FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Polish: Pacjenci poniżej 18 roku życia narażeni są na zwiększone ryzyko wystąpienia skutków ubocznych takich jak wrogość (szczególnie agresja, zachowania buntownicze i przejawy gniewu) oraz labilność emocjonalna.
English: INDUSTRIAL FARMACEUTICA CANTABRIA, S.A., Carretera Cazoña-Adarzo, s/n., Santander 39011, Spain
Polish: Hiszpania INDUSTRIAL FARMACEUTICA CANTABRIA, S.A., Carretera Cazoña-Adarzo, s/n., Santander 39011, Spain
English: LABORATORIOS SPYFARMA, S.A, Crta.
Polish: Hiszpania LABORATORIOS SPYFARMA, S.A, Crta.
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Polish: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Polish: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
Polish: Portugalia Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
English: LABORATORIOS DECROX, Crta.
Polish: Hiszpania LABORATORIOS DECROX, Crta.
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
Polish: Uwaga: Niniejszy dział Charakterystyki Produktu Leczniczego jest tym, który został dołączony w formie aneksu do decyzji Komisji na podstawie odwołania się do art.31.
English: ORGANON ESPAÑOLA, S.A., Ctra.
Polish: Hiszpania ORGANON ESPAÑOLA, S.A., Ctra.
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Polish: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Polish: Portugalia Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Polish: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: SUMOL PHARMA, S.A., Andorra, 64.
Polish: Hiszpania SUMOL PHARMA, S.A., Andorra, 64.
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Polish: Dodatkowo, w niektórych próbach wzięli udział pacjenci cierpiący na zespół nadpobudliwości psychoruchowej z zaburzeniami koncentracji uwagi (ADHD).
English: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Polish: Portugalia Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
English: IRISFARMA, S.A.Avda.
Polish: Hiszpania IRISFARMA, S.A.Avda.
English: Luxembourg S.M.B.
Polish: Luksemburg S.M.B.
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Polish: Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Box 7071
Polish: Postbus 7071
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Polish: PODSTAWY ZMIANY CHARAKTERYSTYK PRODUKTU LECZNICZEGO
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Polish: Uwaga: Niniejszy dział ulotki dla pacjenta jest tym, który został dołączony w formie aneksu do decyzji Komisji na podstawie odwołania do art.31.
English: FAES FARMA, S.A., Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
Polish: Hiszpania FAES FARMA, S.A., Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
English: The CHMP agreed that there was a potential signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs.
Polish: CHMP przyznał, że występują potencjalne oznaki wzrostu liczby zachowań samobójczych, w tym prób samobójczych oraz wyobrażeń samobójczych i/lub powiązanych zachowań, takich jak autoagresja, wrogość oraz labilność nastroju u dzieci i młodzieży leczonych SSRI oraz SNRI.
English: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Polish: Luksemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Polish: ZAŁĄCZNIK I WYKAZ NAZW, POSTACI FARMACEUTYCZNYCH, DAWEK PRODUKTU LECZNICZEGO, DROGI PODANIA, WYTWÓRCÓW ODPOWIEDZIALNYCH ZA ZWOLNIENIE SERII W PAŃSTWACH CZŁONKOWSKICH
English: Netherlands Merck Generics BV Dieselweg 25
Polish: Merck Generics BV Dieselweg 25
English: WYETH FARMA S.A., Ctra.
Polish: Hiszpania WYETH FARMA S.A., Ctra.
English: Tablets
Polish: Tablet
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Polish: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: LABORATORIOS RUBIO, S.A., Industria 29 - Pol. Ind. Comte de Sert., Castellbisbal 08755, Spain
Polish: Hiszpania LABORATORIOS RUBIO, S.A., Industria 29 - Pol. Ind. Comte de Sert., Castellbisbal 08755, Spain
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Polish: Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Polish: Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Polish: Portugalia Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
English: Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Polish: Portugalia Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
English: Belgium OLYMPO PHARMA B.V.B.A.
Polish: OLYMPO PHARMA B.V.B.A.
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Polish: Portugalia Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
English: DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain
Polish: Hiszpania DERMOGEN FARMA, S.A., SAN RAFAEL, 3, Alcobendas 28108, Spain
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Polish: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Polish: III.2 ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI SPC W PRZYPADKU ATOMOKSETYNY
English: Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Polish: Portugalia Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
English: Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Polish: Portugalia Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Polish: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Polish: Portugalia Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Polish: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Lange Munteplein 7b 4, 8500
Polish: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Polish: Portugalia Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
English: Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Polish: Portugalia Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
English: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Polish: Luksemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
English: ICN IBERICA, S.A., Casanova, 2731., Corbera de Llobregat 08757, Spain
Polish: Hiszpania ICN IBERICA, S.A., Casanova, 2731., Corbera de Llobregat 08757, Spain
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Polish: Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Polish: Portugalia Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Polish: IV.2 ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI PL W PRZYPADKU ATOMOKSETYNY
English: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Polish: Portugalia Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
Polish: Portugalia Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Polish: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Whereas - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine;
Polish: Mając na uwadze, co następuje: - Komitet rozważył skierowanie na mocy art. 31 dyrektywy 2001/83/WE, z późniejszymi zmianami, w związku z produktami leczniczymi zawierającymi atomoksetynę, citalopram, escitalopram, fluoksetynę, fluwoksaminę, mianserynę, milnacipran, mirtazapinę, paroksetynę, reboksetynę, sertalinę i wenlafaksynę,
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Polish: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Polish: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Polish: GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Polish: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Polish: Holandia ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: III.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR FLUOXETINE,
Polish: III.I ZMIANY, KTÓRE NALEŻY WPROWADZIĆ W ODPOWIEDNIEJ CZĘŚCI SPC W PRZYPADKU FLUOKSETYNY,
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Polish: Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: 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
English: IPSEN PHARMA, S.A., Ctra.
Polish: Hiszpania IPSEN PHARMA, S.A., Ctra.
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Polish: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Polish: W kilku próbach uczestniczyli pacjenci z różnego rodzaju zaburzeniami lękowymi (zaburzeniami obsesyjno-kompulsywnymi (OCD), uogólnionymi zaburzeniami lękowymi (GAD) oraz zespołem fobii społecznej (SAD)).
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Polish: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: LABORATORIOS DECROX, S.A., Crta.
Polish: Hiszpania LABORATORIOS DECROX, S.A., Crta.
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Polish: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Polish: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Polish: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: 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
English: Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Polish: Nave 2, Avilés (Asturias) 33400, Spain
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Polish: via Nocera Umbra 75 00100 Roma Italy
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Polish: SNRI działają na neuroprzekaźniki noradrenaliny i serotoniny.
English: 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
English: 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.
English: DISTA, Avda.
Polish: Hiszpania DISTA, Avda.
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Polish: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Polish: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Polish: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Polish: 1 Skrót SSRI oznacza „Selektywny inhibitor wychwytu zwrotnego serotoniny”.
English: ACOST COMERCIAL GENERICPHARMA, Ferraz, 10.
Polish: Hiszpania ACOST COMERCIAL GENERICPHARMA, Ferraz, 10.
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
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.
English: 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
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Polish: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda.
Polish: Hiszpania LABORATORIOS AGEN GENERICOS FARMACEUTICOS, S.L., Avda.
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Polish: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: 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
English: 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
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Polish: ZAŁĄCZNIK III ZMIANY W CHARAKTERYSTYCE PRODUKTU LECZNICZEGO
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Polish: Europark Oost 34, 9100 St. Niklaas, Belgium
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Polish: Jeśli po rozpoczęciu leczenia nastąpił rozwój lub nasilenie któregokolwiek z wyżej wymienionych objawów, należy poinformować o tym swojego lekarza.
English: 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
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Polish: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Polish: Jednakże w badaniach nad depresją występowały wyraźne oznaki zachowań samobójczych.
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Polish: Portugalia Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Polish: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Polish: Portugalia Germed Farmacêutica, Lda., Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Polish: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Polish: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: 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
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Polish: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Oral solution
Polish: Prozit Oral Solution
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Polish: Luksemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: 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
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Polish: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Polish: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Polish: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: B.V. Postbus 75
Polish: Postbus 75
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Polish: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Polish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Polish: Viale Amelia, 70 00181 Roma Italy
English: 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
English: 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
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Polish: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: 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
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Polish: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: 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
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Polish: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Polish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Polish: Alfred Tiefenbacher (GmbH & Co. KG)
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
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).
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Polish: Rijksweg 12 2870 Puurs, Belgium
English: INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A., Laguna, 42-44.
Polish: Hiszpania INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A., Laguna, 42-44.
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Polish: ZAŁĄCZNIK IV ZMIANY W ULOTCE DLA PACJENTA
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Polish: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Polish: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Polish: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
Polish: Hiszpania LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Polish: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Wilbury Way
Polish: 1 The Cam Centre Wilbury Way
English: Denmark 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
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Polish: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: 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
English: 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
English: 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
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Polish: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany