FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Swedish: Danmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
English: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Swedish: Frankrike SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Swedish: Nederländerna Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Swedish: Luxemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Swedish: Nederländerna Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
Swedish: Grekland GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece
English: Merck dura GmbH Postfach 100635
Swedish: Tyskland Merck dura GmbH Postfach 100635
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Swedish: Danmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Swedish: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Swedish: Danmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Fluoxetin „Lilly“ 20mglösliche Tabletten
Swedish: Fluoxetin „Lilly“ 20mglösliche Tablettten
English: Sandoz Pharmaceuticals GmbH Dieselstr.
Swedish: Tyskland Sandoz Pharmaceuticals GmbH Dieselstr.
English: PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
Swedish: Grekland PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
English: Solvay Arzneimittel GmbH Postfach 220
Swedish: Tyskland Solvay Arzneimittel GmbH Postfach 220
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Swedish: Nederländerna Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Swedish: Viale Amelia, 70 00181 Roma Italy
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
Swedish: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Swedish: Danmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
Swedish: Pharmaceutical Works Polpharma S.A., ul.
English: Wyeth-Lederle Pharma GmbH, Storchengasse 1
Swedish: Lettland Wyeth-Lederle Pharma GmbH, Storchengasse 1
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Swedish: Nederländerna Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Swedish: Frankrike LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Swedish: Danmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Juta Pharma GmbH Gutenbergstr.
Swedish: Tyskland Juta Pharma GmbH Gutenbergstr.
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Swedish: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Pharmacia GmbH Pfizerstr.
Swedish: Tyskland Pharmacia GmbH Pfizerstr.
English: IIP-Institut fuer industrielle Pharmazie Benzstr.
Swedish: Tyskland IIP-Institut fuer industrielle Pharmazie Benzstr.
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Swedish: Danmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Swedish: Storbritannien Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
English: Egis Pharmaceuticals, Kereszturi ut H-1106 Budapest
Swedish: Lettland Egis Pharmaceuticals, Kereszturi ut H-1106 Budapest
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Swedish: Nederländerna Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Swedish: Danmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Swedish: Nederländerna Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Swedish: Luxemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: Gedeon Richter LTD, Gyomroi 19-21
Swedish: Lettland Gedeon Richter LTD, Gyomroi 19-21
English: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Swedish: Storbritannien Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Swedish: Rijksweg 12 2870 Puurs, Belgium
English: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
Swedish: Tyskland Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Swedish: Storbritannien Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
English: Denmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
Swedish: Danmark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Swedish: Danmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: Heumann Pharma GmbH & Co. Generica KG
Swedish: Tyskland Heumann Pharma GmbH & Co. Generica KG
English: NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
Swedish: Grekland NOVEXAL HELLAS, Agiou Dimitriou 25 17455 Kalamaki Greece
English: BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
Swedish: Grekland BROS, Avgis &Galinis 15, 14564 N.kifissia, Greece
English: BC Biochemie Pharma GmbH Dieselstr.
Swedish: Tyskland BC Biochemie Pharma GmbH Dieselstr.
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Swedish: Danmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
Swedish: Grekland FARAN, Ahaias & trizinias, 14564 N.Kifissia, Greece
English: Boehringer Ingelheim Pharma GmbH & Co.KG
Swedish: Tyskland Boehringer Ingelheim Pharma GmbH & Co.KG
English: Luxembourg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
Swedish: Luxemburg GLAXO SMITH KLINE S.A. Rue du Tilleul 13, B-1332 GENVAL, Belgium
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Swedish: Nederländerna Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: 16, Chemin de Coquelicots CH - 1214 Geneva
Swedish: Slovakien Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
English: Wyeth Pharma GmbH Postfach 8806
Swedish: Tyskland Wyeth Pharma GmbH Postfach 8806
English: Luxembourg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
Swedish: Luxemburg ELI LILLY BENELUX S.A. Rue de l'Etuve 52 1000 Bruxelles, Belgium
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Swedish: Nederländerna Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Swedish: SNRI-produkter påverkar norepinefrin- och serotoninneurotransmittorerna.
English: Frankfurter Str. 129a D-64293 Darmstadt
Swedish: Tyskland Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Swedish: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Swedish: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Swedish: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: STADA GmbH Stadastr.
Swedish: Tyskland STADA GmbH Stadastr.
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.
Swedish: - För atomoxetin, som indikeras endast vid behandling av ADHD, ansåg kommittén att en varning som återspeglar att ökad fientlighet (främst aggression, trots och ilska) och emotionell instabilitet observerats i större omfattning vid kliniska försök på barn och ungdomar som behandlades med atomoxetin jämfört med de som behandlades med placebo och att en varning om att läkemedlet inte har någon effekt vid depression skall ingå i produktresuméerna och den relevanta delen i bipacksedlar för läkemedel som innehåller atomoxetin.
English: ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
Swedish: Grekland ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece
English: WINTHROP médicaments 174 avenue de France 75013 Paris
Swedish: Frankrike WINTHROP médicaments 174 avenue de France
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Swedish: Nederländerna Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
Swedish: Grekland NOVARTIS HELLAS, 12 Km National Road Athinon-Lamias, 14410 Metamorfosi, Greece
English: Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001 Ljubljana, Slovenia
Swedish: Slovenien Medis, Podjetje za proizvodnjo in trženje d.o.o., Brnčičeva 1, SI-1001
English: RANBAXY (UK) LTD., EALING, LONDON
Swedish: Tjeckien RANBAXY (UK) LTD., EALING, LONDON
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Swedish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Capsule,hard
Swedish: Kapsel, hård
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Swedish: Nederländerna Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Swedish: Storbritannien Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
English: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
Swedish: Storbritannien Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
English: Chemical Works of Gedeon Richter Ltd, Gyömrői út 19-21
Swedish: Lettland Chemical Works of Gedeon Richter Ltd, Gyömrői út 19-21
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Swedish: Nederländerna Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
Swedish: Grekland PFIZER HELLAS, 5 Alketou, 116 33 Athens, Greece
English: Stadapharm GmbH Stadastr.
Swedish: Tyskland Stadapharm GmbH Stadastr.
English: Pierre Fabre Medicament, Place Abel Gance 45
Swedish: Lettland Pierre Fabre Medicament, Place Abel Gance 45
English: NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
Swedish: Grekland NOVEXAL HELLAS, Agiou Dimitriou 25, 17455 Kalamaki, Greece
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Swedish: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Swedish: Storbritannien Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
English: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
Swedish: Tyskland Hennig Arzneimittel GmbH & Co.KG Postfach 1240
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Swedish: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Belgium BEXAL S.P.R.L.
Swedish: BEXAL S.P.R.L.
English: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Swedish: Fabrik , Holger Danskaes Vej 89, DK - 2000
English: SANDOZ GMBH, KUNDL Biochemiestrasse 10
Swedish: Tjeckien SANDOZ GMBH, KUNDL Biochemiestrasse 10
English: ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
Swedish: Grekland ALVIA AE, 18Km Leoforos Marathonos, 15344 Pallini Attikis, Greece
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Swedish: Storbritannien Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Swedish: Nederländerna Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Swedish: Nederländerna Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Swedish: Slovakien Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
English: GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
Swedish: Grekland GENEPHARM AEBE, 18 Km Marathonos Av., 15351 Palini Attikis, Greece
English: Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Swedish: Frankrike Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Swedish: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Swedish: StorbritannienA Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
English: S.A. Laboratoires S.M.B.
Swedish: Laboratoires S.M.B.
English: 13 rue pagès
Swedish: Frankrike Lilly France 13 rue pagès
English: Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Swedish: Nederländerna KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
English: 20 mg/0,5 ml Concentrate for solution for infusion
Swedish: 20 mg/0,5 ml Koncentrat till infusionsvätska, lösning
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Swedish: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Swedish: Nederländerna Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Swedish: Danmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Swedish: Storbritannien Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Swedish: Danmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Swedish: Nederländerna Alfred Tiefenbacher (GmbH & Co.
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.
Swedish: CHMP drog därför slutsatsen att en varning som återspeglar att ökad fientlighet (främst aggression, trots och ilska) och emotionell instabilitet observerats i större omfattning vid kliniska försök på barn och ungdomar som behandlades med atomoxetin jämfört med de som behandlades med placebo och en varning om att läkemedlet inte har någon effekt vid depression skall ingå i produktresuméerna och den relevanta delen i bipacksedlarna för läkemedel som innehåller atomoxetin.
English: NL - 1381 CP Weesp THE NETHERLANDS
Swedish: NL - 1381 CP Weesp
English: Aliud Pharma GmbH & Co.KG Postfach 1380
Swedish: Tyskland Aliud Pharma GmbH & Co.KG Postfach 1380
English: HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07
Swedish: Tjeckien HEXAL AG, HOLZKIRCHEN, Industriestraße 25, 836 07
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Swedish: Frankrike Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Swedish: Luxemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
Swedish: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Swedish: Nederländerna Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Temmler Pharma GmbH & Co.KG Postfach 2269
Swedish: Tyskland Temmler Pharma GmbH & Co.KG Postfach 2269
English: - The Committee, as a consequence, 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.
Swedish: - Till följd härav slog kommittén fast att självmordsrelaterat beteende (självmordsförsök och självmordstankar) och fientlighet (främst aggression, trots och ilska) observerades i högre grad vid kliniska försök på barn och ungdomar som behandlades med antidepressiver jämfört med de som behandlades med placebo, och att en varning för detta skall ingå i produktresuméerna och i den relevanta delen av bipacksedlarna för läkemedel som innehåller citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Swedish: Danmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Swedish: Frankrike Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
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;
Swedish: Med beaktande av följande: - Kommittén beaktade det hänskjutande som gjorts enligt artikel 31 i direktiv 2001/83/EG, i dess senaste lydelse, för läkemedel som innehåller atomoxetin, citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
English: 264 Rue du faubourg saint honoré 75008 Paris - France
Swedish: Frankrike MG PHARMA 264 Rue du faubourg saint honoré 75008 Paris - France
English: 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Swedish: Frankrike IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Swedish: Danmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: Rodleben Pharma GmbH Postfach 205
Swedish: Tyskland Rodleben Pharma GmbH Postfach 205
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.
Swedish: CHMP slog fast att självmordsrelaterat beteende (självmordsförsök och självmordstankar) och fientlighet (främst aggression, trots och ilska) observerades i högre grad vid kliniska försök på barn och ungdomar som behandlades med antidepressiver jämfört med de som behandlades med placebo, och att en varning för detta skall ingå i produktresuméerna och i den relevanta delen av bipacksedlarna för läkemedel som innehåller citalopram, escitalopram, fluoxetin, fluvoxamin, mianserin, milnacipran, mirtazapin, paroxetin, reboxetin, sertralin och venlafaxin.
English: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Swedish: Frankrike EG Labo laboratoire Eurogenerics le Quintet Batiment A
English: ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
Swedish: Tjeckien ZENTIVA A.S., HLOHOVEC, Nitrianska 100, 920 27 Hlohovec, Slovak Republic
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Swedish: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: TAD Pharma GmbH Postfach 720
Swedish: Tyskland TAD Pharma GmbH Postfach 720
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)
Swedish: ÖVERGRIPANDE SAMMANFATTNING AV DEN VETENSKAPLIGA UTVÄRDERINGEN AV LÄKEMEDEL SOM INNEHÅLLER FLUOXETIN, FLUVOXAMIN, SERTRALIN, PAROXETIN, CITALOPRAM, ESCITALOPRAM, ATOMOXETIN, VENLAFAXIN, MIANSERIN, MILNACIPRAN, REBOXETIN OCH MIRTAZAPIN (se bilaga 1)
English: Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Swedish: Louisalaan 149/24 B-1050 Brussel, Belgium
English: Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Swedish: Danmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
English: Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Swedish: Rue-de-la-Pastorale 26-28
English: GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Swedish: Frankrike GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Swedish: Storbritannien Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Swedish: Storbritannien Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
English: Denmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
Swedish: Danmark Desitin Arzneimittel GmbH, Weg beim Jaeger 214, D-22335 Hamburg, Germany
English: H.Lundbeck A/S Ottiliavej 7-9
Swedish: Tyskland H.Lundbeck A/S Ottiliavej 7-9
English: PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Swedish: Frankrike PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
English: Belgium A.H.P.
Swedish: A.H.P.
English: Modified Release Capsule, hard
Swedish: Kapsel med modifierad frisättning, hård