FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: Cipramil Infusionsloesungskonzentrat 20 mg
Hungarian: Infusionsloesungskonzentra t 20 mg
Portuguese: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Hungarian: Görögország NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki
Portuguese: Zentiva a.s., Nitrianska 100 92027 Hlohovec SLOVAKIA
Hungarian: Lettország Zentiva a.s., Nitrianska 100 92027 Hlohovec
Portuguese: Luxemburgo MERCK N.V.
Hungarian: Belgium MERCK N.V.
Portuguese: PARETIN 20mg
Hungarian: PARETIN 20mg 20mg
Portuguese: Cápsula dura gastroresistente
Hungarian: Szabályozott hatóanyagleadású keménykapszula
Portuguese: Républica Checa MEDOCHEMIE LTD., LIMASSOL, Constantinoupoleos St. 1-10, P.O.Box 51409, 3505 Limassol, Cyprus
Hungarian: Csehország MEDOCHEMIE LTD., LIMASSOL, Constantinoupoleos St. 1-10, P.O.Box 51409, 3505 Limassol, Cyprus
Portuguese: Fevarin Tabs 50 mg
Hungarian: Fevarin Tabs 50 mg 50 mg
Portuguese: Via Della Libertà, 30 10095 Grugliasco - Torino Italy
Hungarian: 10095 Grugliasco - Torino Italy
Portuguese: Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL)
Hungarian: Svédország Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL)
Portuguese: Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Hungarian: Magyarország Solvay Pharmaceuticals B.V.NL-1381 CP Weesp, C.J. van Houtenlaan 36.
Portuguese: Laboratoires SMB S.A., Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium
Hungarian: Finnország Laboratoires SMB S.A., Rue de la Pastorale 26-28, 1080 BRUSSELS, Belgium
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Hungarian: Hollandia Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Portuguese: de Burgos, 16 D - 5ª Planta, Madrid 28036, Spain
Hungarian: Burgos, 16 D - 5ª Planta, Madrid 28036, Spain
Portuguese: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Hungarian: Portugália Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Portuguese: Paluxetil 20mg-Filmtabletten
Hungarian: Paluxetil 20mgFilmtabletten
Portuguese: Synthon BV Microweg 22 6545 CM Nijmegen Nederländerna (NLD)
Hungarian: Svédország Synthon BV Microweg 22 6545 CM Nijmegen Nederländerna (NLD)
Portuguese: Reino Unido Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Hungarian: Nagy-Britannia Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Portuguese: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, 2 Dublin, Ireland
Hungarian: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Portuguese: Ixel 50mg-Kapseln
Hungarian: Ixel 50mg-Kapseln 50mg
Portuguese: FUNDAMENTOS PARA A ALTERAÇÃO DOS RESUMOS DAS CARACTERÍSTICAS DO MEDICAMENTO
Hungarian: AZ ALKALMAZÁSI ELŐÍRÁSOK MÓDOSÍTÁSÁNAK INDOKLÁSA
Portuguese: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Hungarian: Spanyolország LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Portuguese: Mianserin „Arcana" 30mgFilmtabletten
Hungarian: Mianserin „Arcana" 30mg-Filmtabletten
Portuguese: Paroxetin "Arcana" 20mgFilmtabletten
Hungarian: Paroxetin "Arcana" 20mg-Filmtabletten
Portuguese: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Hungarian: Spanyolország LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Portuguese: Países Baixos Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Hungarian: Hollandia Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Portuguese: Reino Unido Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Hungarian: Athlone Laboratories Limited, Ballymurray, Co.
Portuguese: Fluvoxamine-maleaat 100 A, tablets 100 mg
Hungarian: Fluvoxamine-maleaat 100 A, tablets
Portuguese: Mirtabene 30mg-Filmtabletten
Hungarian: Mirtabene 30mgFilmtabletten
Portuguese: Merck, S.A., Rua Alfredo da Silva, 3-C 1300-040 Lisboa Portugal
Hungarian: Portugália Merck, S.A., Rua Alfredo da Silva, 3-C 1300-040 Lisboa Portugal
Portuguese: S.p.A.
Hungarian: S.A.
Portuguese: Efectin ER 150mg-Kapseln
Hungarian: Efectin ER 150mgKapseln
Portuguese: Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Hungarian: Magyarország Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG
Portuguese: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain
Hungarian: Spanyolország LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain
Portuguese: PAROXETINA HEXAL 40 mg 40 mg
Hungarian: PAROXETINA HEXAL 40 mg
Portuguese: Efexor 37,5, tablets
Hungarian: Efexor 37,5, tablets 37,5 mg
Portuguese: Países Baixos KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin
Hungarian: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Portuguese: Reino Unido Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Hungarian: Nagy-Britannia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Portuguese: Teva Pharma B.V.
Hungarian: Finnország Teva Pharma B.V.
Portuguese: LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Hungarian: Spanyolország LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Portuguese: TAMARANG, S.A, Balmes, 84 - 4º2ª, Barcelona ( Spain), 08008, Spain
Hungarian: Spanyolország TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona ( Spain), 08008, Spain
Portuguese: Via Licino, 11-13-15 Erba 22036 Como Italy
Hungarian: Via Licino, 11-13-15
Portuguese: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Hungarian: Spanyolország LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Portuguese: Paroxetine HCl-anhydraat 20 A, tabletten 20 mg
Hungarian: Paroxetine HClanhydraat 20 A, tabletten 20 mg
Portuguese: Fluoxetin „Lannacher" 20mgKapseln
Hungarian: Fluoxetin „Lannacher" 20mg-Kapseln
Portuguese: Organon N.V., P.O Box 20, 5340 BH Oss, NL
Hungarian: Lengyelország Organon N.V., P.O Box 20, 5340 BH Oss, NL
Portuguese: Benedetti S.p.A.
Hungarian: Olaszország Benedetti S.p.A.
Portuguese: H. Lundbeck A/S Ottiliavej 9
Hungarian: Olaszország H. Lundbeck A/S Ottiliavej 9
Portuguese: Pharmacia GmbH Pfizerstr.
Hungarian: Németország Pharmacia GmbH Pfizerstr.
Portuguese: Reino Unido Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Hungarian: Nagy-Britannia Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co.
Portuguese: LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Hungarian: Spanyolország LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Portuguese: Seropram 40mg/ml-Tropfen
Hungarian: Seropram 40mg/mlTropfen
Portuguese: EFECTIN ER 150 mg kapszula 150mg
Hungarian: EFECTIN ER 150 mg kapszula
Portuguese: EFECTIN ER 75 mg kapszula 75mg
Hungarian: EFECTIN ER 75 mg kapszula
Portuguese: MAGRILAN 20mg
Hungarian: MAGRILAN 20mg 20mg
Portuguese: Sertrabeck 50 mg
Hungarian: Sertrabeck 50 mg 50 mg
Portuguese: CITALOPRAM/GENEPHARM 40mg/ml
Hungarian: CITALOPRAM/ALVIA 40mg/ml
Portuguese: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Hungarian: Rue du Tilleul 13, 1332 GENVAL, Belgium
Portuguese: H. Lundbeck A/S Ottiliavej 7-9 DK2500 Köpenhamn-Valby Danmark (DNK)
Hungarian: Svédország H. Lundbeck A/S Ottiliavej 7-9 DK-2500 Köpenhamn-Valby Danmark (DNK)
Portuguese: QUALIX PHARMACEUTICALS, S.A., Sardenya, 350, Barcelona 08025, Spain
Hungarian: Spanyolország QUALIX PHARMACEUTICALS, S.A., Sardenya, 350, Barcelona 08025, Spain
Portuguese: Luxemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Hungarian: Bld de la Plaine 17 1050 Bruxelles, Belgium
Portuguese: Mianserixx 30mg
Hungarian: Mianserixx 30mg 30 mg
Portuguese: MIANSERIN-MERCK 10 mg tabletta
Hungarian: MIANSERINMERCK 10 mg tabletta
Portuguese: Sertralin AWD 50 mg
Hungarian: Sertralin AWD 50 mg 50 mg
Portuguese: Mirtazapin "Alternova" 45mgFilmtabletten
Hungarian: Mirtazapin "Alternova" 45mg-Filmtabletten
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, NL-2003 RN Haarlem
Hungarian: Hollandia Pharmachemie B.V., Postbus 552, NL-2003 RN Haarlem
Portuguese: PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Hungarian: CHRISPA ALFA, PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE
Portuguese: Paroxetin "Saluts" 20mgFilmtabletten
Hungarian: Paroxetin "Saluts" 20mg-Filmtabletten
Portuguese: Républica Checa CHEMICAL WORKS OF GEDEON RICHTER LTD., 1103 BUDAPEST, Gyömröi út 19-21, HUNGARY
Hungarian: Csehország CHEMICAL WORKS OF GEDEON RICHTER LTD., 1103 BUDAPEST, Gyömröi út 19-21, HUNGARY
Portuguese: Países Baixos Alfred Tiefenbacher (GmbH & Co. KG)
Hungarian: Alfred Tiefenbacher (GmbH & Co.
