FrancophonIA/ELRC3.0 huggingface dataset:
French: Royaume-Uni Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Polish: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
French: Allemagne Pfizer Pharma GmbH Pfizerstr.
Polish: Pfizer Pharma GmbH Pfizerstr.
French: Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209 Carnaxide Portugal
Polish: Portugalia Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209
French: Royaume-Uni Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
Polish: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
French: IPSEN PHARMA, S.A., Ctra.
Polish: Hiszpania IPSEN PHARMA, S.A., Ctra.
French: Allemagne Winthrop Arzneimittel GmbH Industriestr.
Polish: Winthrop Arzneimittel GmbH Industriestr.
French: Pays-Bas ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Polish: Holandia ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
French: LABORATORIOS DECROX, S.A., Crta.
Polish: Hiszpania LABORATORIOS DECROX, S.A., Crta.
French: Danemark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Polish: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
French: Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089 Sintra Portugal
Polish: Portugalia Jaba Farmacêutica, S.A., Edifício Jaba - Rua da Tapada Grande, 2 - Zona Industrial da Abrunheira 2710-089
French: Danemark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Polish: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
French: Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Polish: Nave 2, Avilés (Asturias) 33400, Spain
French: Danemark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Polish: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
French: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Polish: Portugalia Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
French: Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Polish: Portugalia Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S.
French: MOTIFS DE MODIFICATION DES RÉSUMÉS DES CARACTÉRISTIQUES DU PRODUIT
Polish: PODSTAWY ZMIANY CHARAKTERYSTYK PRODUKTU LECZNICZEGO
French: III.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DU RCP DE L'ATOMOXÉTINE
Polish: III.2 ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI SPC W PRZYPADKU ATOMOKSETYNY
French: DISTA, Avda.
Polish: Hiszpania DISTA, Avda.
French: LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda.
Polish: Hiszpania LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda.
French: Danemark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Polish: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
French: ACOST COMERCIAL GENERICPHARMA, Ferraz, 10.
Polish: Hiszpania ACOST COMERCIAL GENERICPHARMA, Ferraz, 10.
French: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Polish: Luksemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
French: Royaume-Uni Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Polish: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
French: Allemagne Esparma GmbH Postfach 1461
Polish: Esparma GmbH Postfach 1461
French: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Polish: Portugalia Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
French: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Polish: Luksemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
French: Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801 Coimbra Portugal
Polish: Portugalia Bluepharma - Indústria Farmacêutica, S.A., São Martinho do Bispo 3041-801
French: Allemagne Krewel Meuselbach GmbH Postfach 1263
Polish: Krewel Meuselbach GmbH Postfach 1263
French: Allemagne Neuraxpharm Arzneimittel GmbH & Co.KG
Polish: Neuraxpharm Arzneimittel GmbH & Co.KG
French: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Polish: Portugalia Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
French: Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Polish: Portugalia Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
French: Allemagne Hormosan-Kwizda GmbH Postfach 600340
Polish: Hormosan-Kwizda GmbH Postfach 600340
French: Avenue Mercator 1 1300 Wavre, Belgium
Polish: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
French: Luxembourg MERCK N.V.
Polish: Luksemburg MERCK N.V.
French: Luxembourg EUROGENERICS N.V.
Polish: Luksemburg EUROGENERICS N.V.
French: Danemark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Polish: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
French: IV.I MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DE LA NOTICE DU PRODUIT CONCERNANT LA FLUOXÉTINE, LA FLUVOXAMINE, LA
Polish: IV.I ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI ULOTKI DLA PACJENTA W PRZYPADKU FLUOKSETYNY, FLUWOKSAMINY, SERTRALINY,
French: Danemark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Polish: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
French: Allemagne Juta Pharma GmbH Gutenbergstr.
Polish: Juta Pharma GmbH Gutenbergstr.
French: Allemagne Merck dura GmbH Postfach 100635
Polish: Merck dura GmbH Postfach 100635
French: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Polish: Portugalia Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
French: Allemagne BC Biochemie Pharma GmbH Dieselstr.
Polish: BC Biochemie Pharma GmbH Dieselstr.
French: Allemagne Sandoz Pharmaceuticals GmbH Dieselstr.
Polish: Sandoz Pharmaceuticals GmbH Dieselstr.
French: Luxembourg SOCOBOM N.V.
Polish: Luksemburg SOCOBOM N.V.
French: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Polish: Portugalia Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
French: Allemagne Heumann Pharma GmbH & Co. Generica KG
Polish: Heumann Pharma GmbH & Co. Generica KG
French: Allemagne Solvay Arzneimittel GmbH Postfach 220
Polish: Solvay Arzneimittel GmbH Postfach 220
French: Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Polish: Portugalia Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
French: Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
Polish: Portugalia Pierre Fabre Médicament Portugal, Lda., Rua Rodrigo da Fonseca, n.º1782º Esq. 1099-067 Lisboa Portugal
French: Allemagne Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Polish: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
French: La CE a demandé au CHMP son avis sur le bien-fondé d'un maintien, d'une modification, d'une suspension ou d'un retrait de l'autorisation de mise sur le marché des spécialités pharmaceutiques contenant les principes actifs sus-mentionnés.
Polish: KE wystąpiła do CHMP o wydanie opinii, czy pozwolenie na dopuszczenie do obrotu produktów leczniczych mających w składzie wyżej wymienione substancje czynne powinno zostać utrzymane, zmienione, zawieszone czy cofnięte.
French: Capsule molle à libération prolongée
Polish: Kapsułka o przedłużonym uwalnianiu
French: Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Polish: Portugalia Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
French: Allemagne Wyeth Pharma GmbH Postfach 8806
Polish: Wyeth Pharma GmbH Postfach 8806
French: Royaume-Uni Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
Polish: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
French: INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A., Laguna, 42-44.
Polish: Hiszpania INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A., Laguna, 42-44.
French: LABORATORIOS DR. ESTEVE, S.A, Avda.
Polish: Hiszpania LABORATORIOS DR. ESTEVE, S.A, Avda.
French: Royaume-Uni Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Polish: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
French: Royaume-Uni Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Polish: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
French: Allemagne Boehringer Ingelheim Pharma GmbH & Co.KG
Polish: Boehringer Ingelheim Pharma GmbH & Co.KG
French: LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
Polish: Hiszpania LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
French: Danemark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Polish: Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
French: Allemagne Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Polish: Frankfurter Str. 129a D-64293 Darmstadt
French: Danemark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Polish: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
French: Allemagne Pharmacia GmbH Pfizerstr.
Polish: Pharmacia GmbH Pfizerstr.
French: Zoloft 25 mg + 50 mg 25 mg + 50 mg Comprimé pelliculé
Polish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Tabletka powlekana
French: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Polish: Luksemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
French: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Polish: Portugalia Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
French: Danemark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Polish: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
French: Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
Polish: Portugalia Merck Genéricos - Produtos Farmacêuticos, Lda., Rua Alfredo da Silva, 3 - C - 4º 1300-040 Lisboa Portugal
French: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Polish: Portugalia ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
French: Royaume-Uni Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Polish: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
French: Danemark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Polish: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
French: Danemark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Polish: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
French: 2 IRSN correspond à « Inhibiteur de la Recapture de la Sérotonine et de la Noradrénaline ».
Polish: Skrót SNRI oznacza „Selektywny inhibitor wychwytu zwrotnego serotoniny i noraderenaliny".
French: Royaume-Uni Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Polish: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
French: Royaume-Uni Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Polish: Wielka Brytania Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
French: Danemark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Polish: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
French: Slovaquie Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Polish: 16, Chemin de Coquelicots CH - 1214 Geneva
French: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Polish: Portugalia Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
French: LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
Polish: Hiszpania LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Polish: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
French: IV.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DE LA NOTICE DU PRODUIT CONCERNANT L'ATOMOXÉTINE
Polish: IV.2 ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI PL W PRZYPADKU ATOMOKSETYNY
French: Danemark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Polish: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Polish: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
French: Slovaquie Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Polish: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
French: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Polish: Hiszpania MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
French: La majorité des études avaient inclu des patients atteints de troubles dépressifs majeurs, tandis qu'un nombre restreint d'entre elles avaient inclu des patients atteints de divers troubles anxieux (Trouble Obsessionnel Compulsif (TOC), Trouble Anxieux Généralisé (TAG) et Trouble Anxiété Sociale).
Polish: W kilku próbach uczestniczyli pacjenci z różnego rodzaju zaburzeniami lękowymi (zaburzeniami obsesyjno-kompulsywnymi (OCD), uogólnionymi zaburzeniami lękowymi (GAD) oraz zespołem fobii społecznej (SAD)).
French: Il est également important de savoir que les patients de moins de 18 ans présentent un risque accru d'effets indésirables, tels que tentative de suicide, pensées suicidaires et comportement hostile (principalement agressivité, comportement d'opposition et colère) lorsqu'ils sont traités par cette classe de médicaments.
Polish: Należy również podkreślić, że przy przyjmowaniu leków tej klasy pacjenci poniżej 18 roku życia narażeni są na zwiększone ryzyko wystąpienia skutków ubocznych takich jak próby samobójcze, myśli samobójcze i wrogość (szczególnie agresja, zachowania buntownicze i przejawy gniewu).
French: Fabrik , Holger Danskaes Vej 89, DK - 2000
Polish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
French: LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Polish: Hiszpania LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
French: Pelplińska 19, 83-200 Starogard Gdański, Poland
Polish: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
French: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Polish: Luksemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
French: JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Polish: Hiszpania JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
French: INVICTA FARMA, S.A., Avda.
Polish: Hiszpania INVICTA FARMA, S.A., Avda.
French: Royaume-Uni Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Polish: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
French: Allemagne Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Polish: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
French: Luxembourg ORGANON EUROPE B.V.
Polish: Luksemburg ORGANON EUROPE B.V.
French: Un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle ont été plus fréquemment observés au cours d'études cliniques chez les enfants et adolescents traités par [Nom de Fantaisie] par rapport à ceux traités par placebo.
Polish: W toku prób klinicznych wrogość (szczególnie agresję, zachowania buntownicze i przejawy gniewu) oraz labilność emocjonalną obserwowano częściej u dzieci i młodzieży leczonych [nazwa handlowa] niż u grupy, której podawano placebo.
French: ANNEXE III MODIFICATIONS DU RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT
Polish: ZAŁĄCZNIK III ZMIANY W CHARAKTERYSTYCE PRODUKTU LECZNICZEGO
French: JUSTE, S.A.Q.F., Juan Ign 28027acio Luca de Tena, 8, Madrid, Spain
Polish: Hiszpania JUSTE, S.A.Q.F., Juan Ign 28027acio Luca de Tena, 8, Madrid, Spain
French: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Polish: Portugalia Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
French: GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
Polish: Hiszpania GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
French: CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Polish: Hiszpania CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
French: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Polish: Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
French: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Polish: Portugalia toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
French: Luxembourg ORGANON EUROPE N.V.
Polish: Luksemburg ORGANON EUROPE N.V.
French: ANNEXE IV MODIFICATIONS DE LA NOTICE DU PRODUIT
Polish: ZAŁĄCZNIK IV ZMIANY W ULOTCE DLA PACJENTA
French: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Polish: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
French: Allemagne Aliud Pharma GmbH & Co.KG Postfach 1380
Polish: Aliud Pharma GmbH & Co.KG Postfach 1380
French: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Polish: Portugalia toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
French: Allemagne Rodleben Pharma GmbH Postfach 205
Polish: Rodleben Pharma GmbH Postfach 205
French: FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
Polish: Hiszpania FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
French: DEXTER FARMACEUTICA, S.A., Avda.
Polish: Hiszpania DEXTER FARMACEUTICA, S.A., Avda.
French: Royaume-Uni Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Polish: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
French: Allemagne Synthon B.V.
Polish: Synthon B.V.
French: Allemagne TAD Pharma GmbH Postfach 720
Polish: TAD Pharma GmbH Postfach 720
French: Danemark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Polish: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
French: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Polish: Luksemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
French: Le CHMP a considéré qu'aucun signal d'augmentation du risque de comportement de type suicidaire n'était présent dans les études portant sur l'atomoxétine.
Polish: CHMP uznał, że w badaniach z udziałem atomoksetyny nie wystąpiły oznaki zwiększonego ryzyka wystąpienia zachowań samobójczych, wystąpiły jednak oznaki zwiększonego ryzyka nieprawidłowości w zachowaniu przy zwiększonym poziomie skutków w postaci agresji i wrogości.
French: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Polish: Portugalia Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
French: Przemyslow 2, 35-959 Rzeszow, Poland
Polish: ICN Polfa Rzeszow, ul. Przemyslow 2, 35-959 Rzeszow, Poland
French: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Polish: Portugalia Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
French: SOLVAY PHARMA, S.A., Avda.
Polish: Hiszpania SOLVAY PHARMA, S.A., Avda.
French: PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Polish: Hiszpania PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
French: LABORATORIOS DR. ESTEVE, S.A., Avda.
Polish: Hiszpania LABORATORIOS DR. ESTEVE, S.A., Avda.
French: Allemagne H.Lundbeck A/S Ottiliavej 7-9
Polish: H.Lundbeck A/S Ottiliavej 7-9
French: Royaume-Uni Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Polish: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
French: Przemyslowa, PL - 35 959 Rzeszow
Polish: ICN Polfa Rzesów S.A., ul. Przemyslowa, PL - 35 959 Rzeszow
French: Allemagne Neosan Filchnerstr.
Polish: Filchnerstr.
French: De plus, était noté un signal concernant des effets indésirables associés tels que comportement hostile, automutilation et labilité émotionnelle avec la plupart des produits et dans la plupart des indications.
Polish: Ponadto przy prawie wszystkich produktach i wskazaniach do stosowania wystąpiły oznaki powiązanych działań niepożądanych, takich jak wrogość, autoagresja oraz labilność emocjonalna.
French: Allemagne Temmler Pharma GmbH & Co.KG Postfach 2269
Polish: Temmler Pharma GmbH & Co.KG Postfach 2269
French: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Polish: Portugalia Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
French: Danemark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Polish: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
French: Rue-de-la-Pastorale 26-28
Polish: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
French: Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq. 1500-252 Lisboa Portugal
Polish: Portugalia Medilusa - Comércio e Indústria de Especialidades Farmacêuticas, Lda., Rua Duarte Galvão, n.º13 R/C Esq.
French: Royaume-Uni Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Polish: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
French: Kubickiego 11, 02-954 Warszawa, Poland
Polish: Ranbaxy (Poland) Sp. z o.o., ul. Kubickiego 11, 02-954 Warszawa, Poland
French: Danemark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Polish: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
French: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Polish: Hiszpania TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
French: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Polish: 2696-901 Bobadela Portugal
French: ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022 Barcelona, Spain
Polish: Hiszpania ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022
French: Vous devez également savoir que la sécurité à long terme sur la croissance, la maturation et le développement comportemental et cognitif de [Nom de Fantaisie] n'a pas encore été établie dans cette tranche d'âge.
Polish: Ponadto, jak do tej pory brak jest danych dotyczących długoterminowego bezpieczeństwa stosowania [nazwa handlowa] w tej grupie wiekowej dotyczących wzrostu, dojrzewania oraz rozwoju poznawczego i rozwoju zachowania.
French: Royaume-Uni John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Polish: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK