FrancophonIA/ELRC3.0 huggingface dataset:
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.
French: Le CHMP a reconnuqu'il existait un signal potentiel d'une augmentation de comportement suicidaire, comprenant des tentatives de suicide et des idées suicidaires et/ou des comportements associés tels que automutilation, comportement hostile et labilité émotionnelle chez les enfants et adolescents traités par ISRS et IRSN.
English: Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
French: Royaume-Uni Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
English: Holsten Pharma GmbH Im Buergerstock 7
French: Allemagne Holsten Pharma GmbH Im Buergerstock 7
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
French: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Lange Munteplein 7b 4, 8500
French: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
French: Danemark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
French: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
French: Royaume-Uni Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Republic of Ireland
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
French: Les IRSN agissent sur les neurotransmetteurs noradrénaline et sérotonine.
English: GlaxoSmithKline Slovakia s.r.o.
French: Slovaquie GlaxoSmithKline Slovakia s.r.o.
English: CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
French: Royaume-Uni CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
French: 1 ISRS correspond à « Inhibiteur Sélectif de la Recapture de la Sérotonine ».
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
French: Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
English: SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
French: Royaume-Uni SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
English: HEXAL AG Postfach 1263
French: Allemagne HEXAL AG Postfach 1263
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
French: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
French: Danemark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Merz Pharmaceuticals GmbH Eckenheimer Landstr.
French: Allemagne Merz Pharmaceuticals GmbH Eckenheimer Landstr.
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
French: GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
French: Royaume-Uni Ratiopharm UK Limited, 5 Jackson Close, Grove Road, Cosham, Portsmouth, Hants PO6 1UP; UK
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
French: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
French: Danemark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Desitin Arzneimittel GmbH Postfach 630164
French: Allemagne Desitin Arzneimittel GmbH Postfach 630164
English: Pfizer Pharma GmbH Pfizerstr.
French: Allemagne Pfizer Pharma GmbH Pfizerstr.
English: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
French: Royaume-Uni Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
French: Danemark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: III.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR ATOMOXETINE
French: III.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DU RCP DE L'ATOMOXÉTINE
English: Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
French: Royaume-Uni Relonchem Limited, 27 Old Gloucester Street, London WC1 3XX; UK
English: Winthrop Arzneimittel GmbH Industriestr.
French: Allemagne Winthrop Arzneimittel GmbH Industriestr.
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
French: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
French: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
French: Pays-Bas ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
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;
French: - Le Comité, au vu des données disponibles issues des études cliniques, a conclu qu'il existait un signal de comportement de type suicidaire, comprenant des tentatives de suicide et des idées suicidaires et/ou des comportements associés tels que automutilation, comportement hostile et labilité émotionnelle chez les enfants et adolescents traités par Inhibiteurs Sélectifs de la Recapture de la Sérotonine et Inhibiteurs de la Recapture de la Sérotonine et de la Noradrénaline, tels que les médicaments sus-mentionnés ;
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
French: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
French: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
French: via Nocera Umbra 75 00100 Roma Italy
English: Synthon B.V.
French: Allemagne Synthon B.V.
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
French: Danemark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
French: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
French: Danemark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
French: Danemark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
French: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
French: Royaume-Uni Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: Esparma GmbH Postfach 1461
French: Allemagne Esparma GmbH Postfach 1461
English: Krewel Meuselbach GmbH Postfach 1263
French: Allemagne Krewel Meuselbach GmbH Postfach 1263
English: Neuraxpharm Arzneimittel GmbH & Co.KG
French: Allemagne Neuraxpharm Arzneimittel GmbH & Co.KG
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
French: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
French: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
French: Zoloft 25 mg + 50 mg 25 mg + 50 mg Comprimé pelliculé
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
French: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Hormosan-Kwizda GmbH Postfach 600340
French: Allemagne Hormosan-Kwizda GmbH Postfach 600340
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
French: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
French: Si l'un de ces symptômes apparaît ou s'aggrave après le début du traitement, vous devez en informer votre médecin.
English: Juta Pharma GmbH Gutenbergstr.
French: Allemagne Juta Pharma GmbH Gutenbergstr.
English: Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
French: Danemark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
English: Merck dura GmbH Postfach 100635
French: Allemagne Merck dura GmbH Postfach 100635
English: BC Biochemie Pharma GmbH Dieselstr.
French: Allemagne BC Biochemie Pharma GmbH Dieselstr.
English: Sandoz Pharmaceuticals GmbH Dieselstr.
French: Allemagne Sandoz Pharmaceuticals GmbH Dieselstr.
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
French: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
French: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
French: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
French: Danemark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
French: Avenue Mercator 1 1300 Wavre, Belgium
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
French: Danemark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: B.V. Postbus 75
French: Postbus 75
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
French: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Heumann Pharma GmbH & Co. Generica KG
French: Allemagne Heumann Pharma GmbH & Co. Generica KG
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
French: Viale Amelia, 70 00181 Roma Italy
English: Oral solution, single dose Oral use
French: Solution buvable, dose unique
English: Solvay Arzneimittel GmbH Postfach 220
French: Allemagne Solvay Arzneimittel GmbH Postfach 220
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
French: Danemark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
French: Pharmaceutical Works Polpharma S.A., ul.
English: Belgium GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
French: GLAXO SMITH KLINE S.A. Rue du Tilleul 13, 1332 GENVAL, Belgium
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
French: Note: Ce Résumé des Caractéristiques du Produit (RCP) est celui annexé à la décision de la Commission relative à la saisine communautaire conformément à l'Article 31 de la Directive 2001/83/CE du parlement européen et du conseil.
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
French: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
French: Danemark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
French: Danemark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
French: Allemagne Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
French: Danemark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
French: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
French: Royaume-Uni Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
French: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
French: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
French: Royaume-Uni Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
English: Wyeth Pharma GmbH Postfach 8806
French: Allemagne Wyeth Pharma GmbH Postfach 8806
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
French: Rijksweg 12 2870 Puurs, Belgium
English: S.A. Laboratoires S.M.B.
French: Laboratoires S.M.B.
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
French: Royaume-Uni 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
French: Danemark Merck NM AB, Ynglingagatan 14, 11347, P.Box 22033, S-10435
English: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
French: Royaume-Uni Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
French: Danemark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
French: IV.2 MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DE LA NOTICE DU PRODUIT CONCERNANT L'ATOMOXÉTINE
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
French: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: STADA GmbH Stadastr.
French: Allemagne STADA GmbH Stadastr.
English: Boehringer Ingelheim Pharma GmbH & Co.KG
French: Allemagne Boehringer Ingelheim Pharma GmbH & Co.KG
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
French: Danemark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Frankfurter Str. 129a D-64293 Darmstadt
French: Allemagne Generics (UK) Ltd. Frankfurter Str. 129a D-64293 Darmstadt
English: Wilbury Way
French: 1 The Cam Centre Wilbury Way
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
French: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Pharmacia GmbH Pfizerstr.
French: Allemagne Pharmacia GmbH Pfizerstr.
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
French: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
French: 2 IRSN correspond à « Inhibiteur de la Recapture de la Sérotonine et de la Noradrénaline ».
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
French: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Van-der-Smissen-Strasse 1
French: KG) Van-der-Smissen-Str. 1
English: Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
French: Royaume-Uni Organon Laboratories Limited, Cambridge Science Park, Milton Road, Cambs CB4 0FL; UK
English: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
French: Royaume-Uni Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
English: 16, Chemin de Coquelicots CH - 1214 Geneva
French: Slovaquie Eli Lilly Export S.A. 16, Chemin de Coquelicots CH - 1214 Geneva
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
French: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
French: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
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;
French: Considérant que - Le Comité a pris en compte la saisine en vertu de l'article 31 de la Directive 2001/83/CE, telle que modifiée, concernant les spécialités pharmaceutiques contenant de l'atomoxétine, du citalopram, de l'escitalopram, de la fluoxétine, de la fluvoxamine, de la miansérine, du milnacipran, de la mirtazapine, de la paroxétine, de la reboxétine, de la sertraline et de la venlafaxine ;
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.
French: Un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle ont été plus fréquemment observés au cours d'études cliniques chez les enfants et adolescents traités par [Nom de Fantaisie] par rapport à ceux traités par placebo.
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
French: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
French: Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
French: Royaume-Uni Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
French: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
French: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
French: Fabrik , Holger Danskaes Vej 89, DK - 2000
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
French: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
English: Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
French: Slovaquie Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
English: Belgium BEXAL S.P.R.L.
French: BEXAL S.P.R.L.
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
French: Royaume-Uni Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Hennig Arzneimittel GmbH & Co.KG Postfach 1240
French: Allemagne Hennig Arzneimittel GmbH & Co.KG Postfach 1240
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
French: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
French: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
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.
French: - Concernant l'atomoxétine, laquelle est uniquement indiquée dans le traitement du TDAH, le Comité a conclu qu'une mise en garde rapportant qu'un comportement hostile (principalement agressivité, comportement d'opposition et colère) et une labilité émotionnelle avaient été plus fréquemment observés au cours des études cliniques chez les enfants et adolescents traités par atomoxétine par rapport à ceux traités par placebo, ainsi qu'une mise en garde indiquant l'absence d'efficacité dans la dépression, devaient être incluses dans les Résumés des Caractéristiques du Produit et dans la rubrique concernée des Notices du Produit des spécialités pharmaceutiques contenant de l'atomoxétine.
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
French: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
French: Danemark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Aliud Pharma GmbH & Co.KG Postfach 1380
French: Allemagne Aliud Pharma GmbH & Co.KG Postfach 1380
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
French: Danemark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Rodleben Pharma GmbH Postfach 205
French: Allemagne Rodleben Pharma GmbH Postfach 205
English: Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
French: Royaume-Uni Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
English: III.I AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SPC FOR FLUOXETINE,
French: IV.I MODIFICATIONS À INCLURE DANS LA RUBRIQUE CONCERNÉE DE LA NOTICE DU PRODUIT CONCERNANT LA FLUOXÉTINE, LA FLUVOXAMINE, LA
English: TAD Pharma GmbH Postfach 720
French: Allemagne TAD Pharma GmbH Postfach 720
English: Lithuania SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
French: SmithKline Beecham plc, SB House, Great West road, Brentford , Middlesex, United Kingdom
English: Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
French: Danemark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
French: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
French: Danemark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
French: ANNEXE IV MODIFICATIONS DE LA NOTICE DU PRODUIT
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
French: Royaume-Uni Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: Filchnerstr.
French: Allemagne Neosan Filchnerstr.
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
French: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: H.Lundbeck A/S Ottiliavej 7-9
French: Allemagne H.Lundbeck A/S Ottiliavej 7-9