FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: Um medicamento listado no Anexo IB pode ser considerado crítico pelo(s) Estado(s)Membro(s) com base na avaliação da potencial necessidade médica ainda por satisfazer, considerando a disponibilidade de medicamentos alternativos adequados no(s) respetivo(s) Estado(s)-Membro(s) e, se adequado, a natureza da doença a ser tratada.
Dutch: Een geneesmiddel dat in bijlage IB is opgenomen kan door de lidstaat of lidstaten van cruciaal belang geacht worden op basis van een beoordeling als potentieel onvervulde medische behoefte, daarbij de beschikbaarheid van geschikte alternatieve geneesmiddelen in de respectieve lidstaat of lidstaten en, waar van toepassing, de aard van de te behandelen ziekte in aanmerking nemende.
Portuguese: As seguintes conclusões foram, em conformidade, adotadas pelo CHMP, com base na avaliação das respostas dos titulares de AIM e depois de ter sido dada devida consideração a todos os argumentos apresentados pelos titulares de AIM:
Dutch: Op basis van de beoordeling van de antwoorden van de vergunninghouders en na alle door de vergunninghouders aangevoerde argumenten terdege in aanmerking genomen te hebben, nam het CHMP dienovereenkomstig de volgende conclusies aan:
Portuguese: O CHMP concluiu que os resultados críticos das BPC não permitem que esses estudos sejam invocados para estabelecer a bioequivalência relativamente ao medicamento de referência da UE.
Dutch: Het CHMP concludeerde dat deze onderzoeken op basis van de kritieke GCP-bevindingen niet betrouwbaar genoeg zijn om de bioequivalentie ten opzichte van het EU-referentiegeneesmiddel vast te stellen.
Portuguese: O CHMP considera que este argumento não substitui a necessidade de estabelecer a bioequivalência com um medicamento de referência da UE para se concluir quanto ao perfil benefício-risco positivo dos medicamentos em causa.
Dutch: Het CHMP is van mening dat dit argument niet wegneemt dat de bio-equivalentie ten opzichte van een EU-referentiegeneesmiddel moet worden vastgesteld om te kunnen concluderen dat de batenrisicoverhouding van de desbetreffende geneesmiddelen positief is.
Portuguese: Por conseguinte, o titular da AIM mantém a necessidade de estabelecer a bioequivalência com o medicamento de referência da UE para se concluir quanto ao perfil benefício-risco positivo do medicamento.
Dutch: De vergunninghouder moet dan ook nog steeds de bio-equivalentie ten opzichte van het EUreferentiegeneesmiddel vaststellen om te kunnen concluderen dat de baten-risicoverhouding van het geneesmiddel positief is.
Portuguese: • o Comité concluiu, para as Autorizações de Introdução no Mercado dos medicamentos do Anexo IA contendo Bendroflumetiazida, Bosentano, Fexofenadina, Lansoprazol, Levetiracetam, Levocetirizina, Metoclopramida, Nebivolol e Venlafaxina, que o perfil benefício-risco é positivo nas indicações aprovadas,
Dutch: • het CHMP voor de handelsvergunningen van de in bijlage IA opgenomen geneesmiddelen die bendroflumethiazide, bosentan, fexofenadine, lansoprazol, levetiracetam, levocetirizine,
Portuguese: Caso, durante esse período, o(s) Estado(s)-Membro(s) considerar(em) que um medicamento deixou de ser crítico, aplicar-se-á a suspensão da Autorização de Introdução no Mercado em causa.
Dutch: Mocht(en) de lidstaat of lidstaten een geneesmiddel in de loop van deze periode niet langer van cruciaal belang achten, dan wordt de schorsing van de desbetreffende handelsvergunning alsnog van kracht.
Portuguese: Caso, durante esse período, o(s) Estado(s)-Membro(s) considerar(em) que um medicamento deixou de ser crítico, aplicar-se-á a suspensão da(s) Autorização(ões) de Introdução no Mercado em causa.
Dutch: Mocht(en) de lidstaat of lidstaten een geneesmiddel in de loop van deze periode niet langer van cruciaal belang achten, dan wordt de schorsing van de desbetreffende handelsvergunning(en) alsnog van kracht.
Portuguese: 46015- Valencia (Valencia)
Dutch: 46015- Valencia (Valencia) Spain
Portuguese: Anexo I Lista de nomes, formas farmacêuticas, dosagens dos medicamentos, vias de administração, titulares da autorização de introdução no mercado nos Estados-Membros
Dutch: Bijlage I Lijst met namen, farmaceutische vormen, sterkten van de geneesmiddelen, toedieningswegen, houders van de vergunning voor het in de handel brengen in de lidstaten
Portuguese: F-94200 Ivry-sur-Seine France
Dutch: F-94200 Ivry-sur-Seine Frankrijk
Portuguese: Bendroflumetiazida Bendroflumetiazid Alternova
Dutch: Bendroflumethiazide Bendroflumetiazid Alternova
Portuguese: Pharmazac SA 31 Naoussis street Athens 1447
Dutch: Griekenland Pharmazac SA 31 Naoussis street Athens 1447
Portuguese: Áustria ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Dutch: Oostenrijk ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Portuguese: Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive Castleford
Dutch: Denemarken Norton Healthcare Ltd T/A Ivax Pharmaceuticals UK Ridings Point, Whistler Drive Castleford
Portuguese: Cipla Chanelle Generics Limited
Dutch: Denemarken Cipla Chanelle Generics Limited
Portuguese: 20052 Monza Italy
Dutch: 20052 Monza
Portuguese: Estado-Membro UE/EEE
Dutch: Lidstaat (EEA)
Portuguese: Anexo IB: Medicamentos para os quais se recomenda a suspensão das Autorizações de Introdução no Mercado Estado-Membro
Dutch: Bijlage IB: Producten waarvoor schorsing van de handelsvergunningen wordt aanbevolen Lidstaat (EEA)
Portuguese: Hidrocortisona
Dutch: Hydrocortison
Portuguese: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT
Dutch: Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT United Kingdom
Portuguese: Sofia 1582
Dutch: Sofia 1582 Bulgaria
Portuguese: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2Vinohrady
Dutch: Genericon s.r.o., Anny Letenské 1108/15, 120 00 Praha 2 - Vinohrady Czech Republic
Portuguese: Sage House 319 Pinner Road, North Harrow
Dutch: 319 Pinner Road, North Harrow
Portuguese: Tramadol/paraceta mol
Dutch: Tramadol/paracetamol
Portuguese: Bosentano monohidratado
Dutch: Bosentan monohydraat
Portuguese: 18 Km Marathon Avenue, 15351 Pallini Greece
Dutch: Griekenland Genepharm S.A. 18 Km Marathon Avenue, 15351 Pallini
Portuguese: Países Baixos Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Dutch: Nederland Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Portuguese: Ácido alendrónico Alendronat Accord Veckotablett
Dutch: Alendronat Accord Veckotablett
Portuguese: Países Baixos Farmaprojects, S.A.U.
Dutch: Nederland Farmaprojects, S.A.U.
Portuguese: Anexo IA: Medicamentos para os quais se recomenda a manutenção das Autorizações de Introdução no Mercado Estado
Dutch: Bijlage IA: Producten waarvoor handhaving van de handelsvergunningen wordt aanbevolen Lidstaat (EEA)
Portuguese: República Checa GNR Czech s.r.o.
Dutch: GNR Czech s.r.o.
Portuguese: Dr. Reddy's Laboratories Romania SRL 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Dutch: 71st-73rd Nicolae Caramfil, Floor 5, Space 10, Sector 1, Bucuresti, Romania
Portuguese: Huetteldorfer Straße 299 1140 Wien
Dutch: Arcana Arzneimittel GmbH Huetteldorfer Straße 299 1140 Wien
Portuguese: Abdi Farma, Unipessoal Lda. Quinta da Fonte, Rua dos Malhoes
Dutch: Quinta da Fonte, Rua dos Malhoes
Portuguese: Países Baixos Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1
Dutch: Nederland Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1
Portuguese: Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172
Dutch: 1 G. M. Dimitrov Blvd. Sofia 1172
Portuguese: Sieger Pharma A.E. Marathonos Avenue 106 Pikermi 19009
Dutch: Griekenland Sieger Pharma A.E. Marathonos Avenue 106
Portuguese: Nome de fantasia Dosagem Forma farmacêutica
Dutch: Fantasienaam Sterkte Farmaceutische vorm
Portuguese: Clobazam CLOBAZAM AUDEN 10mg TABLETS
Dutch: CLOBAZAM AUDEN 10mg TABLETS
Portuguese: 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom
Dutch: Forum Products Limted Crown House 2-8 Gloucester Road Redhill Surrey RH1 1FH United Kingdom
Portuguese: Cefpodoxima proxetilnazol
Dutch: Cefpodoxime proxetil
Portuguese: Ácido alendrónico Ácido alendrónico Labesfal
Dutch: Ácido alendrónico Labesfal
Portuguese: Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Dutch: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Portuguese: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate
Dutch: Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom
Portuguese: Lambda Therapeutic Limited
Dutch: Lambda Therapeutic Limited Sage House
Portuguese: Valsartan/hydrochlorthiazi d "Fair-Med"
Dutch: Valsartan/hydrochlort hiazid "Fair-Med"
Portuguese: República Checa Actavis Group PTC ehf.
Dutch: Denemarken Actavis Group PTC ehf.
Portuguese: Ácido alendrónico ALENDRONATO RANBAXY ITALIA
Dutch: ALENDRONATO RANBAXY ITALIA
Portuguese: Cefpodoxima Alkaloid 200 mg Comprimido
Dutch: Cefpodoxima Alkaloid 200 mg Tablet
Portuguese: Trimetazidina
Dutch: Trimetazidine
Portuguese: Ácido alendrónico Alendronato Pensa 70 mg compresse
Dutch: Alendronato Pensa 70 mg compresse
Portuguese: Grange Road Dublin 13
Dutch: Grange Road
Portuguese: Clobazam Clobazam Sandoz 10 mg, tabletten
Dutch: Clobazam Sandoz 10 mg, tabletten
Portuguese: Ebastina
Dutch: Ebastine
Portuguese: Esomeprazole Mylan
Dutch: ESOMEPRAZOLO MYLAN
Portuguese: Entacapona
Dutch: Entacapone
Portuguese: Sage House, 319 Pinner Road
Dutch: Accord Healthcare Limited Sage House, 319 Pinner Road
Portuguese: Calea Floreasca Street No 169A, district 2 Bucharest
Dutch: Sandoz Pharma Services SRL Calea Floreasca Street No 169A, district 2
Portuguese: Dr Reddy's Laboratories (UK) Limited 6 Riverview Road, Beverley
Dutch: Dr Reddy's Laboratories (UK) Limited
Portuguese: Comprimido
Dutch: Tablets
Portuguese: Metoclopramida METOCLOPRAMIDE ACCORD
Dutch: METOCLOPRAMIDE ACCORD
Portuguese: Clonazepam Clonazepam 500mcg Tablet
Dutch: Clonazepam 500mcg Tablet
Portuguese: Desloratadine/Genepharm 5 mg δισκία επικαλυμμένα με υμένιο,
Dutch: Desloratadine/Geneph arm 5 mg δισκία επικαλυμμένα με υμένιο,
Portuguese: Irbesartan HCTZ Fair-Med 300+25 mg Filmtabletten
Dutch: Irbesartan HCTZ FairMed 300+25 mg Filmtabletten
Portuguese: Fexofenadina
Dutch: Fexofenadine
Portuguese: Desloratadine/Genepharm 2,5 mg δισκία διασπειρόμενα στο στόμα
Dutch: Desloratadine/Geneph arm 2,5 mg δισκία διασπειρόμενα στο στόμα
Portuguese: República Checa Abbott Laboratories, s.r.o.
Dutch: Abbott Laboratories, s.r.o.
Portuguese: Eletriptano
Dutch: Eletriptan
Portuguese: Países Baixos ratiopharm Nederland B.V.
Dutch: Nederland ratiopharm Nederland B.V. Swensweg 5
Portuguese: Cápsula
Dutch: Capsules
Portuguese: 19 avenue de Norvège 91953 Courtaboeuf Cedex
Dutch: Medipha Sante Les Fjords - Immeuble Oslo 19 avenue de Norvège 91953 Courtaboeuf Cedex France
Portuguese: Comprimido com incisões
Dutch: Tablet met breuklijn
Portuguese: Ácido alendrónico ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Dutch: ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Portuguese: República Checa Glenmark Pharmaceuticals s.r.o.
Dutch: Glenmark Pharmaceuticals s.r.o.
Portuguese: 500 02 Hradec Králové Czech Republic
Dutch: Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic
Portuguese: Studio 8B Ard Gaoithe Commercial Centre, Business Park Cashel Road Clonmel, Co Tipperary Ireland
Dutch: Studio 8B Ard Gaoithe Commercial Centre, Business Park
Portuguese: Bolamyn/Metabet SR 1000mg Prolonged Release Tablets
Dutch: Metforminehydrochloride Bolamyn/Metabet SR 1000mg Prolonged
Portuguese: Rua Doutor António Loureiro Borges Edíficio Arquiparque 1, R/C Esqº
Dutch: Edíficio Arquiparque 1, R/C Esqº
Portuguese: Veluwezoom 22 1327 AH Almere The Netherlands
Dutch: 1327 AH Almere The Netherlands
Portuguese: Valsartan/hydrochlorthiazi d "Fair-Med" Coated tablets
Dutch: Valsartan/hydrochlort hiazid "Fair-Med" Coated tablets
Portuguese: Levodopa/Carbidopa/Enta capone film-coated tablets 150/37.5/200mg mg/37,5 mg/200 mg
Dutch: Levodopa/Carbidopa/ Entacapone filmcoated tablets 150/37.5/200mg mg/37,5 mg/200 mg
Portuguese: Lansoprazol
Dutch: Lansoprazole
Portuguese: Clobazam Clobazam TioFarma 20 mg, tabletten
Dutch: Clobazam TioFarma 20 mg, tabletten
Portuguese: Tacpan 1 mg Hartkapseln 1 mg
Dutch: Tacpan 1 mg Hartkapseln
Portuguese: Ácido alendrónico Acide Alendronique Ranbaxy 70 mg, comprimé
Dutch: Acide Alendronique Ranbaxy 70 mg, comprimé
Portuguese: Metoclopramide Orifarm 10 mg Comprimido
Dutch: Metoclopramide Orifarm 10 mg Tablet
Portuguese: Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα
Dutch: Desloratadine/Geneph arm 5 mg δισκία διασπειρόμενα στο στόμα
Portuguese: 1000 mg Comprimido
Dutch: 1000 mg Tablet
Portuguese: Venlafaxine Fair-Med
Dutch: VENLAFAXINE FAIRMED
Portuguese: Gluforlyn XR 500 mg retard tabletta
Dutch: Metforminehydrochloride Gluforlyn XR 500 mg retard tabletta
Portuguese: Planckstrasse 13 DE-22765 Hamburg Germany irbesartan
Dutch: DE-22765 Hamburg Germany irbesartan
Portuguese: Clobazam Clobazam TioFarma 10 mg, tabletten
Dutch: Clobazam TioFarma 10 mg, tabletten
Portuguese: Dipiridamol
Dutch: Dipyridamol
Portuguese: Telmisartan/hidroc lorotiazida
Dutch: Telmisartan/ hydrochlorothiazide
Portuguese: Clonazepam Clonazepam TioFarma 0,5 mg tabletten, tabletten
Dutch: Clonazepam TioFarma 0,5 mg tabletten, tabletten
Portuguese: Irbesartan Fair-Med
Dutch: Irbesartan HCT FairMed
Portuguese: Levetiracetam Levetiracetam beta 1000 mg, Filmtabeltten
Dutch: Levetiracetam beta 1000 mg, Filmtabeltten
Portuguese: Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
Dutch: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Portuguese: Eurogenus Farmacêutica, Sociedade Unipessoal, Lda. Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal
Dutch: Rua Alto do Montijo, 13 - 2º Dto., Edifício Monsanto 2790-012 Carnaxide Portugal
Portuguese: Ácido alendrónico Alendronat Ranbaxy Veckotablett 70 mg tabletter
Dutch: Alendronat Ranbaxy Veckotablett 70 mg tabletter
Portuguese: Donepezil/ Generics
Dutch: ESOMEPRAZOLE/ GENERICS
Portuguese: East Yorkshire HU17 0LD United Kingdom
Dutch: 6 Riverview Road, Beverley East Yorkshire HU17 0LD United Kingdom
Portuguese: Valsartan 320mg Capsules 320 mg Cápsula
Dutch: Valsartan 320mg Capsules
Portuguese: Cloridrato de metoclopramida metoclopramide hydrochloride 10mg tablets
Dutch: Metforminehydrochloride metoclopramide hydrochloride 10mg tablets
Portuguese: Ácido alendrónico ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Dutch: ACIDO ALENDRONICO SEMANAL RANBAXY 70 mg COMPRIMIDOS EFG
Portuguese: Oxalato de escitalopram
Dutch: Escitalopram
Portuguese: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2
Dutch: Lagoas Park, Edifício 5 A, Piso 2
Portuguese: Peseri Trading Limited 20 Queen Frederica Street
Dutch: Peseri Trading Limited 20 Queen Frederica Street El-Greco House, office 301 1066 Nicosia Cyprus
Portuguese: Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
Dutch: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Portuguese: Clonazepam Clonazepam TioFarma 2 mg tabletten, tabletten
Dutch: Clonazepam TioFarma 2 mg tabletten, tabletten
Portuguese: Valsartan/hydrochlorthiazi d "Fair-Med" Coated tablets mg/12,5 mg
Dutch: Valsartan/hydrochlort hiazid "Fair-Med" Coated tablets mg/12,5 mg
Portuguese: Pioglitazone 30mg Tablets 30 mg Comprimido
Dutch: Pioglitazone 30mg Tablets
Portuguese: Clonazepam Clonazepam Sandoz 0,5 mg, tabletten
Dutch: Clonazepam Sandoz 0,5 mg, tabletten
Portuguese: ACCORD HEALTHCARE France SAS 45 Rue de Fbg de Roubaix
Dutch: 45 Rue de Fbg de Roubaix 59000 Lille
Portuguese: Ácido alendrónico Alendronic Acid Once Weekly 70 mg Tablets
Dutch: Alendronic Acid Once Weekly 70 mg Tablets
Portuguese: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTES EFG
Dutch: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTE S EFG
Portuguese: 0,5 mg Comprimido
Dutch: 0,5 mg Tablet
Portuguese: Aleric Deslo Active
Dutch: Aleric Deslo Active 5 mg
Portuguese: Desmopressina DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Dutch: DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Portuguese: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTES EFG
Dutch: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTE S EFG
Portuguese: Rizatriptano
Dutch: Rizatriptan
Portuguese: Irbesartanas/Hidrochloroti azidas Torrent
Dutch: Irbesartan/hydrochlorothi azide
Portuguese: Ácido alendrónico alendronic acid 70mg Once Daily Tablets
Dutch: Alendroninezuur alendronic acid 70mg Once Daily Tablets
Portuguese: 2,5 mg Comprimido
Dutch: 2,5 mg Tablet
Portuguese: Edifícios AzevedosEstrada Nacional 117-2, Alfragide
Dutch: Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal
Portuguese: DONEPEZIL MYLAN GENERICS ITALIA
Dutch: Donepezilhydrochloride DONEPEZIL MYLAN GENERICS ITALIA
Portuguese: Slavojova 579/9
Dutch: Slavojova 579/9 128 00 Praha 2
Portuguese: Alembic Pharmaceuticals Europe Limited Palazzo Pietro Stiges, 103, Strait Street VLT 1436 Valletta Malta
Dutch: Palazzo Pietro Stiges, 103, Strait Street
Portuguese: IRBESARTAN/HIDROCLOR OTIAZIDA WELDING 300 mg/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Dutch: IRBESARTAN/HIDROC LOROTIAZIDA WELDING 300 MG/25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Portuguese: TRAMADOL PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Dutch: PARACETAMOL NIALEX 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Portuguese: Levodopa/carbidop a/entacapona
Dutch: Levodopa/carbidopa/enta capon
Portuguese: Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde tabletten
Dutch: Irbesartan Hydrochloorthiazide Torrent 300 mg/25 mg filmomhulde tabletten
Portuguese: Ácido alendrónico Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Dutch: Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Portuguese: Valsartan 80mg Capsules 80 mg Cápsula
Dutch: Valsartan 80mg Capsules
Portuguese: Valsartan 160mg Capsules 160 mg Cápsula
Dutch: Valsartan 160mg Capsules
Portuguese: Tacpan 5 mg Hartkapseln 5 mg
Dutch: Tacpan 5 mg Hartkapseln
Portuguese: Escitalopram Escitalopram PharmaS 10 mg filmom obložene tablete
Dutch: Escitalopram PharmaS 10 mg filmom obložene tablete
Portuguese: 150 mg Cápsula
Dutch: 150 mg Capsule
Portuguese: 750 mg Comprimido
Dutch: 750 mg Tablet
Portuguese: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Dutch: Levetiracetam beta 750 mg, Filmtabletten
Portuguese: 250 mg Comprimido
Dutch: 250 mg Tablet
Portuguese: Phenoxymethylpenicillin 250mg Film-coated Tablets
Dutch: Fenoxymethylpenicilline Phenoxymethylpenicill in 250mg Film-coated
Portuguese: Telmisartan 80mg Tablets 80 mg Comprimido
Dutch: Telmisartan 80mg Tablets
Portuguese: Valsartan/Hydrochlorothia zide Fair-Med 160 mg/12.5 mg film-coated tablets.
Dutch: Valsartan/Hydrochloro thiazide Fair-Med 160 mg/12.5 mg filmcoated tablets.
Portuguese: Metformin Actavis Retard 750 mg
Dutch: Metforminehydrochloride Metformin Actavis Retard 750 mg
Portuguese: 15 mg Comprimido gastrorresistente
Dutch: 15 mg Gastroresistente tablet
Portuguese: Desmopressina DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Dutch: DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Portuguese: Clonazepam Clonazepam Sandoz 2 mg, tabletten
Dutch: Clonazepam Sandoz 2 mg, tabletten
Portuguese: Rizatriptan Mylan 5 mg 5 mg
Dutch: Rizatriptan Mylan 5 mg
Portuguese: Irbesartanas/Hidrochloroti azidas Torrent mg/12,5 mg
Dutch: Irbesartanas/Hidrochl orotiazidas Torrent mg/12,5 mg
Portuguese: Desmopressina DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Dutch: DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Portuguese: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Dutch: Levetiracetam beta 250 mg, Filmtabletten
Portuguese: 1000 mg Comprimido de libertação prolongada
Dutch: 1000 mg Tablet met verlengde afgifte
Portuguese: 200 mg Cápsula
Dutch: 200 mg Capsule
Portuguese: 32 mg Comprimido
Dutch: 32 mg Tablet
Portuguese: Pioglitazone 45mg Tablets 45 mg Comprimido
Dutch: Pioglitazone 45mg Tablets
Portuguese: VALSARTAN/HIDROCLORO TIAZIDA CODRAMOL 160/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Dutch: VALSARTAN/HIDROCL OROTIAZIDA CODRAMOL 160/25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Portuguese: Fair-Med Healthcare GmbH
Dutch: Fair-Med Healthcare GmbH Planckstrasse 13
Portuguese: Inaller 5 mg filmtabletta 5 mg
Dutch: Inaller 5 mg filmtabletta
Portuguese: 70 mg Comprimido
Dutch: 70 mg tablet
Portuguese: Donepezil Hydrochloride 5mg Orodispersible Tables
Dutch: Donepezilhydrochloride Donepezil Hydrochloride 5mg Orodispersible Tables
Portuguese: Escitalopram 20mg Filmcoated tablets
Dutch: Escitalopram 20mg Film-coated tablets
Portuguese: Irbesartan Welding
Dutch: Germany irbesartan
Portuguese: Os doentes e os profissionais de saúde são informados do seguinte:
Dutch: Patiënten en beroepsbeoefenaren in de gezondheidszorg wordt gewezen op het volgende:
Portuguese: • Os doentes deverão continuar a tomar os seus medicamentos conforme prescrito e contactar o seu médico ou farmacêutico caso tenham alguma dúvida.
Dutch: • Patiënten moeten hun geneesmiddelen blijven gebruiken zoals voorgeschreven en contact opnemen met hun arts of apotheker als ze vragen hebben.
Portuguese: Informações destinadas aos doentes e aos profissionais de saúde
Dutch: Informatie voor patiënten en beroepsbeoefenaren in de gezondheidszorg
Portuguese: No caso dos medicamentos considerados críticos, as empresas dispõem de 12 meses para submeter dados adicionais.
Dutch: Voor geneesmiddelen die kritisch geacht worden krijgen firma's twaalf maanden de tijd om aanvullende gegevens in te dienen.
Portuguese: A recomendação do CHMP foi enviada para a Comissão Europeia para emissão de uma decisão juridicamente vinculativa.
Dutch: De aanbeveling van het CHMP werd toegezonden aan de Europese Commissie zodat zij hierover een juridisch bindend besluit kon nemen.
Portuguese: Alguns destes medicamentos podem ser mantidos no mercado em alguns países, caso sejam clinicamente críticos para os doentes, dado que as alternativas não satisfazem as necessidades dos doentes.
Dutch: Enkele van deze geneesmiddelen mogen in sommige landen op de markt blijven als ze van kritisch belang zijn voor patiënten omdat alternatieven niet voorzien in de behoeften van patiënten.
Portuguese: A natureza sistemática das manipulações, o longo período de tempo durante o qual ocorreram, e o número de membros do pessoal envolvidos geram dúvidas sobre a integridade da realização dos ensaios no local, de um modo geral, e sobre a fiabilidade dos dados gerados.
Dutch: Door de systematische aard van de manipulaties, de lange tijd gedurende welke de manipulaties plaatsvonden en het aantal medewerkers dat erbij betrokken was, konden de integriteit van de op de locatie uitgevoerde onderzoeken en de betrouwbaarheid van de gegenereerde gegevens in twijfel worden getrokken.
Portuguese: A EMA e as autoridades nacionais colaboram estreitamente com parceiros internacionais para garantir que os estudos que sustentam as Autorizações de Introdução no Mercado na UE são realizados de acordo com os mais elevados padrões e que as empresas envolvidas respeitam totalmente todos os aspetos das Boas Práticas Clínicas (BPC).
Dutch: EMA en de nationale instanties werken nauw samen met internationale partners om ervoor te zorgen dat onderzoeken ter onderbouwing van handelsvergunningen in de EU volgens de hoogste normen worden uitgevoerd en dat de betrokken firma's volledig voldoen aan alle aspecten van de goede klinische praktijk (GCP).
Portuguese: A inspeção revelou manipulações dos dados de eletrocardiogramas (ECG) durante a realização de alguns estudos de medicamentos genéricos, que aparentemente ocorreram durante um período de pelo menos cinco anos.
Dutch: De inspectie bracht aan het licht dat gegevens van elektrocardiogrammen (ECG's) gemanipuleerd waren tijdens enkele onderzoeken met generieke geneesmiddelen; deze manipulaties bleken gedurende een periode van ten minste vijf jaar te hebben plaatsgevonden.