FrancophonIA/ELRC3.0 huggingface dataset:
Spanish: Eslovaquia ICN Polfa Rzesów S.A., ul.
Italian: Slovacchia ICN Polfa Rzesów S.A., ul.
Spanish: Dinamarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Italian: Danimarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Spanish: Dinamarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Italian: Danimarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Spanish: Pfizer Pharma GmbH Pfizerstr.
Italian: Germania Pfizer Pharma GmbH Pfizerstr.
Spanish: Cápsula dura gastrorresistente
Italian: Gastro-resistant capsule hard
Spanish: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Italian: Portogallo Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Spanish: Países Bajos Centrafarm Services B.V.
Italian: Centrafarm Services B.V.
Spanish: La hostilidad (predominantemente agresión, comportamiento contrario e irritación) y la inestabilidad emocional fueron constatadas con más frecuencia en ensayos clínicos con niños y adolescentes tratados con [Nombre de Fantasía]frente a aquellos tratados con placebo.
Italian: Ostilità (essenzialmente aggressività, comportamento di opposizione e collera) e predisposizione emotiva sono state osservate con maggiore frequenza negli studi clinici effettuati su bambini e adolescenti trattati con [nome di fantasia] rispetto a quelli trattati con placebo.
Spanish: Dinamarca GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Italian: Danimarca GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Spanish: Países Bajos Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Italian: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Spanish: Merck dura GmbH Postfach 100635
Italian: Germania Merck dura GmbH Postfach 100635
Spanish: Alemania betapharm Arzneimittel GmbH Kobelweg 95
Italian: Germania Betapharm Arzneimittel GmbH Kobelweg 95
Spanish: Wilbury Way
Italian: 1 The Cam Centre Wilbury Way
Spanish: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Italian: Portogallo Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Spanish: Países Bajos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Italian: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Spanish: Países Bajos Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Italian: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Spanish: Sandoz Pharmaceuticals GmbH Dieselstr.
Italian: Germania Sandoz Pharmaceuticals GmbH Dieselstr.
Spanish: Países Bajos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Italian: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Spanish: AREMIS 20 mg/ml concentrated liquid for Vía oral
Italian: AREMIS 20 mg/ml concentrated liquid for oral use
Spanish: Países Bajos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Italian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Spanish: Reino Unido Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Italian: Regno Unito Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Spanish: Países Bajos Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Italian: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Spanish: , C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
Italian: TEVA GENERICOS ESPAÑOLA, S.L. , C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
Spanish: Dinamarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Italian: Danimarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Spanish: Juta Pharma GmbH Gutenbergstr.
Italian: Germania Juta Pharma GmbH Gutenbergstr.
Spanish: Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Italian: Portogallo Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Spanish: Dinamarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Italian: Danimarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Spanish: Dinamarca Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Italian: Danimarca Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Spanish: Eslovaquia Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Italian: Slovacchia Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Spanish: Pharmacia GmbH Pfizerstr.
Italian: Germania Pharmacia GmbH Pfizerstr.
Spanish: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Italian: Portogallo Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Spanish: Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Italian: Portogallo Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Spanish: Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Italian: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Spanish: Países Bajos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Italian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Spanish: Solvay Arzneimittel GmbH Postfach 220
Italian: Germania Solvay Arzneimittel GmbH Postfach 220
Spanish: Reino Unido Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Italian: Regno Unito Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Spanish: Dinamarca Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Italian: Danimarca Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Spanish: Dinamarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Italian: Danimarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Spanish: Países Bajos Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Italian: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Spanish: Dinamarca Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Italian: Danimarca Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Spanish: Dinamarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Italian: Danimarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Spanish: Considerando que: - el Comité ha examinado la remisión efectuada conforme al artículo 31 de la Directiva 2001/83/CE, modificada, respecto a los medicamentos que contienen atomoxetina, citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina y venlafaxina;
Italian: Considerato - che il comitato ha esaminato il deferimento presentato ai sensi dell'articolo 31 della direttiva 2001/83/CE e successive modifiche per i medicinali contenenti atomoxetina, citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina;
Spanish: Reino Unido Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Italian: Regno Unito Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks;
Spanish: Wyeth Pharma GmbH Postfach 8806
Italian: Germania Wyeth Pharma GmbH Postfach 8806
Spanish: Reino Unido Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Italian: Regno Unito Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Spanish: Zoloft 20 mg/ml, solution for Vía oral
Italian: Zoloft 20 mg/ml, solution for oral use
Spanish: Reino Unido Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Italian: Regno Unito Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Spanish: Luxemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Italian: Lussemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Spanish: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Italian: Germania Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Spanish: Países Bajos Katwijk Farma B.V.
Italian: Katwijk Farma B.V.
Spanish: Via Tor Sapienza, 138 00155 Roma Italy
Italian: Polifarma S.p.A. Via Tor Sapienza, 138 00155 Roma Italy
Spanish: Via Matteo Civitali, 1 20148 Milano Italy
Italian: Recordati S.p.A. Via Matteo Civitali, 1 20148 Milano Italy
Spanish: Países Bajos Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Italian: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Spanish: Via Dei Castelli Romani, 22 00040 Pomezia - Roma Italy
Italian: So. Se. Pharm S.r.l. Via Dei Castelli Romani, 22 00040 Pomezia - Roma Italy
Spanish: Van-der-Smissen-Strasse 1
Italian: KG) Van-der-Smissen-Str. 1
Spanish: A la vez, debe saber que en pacientes menores de 18 años existe un mayor riesgo de efectos adversos como intentos de suicidio, ideas de suicidio y hostilidad (predominantemente agresión, comportamiento de confrontación e irritación) cuando ingieren esta clase de medicamentos.
Italian: È inoltre opportuno sapere che, in caso di assunzione di questa classe di medicinali, i pazienti al di sotto di 18 anni di età presentano un rischio aumentato di effetti collaterali quali tentativi di suicidio, ideazione suicida e ostilità (essenzialmente aggressività, comportamento di opposizione e collera).
Spanish: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Italian: Portogallo ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Spanish: Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Italian: Portogallo Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Spanish: Frankfurter Str. 129a D-64293 Darmstadt
Italian: Germania Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Spanish: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Italian: Portogallo Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
Spanish: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Italian: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Spanish: Betapharm Arzneimittel GmbH Kobelweg 95
Italian: Germania betapharm Arzneimittel GmbH Kobelweg 95
Spanish: Países Bajos Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Italian: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Spanish: Boehringer Ingelheim Pharma GmbH & Co.KG
Italian: Germania Boehringer Ingelheim Pharma GmbH & Co.KG
Spanish: Via Roccamandolfi, 1 00156 Roma Italy
Italian: Union Health S.r.l. Via Roccamandolfi, 1 00156 Roma Italy
Spanish: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Italian: Portogallo Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Spanish: Gotas orales en solución Vía oral
Italian: Gocce orali, soluzione Via orale
Spanish: Fluoxetine Solución oral 4mg/ml
Italian: Fluoxetine Oral Solution 4mg/ml
Spanish: Países Bajos Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Italian: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Spanish: Países Bajos Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Italian: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Spanish: Reino Unido Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Italian: Regno Unito Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Spanish: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Italian: Regno Unito Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Spanish: Países Bajos Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Italian: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Spanish: Eslovaquia Pfizer Limited, Sandwich Kent CT13 9NJ
Italian: Slovacchia Pfizer Limited, Sandwich Kent CT13 9NJ
Spanish: Eslovaquia Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Italian: Slovacchia Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Spanish: Luxemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Italian: Lussemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Spanish: S.A. Laboratoires S.M.B.
Italian: Germania S.A. Laboratoires S.M.B.
Spanish: Via Vallisneri, 10 20133 Milano Italy
Italian: Valeas S.p.A. Via Vallisneri, 10 20133 Milano Italy
Spanish: RESUMEN GENERAL DE LA EVALUACIÓN CIENTÍFICA DE LOS MEDICAMENTOS QUE CONTIENEN FLUOXETINA, FLUVOXAMINA, SERTRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, ATOMOXATINA, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA Y MIRTAZAPINA (véase Anexo I)
Italian: RIASSUNTO GENERALE DELLA VALUTAZIONE SCIENTIFICA DEI MEDICINALI CONTENENTI FLUOXETINA, FLUVOXAMINA, SETRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, ATOMOXETINA, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA (cfr. allegato I)
Spanish: Países Bajos GlaxoSmithKline B.V.
Italian: GlaxoSmithKline B.V.
Spanish: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Italian: Regno Unito Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Spanish: Países Bajos Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Italian: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Spanish: Rodleben Pharma GmbH Postfach 205
Italian: Germania Rodleben Pharma GmbH Postfach 205
Spanish: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Italian: Portogallo Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Spanish: Países Bajos Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Spanish: SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090 Bruxelles, Belgium
Italian: Lussemburgo SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Spanish: UXAFARMA S.A., Avda. J.V.
Italian: UXAFARMA S.A., Avda.
