FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
Swedish: Frankrike TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
Portuguese: A maioria dos ensaios incluiu doentes com perturbações depressivas major (PDM), enquanto alguns envolveram doentes com diversas perturbações de ansiedade (Perturbação Obsessivo-Compulsiva (POC), Perturbação de Ansiedade Generalizada (PAG) e Perturbação de Ansiedade Social (PAS)).
Swedish: De flesta av försöken omfattade patienter med svår depressiv störning (MDD), men en del omfattade patienter med diverse ångestneuroser, (tvångssyndrom - OCD), allmän ångest (GAD) och social ångest (SAD).
Portuguese: Solvay Pharma 42 rue Rouget de lisle BP 22
Swedish: Frankrike Solvay Pharma 42 rue Rouget de lisle BP 22
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.
Swedish: CHMP ansåg att det inte fanns några tecken på ökad risk för självmordsbeteende i undersökningarna om atomoxetin, men att det fanns tecken på en ökad risk för onormalt beteende med ökade aggressions- och fientlighetseffekter.
Portuguese: Républica Checa SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02
Swedish: Tjeckien SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02
Portuguese: [Nome de fantasia] não deve ser utilizado no tratamento de crianças e adolescentes com idade inferior a 18 anos <, excepto nos casos de doentes com [indicação aprovada]>.
Swedish: [Fantasinamn] skall inte användas vid behandling av barn och ungdomar under 18 år <, förutom till patienter med [godkänd indikation]>.
Portuguese: O CHMP reavaliou os dados apresentados pelos titulares de autorizações de introdução no mercado relativamente ao sinal de comportamento suicida em crianças e adolescentes.
Swedish: CHMP granskade de uppgifter som innehavarna av godkännande för försäljning lämnat in och som har samband med självmordsbeteende hos barn och ungdomar.
Portuguese: Vajnorská 100/A, SK-841 01 Bratislava
Swedish: Vajnorská 100/A, SK-841 01
Portuguese: Organon GmbH Mittenheimer Str. 62
Swedish: Tyskland Organon GmbH Mittenheimer Str. 62
Portuguese: Synthon Bv Microweg 22
Swedish: Frankrike Synthon Bv Microweg 22
Portuguese: A/S GEA Farmaceut.
Swedish: Slovakien A/S GEA Farmaceut.
Portuguese: Apenas alguns destes medicamentos estão autorizados para o tratamento de crianças e adolescentes com perturbação obsessivo-compulsiva e um deles para o tratamento de défice de atenção/distúrbio de hiperactividade.
Swedish: Bara vissa av dessa produkter är godkända för behandling av barn och ungdomar med tvångssyndrom och bara en av dem för behandling av ADHD.
Portuguese: Solvay Pharmaceuticals B.V., [P.O.Box 900
Swedish: Lettland Solvay Pharmaceuticals B.V., [P.O.Box 900
Portuguese: Países Baixos Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Swedish: Nederländerna Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Portuguese: Os ISRS são descritos como "selectivos" porque afectam apenas as bombas de recaptação responsáveis pela serotonina.
Swedish: SSRI sägs vara "selektiva" eftersom de endast berör serotonintransportörerna.
Portuguese: KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Swedish: Grekland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Portuguese: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Swedish: Danmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Portuguese: Sirowa Riga A/S, Katrīnas dambis 16 Rīga, LV - 1045
Swedish: Lettland Sirowa Riga A/S, Katrīnas dambis 16 Rīga, LV - 1045
Portuguese: Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, Luxembourg
Swedish: Slovenien Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen,
Portuguese: Luxemburgo LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Swedish: Luxemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Portuguese: PAS "Grindeks", Krustpils iela 53 LV-1057, Rīga
Swedish: Lettland PAS "Grindeks", Krustpils iela 53 LV-1057, Rīga
Portuguese: STADA Arzneimittel AG Stadastr.
