FrancophonIA/ELRC3.0 huggingface dataset:
Danish: John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG Storbritannien och Nordirland (GBR)
Slovak: John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG
Danish: LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Slovak: ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Danish: Storbritannien Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Slovak: Veľká Británia Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Slovak: Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Danish: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Slovak: Bld de la Plaine 17 1050 Bruxelles, Belgium
Danish: Efectin 25mg-Tabletten 25mg
Slovak: Efectin 25mg-Tabletaten 25mg
Danish: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Slovak: Uzsoki út 36/A, 1145 Budapest, Hungary
Danish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Slovak: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER OG INDLÆGSSEDLER FREMLAGT AF EMEA
Slovak: VEDECKÉ ZÁVERY A ODÔVODNENIE ZMIEN A DOPLNKOV V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Danish: Solvex 4 mg Tabletten 4 mg
Slovak: Solvex 4 mg Tabletaten 4 mg
Danish: FARMANEU, S.L., Rambla de Cataluña, 47 - 1º, 08007 Barcelona, Spain
Slovak: Rambla de Cataluña, 47 - 1º, 08007
Danish: Inpharmco-Mianserin30mg-Tabletten
Slovak: Inpharmco-Mianserin-30mgTabletaten
Danish: CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Slovak: Juan Ignacio Luca de Tena, 8, Madrid 28027,
Danish: Tyskland SIEMENS & CO Postfach 1262
Slovak: & CO Postfach 1262
Danish: Storbritannien 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.
Danish: A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Slovak: Španielsko A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Danish: 67, 02631 Espoo, Finland
Slovak: Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Danish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Slovak: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Hexal B.V.
Slovak: Holandsko Hexal B.V.
Danish: Benedetti S.p.A.
Slovak: Taliansko Benedetti S.p.A.
Danish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Slovak: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Danish: Estland Estland ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Slovak: Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Danish: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko GLAXOSMITHKLINE 100 route de Versailles 78163
Danish: Danmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovak: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: IPSEN PHARMA, S.A., Ctra.
Slovak: Španielsko IPSEN PHARMA, S.A.,
Danish: Danmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovak: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Danish: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Slovak: Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Danish: Farma Uno S.r.l.
Slovak: Taliansko Farma Uno S.r.l.
Danish: Rijksweg 12 2870 Puurs, Belgium
Slovak: Rijksweg 12 2870
Danish: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Slovak: Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Danish: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Slovak: Šmarješka cesta 6, SL - 850 01 Novo Mesto
Danish: Przemysłowa 2, 35-959 Rzeszów, Poland
Slovak: ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland
Danish: Biores Italia S.r.l.
Slovak: Taliansko Biores Italia S.r.l.
Danish: Grœkenland UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Slovak: UNI-PHARMA AEBE, 14 Km National Road Athinon-Lamias, 14564 K.kifissia, Greece
Danish: Storbritannien Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Slovak: Veľká Británia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Danish: Felixsan 50mgFilmtabletten
Slovak: Felixsan 50mg-Filmtabletten
Danish: CHMP konkluderede, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
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).
Danish: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Danish: Castel San Giorgio 84083 Salerno Italy
Slovak: Castel San Giorgio 84083
Danish: Mianserin Organon 10mg 10 mg
Slovak: Mianserin Organon 10mg
Danish: Grœkenland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Slovak: PHARMATEN, 6 Dervenakion, 15351
Danish: GlaxoSmithKline B.V.
Slovak: Holandsko GlaxoSmithKline B.V.
Danish: DISTA, Avda.
Slovak: Španielsko DISTA, Avda.
Danish: 2, navnlig hvad angår disses brug i den pædiatriske patientgruppe: fluoxetin, fluvoxamin, sertralin, paroxetin, citalopram, escitalopram, atomoxetin, duloxetin, venlafaxin, mianserin, milnacipran, reboxetin og mirtazapin.
Slovak: predovšetkým v súvislosti s ich používaním u detskej populácie: fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, atomoxetín, duloxetín, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín.
Danish: Grœkenland ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Slovak: AE, 34 Filellinon Street, 15232 Halandri, Greece
Danish: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Slovak: Via Robert Koch 1.2, 201 52, Milano, Italy
Danish: Grœkenland FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Slovak: FARMASERV LILLY, 15 Km National Road, Athinon-Lamias, 14564 Kifissia, Greece
Danish: Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Slovak: Siebenbrunnengasse 21, 1050 Wien, Austria
Danish: Desiflu voxamin 50 mg 50 mg
Slovak: Desiflu voxamin 50 mg
Danish: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Slovak: Estrada Nacional 10, Km 140,260
Danish: Mianserin Organon 60mg 60 mg
Slovak: Mianserin Organon 60mg
Danish: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Slovak: Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Danish: Storbritannien Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Slovak: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Danish: Latvian JSC Grindeks, Krustpils ul.
Slovak: Grindeks, Krustpils ul.
Danish: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Slovak: Luxembursko LUNDBECK S.A., 225 AV.
Danish: PLIVA Pharma Nordic A/S H.P.
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000
Danish: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Slovak: Španielsko LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Danish: Mare de Déu de Montserrat, 221 Barcelona 08041, Spain
Slovak: Mare de Déu de Montserrat, 221, 08041
Danish: Fluxone Divule 20 mg ueberzogene Tabletten
Slovak: Divule 20 mg ueberzogene Tabletaten
Danish: Via Bianchi Maria Visconti 20122 Milano, Italy
Slovak: Visconti 20122 Milano, Italy
Danish: Fluoxstad 20 mg Tabletten
Slovak: Fluoxstad 20 mg Tabletaten
Danish: Pliva Kraków Zakłady Farmaceutyczne S.A. ul.
Slovak: Pliva Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80
Danish: Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Slovak: São Martinho do Bispo 3041-801
Danish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
Slovak: & Co.KG Wegenerstr.
Danish: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Slovak: Španielsko LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Danish: Organon, P.O. Box 20, Oss, Netherland
Slovak: Box 20, Oss, Netherland
Danish: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Danish: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Slovak: Calle Sardenya, 350 E08025 Barcelona Espanha
Danish: I.C.C.
Slovak: C.T.
Danish: Mianserin 30mg Holsten 30 mg
Slovak: Mianserin 30mg Holsten
Danish: Kapsel med modificeret udløsning
Slovak: Kapsula s predĺženým uvoľňovaním
Danish: IPSO Pharma S.r.l.
Slovak: Taliansko IPSO Pharma S.r.l.
Danish: Abbott S.p.A.
Slovak: Taliansko Abbott S.p.A.
Danish: REMEDICA LTD, AHARNON STR, P.O.BOX 51706, INDUSTRIAL ESTATE 3508 LEMESOS, CYPRUS
Slovak: LTD, AHARNON STR, P.O.BOX 51706, INDUSTRIAL ESTATE 3508 LEMESOS, CYPRUS
Danish: Mutan 20mgFilmtabletten
Slovak: Mutan 20mg-Filmtabletten
Danish: BILAG IV ÆNDRINGER I INDLÆGSSEDLEN
Slovak: PRÍLOHA IV NÁVRH ZMIEN V PÍSOMNEJ INFORMÁCII PRE POUŽÍVATEĽOV
Danish: Ranbaxy (UK) Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Slovak: Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Danish: LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Slovak: Španielsko LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Danish: Tolvon, tablets 3 mg 30 mg
Slovak: Tolvon, tablets 3 mg
Danish: Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Slovak: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Danish: Asentra 100 mg Tabletten, coated tablets
Slovak: Asentra 100 mg Tabletaten, coated tablets
Danish: Lampugnani Farmaceutici S.p.A.
Slovak: Taliansko Lampugnani Farmaceutici S.p.A.
Danish: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Slovak: Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Danish: Danmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Slovak: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Danish: Fluoxetin „Lannacher" 20mg-Kapseln
Slovak: Fluoxetin „Lannacher" 20mgKapseln
Danish: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Slovak: Sousa da Câmara, 207-211 1074803
Danish: Mianserin „Arcana" 30mg-Filmtabletten
Slovak: Mianserin „Arcana" 30mgFilmtabletten
Danish: Seroxat 2mg/ml-orale Lösung
Slovak: Seroxat 2mg/ml-orale
Danish: Asentra 50 mg Tabletten, coated tablets
Slovak: Asentra 50 mg Tabletaten, coated tablets
Danish: Europark Oost 34, 9100 St. Niklaas, Belgium
Slovak: Oost 34, 9100 St.
Danish: Apotex Europe Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR)
Slovak: Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR)
Danish: Fluoxetin-ratiopharm 20 mg Tabletten
Slovak: Fluoxetin-ratiopharm 20 mg Tabletaten
Danish: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Slovak: Rue du Tilleul 13, 1332 GENVAL, Belgium
Danish: Grœkenland BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Slovak: AE, 25 G.LYRA 14564 K.Kifissia, Greece
Danish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
Slovak: & Co.KG Postfach 1380
Danish: ACOST COMERCIAL GENERICPHARMA, Ferraz, 10. 1º Izq., Madrid, 28008, Spain
Slovak: Španielsko ACOST COMERCIAL GENERICPHARMA, Ferraz, 10. 1º Izq., Madrid, 28008,
Danish: Fevarin Tabs 100 mg 100 mg
Slovak: Fevarin Tabs 100 mg
Danish: Inpharmco-Mianserin10mg-Tabletten
Slovak: Inpharmco-Mianserin-10mgTabletaten
Danish: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Slovak: HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Danish: 16, Chemin de Coquelicots CH - 1214 Geneva
Slovak: CH - 1214 Geneva
Danish: Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA
Slovak: Nitrianska 100 92027 Hlohovec SLOVAKIA
Danish: Storbritannien Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Slovak: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Danish: Mianserin 10mg Holsten 10 mg
Slovak: Mianserin 10mg Holsten
Danish: Domaniewska 50 C, 02-672 Warszawa,.
Slovak: Ul. Domaniewska 50 C, 02-672 Warszawa,.
Danish: Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Slovak: Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Danish: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Slovak: Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Danish: KERN PHARMA, S.L., Venus, 72.
Slovak: Španielsko KERN PHARMA, S.L.,
Danish: ELI LILLY ČR s.r.o., Praha, Czech Republic
Slovak: ELI LILLY ČR s.r.o.,
Danish: Tyskland Synthon B.V.
Slovak: Synthon B.V.
Danish: Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Slovak: 12 Station Close Potters Bar, Herts, England
Danish: Flux „Hexal" Tabs 40mgTabletten
Slovak: Flux „Hexal" Tabs 40mg-Tabletten 40mg
Danish: Fluoxetin 20 - 1 A Pharma
Slovak: Fluoxetin 20 - 1
Danish: D-70839 Gerlingen
Slovak: D-70839
Danish: Tyskland biomo pharma GmbH Josef-Dietzgen-Str. 3
Slovak: Nemecko biomo pharma GmbH Josef-Dietzgen-Str.
Danish: Valda Laboratori Farmaceutici S.p.A.
Slovak: Taliansko Valda Laboratori Farmaceutici S.p.A.
Danish: TEVA Classics le palatin1 1, cours du triangle
Slovak: 1, cours du triangle
Danish: Sertra Krka 100 mg Tabletten, tablets
Slovak: Sertra Krka 100 mg Tabletaten, tablets
Danish: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Slovak: Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Danish: LITAPHAR, S.A., Orendaundi, 9, Guipuzcoa, 20730, Spain
Slovak: Orendaundi, 9, Guipuzcoa, 20730, Spain
Danish: Tolvon 60 mg, tablets 60 mg
Slovak: Tolvon 60 mg, tablets
Danish: Poligono Industrial Colon II., Terrassa, 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa, 08228,
Danish: Fluoxetin "Genericon" 20mg-Filmtabletten
Slovak: Fluoxetin "Genericon" 20mgFilmtabletten
Danish: Paroxetin "Merckle" 20mg-Filmtabletten
Slovak: "Merckle" 20mg-Filmtabletten
Danish: Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Slovak: Estrada Nacional 117-2 2724-503
Danish: Via Licino, 11-13-15 Erba 22036 Como Italy
Slovak: Via Licino, 11-13-15
Danish: - CHMP konkluderede derfor, at der i produktresumeet og de relevante dele af indlægssedlen for lægemidler indeholdende citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin og venlafaxin skulle indføjes en advarsel om, at selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske undersøgelser blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
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).
Danish: D-89231 Neu-Ulm
Slovak: D-89231
Danish: SERTRALIN indeholder medicinsk product med markeføringstilladelse i den Europœiske Union
Slovak: SERTRALINUM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Danish: Storbritannien Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Slovak: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Danish: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Slovak: Luxembursko H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Danish: III.I ÆNDRINGER I DE RELEVANTE DELE AF PRODUKTRESUMEET FOR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN
Slovak: III.I NÁVRH ZMENY A DOPLNKU príslušného odseku spc pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
Danish: ZENTIVA A.S., PRAGUE, U Kabelovny 130, 102 37 Praha 10Horní Měcholupy, Czech Republic
Slovak: PRAGUE, U Kabelovny 130, 102 37 Praha 10Horní Měcholupy, Czech Republic
Danish: DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain
Slovak: SAN RAFAEL, 3, Alcobendas 28108,
Danish: RATIOPHARM ESPAÑA, S.A., Avda.
Slovak: Španielsko RATIOPHARM ESPAÑA, S.A.,
Danish: D-13407 Berlin
Slovak: D-40764
Danish: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spain
Slovak: Ronda de Dalt, Edificio Amsterdam 08940, Spain
Danish: Tyskland F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
Slovak: Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010
Danish: Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Slovak: Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Danish: Fluoxetina Ratiopharm GmbH
Slovak: Ratiopharm GmbH
Danish: SMITHKLINE BEECHAM PLC 980 GREAT WEST ROAD BRENTFORD
Slovak: SMITHKLINE BEECHAM PLC 980 GREAT
Danish: Danmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Glaxo Smith Kline Kft., Csörsz u. 43.
Slovak: GLAXO SMITH KLINE S.A.
Danish: ADOFEN 20 mg oral solution
Slovak: ADOFEN 20 mg oral solution 20 mg
Danish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Slovak: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
Danish: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Slovak: Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Danish: RENEURON 20 mg oral solution
Slovak: RENEURON 20 mg oral solution 20 mg
Danish: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland
Slovak: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co.
Danish: Fluoxetin-TEVA 10 mg Tabletten
Slovak: Fluoxetin-TEVA 10 mg Tabletaten 10 mg
Danish: Sertra Krka 50 mg Tabletten, tablets
Slovak: Sertra Krka 50 mg Tabletaten, tablets
Danish: McDermott Laboratories Ltd trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL)
Slovak: Ltd trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL)
Danish: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Slovak: Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Danish: Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Slovak: Maďarsko Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Danish: Fluoxetin 10 - 1 A Pharma
Slovak: Fluoxetin 10 - 1
Danish: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Ámsterdam, 08940
Slovak: Ronda de Dalt, Edificio Ámsterdam, 08940
Danish: Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary, Ireland
Slovak: Clonmel Healthcare Limited Waterford Road, Clonmel, Co.
Danish: Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Slovak: Pinewood Laboratories Ltd Ballymacarbry, Clonmel, Co.
Danish: Pharmascope Ltd., Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
Slovak: Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Slovak: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Danish: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain
Slovak: Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008,
Danish: Storbritannien Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Slovak: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Danish: Mianserin „Arcana" 10mg-Filmtabletten
Slovak: Mianserin „Arcana" 10mgFilmtabletten
Danish: Mianserin-neuraxpharm 60mg
Slovak: Mianserin-neuraxpharm 60mg 60 mg
Danish: de la Industria, 30, Alcobendas, 28108, Spain
Slovak: de la Industria, 30, Alcobendas, 28108,
Danish: Tyskland Krewel Meuselbach GmbH Postfach 1263
Slovak: Krewel Meuselbach GmbH
Danish: 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
Danish: Flux „Hexal" Tabs 10mgTabletten
Slovak: Flux „Hexal" Tabs 10mg-Tabletten 10mg
Danish: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko PAUCOURT 100 route de Versailles 78163
Danish: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Slovak: Severo Ochoa, 2 Tres Cantos, Spain
Danish: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52 1000 Bruxelles, Belgium
Danish: Fluoxetin 40 - 1 A Pharma
Slovak: Fluoxetin 40 - 1
Danish: Mirtatsapiini Ennapharma 45 mg
Slovak: Ennapharma 45 mg
Danish: Dispergible tablets
Slovak: Dispergovateľná tableta
Danish: Paroxetine Tablet OF, filmomhulde tabletten 20 mg
Slovak: Paroxetine Tableta OF, filmomhulde tabletten 20 mg
Danish: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Danish: IV.I ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OG MIRTAZAPIN
Slovak: IV.I NÁVRH ZMENY A DOPLNKU príslušného odseku písomnej informácie pre používateľov pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
Danish: SOLVAY PHARMA, S.A., Avda.
Slovak: Španielsko SOLVAY PHARMA, S.A.,
Danish: Genthon B.V.
Slovak: Holandsko Genthon B.V.
Danish: 20041 Agrate Brianza - Milano Italy
Slovak: Brianza - Milano Italy
Danish: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Danish: Poligono Industrial Colon II., Terrassa 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa 08228,
Danish: G Gam
Slovak: Mianserine G GAM
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE
Slovak: DÔVODY NA POZMENENIE SÚHRNU CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Danish: Koncentrat til injektionsvœske til opløsning
Slovak: Injekčný koncentrát
Danish: Danmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Danish: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Slovak: u. 53., MOM Park F épület
Danish: Gyömröi ut 19-21 H-1103 Budapest X Hungary
Slovak: Gyömröi ut 19-21 H-1103
Danish: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul.
Slovak: Zakłady Farmaceutyczne "POLPHARMA"