FrancophonIA/ELRC3.0 huggingface dataset:
English: Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
Estonian: Prantsusmaa Arrow generiques 26 avenue Tony Garnier 69007 Lyon - France
English: Luxembourg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
Estonian: Luksemburg SOLVAY PHARMA, 3 Avenue du Bourgmestre, E. Demunter, B-1090
English: Netherlands Merck Generics BV Dieselweg 25
Estonian: Merck Generics BV Dieselweg 25
English: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Estonian: Ühendkuningriik Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
English: Suspension
Estonian: Suspensioon
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Estonian: Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Estonian: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Estonian: Sellele vaatamata võib arst [Ravimi nimetus, osastavas käändes] määrata ka alla 18aastastele patsientidele juhul, kui ta leiab, et see on patsiendi huvides.
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Estonian: Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Estonian: Prantsusmaa ORGANON 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
English: Belgium OLYMPO PHARMA B.V.B.A.
Estonian: OLYMPO PHARMA B.V.B.A.
English: N.V. Organon, P.O.
Estonian: Organon, P.O.
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Estonian: 1 SSTI tähistab selektiivseid serotoniini tagasihaarde inhibiitoreid (SSRI, Serotonin-Selective Reuptake Inhibitors).
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Estonian: Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
Estonian: Eelmainitud ravimite kasutamine laste ja noorukite depressiooni ja ärevushäirete raviks ei ole Euroopas kõikjal lubatud.
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Estonian: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Estonian: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: Lange Munteplein 7b 4, 8500
Estonian: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: Luxembourg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
Estonian: Luksemburg LUNDBECK S.A., 225 AV. Moliére B-1050 Bruxelles
English: BOUCHARA RECORDATI 68 Rue Marjolin BP 67
Estonian: Prantsusmaa BOUCHARA RECORDATI 68 Rue Marjolin
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Estonian: [Ravimi nimetus, osastavas käändes] ei tohi tavaolukorras kasutada laste ja alla 18aastaste noorukite ravimisel, < välja arvatud [heakskiidetud näidustustega] patsientidel]>.
English: CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
Estonian: Ühendkuningriik CP Pharmaceuticals Limited, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK
English: Netherlands Arrow Pharma B.V., C/o Resolution, Wedgewood Way, Stevenage, UKSG1 4 QT Herts
Estonian: 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
Estonian: Ühendkuningriik SmithKline Beecham Phamraceuticals Limited, Stockley Park West, Uxbridge, Middx UB11 1BT, UK
English: Netherlands AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
Estonian: AbZ Pharma GmbH, Postfach 1152, D-89135 Blaubeuren
English: Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Estonian: ORGANON BELGIE Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
English: Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
Estonian: Ühendkuningriik Teva Pharmaceuticals Limited, Barclays House, 1 Gatehouse Way, Aylesbury, Bucks HP19 8DB; UK
English: Denmark Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
Estonian: Billev Pharma Aps, Elmegårdsvej 1A, DK-3630 Jægerspris, Denmark
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Estonian: GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Estonian: Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Estonian: CHMP kontrollis müügiloa hoidjate poolt esitatud andmetes sisalduvaid viiteid suitsiidikäitumise kohta laste ja noorukite hulgas.
English: 11, avenue Dubonnet 92400 Courbevoie France
Estonian: Prantsusmaa CHIESI 11, avenue Dubonnet 92400 Courbevoie France
English: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Estonian: Ühendkuningriik Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Estonian: Enamikus katsetes koosnes uuringugrupp peamiselt depressiivsete häiretega patsientidest, mõne katse puhul olid kaasatud ka erinevate ärevushäirete käes kannatavad patsiendid (obsessiiv-kompulsiivne häire, generaliseerunud ärevushäire ja sotsiaalärevus).
English: Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Estonian: Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
English: Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Estonian: Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Estonian: ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Estonian: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Estonian: Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Estonian: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: RATIOPHARM Graf Arco Strasse 3
Estonian: Prantsusmaa RATIOPHARM Graf Arco Strasse 3
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Estonian: Luksemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Estonian: via Nocera Umbra 75 00100 Roma Italy
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Estonian: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Estonian: Alla 18aastastel lastel esineb suurenenud risk kõrvaltoimete, nagu näiteks vaenulik käitumine (peamiselt vägivaldsus, vastanduv käitumine ja viha) ja emotsionaalne labiilsus, tekkeks.
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Estonian: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Estonian: Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Estonian: Luksemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
English: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Estonian: Prantsusmaa Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
Estonian: Lisaks ei ole antud vanusegrupis veel tõestatud [Ravimi nimetus, omastavad käändes] kasutamise pikaajaline ohutus kasvamisele, küpsemisele ja kognitiivsele ning käitumuslikule arengule.
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Estonian: Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Estonian: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Ashbourne Industrial Estate Unit 107
Estonian: Prantsusmaa Pharmascope Ashbourne Industrial Estate Unit 107
English: Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Estonian: Europark Oost 34, 9100 St. Niklaas, Belgium
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Estonian: Ühendkuningriik Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Estonian: Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
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.
Estonian: CHMP leidis, et atomoksetiini uuringutest ei leitud viiteid suitsiidikäitumise ohu suurenemise kohta, kuid peamiselt vägivaldsuse ja vaenulikkusena avalduvad käitumishäired siiski sagenesid.
English: Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Estonian: ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Estonian: Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Estonian: Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Estonian: Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Estonian: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: Member State Marketing Authorisation Holder Invented Name
Estonian: Liikmesriik Müügiloa hoidja
English: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Estonian: Prantsusmaa SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
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.
Estonian: CHMP nõustus, et eksisteerib võimalik oht suitsiidikäitumise, sealhulgas enesetapukatsete, enesetapumõtete või sellega seotud käitumismallide, nagu enesevigastamine, vaenulikkus ja emotsionaalne labiilsus, sagenemiseks SSTI-de ja SNTI-dega ravitud lastel ja noorukitel.
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Estonian: Luksemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Estonian: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Estonian: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Estonian: Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Lithuania Pharmaceutical Works Polpharma S.A., ul.
Estonian: Pharmaceutical Works Polpharma S.A., ul.
English: Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Estonian: Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
English: LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Estonian: Prantsusmaa LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
English: B.V. Postbus 75
Estonian: Postbus 75
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Estonian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Estonian: Viale Amelia, 70 00181 Roma Italy
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Estonian: Zoloft 25 mg + 50 mg 25 mg + 50 mg Õhukese polümeerkilega kaetud tablett
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Estonian: Lisaks sellele täheldati suitsiidikäitumisega seotud kõrvaltoimete (näiteks vaenulikkus, enesevigastamine ning emotsionaalne labiilsus) sagenemist peaaegu kõigis ravimite ning näidustuste kohta teostatud uuringutes.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Estonian: Informeerige oma arsti, kui alla 18aastasel [Ravimi nimetus, omastavas käändes] kasutajal tekib või süveneb mõni ülalloetletud kõrvaltoimetest.
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Estonian: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Estonian: Ühendkuningriik Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Estonian: Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Estonian: Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Estonian: Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Estonian: Ühendkuningriik Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
English: ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
Estonian: IV LISA PAKENDI INFOLEHE PARANDUSED
English: Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Estonian: 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;
Estonian: Arvestades järgmist: - komitee arutas direktiivi 2001/83/EÜ artikli 31 parandatud versiooni alusel algatatud atomoksetiini, estsitalopraami, fluoksetiini, fluvoksamiini, mianseriini, milnatsipraani, mirtasapiini, paroksetiini, reboksetiini, sertraliini, tsitalopraami ja venlafaksiini sisaldavate ravimite küsimust;
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Estonian: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Estonian: Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: WINTHROP médicaments 174 avenue de France 75013 Paris
Estonian: Prantsusmaa WINTHROP médicaments 174 avenue de France
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Estonian: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
English: Wilbury Way
Estonian: 1 The Cam Centre Wilbury Way
English: Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Estonian: Ühendkuningriik Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
English: Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Estonian: Ühendkuningriik Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Estonian: 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
Estonian: Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
English: Van-der-Smissen-Strasse 1
Estonian: KG) Van-der-Smissen-Str. 1
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Estonian: Saksamaa ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Estonian: IV.2 ATOMOKSETIINI PAKENDI INFOLEHE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Estonian: [Ravimi nimetus, omastavas käändes] kasutamine ei ole näidustatud peamiselt depressiooniga kulgevate häirete ning ärevusseisundite ravis, sest täiskasvanud patsientidel läbi viidud kliinilistes katsetes ei leitud erinevust ravimit saava grupi ning platseebogrupi vahel, mistõttu võib öelda, et ravimi kasutamine antud näidustustel tulemust ei anna.
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Estonian: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Estonian: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Estonian: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Estonian: Ühendkuningriik Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Estonian: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Estonian: Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Estonian: Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Estonian: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Estonian: Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Estonian: Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Estonian: Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
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;
Estonian: - olemasoleva teabe põhjal järeldas komitee, et eksisteerib võimalik oht suitsiidikäitumise (sealhulgas enesetapukatsete, enesetapumõtete või sellega seotud käitumismallide, nagu enesevigastamine, vaenulikkus ja emotsionaalne labiilsus) sagenemiseks selektiivsete serotoniini tagasihaarde inhibiitorite ja serotoniini-noradrenaliini tagasihaarde inhibiitoritega (näiteks eelpool loetletud ravimitega) ravitud lastel ja noorukitel;
English: Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Estonian: TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
English: 13 rue pagès
Estonian: Prantsusmaa Lilly France 13 rue pagès
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Estonian: Lisaks tuleks silmas pidada, et alla 18aastastel lastel esineb antud ravimgruppi kuuluvate preparaatide kasutamisel suurenenud risk kõrvaltoimete, nagu näiteks enesetapukatse, suitsiidimõtted ja vaenulik käitumine (peamiselt vägivaldsus, vastanduv käitumine ja viha), tekkeks.
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Estonian: Ühendkuningriik Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Estonian: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Estonian: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Belgium BEXAL S.P.R.L.
Estonian: BEXAL S.P.R.L.
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Estonian: Lisaks otsustas ravimpreparaatide komitee, et atomoksetiini puhul on sobilikum rakendada teise sisuga hoiatusi, sest antud ravimi ainus kasutamisnäidustus on tähelepanu defitsiidi ja hüperaktiivsuse häire.
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Estonian: Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Estonian: BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
English: Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Estonian: Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Estonian: Prantsusmaa Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
English: AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Estonian: KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
English: Pharmaceutical form Route of administration
Estonian: Ravimvorm Manustamisviis
English: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Estonian: Prantsusmaa EG Labo laboratoire Eurogenerics le Quintet Batiment A
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Estonian: Prantsusmaa Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Estonian: Prantsusmaa Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Estonian: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Estonian: Luksemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Estonian: Saksamaa ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
English: Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Estonian: Ühendkuningriik Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
English: Zoloft 20 mg/ml, solution for oral use
Estonian: Zoloft 20 mg/ml, solution for Peroraalne
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Estonian: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy