FrancophonIA/ELRC3.0 huggingface dataset:
Italian: LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Slovak: ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Italian: Langenfeld, Germany
Slovak: Langenfeld Tyskland (DEU)
Italian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Slovak: Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Italian: 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
Italian: Efectin 25mg-Tabletten 25mg
Slovak: Efectin 25mg-Tabletaten 25mg
Italian: Danimarca Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovak: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: Solvex 4 mg Tabletten 4 mg
Slovak: Solvex 4 mg Tabletaten 4 mg
Italian: FARMANEU, S.L., Rambla de Cataluña, 47 - 1º, 08007 Barcelona, Spain
Slovak: Rambla de Cataluña, 47 - 1º, 08007
Italian: Inpharmco-Mianserin30mg-Tabletten
Slovak: Inpharmco-Mianserin-30mgTabletaten
Italian: CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Slovak: Juan Ignacio Luca de Tena, 8, Madrid 28027,
Italian: GlaxoSmithKline B.V.
Slovak: Holandsko GlaxoSmithKline B.V.
Italian: 67, 02631 Espoo, Finland
Slovak: Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Italian: IPSEN PHARMA, S.A., Ctra.
Slovak: Španielsko IPSEN PHARMA, S.A.,
Italian: Hexal B.V.
Slovak: Holandsko Hexal B.V.
Italian: Regno Unito 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
Italian: Danimarca 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
Italian: Portogallo Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Slovak: Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Italian: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko GLAXOSMITHKLINE 100 route de Versailles 78163
Italian: Portogallo Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Slovak: Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Italian: Il CHMP ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con 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).
Italian: A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Slovak: Španielsko A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Italian: Danimarca Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Slovak: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: Glaxo Smith Kline Kft., Csörsz u. 43.
Slovak: GLAXO SMITH KLINE S.A.
Italian: ALLEGATO II CONCLUSIONI SCIENTIFICHE E MOTIVI DELLA MODIFICA DEI RIASSUNTI DELLE CARATTERISTICHE DEL PRODOTTO E DEI FOGLI ILLUSTRATIVI PRESENTATI DALL'EMEA
Slovak: VEDECKÉ ZÁVERY A ODÔVODNENIE ZMIEN A DOPLNKOV V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Italian: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Slovak: Uzsoki út 36/A, 1145 Budapest, Hungary
Italian: SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Slovak: Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Italian: Regno Unito Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Slovak: Veľká Británia Athlone Laboratories Limited, Ballymurray, Co.
Italian: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Slovak: Taliansko Angenerico S.p.A. via Nocera Umbra 75
Italian: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Slovak: AE, 25 G.LYRA 14564 K.Kifissia, Greece
Italian: Portogallo Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Slovak: Lagoas Park - Edifício nº 10 2740-244
Italian: Danimarca N.V.
Slovak: Maďarsko N.V.
Italian: Felixsan 50mgFilmtabletten
Slovak: Felixsan 50mg-Filmtabletten
Italian: Przemysłowa 2, 35-959 Rzeszów, Poland
Slovak: ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland
Italian: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Italian: A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK)
Slovak: A/S GEA Farmaceutisk Fabrik, Holger Danskaes Vej 89, DK - 2000 Fraderiksberg
Italian: Castel San Giorgio 84083 Salerno Italy
Slovak: Castel San Giorgio 84083
Italian: Regno Unito 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.
Italian: Mianserin Organon 10mg 10 mg
Slovak: Mianserin Organon 10mg
Italian: DISTA, Avda.
Slovak: Španielsko DISTA, Avda.
Italian: Germania Synthon B.V.
Slovak: Synthon B.V.
Italian: Germania F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6
Slovak: Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010
Italian: I.C.C.
Slovak: C.T.
Italian: Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Slovak: Siebenbrunnengasse 21, 1050 Wien, Austria
Italian: Portogallo 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
Italian: Desiflu voxamin 50 mg 50 mg
Slovak: Desiflu voxamin 50 mg
Italian: Regno Unito Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Slovak: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Mianserin Organon 60mg 60 mg
Slovak: Mianserin Organon 60mg
Italian: Lussemburgo LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Slovak: Luxembursko LUNDBECK S.A., 225 AV.
Italian: Latvian JSC Grindeks, Krustpils ul.
Slovak: Grindeks, Krustpils ul.
Italian: PLIVA Pharma Nordic A/S H.P.
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000
Italian: 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
Italian: Portogallo Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Slovak: Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide
Italian: Mare de Déu de Montserrat, 221 Barcelona 08041, Spain
Slovak: Mare de Déu de Montserrat, 221, 08041
Italian: Portogallo 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
Italian: Fluxone Divule 20 mg ueberzogene Tabletten
Slovak: Divule 20 mg ueberzogene Tabletaten
Italian: ELI LILLY ČR s.r.o., Praha, Czech Republic
Slovak: ELI LILLY ČR s.r.o.,
Italian: Fluoxstad 20 mg Tabletten
Slovak: Fluoxstad 20 mg Tabletaten
Italian: Pliva Kraków Zakłady Farmaceutyczne S.A. ul.
Slovak: Pliva Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80
Italian: - che, di conseguenza, il comitato ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con 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).
Italian: LABORATORIOS CINFA, S.A., Olaz-Chipi, 10.
Slovak: Olaz-Chipi, 10. Polig.
Italian: Portogallo 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
Italian: 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
Italian: Regno Unito Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Slovak: Veľká Británia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Italian: Mianserin 30mg Holsten 30 mg
Slovak: Mianserin 30mg Holsten
Italian: Portogallo 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
Italian: KERN PHARMA, S.L., Venus, 72.
Slovak: Španielsko KERN PHARMA, S.L.,
Italian: SOLVAY PHARMA, S.A., Avda.
Slovak: Španielsko SOLVAY PHARMA, S.A.,
Italian: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Slovak: Via Ponte della Fabbrica 3/A 35031
Italian: Slovacchia Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Slovak: Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Italian: 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
Italian: Mutan 20mgFilmtabletten
Slovak: Mutan 20mg-Filmtabletten
Italian: Rijksweg 12 2870 Puurs, Belgium
Slovak: Rijksweg 12 2870
Italian: Ranbaxy (UK) Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Slovak: Ltd 95 Park Lane Mayfair London WIK 7TE, UK
Italian: LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Slovak: Španielsko LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Italian: Danimarca 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
Italian: Danimarca Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Slovak: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Italian: Tolvon, tablets 3 mg 30 mg
Slovak: Tolvon, tablets 3 mg
Italian: Asentra 100 mg Tabletten, coated tablets
Slovak: Asentra 100 mg Tabletaten, coated tablets
Italian: Fluoxetin „Lannacher" 20mg-Kapseln
Slovak: Fluoxetin „Lannacher" 20mgKapseln
Italian: Mianserin „Arcana" 30mg-Filmtabletten
Slovak: Mianserin „Arcana" 30mgFilmtabletten
Italian: Seroxat 2mg/ml-orale Lösung
Slovak: Seroxat 2mg/ml-orale
Italian: Asentra 50 mg Tabletten, coated tablets
Slovak: Asentra 50 mg Tabletaten, coated tablets
Italian: Portogallo Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Slovak: Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Italian: Regno Unito 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
Italian: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Slovak: & Areos, 13451 Kamatero Attikis, Greece
Italian: 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)
Italian: Fluoxetin-ratiopharm 20 mg Tabletten
Slovak: Fluoxetin-ratiopharm 20 mg Tabletaten
Italian: Fluoxetina Bluepharma Indústria Farmacêutica S.A. 20 mg cápsulas
Slovak: Fluoxetina Bluepharma Indústria Farmacêutica S.A.
Italian: Fevarin Tabs 100 mg 100 mg
Slovak: Fevarin Tabs 100 mg
Italian: Inpharmco-Mianserin10mg-Tabletten
Slovak: Inpharmco-Mianserin-10mgTabletaten
Italian: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Slovak: Rue du Tilleul 13, 1332 GENVAL, Belgium
Italian: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Slovak: HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Italian: Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA
Slovak: Nitrianska 100 92027 Hlohovec SLOVAKIA
Italian: Germania Biomo pharma GmbH Josef-Dietzgen-Str. 3
Slovak: Nemecko biomo pharma GmbH Josef-Dietzgen-Str.
Italian: Germania Aliud Pharma GmbH & Co.KG Postfach 1380
Slovak: & Co.KG Postfach 1380
Italian: Mianserin 10mg Holsten 10 mg
Slovak: Mianserin 10mg Holsten
Italian: Domaniewska 50 C, 02-672 Warszawa,.
Slovak: Ul. Domaniewska 50 C, 02-672 Warszawa,.
Italian: Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Slovak: 12 Station Close Potters Bar, Herts, England
Italian: ACOST COMERCIAL GENERICPHARMA, S.L., Ferraz, 10.
Slovak: Španielsko ACOST COMERCIAL GENERICPHARMA, S.L.,
Italian: Flux „Hexal" Tabs 40mgTabletten
Slovak: Flux „Hexal" Tabs 40mg-Tabletten 40mg
Italian: Fluoxetin 20 - 1 A Pharma
Slovak: Fluoxetin 20 - 1
Italian: Fabrik , Holger Danskaes Vej 89, DK - 2000
Slovak: Farmaceutisk Fabrik Holger Danskes Vej 89 2000
Italian: RATIOPHARM ESPAÑA, S.A., Avda.
Slovak: Španielsko RATIOPHARM ESPAÑA, S.A.,
Italian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Italian: TEVA Classics le palatin1 1, cours du triangle
Slovak: 1, cours du triangle
Italian: D-70839 Gerlingen
Slovak: D-70839
Italian: Sertra Krka 100 mg Tabletten, tablets
Slovak: Sertra Krka 100 mg Tabletaten, tablets
Italian: GlaxoSmithKline Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Slovak: Pharma GmbH, Albert Schweitzer Gasse 6, 1140 Wien, Austria
Italian: LITAPHAR, S.A., Orendaundi, 9, Guipuzcoa, 20730, Spain
Slovak: Orendaundi, 9, Guipuzcoa, 20730, Spain
Italian: Tolvon 60 mg, tablets 60 mg
Slovak: Tolvon 60 mg, tablets
Italian: Poligono Industrial Colon II., Terrassa, 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa, 08228,
Italian: Regno Unito Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Slovak: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Italian: Fluoxetin "Genericon" 20mg-Filmtabletten
Slovak: Fluoxetin "Genericon" 20mgFilmtabletten
Italian: Paroxetin "Merckle" 20mg-Filmtabletten
Slovak: "Merckle" 20mg-Filmtabletten
Italian: Medicinali contenenti MIRTAZAPINA con autorizzazione all'immissione in commercio nell'Unione Europea Stato Membro Titolare dell'autorizzazione alla produzione
Slovak: MIRTAZAPÍN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Italian: Pharmascope Ltd., Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
Slovak: Unit 107, Ashbourne Industrial Estate, CO. MEATH, Ireland
Italian: D-89231 Neu-Ulm
Slovak: D-89231
Italian: III.I MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO DI FLUOXETINA, FLUVOXAMINA, SERTRALINA, PAROXETINA, CITALOPRAM, ESCITALOPRAM, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA
Slovak: III.I NÁVRH ZMENY A DOPLNKU príslušného odseku spc pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
Italian: 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
Italian: DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain
Slovak: SAN RAFAEL, 3, Alcobendas 28108,
Italian: Europark Oost 34, 9100 St. Niklaas, Belgium
Slovak: Oost 34, 9100 St.
Italian: D-13407 Berlin
Slovak: D-40764
Italian: KIRON PHARMACEUTICA Groesbeekseweg 11
Slovak: Groesbeekseweg 11
Italian: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spain
Slovak: Ronda de Dalt, Edificio Amsterdam 08940, Spain
Italian: Regno Unito Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Slovak: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Italian: Fluoxetina Ratiopharm GmbH
Slovak: Ratiopharm GmbH
Italian: SMITHKLINE BEECHAM PLC 980 GREAT WEST ROAD BRENTFORD
Slovak: SMITHKLINE BEECHAM PLC 980 GREAT
Italian: ADOFEN 20 mg oral solution
Slovak: ADOFEN 20 mg oral solution 20 mg
Italian: Slovacchia Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Slovak: Via Robert Koch 1.2, 201 52, Milano, Italy
Italian: Danimarca Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Italian: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Slovak: Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Italian: RENEURON 20 mg oral solution
Slovak: RENEURON 20 mg oral solution 20 mg
Italian: Fluoxetin-TEVA 10 mg Tabletten
Slovak: Fluoxetin-TEVA 10 mg Tabletaten 10 mg
Italian: Regno Unito Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Slovak: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Italian: Sertra Krka 50 mg Tabletten, tablets
Slovak: Sertra Krka 50 mg Tabletaten, tablets
Italian: 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)
Italian: Portogallo 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
Italian: Lussemburgo H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Slovak: Luxembursko H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Italian: Fluoxetin 10 - 1 A Pharma
Slovak: Fluoxetin 10 - 1
Italian: Portogallo 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
Italian: Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Slovak: Maďarsko Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Italian: Germania biomo pharma GmbH Josef-Dietzgen-Str. 3
Slovak: Biomo pharma GmbH Josef-Dietzgen-Str.
Italian: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Ámsterdam, 08940
Slovak: Ronda de Dalt, Edificio Ámsterdam, 08940
Italian: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko PAUCOURT 100 route de Versailles 78163
Italian: Portogallo Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Slovak: Calle Sardenya, 350 E08025 Barcelona Espanha
Italian: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain
Slovak: Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008,
Italian: Mianserin „Arcana" 10mg-Filmtabletten
Slovak: Mianserin „Arcana" 10mgFilmtabletten
Italian: Gyömröi ut 19-21 H-1103 Budapest X Hungary
Slovak: Gyömröi ut 19-21 H-1103
Italian: Danimarca Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Slovak: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
Italian: Mianserin-neuraxpharm 60mg
Slovak: Mianserin-neuraxpharm 60mg 60 mg
Italian: de la Industria, 30, Alcobendas, 28108, Spain
Slovak: de la Industria, 30, Alcobendas, 28108,
Italian: 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
Italian: Flux „Hexal" Tabs 10mgTabletten
Slovak: Flux „Hexal" Tabs 10mg-Tabletten 10mg
Italian: Lundbeck Pharma svetovalno podjetje d.o.o., Prešernova 1, SI-2000 Maribor, Slovenia
Slovak: Prešernova 1, SI-2000 Maribor, Slovenia
Italian: Danimarca Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Slovak: Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Italian: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Slovak: Severo Ochoa, 2 Tres Cantos, Spain
Italian: Fluoxetin 40 - 1 A Pharma
Slovak: Fluoxetin 40 - 1
Italian: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Italian: Mirtatsapiini Ennapharma 45 mg
Slovak: Ennapharma 45 mg
Italian: Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Italian: Paroxetine Tablet OF, filmomhulde tabletten 20 mg
Slovak: Paroxetine Tableta OF, filmomhulde tabletten 20 mg
Italian: Germania Krewel Meuselbach GmbH Postfach 1263
Slovak: Krewel Meuselbach GmbH
Italian: Genthon B.V.
Slovak: Holandsko Genthon B.V.
Italian: 20041 Agrate Brianza - Milano Italy
Slovak: Brianza - Milano Italy
Italian: Danimarca Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Slovak: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Italian: Portogallo Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Slovak: Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Italian: Poligono Industrial Colon II., Terrassa 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa 08228,
Italian: G Gam
Slovak: Mianserine G GAM
Italian: Pfizer Kft.1123 Bp, Alkotás u. 53., MOM Park F épület
Slovak: u. 53., MOM Park F épület
Italian: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul.
Slovak: Zakłady Farmaceutyczne "POLPHARMA"
Italian: Mianserine HCl 30 mg Katwijk, tablets
Slovak: HCl 30 mg Katwijk, tablets
Italian: 90 bustine (con un cucchiaio dosatore)
Slovak: 90 vreciek (s dávkovacou lyžicou)
Italian: Numero AIC (EU) Nome (di fantasia)
Slovak: (EÚ) číslo (Vymyslený) názov
Italian: • adulti e bambini a partire dai sei anni di età con malattia renale cronica (di lungo termine).
Slovak: • dospelých a detí od šiestich rokov s chronickým (dlhodobým) ochorením obličiek.
Italian: Tale autorizzazione si basava sull'autorizzazione rilasciata per Renvela nel 2009 ("consenso informato").
Slovak: Toto povolenie bolo vydané na základe povolenia vydaného v roku 2009 pre liek Renvela (tzv. informovaný súhlas).
Italian: • pazienti adulti sottoposti a dialisi (una tecnica impiegata per eliminare sostanze indesiderate presenti nel sangue);
Slovak: • dospelých pacientov na dialýze (metóda na odstránenie nežiaducich látok z krvi);
Italian: Sevelamer carbonate Winthrop ha ricevuto un'autorizzazione all'immissione in commercio valida in tutta l'UE il 15 gennaio 2015.
Slovak: Lieku Sevelamer carbonate Winthrop bolo dňa 15. januára 2015 udelené povolenie na uvedenie na trh platné v celej EÚ.
Italian: Ulteriori informazioni su Sevelamer carbonate Winthrop sono disponibili sul sito web dell'Agenzia: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Slovak: Ďalšie informácie o lieku Sevelamer carbonate Winthrop sa nachádzajú na webovej stránke agentúry: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.