FrancophonIA/ELRC3.0 huggingface dataset:
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Latvian: Nīderlande Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Latvian: Nīderlande Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Latvian: Nīderlande Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Latvian: Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
English: So. Se. Pharm S.r.l.
Latvian: Se. Pharm S.r.l.
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Latvian: Nīderlande Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: GlaxoSmithKline (Ireland) Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Latvian: Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Latvian: III.2. GROZĪJUMI, KAS JĀIEKĻAUJ ATTIECĪGAJĀ ATOMOKSETĪNA ZĀĻU APRAKSTA IEDAĻĀ
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Latvian: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Latvian: Portugāle Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Latvian: Nīderlande Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Gladem 20mg/mlKonzentrat zur Herstellung einer Trinklösung
Latvian: Gladem 20mg/ml-Konzentrat zur Herstellung einer Trinklösung
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Latvian: Rijksweg 12 2870 Puurs, Belgium
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Latvian: TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: Desifluvox amin 25 mg 25 mg
Latvian: Desifluvox amin 25 mg
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Latvian: PAMATOJUMS GROZĪJUMU IZDARĪŠANAI ZĀĻU APRAKSTOS
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Latvian: Nīderlande Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Latvian: Nīderlande Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Latvian: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Remeron 15mg/mlLösung zum Einnehmen
Latvian: Remeron 15mg/ml-Lösung zum Einnehmen
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Latvian: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Via Nettunense, 90 04011 Aprilia - Roma Italy
Latvian: Wyeth Lederle S.p.A. Via Nettunense, 90 04011 Aprilia - Roma Italy
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Latvian: Nīderlande Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Oral Solution
Latvian: Prozit Oral Solution
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Latvian: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Latvian: Ar SNRI apzīmē “serotonīna norepinefrīna atpakaļuzņemšanas inhibitoru”.
English: ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Latvian: Portugāle ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
English: Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244 Porto Salvo Portugal
Latvian: Portugāle Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda., Empreendimento Lagoas ParkEdifício 7, 2º e 3º andar 2740-244
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Latvian: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: 1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine.
Latvian: zālēm, jo īpaši par to lietošanu bērniem - fluoksetīns, fluvoksamīns, sertralīns, paroksetīns, citaloprams, escitaloprams, atomoksetīns, duloksetīns, venlafaksīns, mianserīns, milnaciprans, reboksetīns, un mirtazapīns.
English: Via Matteo Civitali, 1 20148 Milano Italy
Latvian: Recordati S.p.A. Via Matteo Civitali, 1 20148 Milano Italy
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Latvian: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Latvian: Nīderlande Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Latvian: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: PAROXETINE,
Latvian: PAROKSETĪNA,
English: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Latvian: Portugāle Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Latvian: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Cipramil Infusionsloesungskonzentrat 40 mg
Latvian: Infusionsloesungskonzentrat 40 mg
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Latvian: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Latvian: 2 SNRIs iedarbojas uz neirotransmiteriem noradrenalīnu un serotonīnu.
English: Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Latvian: Portugāle Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
English: Devon, EX32 8NS UNITED KINGDOM
Latvian: Devon, EX32
English: Miraflores 1495-153 Algés Portugal
Latvian: Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
English: Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
Latvian: Norvēģija Alpharma ApS, Dalslandsgade 11, DK-2300 København S, Denmark
English: Belgium BEXAL S.P.R.L.
Latvian: BEXAL S.P.R.L.
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Latvian: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Latvian: Nīderlande Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Latvian: Nīderlande KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Latvian: Nīderlande Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Latvian: Nīderlande Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Fluvoxaminmaleat “Solvay” 100mgFilmtabletten
Latvian: Fluvoxaminmaleat “Solvay” 100mg-Filmtabletten
English: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Latvian: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
English: Desiflu voxamin 100 mg 100 mg
Latvian: Desiflu voxamin 100 mg
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Latvian: Nīderlande Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with [Invented Name] compared to those treated with placebo.
