natgillin/translations-raw huggingface dataset:
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
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