natgillin/translations-raw huggingface dataset:
Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
GenRx B.V., Postbus 75, NL-6920 AB Duiven
Netherlands ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
Holland ct Arzneimittel GmbH, Postfach 510124, D-13361 Berlijn
The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
CHMP kontrollis müügiloa hoidjate poolt esitatud andmetes sisalduvaid viiteid suitsiidikäitumise kohta laste ja noorukite hulgas.
11, avenue Dubonnet 92400 Courbevoie France
Prantsusmaa CHIESI 11, avenue Dubonnet 92400 Courbevoie France
Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Ühendkuningriik Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
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)).
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).
Denmark Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Imi Pharma AS, Literbuen 9, DK-2740 Skovlunde, Denmark
Netherlands Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Centrafarm Services B.V., Postbus 289, NL-4870 AG Etten Leur
Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
RATIOPHARM Graf Arco Strasse 3
Prantsusmaa RATIOPHARM Graf Arco Strasse 3
Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Luksemburg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
via Nocera Umbra 75 00100 Roma Italy
Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Alla 18aastastel lastel esineb suurenenud risk kõrvaltoimete, nagu näiteks vaenulik käitumine (peamiselt vägivaldsus, vastanduv käitumine ja viha) ja emotsionaalne labiilsus, tekkeks.
Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Luxembourg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
Luksemburg Pharmacia S.A., 17 Boulevard De La, B-1050 Bruxelles, Belgium
42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Prantsusmaa Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
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.
Lisaks ei ole antud vanusegrupis veel tõestatud [Ravimi nimetus, omastavad käändes] kasutamise pikaajaline ohutus kasvamisele, küpsemisele ja kognitiivsele ning käitumuslikule arengule.
Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Ashbourne Industrial Estate Unit 107
Prantsusmaa Pharmascope Ashbourne Industrial Estate Unit 107
Belgium APOGENPHARMA B.V. Europark Oost 34, 9100 St. Niklaas, Belgium
Europark Oost 34, 9100 St. Niklaas, Belgium
Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Ühendkuningriik Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
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.
CHMP leidis, et atomoksetiini uuringutest ei leitud viiteid suitsiidikäitumise ohu suurenemise kohta, kuid peamiselt vägivaldsuse ja vaenulikkusena avalduvad käitumishäired siiski sagenesid.
Belgium ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
ELI LILLY BENELUX S.A., Rue de l'Etuve 52, 1000 Bruxelles, Belgium
Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Member State Marketing Authorisation Holder Invented Name
Liikmesriik Müügiloa hoidja
SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Prantsusmaa SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
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.
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.
Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Luksemburg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Lithuania Pharmaceutical Works Polpharma S.A., ul.
Pharmaceutical Works Polpharma S.A., ul.
Luxembourg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
Luksemburg PFIZER S.A. Bld de la Plaine 17 1050 Bruxelles, Belgium
LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand 75012 Paris
Prantsusmaa LABORATOIRE RPG - RANBAXY PHARMACIE GENERIQUES 4 place Louis Armand
B.V. Postbus 75
Postbus 75
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Angelini S.p.A. Viale Amelia, 70 00181 Roma Italy
Viale Amelia, 70 00181 Roma Italy
Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Zoloft 25 mg + 50 mg 25 mg + 50 mg Õhukese polümeerkilega kaetud tablett
Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Lisaks sellele täheldati suitsiidikäitumisega seotud kõrvaltoimete (näiteks vaenulikkus, enesevigastamine ning emotsionaalne labiilsus) sagenemist peaaegu kõigis ravimite ning näidustuste kohta teostatud uuringutes.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Informeerige oma arsti, kui alla 18aastasel [Ravimi nimetus, omastavas käändes] kasutajal tekib või süveneb mõni ülalloetletud kõrvaltoimetest.
Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Ühendkuningriik Neolab Limited; 57 High Street; Odiham; Hants RG29 1LF, U.K.
Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Ühendkuningriik Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET
IV LISA PAKENDI INFOLEHE PARANDUSED
Belgium PHARMACIA N.V. Rijksweg 12 2870 Puurs, Belgium
Rijksweg 12 2870 Puurs, Belgium
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;
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;
Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
WINTHROP médicaments 174 avenue de France 75013 Paris
Prantsusmaa WINTHROP médicaments 174 avenue de France
Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Wilbury Way
1 The Cam Centre Wilbury Way
Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Ühendkuningriik Eli Lilly & Company Limited; Lilly House, Priestley Road; Basingstoke, Hants RG24 9NL; UK
Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Ühendkuningriik Neolab Limited, 57 High Street, Odiham, Hants RG29 1LF, UK
Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Van-der-Smissen-Strasse 1
KG) Van-der-Smissen-Str. 1
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Saksamaa ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
IV.2 ATOMOKSETIINI PAKENDI INFOLEHE ASJAKOHASTESSE LÕIKUDESSE LISATAVAD PARANDUSED
[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.
[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.
Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Ühendkuningriik Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Netherlands Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Lichtenstein Pharmazeutika GmbH & Co. OHG, Industriestrasse 26, D56218 Mülheim-Kärlich
Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Hexal AG, Postfach 1263, D-83602 Holzkirchen
Netherlands Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739
Neuraxpharm Arzneimittel GmbH & Co KG, Postfach 1439, D-40739 Langefeld
- 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;
- 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;
Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
13 rue pagès
Prantsusmaa Lilly France 13 rue pagès
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.
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.
Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Ühendkuningriik Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Belgium BEXAL S.P.R.L.
BEXAL S.P.R.L.