Portuguese: Reino Unido Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Hungarian: Nagy-Britannia Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Portuguese: Allenopar 20mg-Filmtabletten
Hungarian: Allenopar 20mgFilmtabletten
Portuguese: Organon N.V., P.O Box 20, 5340 BH Oss, The Netherlands
Hungarian: Lengyelország Organon N.V., P.O Box 20, 5340 BH Oss, The Netherlands
Portuguese: Paroxetin-ratiopharm® 20mg
Hungarian: Paroxetinratiopharm® 20mg
Portuguese: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co. Tipperary, Ireland
Hungarian: Clonmel Healthcare Limited, Waterford Road, Clonmel, Co.
Portuguese: SERTRALIN IREX 100 MG 100 mg
Hungarian: SERTRALIN IREX 100 MG
Portuguese: Gedeon Richter Ltd., Gyomoroi ut 19-21, H-1103 Budapeszt, HU
Hungarian: Lengyelország Gedeon Richter Ltd., Gyomoroi ut 19-21, H-1103 Budapeszt, HU
Portuguese: Reino Unido Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Hungarian: Nagy-Britannia Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Portuguese: Mianserin „Arcana" 10mgFilmtabletten
Hungarian: Mianserin „Arcana" 10mg-Filmtabletten
Portuguese: Considerando que, - o Comité considerou o procedimento previsto no artigo 31.º da Directiva 2001/83/CE, com a última redacção que lhe foi dada, relativa aos medicamentos que contêm atomoxetina, citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina;
Hungarian: Mivel - A Bizottság megvizsgálta az atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin és venlafaxin tartalmú gyógyszerkészítményekre vonatkozó beadványt a módosított 2001/83/EK irányelv 31. cikkének tekintetében;
Portuguese: Sertralin AWD 100 mg
Hungarian: Sertralin AWD 100 mg 100 mg
Portuguese: Abbott S.p.A.
Hungarian: Olaszország Abbott S.p.A.
Portuguese: UCB Pharma Ges.m.b.H., Brünnerstr.
Hungarian: UCB Pharma Ges.m.b.H.,
Portuguese: Solvay Pharmaceuticals BV, CJ Van Houtenlaan 36 1381 CP Weesp Nederländerna (NLD)
Hungarian: Svédország Solvay Pharmaceuticals BV, CJ Van Houtenlaan 36 1381 CP Weesp Nederländerna (NLD)
Portuguese: O CHMP concordou existir um potencial sinal relativo ao aumento de comportamentos suicidas, incluindo tentativas de suicídio e ideação suicida e/ou comportamentos relacionados, tais como auto-agressão, hostilidade e labilidade afectiva, em crianças e adolescentes tratados com ISRS e ISRSN.
Hungarian: A CHMP egyöntetű véleménye az volt, hogy az SSRI-vel és SNRI-vel kezelt gyermekek és serdülőkorúak esetén az öngyilkossági késztetés valamint az öngyilkossági szándék lehetséges fokozódásának jelei, beleértve az öngyilkossági kísérleteket, valamint ezzel összefüggésben önpusztítás, ellenséges magatartás, és hangulati labilitás mutatkoznak.
Portuguese: Républica Checa LEK PHARMACEUTICALS D.D., LJUBLJANA, Verovškova 57, 1526
Hungarian: Csehország LEK PHARMACEUTICALS D.D., LJUBLJANA, Verovškova 57, 1526
Portuguese: Generics (UK) Ltd.
Hungarian: Németország Generics (UK) Ltd. Frankfurter Str.
Portuguese: Strattera 18 mg, harde capsules 18 mg
Hungarian: Strattera 18 mg, harde capsules
Portuguese: Reino Unido Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Hungarian: Nagy-Britannia Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Portuguese: Luxemburgo H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Hungarian: Luxemburg H. Lundbeck A/S Ottiliavej 9, CopehagenValby, DK 2500
Portuguese: Citalopram "1A Pharma" 20mgFilmtabletten
Hungarian: Citalopram "1A Pharma" 20mg-Filmtabletten
Portuguese: Paroxetin-neuraxpharm 20 mg Filmtabletten
Hungarian: Paroxetinneuraxpharm 20 mg Filmtabletten
Portuguese: Fluneurin 40mg Tabs
Hungarian: Fluneurin 40mg Tabs 40 mg
Portuguese: Via Nettunense, 90 04011 Aprilia - Roma Italy
Hungarian: 04011 Aprilia - Roma Italy
Portuguese: Medicamentos contendo MIRTAZAPINE com Autorização de Introdução no Mercado na União Europeia Estado Membro Titular da Autorização da Introdução no Mercado
Hungarian: Forgalomba hozatali engedéllyel rendelkező MIRTAZAPINE-t tartalmazó gyógyszerek az Európai Únió területén Tagállam Forgalomba hozatali engedély jogosultja
Portuguese: LERIVON 30MG
Hungarian: LERIVON 30MG 30 mg
Portuguese: SEROPRAM 40 mg/ml cseppek 40 mg/ml
Hungarian: SEROPRAM 40 mg/ml cseppek
Portuguese: A pedido da Comissão Europeia, o CHMP procedeu à reavaliação dos dados de ensaios clínicos disponibilizados às autoridades nacionais competentes, em particular no que respeita à sua utilização na população pediátrica, relativos aos seguintes medicamentos ISRS
Hungarian: Az Európai Bizottság felkérésére a CHMP (Emberi felhasználásra szánt gyógyszerkészítmények értékelő bizottsága) felülvizsgálta az alábbi SSRI
Portuguese: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Hungarian: Portugália Lacer, S.A., Calle Sardenya, 350 E-08025 Barcelona Espanha
Portuguese: ADOFEN 20 mg oral solution 20 mg
Hungarian: ADOFEN 20 mg oral solution
Portuguese: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Hungarian: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 A - Miraflores 1495-153 Algés Portugal
Portuguese: Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Hungarian: Johann Strauß Gasse 7, 1040 Wien, Austria
Portuguese: GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria
Hungarian: GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien,
Portuguese: DALCIPRAN 25MG
Hungarian: DALCIPRAN 25MG 25 mg
Portuguese: Flux „Hexal" Tabs 10mg-Tabletten 10mg
Hungarian: Flux „Hexal" Tabs 10mg-Tabletten
Portuguese: RENEURON 20 mg oral solution 20 mg
Hungarian: RENEURON 20 mg oral solution
Portuguese: Glaxo Smith Kline Kft., Csörsz u. 43.
Hungarian: Belgium GLAXO SMITH KLINE S.A.
Portuguese: Mirtazapin "Alternova" 30mgFilmtabletten
Hungarian: Mirtazapin "Alternova" 30mg-Filmtabletten
Portuguese: Mirtabene „ratiopharm" 45mgFilmtabletten
Hungarian: Mirtabene „ratiopharm" 45mg-Filmtabletten
Portuguese: Glaxopar 20mg-Filmtabletten
Hungarian: Glaxopar 20mgFilmtabletten
Portuguese: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Hungarian: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Portuguese: REXETIN 30MG
Hungarian: REXETIN 30MG 30mg
Portuguese: Dalcipran 50mg-Kapseln
Hungarian: Dalcipran 50mgKapseln
Portuguese: Mepha Lda, Rua Elias Garcia, nr 28-C Edificio 4-Venda Nova, 2701-335 Amadora, Portugal
Hungarian: Lengyelország Mepha Lda, Rua Elias Garcia, nr 28-C Edificio 4-Venda Nova, 2701-335 Amadora, Portugal
Portuguese: POL-NIL Sp. z o.o., ul.
Hungarian: Lengyelország POL-NIL Sp. z o.o., ul.
Portuguese: Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Hungarian: Magyarország Richter Gedeon Rt., Gyömröi út 19-21, 1103 Budapest, Hungary
Portuguese: Sertrabeck 100 mg
Hungarian: Sertrabeck 100 mg 100 mg
Portuguese: Républica Checa N.V.ORGANON, OSS PO Box 20,5340 BH Oss, Netherlands
Hungarian: Csehország N.V.ORGANON, OSS PO Box 20,5340 BH Oss, Netherlands
Portuguese: Alemanha ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten 20 mg
Hungarian: D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Portuguese: Efexor 75, tablets
Hungarian: Efexor 75, tablets 75 mg
Portuguese: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Hungarian: Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Portuguese: SmithKline Beecham plc, SB House, Great West road, Brentford ,
Hungarian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Portuguese: Reino Unido Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Hungarian: Nagy-Britannia Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Portuguese: FLUCTIN Tabletten
Hungarian: Bevont tabletta
Portuguese: PHARMACIA N.V.
Hungarian: Belgium PHARMACIA N.V.
Portuguese: Strattera 5 mg, harde capsules 5 mg
Hungarian: Strattera 5 mg, harde capsules
Portuguese: Hamburg, Germany
Hungarian: Budapest, Hungary
Portuguese: Républica Checa N.V.ORGANON, OSS, PO Box 20, 5340 BH Oss, Netherlands
Hungarian: Csehország N.V.ORGANON, OSS, PO Box 20, 5340 BH Oss, Netherlands
Portuguese: Fluoxetin "Genericon" 20mgFilmtabletten
Hungarian: Fluoxetin "Genericon" 20mg-Filmtabletten
Portuguese: Mianserin-neuraxpharm 60mg
Hungarian: Mianserinneuraxpharm 60mg
Portuguese: Apotex Europe Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR)
Hungarian: Svédország Apotex Europe Ltd Rowan House 41, London Street Reading, Berkshire RG1 4PS Storbritannien och Nordirland (GBR)
Portuguese: Teva Pharma S.p.A.
Hungarian: Olaszország Teva Pharma S.p.A.
Portuguese: Solvay Pharmaceuticals B.V., [P.O.Box 900
Hungarian: Lettország Solvay Pharmaceuticals B.V., [P.O.Box 900 NL - 1380 DA Weesp]
Portuguese: FLUOXETIN-CHINOIN 20 mg kapszula
Hungarian: FLUOXETINCHINOIN 20 mg kapszula
Portuguese: HAPILUX 20mg
Hungarian: HAPILUX 20mg 20mg
Portuguese: Deprozel 20 mg
Hungarian: Deprozel 20 mg 20 mg
Portuguese: Largo U. Boccioni, 1 21040 Origgio Varese Italy
Hungarian: 21040 Origgio Varese Italy
Portuguese: Por conseguinte o CHMP concluiu que, no Resumo das Características do Medicamento e na secção relevante do Folheto Informativo de medicamentos que contêm atomoxetina, deve incluir-se uma advertência para o facto de a hostilidade (predominantemente agressão, comportamento de oposição e cólera) e a labilidade emocional terem sido observadas com maior frequência em ensaios clínicos com crianças e adolescentes que se encontravam a tomar atomoxetina, em comparação com os que se encontravam a tomar placebo, bem como uma advertência indicando a ineficácia no tratamento da depressão.
Hungarian: Ezért a CHMP határozata szerint az atomoxetint tartalmazó gyógyszerkészítmények alkalmazási előírásában, és betegtájékoztatóik vonatkozó részében figyelmeztetést kell feltüntetni arra vonatkozóan, hogy a klinikai vizsgálatokban az atomoxetinnel kezelt gyermekeknél és serdülőkorúaknál gyakrabban figyeltek meg ellenségességet (jellemzően agresszív, erőszakos viselkedést, ellenkezést és dühöt), mint a placebóval kezelt csoportban, valamint arra vonatkozóan, hogy ezek a gyógyszerkészítmények nem hatékonyak a depresszió kezelésében.
Portuguese: 67, 02631 Espoo, Finland
Hungarian: Finnország Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Portuguese: Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209 Carnaxide Portugal
Hungarian: Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq.
Portuguese: Cita 20mg film - coated tablets 20 mg
Hungarian: Cita 20mg film - coated tablets
Portuguese: LITAPHAR, S.A.Orendaundi, 9 20730 Guipuzcoa, Spain
Hungarian: Spanyolország LITAPHAR, S.A.Orendaundi, 9 20730 Guipuzcoa, Spain
Portuguese: Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Hungarian: Arrow Generics, Ltd., Unit 2 - Eastman Way SG1 4SZ Stevenage - Hertfordshire, U.K.
Portuguese: MIRZATEN 30mg
Hungarian: MIRZATEN 30mg 30mg
Portuguese: Mianserixx 10mg
Hungarian: Mianserixx 10mg 10 mg
Portuguese: Mirtazapin "Alternova" 15mgFilmtabletten
Hungarian: Mirtazapin "Alternova" 15mg-Filmtabletten
Portuguese: Reino Unido Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Hungarian: Nagy-Britannia Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Portuguese: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Hungarian: Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Portuguese: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Hungarian: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Portuguese: Felicium 20mg-Kapseln
Hungarian: Felicium 20mgKapseln
Portuguese: Cita 10 mg film - coated tablets 10 mg
Hungarian: Cita 10 mg film - coated tablets
Portuguese: Reino Unido Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Hungarian: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Portuguese: Efectin 37,5mg-Tabletten
Hungarian: Efectin 37,5mgTabletten
Portuguese: 90 sachets (com uma colher de dosagem)
Hungarian: 90 tasak (adagoló kanállal)
Portuguese: Esta autorização foi baseada na autorização concedida para Renvela em 2009 («consentimento informado»).
Hungarian: Az engedély a Renvela 2009. évi engedélyén alapul („informed consent").
Portuguese: • doentes adultos sujeitos a diálise (uma técnica para remover substâncias indesejáveis do sangue);
Hungarian: • dializált felnőtt betegeknél (a dialízis a nemkívánatos anyagokat távolítja el a vérből);
Portuguese: Mais informações sobre Sevelamer carbonate Winthrop podem ser encontradas no sítio da internet da Agência: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Hungarian: A Sevelamer carbonate Winthrop-pal kapcsolatban további információ az Európai Gyógyszerügynökség honlapján található: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Portuguese: ( carbonato de sevelâmero)
Hungarian: (szevelamer-karbonát)
Portuguese: A 15 de janeiro de 2015, Sevelamer carbonate Winthrop recebeu uma Autorização de Introdução no Mercado, válida para toda a União Europeia.
Hungarian: 2015. január 15-én a Sevelamer carbonate Winthrop az Európai Unió egész területére érvényes forgalombahozatali engedélyt kapott.
Portuguese: • adultos e crianças a partir dos 6 anos de idade com doença renal crónica (longo-prazo).
Hungarian: • krónikus (hosszú ideig fennálló) vesebetegségben szenvedő felnőtteknél és gyermekeknél 6 éves kortól.
Portuguese: Sevelamer carbonate Winthrop encontra-se disponível na forma de comprimidos (800 mg) e de pó (800 mg e 2,4 g) a tomar 3 vezes ao dia com as refeições.
Hungarian: A Sevelamer carbonate Winthrop tabletta (800 mg) és por (800 mg és 2,4 g) formájában kapható, és naponta 3-szor, étkezés közben kell bevenni.
Portuguese: A dose a tomar depende do nível de fosfato no sangue do doente e, no caso das crianças, da sua altura e peso.
Hungarian: Az alkalmazandó adag a beteg vérének foszfátszintjétől, illetve gyermekek esetén a magasságtól és a testsúlytól függ.
Portuguese: Por conseguinte, a Agência Europeia de Medicamentos concluiu que os benefícios de Sevelamer carbonate Winthrop são superiores aos seus riscos e o medicamento pode ser autorizado para utilização na UE.
Hungarian: Az Európai Gyógyszerügynökség megállapította, hogy a Sevelamer carbonate Winthrop alkalmazásának előnyei meghaladják a kockázatokat, ezért a gyógyszer alkalmazása az EU-ban engedélyezhető.
Portuguese: Por último, um estudo principal também demonstrou que Sevelamer carbonate Winthrop foi eficaz na redução dos níveis de fosfato em 100 crianças: as crianças que tomaram Sevelamer carbonate Winthrop registaram uma maior redução no nível de fósforo (0,87 mg/dl) do que as crianças que receberam placebo (tratamento simulado), que registaram um aumento no nível de fósforo de 0,04 mg/dl.
Hungarian: Végül pedig egy fő vizsgálat azt is igazolta, hogy a Sevelamer carbonate Winthrop hatékonyan csökkentette 100 gyermek foszfátszinjét: a Sevelamer carbonate Winthrop-ot szedő gyermekeknél nagyobb mértékben csökkent a foszforszint (0,87 mg/dl), mint a placebót (hatóanyag nélküli készítményt) szedő gyerekeknél, akiknél 0,04 mg/dl-rel nőtt a foszfor szintje.