FrancophonIA/ELRC3.0 huggingface dataset:
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Italian: IV.2 MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL FOGLIETTO ILLUSTRATIVO PER ATOMOXETINA
English: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Italian: Portogallo Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Italian: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Italian: Danimarca Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Italian: Lussemburgo Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Italian: Lussemburgo WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: III.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR FLUOXETINE,
Italian: IV.I MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL FOGLIO ILLUSTRATIVO DI FLUOXETINA,
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Italian: Danimarca PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Italian: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Via Nettunense, 90 04011 Aprilia - Roma Italy
Italian: Wyeth Lederle S.p.A. Via Nettunense, 90 04011 Aprilia - Roma Italy
English: Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Italian: Portogallo Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Italian: Regno Unito Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: - The Committee, in view of available data from clinical trials, concluded that there is a signal of suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
Italian: - che il comitato, alla luce di dati disponibili desunti da studi clinici, ha concluso che vi è un segnale di comportamento suicidario, compresi tentativi di suicidio e ideazione suicida e/o disturbi comportamentali quali autolesionismo, ostilità e predisposizione emotiva, nei bambini e adolescenti trattati con inibitori selettivi della ricaptazione della serotonina e con inibitori della ricaptazione della serotonina-norepinefrina, quali i medicinali suindicati;
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Italian: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Italian: Portogallo Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
English: Esparma GmbH Postfach 1461
Italian: Germania Esparma GmbH Postfach 1461
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Italian: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Via Licino, 11-13-15 Erba 22036 Como Italy
Italian: Lisapharma S.p.A. Via Licino, 11-13-15 Erba 22036 Como Italy
English: Via di Scandicci, 37 50143 Firenze Italy
Italian: S.p.A. Via di Scandicci, 37 50143 Firenze Italy
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Italian: Portogallo Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
Italian: Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A. VIA LICINIO 11
English: Hormosan-Kwizda GmbH Postfach 600340
Italian: Germania Hormosan-Kwizda GmbH Postfach 600340
English: Krewel Meuselbach GmbH Postfach 1263
Italian: Germania Krewel Meuselbach GmbH Postfach 1263
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Italian: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Italian: Portogallo Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Neuraxpharm Arzneimittel GmbH & Co.KG
Italian: Germania Neuraxpharm Arzneimittel GmbH & Co.KG
English: BC Biochemie Pharma GmbH Dieselstr.
Italian: Germania BC Biochemie Pharma GmbH Dieselstr.
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Italian: Zoloft 25 mg + 50 mg 25 mg + 50 mg Compressa rivestita con film Via orale
English: Pfizer Pharma GmbH Pfizerstr.
Italian: Germania Pfizer Pharma GmbH Pfizerstr.
English: 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
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Italian: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
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).
English: Merck dura GmbH Postfach 100635
Italian: Germania Merck dura GmbH Postfach 100635
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Italian: Danimarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Italian: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Italian: Danimarca GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: , C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
Italian: TEVA GENERICOS ESPAÑOLA, S.L. , C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Italian: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: 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
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Italian: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Italian: Lussemburgo TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Italian: Danimarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Sandoz Pharmaceuticals GmbH Dieselstr.
Italian: Germania Sandoz Pharmaceuticals GmbH Dieselstr.
English: Wilbury Way
Italian: 1 The Cam Centre Wilbury Way
English: B.V. Postbus 75
Italian: Postbus 75
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Italian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Synthon B.V.
Italian: Germania Synthon B.V.
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
Italian: Pharmaceutical Works Polpharma S.A., ul.
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Italian: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Juta Pharma GmbH Gutenbergstr.
Italian: Germania Juta Pharma GmbH Gutenbergstr.
English: 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
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Italian: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Denmark 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
English: Pharmacia GmbH Pfizerstr.
Italian: Germania Pharmacia GmbH Pfizerstr.
English: 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
English: 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
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Italian: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Italian: Danimarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Italian: Lussemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Solvay Arzneimittel GmbH Postfach 220
Italian: Germania Solvay Arzneimittel GmbH Postfach 220
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Italian: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Italian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: 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.
English: 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
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Italian: Danimarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Italian: Regno Unito Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Italian: Danimarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Italian: Rijksweg 12 2870 Puurs, Belgium
English: Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with 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.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with 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.
English: Oral Suspension
Italian: Sospensione orale
English: S.A. Laboratoires S.M.B.
Italian: Laboratoires S.M.B.
English: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Italian: Regno Unito Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Italian: Danimarca Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Denmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Italian: Danimarca Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Italian: Regno Unito Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
English: Wyeth Pharma GmbH Postfach 8806
Italian: Germania Wyeth Pharma GmbH Postfach 8806
English: Concentrate for oral solution Oral use
Italian: Concentrato per soluzione orale
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Italian: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Belgium BEXAL S.P.R.L.
Italian: BEXAL S.P.R.L.
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Italian: Danimarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: STADA GmbH Stadastr.
Italian: Germania STADA GmbH Stadastr.
English: Luxembourg 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
English: Via Matteo Civitali, 1 20148 Milano Italy
Italian: Recordati S.p.A. Via Matteo Civitali, 1 20148 Milano Italy
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Italian: SNRI sta per “Inibitore della ricaptazione della serotonina-norepinefrina” (Serotonin-Norepinephrine Reuptake Inhibitor).
English: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Italian: Germania Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
English: 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
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Italian: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Van-der-Smissen-Strasse 1
Italian: KG) Van-der-Smissen-Str. 1
English: Frankfurter Str. 129a D-64293 Darmstadt
Italian: Germania Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
English: 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
English: 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
English: 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
English: 16, Chemin de Coquelicots CH - 1214 Geneva
Italian: Slovacchia Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
English: ORAL SOLUTION
Italian: Soluzione orale
English: Boehringer Ingelheim Pharma GmbH & Co.KG
Italian: Germania Boehringer Ingelheim Pharma GmbH & Co.KG
English: 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
English: 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
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Italian: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: 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.
English: CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Italian: PAROXETINA, CITALOPRAM, ESCITALOPRAM, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Italian: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: 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
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Italian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Via Roccamandolfi, 1 00156 Roma Italy
Italian: Union Health S.r.l. Via Roccamandolfi, 1 00156 Roma Italy
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Italian: Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Italian: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: 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
English: Luxembourg 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
English: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Italian: Fabrik , Holger Danskaes Vej 89, DK - 2000
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Italian: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Italian: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
English: Stadapharm GmbH Stadastr.
Italian: Germania Stadapharm GmbH Stadastr.
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Italian: Regno Unito Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Via Tor Sapienza, 138 00155 Roma Italy
Italian: Polifarma S.p.A. Via Tor Sapienza, 138 00155 Roma Italy
English: 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
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Italian: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Whereas - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine;
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;
English: Via Vallisneri, 10 20133 Milano Italy
Italian: Valeas S.p.A. Via Vallisneri, 10 20133 Milano Italy
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Rodleben Pharma GmbH Postfach 205
Italian: Germania Rodleben Pharma GmbH Postfach 205
English: 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
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Italian: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Italian: Germania Hennig Arzneimittel GmbH & Co.KG Postfach 1240
English: 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
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Italian: Danimarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Italian: Lussemburgo Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: 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)
English: Aliud Pharma GmbH & Co.KG Postfach 1380
Italian: Germania Aliud Pharma GmbH & Co.KG Postfach 1380
English: Via V. Grassi, 13 00155 ROMA, Italy
Italian: Biores Italia S.r.l. Via V. Grassi, 13 00155 ROMA, Italy
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Italian: Per tutti i prodotti e indicazioni, vi era inoltre un segnale relativo ad eventi avversi quale l'ostilità, l'autolesionismo e la predisposizione emotiva.
English: 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
English: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Italian: Regno Unito Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Italian: Danimarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Via Bianchi Maria Visconti 20122 Milano, Italy
Italian: Lampugnani Farmaceutici S.p.A. Via Bianchi Maria Visconti 20122 Milano, Italy
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Italian: Danimarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Italian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Italian: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: 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
English: Via E. Folli, 50 20134 Milano Italy
Italian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
English: TAD Pharma GmbH Postfach 720
Italian: Germania TAD Pharma GmbH Postfach 720
English: Via Vittorio Grassi, 9/11 00155 Roma Italy
Italian: Sepi Chimica S.r.l. Via Vittorio Grassi, 9/11 00155 Roma Italy
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Italian: Danimarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland