FrancophonIA/ELRC3.0 huggingface dataset:
French: Allemagne Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Portuguese: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
French: Allemagne Wyeth Pharma GmbH Postfach 8806
Portuguese: Wyeth Pharma GmbH Postfach 8806
French: Remeron 15mg/mlLösung zum Einnehmen
Portuguese: Remeron 15mg/ml-Lösung zum Einnehmen
French: Danemark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Portuguese: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
French: 1 The Cam Centre Wilbury Way
Portuguese: Wilbury Way
French: Royaume-Uni Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Portuguese: Reino Unido Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
French: Considérant que - Le Comité a pris en compte la saisine en vertu de l'article 31 de la Directive 2001/83/CE, telle que modifiée, concernant les spécialités pharmaceutiques contenant de l'atomoxétine, du citalopram, de l'escitalopram, de la fluoxétine, de la fluvoxamine, de la miansérine, du milnacipran, de la mirtazapine, de la paroxétine, de la reboxétine, de la sertraline et de la venlafaxine ;
Portuguese: Considerando que, - o Comité considerou o procedimento previsto no artigo 31.º da Directiva 2001/83/CE, com a última redacção que lhe foi dada, relativa aos medicamentos que contêm atomoxetina, citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina;
French: Katwijk Farma B.V.
Portuguese: Países Baixos Katwijk Farma B.V.
French: Allemagne STADA GmbH Stadastr.
Portuguese: STADA GmbH Stadastr.
French: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Portuguese: Países Baixos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
French: Allemagne Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Portuguese: Frankfurter Str. 129a D-64293 Darmstadt
French: Allemagne Boehringer Ingelheim Pharma GmbH & Co.KG
Portuguese: Boehringer Ingelheim Pharma GmbH & Co.KG
French: Danemark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Portuguese: Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
French: Royaume-Uni Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Portuguese: Reino Unido Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
French: Efexor XR 150, capsules 150 mg
Portuguese: Efexor XR 150, capsules
French: Slovaquie Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Portuguese: 16, Chemin de Coquelicots CH - 1214 Geneva
French: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Portuguese: Luxemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
French: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Portuguese: Países Baixos Hexal B.V., Postbus 251, NL-2180 AG Hillegom
French: Danemark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Portuguese: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
French: Allemagne Pharmacia GmbH Pfizerstr.
Portuguese: Pharmacia GmbH Pfizerstr.
French: KG) Van-der-Smissen-Str. 1
Portuguese: Van-der-Smissen-Strasse 1
French: Zoloft 20 mg/ml, solution for oral use
Portuguese: Zoloft 20 mg/ml, solution for Via oral
French: Lyophilisat oral
Portuguese: Suspensão oral
French: Danemark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Portuguese: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
French: Royaume-Uni Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Portuguese: Reino Unido Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
French: SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Portuguese: Républica Checa SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
French: Danemark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Portuguese: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
French: Danemark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Portuguese: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
French: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Portuguese: Países Baixos Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
French: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Portuguese: Luxemburgo ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
French: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Portuguese: Países Baixos Apothecon B.V., Postbus 324, NL3770 AH Barneveld
French: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Portuguese: Países Baixos Sandoz B.V., Postbus 216, NL-1380 AE Weesp
French: Allemagne Stadapharm GmbH Stadastr.
Portuguese: Stadapharm GmbH Stadastr.
French: Gladem 50mgFilmtabletten
Portuguese: Gladem 50mg-Filmtabletten
French: D-64206 Darmstadt paroxedura 30 mg Filmtabletten
Portuguese: D-64206 Darmstadt paroxedura 30 mg Filmtabletten 30 mg
French: Luxembourg ORGANON EUROPE N.V.
Portuguese: Luxemburgo ORGANON EUROPE N.V.
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
French: Luxembourg ORGANON EUROPE B.V.
Portuguese: Luxemburgo ORGANON EUROPE B.V.
French: Des comportements de type suicidaire (tentatives de suicide et idées suicidaires) et de type hostile (principalement agressivité, comportement d'opposition et colère) ont été plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités par antidépresseurs par rapport à ceux traités par placebo.
Portuguese: Foram observados com maior frequência comportamentos relacionados com o suicídio (tentativa de suicídio e ideação suicida) e hostilidade (predominantemente agressão, comportamento de oposição e cólera) em ensaios clínicos com crianças e adolescentes que se encontravam a tomar antidepressivos, em comparação com os que se encontravam a tomar placebo.
French: Danemark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Portuguese: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
French: Royaume-Uni Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Portuguese: Reino Unido Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
French: Allemagne IIP-Institut fuer industrielle Pharmazie Benzstr.
Portuguese: IIP-Institut fuer industrielle Pharmazie
French: Slovaquie Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Portuguese: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
French: Allemagne Aliud Pharma GmbH & Co.KG Postfach 1380
Portuguese: Aliud Pharma GmbH & Co.KG Postfach 1380
French: Un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle ont été plus fréquemment observés au cours d'études cliniques chez les enfants et adolescents traités par [Nom de Fantaisie] par rapport à ceux traités par placebo.
Portuguese: Foram observadas com maior frequência, hostilidade (predominantemente agressão, comportamento de oposição e cólera) e labilidade emocional em ensaios clínicos com crianças e adolescentes que se encontravam a tomar [Nome de Fantasia], em comparação com os que se encontravam a tomar placebo.
French: Fabrik , Holger Danskaes Vej 89, DK - 2000
Portuguese: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
French: Danemark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Portuguese: Alternova A/S, Industriparken 25, DK-2750 Ballerup, Denmark
French: Comprimé/gélule à libération modifiée
Portuguese: Cápsula de libertação modificada
French: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Portuguese: Países Baixos Solvay Pharma B.V., Postbus 501, NL-1380 AM Weesp
French: Venlafaxin Wyeth retard 150 mg
Portuguese: Venlafaxin Wyeth retard 150 mg 150 mg
French: III.I MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DU RCP DES PRODUITS FLUOXÉTINE, FLUVOXAMINE, SERTRALINE, PAROXÉTINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSÉRINE, MILNACIPRAN, REBOXÉTINE ET MIRTAZAPINE
Portuguese: III.I ALTERAÇÕES A INCLUIR NA SECÇÃO RELEVANTE DO RCM DE FLUOXETINA, FLUVOXAMINA, SERTRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA
French: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
Portuguese: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale
French: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
French: D-64206 Darmstadt paroxedura 20 mg Filmtabletten
Portuguese: D-64206 Darmstadt paroxedura 20 mg Filmtabletten 20 mg
French: Efexor XR 37,5, capsule 37,5 mg
Portuguese: Efexor XR 37,5, capsule
French: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Portuguese: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
French: Desiflu voxamin 100 mg 100 mg
Portuguese: Desiflu voxamin 100 mg
French: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Portuguese: Países Baixos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
French: Capsule molle à libération prolongée
Portuguese: Cápsula mole de libertaçao prolongada
French: RANBAXY (UK) LTD., EALING, LONDON
Portuguese: Républica Checa RANBAXY (UK) LTD., EALING, LONDON
French: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Portuguese: Países Baixos Hexal AG, Postfach 1263, D-83602 Holzkirchen
French: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Portuguese: Países Baixos Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
French: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Portuguese: Luxemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
French: Royaume-Uni John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Portuguese: Reino Unido John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
French: Inpharmco-Mianserin30mg-Tabletten
Portuguese: Inpharmco-Mianserin-30mgTabletten
French: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Portuguese: Países Baixos Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
French: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Portuguese: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
French: Allemagne Synthon B.V.
Portuguese: Synthon B.V.
French: Tresleen 50mgFilmtabletten
Portuguese: Tresleen 50mg-Filmtabletten
French: Fluoxetin Hexal 4mg/ml Loesung
Portuguese: Fluoxetin Hexal 4mg/ml Loesung 20 mg
French: Royaume-Uni Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Portuguese: Reino Unido Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: RÉSUMÉ GÉNÉRAL DE L'ÉVALUATION SCIENTIFIQUE DES SPÉCIALITÉS PHARMACEUTIQUES CONTENANT DE LA FLUOXÉTINE, DE LA FLUVOXAMINE, DE LA SERTRALINE, DE LA PAROXÉTINE, DU CITALOPRAM, DE L'ESCITALOPRAM, DE L'ATOMOXÉTINE, DE LA VENLAFAXINE, DE LA MIANSERINE, DU MILNACIPRAN, DE LA REBOXÉTINE ET DE LA MIRTAZAPINE (voir Annexe I)
Portuguese: RESUMO GERAL DA AVALIAÇÃO CIENTÍFICA DOS MEDICAMENTOS QUE CONTÊM FLUOXETINA, FLUVOXAMINA, SERTRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, ATOMOXETINA, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINE (consultar Anexo I)
French: Allemagne Rodleben Pharma GmbH Postfach 205
Portuguese: Rodleben Pharma GmbH Postfach 205
French: Allemagne Temmler Pharma GmbH & Co.KG Postfach 2269
Portuguese: Temmler Pharma GmbH & Co.KG Postfach 2269
French: Allemagne TAD Pharma GmbH Postfach 720
Portuguese: TAD Pharma GmbH Postfach 720
French: Danemark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Portuguese: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
French: Prozac Durapac 90 mg Cápsulas Duras GastroResistentes
Portuguese: Prozac Durapac 90 mg Cápsulas Duras Gastro-Resistentes
French: Floccin 20mg/5mlLösung zum Einnehmen
Portuguese: Floccin 20mg/5ml-Lösung zum Einnehmen
French: Fluoxetin „Lilly" 20mglösliche Tabletten
Portuguese: Fluoxetin „Lilly" 20mg-lösliche Tabletten
French: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Portuguese: Países Baixos Alpharma B.V., Postbus 313, NL-3740 AH Baarn
French: Paroxetin "Salutas" 40mg-Filmtabletten
Portuguese: Paroxetin "Salutas" 40mgFilmtabletten
French: Fluxet 20 mg snap-tab 20 mg
Portuguese: Fluxet 20 mg snap-tab
French: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Portuguese: Países Baixos Genthon B.V., Postbus 7071, NL6503 GN Nijmegen
French: Royaume-Uni KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Portuguese: Reino Unido KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
French: Desiflu voxamin 50 mg 50 mg
Portuguese: Desiflu voxamin 50 mg
French: Portal capsules 20 mg 20 mg
Portuguese: Portal capsules 20 mg
French: Royaume-Uni Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Portuguese: Reino Unido Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
French: Venlafaxin Wyeth retard 75 mg
Portuguese: Venlafaxin Wyeth retard 75 mg 75 mg
French: Royaume-Uni Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Portuguese: Reino Unido Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: Allemagne Neosan Filchnerstr.
Portuguese: Filchnerstr.
French: Tolvon, tablets 10 mg 10 mg
Portuguese: Tolvon, tablets 10 mg
French: SANDOZ GMBH, KUNDL Biochemiestrasse 10
Portuguese: Républica Checa SANDOZ GMBH, KUNDL Biochemiestrasse 10
French: Allemagne H.Lundbeck A/S Ottiliavej 7-9
Portuguese: H.Lundbeck A/S Ottiliavej 7-9
French: GenRx B.V.
Portuguese: Países Baixos GenRx B.V.
French: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Portuguese: Luxemburgo Ratiopharm GmbH, Postfach 3380, D-89070 Ulm, Germany
French: ZOLOFT OC 20mg/ml 20mg/ml
Portuguese: ZOLOFT OC 20mg/ml
French: Rue-de-la-Pastorale 26-28
Portuguese: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
French: EFEXOR 37,5 MG 37.5mg
Portuguese: EFEXOR 37,5 MG
French: Royaume-Uni Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Portuguese: Reino Unido Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
French: SEROXAT 30mg tbl flm 30mg
Portuguese: SEROXAT 30mg tbl flm
French: Danemark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Portuguese: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
French: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
French: Allemagne ct-Arzneimittel GmbH Lengeder Str. 42a
Portuguese: Alemanha ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
French: Remeron 15 mg/ml, oral solution
Portuguese: Remeron 15 mg/ml, oral solution 15 mg/ml
French: Danemark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Portuguese: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
French: Inpharmco-Mianserin10mg-Tabletten
Portuguese: Inpharmco-Mianserin-10mgTabletten
French: EDRONAX 4 MG N
Portuguese: EDRONAX 4 MG
French: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Portuguese: Países Baixos Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
French: Felixsan 50mgFilmtabletten
Portuguese: Felixsan 50mg-Filmtabletten
French: Danemark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Portuguese: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
French: Danemark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Portuguese: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
French: Solvex 4 mg Tabletten 4 mg
Portuguese: Solvex 4 mg Tabletten
French: Solution à diluer injectable
Portuguese: Concentrado para solução injectável
French: Paroxetin "Merckle" 20mg-Filmtabletten
Portuguese: Paroxetin "Merckle" 20mgFilmtabletten
French: Trevilor retard 75 mg 75 mg
Portuguese: Trevilor retard 75 mg
French: Royaume-Uni Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Portuguese: Reino Unido Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
French: Mutan 20mgFilmtabletten
Portuguese: Mutan 20mg-Filmtabletten
French: Gélule à libération prolongée
Portuguese: Cápsula de libertaçao prolongada
French: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Portuguese: Luxemburgo DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
French: SEROXAT 30 MG 30 mg
Portuguese: SEROXAT 30 MG
French: Efexor XR 75, capsules 75 mg
Portuguese: Efexor XR 75, capsules
French: Fluvoxamine-maleaat 50 A, tablets
Portuguese: Fluvoxamine-maleaat 50 A, tablets 50 mg
French: Efectin ER 150mgKapseln
Portuguese: Efectin ER 150mg-Kapseln
French: Mianserin 30mg Holsten 30 mg
Portuguese: Mianserin 30mg Holsten
French: Mianserin Organon 10mg 10 mg
Portuguese: Mianserin Organon 10mg
French: Organon, P.O. Box 20, Oss, Netherland
Portuguese: Box 20, Oss, Netherland
French: Royaume-Uni Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Portuguese: Reino Unido Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
French: SEROXAT 20mg tbl flm 20mg
Portuguese: SEROXAT 20mg tbl flm
French: Vous devez informer votre médecin si l'un des symptômes énumérés ci-dessus apparaît ou s'aggrave lors de la prise de [Nom de Fantaisie] par un patient de moins de 18 ans. Vous devez également savoir que la sécurité à long terme concernant la croissance, la maturation et le développement cognitif et comportemental de [Nom de Fantaisie] n'a pas encore été établiedans cette tranche d'âge.
Portuguese: Deverá informar o seu médico se algum dos sintomas acima mencionados se desenvolver ou piorar quando doentes com menos de 18 anos estejam a tomar [Nome de fantasia].
French: Tolvon, tablets 3 mg 30 mg
Portuguese: Tolvon, tablets 3 mg
French: Royaume-Uni Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Portuguese: Reino Unido Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
French: PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
Portuguese: Républica Checa LICHTENSTEIN PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
French: Efexor Modified Release XL
Portuguese: Efexor Modified Release XL 150 mg
French: Paluxetil 20mgFilmtabletten
Portuguese: Paluxetil 20mg-Filmtabletten
French: KG Elisabeth-Selbert-Str. 1
Portuguese: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
French: Mianserin Organon 60mg 60 mg
Portuguese: Mianserin Organon 60mg
French: Mianserin „Arcana" 30mg-Filmtabletten
Portuguese: Mianserin „Arcana" 30mgFilmtabletten
French: - Concernant l'atomoxétine, laquelle est uniquement indiquée dans le traitement du TDAH, le Comité a conclu qu'une mise en garde rapportant qu'un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle avaient été plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités par atomoxétine par rapport à ceux traités par placebo, ainsi qu'une mise en garde indiquant l'absence d'efficacité dans la dépression, devaient être incluses dans les Résumés des Caractéristiques du Produit et dans la rubrique concernée des Notices du Produit des spécialités pharmaceutiques contenant de l'atomoxétine.
Portuguese: - no que se refere à atomoxetina, a qual está apenas indicada no tratamento de défice de atenção/distúrbio de hiperactividade, o Comité concluiu que, no Resumo das Características do Medicamento e na secção relevante do Folheto Informativo de medicamentos que contêm atomoxetina, deve incluir-se uma advertência para o facto de a hostilidade (predominantemente agressão, comportamento de oposição e cólera) e a labilidade emocional terem sido observadas com maior frequência em ensaios clínicos com crianças e adolescentes que se encontravam a tomar atomoxetina, em comparação com os que se encontravam a tomar placebo, bem como uma advertência indicando a ineficácia no tratamento da depressão.
French: HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07
Portuguese: Républica Checa HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07
French: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
Portuguese: Box 158 Sköyen N-0212 Oslo Norge (NOR)
French: Fluvoxamine-maleaat 100 A, tablets
Portuguese: Fluvoxamine-maleaat 100 A, tablets 100 mg
French: Mirtabene 30mgFilmtabletten
Portuguese: Mirtabene 30mg-Filmtabletten
French: Mirtatsapiini APS Limited 15 mg
Portuguese: Mirtatsapiini APS Limited
French: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Portuguese: Républica Checa ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
French: Sertralin AWD 100 mg 100 mg
Portuguese: Sertralin AWD 100 mg
French: Slovaquie Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Portuguese: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
French: Paroxetin "Arcana" 20mg-Filmtabletten
Portuguese: Paroxetin "Arcana" 20mgFilmtabletten
French: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Portuguese: Países Baixos KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin
French: Paroxetin "Interpharm" 20mg-Filmtabletten
Portuguese: Paroxetin "Interpharm" 20mgFilmtabletten
French: Solution buvable en gouttes Voie orale
Portuguese: Gotas orais, solução Via oral
French: Sertralin AWD 50 mg 50 mg
Portuguese: Sertralin AWD 50 mg
French: Trevilor Tabletten 37,5mg 37.5 mg
Portuguese: Trevilor Tabletten 37,5mg
French: PFIZER SPOL.
Portuguese: Républica Checa PFIZER SPOL.
French: Note: Cette notice est celle annexée à la décision de la Commission relative à la saisine communautaire conformément à l'Article 31 de la Directive 2001/83/CE du parlement européen et du conseil..
Portuguese: "Nota: Esta secção do folheto informativo foi anexada à Decisão da Comissão na sequência do procedimento de arbitragem ao abrigo do Artigo 31.
French: Danemark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Portuguese: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
French: Le CHMP a considéré qu'aucun signal d'augmentation du risque de comportement de type suicidaire n'était présent dans les études portant sur l'atomoxétine.
Portuguese: O CHMP considerou não haver qualquer sinal de aumento do risco de comportamentos relacionados com o suicídio nos estudos referentes à atomoxetina, verificando, contudo, sinais de um aumento do risco de anomalias comportamentais, com mais reacções de agressão e hostilidade.
French: Fluoxetin „Lannacher" 20mg-Kapseln
Portuguese: Fluoxetin „Lannacher" 20mgKapseln
French: Royaume-Uni Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Portuguese: Reino Unido Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
French: Comprimé dispersible Voie orale
Portuguese: Comprimido dispersível Via oral
French: PAROXETINA HEXAL 40 mg
Portuguese: PAROXETINA HEXAL 40 mg 40 mg
French: Royaume-Uni Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Portuguese: Reino Unido Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: Hexal B.V.
Portuguese: Países Baixos Hexal B.V.
French: Mirtazapin "Alternova" 45mg-Filmtabletten
Portuguese: Mirtazapin "Alternova" 45mgFilmtabletten