FrancophonIA/ELRC3.0 huggingface dataset:
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Finnish: Luxemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Finnish: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Finnish: Iso-Britannia Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Finnish: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Finnish: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Finnish: Iso-Britannia Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Finnish: Rijksweg 12 2870 Puurs, 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;
Finnish: Ottaen huomioon, että - komitea on käsitellyt muutetun direktiivin 2001/83/EY 31 artiklan mukaista pyyntöä, joka koskee atomoksetiinia, sitalopraamia, eskitalopraamia, fluoksetiinia, fluvoksamiinia, mianseriinia, milnasipraania, mirtatsapiinia, paroksetiinia, reboksetiinia sertraliinia ja venlafaksiinia sisältäviä lääkkeitä;
English: SERTRALINE,
Finnish: SERTRALIINIA,
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Finnish: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Finnish: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Finnish: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Finnish: Luxemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Finnish: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Wilbury Way
Finnish: 1 The Cam Centre Wilbury Way
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Finnish: Luxemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Finnish: 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
Finnish: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Finnish: Iso-Britannia Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Finnish: Iso-Britannia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Van-der-Smissen-Strasse 1
Finnish: KG) Van-der-Smissen-Str. 1
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Finnish: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Finnish: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Finnish: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Finnish: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Finnish: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Finnish: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Finnish: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Finnish: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Finnish: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Finnish: Saksa ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Finnish: Iso-Britannia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
English: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Finnish: Iso-Britannia Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Finnish: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Finnish: Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Finnish: 2 SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) merkitsee selektiivistä serotoniinin ja noradrenaliinin takaisinoton estäjää.
English: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Finnish: Iso-Britannia Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Finnish: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Finnish: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Belgium BEXAL S.P.R.L.
Finnish: BEXAL S.P.R.L.
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Finnish: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Finnish: Zoloft 25 mg + 50 mg 25 mg + 50 mg Tabletti, kalvopäällysteinen Suun kautta
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Finnish: Iso-Britannia Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Finnish: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Finnish: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Finnish: Portugali toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Finnish: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
Finnish: Portugali toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, 5º D - Queluz de Baixo 2730-055 Barcarena Portugal
English: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Finnish: Iso-Britannia Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
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.
Finnish: Suisidaalista käyttäytymistä (itsemurhayrityksiä ja itsemurha-ajatuksia) sekä vihamielisyyttä (pääasiassa aggressiota, vastustavaa käyttäytymistä ja vihaa) havaittiin kliinisissä tutkimuksissa useammin masennuslääkkeitä saaneilla lapsilla ja nuorilla kuin lumelääkettä saaneilla lapsilla ja nuorilla.
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Finnish: Luxemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Finnish: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Finnish: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
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.
Finnish: CHMP katsoi, että SSRI- ja SNRI-hoitoa saaneiden lasten ja nuorten suisidaalinen käyttäytyminenmukaan lukien itsemurhayritykset ja itsemurha-ajatukset ja/tai sen kaltainen käyttäytyminen, kuten itsensä vahingoittaminen, vihamielisyys ja mielialan epävakaisuus - olivat mahdollisesti yleistyneet.
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
Finnish: III.2 MUUTOKSET ATOMOKSETIININ VALMISTEYHTEENVEDON ASIANOMAISEEN KOHTAAN
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Finnish: Lisäksi haittavaikutuksena havaittiin merkkejä haitallisesta käyttäytymisestä, jota oli esimerkiksi vihamielisyys, itsensä vahingoittaminen ja emotionaalinen epävakaus.
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Finnish: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Finnish: Louisalaan 149/24 B-1050 Brussel, Belgium
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.
Finnish: CHMP tuli siihen tulokseen, että atomoksetiinin tutkimuksissa ei ilmennyt signaalia lisääntyneestä suisidaalisen käyttäytymisen riskistä.
English: Lithuania ICN Polfa Rzeszow, ul.
Finnish: ICN Polfa Rzeszow, ul.
English: Belgium A.H.P.
Finnish: A.H.P.
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Finnish: NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Dispersible tablets
Finnish: Dispergoituva tabletti
English: Belgium Laboratoires S.M.B.
Finnish: Laboratoires S.M.B.
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Finnish: Iso-Britannia Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Finnish: Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Finnish: Iso-Britannia Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Finnish: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Finnish: Iso-Britannia Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
English: Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Finnish: TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
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.
Finnish: Vihamielisyyttä (pääasiassa aggressiota, vastustavaa käyttäytymistä ja vihaa) sekä emotionaalista epävakaisuutta havaittiin kliinisissä tutkimuksissa useammin [kauppanimi] saaneilla lapsilla ja nuorilla kuin lumelääkettä saaneilla lapsilla ja nuorilla.
English: Member State Marketing Authorisation Holder Invented Name
Finnish: Jäsenvaltio Myyntiluvan haltija
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Finnish: KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
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.
Finnish: 2valmisteiden kliinisistä tutkimuksista, erityisesti niiden käytöstä lapsipotilailla: fluoksetiini, fluvoksamiini, sertraliini, paroksetiini, sitalopraami, eskitalopraami, atomoksetiini, duloksetiini, venlafaksiini, mianseriini, milnasipraani, reboksetiini ja mirtatsapiini.
English: Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Finnish: Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Finnish: Iso-Britannia Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Finnish: ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Finnish: Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Finnish: Iso-Britannia Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
English: 6XA, United Kingdom
Finnish: 8RB, UK
English: Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Finnish: Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Finnish: Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
English: Box 20, Oss, Netherland
Finnish: Organon, P.O. Box 20, Oss, Netherland
English: Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Finnish: Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
English: KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
Finnish: Iso-Britannia KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland
English: Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
Finnish: Iso-Britannia Generics (UK) Limited; Albany Gate; Darkes Lane; Potters Bar, Herts EN6 1AG; UK
English: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Finnish: Alpharma AS, P.O. Box 158 Sköyen N-0212 Oslo Norge (NOR)
English: Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Finnish: Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Finnish: Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
English: Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Finnish: Iso-Britannia Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Finnish: Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
English: Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Finnish: Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
English: Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str. 1
Finnish: KG Elisabeth-Selbert-Str. 1
English: N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Finnish: Organon , P.O.Box 20, NL - 5340 BH OSS
English: N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Finnish: Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
English: Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Finnish: Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Finnish: OrganonKloosterstraat 6., 5349AB Oss The Netherlands
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Finnish: Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
English: Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
Finnish: Iso-Britannia Sandoz Limited, 37 Woolmer Way, Bordon, Hants GU35 9QE; UK
English: John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Finnish: Iso-Britannia John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
English: Fevarin Tabs 50 mg 50 mg
Finnish: Fevarin Tabs 50 mg
English: Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Finnish: Iso-Britannia Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
English: 20 mg/0,5 ml Concentrate for solution for infusion
Finnish: 20 mg/0,5 ml Infuusiokonsentraatti, liuosta varten
English: Netherlands N.V. Organon t.a.v.
Finnish: Organon t.a.v.
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;
Finnish: - komitea katsoo kliinisistä tutkimuksista saatavissa olevien tietojen valossa, että SSRI- ja SNRI-hoitoa (eli edellä mainittuja tuotteita) saaneissa lapsissa ja nuorissa on havaittavissa suisidaalisen käyttäytymisen signaali, johon sisältyy itsemurhayrityksiä ja itsemurha-ajatuksia ja/tai sen kaltaista käyttäytymistä, kuten itsensä vahingoittamista, vihamielisyyttä ja mielialan epävakaisuutta;
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
Finnish: Iso-Britannia Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, UK
English: Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
Finnish: Iso-Britannia Sandoz Limited; 37 Woolmer Way; Bordon, Hants GU35 9QE, U.K.
English: Denmark Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Finnish: Alpharma Aps, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Luxembourg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
Finnish: Luxemburg H. Lundbeck A/S Ottiliavej 9, Copehagen-Valby, DK 2500
English: Luxembourg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Finnish: Luxemburg DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Finnish: Alfred Tiefenbacher (GmbH & Co.
English: Netherlands N.V. Organon, Postbus 20, NL-5340 BH Oss
Finnish: Organon, Postbus 20, NL-5340 BH Oss
English: Denmark Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
Finnish: Alpharma AS, Harbitzalleen 3, N-0212 Skoyen, Oslo, Norway
English: Synthon BV, Microweg 22, P.O.
Finnish: Synthon BV, Microweg 22, P.O. Box 7071
English: III.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR FLUOXETINE,
Finnish: III.I MUUTOKSET FLUOKSETIININ,
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Finnish: Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel
Finnish: Molièrelaan 225 1050 Brussel
English: Belgium TOPGEN N.V. Demunterlaan 1 b 9, 1090 Brussel, Belgium
Finnish: Demunterlaan 1 b 9, 1090 Brussel, 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.
Finnish: - yksinomaan ADHD:n hoitoon käytettävästä atomoksetiinista komitea katsoi, että atomoksetiinia sisältävien lääkkeiden valmisteyhteenvedoissa ja pakkausselosteen asiaan liittyvissä osissa pitäisi olla varoitus siitä, että vihamielisyyttä (pääasiassa aggressiota, vastustavaa käyttäytymistä ja vihaa) sekä emotionaalista epävakaisuutta havaittiin kliinisissä tutkimuksissa useammin atomoksetiinia saaneilla lapsilla ja nuorilla kuin lumelääkettä saaneilla lapsilla ja nuorilla;
English: Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Finnish: Iso-Britannia Pharmascope Limited, Unit 107, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Netherlands Centrafarm Services B.V. Postbus 289
Finnish: Centrafarm Services B.V.
English: Belgium LUNDBECK N.V. Molièrelaan 225 1050 Brussel, Belgium
Finnish: Molièrelaan 225 1050 Brussel, Belgium
English: Belgium SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
Finnish: SANDOZ N.V.Medialaan 40 1800 VILVOORDE, Belgium
English: Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
Finnish: Iso-Britannia Synthon BV, Microweg 22, Nijmegen, 6546 CM, Netherlands
English: Luxembourg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
Finnish: Luxemburg PIERRE FABRE MEDICAMENT, BOULOGNE CEDEX, 45 place Abel Gance, 921 00 Boulogne Cedex, France
English: Belgium PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17
Finnish: PFIZER MANUFACTURING BELGIUM S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
Finnish: Iso-Britannia Norton Healthcare Limited; Ivax Quay; Albert Basin; Royal Docks; London E16 2QJ; UK
English: FLUVOXAMINE,
Finnish: FLUVOKSAMIININ,
English: Belgium DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
Finnish: DOCPHARMA N.V., Ambachtenlaan 13 H, B-3001 Heverlee, Belgium
English: Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK
Finnish: Iso-Britannia Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
English: Denmark Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
Finnish: Combino Pharm S.L., C/Fructuos Gelabert 6-8, ES-08970 Sant Joan, Despi, Barc, Spain
English: Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Finnish: Luxemburg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
English: Belgium TOPGEN N.V. Demunterlaan 1 1090 BRUSSEL, Belgium
Finnish: Demunterlaan 1 1090 BRUSSEL, Belgium