Spanish: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Italian: Germania Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Spanish: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Italian: Portogallo toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Spanish: Países Bajos Hexal AG, Postfach 1263, D-83602 Holzkirchen
Italian: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Spanish: Reino Unido John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Italian: Regno Unito John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Spanish: Países Bajos Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Spanish: Dinamarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Italian: Danimarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Spanish: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Italian: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Spanish: Dinamarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Italian: Danimarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Spanish: Aliud Pharma GmbH & Co.KG Postfach 1380
Italian: Germania Aliud Pharma GmbH & Co.KG Postfach 1380
Spanish: Via V. Grassi, 13 00155 ROMA, Italy
Italian: Biores Italia S.r.l. Via V. Grassi, 13 00155 ROMA, Italy
Spanish: Dinamarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Italian: Danimarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Spanish: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Italian: Portogallo toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Spanish: Comprimido recubierto con películas
Italian: Compressa rivestita con films
Spanish: Dinamarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Italian: Danimarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Spanish: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Italian: Portogallo Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Spanish: Reino Unido Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Italian: Regno Unito Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Spanish: Via Bianchi Maria Visconti 20122 Milano, Italy
Italian: Lampugnani Farmaceutici S.p.A. Via Bianchi Maria Visconti 20122 Milano, Italy
Spanish: Via Vittorio Grassi, 9/11 00155 Roma Italy
Italian: Sepi Chimica S.r.l. Via Vittorio Grassi, 9/11 00155 Roma Italy
Spanish: ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Italian: Lussemburgo ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Spanish: Comprimido efervescente Vía oral
Italian: Compressa effervescente Via orale
Spanish: Eslovaquia Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Italian: Slovacchia Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Spanish: Eslovaquia Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Italian: Slovacchia Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Spanish: Via E. Folli, 50 20134 Milano Italy
Italian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
Spanish: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Italian: Portogallo Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Spanish: TAD Pharma GmbH Postfach 720
Italian: Germania TAD Pharma GmbH Postfach 720
Spanish: Reino Unido KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Italian: Regno Unito KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Spanish: (intentos de suicidio e ideas de suicidio), y la hostilidad (predominantemente agresión, comportamiento de confrontación e irritación) fueron constatadas con más frecuencia en ensayos clínicos con niños y adolescentes tratados con antidepresivos frente a aquellos tratados con placebo.
Italian: Comportamenti suicidari (tentativi di suicidio e ideazione suicidaria) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati con maggiore frequenza negli studi clinici effettuati su bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con placebo.
Spanish: Países Bajos KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Italian: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Spanish: Eslovaquia GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria
Italian: Slovacchia GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria
Spanish: Reino Unido Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Regno Unito Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Spanish: Via A. Fleming, 2 37135 Verona Italy
Italian: Glaxosmithkline S.p.A. Via A. Fleming, 2 37135 Verona Italy
Spanish: Reino Unido Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Italian: Regno Unito Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Spanish: LABORATORIOS SPYFARMA, S.A, Crta. Sevilla Malaga, Km 55., Alcalá de Guadaira 41500, Spain
Italian: Sevilla Malaga, Km 55., Alcalá de Guadaira 41500, Spain
Spanish: PFIZER, S.A., Avda. de Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas, Spain
Italian: de Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas, Spain
Spanish: Temmler Pharma GmbH & Co.KG Postfach 2269
Italian: Germania Temmler Pharma GmbH & Co.KG Postfach 2269
Spanish: H.Lundbeck A/S Ottiliavej 7-9
Italian: Germania H.Lundbeck A/S Ottiliavej 7-9
Spanish: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Italian: Portogallo Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
Spanish: Reino Unido Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Regno Unito Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Spanish: Eslovaquia Zentiva a.s., U Kabelovny 130, Dolní Mecholupy , CZ - 102 37 Praha 10
Italian: Slovacchia Zentiva a.s., U Kabelovny 130, Dolní Mecholupy , CZ - 102 37 Praha 10
Spanish: Luxemburgo Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Italian: Lussemburgo Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Spanish: Eslovaquia Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
Italian: Slovacchia Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
Spanish: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Italian: Rue-de-la-Pastorale 26-28
Spanish: Dinamarca Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: Danimarca Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Spanish: Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Italian: Portogallo Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
Spanish: Via G. Richard, 7 20143 Milano Italy
Italian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
Spanish: III.2 MODIFICACIONES QUE DEBERÁN INCLUIRSE EN LA SECCIÓN RELEVANTE DEL RCP POR LO QUE SE REFIERE A LA ATOMOXETINA
Italian: III.2 MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO PER ATOMOXETINA
Spanish: Concentrado para solución oral Vía oral
Italian: Concentrato per soluzione orale
Spanish: Synthon B.V.
Italian: Germania Synthon B.V.
Spanish: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Italian: 2696-901 Bobadela Portugal
Spanish: Reino Unido Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Italian: Regno Unito Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Spanish: Viale Monza, 20 20128 Milano Italy
Italian: Ratiopharm Italia S.r.l. Viale Monza, 20 20128 Milano Italy
Spanish: El CHMP concluyó que los Resúmenes de las Características del Producto, así como la sección correspondiente de los prospectos del citalopram, el escitalopram, la fluoxetina, la fluvoxamina, la mianserina, el milnacipram, la mirtazapina, la paroxetina, la reboxetina, la sertralina y la venlafaxina que contienen productos médicos deberían incluir una advertencia para informar de que los comportamientos suicidas (intentos de suicidio y pensamientos de suicidio), y la hostilidad (especialmente agresividad, comportamiento contrario e irritación) se observaban con más frecuencia en los ensayos clínicos practicados a niños y adolescentes tratados con antidepresivos frente a aquellos tratados con placebo.
Italian: Il CHMP ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con placebo.