natgillin/translations-raw huggingface dataset:
The CHMP concluded that a warning to reflect that 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, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products. 
Výbor CHMP rozhodol, že do Súhrnu charakteristických vlastností lieku a príslušnej časti Písomnej informácie pre používateľov pre lieky obsahujúce citalopram, escitalopram, fluoxetín, fluvoxamín, mianserín, milnacipran, mirtazapín, paroxetín, reboxetín, sertralín a venlafaxín sa má zaradiť varovanie o tom, že v klinických štúdiách u detí a dospievajúcich liečených antidepresívami sa v porovnaní s placebom častejšie pozorovalo samovražedné správanie (samovražedné pokusy a samovražedné myšlienky) a hostilita (predovšetkým agresia, protichodné správanie a zlosť).
Mirtazapine Sandoz 30, filmomhulde tabletten 30 mg 
Sandoz 30, filmomhulde tabletten 30 mg
Heumann Pharma GmbH & Co. 
Heumann Pharma GmbH
PharmaSelect GmbH Am Saegewerk 13 
PharmaSelect GmbH
EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest 
Keresztúri út 30-38, HU - 1160 Budapest
GENERICS UK LTD, Station Close Potters Bar, Hertfordhsire, EN6 1TL, UK 
Španielsko GENERICS UK LTD, Station Close Potters Bar, Hertfordhsire, EN6 1TL, UK
Generics[UK] Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL 
Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL
FLOXET 10 MG 10 mg 
FLOXET 10 MG
Leciva A.S., U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic 
U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg 
3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A., Annopol 6B, 03-236 Warszawa, Poland 
POL-NIL Sp. z o.o., ul. Annopol 6A 03-236 Warszawa, Poland
Peplinska 19, 83-200 
Ambachtenlaan 13, 3001
Paroxetine Sandoz 20, filmomhulde tabletten 20 mg 
Sandoz 20, filmomhulde tabletten 20 mg
Levofarma S.r.l. 
Taliansko Levofarma S.r.l.
INDUSTRIAL FARMACEUTICA CANTABRIA, S.A., Carretera Cazoña-Adarzo, s/n., Santander 39011, Spain 
Carretera Cazoña-Adarzo, s/n.,
Sertraline 50 mg Tabletten, coated tablets 
Sertraline 50 mg Tabletaten, coated tablets
Temmler Pharma GmbH & Co.KG Postfach 2269 
& Co.KG Postfach 2269
Fujisawa Deutschland GmbH Bergam-Laim Str. 129, D-81673 Munchen, Germany 
Str. 129, D-81673 Munchen, Germany
Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal 
Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338
Fluvoxamin-ratiopharm 50 mg 
Fluvoxamin-ratiopharm 50 mg 50 mg
LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain 
Doctor Zamenhof, 36., Madrid, 28027,
Sertraline 100 mg Tabletten, coated tablets 
Sertraline 100 mg Tabletaten, coated tablets
Mirtazapine Sandoz 45, filmomhulde tabletten 45 mg 
Sandoz 45, filmomhulde tabletten 45 mg
Netherlands GlaxoSmithKline B.V. Postbus 780 
Holandsko GlaxoSmithKline B.V.
Fluoxetin „Genericon“ 40mg-Kapseln 
Fluoxetin „Genericon“ 40mgKapseln
- The Committee, as a consequence, concluded that a warning to reflect that 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, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products. 
- v dôsledku týchto signálov výbor dospel k záveru, že do Súhrnu charakteristických vlastností lieku a príslušnej časti Písomnej informácie pre používateľov pre lieky obsahujúce citalopram, escitalopram, fluoxetín, fluvoxamín, mianserín, milnacipran, mirtazapín, paroxetín, reboxetín, sertralín a venlafaxín sa má zaradiť varovanie o tom, že v klinických štúdiách u detí a dospievajúcich liečených antidepresívami sa v porovnaní s placebom pozorovalo častejšie samovražedné správanie (samovražedné pokusy a samovražedné myšlienky) a hostilita (predovšetkým agresia, protichodné správanie a zlosť).
