FrancophonIA/ELRC3.0 huggingface dataset:
English: Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Slovak: Maďarsko Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
English: Fluoxetin 10 - 1 A Pharma
Slovak: Fluoxetin 10 - 1
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Ámsterdam, 08940
Slovak: Ronda de Dalt, Edificio Ámsterdam, 08940
English: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko PAUCOURT 100 route de Versailles 78163
English: Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland
Slovak: Clonmel Healthcare Limited Waterford Road, Clonmel, Co.
English: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain
Slovak: Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008,
English: Mianserin „Arcana“ 10mg-Filmtabletten
Slovak: Mianserin „Arcana“ 10mgFilmtabletten
English: Mianserin-neuraxpharm 60mg
Slovak: Mianserin-neuraxpharm 60mg 60 mg
English: de la Industria, 30, Alcobendas, 28108, Spain
Slovak: de la Industria, 30, Alcobendas, 28108,
English: Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124 SOLNA, Sweden
Slovak: Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124
English: Flux „Hexal“ Tabs 10mgTabletten
Slovak: Flux „Hexal“ Tabs 10mg-Tabletten 10mg
English: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland
Slovak: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co.
English: Fluoxetin “Genericon” 20mg-Filmtabletten
Slovak: Fluoxetin “Genericon” 20mgFilmtabletten
English: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Slovak: Severo Ochoa, 2 Tres Cantos, Spain
English: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
English: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
English: SOLVAY PHARMA, S.A., Avda.
Slovak: Španielsko SOLVAY PHARMA, S.A.,
English: Fluoxetin 40 - 1 A Pharma
Slovak: Fluoxetin 40 - 1
English: Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
Slovak: Prešernova 1, SI-2000 Maribor, Slovenia
English: Mirtatsapiini Ennapharma 45 mg
Slovak: Ennapharma 45 mg
English: Paroxetine Tablet OF, filmomhulde tabletten 20 mg
Slovak: Paroxetine Tableta OF, filmomhulde tabletten 20 mg
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Slovak: Organon, Postbus 20, NL-5340 BH Oss
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: 20041 Agrate Brianza - Milano Italy
Slovak: Brianza - Milano Italy
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Slovak: Veľká Británia Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co.
English: Poligono Industrial Colon II., Terrassa 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa 08228,
English: G GAM
Slovak: Mianserine G GAM
English: Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Slovak: Heizel Esplanade b 22 1020 Brussel, Belgium
English: Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal
Slovak: Rua Alfredo da Silva nº 16, 2610-016
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Solvay Arzneimittel GmbH Postfach 220
Slovak: Solvay Arzneimittel GmbH
English: Netherlands N.V. Organon t.a.v.
Slovak: Organon t.a.v.
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Slovak: Laarstraat 16 2610 WILRIJK, Belgium
English: IV.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PACKAGE LEAFLET FOR FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Slovak: III.I NÁVRH ZMENY A DOPLNKU príslušného odseku spc pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
English: D-64206 Darmstadt
Slovak: D-64206
English: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Slovak: u. 53., MOM Park F épület
English: Gyömröi ut 19-21 H-1103 Budapest X Hungary
Slovak: Gyömröi ut 19-21 H-1103
English: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul.
Slovak: Zakłady Farmaceutyczne "POLPHARMA"
English: Mianserine HCl 30 mg Katwijk, tablets
Slovak: HCl 30 mg Katwijk, tablets
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: D-90449 Nuernberg
Slovak: D-90449
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Slovak: KG Leipziger Str. 7-13
English: MIABENE 10 MG 10 mg
Slovak: MIABENE 10 MG
English: Efectin 75mg-Tabletten 75mg
Slovak: Efectin 75mg-Tabletaten 75mg
English: Fluoxetina Bluepharma Indústria Farmacêutica S.A. 20 mg cápsulas
Slovak: Fluoxetina Bluepharma Indústria Farmacêutica S.A.
English: de la Industria, 30, Alcobendas, 28108 Spain
Slovak: de la Industria, 30, Alcobendas, 28108
English: D-89231 Neu-Ulm
Slovak: D-89231
English: SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko SAINT GERMAIN 100 route de Versailles 78163
English: Mianserin-TEVA 10 mg 10 mg
Slovak: Mianserin-TEVA 10 mg
English: Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Slovak: Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
English: PFIZER, S.A., Avda.
Slovak: Španielsko PFIZER, S.A.,
English: LERIVON 60MG 60 mg
Slovak: LERIVON 60MG
English: Fluvoxamin “1A Pharma” 50mg-Filmtabletten
Slovak: Fluvoxamin “1A Pharma” 50mgFilmtabletten
English: Mianserin-neuraxpharm 30mg
Slovak: Mianserin-neuraxpharm 30mg 30 mg
English: Mianserine HCl 10 mg Katwijk, tablets
Slovak: HCl 10 mg Katwijk, tablets
English: TEVA Classics le palatin1 1, cours du triangle
Slovak: 1, cours du triangle
English: Fluoxemerck 20 mg 20 mg
Slovak: Fluoxemerck 20 mg
English: Felicium 20mg-Kapseln 20mg
Slovak: Felicium 20mg-Kapseln
English: Dispersable tablet
Slovak: Dispergovateľná tableta
English: Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
Slovak: Holandsko H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
English: Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Slovak: Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
English: D-82041 Oberhaching
Slovak: D-82041
English: Pharmascope Ltd., Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
Slovak: Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
English: LERIVON 10MG 10 mg
Slovak: LERIVON 10MG
English: Fluvoxamin-ratiopharm 100 mg
Slovak: Fluvoxamin-ratiopharm 100 mg 100 mg
English: COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, Sant Joan Despi 08970, Spain
Slovak: Fructuos Gelabert, 6-8, Sant Joan Despi 08970, Spain
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Slovak: Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Slovak: Holandsko KRKA Pharma Dublin, 1 Stokes Place, St.
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Slovak: Holandsko Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, IRL
Slovak: Pinewood Laboratories Ltd Ballymacarbry, Clonmel, Co.
English: Constantinoupoleos Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus
Slovak: Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus
English: VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Slovak: VENLAFAXÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Slovak: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: Fluvoxamin “1A Pharma” 100mg-Filmtabletten
Slovak: Fluvoxamin “1A Pharma” 100mgFilmtabletten
English: Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL
Slovak: Ltd Station Close Potters Bar Hertfordshire EN6 1TL
English: Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal
Slovak: Grande, 2 - Zona Industrial da Abrunheira 2710-089
English: H. Lundbeck A/Sm 9 Ottiliavej DK-2500 Valby Copenhagen
Slovak: Lundbeck A/Sm 9 Ottiliavej DK-2500 Valby Copenhagen
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Slovak: Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: Netherlands Katwijk Farma B.V. Postbus 408
Slovak: Holandsko Katwijk Farma B.V.
English: Apotex Europe Ltd, 41 London Street Reading, Berkshire , RG1 4PS UK
Slovak: Ltd, 41 London Street Reading, Berkshire , RG1 4PS UK
English: Rodleben Pharma GmbH Postfach 205
Slovak: Rodleben Pharma GmbH
English: Efectin 50mg-Tabletten 50mg
Slovak: Efectin 50mg-Tabletaten 50mg
English: ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022 Barcelona, Spain
Slovak: Ronda General Mitre, 151, 08022
English: Fluoxetin-RPh 20mg 20 mg
Slovak: Fluoxetin-RPh 20mg
English: LERIVON 30MG 30 mg
Slovak: LERIVON 30MG
English: MIANSERIN 60 MG GENERICS
Slovak: MIANSERIN 60 MG GENERICS 60 mg
English: Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08 France
Slovak: Francúzsko Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08
English: Tolvon 60mgFilmtabletten
Slovak: Tolvon 60mg-Filmtabletten
English: de Burgos, 16 D - 5ª Planta 28036 Madrid, Spain
Slovak: Avda. de Burgos, 16 D - 5ª Planta 28036 Madrid, Spain
English: Paroxetin "Merck NM" 30 mg
Slovak: "Merck NM" 30 mg
English: D-80339 Muenchen
Slovak: D-80339
English: Tolvon 30mgFilmtabletten
Slovak: Tolvon 30mg-Filmtabletten
English: Fluoxetine 20 A, capsules 20 mg
Slovak: Fluoxetine 20 A, capsules 20 mg 20 mg
English: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Slovak: Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
English: Floxyfral 50mgFilmtabletten
Slovak: Floxyfral 50mg-Filmtabletten 50mg
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 Overijse
Slovak: Brusselsesteenweg 288 3090 Overijse
English: Bracco S.p.A.
Slovak: Taliansko Bracco S.p.A.
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Slovak: Luxembursko Pharmacia S.A., 17 Boulevard
English: Flux „Hexal“ Tabs 20mgTabletten
Slovak: Flux „Hexal“ Tabs 20mg-Tabletten 20mg
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Slovak: Francúzsko Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: Netherlands Niche Generics Ltd. 1 The Cam Centre
Slovak: Holandsko Niche Generics Ltd.
English: Flux „Hexal“ 20mgKapseln
Slovak: Flux „Hexal“ 20mg-Kapseln
English: SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013 Barcelona, Spain
Slovak: Španielsko SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013
English: Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
Slovak: Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
English: Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Slovak: Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338
English: RATIOPHARM Graf Arco Strasse 3
Slovak: Francúzsko RATIOPHARM Graf Arco
English: 49 Avenue Georges Pompidou 92300 Levallois Perret - France
Slovak: Francúzsko SANDOZ 49 Avenue Georges Pompidou 92300 Levallois Perret - France
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Slovak: & Co KG, Postfach 1439, D-40739
English: Gedeon Richter Ltd., Gyomoroi ut 1921, H-1103 Budapeszt, HU
Slovak: Gyomoroi ut 1921, H-1103 Budapeszt, HU
English: Fluvoxamin-ratiopharm 25 mg
Slovak: Fluvoxamin-ratiopharm 25 mg 25 mg
English: Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Slovak: Luxembursko PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
English: Belgium RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
Slovak: Rue St, Lambert 141 1200 BRUXELLES, Belgium
English: COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
Slovak: Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
English: Edronax 2 mg Tabletten 2 mg
Slovak: Edronax 2 mg Tabletaten 2 mg
English: PHARMAGENUS ,S.A, Passeig de Gracia, 55 5º 1ª., 08007 Barcelona, Spain
Slovak: Passeig de Gracia, 55 5º 1ª., 08007 Barcelona, Spain
English: CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE
Slovak: ATOMOXETÍN, VENLAFAXÍN, MIANSERÍN, MILNACIPRAN, REBOXETÍN A MIRTAZAPÍN (pozri prílohu I)
English: 49 avenue Georges Pompidou 92300 Levallois-Perret France
Slovak: Francúzsko SANDOZ 49 avenue Georges Pompidou 92300 Levallois-Perret France
English: Egis Pharmaceuticals Ltd., Kereszturi ut 30-38, H-1106 Budapeszt, HU
Slovak: Kereszturi ut 30-38, H-1106 Budapeszt, HU
English: Fluoxetine „Stada“ 20mg-Kapseln
Slovak: Fluoxetine „Stada“ 20mg-Kapseln 20mg
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Slovak: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: MIANSERIN 10 MG GENERICS
Slovak: MIANSERIN 10 MG GENERICS 10 mg
English: Mianserin-TEVA 30 mg 30 mg
Slovak: Mianserin-TEVA 30 mg
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Slovak: Veľká Británia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: Fluvohexal 50mg Filmtabletten
Slovak: Fluvohexal 50mg Filmtabletten 50 mg
English: de Burgos, 16 D - 5ª Planta, 28036 Madrid, Spain
Slovak: Avda. de Burgos, 16 D - 5ª Planta, 28036 Madrid, Spain
English: H. Lundbeck A/S Ottiliavej 9, Kopehagen-Valby, DK 2500
Slovak: Lundbeck A/S Ottiliavej 9, Kopehagen-Valby, DK 2500
English: Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
Slovak: Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
English: MIABENE 30 MG 30 mg
Slovak: MIABENE 30 MG
English: Mutan 20mg-Kapseln 20mg
Slovak: Mutan 20mg-Kapseln
English: Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338 Prior Velho Portugal
Slovak: Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Slovak: Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: - For atomoxetine, which is only indicated in the treatment of ADHD, the Committee 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 relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Slovak: - výbor dospel k záveru, že pre atomoxetín, ktorý je indikovaný iba na liečbu ADHD, sa do Súhrnu charakteristických vlastností lieku a príslušnej časti Písomnej informácie pre používateľov pre lieky obsahujúce atomoxetín 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.
English: LECIVA A.S., Dolni Mecholupy 130, 102 37 Praha 10, Czech Republic
Slovak: Dolni Mecholupy 130, 102 37 Praha 10, Czech Republic
English: Mianserin „ratiopharm“ 10mg-Filmtabletten
Slovak: Mianserin „ratiopharm“ 10mgFilmtabletten
English: FLOXET 10 mg kapszula 10 mg
Slovak: FLOXET 10 mg kapszula
English: RATIOPHARM ESPAÑA S.A., Avda.
Slovak: Španielsko RATIOPHARM ESPAÑA S.A.,
English: D-40764 Langenfeld
Slovak: D-40764
English: TAMARANG, S.A, Balmes, 84 - 4º2ª, Barcelona 08008, Spain
Slovak: Španielsko TAMARANG, S.A, Balmes, 84 - 4º2ª, Barcelona 08008,
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Slovak: Veľká Británia Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
Slovak: Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
English: Valeas S.p.A.
Slovak: Taliansko Valeas S.p.A.
English: Coated tablets
Slovak: Obalená tableta
English: D-65433 Floersheim
Slovak: D-65433
English: PROZAC 20 mg kapszula 20 mg
Slovak: PROZAC 20 mg kapszula
English: Fluoxetine EB 20, capsules 20 mg
Slovak: Fluoxetine EB 20, capsules 20 mg 20 mg
English: SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Slovak: SERTRALINUM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
English: de Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas, Spain
Slovak: Empresarial La Moraleja, 28108
English: Floxyfral 100mgFilmtabletten
Slovak: Floxyfral 100mg-Filmtabletten 100mg
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Slovak: & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
English: MIDDLESEX TW8 9GS UK
Slovak: TW8 9GS UK
English: 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.
Slovak: 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).
English: Mirtazapine Sandoz 30, filmomhulde tabletten 30 mg
Slovak: Sandoz 30, filmomhulde tabletten 30 mg
English: Heumann Pharma GmbH & Co.
Slovak: Heumann Pharma GmbH
English: PharmaSelect GmbH Am Saegewerk 13
Slovak: PharmaSelect GmbH
English: EGIS Pharmaceuticals Ltd., Keresztúri út 30-38, HU - 1160 Budapest
Slovak: Keresztúri út 30-38, HU - 1160 Budapest
English: GENERICS UK LTD, Station Close Potters Bar, Hertfordhsire, EN6 1TL, UK
Slovak: Španielsko GENERICS UK LTD, Station Close Potters Bar, Hertfordhsire, EN6 1TL, UK
English: Generics[UK] Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL
Slovak: Ltd., Station Close, Potters Bar, , UK - Herts EN6 1TL
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 OVERIJSE, Belgium
Slovak: Brusselsesteenweg 288 3090 OVERIJSE, Belgium
English: FLOXET 10 MG 10 mg
Slovak: FLOXET 10 MG
English: Leciva A.S., U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic
Slovak: U kabelovny 130, Dolni Mecholupy, 102 37 Prague 10, Czech Republic
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
Slovak: 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg
English: ANPHARM Przedsiębiorstwo Farmaceutyczne S.A., Annopol 6B, 03-236 Warszawa, Poland
Slovak: POL-NIL Sp. z o.o., ul. Annopol 6A 03-236 Warszawa, Poland
English: Peplinska 19, 83-200
Slovak: Ambachtenlaan 13, 3001
English: Paroxetine Sandoz 20, filmomhulde tabletten 20 mg
Slovak: Sandoz 20, filmomhulde tabletten 20 mg
English: Levofarma S.r.l.
Slovak: Taliansko Levofarma S.r.l.
English: INDUSTRIAL FARMACEUTICA CANTABRIA, S.A., Carretera Cazoña-Adarzo, s/n., Santander 39011, Spain
Slovak: Carretera Cazoña-Adarzo, s/n.,
English: Sertraline 50 mg Tabletten, coated tablets
Slovak: Sertraline 50 mg Tabletaten, coated tablets
English: Temmler Pharma GmbH & Co.KG Postfach 2269
Slovak: & Co.KG Postfach 2269
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Slovak: Demunterlaan 1 1090 BRUSSEL, Belgium
English: Fujisawa Deutschland GmbH Bergam-Laim Str. 129, D-81673 Munchen, Germany
Slovak: Str. 129, D-81673 Munchen, Germany
English: Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Slovak: Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338
English: Mianserin 10mg Desitin 10 mg
Slovak: Mianserin 10mg Desitin
English: Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Slovak: Seidengasse 33-35, 1070 Wien, Austria
English: Fluvoxamin-ratiopharm 50 mg
Slovak: Fluvoxamin-ratiopharm 50 mg 50 mg
English: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Slovak: Doctor Zamenhof, 36., Madrid, 28027,
English: Sertraline 100 mg Tabletten, coated tablets
Slovak: Sertraline 100 mg Tabletaten, coated tablets
English: Mirtazapine Sandoz 45, filmomhulde tabletten 45 mg
Slovak: Sandoz 45, filmomhulde tabletten 45 mg
English: RIMAFAR, S.L., Pol. Ind. Malpica Calle C, Nº 4, Zaragoza (spain), 50016, Spain
Slovak: Malpica Calle C, Nº 4, Zaragoza (spain), 50016, Spain
English: Netherlands GlaxoSmithKline B.V. Postbus 780
Slovak: Holandsko GlaxoSmithKline B.V.
English: Fluoxetin „Genericon“ 40mg-Kapseln
Slovak: Fluoxetin „Genericon“ 40mgKapseln
English: PORTAL 20 mg kapszula 20 mg
Slovak: PORTAL 20 mg kapszula
English: - 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.
Slovak: - 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).
English: Zentiva a.s., U kabelovny 130, 102 37 Prague 10 , Czech Republic
Slovak: U kabelovny 130, 102 37 Prague 10 , Czech Republic
English: MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Slovak: MILNACIPRAN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
English: USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain
Slovak: Španielsko ACOST COMERCIAL GENERICPHARMA, Ferraz, 10. 1º Izq., Madrid, 28008,
English: FEVARIN 100 mg filmtabletta
Slovak: FEVARIN 100 mg filmtabletta 100 mg
English: Fluoxetin “Arcana” 20mg-Kapseln
Slovak: Fluoxetin “Arcana” 20mg-Kapseln 20mg
English: Fluvoxabeta 100 mg 100 mg
Slovak: Fluvoxabeta 100 mg
English: Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK
Slovak: Maďarsko Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK