FrancophonIA/ELRC3.0 huggingface dataset:
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Lithuanian: Latvian JSC Grindeks, Krustpils ul.
English: Pfizer European Service Center N.V./S.A.
Lithuanian: Pfizer European Service Center N.V./S.
English: Luxembourg Chemische Tempelhof GMBH, Lengedestr.
Lithuanian: Liuksemburgas Chemische Tempelhof GMBH, Lengedestr.
English: N.V. Organon Molenstraat 110.
Lithuanian: Organon Molenstraat 110.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Lithuanian: Nagrinėjant elgesį, siejamą su polinkiu į savižudybę, nustatyta, kad nė vienuose tyrimuose, kurių duomenys buvo peržiūrėti, nebuvo pranešta apie savižudybės atvejus.
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Lithuanian: Buvo peržiūrėti kompetentingoms institucijoms pateikti trumpalaikių, placebu kontroliuojamų, randomizuotų klinikinių tyrimų duomenys, medicinos literatūroje paskelbti randomizuotų klinikinių tyrimų duomenys, stebimųjų ir ekologinių tyrimų duomenys.
English: As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Lithuanian: Kaip ir vartojant kitus psichotropinius vaistus, negalima atmesti retų sunkių psichinių šalutinių reakcijų galimybės.
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Lithuanian: Pastaba: Ši informacinio lapelio dalis yra tas priedas, kuris buvo pridėtas prie Komisijos sprendimo dėl šios kreipimosi procedūros pagal 31 straipsnį.
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Lithuanian: Tik kai kuriuos šių preparatų leista naudoti vaikams ir paaugliams, sergantiems obsesiniu-kompulsiniu sutrikimu, gydyti, o vieną jų - vaikams ir paaugliams, sergantiems dėmesio stokos / hiperaktyvumo sutrikimu, gydyti.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Lithuanian: Be to, trūksta ilgalaikio saugumo duomenų apie poveikį vaikų ir paauglių augimui, brendimui ir jų pažinimo bei elgsenos vystymuisi.
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Lithuanian: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.
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 .
Lithuanian: Pastaba: Ši Preparato charakteristikų santraukos dalis yra tas priedas, kuris buvo pridėtas prie Komisijos sprendimo dėl šios kreipimosi procedūros pagal 31 straipsnį.
English: St. Stephens Green, Dublin 2 Ireland
Lithuanian: Stephens Green, Dublin 2 Ireland
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Lithuanian: [Sugalvotas pavadinimas] paprastai nėra skiriamas vaikams ir jaunesniems nei 18 metų paaugliams, <išskyrus pacientus, sergančius [patvirtinta indikacija]>.
English: These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
Lithuanian: Europoje šiais preparatais gydyti depresija ir nerimo sutrikimais sergančių vaikų ir paauglių neleidžiama.
English: Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability.
Lithuanian: Pacientai, pradedami gydyti nuo dėmesio stokos / hiperaktyvumo sutrikimo, turi būti atidžiai stebimi dėl priešiškumo ar emocinio nepastovumo apraiškų atsiradimo ar pasunkėjimo.
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)).
Lithuanian: Daugumoje tyrimų dalyvavo didžiąja depresija sergantys pacientai, keliuose buvo tiriami pacientai, sergantys įvairiais nerimo sutrikimais (obsesiniu-kompulsiniu sutrikimu (OKS), generalizuoto nerimo sutrikimu (GNS) ir socialinio nerimo sutrikimu (SNS)).
English: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Lithuanian: Portugalija Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Lithuanian: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Lithuanian: Jaunesniems nei 18 metų pacientams padidėja šalutinio poveikio, kaip priešiškumas (daugiausia agresijos, opozicinio neklusnumo ir pykčio) ir emocinio nepastovumo pavojus.
English: 23 -25 Avenue du Docteur Lannelongue
Lithuanian: Prancūzija BERAL 23 -25 Avenue du Docteur Lannelongue
English: /8121AA Olst, Veerweg 12.The Netherlands
Lithuanian: van Houtenlaan 36. /8121AA Olst, Veerweg 12.The Netherlands
English: SVUS PHARMA A.S., HRADEC KRÁLOVÉ, Škroupova 957, 500 02 Hradec Králové, Czech Republic
Lithuanian: , HRADEC KRÁLOVÉ, Škroupova 957, 500 02 Hradec Králové, Czech Republic
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Lithuanian: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Lithuanian: [Sugalvotas pavadinimas] neskiriamas didžiosios depresijos epizodams ir (arba) nerimui gydyti, nes klinikiniai tyrimai, atlikti su suaugusiaisiais, neparodė jokio vaisto teigiamo poveikio, palyginti su placebu, tad veiksmingumo rodiklis šioms indikacijoms yra neigiamas.
English: The CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out respectively in Annexes III and IV.
Lithuanian: CHMP rekomendavo palikti galioti I priede minimų vaistinių preparatų registravimo liudijimus ir jų atitinkamuose Preparato charakteristikų santraukose ir Informacinių lapelių skyriuose atlikti pakeitimus, pateiktus atitinkamai III ir IV prieduose.
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Lithuanian: SSRI preparatai vadinami selektyviaisiais, nes jie veikia tik serotonino reabsorbciją.
English: Suspension
Lithuanian: Suspensija
English: Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Lithuanian: Portugalija Alpharma ApS, Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Lithuanian: Tačiau depresijos tyrimuose buvo stebimi aiškūs elgesio, siejamo su polinkiu į savižudybę, signalai, kurie kiek silpnesni nerimo tyrimuose.
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Lithuanian: Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
Lithuanian: Portugalija Laboratórios Azevedos - Indústria Farmacêutica, S.A., Estrada Nacional 117-2 2724-503 Alfragide Portugal
English: Jelfa S.A. Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
Lithuanian: Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
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
Lithuanian: I PRIEDAS SUGALVOTŲ PAVADINIMŲ, VAISTO FORMŲ, STIPRUMO, VARTOJIMO BŪDŲ IR REGISTRAVIMO LIUDIJIMO TURĖTOJŲ VALSTYBĖSE NARĖSE SĄRAŠAS
English: Winthrop Farmacêutica Portugal, Lda.
Lithuanian: Portugalija Winthrop Farmacêutica Portugal, Lda.
English: Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Lithuanian: Portugalija Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
English: Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Lithuanian: Portugalija Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
English: Vetiquima - Produtos Químicos, Lda.
Lithuanian: Portugalija Vetiquima - Produtos Químicos, Lda.
English: Luxembourg S.M.B.
Lithuanian: Liuksemburgas S.M.B.
English: Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Lithuanian: Portugalija Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
English: Netherlands Merck Generics BV Dieselweg 25
Lithuanian: Merck Generics BV Dieselweg 25
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Lithuanian: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Lithuanian: Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Lithuanian: Būtinai pasakykite gydytojui, jei pradėjus gydymą pasireiškė ar pasunkėjo bent vienas iš pirmiau išvardytų simptomų.
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Lithuanian: Taip pat keliuose tyrimuose dalyvavo dėmesio stokos / hiperaktyvumo sutrikimu (DSHS) sergantys pacientai.
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Lithuanian: Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Belgium OLYMPO PHARMA B.V.B.A.
Lithuanian: OLYMPO PHARMA B.V.B.A.
English: S.R.O., PRAGUE, Stroupežnického 17, 150 00 Praha 5, Czech Republic
Lithuanian: , PRAGUE, Stroupežnického 17, 150 00 Praha 5, Czech Republic
English: Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI
Lithuanian: Žmonėms skirtų vaistų komitetas (CHMP) Europos Komisijos reikalavimu peržiūrėjo nacionalinių kompetentingų institucijų surinktus SSRI
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Lithuanian: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Wyeth Medica Ireland - Little Connell, Newbridge, Co. Kildare, (Ireland)
Lithuanian: Wyeth Medica Ireland - Little Connell, Newbridge, Co.
English: Frankfurter Str. 129a D-64293 Darmstadt
Lithuanian: 129a D-64293 Darmstadt
English: [Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Lithuanian: [Sugalvotas pavadinimas] draudžiama skirti vaikams ir jaunesniems nei 18 metų paaugliams, <išskyrus pacientus, sergančius [patvirtinta indikacija]>.
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Lithuanian: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Lithuanian: Portugalija Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Lithuanian: 1 SSRI - selektyvieji serotonino reabsorbcijos inhibitoriai.
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
Lithuanian: CHMP nustatė, kad atomoksetino tyrimuose nepastebėta elgesio, siejamo su padidėjusiu polinkiu į savižudybę, pavojaus, nors elgesio sutrikimų, susijusių su agresijos ir priešiškumo padidėjimu, didesnis pavojus yra.
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Lithuanian: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Lange Munteplein 7b 4, 8500
Lithuanian: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Laboratórios Atral, S.A., Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
Lithuanian: , Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Lithuanian: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: N.V. Organon, P.O.
Lithuanian: Organon, P.O.
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Lithuanian: Liuksemburgas Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: Remeron 3mg/mlKonzentrat zur Herstellung einer Infusionslösung
Lithuanian: Remeron 3mg/ml-Konzentrat zur Herstellung einer Infusionslösung
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Lithuanian: Nepaisant to, gydytojas gali skirti [sugalvotas pavadinimas] jaunesniems nei 18 metų pacientams, jei, jo manymu, tai yra jiems tinkamiausias gydymas.
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Lithuanian: Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Lithuanian: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Lithuanian: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Lithuanian: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
Lithuanian: Portugalija Prodome - Companhia Portuguesa de Genéricos, Lda., Rua Gomes Freire, n.º 9-A 1150-175 Lisboa Portugal
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Lithuanian: GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
Lithuanian: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Lithuanian: II PRIEDAS EUROPOS VAISTŲ AGENTŪROS PATEIKTŲ MOKSLINIŲ IŠVADŲ IR PREPARATO CHARAKTERISTIKŲ SANTRAUKŲ BEI INFORMACINIŲ LAPELIŲ PATAISYMŲ PAGRINDAI
English: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Lithuanian: Portugalija Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
English: VEGAL FARMACEUTICA, S.L., Tramontana, 44, 28223 Pozuelo de Alarcón, Spain
Lithuanian: L., Tramontana, 44, 28223 Pozuelo de Alarcón, Spain
English: Lundbeck ( Ireland ) Limited, 14 Deansgrange Industrial Estate, Blackrock, Co. Dublin, Ireland
Lithuanian: Lundbeck ( Ireland ) Limited, 14 Deansgrange Industrial Estate, Blackrock, Co.
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Lithuanian: Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Lithuanian: Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.,
Lithuanian: Portugalija Alodial Farmacêutica - Comércio de Produtos Farmacêuticos, Lda.
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Lithuanian: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Alter, S.A., Estrada Marco do GriloZemouto 2830 Coina Portugal
Lithuanian: , Estrada Marco do GriloZemouto 2830 Coina Portugal
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Lithuanian: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Lithuanian: ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Lithuanian: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Lithuanian: SNRI preparatai veikia serotonino ir noradrenalino neurotransmiterius.
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Lithuanian: Liuksemburgas WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Lithuanian: via Nocera Umbra 75 00100 Roma Italy
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Lithuanian: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Lithuanian: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209 Carnaxide Portugal
Lithuanian: Portugalija Catarina Vieira, Rua Caetano Beirão, nº 3 R/C Esq. - Outurela 2790-209
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Lithuanian: PREPARATO CHARAKTERISTIKŲ SANTRAUKŲ PATAISŲ PAGRINDIMAS
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Lithuanian: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: TEVA GENERICOS ESPAÑOLA, S.L.C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.Madrid, Spain
Lithuanian: TEVA GENERICOS ESPAÑOLA, S.L.C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
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;
Lithuanian: Kadangi - Komitetas svarstė pagal iš dalies pakeistos Direktyvos 2001/83/EB 31 straipsnį pateiktos arbitražo procedūros klausimus dėl vaistinių preparatų, kurių sudėtyje yra atomoksetino, citalopramo, escitalopramo, fluoksetino, fluvoksamino, mianserino, milnaciprano, mirtazapino, paroksetino, reboksetino, sertralino ir venlafaksino;
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Lithuanian: 2 SNRI - serotonino ir noradrenalino reabsorbcijos inhibitoriai.
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Lithuanian: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Lithuanian: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Lithuanian: V. Rijksweg 12 2870 Puurs, Belgium
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Lithuanian: Portugalija Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 13 - 1º Dto.
English: A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Lithuanian: Menarini Industrie Farmaceutiche Riunite S.r.l.
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Lithuanian: IV PRIEDAS INFORMACINIO LAPELIO PAKEITIMAI
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Lithuanian: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: FAES FARMA, S.A., Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
Lithuanian: , Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Lithuanian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Lithuanian: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050094 Lisboa Portugal
Lithuanian: Portugalija Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda, Praça Duque de Saldanha n.º 1 - 4º E 1050-094
English: KRKA,p.o.,68000 NOVO MESTOSLOVENIA
Lithuanian: ,68000 NOVO MESTOSLOVENIA
English: Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
Lithuanian: Norvegija Pfizer AS, P.O.Box 3, NO-1324 Lysaker, Norway
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Lithuanian: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
Lithuanian: Norvegija Nycomed Pharma AS, P.O.Box 205, NO-1372 Asker, Norway
English: Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Lithuanian: Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Lithuanian: Avenue Mercator 1 1300 Wavre, Belgium
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Lithuanian: Po pirminės duomenų, kuriuos turėjo nacionalinės kompetentingos institucijos, peržiūros Žmonėms skirtų vaistų komitetas nusprendė, kad yra pagrindo manyti, jog nuo šių preparatų vaikams ir paaugliams padidėja elgesio, siejamo su polinkiu į savižudybę, pavojus.
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Lithuanian: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Lithuanian: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Lithuanian: Būtinai pasakykite gydytojui, jei jaunesniems nei 18 metų pacientams, vartojantiems [sugalvotas pavadinimas], pasireiškė ar pasunkėjo bent vienas iš pirmiau išvardytų simptomų.
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Lithuanian: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Lithuanian: , Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
English: GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
Lithuanian: Norvegija GlaxoSmithKline AS, P.O.Box 180 Vinderen, NO-0319 Oslo, Norway
English: Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Lithuanian: Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Lithuanian: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: SERTRALINE,
Lithuanian: SERTRALINO,
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Lithuanian: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Lithuanian: Be to, Komitetas nusprendė, kad į atomoksetino aprašus turėtų būti įtrauktas kitoks įspėjimas, nes šis vaistas skirtas tik dėmesio stokos / hiperaktyvumo sutrikimui gydyti.