Zentiva a.s., U kabelovny 130, 102 37 Prague 10 , Czech Republic 
U kabelovny 130, 102 37 Prague 10 , Czech Republic
MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
MILNACIPRAN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain 
Španielsko ACOST COMERCIAL GENERICPHARMA, Ferraz, 10. 1º Izq., Madrid, 28008,
FEVARIN 100 mg filmtabletta 
FEVARIN 100 mg filmtabletta 100 mg
Fluoxetin “Arcana” 20mg-Kapseln 
Fluoxetin “Arcana” 20mg-Kapseln 20mg
Fluvoxabeta 100 mg 100 mg 
Fluvoxabeta 100 mg
Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK 
Maďarsko Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK
Fluoxetine 20 PCH, tablets 20 mg 
Fluoxetine 20 PCH, tablets 20 mg 20 mg
GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain 
Severo Ochoa, 2, Tres Cantos, 28760, Spain
Paroxetin "Merck NM" 20 mg 
"Merck NM" 20 mg
LABORATORIOS ALTER, S.A., Mateo Inurria, 30., 28036 Madrid, Spain 
Mateo Inurria, 30., 28036 Madrid, Spain
Luxembourg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany 
Luxembursko HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
Belgium MERCK N.V. Brusselsesteenweg 288, 3090 OVERIJSE, Belgium 
Brusselsesteenweg 288, 3090 OVERIJSE, Belgium
FEVARIN 50 mg filmtabletta 
FEVARIN 50 mg filmtabletta 50 mg
3700 AT Zeist 
3700 AT
MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
MIRTAZAPÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Fluoxetina Irex 20 mg Cápsulas 
Fluoxetina Irex 20 mg Cápsulas 20 mg
Stockholm, Sweden 
SOLNA, Sweden
PHARMABRAND AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece 
AEBE, 15 Km National Road Athinon-Lamias, 14510 Kifissia, Greece
Felicium 20mg-Tabletten 20mg 
Felicium 20mg-Tabletten
Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland 
Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co.
de la Industria, 30, Alcobendas 28108, Spain 
Avda. de la Industria, 30, Alcobendas 28108,
Fluvohexal 100mg Filmtabletten 
Fluvohexal 100mg Filmtabletten 100 mg
Instituto Luso-Fármaco, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
Fluvoxam beta 100mg 100 mg 
Fluvoxam beta 100mg
GlaxoSmithKline Slovakia s.r.o. 
Španielsko GLAXOSMITHKLINE, S.A.,
Fluoxetin-neuraxpharm 20 mg 
Fluoxetin-neuraxpharm 20 mg 20 mg
Fluvoxamin beta 50mg 50 mg 
Fluvoxamin beta 50mg
MUNDOGEN FARMA, S.A., Severo Ochoa, 2, Tres Cantos 28760, Spain 
Severo Ochoa, 2, Tres Cantos 28760, Spain
Ranbaxy (UK) Ltd, C.P.House, 97-107 Uxbridge Road, Eabing, London, W5 5TL, U.K. 
Ltd, C.P.House, 97-107 Uxbridge Road, Eabing, London, W5 5TL, U.K.
Mirtatsapiini Ennapharma 30 mg 
Ennapharma 30 mg
Mundipharma 
A Pharma
Fluvoxaminemaleaat 25 mg, tablets 
Fluvoxaminemaleaat 25 mg, tablets 25 mg
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten 
3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Domaniewska 50 C 02-672 Warszawa, Poland 
Ul. Domaniewska 50 C 02-672 Warszawa, Poland
Laboratoires SMB S.A., Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium 
Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium
Fluoxetina ITF 20 mg Cápsulas 
Fluoxetina ITF 20 mg Cápsulas 20 mg
Generics Ltd., Potters Bar, 12 station Close, EN6 1TL Hertfordshire, UK 
Potters Bar, 12 station Close, EN6 1TL Hertfordshire, UK
Lisapharma S.p.A. 
Taliansko Lisapharma S.p.A.
Netherlands GenRx B.V. Postbus 75 
Holandsko GenRx B.V.
Flustad 20 mg, dispersible tablets 
Flustad 20 mg, dispersible tablets 20 mg
Eli Lilly and Company Limited Kingsclere Road Basingstoke Hampshire, RG21 6XA , UK 
Eli Lilly and Company Limited Kingsclere Road Basingstoke Hampshire, RG21 6XA
Apotex Europe Ltd, Rowan House, 41 London Street, Reading, BERKSHIRE RG14PS, United Kingdom 
Ltd, Rowan House, 41 London Street, Reading, BERKSHIRE RG14PS, United Kingdom
Mianserine Distrireti 
Francúzsko DISTRIRETI
Fluoxetina toLife 20 mg cápsulas 
Fluoxetina toLife 20 mg cápsulas 20 mg
LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain 
Doctor Zamenhof, 36., Madrid 28027,
Mianserine HCl Gf 10 mg, tablets 
HCl Gf 10 mg, tablets 10 mg
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten 
Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Mianserine HCl Gf 30 mg, tablets 
HCl Gf 30 mg, tablets 30 mg
Fluoxetina Germed 20 mg cápsula 
Fluoxetina Germed 20 mg cápsula 20 mg
Apotex Europe Ltd., Rowan House, 41 London Street, Reading Berkshire UKRG14PS 
Rowan House, 41 London Street, Reading Berkshire UKRG14PS
Teva Pharma S.p.A. 
Taliansko Teva Pharma S.p.A.
Krka d.d., Smarjeska cesta 6, 8501 Novo mesto,. 
Smarjeska cesta 6, 8501
Trevilor Tabletten 25mg 25 mg 
Trevilor TabletTabletaten 25mg
BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain 
Španielsko BEXAL FARMACEUTICA, S.A Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain
Fluctine 20mg/5ml-orale Lösung 
Fluctine 20mg/5ml-orale Lösung 20mg
PHARMAZEUTIKA GmbH & Co., Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY 
Industriestrasse 10, 82256 Fürstenfeldbruck, GERMANY
Desitin Arzneimittel GmbH Weg Beim Jäger 214 223 35 Hamburg Tyskland (DEU) 
Weg Beim Jäger 214 223 35 Hamburg Tyskland (DEU)
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89070 Ulm 
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89070
Fluvoxam beta 50mg 50 mg 
Fluvoxam beta 50mg
Paroxetin Sandoz 20 mg Tabletten 
Paroxetin Sandoz 20 mg Tabletaten
Paroxetina Normal 20 mg comprimidos 
Normal 20 mg comprimidos
ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
ESCITALOPRAM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France 
Rolland 75 159 Paris cedex 14 France
Fluoxetina Farmoz 20 mg Cápsulas 
Fluoxetina Farmoz 20 mg Cápsulas 20 mg
H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark 
Veľká Británia H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Lexapro & Entact 
& Entact
Fluvoxamina Sandoz 100 mg Comprimidos Revestidos por Película 
Fluvoxamina Sandoz 100 mg Comprimidos
Mirtazapine Sandoz 15, filmomhulde tabletten 15 mg 
Sandoz 15, filmomhulde tabletten 15 mg
Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK 
York Road, London SW11 3SD; UK
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten 
3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, 2 Dublin, Ireland 
Pharma Dublin Limited, 1 Stokes Place, St.
LABORATORIO STADA, S.L., Frederic Mompou, 5, Sant Just Desvern, 08960, Spain 
Španielsko LABORATORIO STADA, S.L., Frederic Mompou, 5, Sant Just Desvern, 08960, Spain
ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
ATOMOXETÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
UCB Pharma Ges.m.b.H., Brünnerstr. 
Allen Pharmazeutika Ges.m.b.H.,
REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
REBOXETINUM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Mirtazapine Sandoz 15 mg 
Sandoz 15 mg
Fluoxetina Mepha 20 mg Cápsulas 
Fluoxetina Mepha 20 mg Cápsulas 20 mg
MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, Mollet del Valles, 08100, Spain 
Španielsko MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, Mollet del Valles, 08100, Spain
Fluoxetine 20 PCH, capsules 20 mg 
Fluoxetine 20 PCH, capsules 20 mg 20 mg
Fluoxetin 20 Heumann 20 mg 
Fluoxetin 20 Heumann
Fluoxetine Gf 20 mg/5 ml, oral solution 
Gf 20 mg/5 ml, oral solution
Domaniewska 50 C, 02-672 Warszawa, Poland 
Ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Venlafaxina Prodome 75 mg Comprimidos 
Prodome 75 mg Comprimidos
CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
CITALOPRAM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Edronax 4 mg Tabletten 4 mg 
Edronax 4 mg Tabletaten 4 mg
Mirtazapin "Neuraxpharm" 
"Neuraxpharm"
Fluox HEXAL 10mg Kapseln 
Fluox HEXAL 10mg Kapseln 10 mg
Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9. 
Maďarsko Lundbeck A/S 2500 KoppenhagaValby, Ottiliavej 9. Denmark
Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria 
Faromed Handelsges.m.b.H., Johann Strauß
MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, 08100 Mollet del Valles, Spain 
Španielsko MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, 08100 Mollet del Valles, Spain
MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, Mollet del Valles 08100, Spain 
Španielsko MERCK GENERICOS, S.L, CTRA.N152,KM 19 - POLiGONO MERCK, Mollet del Valles 08100, Spain
Hormosan-Kwizda GmbH Postfach 600340 
Postfach 600340
PHARMAGENUS ,S.A, Passeig de Gracia, 55 5º 1ª., Barcelona 08007, Spain 
Passeig de Gracia, 55 5º 1ª., Barcelona 08007,
EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary. 
Rt., Keresztúri út 30-38, 1106 Budapest, Hungary.
Odrowąża 13, 03-310 Warszawa, Poland 
Biovena Pharma Sp. z o.o., ul. Odrowąża 13, 03-310 Warszawa, Poland
GlaxoSmithKline Latvia SIA Bruņinieku iela 5 
GlaxoSmithKline Latvia SIA
Fluoxetine Gf 20 mg, tablets 
Fluoxetine 20 mg, tablets
Via Livornese, 897 La Vettola 56010 Pisa Italy 
Via Livornese, 897
D-64206 Darmstadt paroxedura 30 mg Filmtabletten 
Darmstadt paroxedura 30 mg Filmtabletten
A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK) 
Farmaceutisk Fabrik Holger Danskes Vej 89 2000
Fluox 20 mg-ratiopharm 20 mg 
Fluox 20 mg-ratiopharm
Fluoxetina Salipax 20 mg Cápsulas 
Fluoxetina Salipax 20 mg Cápsulas 20 mg
EFARMES, S.A., Sardenya, 350., 08025 Barcelona, Spain 
Sardenya, 350., 08025 Barcelona, Spain
Paroxetine Gf 20 mg, omhulde tabletten 
Gf 20 mg, omhulde tabletten
LURAMON 20 mg hard capsules 
LURAMON 20 mg hard capsules 20 mg
WYETH FARMA S.A., Ctra. 
Španielsko FERRER FARMA, S.A.,
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten 
3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
ADOFEN 20 mg dispersible tablets 
ADOFEN 20 mg dispersible tablets 20 mg
IRISFARMA, S.A.Avda. 
FARMA, S.A.,
Fluoxetin „Genericon“ 20mg-Kapseln 
Fluoxetin „Genericon“ 20mgKapseln
PHARMAGENUS ,S.A, Passeig de Gracia, 55 5º 1ª, Barcelona 08007, Spain 
Passeig de Gracia, 55 5º 1ª, Barcelona 08007,
LEK farmacevtska družba d.d., Verovškova 57, SI-1526 Ljubljana, Slovenia 
Verovškova 57, SI-1526 Ljubljana, Slovenia
Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary 
H-1106 Budapest, Kereszturi ut 30-38,
LABORATORIO STADA, S.L Frederic Mompou, 5, Sant Just Desvern 08960, Spain 
Španielsko LABORATORIO STADA, S.L Frederic Mompou, 5, Sant Just Desvern 08960, Spain
PAROXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
PAROXETÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Fluoxetin-ratiopharm Loesung 
Fluoxetin-ratiopharm
LABORATORIOS ALTER, S.A., Mateo Inurria, 30., Madrid, 28036, Spain 
Mateo Inurria, 30., Madrid, 28036,
Paroxetine Sandoz 20, tabletten 20 mg 
Sandoz 20, tabletten 20 mg
Generics UK Ltd., Albany Gate Darkes Lane, Potters Bar Herts EN6 1AG, England 
Albany Gate Darkes Lane, Potters Bar Herts EN6 1AG, England
Fluoxetin „Genericon“ 20mg/5ml-orale Lösung 
Fluoxetin „Genericon“ 20mg/5mlorale Lösung
Citalopram Sandoz 40 mg tabletki powlekane 
Sandoz 40 mg tabletki powlekane
STADA., Frederic Mompou, 5, Sant Just Desvern 08960, Spain 
Frederic Mompou, 5, Sant Just Desvern 08960, Spain
Krka d.d., Smarjeska cesta 6, 8501 Novo mesto, Slovenia 
Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto, Slovenia
Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K. 
Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Mepha Ltd, Rua Elias Garcia No 28, C Edificio 4, Venda Nova, 2701 355, Amadora, Portugal 
No 28, C Edificio 4, Venda Nova, 2701 355, Amadora, Portugal
Therefore the CHMP concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and the relevant section of the Package Leaflets of atomoxetine containing medicinal products. 
Preto výbor CHMP dospel k záveru, že do Súhrnu charakteristických vlastností lieku a príslušnej časti Písomnej informácie pre používateľov pre lieky obsahujúce atomoxetín sa má zaradiť varovanie o tom, že v klinických štúdiách u detí a dospievajúcich liečených atomoxetínom sa v porovnaní s placebom pozorovali častejšie prípady hostility (predovšetkým agresia, protichodné správanie a zlosť) a emočnej lability.
Solvay Pharma Ges.m.b.H., Donaustr. 
Lannacher Heilmittel Ges.m.b.H.,
Prolonged release capsule, hard 
Tvrdá kapsula s predĺženým uvoľnovaním
Laboratories, 26-28 Rue de la Pastorale, B-1080 Bruxelles, Belgium 
Rue de la Pastorale, B-1080 Bruxelles, Belgium
Fluoxetina Flomex 20 mg Cápsulas 
Fluoxetina Flomex 20 mg Cápsulas 20 mg
Fluoxetina Alter 20 mg Cápsulas 
Fluoxetina Alter 20 mg Cápsulas 20 mg
Fluoxetina Ciclum 20 mg Cápsulas 
Fluoxetina Ciclum 20 mg Cápsulas 20 mg
Generics (UK) Limited, Station Close, Potters Bar, HERTFORDSHIRE EN61TL, United Kingdom 
Limited, Station Close, Potters Bar, HERTFORDSHIRE EN61TL, United Kingdom
FLUCTIN Tabletten 20 mg 
Tabletaten 20 mg
Fluoxetina Prodome 20 mg/5 ml Solução Oral 
Prodome 20 mg/5 ml Solução Oral
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln 
3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln 20 mg
Generics (UK) Limited, Station Close, Potters Bar, HERTFORDSHIRE EN6 1T, UK 
Limited, Station Close, Potters Bar, HERTFORDSHIRE EN6 1T, UK
de Burgos, 16 D - 5ª Planta, Madrid 28036, Spain 
Avda. de Burgos, 16 D - 5ª Planta, Madrid 28036,
H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK 
LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
FLUOXETÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Fluoxetine 20 mg Katwijk, capsules 
Fluoxetine 20 mg Katwijk, capsules 20 mg
REMERON Soltab 45mg 45mg 
Soltab 45mg 45mg
MIANSERINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
MIANSERÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Lek Pharmaceuticals d.d., Verevskova 57, Ljubljana, 1526, Slovenia 
Verevskova 57, Ljubljana, 1526, Slovenia
Fluoxetina Prodome 20 mg Cápsulas 
Prodome 20 mg Cápsulas
ADOFEN 20 mg hard capsules 
ADOFEN 20 mg hard capsules 20 mg
Generics (UK) Limited, 12 Station Close, Potters Bar Hertfordshire, EN6 1TL , UK 
Limited, 12 Station Close, Potters Bar Hertfordshire, EN6 1TL , UK
FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain 
Osi, 7-9, Barcelona, 08034, Spain
FERRER INTERNACIONAL, S.A., Gran Via Carlos III, 94, Barcelona 08028, Spain 
Gran Via Carlos III, 94, Barcelona 08028,
LILLY, S.A., Avda. 
Španielsko LILLY, S.A.,
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich 
OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Lexapro 10 mg, film coated tablets 
Lexapro 10 mg, film coated tablets 10 mg
Paroxetine Merck 20 mg, tabletten 
Merck 20 mg, tabletten
Lexapro 20 mg, film coated tablets 
Lexapro 20 mg, film coated tablets 20 mg
D-85764 Oberschleissheim 
D-85764
USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid 28008, Spain 
Ferraz, 10. 1º Izq., Madrid 28008,
STADA, Frederic Mompou, 5, 08960 Sant Just Desvern, Spain 
Frederic Mompou, 5, 08960 Sant Just Desvern, Spain
Lilly Farma - Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 4 - Piso 3 - ArquiparqueMiraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges, nº 4 - Piso 3 - ArquiparqueMiraflores 1495-131
RENEURON 20 mg hard capsules 
RENEURON 20 mg hard capsules 20 mg
STADA., Frederic Mompou, 5, 08960 Sant Just Desvern, Spain 
Španielsko STADA, Frederic Mompou, 5, 08960 Sant Just Desvern, Spain
Luxembourg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany 
Luxembursko HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
Mogilska 80, 31-546 Kraków, Poland 
Pliva Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80, 31-546 Kraków, Poland
Fluoxetine 20, capsules 20 mg 
Fluoxetine 20, capsules 20 mg 20 mg
LABORATORIOS ALTER, S.A., Mateo Inurria, 30., Madrid 28036, Spain 
Mateo Inurria, 30., Madrid 28036,
Fluoxetin-neuraxpharm 20 T 
Fluoxetin-neuraxpharm 20 T 20 mg
SmithKline Beecham Plc, 980 Great West Road, BRENTFORD, MIDDLESEX TW8 9GS, UK 
SmithKline Beecham Plc, 980 Great West Road, BRENTFORD, MIDDLESEX
EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary 
Rt., Keresztúri út 30-38, 1106 Budapest, Hungary
Norton Healthcare Ltd., Ivax Quays, Albert Basin, Royal Docks London E16 2QJ United Kingdom 
Ivax Quays, Albert Basin, Royal Docks London E16 2QJ United Kingdom
GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece 
GENEPHARM AEBE, 18 Km Marathonos
Fluoxetin Hexal 10mg Kapseln 
Fluoxetin Hexal 10mg Kapseln 10 mg
Mianserin-CT 30mg Filmtabletten 
Mianserin-CT 30mg Filmtabletten 30 mg
CHEMICAL WORKS OF GEDEON RICHTER LTD., 1103 BUDAPEST, Gyömröi út 19-21, HUNGARY 
RICHTER LTD., 1103 BUDAPEST, Gyömröi út 19-21, HUNGARY
LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain 
Nieremberg, 10., Madrid 28002,
LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain 
ANGENERICO, S.L.Osio, 7-9 08034
STRATTERA 5 mg Hartkapseln 
5 mg Hartkapseln
Fluoxetina Generis 20 mg Cápsulas 
Fluoxetina Generis 20 mg Cápsulas 20 mg
Denmark Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220 
DuraScan Medical Products A/S C.F.Tietgens Boulevard 40 DK-5220
Actavis Nordic A/S, 2970 Horsholm, Hammervej 7. 
Maďarsko Actavis Nordic A/S, 2970 Horsholm, Hammervej 7. Denmark
Oral suspension 
Paroxetine Suspensie
Pierre Fabre Medicament, 45 Place Abel Gance, 92654 BOULOGNE CEDEX France 
Pierre Fabre Medicament, 45 Place Abel Gance, 92654 BOULOGNE CEDEX
Merck dura GmbH Postfach 100635 
Postfach 100635
20 mg/0,5 ml Concentrate for solution for infusion 
20 mg/0,5 ml Infúzny koncentrát
Mirtatsapiini Teva 
Mirtatsapiini
Lexapro 15 mg, film coated tablets 
Lexapro 15 mg, film coated tablets 15 mg
Mirtazapine Dumex 45 mg, filmomhulde tabletten 
Dumex 45 mg, filmomhulde tabletten
Mirtazapine Dumex 15 mg, filmomhulde tabletten 
Dumex 15 mg, filmomhulde tabletten