Swedish: Tyskland STADA Arzneimittel AG Stadastr.
Portuguese: Républica Checa TORREX PHARMA S.R.O., 140 00 PRAHA
Swedish: Tjeckien TORREX PHARMA S.R.O., 140 00 PRAHA
Portuguese: Républica Checa ELI LILLY ČR s.r.o., Praha, Czech Republic
Swedish: Tjeckien ELI LILLY ČR s.r.o., Praha, Czech Republic
Portuguese: Glaxo Group Limited, Greenford, Middlesex, UB6 ONN
Swedish: Lettland Glaxo Group Limited, Greenford, Middlesex, UB6 ONN
Portuguese: HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Swedish: Grekland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Portuguese: FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
Swedish: Grekland FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
Portuguese: 23 -25 Avenue du Docteur Lannelongue
Swedish: Frankrike BERAL 23 -25 Avenue du Docteur Lannelongue
Portuguese: Luxemburgo SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Swedish: Luxemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Portuguese: Reino Unido Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Swedish: Storbritannien Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Portuguese: Apesar disso, o médico poderá prescrever [Nome de fantasia] para doentes com idade inferior a 18 anos quando decida que tal é necessário.
Swedish: Trots detta kan [Fantasinamn] skrivas ut av läkare till patienter under 18 år, om läkaren anser att detta är lämpligt.
Portuguese: Reino Unido Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Swedish: Storbritannien Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Portuguese: FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Swedish: Grekland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Portuguese: Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Swedish: Frankrike Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Portuguese: Reino Unido Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Swedish: Storbritannien Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Portuguese: Países Baixos Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Swedish: Nederländerna Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Portuguese: Países Baixos Eli Lilly Nederland BV Postbus 379
Swedish: Nederländerna Eli Lilly Nederland BV Postbus 379
Portuguese: 1 A Pharma GmbH Keltenring 1 + 3
Swedish: Tyskland 1 A Pharma GmbH Keltenring 1 + 3
Portuguese: H-1103, Budapest Hungary
Swedish: H-1103, Budapest
Portuguese: Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Swedish: Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Portuguese: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Swedish: Grekland REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Portuguese: Reino Unido Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Swedish: Storbritannien Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Portuguese: Tablet
Swedish: Tabletts
Portuguese: Países Baixos Merck Generics BV Dieselweg 25
Swedish: Nederländerna Merck Generics BV Dieselweg 25
Portuguese: Países Baixos Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Swedish: Nederländerna Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Portuguese: RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Swedish: Grekland RAFARM AEBEE, Kapodistriou & Korinthou 12, 15451 N.Psyhiko, Greece
Portuguese: Reino Unido Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Swedish: Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Portuguese: SIEMENS & CO Postfach 1262
Swedish: Tyskland SIEMENS & CO Postfach 1262
Portuguese: Remeron 3mg/ml-Konzentrat zur Herstellung einer Infusionslösung
Swedish: Remeron 3mg/mlKonzentrat zur Herstellung einer Infusionslösung
Portuguese: Républica Checa PHARMACIA LTD., MILTON KEYNES, Davy Avenue, Knowlhill, MK5 8PH KnoMilton Keynes, UK
Swedish: Tjeckien PHARMACIA LTD., MILTON KEYNES, Davy Avenue, Knowlhill, MK5 8PH KnoMilton Keynes, UK
Portuguese: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Swedish: Danmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Portuguese: GlaxoSmithKline Slovakia s.r.o.
Swedish: Slovakien GlaxoSmithKline Slovakia s.r.o.
Portuguese: Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Swedish: Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Portuguese: 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Swedish: Frankrike ORGANON 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Portuguese: PharmaSelect GmbH Am Saegewerk 13
Swedish: Tyskland PharmaSelect GmbH Am Saegewerk 13
Portuguese: LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Swedish: Grekland LUNDBECK HELLAS, 64a Kifissias Aven, 15125 Maroussi, Greece
Portuguese: Países Baixos Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Swedish: Nederländerna Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Portuguese: Winthrop Arzneimittel GmbH Industriestr.
Swedish: Tyskland Winthrop Arzneimittel GmbH Industriestr.
Portuguese: ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Swedish: Grekland ANTOR EPE, 4 Omirou Street, Maroussi Attikis 15126, Greece
Portuguese: Reino Unido Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Swedish: Storbritannien Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Portuguese: Reino Unido SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Swedish: Storbritannien SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
Portuguese: FUNDAMENTOS PARA A ALTERAÇÃO DOS RESUMOS DAS CARACTERÍSTICAS DO MEDICAMENTO
Swedish: SKÄL FÖR ÄNDRING AV PRODUKTRESUMÉERNA
Portuguese: H - 1103 Budapest HUNGARY
Swedish: H - 1103 Budapest
Portuguese: Países Baixos Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Swedish: Nederländerna Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Portuguese: AAI Deutschland GmbH & Co.KG Wegenerstr.
Swedish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
Portuguese: Se o seu médico prescreveu [Nome de fantasia] para um doente com menos de 18 anos e gostaria de discutir esta questão, queira voltar a contactá-lo.
Swedish: Om du är under 18 år och vill diskutera varför du fått detta läkemedel, ska du vända dig till din läkare igen.
Portuguese: ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Swedish: Grekland ALLERTEC HELLAS AE, 20 Phaethonos, 55132 N.Krini Thessaloniki, Greece
Portuguese: BOUCHARA RECORDATI 68 Rue Marjolin BP 67
Swedish: Frankrike BOUCHARA RECORDATI 68 Rue Marjolin
Portuguese: Países Baixos AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Swedish: Nederländerna AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Portuguese: Reino Unido Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Swedish: Storbritannien Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Portuguese: Reino Unido Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Swedish: Storbritannien Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Portuguese: Luxemburgo TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Swedish: Luxemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Portuguese: Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
Swedish: Slovenien Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
Portuguese: IV.2 ALTERAÇÕES A INCLUIR NA SECÇÃO RELEVANTE DO FOLHETO INFORMATIVO DE ATOMOXETINA
Swedish: IV.2 ÄNDRINGAR SOM SKALL FÖRAS IN I RELEVANT AVDELNING PÅ BIPACKSEDELN FÖR ATOMOXETIN
Portuguese: Reino Unido Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Swedish: Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Portuguese: Países Baixos Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Swedish: Nederländerna Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Portuguese: ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777 Elliniko, Greece
Swedish: Grekland ORGANON HELLAS Vouliagmenis Avenue 122 P.O Box 73893, 16777
Portuguese: SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Swedish: Slovenien SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Portuguese: HEXAL AG Postfach 1263
Swedish: Tyskland HEXAL AG Postfach 1263
Portuguese: [Nome de fantasia] não deve normalmente ser utilizado em crianças e adolescentes com idade inferior a 18 anos < excepto no caso de doentes com [indicação aprovada]>.
Swedish: Användning hos barn och ungdomar under 18 år [Fantasinamn] ska normalt inte användas vid behandling av barn och ungdomar under 18 år <, förutom till patienter med [godkänd indikation]>.
Portuguese: Reino Unido Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Swedish: Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Portuguese: RATIOPHARM Graf Arco Strasse 3
Swedish: Frankrike RATIOPHARM Graf Arco Strasse 3
Portuguese: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Swedish: Danmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Portuguese: Países Baixos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Swedish: Nederländerna Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Portuguese: Reino Unido CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Swedish: Storbritannien CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Portuguese: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Swedish: Grekland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Portuguese: Desitin Arzneimittel GmbH Postfach 630164
Swedish: Tyskland Desitin Arzneimittel GmbH Postfach 630164
Portuguese: Países Baixos ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Swedish: Nederländerna ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Portuguese: TEVA Generics GmbH Kandelstr.
Swedish: Tyskland TEVA Generics GmbH Kandelstr.
Portuguese: Reino Unido Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Swedish: Storbritannien Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Portuguese: SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Swedish: Grekland SOLVAY PHARMA, 63 Agiou Dimitriou 17456 Alimos, Greece
Portuguese: ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Swedish: Frankrike ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Portuguese: Holsten Pharma GmbH Im Buergerstock 7
Swedish: Tyskland Holsten Pharma GmbH Im Buergerstock 7
Portuguese: ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Swedish: Grekland ELPEN AE, 21Km Leoforos Marathonos, 19009 Pikermi Attikis, Greece
Portuguese: Luxemburgo SOCOBOM N.V.
Swedish: Luxemburg SOCOBOM N.V.
Portuguese: Reino Unido Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Swedish: Storbritannien Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Portuguese: Países Baixos Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Swedish: Nederländerna Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Portuguese: Luxemburgo MERCK N.V.
Swedish: Luxemburg MERCK N.V.
Portuguese: 11, avenue Dubonnet 92400 Courbevoie France
Swedish: Frankrike CHIESI 11, avenue Dubonnet 92400 Courbevoie France
Portuguese: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Swedish: Slovenien Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
Portuguese: PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Swedish: Grekland PHARMACYPRIA HELLAS, 6 Paster, 11521 Ampelokipi Athens, Greece
Portuguese: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Swedish: Danmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Portuguese: ANEXO II CONCLUSÕES CIENTÍFICAS E FUNDAMENTOS PARA A ALTERAÇÃO DOS RESUMOS DAS CARACTERÍSTICAS DO MEDICAMENTO (RCM) E DOS FOLHETOS INFORMATIVOS APRESENTADOS PELA EMEA
Swedish: BILAGA II EMEA:S VETENSKAPLIGA SLUTSATSER OCH SKÄLEN TILL ÄNDRING AV PRODUKTRESUMÉERNA OCH BIPACKSEDLARNA
Portuguese: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Swedish: Danmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Portuguese: VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Swedish: Grekland VERISFIELD LTD UK, 41 Chalton Street, London, NW1 1JD, U.K.
Portuguese: Imi Pharma AS, Literbuen 9, DK2740 Skovlunde, Denmark
Swedish: Danmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Portuguese: A análise de comportamentos relacionados com o suicídio dos estudos reavaliados, demonstrou a inexistência de notificações de suicídio consumado.
Swedish: Undersökningar av självmordsrelaterat beteende visade på att inget självmord rapporterats i någon av de undersökningar som granskats.
Portuguese: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Swedish: Danmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Portuguese: WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Swedish: Grekland WYETH HELLAS, Kyprou 126& 25 Martiou, 164 52 Argyroupoli, Greece
Portuguese: GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Swedish: Grekland GLAXOSMITHKLINE AEBE, 266 Kifissias Av 15232 Halandri, Greece
Portuguese: - o Comité, perante os dados provenientes de ensaios clínicos, concluiu haver um sinal de comportamento suicida, incluindo tentativas de suicídio e ideação suicida e/ou comportamentos relacionados, tais como auto-agressão, hostilidade e labilidade afectiva, em crianças e adolescentes tratados com inibidores selectivos da recaptação da serotonina e com inibidores selectivos da recaptação da serotonina e da noradrenalina, tais como os medicamentos supracitados;
Swedish: - Kommittén fann, med beaktande av de uppgifter från kliniska försök som fanns tillgängliga, att det finns tecken på självmordsbeteende, inbegripet självmordsförsök och självmordstankar och/eller relaterat beteende såsom självskadebeteende, fientlighet och humörsvängningar hos barn och ungdomar som behandlas med selektiva serotoninåterupptagshämmare samt serotonin-norepinefrinupptagshämmare såsom de ovan angivna läkemedlen.
Portuguese: O CHMP concordou existir um potencial sinal relativo ao aumento de comportamentos suicidas, incluindo tentativas de suicídio e ideação suicida e/ou comportamentos relacionados, tais como auto-agressão, hostilidade e labilidade afectiva, em crianças e adolescentes tratados com ISRS e ISRSN.
Swedish: CHMP kom fram till att det finns ett potentiellt symptom på ökat självmordsbeteende, inbegripet självmordsförsök och självmordstankar och/eller relaterat beteende såsom självskadebeteende, fientlighet och humörsvängningar hos barn och ungdomar som behandlas med SSRI
Portuguese: Luxemburgo WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Swedish: Luxemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Portuguese: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Swedish: Frankrike Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Portuguese: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Swedish: Slovenien Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Portuguese: Os ISRSN actuam nos neurotransmissores noradrenalina e serotonina.
Swedish: SNRI-produkter påverkar norepinefrin- och serotoninneurotransmittorerna.
Portuguese: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000
Swedish: Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Portuguese: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Swedish: Grekland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Portuguese: Luxemburgo Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Swedish: Luxemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Portuguese: Reino Unido Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Swedish: Storbritannien Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Portuguese: Esparma GmbH Postfach 1461
Swedish: Tyskland Esparma GmbH Postfach 1461
Portuguese: Ashbourne Industrial Estate Unit 107
Swedish: Frankrike Pharmascope Ashbourne Industrial Estate Unit 107
Portuguese: ANEXO IV ALTERAÇÕES AO FOLHETO INFORMATIVO
Swedish: BILAGA IV ÄNDRINGAR I BIPACKSEDELN
Portuguese: Países Baixos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Swedish: Nederländerna Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Portuguese: III.2 ALTERAÇÕES A INCLUIR NA SECÇÃO RELEVANTE DO RCM DE ATOMOXETINA
Swedish: III.2 ÄNDRINGAR SOM SKALL FÖRAS IN I RELEVANT AVDELNING I PRODUKTRESUMÉN FÖR ATOMOXETIN
Portuguese: Países Baixos GenRx B.V., Postbus 75, NL-6920 AB Duiven
Swedish: Nederländerna GenRx B.V., Postbus 75, NL-6920 AB Duiven
Portuguese: Républica Checa RANBAXY (UK) LTD., EALING, LONDON
Swedish: Tjeckien RANBAXY (UK) LTD., EALING, LONDON
Portuguese: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Swedish: Grekland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
Portuguese: Luxemburgo EUROGENERICS N.V.
Swedish: Luxemburg EUROGENERICS N.V.
Portuguese: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Swedish: Danmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Portuguese: Krewel Meuselbach GmbH Postfach 1263
Swedish: Tyskland Krewel Meuselbach GmbH Postfach 1263
Portuguese: Hormosan-Kwizda GmbH Postfach 600340
Swedish: Tyskland Hormosan-Kwizda GmbH Postfach 600340
Portuguese: Países Baixos Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Swedish: Nederländerna Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Portuguese: Países Baixos Hexal AG, Postfach 1263, D-83602 Holzkirchen
Swedish: Nederländerna Hexal AG, Postfach 1263, D-83602 Holzkirchen
Portuguese: Vetiquima - Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Swedish: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Portuguese: Países Baixos Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Swedish: Nederländerna Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Portuguese: Gladem 20mg/ml-Konzentrat zur Herstellung einer Trinklösung
Swedish: Gladem 20mg/mlKonzentrat zur Herstellung einer Trinklösung
Portuguese: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Swedish: Frankrike SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Portuguese: Solvay Arzneimittel GmbH Postfach 220
Swedish: Tyskland Solvay Arzneimittel GmbH Postfach 220
Portuguese: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Swedish: Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Portuguese: Países Baixos Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Swedish: Nederländerna Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Portuguese: Neuraxpharm Arzneimittel GmbH & Co.KG
Swedish: Tyskland Neuraxpharm Arzneimittel GmbH & Co.KG