FrancophonIA/ELRC3.0 huggingface dataset:
Portuguese: Républica Checa SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02
Greek: SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02 Hradec Králové, Czech Republic
Portuguese: GlaxoSmithKline GmbH & Co. KG Theresienhoehe 11
Greek: Γερµανία GlaxoSmithKline GmbH & Co. KG Theresienhoehe 11
Portuguese: ANPHARM Przedsiębiorstwo Farmaceutyczne S.A., Annopol 6B, 03-236 Warszawa, Poland
Greek: Πολωνία ANPHARM Przedsiębiorstwo Farmaceutyczne S.A., Annopol 6B, 03-236 Warszawa, Poland
Portuguese: Pfizer AB Box 501 183 25 Täby Sverige (SWE)
Greek: Σουηδία Pfizer AB Box 501 183 25 Täby Sverige (SWE)
Portuguese: Reino Unido Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Greek: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA;
Portuguese: Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Greek: Σλοβενία Torrex Pharma, d.o.o., Trdinova 4, SI1000 Ljubljana, Slovenia
Portuguese: Apesar disso, o médico poderá prescrever [Nome de fantasia] para doentes com idade inferior a 18 anos quando decida que tal é necessário.
Greek: Εντούτοις, ο γιατρός σας µπορεί να χορηγήσει το [επινοηθείσα ονοµασία] σε ασθενείς κάτω των 18 ετών, εάν θεωρήσει ότι αυτό είναι προς όφελός τους.
Portuguese: Eli Lilly Sweden AB Box 721 169 27 Solna Sverige (SWE)
Greek: Σουηδία Eli Lilly Sweden AB Box 721 169 27 Solna Sverige (SWE)
Portuguese: Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Greek: Νορβηγία Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Portuguese: Reino Unido Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Greek: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Portuguese: IV.2 ALTERAÇÕES A INCLUIR NA SECÇÃO RELEVANTE DO FOLHETO INFORMATIVO DE ATOMOXETINA
Greek: IV.2 ΤΡΟΠΟΠΟΙΗΣΕΙΣ ΠΟΥ ΠΡΕΠΕΙ ΝΑ ΠΕΡΙΛΗΦΘΟΥΝ ΣΤΟ ΣΧΕΤΙΚΟ ΚΕΦΑΛΑΙΟ ΤΟΥ ΦΥΛΛΟΥ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ ΓΙΑ ΤΗΝ ΑΤΟΜΟΞΕΤΙΝΗ
Portuguese: Laboratoires IREX 7, Avenue Gallieni 94257 Gentilly Cedex Frankrike (FRA)
Greek: Σουηδία Laboratoires IREX 7, Avenue Gallieni 94257 Gentilly Cedex Frankrike (FRA)
Portuguese: Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Greek: Πορτογαλία Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S.
Portuguese: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000
Greek: Σλοβενία GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, SI-1000 Ljubljana, Slovenia
Portuguese: Reino Unido Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
Greek: Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP;
Portuguese: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul.
Greek: Πολωνία Zakłady Farmaceutyczne "POLPHARMA" S.A., ul.
Portuguese: Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Greek: Νορβηγία Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Portuguese: Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000 Ljubljana, Slovenia
Greek: Σλοβενία Wyeth Whitehall, Podružnica v Sloveniji, Topniška 4a, SI-1000
Portuguese: Países Baixos GenRx B.V., Postbus 75, NL-6920 AB Duiven
Greek: Ολλανδία GenRx B.V., Postbus 75, NL-6920 AB Duiven
Portuguese: Ranbaxy Ireland Limited, Cork Road, Cashel, Co. Tipperary, Ireland
Greek: Ιρλανδία Ranbaxy Ireland Limited, Cork Road, Cashel, Co. Tipperary, Ireland
Portuguese: John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG Storbritannien och Nordirland (GBR)
Greek: Σουηδία John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG Storbritannien och Nordirland (GBR)
Portuguese: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Greek: Πορτογαλία Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Portuguese: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Greek: Ουγγαρία Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Portuguese: Países Baixos Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Greek: Ολλανδία Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Portuguese: Países Baixos GlaxoSmithKline B.V.
Greek: Ολλανδία GlaxoSmithKline B.V.
Portuguese: Países Baixos Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Greek: Ολλανδία Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Portuguese: GlaxoSmithKline AB Box 263 431 23 Mölndal Sverige (SWE)
Greek: Σουηδία GlaxoSmithKline AB Box 263 431 23 Mölndal Sverige (SWE)
Portuguese: Pharmacia GmbH Pfizerstr.
Greek: Γερµανία Pharmacia GmbH Pfizerstr.
Portuguese: Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Greek: Νορβηγία Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Portuguese: Boehringer Ingelheim Pharma GmbH & Co.KG
Greek: Γερµανία Boehringer Ingelheim Pharma GmbH & Co.KG
Portuguese: Betapharm Arzneimittel GmbH Kobelweg 95
Greek: Γερµανία Betapharm Arzneimittel GmbH Kobelweg 95
Portuguese: Países Baixos Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Greek: Ολλανδία Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Portuguese: Sandoz Pharmaceuticals GmbH Dieselstr.
Greek: Γερµανία Sandoz Pharmaceuticals GmbH Dieselstr.
Portuguese: Solvay Arzneimittel GmbH Postfach 220
Greek: Γερµανία Solvay Arzneimittel GmbH Postfach 220
Portuguese: Merck dura GmbH Postfach 100635
Greek: Γερµανία Merck dura GmbH Postfach 100635
Portuguese: Gladem 20mg/ml-Konzentrat zur Herstellung einer Trinklösung
Greek: Gladem 20mg/mlKonzentrat zur Herstellung einer Trinklösung
Portuguese: Reino Unido Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Greek: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX;
Portuguese: Hormosan-Kwizda GmbH Postfach 600340
Greek: Γερµανία Hormosan-Kwizda GmbH Postfach 600340
Portuguese: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Greek: Πορτογαλία Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Portuguese: Países Baixos Hexal AG, Postfach 1263, D-83602 Holzkirchen
Greek: Ολλανδία Hexal AG, Postfach 1263, D-83602 Holzkirchen
Portuguese: Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2Zona Industrial da Abrunheira 2710089 Sintra Portugal
Greek: Πορτογαλία Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089
Portuguese: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Greek: Γερµανία Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Portuguese: Reino Unido Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Greek: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT;
Portuguese: Desifluvox amin 25 mg
Greek: Desifluvox amin 25 mg 25 mg
Portuguese: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
Greek: Ιρλανδία Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co.
Portuguese: Países Baixos Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Greek: Ολλανδία Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Portuguese: APS/Berk/Approved Prescription Service, Brampton Road, Hampden Park ,Eastbourne, East Sussex BN 22 9 AG, United Kingdom
Greek: Φινλανδία APS/Berk/Approved Prescription Service, Brampton Road, Hampden Park ,Eastbourne, East Sussex BN 22 9
Portuguese: Neuraxpharm Arzneimittel GmbH & Co.KG
Greek: Γερµανία Neuraxpharm Arzneimittel GmbH & Co.KG
Portuguese: Luxemburgo TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Greek: Λουξεµβούργο TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Portuguese: Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Greek: Ουγγαρία Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Portuguese: Frankfurter Str. 129a D-64293 Darmstadt
Greek: Γερµανία Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Portuguese: Tresleen 20mg/ml-Konzentrat zur Herstellung einer Trinklösung
Greek: Tresleen 20mg/mlKonzentrat zur Herstellung einer Trinklösung
Portuguese: Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Greek: Ουγγαρία Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Portuguese: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 302º 1069-037 Lisboa Portugal
Greek: Πορτογαλία Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Portuguese: Países Baixos Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Greek: Ολλανδία Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Portuguese: Pharmaceutical Works Polpharma S.A., ul.
Greek: Λιθουανία Pharmaceutical Works Polpharma S.A., ul.
Portuguese: Porém, verificaram-se sinais evidentes de comportamentos relacionados com o suicídio nos estudos relativos a depressão e sinais menos evidentes nos estudos relativos a ansiedade.
Greek: Ωστόσο, υπήρξε σαφώς προειδοποιητικό σήµα εκδήλωσης αυτοκτονικής συµπεριφοράς στις µελέτες κατάθλιψης ενώ λιγότερο ισχυρό ήταν το σήµα αυτό στις µελέτες αγχωδών διαταραχών.
Portuguese: 1 ISRS - "inibidores selectivos da recaptação da serotonina".
Greek: 1 SSRI σηµαίνει «εκλεκτικός αναστολέας της επαναπρόσληψης σεροτονίνης (ΕΑΕΣ)».
Portuguese: STADA GmbH Stadastr.
Greek: Γερµανία STADA GmbH Stadastr.
Portuguese: Wyeth Pharma GmbH Postfach 8806
Greek: Γερµανία Wyeth Pharma GmbH Postfach 8806
Portuguese: John Wyeth & Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
Greek: Φινλανδία John Wyeth & Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
Portuguese: Pierre Fabre Pharma Norden Ab, Turebergs Torg 1, plan 2, 19147 SOLLENTUNA, Sweden
Greek: Φινλανδία Pierre Fabre Pharma Norden Ab, Turebergs Torg 1, plan 2, 19147
Portuguese: Países Baixos Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Greek: Ολλανδία Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
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;
Greek: Εκτιµώντας τα ακόλουθα: - Η επιτροπή εξέτασε το παραπεµπτικό που υπεβλήθη σύµφωνα µε το άρθρο 31 της Οδηγίας 2001/83/ΕΚ, όπως αυτή τροποποιήθηκε, για φαρµακευτικά προϊόντα που περιέχουν ατοµοξετίνη, σιταλοπράµη, εσιταλοπράµη, φθοροξετίνη, φλουβοξαµίνη, µιανσερίνη, µιλνασιπράνη, µιρταζαπίνη, παροξετίνη, ρεµποξετίνη, σερτραλίνη και βενλαφαξίνη
Portuguese: Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Greek: Αυστρία Faromed Handelsges.m.b.H., Johann Strauß Gasse 7, 1040 Wien, Austria
Portuguese: Remeron 15mg/ml-Lösung zum Einnehmen
Greek: Remeron 15mg/mlLösung zum Einnehmen
Portuguese: Reino Unido Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Greek: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG;
Portuguese: Stadapharm GmbH Stadastr.
Greek: Γερµανία Stadapharm GmbH Stadastr.
Portuguese: O Comité concluiu também que uma advertência diferente seria mais adequada no caso da atomoxetina, a qual está apenas indicada no tratamento de défice de atenção/distúrbio de hiperactividade.
Greek: Η επιτροπή έκρινε επίσης ότι πρέπει να περιληφθεί διαφορετική προειδοποίηση για την ατοµοξετίνη, η οποία χορηγείται µόνον για τη θεραπεία του συνδρόµου ADHD.
Portuguese: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Greek: Λιθουανία N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Portuguese: N.V.Organon, Kloosterstraat 6, P.O.BOX 20, 5340, the Netherlands
Greek: Φινλανδία N.V.Organon, Kloosterstraat 6, P.O.BOX 20, 5340, the Netherlands
Portuguese: Reino Unido Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Greek: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Portuguese: Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Greek: Αυστρία Organon Ges.m.b.H., Siebenbrunnengasse 21, 1050 Wien, Austria
Portuguese: Países Baixos Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Greek: Ολλανδία Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Portuguese: Eli Lilly and Company Ltd.
Greek: Eli Lilly & Company Limited;
Portuguese: Efexor XR 150, capsules
Greek: Efexor XR 150, capsules 150 mg
Portuguese: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Greek: Γερµανία AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Portuguese: IIP-Institut fuer industrielle Pharmazie
Greek: Γερµανία IIP-Institut fuer industrielle Pharmazie Benzstr.
Portuguese: Solvay Healthcare Limited Mansbridge Road, West End Southampton, SO18 3JD, UK
Greek: Ιρλανδία Solvay Healthcare Limited Mansbridge Road, West End Southampton, SO18 3JD, UK
Portuguese: ANEXO IV ALTERAÇÕES AO FOLHETO INFORMATIVO
Greek: ΠΑΡΑΡΤΗΜΑ IV ΤΡΟΠΟΠΟΙΗΣΕΙΣ ΣΤΟ ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ
Portuguese: Alpharma ApS, Dalslandsgade 11, P.B 1736, 2300 COPENHAGEN S, Denmark
Greek: Φινλανδία Alpharma ApS, Dalslandsgade 11, P.B 1736, 2300 COPENHAGEN S, Denmark
Portuguese: Países Baixos Katwijk Farma B.V.
Greek: Ολλανδία Katwijk Farma B.V.
Portuguese: Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 511, 1021 Wien, Austria
Greek: Αυστρία Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria
Portuguese: A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK)
Greek: Σουηδία A/S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 2000 Frederiksberg Danmark (DNK)
Portuguese: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Greek: Σλοβενία Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
Portuguese: Zoloft 20 mg/ml, solution for Via oral
Greek: Zoloft 20 mg/ml, solution for oral use
Portuguese: Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Greek: Πορτογαλία Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Portuguese: Países Baixos Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Greek: Ολλανδία Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Portuguese: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Greek: Νορβηγία Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Portuguese: Países Baixos Centrafarm Services B.V.
Greek: Ολλανδία Centrafarm Services B.V.
Portuguese: MOM Park Gesztenyés torony, 1124 Budapest, Hungary
Greek: 43. MOM Park Gesztenyés torony, 1124
Portuguese: Alemanha betapharm Arzneimittel GmbH Kobelweg 95
Greek: Γερµανία betapharm Arzneimittel GmbH Kobelweg 95
Portuguese: Países Baixos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Greek: Ολλανδία Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Portuguese: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Greek: Πορτογαλία Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
Portuguese: Républica Checa SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Greek: SMTIHKLINE BEECHAM PHARMACEUTICALS, TW8 9EP Brentford, Middlesex, New Horizont Court, UK
Portuguese: Heumann Pharma GmbH & Co. Generica KG
Greek: Γερµανία Heumann Pharma GmbH & Co. Generica KG
Portuguese: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Greek: Σλοβακία Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Portuguese: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Greek: Granatieri 50018 Scandicci - Firenze Italy
Portuguese: Luxemburgo Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Greek: Λουξεµβούργο Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Portuguese: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Greek: Νορβηγία IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Portuguese: Rodleben Pharma GmbH Postfach 205
Greek: Γερµανία Rodleben Pharma GmbH Postfach 205
Portuguese: Países Baixos Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Greek: Ολλανδία Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Portuguese: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Greek: Πορτογαλία Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Portuguese: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0FL, UK
Greek: Ιρλανδία Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0FL, UK
Portuguese: Pharmacia & Upjohn S.p.A., via Robert Koch 1.2, 20 152 Milano, IT
Greek: Πολωνία Pharmacia & Upjohn S.p.A., via Robert Koch 1.2, 20 152 Milano, IT
Portuguese: Países Baixos Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Greek: Ολλανδία Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Portuguese: Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Greek: Αυστρία Pfizer Corporation Austria Ges.m.b.H., Seidengasse 33-35, 1070 Wien, Austria
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Greek: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Portuguese: Gladem 50mg-Filmtabletten
Greek: Gladem 50mgFilmtabletten
Portuguese: Países Baixos Solvay Pharma B.V., Postbus 501, NL-1380 AM Weesp
Greek: Ολλανδία Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Portuguese: D-64206 Darmstadt paroxedura 30 mg Filmtabletten 30 mg
Greek: D-64206 Darmstadt paroxedura 30 mg Filmtabletten
Portuguese: Aliud Pharma GmbH & Co.KG Postfach 1380
Greek: Γερµανία Aliud Pharma GmbH & Co.KG Postfach 1380
Portuguese: Países Baixos Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Greek: Ολλανδία Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Portuguese: Importa igualmente assinalar que os doentes com idade inferior a 18 anos correm maior risco de sofrerem efeitos secundários tais como, tentativa de suicídio, ideação suicida e hostilidade (predominantemente agressividade, comportamento de oposição e cólera) quando tomam medicamentos desta classe.
Greek: Πρέπει επίσης να γνωρίζετε ότι οι ασθενείς κάτω των 18 ετών, όταν λαµβάνουν τη συγκεκριµένη κατηγορία φαρµάκων, έχουν αυξηµένο κίνδυνο εµφάνισης ανεπιθύµητων ενεργειών, όπως απόπειρες αυτοκτονίας, σκέψεις αυτοκτονίας, εχθρική συµπεριφορά (κυρίως επιθετικότητα, εναντιωτική συµπεριφορά και θυµό).
Portuguese: Luxemburgo WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Greek: Λουξεµβούργο WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Portuguese: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Greek: Πορτογαλία Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Portuguese: - o Comité, perante os dados provenientes de ensaios clínicos, concluiu haver um sinal de comportamento suicida, 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 inibidores selectivos da recaptação da serotonina e com inibidores selectivos da recaptação da serotonina e da noradrenalina, tais como os medicamentos supracitados;
Greek: - Η επιτροπή, υπό το φως των διαθέσιµων δεδοµένων από τις κλινικές δοκιµές, έκρινε ότι υφίσταται προειδοποιητικό σήµα εκδήλωσης αυτοκτονικής συµπεριφοράς, στην οποία περιλαµβάνονται απόπειρες αυτοκτονίας και αυτοκτονικός ιδεασµός, και/ή παρεµφερών συµπεριφορών, όπως αυτοτραυµατισµός, εχθρική συµπεριφορά και συναισθηµατική αστάθεια σε παιδιά και εφήβους που λαµβάνουν επιλεκτικούς αναστολείς επαναπρόσληψης σεροτονίνης και αναστολείς επαναπρόσληψης σεροτονίνης και νορεπινεφρίνης, όπως τα ανωτέρω αναφερθέντα φαρµακευτικά προϊόντα
Portuguese: NL - 1380 DA Weesp] C.J. van Houtenlaan 36
Greek: NL - 1380 DA Weesp] C.J.
Portuguese: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Greek: Πορτογαλία ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Portuguese: Reino Unido Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Greek: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Portuguese: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Greek: Πορτογαλία Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Portuguese: Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Greek: Ουγγαρία Actavis Nordic A/S, 2970 Horsholm, Hammervej 7.
Portuguese: Reino Unido Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Greek: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET;
Portuguese: Reino Unido Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Greek: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL;
Portuguese: Países Baixos Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Greek: Ολλανδία Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Portuguese: Venlafaxin Wyeth retard 150 mg 150 mg
Greek: Venlafaxin Wyeth retard 150 mg
Portuguese: Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Greek: Ισλανδία Generics UK Ltd. 12 Station Close Potters Bar, Herts, England
Portuguese: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale
Greek: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
Portuguese: ICN Polfa Rzeszow, ul.
Greek: Λιθουανία ICN Polfa Rzeszow, ul.
Portuguese: "Nota: Esta secção do folheto informativo foi anexada à Decisão da Comissão na sequência do procedimento de arbitragem ao abrigo do Artigo 31.
Greek: Σηµείωση: Το παρόν τµήµα του Φυλαδίου Οδηγιών αποτελούσε παράρτηµα της Απόφασης της Επιτροπής σχετικά µε το παραπεµπτικό σύµφωνα µε το ΄Αρθρο 31.Το κείµενο ήταν τότε έγκυρο.
Portuguese: Países Baixos Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Greek: Ολλανδία Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Portuguese: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Greek: Πορτογαλία Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
Portuguese: D-64206 Darmstadt paroxedura 20 mg Filmtabletten 20 mg
Greek: D-64206 Darmstadt paroxedura 20 mg Filmtabletten
Portuguese: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Greek: Fabrik , Holger Danskaes Vej 89, DK - 2000
Portuguese: Efexor XR 37,5, capsule
Greek: Efexor XR 37,5, capsule 37,5 mg
Portuguese: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
Greek: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Portuguese: Desiflu voxamin 100 mg
Greek: Desiflu voxamin 100 mg 100 mg
Portuguese: Países Baixos Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Greek: Ολλανδία Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Portuguese: Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º178 - 2º Esq. 1099-067 Lisboa Portugal
Greek: Πορτογαλία Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Portuguese: Teva Pharma B.V.
Greek: Φινλανδία Teva Pharma B.V.
Portuguese: TAD Pharma GmbH Postfach 720
Greek: Γερµανία TAD Pharma GmbH Postfach 720
Portuguese: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Greek: Πορτογαλία Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Portuguese: Pliva Kraków Zakłady Farmaceutyczne S.A., ul.
Greek: Πολωνία Pliva Kraków Zakłady Farmaceutyczne S.A., ul.