Latvian: Naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedību un dusmas), kā arī emocionālo labilitāti biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, ko ārstēja ar [piešķirtais nosaukums] salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi.
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Latvian: PFIZER MANUFACTURING BELGIUM S.A.
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Latvian: Karl-Lueger-Ring 6 A-1010 Wien
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Latvian: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Latvian: Vācija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: 6XA, United Kingdom
Latvian: 8NS; UK
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Latvian: IV PIELIKUMS GROZĪJUMI, KAS ATTIECAS UZ LIETOŠANAS INSTRUKCIJU
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Latvian: Portugāle toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
English: Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327 Amadora Portugal
Latvian: Portugāle Laboratórios Vitória, S.A., Rua Elias Garcia, nº 28 - Venda Nova 2700-327
English: Inpharmco-Mianserin30mg-Tabletten
Latvian: Inpharmco-Mianserin-30mgTabletten
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Latvian: Nīderlande Alfred Tiefenbacher (GmbH & Co.
English: Fluoxetin Hexal 4mg/ml Loesung
Latvian: Fluoxetin Hexal 4mg/ml Loesung 20 mg
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Latvian: Portugāle toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Latvian: Nīderlande Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Prozac Durapac 90 mg Cápsulas Duras GastroResistentes
Latvian: Prozac Durapac 90 mg Cápsulas Duras Gastro-Resistentes
English: Floccin 20mg/5mlLösung zum Einnehmen
Latvian: Floccin 20mg/5ml-Lösung zum Einnehmen
English: S.A. Laboratoires S.M.B.
Latvian: Laboratoires SMB S.A.
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Latvian: Turklāt gandrīz visām zālēm un indikācijām konstatēja pazīmes, kuras saistītas ar blakusparādībām, piemēram, naidīgumu, pašsakropļošanos un emocionālu labilitāti.
English: Belgium A.H.P.
Latvian: A.H.P.
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Latvian: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Paroxetin “Salutas” 40mg-Filmtabletten
Latvian: Paroxetin “Salutas” 40mgFilmtabletten
English: Ranbaxy Ireland Limited, Cork Road, Cashel, Co. Tipperary, Ireland
Latvian: Ranbaxy Ireland Limited, Cork Road, Cashel, Co.
English: Fluoxetin „Lilly“ 20mglösliche Tabletten
Latvian: Fluoxetin „Lilly“ 20mg-lösliche Tabletten
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Latvian: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Latvian: GROZĪJUMI, KAS JĀIEKĻAUJ ATTIECĪGAJĀ ATOMOKSETĪNA LIETOŠANAS INSTRUKCIJAS IEDAĻĀ
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Latvian: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Latvian: Portugāle Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda., Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
English: Mw.drs.S.A.
Latvian: Organon t.a.v. Mw.drs.S.A.
English: Fluxet 20 mg snap-tab 20 mg
Latvian: Fluxet 20 mg snap-tab
English: Via Vallisneri, 10 20133 Milano Italy
Latvian: Valeas S.p.A. Via Vallisneri, 10 20133 Milano Italy
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Latvian: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte;
English: Via Bianchi Maria Visconti 20122 Milano, Italy
Latvian: Lampugnani Farmaceutici S.p.A. Via Bianchi Maria Visconti 20122 Milano, Italy
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.
Latvian: CHMP piekrita, ka bērniem un pusaudžiem, kuri ārstēti ar SSRI un SNRI, bija biežāk sastopamas iespējamās uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību, tostarp pašnāvības mēģinājumiem un domām par pašnāvību un/vai ar to saistīta uzvedība, piemēram, pašsakropļošanās, naidīguma un garastāvokļa labilitātes.
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Latvian: Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Via A. Fleming, 2 37135 Verona Italy
Latvian: Glaxosmithkline S.p.A. Via A. Fleming, 2 37135 Verona Italy
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Latvian: Uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību (pašnāvības mēģinājumiem un domām par pašnāvību), kā arī naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedību un dusmas) biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi.
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Latvian: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Via E. Folli, 50 20134 Milano Italy
Latvian: Bracco S.p.A. Via E. Folli, 50 20134 Milano Italy
English: Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462 4450-013 Matosinhos Portugal
Latvian: Portugāle Medicamed - Produtos Médicos e Farmacêuticos, S.A., Edifício Olympus - Avenida D. Afonso Henriques, 1462
English: N. V. Organon Kloosterstraat 6 5949 AB- OSS The Netherlands
Latvian: V. Organon Kloosterstraat 6 5949 AB- OSS The Netherlands
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Latvian: Ja kāda no iepriekš uzskaitītajām pazīmēm pastiprinās vai tā kļūst izteiktāka, kamēr pacienti, kas ir jaunāki par 18 gadiem, lieto [piešķirtais nosaukums], informējiet savu ārstu.
English: Tolvon, tablets 10 mg 10 mg
Latvian: Tolvon, tablets 10 mg
English: Portal capsules 20 mg 20 mg
Latvian: Portal capsules 20 mg
English: Member State Marketing Authorisation Holder Invented Name
Latvian: Reģistrācijas Apliecības Īpašnieks Izgudrotais nosaukums
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Latvian: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Latvian: Andersens Boulevard 2, DK-1780 København V, Denmark
English: ZOLOFT OC 20mg/ml 20mg/ml
Latvian: ZOLOFT OC 20mg/ml
English: Cipramil Infusionsloesungskonzentrat 20 mg
Latvian: Infusionsloesungskonzentrat 20 mg
English: Lithuania ICN Polfa Rzeszow, ul.
Latvian: ICN Polfa Rzeszow, ul.
English: Inpharmco-Mianserin10mg-Tabletten
Latvian: Inpharmco-Mianserin-10mgTabletten
English: Estrada Nacional 10, Km 140,260 2696-901 Bobadela Portugal
Latvian: 2696-901 Bobadela Portugal
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Latvian: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
Latvian: Athlone Laboratories Limited, Ballymurray, Co.
English: Farmagon AS, P.O.Box 35, 1332 Østerås, Norway
Latvian: Norvēģija Farmagon AS, P.O.Box 35, 1332
English: Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Latvian: Portugāle Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Latvian: Laboratoires S.M.B. Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
English: Desiflu voxamin 50 mg 50 mg
Latvian: Desiflu voxamin 50 mg
English: Laboratório B. A. Farma, Lda., Rua Prof. Sousa da Câmara, 207-211 1074803 Lisboa Portugal
Latvian: Sousa da Câmara, 207-211 1074803 Lisboa Portugal
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Latvian: Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Latvian: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co.
English: 67, 02631 Espoo, Finland
Latvian: Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Latvian: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Latvian: Europark Oost 34, 9100 St.
English: Mutan 20mgFilmtabletten
Latvian: Mutan 20mg-Filmtabletten
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Latvian: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Kortrijk, Belgium
Latvian: Niklaas, Belgium
English: - The Committee, in view of available data from clinical trials, concluded that there is a signal of 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 Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors, such as the medicinal products mentioned above;
Latvian: - Komiteja, ņemot vērā esošos klīniskās izpētes datus secināja, ka bērniem un pusaudžiem, ko ārstēja ar selektīvajiem serotonīna atpakaļuzņemšanas inhibitoriem un serotonīnanoradrenalīna atpakaļuzņemšanas inhibitoriem, kādas ir iepriekš minētās zāles, konstatēja uzvedības pazīmes, kas liecina par tieksmi uz pašnāvību, tostarp pašnāvības mēģinājumiem, domām par pašnāvību, kā arī/vai ar to saistītu uzvedību, piemēram, pašsakropļošanos, naidīgumu un emocionālo labilitāti;
English: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Latvian: SOLVAY PHARMA, 3 Avenue du Bourgmestre, E.
English: Felixsan 50mgFilmtabletten
Latvian: Felixsan 50mg-Filmtabletten
English: Poligono Can Calderon, Viladecans 08840, Spain
Latvian: SUMOL PHARMA, S.A., Andorra, 64. Poligono Can Calderon, Viladecans 08840, Spain
English: Paroxetin “Merckle” 20mg-Filmtabletten
Latvian: Paroxetin “Merckle” 20mgFilmtabletten
English: Paroxetin “Sandoz” 20mg-Tabletten
Latvian: Paroxetin “Sandoz” 20mgTabletten
English: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 A
Latvian: Bexal Produtos Farmacêuticos S.A., Rua Prof.
English: LABORATORIO FARMACEUTICO C.T.
Latvian: LABORATORIO FARMACEUTICO C.T. S.R.L.
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Latvian: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Mianserin 30mg Holsten 30 mg
Latvian: Mianserin 30mg Holsten
English: Via Tor Sapienza, 138 00155 Roma Italy
Latvian: Polifarma S.p.A. Via Tor Sapienza, 138 00155 Roma Italy
English: Mianserin Organon 10mg 10 mg
Latvian: Mianserin Organon 10mg
English: Pol. Ind. Urtinsa II 28923 Alcorcón, Spain
Latvian: Urtinsa II 28923 Alcorcón, Spain
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Latvian: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Citalopram-Hormosan 10mg
Latvian: Citalopram-Hormosan 10mg 10 mg
English: Via G. Richard, 7 20143 Milano Italy
Latvian: Teva Pharma S.p.A. Via G. Richard, 7 20143 Milano Italy
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Latvian: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Latvian: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Latvian: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Efexor Modified Release XL
Latvian: Efexor Modified Release XL 150 mg
English: Mianserin Organon 60mg 60 mg
Latvian: Mianserin Organon 60mg
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Latvian: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Citalopram-Hormosan 40mg
Latvian: Citalopram-Hormosan 40mg 40 mg
English: SERTRALIN IREX 100 MG
Latvian: SERTRALIN IREX 100 MG 100 mg
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Latvian: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: SEROXAT 30 MG 30 mg
Latvian: SEROXAT 30 MG
English: PAROXETINA APOTEX-FARMA
Latvian: PAROXETINA APOTEXFARMA
English: Mianserin „Arcana“ 30mg-Filmtabletten
Latvian: Mianserin „Arcana“ 30mgFilmtabletten
English: Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016 Amadora Portugal
Latvian: Portugāle Ciclum Farma Unipessoal, Lda., Rua Alfredo da Silva, nº 16 2610-016
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Latvian: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Latvian: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Citalopram-Hormosan 20mg
Latvian: Citalopram-Hormosan 20mg 20 mg
English: Paroxetin “Arcana” 20mg-Filmtabletten
Latvian: Paroxetin “Arcana” 20mgFilmtabletten
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Latvian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: - For atomoxetine, which is only indicated in the treatment of ADHD, the Committee concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger), and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Latvian: - Attiecībā uz atomoksetīnu, kas ir indicēts tikai ADHA ārstēšanai, Komiteja uzskata, ka atomoksetīnu saturošo zāļu aprakstā, kā arī attiecīgajā lietošanas instrukciju iedaļā ir jāiekļauj brīdinājums par to, ka naidīgumu (galvenokārt agresivitāti, opozicionāru uzvedība un dusmas), kā arī emocionālo labilitāti biežāk novēroja klīniskajās izpētēs ar bērniem un pusaudžiem, kas tika ārstēti ar antidepresantiem, salīdzinot ar tiem, kurus ārstēja, izmantojot placebo metodi, kā arī brīdinājums, ka zāles nav iedarbīgas pret depresiju.
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Latvian: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Tolvon, tablets 3 mg 30 mg
Latvian: Tolvon, tablets 3 mg
English: Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
Latvian: Portugāle Lacer, S.A., Calle Sardenya, 350 E08025 Barcelona Espanha
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Latvian: Organon , P.O.Box 20, NL - 5340 BH OSS