FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: Luxemburgo EUROGENERICS N.V.
Danish: Luxembourg EUROGENERICS N.V.
Portuguese: Tresleen 20mg/ml-Konzentrat zur Herstellung einer Trinklösung
Danish: Tresleen 20mg/mlKonzentrat zur Herstellung einer Trinklösung
Portuguese: Países Baixos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Portuguese: III.2 ALTERAÇÕES A INCLUIR NA SECÇÃO RELEVANTE DO RCM DE ATOMOXETINA
Danish: III.2 ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR ATOMOXETIN
Portuguese: Juta Pharma GmbH Gutenbergstr.
Danish: Tyskland Juta Pharma GmbH Gutenbergstr.
Portuguese: Países Baixos Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Danish: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Portuguese: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Danish: Grœkenland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Portuguese: Reino Unido Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Danish: Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Portuguese: Países Baixos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Danish: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Portuguese: BC Biochemie Pharma GmbH Dieselstr.
Danish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
Portuguese: Luxemburgo ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Danish: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Portuguese: Pharmacia GmbH Pfizerstr.
Danish: Tyskland Pharmacia GmbH Pfizerstr.
Portuguese: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Danish: Danmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Portuguese: Remeron 15mg/ml-Lösung zum Einnehmen
Danish: Remeron 15mg/mlLösung zum Einnehmen
Portuguese: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Danish: Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Portuguese: Reino Unido Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Danish: Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Portuguese: Heumann Pharma GmbH & Co. Generica KG
Danish: Tyskland Heumann Pharma GmbH & Co. Generica KG
Portuguese: Wilbury Way
Danish: 1 The Cam Centre Wilbury Way
Portuguese: Países Baixos Katwijk Farma B.V.
Danish: Katwijk Farma B.V.
Portuguese: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Danish: Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Portuguese: Países Baixos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Danish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Portuguese: Boehringer Ingelheim Pharma GmbH & Co.KG
Danish: Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
Portuguese: Reino Unido Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Danish: Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Portuguese: Efexor XR 150, capsules
Danish: Efexor XR 150, capsules 150 mg
Portuguese: Wyeth Pharma GmbH Postfach 8806
Danish: Tyskland Wyeth Pharma GmbH Postfach 8806
Portuguese: Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Danish: Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Portuguese: Luxemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Danish: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Portuguese: Países Baixos Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Danish: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Portuguese: Frankfurter Str. 129a D-64293 Darmstadt
Danish: Tyskland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Portuguese: Reino Unido Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Danish: Storbritannien Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Portuguese: Van-der-Smissen-Strasse 1
Danish: KG) Van-der-Smissen-Str. 1
Portuguese: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Danish: Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
Portuguese: STADA GmbH Stadastr.
Danish: Tyskland STADA GmbH Stadastr.
Portuguese: Zoloft 20 mg/ml, solution for Via oral
Danish: Zoloft 20 mg/ml, solution for oral use
Portuguese: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Danish: Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Portuguese: Républica Checa SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Danish: SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Portuguese: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Danish: Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Portuguese: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Danish: Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Portuguese: Países Baixos Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Danish: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Portuguese: Reino Unido Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Danish: Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Portuguese: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Danish: Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Portuguese: Países Baixos Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Danish: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Portuguese: Países Baixos Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Danish: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Portuguese: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Portuguese: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Danish: Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Portuguese: Gladem 50mg-Filmtabletten
Danish: Gladem 50mgFilmtabletten
Portuguese: D-64206 Darmstadt paroxedura 30 mg Filmtabletten 30 mg
Danish: D-64206 Darmstadt paroxedura 30 mg Filmtabletten
Portuguese: Luxemburgo ORGANON EUROPE N.V.
Danish: Luxembourg ORGANON EUROPE N.V.
Portuguese: Stadapharm GmbH Stadastr.
Danish: Tyskland Stadapharm GmbH Stadastr.
Portuguese: Luxemburgo ORGANON EUROPE B.V.
Danish: Luxembourg ORGANON EUROPE B.V.
Portuguese: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Danish: Grœkenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Portuguese: Reino Unido Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Danish: Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Portuguese: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Danish: Grœkenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Portuguese: Alternova A/S, Industriparken 25, DK-2750 Ballerup, Denmark
Danish: Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Portuguese: 1/ISRSN
Danish: 1/SNRI
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Portuguese: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Danish: Grœkenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Portuguese: Países Baixos Solvay Pharma B.V., Postbus 501, NL-1380 AM Weesp
Danish: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
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;
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin.
Portuguese: Venlafaxin Wyeth retard 150 mg 150 mg
Danish: Venlafaxin Wyeth retard 150 mg
Portuguese: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale
Danish: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Danish: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Portuguese: Aliud Pharma GmbH & Co.KG Postfach 1380
Danish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
Portuguese: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Danish: Grœkenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Portuguese: D-64206 Darmstadt paroxedura 20 mg Filmtabletten 20 mg
Danish: D-64206 Darmstadt paroxedura 20 mg Filmtabletten
Portuguese: Efexor XR 37,5, capsule
Danish: Efexor XR 37,5, capsule 37,5 mg
Portuguese: ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Danish: Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Portuguese: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
Danish: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Portuguese: Desiflu voxamin 100 mg
Danish: Desiflu voxamin 100 mg 100 mg
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Danish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Portuguese: Républica Checa RANBAXY (UK) LTD., EALING, LONDON
Danish: RANBAXY (UK) LTD., EALING, LONDON
Portuguese: Países Baixos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Danish: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Portuguese: Intravenous use
Danish: Intravenøs anvendelse
Portuguese: Temmler Pharma GmbH & Co.KG Postfach 2269
Danish: Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
Portuguese: Países Baixos Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Danish: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Portuguese: Luxemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Danish: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Portuguese: Países Baixos Hexal AG, Postfach 1263, D-83602 Holzkirchen
Danish: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Portuguese: Inpharmco-Mianserin-30mgTabletten
Danish: Inpharmco-Mianserin30mg-Tabletten
Portuguese: Países Baixos Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Danish: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
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.
Danish: Fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med [særnavn] sammenholdt med gruppen behandlet med placebo.
Portuguese: GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Danish: Grœkenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Portuguese: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Danish: Grœkenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Portuguese: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Danish: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Portuguese: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Danish: Grœkenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Portuguese: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Danish: Grœkenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Portuguese: Tresleen 50mg-Filmtabletten
Danish: Tresleen 50mgFilmtabletten
Portuguese: Fluoxetin Hexal 4mg/ml Loesung 20 mg
Danish: Fluoxetin Hexal 4mg/ml Loesung
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.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Portuguese: ANEXO III ALTERAÇÕES AO RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO
Danish: BILAG III ÆNDRINGER I PRODUKTRESUMEET
Portuguese: Entact Oral Drops
Danish: Entact Orale dråber
Portuguese: Reino Unido John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Danish: Storbritannien John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Portuguese: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Danish: Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Portuguese: Prozac Durapac 90 mg Cápsulas Duras Gastro-Resistentes
Danish: Prozac Durapac 90 mg Cápsulas Duras GastroResistentes
Portuguese: Floccin 20mg/5ml-Lösung zum Einnehmen
Danish: Floccin 20mg/5mlLösung zum Einnehmen
Portuguese: Reino Unido Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Danish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Portuguese: Fluoxetin „Lilly" 20mg-lösliche Tabletten
Danish: Fluoxetin „Lilly" 20mglösliche Tabletten
Portuguese: IIP-Institut fuer industrielle Pharmazie
Danish: Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
Portuguese: Países Baixos Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Danish: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Portuguese: Paroxetin "Salutas" 40mgFilmtabletten
Danish: Paroxetin "Salutas" 40mg-Filmtabletten
Portuguese: Fluxet 20 mg snap-tab
Danish: Fluxet 20 mg snap-tab 20 mg
Portuguese: Países Baixos Genthon B.V., Postbus 7071, NL6503 GN Nijmegen
Danish: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Portuguese: Desiflu voxamin 50 mg
Danish: Desiflu voxamin 50 mg 50 mg
Portuguese: Países Baixos GlaxoSmithKline B.V.
Danish: GlaxoSmithKline B.V.
Portuguese: Rodleben Pharma GmbH Postfach 205
Danish: Tyskland Rodleben Pharma GmbH Postfach 205
Portuguese: Portal capsules 20 mg
Danish: Portal capsules 20 mg 20 mg
Portuguese: Venlafaxin Wyeth retard 75 mg 75 mg
Danish: Venlafaxin Wyeth retard 75 mg
Portuguese: Tolvon, tablets 10 mg
Danish: Tolvon, tablets 10 mg 10 mg
Portuguese: Países Baixos GenRx B.V.
Danish: GenRx B.V.
Portuguese: Républica Checa SANDOZ GMBH, KUNDL Biochemiestrasse 10
Danish: SANDOZ GMBH, KUNDL Biochemiestrasse 10
Portuguese: S.A. Laboratoires S.M.B.
Danish: Tyskland S.A. Laboratoires S.M.B.
Portuguese: TAD Pharma GmbH Postfach 720
Danish: Tyskland TAD Pharma GmbH Postfach 720
Portuguese: Reino Unido Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Portuguese: Reino Unido KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Danish: Storbritannien KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Portuguese: Reino Unido Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Danish: Storbritannien Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Portuguese: Luxemburgo Ratiopharm GmbH, Postfach 3380, D-89070 Ulm, Germany
Danish: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Portuguese: ZOLOFT OC 20mg/ml
Danish: ZOLOFT OC 20mg/ml 20mg/ml
Portuguese: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Danish: Rue-de-la-Pastorale 26-28
Portuguese: Por conseguinte o CHMP 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.
Danish: CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende atomoxetin skulle indføjes dels en advarsel om, at fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med atomoxetin i forhold til gruppen behandlet med placebo, dels en advarsel om manglende virkning ved behandling af depression.
Portuguese: EFEXOR 37,5 MG
Danish: EFEXOR 37,5 MG 37.5mg
Portuguese: SEROXAT 30mg tbl flm
Danish: SEROXAT 30mg tbl flm 30mg
Portuguese: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Danish: Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Danish: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Portuguese: Remeron 15 mg/ml, oral solution 15 mg/ml
Danish: Remeron 15 mg/ml, oral solution
Portuguese: Inpharmco-Mianserin-10mgTabletten
Danish: Inpharmco-Mianserin10mg-Tabletten
Portuguese: Reino Unido Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Portuguese: EDRONAX 4 MG
Danish: EDRONAX 4 MG N
Portuguese: Países Baixos Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Danish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Portuguese: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Portuguese: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Portuguese: Felixsan 50mg-Filmtabletten
Danish: Felixsan 50mgFilmtabletten
Portuguese: Solvex 4 mg Tabletten
Danish: Solvex 4 mg Tabletten 4 mg
Portuguese: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Portuguese: O CHMP concluiu que, no Resumo das Características do Medicamento e na secção relevante do Folheto Informativo dos medicamentos que contêm citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina, deve incluir-se uma advertência para o facto dos comportamentos relacionados com o suicídio (tentativa de suicídio e ideação suicida) e a hostilidade (predominantemente agressão, comportamento de oposição e cólera) terem sido observados com maior frequência em ensaios clínicos com crianças e adolescentes que se encontravam a tomar antidepressivos, em comparação com os que se encontravam a tomar placebo.
Danish: CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Portuguese: Paroxetin "Merckle" 20mgFilmtabletten
Danish: Paroxetin "Merckle" 20mg-Filmtabletten
Portuguese: ISRSN - "inibidores selectivos da recaptação da serotonina e da noradrenalina".
Danish: 2 SNRI står for ‘Serotonin-Norepinephrine Reuptake Inhibitor' (serotonin-noradrenalin-genoptagelseshæmmer).
Portuguese: Trevilor retard 75 mg
Danish: Trevilor retard 75 mg 75 mg
Portuguese: Mutan 20mg-Filmtabletten
Danish: Mutan 20mgFilmtabletten
Portuguese: Luxemburgo DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Danish: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Portuguese: SEROXAT 30 MG
Danish: SEROXAT 30 MG 30 mg
Portuguese: Efexor XR 75, capsules
Danish: Efexor XR 75, capsules 75 mg
Portuguese: Fluvoxamine-maleaat 50 A, tablets 50 mg
Danish: Fluvoxamine-maleaat 50 A, tablets
Portuguese: Efectin ER 150mg-Kapseln
Danish: Efectin ER 150mgKapseln
Portuguese: Mianserin 30mg Holsten
Danish: Mianserin 30mg Holsten 30 mg
Portuguese: Mianserin Organon 10mg
Danish: Mianserin Organon 10mg 10 mg
Portuguese: Box 20, Oss, Netherland
Danish: Organon, P.O. Box 20, Oss, Netherland
Portuguese: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Danish: KG Elisabeth-Selbert-Str. 1
Portuguese: Reino Unido Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Danish: Storbritannien Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Portuguese: SEROXAT 20mg tbl flm
Danish: SEROXAT 20mg tbl flm 20mg
Portuguese: Tolvon, tablets 3 mg
Danish: Tolvon, tablets 3 mg 30 mg
Portuguese: PAROXETINA HEXAL 40 mg 40 mg
Danish: PAROXETINA HEXAL 40 mg
Portuguese: Républica Checa LICHTENSTEIN PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
Danish: PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
Portuguese: - consequentemente o Comité concluiu que, no Resumo das Características do Medicamento e na secção relevante do Folheto Informativo dos medicamentos que contêm citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina, deve incluir-se uma advertência para o facto de os comportamentos suicidas (tentativa de suicídio e ideação suicida) e a hostilidade (predominantemente agressão, comportamento de oposição e cólera) terem sido observados com maior frequência em ensaios clínicos com crianças e adolescentes que se encontravam a tomar antidepressivos, em comparação com os que se encontravam a tomar placebo .
Danish: - CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
Portuguese: Efexor Modified Release XL 150 mg
Danish: Efexor Modified Release XL
Portuguese: Paluxetil 20mg-Filmtabletten
Danish: Paluxetil 20mgFilmtabletten
Portuguese: Mianserin Organon 60mg
Danish: Mianserin Organon 60mg 60 mg
Portuguese: UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danish: Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Portuguese: Estado Membro Titular da Autorização de Introdução no Mercado
Danish: Medlemsland Indehaver af markedsføringstilladelsen
Portuguese: Reino Unido Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK