FrancophonIA/ELRC3.0 huggingface dataset:
English: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Estonian: Prantsusmaa GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
English: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Estonian: Prantsusmaa PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
English: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Estonian: Prantsusmaa IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Estonian: SNTI tähistab serotoniini-noradrenaliini tagasihaarde inhibiitoreid (SNRI, Serotonin-Norepinephrine Uptake Inhibitors).
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Estonian: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Belgium A.H.P.
Estonian: A.H.P.
English: Lithuania ICN Polfa Rzeszow, ul.
Estonian: ICN Polfa Rzeszow, ul.
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Estonian: Ühendkuningriik Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Estonian: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Belgium Laboratoires S.M.B.
Estonian: Laboratoires S.M.B.
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Estonian: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Estonian: Ühendkuningriik Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Oral suspension
Estonian: Peroraalne suspensioon
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Estonian: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Estonian: Prantsusmaa SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Estonian: Siiski esines selge suund suitsiidikäitumisele depressiooniga patsiente uurivate katsete tulemustes; ärevushäiretega patsiente hõlmavates uuringutes esines sama tendents nõrgemal kujul.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Estonian: III LISA RAVIMI OMADUSTE KOKKUVÕTTE PARANDUSED
English: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Estonian: Ühendkuningriik Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Dispersable tablet
Estonian: Dispergeeritav tablett
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Estonian: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Estonian: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Estonian: Ühendkuningriik Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
English: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Estonian: Ühendkuningriik Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING FLUOXETINE, FLUVOXAMINE, SERTRALINE, PAROXETINE, CITALOPRAM, ESCITALOPRAM, ATOMOXETINE, VENLAFAXINE, MIANSERINE, MILNACIPRAN, REBOXETINE AND MIRTAZAPINE (see Annex I)
Estonian: FLUOKSETIINI, FLUVOKSAMIINI, SERTRALIINI, PAROKSETIINI, TSITALOPRAAMI, ESTSITALOPRAAMI, ATOMOKSETIINI, VENLAFAKSIINI, MIANSERIINI, MILNATSIPRAANI, REBOKSETIINI JA MIRTASAPIINI SISALDAVATE RAVIMITE TEADUSLIKU HINDAMISE KOKKUVÕTE (vaata I lisa)
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Estonian: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Estonian: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Estonian: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Estonian: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Estonian: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Estonian: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Estonian: Ühendkuningriik Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Estonian: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Estonian: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Estonian: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Estonian: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Estonian: Organon , P.O.Box 20, NL - 5340 BH OSS
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Estonian: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Estonian: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Estonian: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Estonian: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Estonian: Ühendkuningriik John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
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
Estonian: Euroopa Komisjoni palvel hindas inimtervishoius kasutatavate ravimite komitee (CHMP) järgnevate SSTI
English: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Estonian: Ühendkuningriik Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Fluneurin 40mg Tabs
Estonian: Fluneurin 40mg Tabs 40 mg
English: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Estonian: Ühendkuningriik Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
English: Fevarin Tabs 50 mg 50 mg
Estonian: Fevarin Tabs 50 mg
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Estonian: KG Elisabeth-Selbert-Str. 1
English: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
Estonian: Prantsusmaa IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Estonian: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Estonian: Ühendkuningriik Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Estonian: Ühendkuningriik Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
English: Paroxetine Tablet OF, filmomhulde tabletten 20 mg
Estonian: Paroxetine Tablett OF, filmomhulde tabletten 20 mg
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Estonian: Alfred Tiefenbacher (GmbH & Co.
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Estonian: Luksemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Estonian: Organon, Postbus 20, NL-5340 BH Oss
English: Netherlands N.V. Organon t.a.v.
Estonian: Organon t.a.v.
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Estonian: Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: Coated tablet
Estonian: Kaetud tabletts
English: 37 avenue Pierre Premier de Serbie 75008 Paris, France
Estonian: Prantsusmaa Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris, France
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Estonian: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Estonian: SNTI-d toimivad nii serotoniinile kui ka noradrenaliinile.
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Estonian: SmithKline Beecham plc, SB House, Great West road, Brentford ,
English: Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Estonian: Ühendkuningriik Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Estonian: Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Estonian: Demunterlaan 1 b 9, 1090 Brussel, Belgium
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Estonian: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: 37 avenue Pierre Premier de Serbie 75008 Paris- France
Estonian: Prantsusmaa Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris- France
English: Netherlands Centrafarm Services B.V. Postbus 289
Estonian: Centrafarm Services B.V.
English: Prolonged release capsule, hard
Estonian: Toimeainet prolongeeritult vabastav kapsel
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
Estonian: Molièrelaan 225 1050 Brussel
English: BAYVIT, S.A., Frederic Mompou, 5, 08960 Sant Just Desvern, Spain
Estonian: Hispaania BAYVIT, S.A., Frederic Mompou, 5, 08960 Sant Just Desvern, Spain
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
Estonian: Molièrelaan 225 1050 Brussel, Belgium
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Estonian: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: 49 Avenue Georges Pompidou 92300 Levallois Perret - France
Estonian: Prantsusmaa SANDOZ 49 Avenue Georges Pompidou 92300 Levallois Perret - France
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Estonian: Prantsusmaa Sandoz 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: Dispersible tablets
Estonian: Dispergeeritav tabletts
English: 49 avenue Georges Pompidou 92300 Levallois-Perret France
Estonian: Prantsusmaa SANDOZ 49 avenue Georges Pompidou 92300 Levallois-Perret France
English: Concentrate for solution for injection
Estonian: Kontsentraat infusioonilahuse valmistamiseks
English: 6XA, United Kingdom
Estonian: 1AG; UK
English: Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Estonian: Luksemburg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Estonian: Ühendkuningriik Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Modified-release tablet capsule Oral use
Estonian: Toimeainet modifitseeritult vabastav tablett, kapsel
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Estonian: III.2 ATOMOKSETIINI RAVIMI OMADUSTE KOKKUVÕTTE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
English: Fluneurin 10mg Tabs
Estonian: Fluneurin 10mg Tabs 10 mg
English: Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Estonian: Ühendkuningriik Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
English: ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Estonian: 93300 aubervilliers - France
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Estonian: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Estonian: Ühendkuningriik Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: 37 avenue Pierre Premier de Serbie 75008 Paris -france
Estonian: Prantsusmaa Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris -france
English: Fluneurin 20mg Tabs
Estonian: Fluneurin 20mg Tabs 20 mg
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Estonian: Demunterlaan 1 1090 BRUSSEL, Belgium
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Estonian: Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad REBOKSETIINI sisaldavad ravimid
English: Luxembourg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
Estonian: Luksemburg HEXAL AG, Industrie Strasse 25, D83607 Holzkirchen, Germany
English: Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Estonian: Rootsi ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
English: Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
Estonian: Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland
English: Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
Estonian: Slovakkia Pierre Fabre Medicament, 45, Place Abel Gance, F - 92 654 Boulogne Cedex
English: Lithuania Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
Estonian: Wyeth Lederle Pharma GmbH, Storchengess 1, A - 1150 Viena, Austria
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
Estonian: Sandoz GmbH, Biochemiestrasse 10, A-6250 Austria
English: Luxembourg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium
Estonian: Luksemburg MERCK S.A., Brusselsesteenweg 288, B-3090 OVERIJSE, Belgium
English: Luxembourg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
Estonian: Luksemburg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
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.
Estonian: - komitee otsustas, et atomoksetiini, mis on näidustatud ainult tähelepanu defitsiidi ja hüperaktiivsuse häire raviks, sisaldavate preparaatide ravimi omaduste kokkuvõttesse ning pakendi infolehte tuleb lisada ravimi nõrgale antidepressiivsele toimele viitav märge ja hoiatus, mis näitaks, et kliinilistes katsetes esines atomoksetiini saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikkust (peamiselt vägivaldsust, vastandavat käitumist ja viha) ja emotsionaalset labiilsust;
English: Denmark Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
Estonian: Synthon BV, Microweg 22, NL-6545 CM, Nijmegen, Netherland
English: Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
Estonian: Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia
English: Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
Estonian: Ühendkuningriik Apotex Europe Limited, Rowan House, 41 London Street, Reading, Berks RG1 4PS; UK
English: Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
Estonian: Ühendkuningriik Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland
English: The CHMP concluded that a warning to reflect that 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, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products.
Estonian: CHMP otsustas, et estsitalopraami, fluoksetiini, fluvoksamiini, mianseriini, milnatsipraani, mirtasapiini, paroksetiini, reboksetiini, sertraliini, tsitalopraami ja venlafaksiini sisaldavate preparaatide ravimi omaduste kokkuvõtetesse ning pakendi infolehtedesse tuleb lisada hoiatus, mis näitaks, et kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha).
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
Estonian: Luksemburg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
English: Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Estonian: Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
Estonian: Luksemburg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
English: AWD.pharma GmbH & Co. KG Leipziger Str. 7-13
Estonian: KG Leipziger Str. 7-13
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Estonian: Saksamaa biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
English: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Estonian: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
English: Netherlands Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
Estonian: Pinewood Laboratories Ltd., Ballymacarbry, IE-Clonmel, Co. Tipperary
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141 1200 Bruxelles
Estonian: Rue St. Lambert 141 1200 Bruxelles
English: MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Estonian: Euroopa Liidus müügiluba omavad MILNATSIPRAANI sisaldavad ravimid
English: H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Estonian: Ühendkuningriik H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Estonian: Saksamaa biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
English: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Estonian: H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
English: Luxembourg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Estonian: Luksemburg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
English: Denmark Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
Estonian: Genthon BV, Microweg 22, NL-6545 CM Nijmegen, Netherland
English: Denmark Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
Estonian: Stada Arzneimittel AG, Staclastrasse 2-18, D-61118 Bad Vibel, Germany
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
Estonian: Arrow Generics Limited, Unit 2, Eastman Way, SG14SZ Hertfordshire, GB
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.
Estonian: Kliinilistes katsetes esines antidepressantidega ravitud lastel ja noorukitel platseebogrupiga võrreldes rohkem suitsiidikäitumist (enesetapukatseid ja suitsiidimõtteid) ja vaenulikkust (peamiselt vägivaldsust, vastanduvat käitumist ja viha).
English: Netherlands Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
Estonian: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel
English: Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Estonian: Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
English: Oropharyngeal use
Estonian: Manustamisviis
English: Denmark Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
Estonian: Arrow Generics Limited, Unit 2, Eastman Way, UK-SG1 4SZ, Hertz, GB
English: Netherlands I.C.C.
Estonian: I.C.C.
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium
Estonian: Rue St. Lambert 141, 1200 Bruxelles, Belgium
English: Therefore the CHMP 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 the relevant section of the Package Leaflets of atomoxetine containing medicinal products.
Estonian: Seetõttu otsustas CHMP, et atomoksetiini sisaldavate preparaatide ravimi omaduste kokkuvõttesse ning pakendi infolehte tuleb lisada ravimi nõrgale antidepressiivsele toimele viitav märge ja hoiatus, mis näitaks, et kliinilistes katsetes esines atomoksetiini saanud lastel ja noorukitel platseebogrupiga võrreldes rohkem vaenulikku käitumist (peamiselt vägivaldsust, vastanduvat käitumist ja viha) ning emotsionaalset labiilsust.
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Estonian: Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: Lithuania Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
Estonian: Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands