natgillin/translations-raw huggingface dataset:
Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary 
Uzsoki út 36/A, 1145 Budapest, Hungary
GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France 
Francúzsko GLAXOSMITHKLINE 100 route de Versailles 78163
Solvex 4 mg Tabletten 4 mg 
Solvex 4 mg Tabletaten 4 mg
FARMANEU, S.L., Rambla de Cataluña, 47 - 1º, 08007 Barcelona, Spain 
Rambla de Cataluña, 47 - 1º, 08007
Inpharmco-Mianserin30mg-Tabletten 
Inpharmco-Mianserin-30mgTabletaten
CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain 
Juan Ignacio Luca de Tena, 8, Madrid 28027,
IPSEN PHARMA, S.A., Ctra. 
Španielsko IPSEN PHARMA, S.A.,
67, 02631 Espoo, Finland 
Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Benedetti S.p.A. 
Taliansko Benedetti S.p.A.
Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal 
Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Farma Uno S.r.l. 
Taliansko Farma Uno S.r.l.
SmithKline Beecham 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom 
Beecham 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom
AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU) 
KG Lepziger Strasse 7-13 D-01097
Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal 
Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia 
Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto 
Šmarješka cesta 6, SL - 850 01 Novo Mesto
Przemysłowa 2, 35-959 Rzeszów, Poland 
ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK 
Veľká Británia Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine. 
predovšetkým v súvislosti s ich používaním u detskej populácie: fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, atomoxetín, duloxetín, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín.
BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece 
AE, 25 G.LYRA 14564 K.Kifissia, Greece
Biores Italia S.r.l. 
Taliansko Biores Italia S.r.l.
Netherlands Alfred Tiefenbacher (GmbH & Co. KG) 
Holandsko Alfred Tiefenbacher (GmbH
Felixsan 50mgFilmtabletten 
Felixsan 50mg-Filmtabletten
Christensens Vej 1 DK-3000 Helsingör Danmark (DNK) 
PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Castel San Giorgio 84083 Salerno Italy 
Castel San Giorgio 84083
Krewel Meuselbach GmbH Postfach 1263 
Krewel Meuselbach GmbH
Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy 
Via Robert Koch 1.2, 201 52, Milano, Italy
DISTA, Avda. 
Španielsko DISTA, Avda.
BC Biochemie Pharma GmbH Dieselstr. 
Biochemie Pharma GmbH Dieselstr. 5
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK 
Veľká Británia Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Hennig Arzneimittel GmbH & Co.KG Postfach 1240 
& Co.KG Postfach 1240
D-89079 Ulm Germania 
3 D-89079 Ulm
16, Chemin de Coquelicots CH - 1214 Geneva 
CH - 1214 Geneva
Fevarin Tabs 100 mg 100 mg 
Fevarin Tabs 100 mg
Aliud Pharma GmbH & Co.KG Postfach 1380 
& Co.KG Postfach 1380
Seroxat 2mg/ml-orale Lösung 
Seroxat 2mg/ml-orale
Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal 
Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Lampugnani Farmaceutici S.p.A. 
Taliansko Lampugnani Farmaceutici S.p.A.
LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain 
Španielsko LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Mare de Déu de Montserrat, 221 Barcelona 08041, Spain 
Mare de Déu de Montserrat, 221, 08041
Fluxone Divule 20 mg ueberzogene Tabletten 
Divule 20 mg ueberzogene Tabletaten
Via Bianchi Maria Visconti 20122 Milano, Italy 
Visconti 20122 Milano, Italy
Fluoxstad 20 mg Tabletten 
Fluoxstad 20 mg Tabletaten
Pliva Kraków Zakłady Farmaceutyczne S.A. ul. 
Pliva Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80
PLIVA Pharma Nordic A/S H.P. 
PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000
LABORATORIOS CINFA, S.A., Olaz-Chipi, 10. 
Olaz-Chipi, 10. Polig.
Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal 
São Martinho do Bispo 3041-801
LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain 
Španielsko LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal 
Estrada Nacional 10, Km 140,260
Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha 
Calle Sardenya, 350 E08025 Barcelona Espanha
Ranbaxy (UK) Ltd 95 Park Lane Mayfair London WIK 7TE, UK 
Ltd 95 Park Lane Mayfair London WIK 7TE, UK
IPSO Pharma S.r.l. 
Taliansko IPSO Pharma S.r.l.
Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom 
Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Abbott S.p.A. 
Taliansko Abbott S.p.A.
Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK 
Veľká Británia Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
REMEDICA LTD, AHARNON STR, P.O.BOX 51706, INDUSTRIAL ESTATE 3508 LEMESOS, CYPRUS 
LTD, AHARNON STR, P.O.BOX 51706, INDUSTRIAL ESTATE 3508 LEMESOS, CYPRUS
Mutan 20mgFilmtabletten 
Mutan 20mg-Filmtabletten
ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic 
HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK 
Veľká Británia Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain 
Španielsko LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Tolvon, tablets 3 mg 30 mg 
Tolvon, tablets 3 mg
Asentra 100 mg Tabletten, coated tablets 
Asentra 100 mg Tabletaten, coated tablets
Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA 
Nitrianska 100 92027 Hlohovec SLOVAKIA
Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal 
Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal 
Sousa da Câmara, 207-211 1074803
Fluoxetin „Lannacher“ 20mg-Kapseln 
Fluoxetin „Lannacher“ 20mgKapseln
Mianserin „Arcana“ 30mg-Filmtabletten 
Mianserin „Arcana“ 30mgFilmtabletten
Asentra 50 mg Tabletten, coated tablets 
Asentra 50 mg Tabletaten, coated tablets
Pharmaceutical form Route of administration 
Via del Commercio-Zone Industriale
REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece 
& Areos, 13451 Kamatero Attikis, Greece
Apotex Europe Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR) 
Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR)
Fluoxetin-ratiopharm 20 mg Tabletten 
Fluoxetin-ratiopharm 20 mg Tabletaten
ELI LILLY ČR s.r.o., Praha, Czech Republic 
ELI LILLY ČR s.r.o.,
KERN PHARMA, S.L., Venus, 72. 
Španielsko KERN PHARMA, S.L.,
ACOST COMERCIAL GENERICPHARMA, S.L., Ferraz, 10. 
Španielsko ACOST COMERCIAL GENERICPHARMA, S.L.,
Inpharmco-Mianserin10mg-Tabletten 
Inpharmco-Mianserin-10mgTabletaten
Glaxo Smith Kline Kft., Csörsz u. 43. 
GLAXO SMITH KLINE S.A.
KIRON PHARMACEUTICA Groesbeekseweg 11 
Groesbeekseweg 11
Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles 
Luxembursko LUNDBECK S.A., 225 AV.
Domaniewska 50 C, 02-672 Warszawa,. 
Ul. Domaniewska 50 C, 02-672 Warszawa,.
Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal 
Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal 
Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Valda Laboratori Farmaceutici S.p.A. 
Taliansko Valda Laboratori Farmaceutici S.p.A.
Generics UK Ltd. 12 Station Close Potters Bar, Herts, England 
12 Station Close Potters Bar, Herts, England
Fluoxetin 20 - 1 A Pharma 
Fluoxetin 20 - 1
Sertra Krka 100 mg Tabletten, tablets 
Sertra Krka 100 mg Tabletaten, tablets
GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria 
Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
LITAPHAR, S.A., Orendaundi, 9, Guipuzcoa, 20730, Spain 
Orendaundi, 9, Guipuzcoa, 20730, Spain
Tolvon 60 mg, tablets 60 mg 
Tolvon 60 mg, tablets
Poligono Industrial Colon II., Terrassa, 08228, Spain 
Poligono Industrial Colon II., Terrassa, 08228,
Holsten Pharma GmbH Im Buergerstock 7 
Holsten Pharma GmbH
Flux „Hexal“ Tabs 40mgTabletten 
Flux „Hexal“ Tabs 40mg-Tabletten 40mg
Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal 
Estrada Nacional 117-2 2724-503
Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500 
Luxembursko H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
ZENTIVA A.S., PRAGUE, U Kabelovny 130, 102 37 Praha 10Horní Měcholupy, Czech Republic 
PRAGUE, U Kabelovny 130, 102 37 Praha 10Horní Měcholupy, Czech Republic
DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain 
SAN RAFAEL, 3, Alcobendas 28108,
RATIOPHARM ESPAÑA, S.A., Avda. 
Španielsko RATIOPHARM ESPAÑA, S.A.,
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland 
Veľká Británia Athlone Laboratories Limited, Ballymurray, Co.
Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spain 
Ronda de Dalt, Edificio Amsterdam 08940, Spain
Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal 
Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Fluoxetina Ratiopharm GmbH 
Ratiopharm GmbH
SMITHKLINE BEECHAM PLC 980 GREAT WEST ROAD BRENTFORD 
SMITHKLINE BEECHAM PLC 980 GREAT
ADOFEN 20 mg oral solution 
ADOFEN 20 mg oral solution 20 mg
RENEURON 20 mg oral solution 
RENEURON 20 mg oral solution 20 mg
Fluoxetin-TEVA 10 mg Tabletten 
Fluoxetin-TEVA 10 mg Tabletaten 10 mg
Sertra Krka 50 mg Tabletten, tablets 
Sertra Krka 50 mg Tabletaten, tablets
McDermott Laboratories Ltd trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL) 
Ltd trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL)
Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK 
Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal 
Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria 
Maďarsko Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Fluoxetin 10 - 1 A Pharma 
Fluoxetin 10 - 1
Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Ámsterdam, 08940 
Ronda de Dalt, Edificio Ámsterdam, 08940
PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France 
Francúzsko PAUCOURT 100 route de Versailles 78163
Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland 
Clonmel Healthcare Limited Waterford Road, Clonmel, Co.
TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain 
Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008,
Mianserin „Arcana“ 10mg-Filmtabletten 
Mianserin „Arcana“ 10mgFilmtabletten
Mianserin-neuraxpharm 60mg 
Mianserin-neuraxpharm 60mg 60 mg
de la Industria, 30, Alcobendas, 28108, Spain 
de la Industria, 30, Alcobendas, 28108,
Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124 SOLNA, Sweden 
Wyeth Lederle Nordiska Ab, Dalvägen 12, B.O.BOX 1822, 17124
Flux „Hexal“ Tabs 10mgTabletten 
Flux „Hexal“ Tabs 10mg-Tabletten 10mg
Fluoxetin “Genericon” 20mg-Filmtabletten 
Fluoxetin “Genericon” 20mgFilmtabletten
MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain 
Severo Ochoa, 2 Tres Cantos, Spain
Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK 
Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K. 
Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
SOLVAY PHARMA, S.A., Avda. 
Španielsko SOLVAY PHARMA, S.A.,
Fluoxetin 40 - 1 A Pharma 
Fluoxetin 40 - 1
Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia 
Prešernova 1, SI-2000 Maribor, Slovenia
Mirtatsapiini Ennapharma 45 mg 
Ennapharma 45 mg
Paroxetine Tablet OF, filmomhulde tabletten 20 mg 
Paroxetine Tableta OF, filmomhulde tabletten 20 mg
20041 Agrate Brianza - Milano Italy 
Brianza - Milano Italy
Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland 
Veľká Británia Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co.
Poligono Industrial Colon II., Terrassa 08228, Spain 
Poligono Industrial Colon II., Terrassa 08228,
G GAM 
Mianserine G GAM
Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 BRUSSEL, Belgium 
Heizel Esplanade b 22 1020 Brussel, Belgium
Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016 Amadora, Portugal 
Rua Alfredo da Silva nº 16, 2610-016
Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium 
Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Solvay Arzneimittel GmbH Postfach 220 
Solvay Arzneimittel GmbH
Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium 
Laarstraat 16 2610 WILRIJK, Belgium
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 
III.I NÁVRH ZMENY A DOPLNKU príslušného odseku spc pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
D-64206 Darmstadt 
D-64206
Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület 
u. 53., MOM Park F épület
Gyömröi ut 19-21 H-1103 Budapest X Hungary 
Gyömröi ut 19-21 H-1103
Zakłady Farmaceutyczne "POLPHARMA" S.A., ul. 
Zakłady Farmaceutyczne "POLPHARMA"
Mianserine HCl 30 mg Katwijk, tablets 
HCl 30 mg Katwijk, tablets
D-90449 Nuernberg 
D-90449
MIABENE 10 MG 10 mg 
MIABENE 10 MG
Efectin 75mg-Tabletten 75mg 
Efectin 75mg-Tabletaten 75mg
de la Industria, 30, Alcobendas, 28108 Spain 
de la Industria, 30, Alcobendas, 28108
D-89231 Neu-Ulm 
D-89231
SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France 
Francúzsko SAINT GERMAIN 100 route de Versailles 78163
Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal 
Rua Alfredo da Silva, nº 16 2720-028 Amadora Portugal
PFIZER, S.A., Avda. 
Španielsko PFIZER, S.A.,
LERIVON 60MG 60 mg 
LERIVON 60MG
Mianserin-neuraxpharm 30mg 
Mianserin-neuraxpharm 30mg 30 mg
Mianserine HCl 10 mg Katwijk, tablets 
HCl 10 mg Katwijk, tablets
TEVA Classics le palatin1 1, cours du triangle 
1, cours du triangle
Fluoxemerck 20 mg 20 mg 
Fluoxemerck 20 mg
Felicium 20mg-Kapseln 20mg 
Felicium 20mg-Kapseln
Dispersable tablet 
Dispergovateľná tableta
Netherlands H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby 
Holandsko H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby
D-82041 Oberhaching 
D-82041
Pharmascope Ltd., Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland 
Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
LERIVON 10MG 10 mg 
LERIVON 10MG
Fluvoxamin-ratiopharm 100 mg 
Fluvoxamin-ratiopharm 100 mg 100 mg
COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, Sant Joan Despi 08970, Spain 
Fructuos Gelabert, 6-8, Sant Joan Despi 08970, Spain
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2 
Holandsko KRKA Pharma Dublin, 1 Stokes Place, St.
Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel 
Holandsko Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, IRL 
Pinewood Laboratories Ltd Ballymacarbry, Clonmel, Co.
Constantinoupoleos Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus 
Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus
VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
VENLAFAXÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL 
Ltd Station Close Potters Bar Hertfordshire EN6 1TL
Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal 
Grande, 2 - Zona Industrial da Abrunheira 2710-089
Netherlands Katwijk Farma B.V. Postbus 408 
Holandsko Katwijk Farma B.V.
Apotex Europe Ltd, 41 London Street Reading, Berkshire , RG1 4PS UK 
Ltd, 41 London Street Reading, Berkshire , RG1 4PS UK
Rodleben Pharma GmbH Postfach 205 
Rodleben Pharma GmbH
Efectin 50mg-Tabletten 50mg 
Efectin 50mg-Tabletaten 50mg
ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022 Barcelona, Spain 
Ronda General Mitre, 151, 08022
Fluoxetin-RPh 20mg 20 mg 
Fluoxetin-RPh 20mg
LERIVON 30MG 30 mg 
LERIVON 30MG
MIANSERIN 60 MG GENERICS 
MIANSERIN 60 MG GENERICS 60 mg
Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08 France 
Francúzsko Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08
Tolvon 60mgFilmtabletten 
Tolvon 60mg-Filmtabletten
de Burgos, 16 D - 5ª Planta 28036 Madrid, Spain 
Avda. de Burgos, 16 D - 5ª Planta 28036 Madrid, Spain
Paroxetin "Merck NM" 30 mg 
"Merck NM" 30 mg
D-80339 Muenchen 
D-80339
Tolvon 30mgFilmtabletten 
Tolvon 30mg-Filmtabletten
Fluoxetine 20 A, capsules 20 mg 
Fluoxetine 20 A, capsules 20 mg 20 mg
Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary 
Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Floxyfral 50mgFilmtabletten 
Floxyfral 50mg-Filmtabletten 50mg
Bracco S.p.A. 
Taliansko Bracco S.p.A.
Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium 
Luxembursko Pharmacia S.A., 17 Boulevard
Flux „Hexal“ Tabs 20mgTabletten 
Flux „Hexal“ Tabs 20mg-Tabletten 20mg
49, avenue Georges Pompidou 92300 Levallois-Perret France 
Francúzsko Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
Netherlands Niche Generics Ltd. 1 The Cam Centre 
Holandsko Niche Generics Ltd.
Flux „Hexal“ 20mgKapseln 
Flux „Hexal“ 20mg-Kapseln
SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013 Barcelona, Spain 
Španielsko SANDOZ FARMACÉUTICA, Gran Via de les Corts Catalanes, 08013
Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal 
Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338
RATIOPHARM Graf Arco Strasse 3 
Francúzsko RATIOPHARM Graf Arco
49 Avenue Georges Pompidou 92300 Levallois Perret - France 
Francúzsko SANDOZ 49 Avenue Georges Pompidou 92300 Levallois Perret - France
Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 
& Co KG, Postfach 1439, D-40739
Gedeon Richter Ltd., Gyomoroi ut 1921, H-1103 Budapeszt, HU 
Gyomoroi ut 1921, H-1103 Budapeszt, HU
Fluvoxamin-ratiopharm 25 mg 
Fluvoxamin-ratiopharm 25 mg 25 mg
Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France 
Luxembursko PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
COMBINO PHARM, S.L., Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain 
Fructuos Gelabert, 6-8, 08970 Sant Joan Despi, Spain
Edronax 2 mg Tabletten 2 mg 
Edronax 2 mg Tabletaten 2 mg
PHARMAGENUS ,S.A, Passeig de Gracia, 55 5º 1ª., 08007 Barcelona, Spain 
Passeig de Gracia, 55 5º 1ª., 08007 Barcelona, Spain
CITALOPRAM, ESCITALOPRAM, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE 
ATOMOXETÍN, VENLAFAXÍN, MIANSERÍN, MILNACIPRAN, REBOXETÍN A MIRTAZAPÍN (pozri prílohu I)
49 avenue Georges Pompidou 92300 Levallois-Perret France 
Francúzsko SANDOZ 49 avenue Georges Pompidou 92300 Levallois-Perret France
Egis Pharmaceuticals Ltd., Kereszturi ut 30-38, H-1106 Budapeszt, HU 
Kereszturi ut 30-38, H-1106 Budapeszt, HU
Fluoxetine „Stada“ 20mg-Kapseln 
Fluoxetine „Stada“ 20mg-Kapseln 20mg
MIANSERIN 10 MG GENERICS 
MIANSERIN 10 MG GENERICS 10 mg
Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands 
Veľká Británia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Fluvohexal 50mg Filmtabletten 
Fluvohexal 50mg Filmtabletten 50 mg
de Burgos, 16 D - 5ª Planta, 28036 Madrid, Spain 
Avda. de Burgos, 16 D - 5ª Planta, 28036 Madrid, Spain
H. Lundbeck A/S Ottiliavej 9, Kopehagen-Valby, DK 2500 
Lundbeck A/S Ottiliavej 9, Kopehagen-Valby, DK 2500
Ranbaxy (UK) Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL 
Ltd, C.P.House, 97107 Uxbridge Road, Eabing,, UKLondon, W5 5TL
MIABENE 30 MG 30 mg 
MIABENE 30 MG
Mutan 20mg-Kapseln 20mg 
Mutan 20mg-Kapseln
Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338 Prior Velho Portugal 
Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium 
Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
- 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. 
- 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.
LECIVA A.S., Dolni Mecholupy 130, 102 37 Praha 10, Czech Republic 
Dolni Mecholupy 130, 102 37 Praha 10, Czech Republic
RATIOPHARM ESPAÑA S.A., Avda. 
Španielsko RATIOPHARM ESPAÑA S.A.,
D-40764 Langenfeld 
D-40764
TAMARANG, S.A, Balmes, 84 - 4º2ª, Barcelona 08008, Spain 
Španielsko TAMARANG, S.A, Balmes, 84 - 4º2ª, Barcelona 08008,
Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK 
Veľká Británia Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
Apotex Europe Ltd., Rowan House, 41 London Street, UK-RG1 4PS Berkshire, 
Rowan House, 41 London Street, UK-RG1 4PS Berkshire,
Valeas S.p.A. 
Taliansko Valeas S.p.A.
Coated tablets 
Obalená tableta
D-65433 Floersheim 
D-65433
Fluoxetine EB 20, capsules 20 mg 
Fluoxetine EB 20, capsules 20 mg 20 mg
SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
SERTRALINUM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
de Europa, 20 B. Parque Empresarial La Moraleja, 28108 Alcobendas, Spain 
Empresarial La Moraleja, 28108
Floxyfral 100mgFilmtabletten 
Floxyfral 100mg-Filmtabletten 100mg
John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK 
& Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
MIDDLESEX TW8 9GS UK 
TW8 9GS UK