FrancophonIA/ELRC3.0 huggingface dataset:
Italian: LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Dutch: Frankrijk LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
Italian: Danimarca Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Dutch: Denemarken Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Italian: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Dutch: Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Italian: Regno Unito Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Dutch: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Italian: Dispersible tablet
Dutch: Dispergeerbare tablet
Italian: SNRI sta per "Inibitore della ricaptazione della serotonina-norepinefrina" (Serotonin-Norepinephrine Reuptake Inhibitor).
Dutch: SNRI staat voor ‘Selective Norepinephrine Re-uptake Inhibitor' (selectieve norepinefrine-heropnameremmer).
Italian: Danimarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Dutch: Denemarken BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Italian: Regno Unito Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Dutch: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Italian: Danimarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Dutch: Denemarken Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Italian: Danimarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Dutch: Denemarken Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Italian: KG) Van-der-Smissen-Str. 1
Dutch: Van-der-Smissen-Strasse 1
Italian: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Dutch: Griekenland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Italian: Danimarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Dutch: Denemarken Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Italian: Regno Unito Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Dutch: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Italian: Diagonal, 507, 08029 Barcelona, Spain
Dutch: Diagonal, 507, 08029 Barcelona, Spanje
Italian: Danimarca Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Dutch: Denemarken Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Italian: Danimarca Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Dutch: Denemarken Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Italian: Regno Unito Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Dutch: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Italian: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Italian: Germania H.Lundbeck A/S Ottiliavej 7-9
Dutch: Duitsland H.Lundbeck A/S Ottiliavej 7-9
Italian: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Dutch: Nederland Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Italian: Germania Solvay Arzneimittel GmbH Postfach 220
Dutch: Duitsland Solvay Arzneimittel GmbH Postfach 220
Italian: Slovacchia Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Dutch: Slowakije Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Italian: Lussemburgo GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Dutch: Luxemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Italian: Stato Membro Titolare dell'autorizzazione alla produzione
Dutch: Houder van de vergunning voor het in handel brengen
Italian: Polifarma S.p.A. Via Tor Sapienza, 138 00155 Roma Italy
Dutch: Via Tor Sapienza, 138 00155 Roma Italy
Italian: Recordati S.p.A. Via Matteo Civitali, 1 20148 Milano Italy
Dutch: Via Matteo Civitali, 1 20148 Milano Italy
Italian: Uso endovenoso
Dutch: Intravenous use
Italian: So. Se. Pharm S.r.l. Via Dei Castelli Romani, 22 00040 Pomezia - Roma Italy
Dutch: Via Dei Castelli Romani, 22 00040 Pomezia - Roma Italy
Italian: WINTHROP médicaments 174 avenue de France 75013 Paris
Dutch: Frankrijk WINTHROP médicaments 174 avenue de France
Italian: Portogallo Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Dutch: Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Italian: Portogallo ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Dutch: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Italian: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Dutch: Griekenland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Italian: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Dutch: Griekenland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Italian: Portogallo Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
Dutch: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Italian: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Dutch: Nederland Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Italian: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Dutch: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Italian: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Dutch: Noorwegen Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Italian: Germania Wyeth Pharma GmbH Postfach 8806
Dutch: Duitsland Wyeth Pharma GmbH Postfach 8806
Italian: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Dutch: Griekenland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Italian: Lussemburgo ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Dutch: Luxemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Italian: Union Health S.r.l. Via Roccamandolfi, 1 00156 Roma Italy
Dutch: Via Roccamandolfi, 1 00156 Roma Italy
Italian: Portogallo Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Dutch: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Italian: Soluzione per infusione Uso endovenoso
Dutch: Oplossing voor intraveneuze infusie
Italian: Regno Unito Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Dutch: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Italian: Regno Unito Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Dutch: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Italian: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Dutch: Griekenland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Italian: Regno Unito Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Dutch: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Italian: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Dutch: Nederland Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Italian: 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
Dutch: Oostenrijk 1A Pharma GmbH, Degengasse 70, 1160 Wien, Austria
Italian: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Dutch: Griekenland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Italian: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Dutch: Noorwegen IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Italian: Germania Boehringer Ingelheim Pharma GmbH & Co.KG
Dutch: Duitsland Boehringer Ingelheim Pharma GmbH & Co.KG
Italian: Ranbaxy (UK) Ltd., C.P.
Dutch: Litouwen Ranbaxy (UK) Ltd., C.P.
Italian: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Dutch: Griekenland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Italian: Regno Unito Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Dutch: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Italian: Hexal AG, Postfach 1263, D-83602 Holzkirchen
Dutch: Nederland Hexal AG, Postfach 1263, D-83602 Holzkirchen
Italian: Regno Unito Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Dutch: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Italian: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
Dutch: Nederland Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Italian: GenRx B.V.
Dutch: Nederland GenRx B.V.
Italian: Hexal Pharma GmbH, Wilhelmimenstr.
Dutch: Oostenrijk Hexal Pharma GmbH, Wilhelmimenstr.
Italian: GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Dutch: Griekenland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Italian: Slovacchia Pfizer Limited, Sandwich Kent CT13 9NJ
Dutch: Slowakije Pfizer Limited, Sandwich Kent CT13 9NJ
Italian: Slovacchia Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Dutch: Slowakije Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Italian: Fevarin tablets
Dutch: Fevarin tabeltten
Italian: Valeas S.p.A. Via Vallisneri, 10 20133 Milano Italy
Dutch: Via Vallisneri, 10 20133 Milano Italy
Italian: Apothecon B.V.
Dutch: Nederland Apothecon B.V.
Italian: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: Nederland Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: Germania Ratiopharm GmbH Graf-Arco-Strasse 3
Dutch: Duitsland Ratiopharm GmbH Graf-Arco-Strasse 3
Italian: Lussemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Dutch: Luxemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Italian: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Dutch: Nederland Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Italian: Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Dutch: Frankrijk Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Italian: Portogallo Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Dutch: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Italian: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Dutch: Nederland Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Italian: 13 rue pagès
Dutch: Frankrijk Lilly France 13 rue pagès
Italian: GlaxoSmithKline B.V.
Dutch: Nederland GlaxoSmithKline B.V.
Italian: Danimarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Dutch: Denemarken Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Italian: Germania biomo pharma GmbH Josef-Dietzgen-Str. 3
Dutch: Duitsland biomo pharma GmbH Josef-Dietzgen-Str. 3
Italian: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Dutch: Hongarije Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Italian: Portogallo toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Dutch: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Italian: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Dutch: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Italian: Lussemburgo Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Dutch: Luxemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Italian: Biores Italia S.r.l. Via V. Grassi, 13 00155 ROMA, Italy
Dutch: Via V. Grassi, 13 00155 ROMA, Italy
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;
Dutch: Overwegende dat - het CHMP de verwijzing heeft beoordeeld, ingediend krachtens artikel 31 van Richtlijn 2001/83/EG, als gewijzigd, met betrekking tot atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine bevattende geneesmiddelen;
Italian: Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Dutch: Oostenrijk Sanova Pharma Ges.m.b.H., Haidestr.4, 1110 Wien, Austria
Italian: Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Dutch: Hongarije Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9.
Italian: Portogallo toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Dutch: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Italian: Germania Aliud Pharma GmbH & Co.KG Postfach 1380
Dutch: Duitsland Aliud Pharma GmbH & Co.KG Postfach 1380
Italian: Germania Lilly Deutschland GmbH Saalburgstr.
Dutch: Duitsland Lilly Deutschland GmbH Saalburgstr.
Italian: Danimarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Dutch: Denemarken Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Italian: Regno Unito Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Dutch: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Italian: Genthon B.V.
Dutch: Nederland Genthon B.V.
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.
Dutch: Het CHMP kwam tot de conclusie dat in de samenvattingen van de productkenmerken (SPC) en in de desbetreffende rubriek van de bijsluiter van citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline en venlafaxine bevattende geneesmiddelen een passage moest worden opgenomen om te waarschuwen dat suïcidaal gedrag (zelfmoordpogingen en zelfmoordgedachten) en vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woedeuitbarstingen) vaker werden waargenomen in klinische onderzoeken onder kinderen en adolescenten die met antidepressiva behandeld werden dan bij met placebo behandelde jonge patiënten.
Italian: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Dutch: Oostenrijk GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Italian: Sepi Chimica S.r.l. Via Vittorio Grassi, 9/11 00155 Roma Italy
Dutch: Via Vittorio Grassi, 9/11 00155 Roma Italy
Italian: Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Dutch: Hongarije Merck Generics Limited UK EN61AG Herts, Potters Bar, Darkes Lane, Albany Gate, U.K.