The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Lisaks otsustas ravimpreparaatide komitee, et atomoksetiini puhul on sobilikum rakendada teise sisuga hoiatusi, sest antud ravimi ainus kasutamisnäidustus on tähelepanu defitsiidi ja hüperaktiivsuse häire.
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Belgium BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
BEXAL S.A. Avenue de Tervuren 36 b 9 1040 BRUXELLES, Belgium
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
Prantsusmaa Winthrop Medicaments 9 Bd Romain Rolland 75 159 Paris cedex 14 France
AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
Pharmaceutical form Route of administration
Ravimvorm Manustamisviis
EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Prantsusmaa EG Labo laboratoire Eurogenerics le Quintet Batiment A
15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Prantsusmaa Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Prantsusmaa Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Luksemburg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Saksamaa ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin paroxetin von ct 20 mg Filmtabletten
Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Ühendkuningriik Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
Zoloft 20 mg/ml, solution for oral use
Zoloft 20 mg/ml, solution for Peroraalne
Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Prantsusmaa GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
Prantsusmaa PAUCOURT 100 route de Versailles 78163 Marly le roi cedex France
15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
Prantsusmaa IVAX 15 rue de l'hotel de ville 92522 Neuilly sur seine CedexFrance citalopram Ivax
2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
SNTI tähistab serotoniini-noradrenaliini tagasihaarde inhibiitoreid (SNRI, Serotonin-Norepinephrine Uptake Inhibitors).
Belgium SOCOBOM N.V. Louisalaan 149/24 B-1050 Brussel, Belgium
Louisalaan 149/24 B-1050 Brussel, Belgium
Belgium A.H.P.
A.H.P.
Lithuania ICN Polfa Rzeszow, ul.
ICN Polfa Rzeszow, ul.
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Ühendkuningriik Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Denmark NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
NM Pharma A/S, Lautrupvang 8, DK2750 Ballerup, Denmark
Belgium Laboratoires S.M.B.
Laboratoires S.M.B.
Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Ühendkuningriik Pharmafile Limited, Medici House, Ashbourne Industrial Estate, Ashbourne, Co. Meath, Republic of Ireland
Oral suspension
Peroraalne suspensioon
Denmark Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Gemelli (Eli Lilly Danmark A/S), Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
Prantsusmaa SAINT GERMAIN 100 route de Versailles 78163 Marly le roi cedex France
However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Siiski esines selge suund suitsiidikäitumisele depressiooniga patsiente uurivate katsete tulemustes; ärevushäiretega patsiente hõlmavates uuringutes esines sama tendents nõrgemal kujul.
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
III LISA RAVIMI OMADUSTE KOKKUVÕTTE PARANDUSED
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Ühendkuningriik Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Dispersable tablet
Dispergeeritav tablett
Belgium TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
TEVA PHARMA BELGIUM Laarstraat 16 2610 WILRIJK, Belgium
Netherlands KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
KRKA Pharma Dublin, 1 Stokes Place, St. Stephen's Green, IE-Dublin 2
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Ühendkuningriik Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Ühendkuningriik Schein Pharmaceutical UK Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
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)
FLUOKSETIINI, FLUVOKSAMIINI, SERTRALIINI, PAROKSETIINI, TSITALOPRAAMI, ESTSITALOPRAAMI, ATOMOKSETIINI, VENLAFAKSIINI, MIANSERIINI, MILNATSIPRAANI, REBOKSETIINI JA MIRTASAPIINI SISALDAVATE RAVIMITE TEADUSLIKU HINDAMISE KOKKUVÕTE (vaata I lisa)
Lithuania Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Slovakofarma, Nitrianka 100, 920 27 Hlohovec, Slovakia
Belgium ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
ARROW GENERICS LIMITED Eastman Way Stevenage Hertfordshire SG1 4SZ UK
Denmark Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Teva Pharma B.V., Industrieweg 23, NL-3640 AE, Mijdrecht, Netherland
Denmark Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Lichtenstein Pharmazeutica GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Denmark Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Winthrop Arzneimittel GmbH, Industriestrasse 10, D-56218 MulheimKarlich, Germany
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Ühendkuningriik Pfizer Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Lithuania Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Gedeon Richter Ltd., 1103 Budapest, Gyomroi ut 19-21, Hungary
Lithuania Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Egis Pharmaceuticals Ltd., H-1106 Budapest, Kereszturi ut 30-38, Hungary
Teva Pharma B.V. Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Industrieweg 23, P.O.BOX 217, 3640 AE MIJDRECHT, the Netherlands
Denmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
N.V. Organon , P.O.Box 20, NL - 5340 BH OSS
Organon , P.O.Box 20, NL - 5340 BH OSS
N.V. Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Organon, Kloosterstraat 6 NL - 5349 AB Oss THE NETHERLANDS
Denmark Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Denmark
N.V. OrganonKloosterstraat 6., 5349AB Oss The Netherlands
OrganonKloosterstraat 6., 5349AB Oss The Netherlands
Denmark Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764
Neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Strasse 23, D-40764 Langenfeld, Germany
John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Ühendkuningriik John Wyeth & Sons Limited, Huntercombe Lane South, Taplow, Maidenhead, Berks SL6 0PH, UK
Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI
Euroopa Komisjoni palvel hindas inimtervishoius kasutatavate ravimite komitee (CHMP) järgnevate SSTI
Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK
Ühendkuningriik Pharmacia Limited, Walton Oaks, Dorking Road, Walton-on-the-Hill, Surrey KT20 7NS, UK