no medicamento de referência, o Hycamtin.