Italian: Lampugnani Farmaceutici S.p.A. Via Bianchi Maria Visconti 20122 Milano, Italy
Dutch: Via Bianchi Maria Visconti 20122 Milano, Italy
Italian: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Italian: Hexal B.V.
Dutch: Nederland Hexal B.V.
Italian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
Dutch: Via E. Folli, 50 20134 Milano Italy
Italian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Dutch: Litouwen SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Italian: Portogallo Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Dutch: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Italian: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Dutch: Frankrijk Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Italian: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Dutch: Frankrijk IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Italian: 264 Rue du faubourg saint honoré 75008 Paris - France
Dutch: Frankrijk MG PHARMA 264 Rue du faubourg saint honoré 75008 Paris - France
Italian: Danimarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Dutch: Denemarken Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Italian: Germania Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Dutch: Duitsland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Italian: Danimarca Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Dutch: Denemarken Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Italian: Glaxosmithkline S.p.A. Via A. Fleming, 2 37135 Verona Italy
Dutch: Via A. Fleming, 2 37135 Verona Italy
Italian: Germania TAD Pharma GmbH Postfach 720
Dutch: Duitsland TAD Pharma GmbH Postfach 720
Italian: Regno Unito Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Dutch: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Italian: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Dutch: Frankrijk EG Labo laboratoire Eurogenerics le Quintet Batiment A
Italian: Germania Pharmacia GmbH Pfizerstr.
Dutch: Duitsland Pharmacia GmbH Pfizerstr.
Italian: Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Dutch: Noorwegen Alpharma AS, P.O.Box 158 Skøyen, NO-0212 Oslo, Norway
Italian: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Dutch: Litouwen Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Italian: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Italian: Danimarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Dutch: Denemarken NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Italian: Germania Temmler Pharma GmbH & Co.KG Postfach 2269
Dutch: Duitsland Temmler Pharma GmbH & Co.KG Postfach 2269
Italian: Portogallo Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Dutch: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Italian: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Italian: ICN Polfa Rzeszow, ul.
Dutch: Litouwen ICN Polfa Rzeszow, ul.
Italian: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Dutch: Nederland KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Italian: Infusione endovenosa
Dutch: Intravenous infusion
Italian: Portogallo Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
Dutch: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Italian: Danimarca Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Dutch: Denemarken Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: - che, di conseguenza, il comitato 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;
Dutch: - het CHMP dientengevolge tot de conclusie kwam dat in de samenvattingen van de productkenmerken (SPC) en in de desbetreffende rubriek van de bijsluiter van citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine bevattende geneesmiddelen een passage moest worden opgenomen om te waarschuwen dat suïcidaal gedrag (zelfmoordpogingen en zelfmoordgedachten) en vijandelijkheid (hoofdzakelijk agressie, onaangepast gedrag en woede-uitbarstingen) vaker werden waargenomen in klinische onderzoeken onder kinderen en adolescenten die met antidepressiva behandeld werden in vergelijking tot met placebo behandelde jonge patiënten.
Italian: Portogallo Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
Dutch: Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Italian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
Dutch: Via G. Richard, 7 20143 Milano Italy
Italian: Slovacchia Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Dutch: Slowakije Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Italian: Regno Unito Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Dutch: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Italian: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Dutch: Nederland Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Italian: 2696-901 Bobadela Portugal
Dutch: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Italian: Pharmachemie B.V.
Dutch: Nederland Pharmachemie B.V.
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)
Dutch: ALGEHELE SAMENVATTING VAN DE WETENSCHAPPELIJKE BEOORDELING VAN GENEESMIDDELEN DIE FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, ATOMOXETINE, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE BEVATTEN (zie bijlage I)
Italian: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Dutch: Hongarije Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Italian: Ratiopharm Italia S.r.l. Viale Monza, 20 20128 Milano Italy
Dutch: Viale Monza, 20 20128 Milano Italy
Italian: Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Dutch: Litouwen Alpharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom
Italian: Danimarca Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Dutch: Denemarken Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Dutch: Frankrijk SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Italian: Regno Unito Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Dutch: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Dutch: Oostenrijk F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Italian: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Dutch: SpanjeSpanje TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain