FrancophonIA/ELRC3.0 huggingface dataset:
Italian: Recordati S.p.A. Via Matteo Civitali, 1 20148 Milano Italy
Polish: Via Matteo Civitali, 1 20148 Milano Italy
Italian: Portogallo Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Polish: Portugalia Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Italian: Danimarca 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
Italian: Regno Unito 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
Italian: Portogallo 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
Italian: Danimarca Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Polish: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Italian: Slovacchia Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
Polish: 16, Chemin de Coquelicots CH - 1214 Geneva
Italian: Portogallo 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
Italian: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Polish: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Italian: Germania Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
Polish: Frankfurter Str. 129a D-64293 Darmstadt
Italian: III.2 MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO PER ATOMOXETINA
Polish: III.2 ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI SPC W PRZYPADKU ATOMOKSETYNY
Italian: Danimarca Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Polish: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Italian: Germania Boehringer Ingelheim Pharma GmbH & Co.KG
Polish: Boehringer Ingelheim Pharma GmbH & Co.KG
Italian: Danimarca BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Polish: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Italian: Union Health S.r.l. Via Roccamandolfi, 1 00156 Roma Italy
Polish: Via Roccamandolfi, 1 00156 Roma Italy
Italian: Portogallo Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
Polish: Portugalia Ciclum Farma Unipessoal Lda., Rua Alfredo da Silva nº 16, 2610-016
Italian: Regno Unito Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Polish: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Italian: Regno Unito 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.
Italian: LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
Polish: Hiszpania LABORATORIOS NORMON, S.A., Nieremberg, 10., Madrid 28002, Spain
Italian: Lussemburgo 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
Italian: Regno Unito 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
Italian: Portogallo Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
Polish: Portugalia Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
Italian: LABORATORIOS DR. ESTEVE, S.A, Avda.
Polish: Hiszpania LABORATORIOS DR. ESTEVE, S.A, Avda.
Italian: Danimarca Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Polish: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Italian: Portogallo 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
Italian: MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Polish: Hiszpania MUNDOGEN FARMA, S.A., Severo Ochoa, 2 Tres Cantos, Spain
Italian: Slovacchia 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
Italian: Lussemburgo ORGANON EUROPE B.V.
Polish: Luksemburg ORGANON EUROPE B.V.
Italian: Portogallo Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Polish: Portugalia Pentafarma - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 5º A 2685-338
Italian: Danimarca Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Polish: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Italian: Regno Unito Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Polish: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Italian: Fabrik , Holger Danskaes Vej 89, DK - 2000
Polish: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Italian: Germania S.A. Laboratoires S.M.B.
Polish: S.A. Laboratoires S.M.B.
Italian: LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Polish: Hiszpania LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Italian: 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
Italian: Regno Unito 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
Italian: Pelplińska 19, 83-200 Starogard Gdański, Poland
Polish: Zakłady Farmaceutyczne "POLPHARMA" S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
Italian: INVICTA FARMA, S.A., Avda.
Polish: Hiszpania INVICTA FARMA, S.A., Avda.
Italian: Valeas S.p.A. Via Vallisneri, 10 20133 Milano Italy
Polish: Via Vallisneri, 10 20133 Milano Italy
Italian: SERTRALINA,
Polish: SERTRALINĘ,
Italian: Portogallo 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
Italian: Lussemburgo PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Polish: Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Italian: 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
Italian: Germania Rodleben Pharma GmbH Postfach 205
Polish: Rodleben Pharma GmbH Postfach 205
Italian: Zoloft 25 mg + 50 mg 25 mg + 50 mg Compressa rivestita con film Via orale
Polish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Tabletka powlekana
Italian: GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
Polish: Hiszpania GLAXOSMITHKLINE, S.A., Severo Ochoa, 2, Tres Cantos, 28760, Spain
Italian: 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
Italian: Germania Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Polish: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Italian: Lussemburgo Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Polish: Luksemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Italian: IV.I MODIFICHE DA INTRODURRE NELLA SEZIONE PERTINENTE DEL FOGLIO ILLUSTRATIVO DI FLUOXETINA,
Polish: III.I ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI SPC W PRZYPADKU FLUOKSETYNY,
Italian: 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)
Italian: PAROXETINA, CITALOPRAM, ESCITALOPRAM, VENLAFAXINA, MIANSERINA, MILNACIPRAN, REBOXETINA E MIRTAZAPINA
Polish: PAROKSETYNY, CITALOPRAMU, ESCITALOPRAMU, WENLAFAKSYNY, MIANSERYNY, MILNACIPRANU, REBOKSETYNY I MIRTAZAPINY
Italian: Portogallo 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
Italian: Germania Aliud Pharma GmbH & Co.KG Postfach 1380
Polish: Aliud Pharma GmbH & Co.KG Postfach 1380
Italian: Biores Italia S.r.l. Via V. Grassi, 13 00155 ROMA, Italy
Polish: Via V. Grassi, 13 00155 ROMA, Italy
Italian: Regno Unito Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Polish: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Italian: Medochemie Ltd, P.O.
Polish: Medochemie Ltd., 1-10
Italian: FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
Polish: Hiszpania FARMA LEPORI, S.A., Osi, 7-9, Barcelona, 08034, Spain
Italian: DEXTER FARMACEUTICA, S.A., Avda.
Polish: Hiszpania DEXTER FARMACEUTICA, S.A., Avda.
Italian: Ostilità (essenzialmente aggressività, comportamento di opposizione e collera) e predisposizione emotiva sono state osservate con maggiore frequenza negli studi clinici effettuati su bambini e adolescenti trattati con [nome di fantasia] rispetto a quelli trattati con 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.
Italian: Lampugnani Farmaceutici S.p.A. Via Bianchi Maria Visconti 20122 Milano, Italy
Polish: Via Bianchi Maria Visconti 20122 Milano, Italy
Italian: Sepi Chimica S.r.l. Via Vittorio Grassi, 9/11 00155 Roma Italy
Polish: Via Vittorio Grassi, 9/11 00155 Roma Italy
Italian: ALLEGATO IV MODIFICHE AL FOGLIO ILLUSTRATIVO
Polish: ZAŁĄCZNIK IV ZMIANY W ULOTCE DLA PACJENTA
Italian: Lussemburgo ORGANON EUROPE N.V.
Polish: Luksemburg ORGANON EUROPE N.V.
Italian: Portogallo 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
Italian: Forma Farmaceutica Via di somministrazione
Polish: Postać farmaceutyczna Droga podania
Italian: Danimarca Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Polish: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Italian: Przemyslow 2, 35-959 Rzeszow, Poland
Polish: ICN Polfa Rzeszow, ul. Przemyslow 2, 35-959 Rzeszow, Poland
Italian: Portogallo Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Polish: Portugalia Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Italian: Przemyslowa, PL - 35 959 Rzeszow
Polish: ICN Polfa Rzesów S.A., ul. Przemyslowa, PL - 35 959 Rzeszow
Italian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
Polish: Via E. Folli, 50 20134 Milano Italy
Italian: Germania TAD Pharma GmbH Postfach 720
Polish: TAD Pharma GmbH Postfach 720
Italian: SOLVAY PHARMA, S.A., Avda.
Polish: Hiszpania SOLVAY PHARMA, S.A., Avda.
Italian: 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
Italian: Regno Unito 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
Italian: Germania H.Lundbeck A/S Ottiliavej 7-9
Polish: H.Lundbeck A/S Ottiliavej 7-9
Italian: Glaxosmithkline S.p.A. Via A. Fleming, 2 37135 Verona Italy
Polish: Via A. Fleming, 2 37135 Verona Italy
Italian: Danimarca Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Polish: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Italian: Germania Temmler Pharma GmbH & Co.KG Postfach 2269
Polish: Temmler Pharma GmbH & Co.KG Postfach 2269
Italian: Concentrato per soluzione per infusione
Polish: Koncentrat do sporządzania roztworu do wstrzykiwań
Italian: Danimarca Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Polish: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Italian: Portogallo Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Polish: Portugalia Arrow Generics, Ltd., Unit 2Eastman Way SG1 4SZ StevenageHertfordshire, U.K.
Italian: Rue-de-la-Pastorale 26-28
Polish: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Italian: Danimarca NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Polish: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Italian: Il CHMP ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con placebo.
Polish: CHMP stwierdził, że w Charakterystykach Produktu Leczniczego oraz w odpowiedniej części ulotek dla pacjenta w przypadku produktów leczniczych zawierających citalopram, escitalopram, fluoksetynę, fluwoksaminę, mianserynę, milnacipran, mirtazapinę, paroksetynę, reboksetynę, sertralinę oraz wenlafaksynę powinno znaleźć się ostrzeżenie odzwierciedlające fakt, że w toku prób klinicznych zachowania samobójcze (próby samobójstwa oraz myśli samobójcze), wrogość (szczególnie agresję, zachowania buntownicze i przejawy gniewu) obserwowano częściej u dzieci i młodzieży leczonych lekami antydepresyjnymi niż u grupy, której podawano placebo.
Italian: LABORATORIOS DR. ESTEVE, S.A., Avda.
Polish: Hiszpania LABORATORIOS DR. ESTEVE, S.A., Avda.
Italian: Kubickiego 11, 02-954 Warszawa, Poland
Polish: Ranbaxy (Poland) Sp. z o.o., ul. Kubickiego 11, 02-954 Warszawa, Poland
Italian: TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Polish: Hiszpania TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Italian: Regno Unito 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
Italian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
Polish: Via G. Richard, 7 20143 Milano Italy
Italian: ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022 Barcelona, Spain
Polish: Hiszpania ALMIRALL PRODESFARMA S.A., Ronda General Mitre 151 , 08022
Italian: Portogallo Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Polish: Portugalia Tecnimede - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros - Edifício Sagres, 3º A 2685338 Prior Velho Portugal
Italian: Ratiopharm Italia S.r.l. Viale Monza, 20 20128 Milano Italy
Polish: Viale Monza, 20 20128 Milano Italy
Italian: Danimarca Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Polish: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: Capsula, morbida
Polish: Kapsułka, twarda
Italian: MUNDOGEN FARMA, S.A., Severo Ochoa, 2, Tres Cantos 28760, Spain
Polish: Hiszpania MUNDOGEN FARMA, S.A., Severo Ochoa, 2, Tres Cantos 28760, Spain
Italian: Regno Unito Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Polish: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: Germania Synthon B.V.
Polish: Synthon B.V.
Italian: Portogallo Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Polish: Portugalia Farmoz - Sociedade TécnicoMedicinal, S.A., Rua Prof. Henrique de Barros, Edifício Sagres, 3ºA 2685-338 Prior Velho Portugal
Italian: LAREQ PHARMA S.L, Laguna, 4244.
Polish: Hiszpania LAREQ PHARMA S.L, Laguna, 4244.
Italian: Regno Unito 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
Italian: Regno Unito Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Polish: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Italian: A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Polish: Hiszpania A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Italian: - che il comitato, per quanto concerne l'atomoxetina indicata solo per il trattamento di ADHD, ha concluso che nei riassunti delle caratteristiche dei prodotti e nei relativi foglietti illustrativi dei prodotti contenenti atomoxetina venga integrato un avvertimento concernente l'ostilità (essenzialmente aggressività, comportamento di opposizione e collera) e predisposizione emotiva frequentemente osservate negli studi clinici relativi a bambini e adolescenti trattati con atomexitina rispetto a quelli trattati con placebo nonché un avvertimento che indichi la mancanza di efficacia nella depressione.
Polish: - W przypadku atomoksetyny, która wskazana jest wyłącznie w leczeniu ADHD, Komitet stwierdził, że w Charakterystykach Produktu Leczniczego oraz w odpowiedniej części ulotek dla pacjenta w przypadku produktów leczniczych zawierających atomoksetynę powinno znaleźć się ostrzeżenie odzwierciedlające fakt, że w toku prób klinicznych wrogość (szczególnie agresję, zachowania buntownicze i przejawy gniewu) oraz labilność emocjonalną obserwowano częściej u dzieci i młodzieży leczonych atomoksetyną niż u grupy, której podawano placebo, a także ostrzeżenie wskazujące na brak skuteczności w leczeniu depresji.
Italian: KG Elisabeth-Selbert-Str. 1
Polish: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Italian: - che, di conseguenza, il comitato ha concluso che nel riassunto delle caratteristiche del prodotto e nei relativi foglietti illustrativi dei medicinali contenenti citalopram, escitalopram, fluoxetina, fluvoxamina, mianserina, milnacipran, mirtazapina, paroxetina, reboxetina, sertralina e venlafaxina deve essere integrato un avvertimento per segnalare che comportamenti suicidari (tentativo di suicidio e ideazione suicida) e ostilità (essenzialmente aggressività, comportamento di opposizione e collera) sono stati osservati più frequentemente negli studi clinici effettuati tra i bambini e adolescenti trattati con antidepressivi rispetto a quelli trattati con placebo;
Polish: - W rezultacie Komitet stwierdził, że w Charakterystykach Produktu Leczniczego oraz w odpowiedniej części ulotek dla pacjenta w przypadku produktów leczniczych zawierających citalopram, escitalopram, fluoksetynę, fluwoksaminę, mianserynę, milnacipran, mirtazapinę, paroksetynę, reboksetynę, sertralinę oraz wenlafaksynę powinno znaleźć się ostrzeżenie odzwierciedlające fakt, że w toku prób klinicznych zachowania samobójcze (próby samobójstwa oraz myśli samobójcze), wrogość (szczególnie agresję, zachowania buntownicze i przejawy gniewu) obserwowano częściej u dzieci i młodzieży leczonych lekami antydepresyjnymi niż u grupy, której podawano placebo.
Italian: Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Polish: PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Italian: Pliva Kraków Zakłady Farmaceutyczne S.A. ul.
Polish: Pliva Kraków Zakłady Farmaceutyczne S.A. ul. Mogilska 80
Italian: Lussemburgo DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Polish: Luksemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Italian: PFIZER, S.A., Avda.
Polish: Hiszpania PFIZER, S.A., Avda.
Italian: Regno Unito Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Polish: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Italian: Alfred Tiefenbacher (GmbH & Co.
Polish: Alfred Tiefenbacher (GmbH & Co. KG)
Italian: USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain
Polish: Hiszpania USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid, 28008, Spain
Italian: Portogallo Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Polish: Portugalia Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
Italian: USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid 28008, Spain
Polish: Hiszpania USO RACIONAL, S.L., Ferraz, 10 - 1º Izda., Madrid 28008, Spain
Italian: Regno Unito Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Polish: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Italian: Danimarca Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Polish: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Polish: Hiszpania LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Italian: PENSA, S.A., Avda.
Polish: Hiszpania PENSA, S.A., Avda.
Italian: Danimarca Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Polish: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Italian: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Polish: Hiszpania LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid, 28027, Spain
Italian: Repubblica Ceca
Polish: Czech Republic
Italian: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Polish: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
Italian: Box 20, Oss, Netherland
Polish: Organon, P.O. Box 20, Oss, Netherland
Italian: Regno Unito KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Polish: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Italian: LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Polish: Hiszpania LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Italian: LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain
Polish: Hiszpania LABORATORIOS ANDROMACO, S.A., Doctor Zamenhof, 36., Madrid 28027, Spain
Italian: LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Polish: Hiszpania LAB. ANGENERICO, S.L.Osio, 7-9 08034 Barcelona, Spain
Italian: Slovacchia Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Polish: Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Italian: Portogallo Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
Polish: Portugalia Beecham Portuguesa - Produtos Farmacêuticos e Químicos, Lda., Rua Dr. António Loureiro Borges n.º 3Arquiparque - Miraflores 1495-131
Italian: Slovacchia Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Polish: Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest
Italian: Danimarca Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Polish: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Italian: Regno Unito Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Polish: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Italian: Danimarca Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Polish: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark