FrancophonIA/ELRC3.0 huggingface dataset:
Greek: Fluoxetine Gf 20 mg/5 ml, solution 4 mg/ml
Slovak: Gf 20 mg/5 ml, solution 4 mg/ml
Greek: Medochemie, 1 - 10 Constantinoupleos Street, 3011, Limasol, Cyprus
Slovak: Street, 3011, Limasol, Cyprus
Greek: Paroxetin "Sandoz" 20mg-Tabletten
Slovak: Paroxetin "Sandoz" 20mg-Tabletaten
Greek: Αυστρία F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Slovak: F.Joh.Kwizda Ges.m.b.H., Dr.Karl Lueger Ring 6, 1010 Wien, Austria
Greek: Laboratories, 26-28 Rue de la
Slovak: Laboratories, 26-28
Greek: Λιθουανία Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Slovak: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Greek: Σουηδία Medis Danmark A/S H. C. Andersens Boulevard 2 DK-1780 Köpenhamn Danmark (DNK)
Slovak: Medis Danmark A/S H. C. Andersens Boulevard 2 DK-1780 Köpenhamn Danmark (DNK)
Greek: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Slovak: PHARMATEN, 6 Dervenakion, 15351
Greek: Νορβηγία Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
Slovak: Merck NM AB, Box 25033, SE-104 35 Stockholm, Sweden
Greek: Πρέπει να ενηµερώσετε το γιατρό σας εάν εκδηλωθεί ή επιδεινωθεί ένα από τα συµπτώµατα που αναφέρονται ανωτέρω, εφόσον το [επινοηθείσα ονοµασία] χορηγείται σε ασθενείς κάτω των 18 ετών.
Slovak: Informujte svojho lekára, ak sa pri užívaní [vymyslený názov] pacientmi mladšími ako 18 rokov objavia, prípadne zhoršia, niektoré prejavy uvedené vyššie.
Greek: PENSA, S.A., Avda.
Slovak: ESTEVE, S.A, Avda.
Greek: Glaxosmithkline S.p.A.
Slovak: Taliansko Glaxosmithkline S.p.A.
Greek: ΒΕΝΛΑΦΑΞΙΝΗ, ΜΙΑΝΣΕΡΙΝΗ, ΜΙΛΝΑΣΙΠΡΑΝΗ, ΡΕΜΠΟΞΕΤΙΝΗ ΚΑΙ ΜΙΡΤΑΖΑΠΙΝΗ
Slovak: ATOMOXETÍN, VENLAFAXÍN, MIANSERÍN, MILNACIPRAN, REBOXETÍN A MIRTAZAPÍN (pozri prílohu I)
Greek: Tolvon, tablets 10 mg 10 mg
Slovak: Tolvon, tablets 10 mg
Greek: COSTAKIS TSISIOS & CO LTD, 25 THESSALONIKIS STR, P.O.BOX 56495, 3307 LEMESOS, CYPRUS
Slovak: & CO LTD, 25 THESSALONIKIS STR, P.O.BOX 56495, 3307 LEMESOS, CYPRUS
Greek: Ολλανδία Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Slovak: Via Ponte della Fabbrica, 3/a, I-35031
Greek: 67, 02631 Espoo, Finland
Slovak: Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Greek: Σλοβενία SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Slovak: Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Greek: Πορτογαλία Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Slovak: Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Greek: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Slovak: Bld de la Plaine 17 1050 Bruxelles, Belgium
Greek: Angelini S.p.A.
Slovak: Taliansko Angelini S.p.A.
Greek: IPSEN PHARMA, S.A., Ctra.
Slovak: Španielsko IPSEN PHARMA, S.A.,
Greek: LABORATORIOS KORHISPANA, S.A.Pasaje Can Politic, 17, 3ª.L' Hospitalet de Llobregat 08907
Slovak: Španielsko LABORATORIOS KORHISPANA, S.A.Pasaje Can Politic, 17, 3ª.L'
Greek: Portal capsules 20 mg 20 mg
Slovak: Portal capsules 20 mg
Greek: Ολλανδία Alfred Tiefenbacher (GmbH & Co. KG)
Slovak: Holandsko Alfred Tiefenbacher (GmbH
Greek: LABORATORIOS DAVUR, S.L, Teide, 4-planta baja.
Slovak: Španielsko LABORATORIOS DAVUR, S.L, Teide, 4-planta baja.
Greek: Πολωνία Solvay Pharmaceuticals B.V., C.J.
Slovak: Solvay Pharmaceuticals B.V., C.J.
Greek: Ουγγαρία Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Slovak: Maďarsko Torrex Pharma GmbH, Lange gasse 76/12, A-1080 Wien, Austria
Greek: 208-214 York Road, London SW11 3SD;
Slovak: York Road, London SW11 3SD; UK
Greek: Ολλανδία GenRx B.V.
Slovak: Holandsko GenRx B.V.
Greek: Efectin 25mg-Tabletten 25mg
Slovak: Efectin 25mg-Tabletaten 25mg
Greek: Πορτογαλία ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Slovak: Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena
Greek: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko GLAXOSMITHKLINE 100 route de Versailles 78163
Greek: Solvex 4 mg Tabletten 4 mg
Slovak: Solvex 4 mg Tabletaten 4 mg
Greek: Πολωνία Alfred E. Tiefenbacher (GmbH&Co.KG), Van-der-SmissenStrasse 1, 22767 Hamburg, DE
Slovak: Alfred E. Tiefenbacher (GmbH&Co.KG), Van-der-SmissenStrasse 1, 22767 Hamburg, DE
Greek: Πορτογαλία Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Slovak: Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Greek: LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Slovak: Španielsko LACER, S.A, Sardenya, 350, 08025 Barcelona, Spain
Greek: FARMANEU, S.L., Rambla de Cataluña, 47 - 1º, 08007 Barcelona, Spain
Slovak: Rambla de Cataluña, 47 - 1º, 08007
Greek: Inpharmco-Mianserin30mg-Tabletten
Slovak: Inpharmco-Mianserin-30mgTabletaten
Greek: CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Slovak: Juan Ignacio Luca de Tena, 8, Madrid 28027,
Greek: Πορτογαλία 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
Greek: A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Slovak: Španielsko A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Greek: Benedetti S.p.A.
Slovak: Taliansko Benedetti S.p.A.
Greek: Ιρλανδία Pinewood Laboratories Ltd Ballymacarbry, Clonmel, Co.
Slovak: Pinewood Laboratories Ltd Ballymacarbry, Clonmel, Co.
Greek: Επιπλέον, υπήρξε προειδοποιητικό σήµα εκδήλωσης παρεµφερών ανεπιθύµητων ενεργειών όπως εχθρική συµπεριφορά, αυτοτραυµατισµός και συναισθηµατική αστάθεια για όλα σχεδόν τα προϊόντα και τις ενδείξεις τους.
Slovak: Navyše sa u takmer všetkých liekov a indikácií vyskytli aj signály týkajúce sa príbuzných nežiaducich príhod, ako hostilita, sebapoškodzovanie a emočná labilita.
Greek: Πορτογαλία Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Slovak: Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés
Greek: Σουηδία AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097
Slovak: KG Lepziger Strasse 7-13 D-01097
Greek: Πορτογαλία Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Slovak: Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Greek: Farma Uno S.r.l.
Slovak: Taliansko Farma Uno S.r.l.
Greek: SOLLENTUNA, Sweden
Slovak: SOLNA, Sweden
Greek: Ολλανδία Genthon B.V.
Slovak: Holandsko Genthon B.V.
Greek: Σουηδία DuraScan Medical Products A/S C.F.Tietgens Boulevard 40 DK-5220
Slovak: DuraScan Medical Products A/S C.F.Tietgens Boulevard 40 DK-5220
Greek: Επίσης, δεν υπάρχουν µέχρι σήµερα µεγάλης διάρκειας στοιχεία ασφάλειας της [επινοηθείσα ονοµασία] όσον αφορά την σωµατική ανάπτυξη, την ωρίµανση, την διανοητική ανάπτυξη και την ανάπτυξη της συµπεριφοράς αυτής της ηλικιακής οµάδας.
Slovak: Zatiaľ nie sú k dispozícii dlhodobé údaje o bezpečnosti [vymyslený názov] u tejto vekovej skupiny týkajúce sa rastu, dospievania a rozvoja poznania a správania.
Greek: BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
Slovak: AE, 25 G.LYRA 14564 K.Kifissia, Greece
Greek: Biores Italia S.r.l.
Slovak: Taliansko Biores Italia S.r.l.
Greek: Felixsan 50mgFilmtabletten
Slovak: Felixsan 50mg-Filmtabletten
Greek: Ολλανδία Niche Generics Ltd. 1 The Cam Centre
Slovak: Holandsko Niche Generics Ltd.
Greek: Castel San Giorgio 84083 Salerno Italy
Slovak: Castel San Giorgio 84083
Greek: Mianserin Organon 10mg 10 mg
Slovak: Mianserin Organon 10mg
Greek: Η CHMP έκρινε ότι στις µελέτες της ατοµοξετίνης δεν υπήρξε προειδοποιητικό σήµα αυξηµένου κινδύνου αυτοκτονικής συµπεριφοράς, υφίσταται, όµως, σήµα αυξηµένου κινδύνου διαταραχών της συµπεριφοράς, κυρίως επιθετικότητας και εχθρικών αντιδράσεων.
Slovak: Výbor CHMP vzal do úvahy, že neexistuje žiadny signál zvýšeného rizika samovražedného správania v štúdiách s atomoxetínom, vyskytovali sa však signály o zvýšenom riziku abnormálneho správania s väčšou agresivitou a hostilitou.
Greek: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Slovak: Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Greek: DISTA, Avda.
Slovak: Španielsko DISTA, Avda.
Greek: Ιρλανδία Wyeth John & Brother Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH, UK
Slovak: Wyeth John & Brother Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH, UK
Greek: Νορβηγία Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
Slovak: Wyeth Lederle Nordiska AB, P.O.Box 1822, SE-171 24 Solna, Sweden
Greek: Πορτογαλία 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
Greek: Desiflu voxamin 50 mg 50 mg
Slovak: Desiflu voxamin 50 mg
Greek: Σλοβακία Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Slovak: Torrex Pharma GmbH, Lange Gasse 76/12, A - 1080 Wien
Greek: Przemysłowa 2, 35-959 Rzeszów, Poland
Slovak: ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland
Greek: Fevarin Tabs 100 mg 100 mg
Slovak: Fevarin Tabs 100 mg
Greek: Πορτογαλία Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Slovak: Lagoas Park - Edifício nº 10 2740-244
Greek: Πορτογαλία 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
Greek: LABORATORIOS CINFA, S.A., Olaz-Chipi, 10.
Slovak: Olaz-Chipi, 10. Polig.
Greek: Mianserin Organon 60mg 60 mg
Slovak: Mianserin Organon 60mg
Greek: Λουξεµβούργο EUROGENERICS N.V.
Slovak: Luxembursko EUROGENERICS N.V.
Greek: Mare de Déu de Montserrat, 221 Barcelona 08041, Spain
Slovak: Mare de Déu de Montserrat, 221, 08041
Greek: Norton Healthcare Limited;
Slovak: Norton Healthcare Ltd.
Greek: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Greek: Γερµανία Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Slovak: & Co.KG Postfach 1240
Greek: 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
Greek: Royal Docks, E 162QJ London, UK
Slovak: Albert Basin Royal Docks, E 162QJ London, UK
Greek: Fluxone Divule 20 mg ueberzogene Tabletten
Slovak: Divule 20 mg ueberzogene Tabletaten
Greek: Via Bianchi Maria Visconti 20122 Milano, Italy
Slovak: Visconti 20122 Milano, Italy
Greek: Λιθουανία Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Slovak: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Greek: 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
Greek: Fluoxstad 20 mg Tabletten
Slovak: Fluoxstad 20 mg Tabletaten
Greek: Πορτογαλία 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
Greek: Λουξεµβούργο Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Slovak: Luxembursko Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Greek: 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
Greek: Ιρλανδία Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hertfordshire, SG4 0TW, UK
Slovak: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hertfordshire, SG4 0TW, UK
Greek: Mianserin 30mg Holsten 30 mg
Slovak: Mianserin 30mg Holsten
Greek: IPSO Pharma S.r.l.
Slovak: Taliansko IPSO Pharma S.r.l.
Greek: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Slovak: HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Greek: Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA
Slovak: Nitrianska 100 92027 Hlohovec SLOVAKIA
Greek: Γερµανία biomo pharma GmbH Josef-Dietzgen-Str. 3
Slovak: Biomo pharma GmbH Josef-Dietzgen-Str.
Greek: Abbott S.p.A.
Slovak: Taliansko Abbott S.p.A.
Greek: Σουηδία Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Slovak: Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Greek: 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
Greek: Mutan 20mgFilmtabletten
Slovak: Mutan 20mg-Filmtabletten
Greek: Ολλανδία Genfarma B.V.
Slovak: Holandsko Genfarma B.V.
Greek: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU;
Slovak: Veľká Británia Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Greek: Rijksweg 12 2870 Puurs, Belgium
Slovak: Rijksweg 12 2870
Greek: Desitin Arzneimittel GmbH Weg Beim Jäger 214 223 35 Hamburg Tyskland (DEU)
Slovak: Weg Beim Jäger 214 223 35 Hamburg Tyskland (DEU)
Greek: Γερµανία Aliud Pharma GmbH & Co.KG Postfach 1380
Slovak: & Co.KG Postfach 1380
Greek: Ουγγαρία Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, U.K.
Greek: Tolvon, tablets 3 mg 30 mg
Slovak: Tolvon, tablets 3 mg
Greek: Ουγγαρία Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Slovak: Uzsoki út 36/A, 1145 Budapest (Hungary)
Greek: Asentra 100 mg Tabletten, coated tablets
Slovak: Asentra 100 mg Tabletaten, coated tablets
Greek: Σουηδία 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
Greek: Lampugnani Farmaceutici S.p.A.
Slovak: Taliansko Lampugnani Farmaceutici S.p.A.
Greek: Ουγγαρία Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Slovak: Maďarsko Ranbaxy UK Ltd.Uxbridge Road 97 London, W5 5TL, UK
Greek: Ισλανδία Pfizer Aps, Lautrupvang 8, DK 2750 Ballerup, Danmark
Slovak: Pfizer Aps, Lautrupvang 8, DK 2750 Ballerup, Danmark
Greek: Fluoxetin „Lannacher" 20mg-Kapseln
Slovak: Fluoxetin „Lannacher" 20mgKapseln
Greek: Πορτογαλία Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Slovak: Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Greek: Mianserin „Arcana" 30mg-Filmtabletten
Slovak: Mianserin „Arcana" 30mgFilmtabletten
Greek: Seroxat 2mg/ml-orale Lösung
Slovak: Seroxat 2mg/ml-orale
Greek: Asentra 50 mg Tabletten, coated tablets
Slovak: Asentra 50 mg Tabletaten, coated tablets
Greek: Λιθουανία SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Slovak: Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Greek: Αυστρία Hexal Pharma GmbH, Wilhelmimenstr.
Slovak: Hexal Pharma GmbH, Wilhelmimenstr.
Greek: REMEDINA, 25 Gounari & Areos, 13451 Kamatero Attikis, Greece
Slovak: & Areos, 13451 Kamatero Attikis, Greece
Greek: Fluoxetin-ratiopharm 20 mg Tabletten
Slovak: Fluoxetin-ratiopharm 20 mg Tabletaten
Greek: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU;
Slovak: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Greek: PLIVA Pharma Nordic A/S H.P.
Slovak: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000
Greek: KERN PHARMA, S.L., Venus, 72.
Slovak: Španielsko KERN PHARMA, S.L.,
Greek: Πόσιµο υγρό
Slovak: Perorálna kvapalina
Greek: Αυστρία Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Slovak: Siebenbrunnengasse 21, 1050 Wien, Austria
Greek: Inpharmco-Mianserin10mg-Tabletten
Slovak: Inpharmco-Mianserin-10mgTabletaten
Greek: Oss, The Netherlands
Slovak: Bunnik, the Netherlands
Greek: KIRON PHARMACEUTICA Groesbeekseweg 11
Slovak: Groesbeekseweg 11
Greek: Σλοβακία Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
Slovak: Desitin Arzneimittel GmbH, Weg beim Jäger 214, D - 22 335 Hamburg
Greek: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Slovak: Rue du Tilleul 13, 1332 GENVAL, Belgium
Greek: H. Lundbeck A/S Ottiliavej 9
Slovak: Taliansko H. Lundbeck A/S Ottiliavej 9
Greek: Πορτογαλία 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
Greek: ΠΑΡΑΡΤΗΜΑ ΙΙ ΕΠΙΣΤΗΜΟΝΙΚΑ ΠΟΡΙΣΜΑΤΑ ΚΑΙ ΛΟΓΟΙ ΓΙΑ ΤΗΝ ΤΡΟΠΟΠΟΙΗΣΗ ΤΩΝ ΠΕΡΙΛΗΨΕΩΝ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ ΚΑΙ ΤΩΝ ΦΥΛΛΩΝ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ, ΠΟΥ ΠΑΡΟΥΣΙΑΣΤΗΚΑΝ ΑΠΟ ΤΟΝ ΕΜΕΑ
Slovak: VEDECKÉ ZÁVERY A ODÔVODNENIE ZMIEN A DOPLNKOV V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Greek: Mianserin 10mg Holsten 10 mg
Slovak: Mianserin 10mg Holsten
Greek: ELI LILLY ČR s.r.o., Praha, Czech Republic
Slovak: ELI LILLY ČR s.r.o.,
Greek: Σλοβακία Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Slovak: Via Robert Koch 1.2, 201 52, Milano, Italy
Greek: ACOST COMERCIAL GENERICPHARMA, S.L., Ferraz, 10.
Slovak: Španielsko ACOST COMERCIAL GENERICPHARMA, S.L.,
Greek: Europark Oost 34, 9100 St. Niklaas, Belgium
Slovak: Oost 34, 9100 St.
Greek: Flux „Hexal" Tabs 40mgTabletten
Slovak: Flux „Hexal" Tabs 40mg-Tabletten 40mg
Greek: Fluoxetin 20 - 1 A Pharma
Slovak: Fluoxetin 20 - 1
Greek: Valda Laboratori Farmaceutici S.p.A.
Slovak: Taliansko Valda Laboratori Farmaceutici S.p.A.
Greek: Sertra Krka 100 mg Tabletten, tablets
Slovak: Sertra Krka 100 mg Tabletaten, tablets
Greek: LITAPHAR, S.A., Orendaundi, 9, Guipuzcoa, 20730, Spain
Slovak: Orendaundi, 9, Guipuzcoa, 20730, Spain
Greek: Tolvon 60 mg, tablets 60 mg
Slovak: Tolvon 60 mg, tablets
Greek: Poligono Industrial Colon II., Terrassa, 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa, 08228,
Greek: Γερµανία Krewel Meuselbach GmbH Postfach 1263
Slovak: Krewel Meuselbach GmbH
Greek: Fluoxetin "Genericon" 20mg-Filmtabletten
Slovak: Fluoxetin "Genericon" 20mgFilmtabletten
Greek: Paroxetin "Merckle" 20mg-Filmtabletten
Slovak: "Merckle" 20mg-Filmtabletten
Greek: Λουξεµβούργο SOCOBOM N.V.
Slovak: Luxembursko SOCOBOM N.V.
Greek: Via Licino, 11-13-15 Erba 22036 Como Italy
Slovak: Via Licino, 11-13-15
Greek: Fabrik , Holger Danskaes Vej 89, DK - 2000
Slovak: Farmaceutisk Fabrik Holger Danskes Vej 89 2000
Greek: 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
Greek: Φαρµακευτικά προϊόντα που περιέχουν σερτραλίνη µε άδεια κυκλοφορίας στην Ευρωπαϊκή Ένωση
Slovak: SERTRALINUM obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Greek: Πολωνία Organon N.V., P.O Box 20, 5340 BH Oss, The Netherlands
Slovak: Organon N.V., P.O Box 20, 5340 BH Oss, The Netherlands
Greek: Organon, PO Box 20 5340 HB Oss, Holland
Slovak: NV. Organon, PO Box 20 5340 HB Oss, Holland
Greek: RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
Slovak: Rue St, Lambert 141 1200 BRUXELLES, Belgium
Greek: DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain
Slovak: SAN RAFAEL, 3, Alcobendas 28108,
Greek: D-13407 Berlin
Slovak: D-40764
Greek: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Slovak: & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Greek: D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Slovak: 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletaten 20 mg
Greek: SMITHKLINE BEECHAM PLC 980 GREAT WEST ROAD BRENTFORD
Slovak: SMITHKLINE BEECHAM PLC 980 GREAT
Greek: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Amsterdam 08940, Spain
Slovak: Ronda de Dalt, Edificio Amsterdam 08940, Spain
Greek: Η CHMP έκρινε ότι στις περιλήψεις των χαρακτηριστικών των προϊόντων και στο σχετικό κεφάλαιο των φύλλων οδηγιών χρήσης των φαρµακευτικών προϊόντων που περιέχουν σιταλοπράµη, εσιταλοπράµη, φθοροξετίνη, φλουβοξαµίνη, µιανσερίνη, µιλνασιπράνη, µιρταζαπίνη, παροξετίνη, ρεµποξετίνη, σερτραλίνη και βενλαφαξίνη πρέπει να περιληφθεί προειδοποίηση, στην οποία να αναφέρεται ότι η εµφάνιση αυτοκτονικής συµπεριφοράς (απόπειρες αυτοκτονίας και σκέψεις αυτοκτονίας), καθώς και η εµφάνιση εχθρικής συµπεριφοράς (κυρίως επιθετικότητα, εναντιωτική συµπεριφορά, θυµός) παρατηρήθηκαν µε µεγαλύτερη συχνότητα σε κλινικές δοκιµές µε παιδιά και εφήβους που λάµβαναν αντικαταθλιπτικά σε σύγκριση µε εκείνους που λάµβαναν εικονικό φάρµακο.
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).
Greek: Fluoxetina Ratiopharm GmbH
Slovak: Ratiopharm GmbH
Greek: ADOFEN 20 mg oral solution
Slovak: ADOFEN 20 mg oral solution 20 mg
Greek: Σουηδία Synthon BV Microweg 22 6545 CM Nijmegen Nederländerna (NLD)
Slovak: Synthon BV Microweg 22 6545 CM Nijmegen Nederländerna (NLD)
Greek: RENEURON 20 mg oral solution
Slovak: RENEURON 20 mg oral solution 20 mg
Greek: Fluoxetin-TEVA 10 mg Tabletten
Slovak: Fluoxetin-TEVA 10 mg Tabletaten 10 mg
Greek: Sertra Krka 50 mg Tabletten, tablets
Slovak: Sertra Krka 50 mg Tabletaten, tablets
Greek: Fluoxetin 10 - 1 A Pharma
Slovak: Fluoxetin 10 - 1
Greek: Νορβηγία Solvay Pharmaceuticals B.V., C. J. van Houtenlaan 36, Weesp, The
Slovak: Solvay Pharmaceuticals B.V., C. J. van Houtenlaan 36, Weesp, The Netherlands
Greek: Πολωνία Hexal Polska Sp.
Slovak: Hexal Polska Sp. z o.o.,
Greek: Hospitalet, 147-149 Cityparc Ronda de Dalt, Edificio Ámsterdam, 08940
Slovak: Ronda de Dalt, Edificio Ámsterdam, 08940
Greek: Πορτογαλία 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
Greek: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain
Slovak: Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008,
Greek: Ranbaxy (UK) Limited;
Slovak: Ranbaxy (UK)
Greek: Carnaxide Portugal
Slovak: Coimbra Portugal
Greek: Mianserin „Arcana" 10mg-Filmtabletten
Slovak: Mianserin „Arcana" 10mgFilmtabletten
Greek: Mianserin-neuraxpharm 60mg
Slovak: Mianserin-neuraxpharm 60mg 60 mg
Greek: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Slovak: Francúzsko PAUCOURT 100 route de Versailles 78163
Greek: de la Industria, 30, Alcobendas, 28108, Spain
Slovak: de la Industria, 30, Alcobendas, 28108,
Greek: Πολωνία Organon N.V., P.O Box 20, 5340 BH Oss, NL
Slovak: Organon N.V., P.O Box 20, 5340 BH Oss, NL
Greek: Flux „Hexal" Tabs 10mgTabletten
Slovak: Flux „Hexal" Tabs 10mg-Tabletten 10mg
Greek: Ολλανδία Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Slovak: Holandsko Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Greek: Γερµανία Desitin Arzneimittel GmbH Postfach 630164
Slovak: Postfach 630164
Greek: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Slovak: Severo Ochoa, 2 Tres Cantos, Spain
Greek: 2-18 D-61118 Bad Vilbel Alemanha
Slovak: Stadastrasse 2-18 D-61118 Bad Vilbel Alemanha
Greek: Fluoxetin 40 - 1 A Pharma
Slovak: Fluoxetin 40 - 1
Greek: Paroxetine Tablet OF, filmomhulde tabletten 20 mg
Slovak: Paroxetine Tableta OF, filmomhulde tabletten 20 mg
Greek: SOLVAY PHARMA, S.A., Avda.
Slovak: Španielsko SOLVAY PHARMA, S.A.,
Greek: 20041 Agrate Brianza - Milano Italy
Slovak: Brianza - Milano Italy
Greek: Ουγγαρία Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Slovak: Uzsoki út 36/A, 1145 Budapest, Hungary
Greek: NL-3771 NC Barneveld
Slovak: NC Barneveld
Greek: Ουγγαρία Glaxo Smith Kline Kft., Csörsz u.
Slovak: Luxembursko GLAXO SMITH KLINE S.A.
Greek: RATIOPHARM ESPAÑA, S.A., Avda.
Slovak: Španielsko RATIOPHARM ESPAÑA, S.A.,
Greek: Poligono Industrial Colon II., Terrassa 08228, Spain
Slovak: Poligono Industrial Colon II., Terrassa 08228,