FrancophonIA/ELRC3.0 huggingface dataset:
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;
Slovak: - výbor vzhľadom na dostupné údaje z klinických skúšok dospel k záveru, že sa vyskytujú signály o samovražednom správaní, ako sú samovražedné pokusy a samovražedné myšlienky a/alebo podobné správanie, ako sebapoškodzovanie, hostilita a nestálosť nálady u detí a dospievajúcich liečených selektívnymi inhibítormi spätného vychytávania serotonínu a selektívnymi inhibítormi spätného vychytávania noradrenalínu a serotonínu, ako sú lieky uvedené vyššie;
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovak: PRÍLOHA III NÁVRH ZMIEN V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
English: Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
Slovak: Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
English: 1050 Bruxelles, Belgium
Slovak: B-1050 Brussel, Belgium
English: Schering Plough S.p.A.
Slovak: Taliansko Schering Plough S.p.A.
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Slovak: Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Slovak: Luxembursko WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
English: Belgium SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
Slovak: SOLVAY PHARMA & CIE Avenue Demunter 3 1090 Brussel, Belgium
English: Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal
Slovak: Portugalsko Labesfal - Laboratórios Almiro, S.A., 3465-051
English: Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain
Slovak: Nave 2, Avilés (Asturias) 33400, Spain
English: Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Slovak: Veľká Británia Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
English: Denmark Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
Slovak: Jacobsen Pharma A/S, Vemmingbund Strandvej 111, DK-6310 Broager, Denmark
English: Denmark PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
Slovak: PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
English: Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven
Slovak: Holandsko GenRx B.V., Postbus 75, NL-6920 AB Duiven
English: J.V.
Slovak: B.V.
English: IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Slovak: Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Slovak: Holandsko Eurobase B.V., Mercuriusweg 8 - 10, NL-3771
English: 11, avenue Dubonnet 92400 Courbevoie France
Slovak: Dubonnet 92400 Courbevoie France
English: Alternova AB Vallgatan 11 170 67 Solna Sverige (SWE)
Slovak: Alternova AB Vallgatan 11 170 67 Solna
English: 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Slovak: Francúzsko Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
English: Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Slovak: Holandsko Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
English: Selvi Laboratorio Bioterapico S.p.A.
Slovak: Taliansko Selvi Laboratorio Bioterapico S.p.A.
English: Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Slovak: Holandsko Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
English: Denmark 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
Slovak: 1A Farma A/S, Herstedøstervej 27-29, DK-2620 Albertslund, Denmark
English: Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet
Slovak: Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmom obalená tableta
English: Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Slovak: Veľká Británia Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
English: Wyeth Lederle S.p.A.
Slovak: Taliansko Wyeth Lederle S.p.A.
English: FAES FARMA, S.A., Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
Slovak: Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
English: Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal
Slovak: Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT)
English: EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou
Slovak: Labo laboratoire Eurogenerics le Quintet Batiment
English: TEVA GENERICOS ESPAÑOLA, S.L.C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.Madrid, Spain
Slovak: Guzman el Bueno 133, Edificio Britania 4ºIzq.Madrid, Spain
English: Bioindustria Farmaceutici S.r.l.Via Valbondione 113, 00188 Roma, Italy
Slovak: Taliansko Bioindustria Farmaceutici S.r.l.Via Valbondione 113, 00188
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Slovak: Samovražedné správanie (pokusy o samovraždu a samovražedné myšlienky) a hostilita (predovšetkým agresia, protichodné správanie) boli v klinických štúdiách častejšie pozorované medzi deťmi a dospievajúcimi liečenými antidepresívami, než u pacientov, ktorí boli liečení placebom.
English: PAROXETINE,
Slovak: PAROXETÍN,
English: Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Slovak: Holandsko Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
English: Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Slovak: Luxembursko TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
English: WINTHROP médicaments 174 avenue de France 75013 Paris
Slovak: Francúzsko WINTHROP médicaments 174 avenue de France
English: Denmark Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
Slovak: Orion Corporation, Orionintie 1, SF02200 Espoo, Finland
English: Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Slovak: Holandsko Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
English: Denmark GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
Slovak: GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Denmark
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Slovak: Avenue Mercator 1 1300 Wavre, Belgium
English: Jelfa S.A. Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
Slovak: Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500
English: N.V. ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
Slovak: ORGANON Kloosterstraat 6P.O.Box 205340 BH OssHolland
English: Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Slovak: Holandsko Apothecon B.V., Postbus 324, NL3770 AH Barneveld
English: Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Slovak: Holandsko Alpharma B.V., Postbus 313, NL-3740 AH Baarn
English: GlaxoSmithKline (Ireland) Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Slovak: Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
English: Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Slovak: Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
English: Alpharma ApS P O Box 1736 DK2300 Köpenhamn S Danmark (DNK)
Slovak: P O Box 1736 DK2300 Köpenhamn S Danmark (DNK)
English: BOUCHARA RECORDATI 68 Rue Marjolin BP 67
Slovak: RECORDATI 68 Rue Marjolin
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 .
Slovak: Poznámka: Uvedená časť súhrnu charakteristických vlastností lieku bola priložená k rozhodnutiu Komisie vydanom v súlade s postupom podľa článku 31. Znenie textu zodpovedá verzii platnej v tom čase.
English: TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
Slovak: Francúzsko TEVA PHARMA 1 COURS DU TRIANGLE
English: Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Slovak: Holandsko Hexal AG, Postfach 1263, D-83602 Holzkirchen
English: Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Slovak: Holandsko Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
English: Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Slovak: Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221
English: LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
Slovak: Španielsko LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
English: Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Slovak: Postfach 900662 D-21046 Hamburg
English: Belgium RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
Slovak: RANBAXY LTD; 95, Park Lane Mayfair; GB-London-WIK 7 TE
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.
Slovak: Nie sú tiež k dispozícii dlhodobé údaje o bezpečnosti používania[vymyslený názov] u tejto vekovej skupiny týkajúce sa rastu, dospievania a rozvoja poznania a správania.
English: SIEMENS & CO Postfach 1262
Slovak: & CO Postfach 1262
English: Michała 67/71, 61-005 Poznań, Poland
Slovak: - Przedsiębiorstwo Farmaceutyczno-Chemiczne, ul. Św. Michała 67/71, 61-005 Poznań, Poland
English: LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Slovak: Španielsko LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037,
English: Desifluvox amin 25 mg 25 mg
Slovak: Desifluvox amin 25 mg
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Slovak: Holandsko Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
English: Vecchi & Piam S.a.p.a.
Slovak: & Piam S.a.p.a.
English: S.A. Laboratoires S.M.B.
Slovak: Laboratoires S.M.B.
English: Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Slovak: Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
English: Pharmacia Spain Ctra.
Slovak: Španielsko Pharmacia Spain Ctra.
English: LABORATORIOS BELMAC, S.ATeide, 4-planta baja.
Slovak: Španielsko LABORATORIOS BELMAC, S.ATeide, 4-planta baja.
English: JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Slovak: Španielsko JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
English: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Slovak: Veľká Británia Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
English: St. Stephens Green, Dublin 2 Ireland
Slovak: Stephens Green, Dublin 2
English: Laboratori Guidotti S.p.A.
Slovak: Taliansko Laboratori Guidotti S.p.A.
English: 92517 Boulogne Billancourt CedexFrance
Slovak: 92517 Boulogne Billancourt
English: AAI Deutschland GmbH & Co.KG Wegenerstr.
Slovak: & Co.KG Wegenerstr.
English: Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Slovak: Maďarsko Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
English: Via Tranquillo Cremona, 10 20092 Cinisello Balsamo Milano Italy
Slovak: Via Tranquillo Cremona, 10 20092
English: D-71011 Boeblingen
Slovak: D-71011
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Slovak: Informujte svojho lekára, ak sa pri užívaní [vymyslený názov] pacientmi mladšími ako 18 rokov objavia, prípadne zhoršia, niektoré prejavy uvedené vyššie.
English: Lithuania Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Slovak: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
English: Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Slovak: Holandsko Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
English: SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Slovak: Francúzsko SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008
English: Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Slovak: Holandsko Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
English: Belgium BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
Slovak: BEXAL S. A. Avenue de Tervuren 36 B 9 1040 BRUXELLES, Belgium
English: Denmark Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
Slovak: Betapharm Arzneimittel GmbH, Steinerne Furt 78, D-86167 Augsburg, Germany
English: Ratiopharm GmbH Graf-Arco-Strasse 3
Slovak: Taliansko Ratiopharm GmbH Graf-Arco-Strasse 3
English: D-60333 Frankfurt
Slovak: D-60333
English: Foix, 62 - Local 9, 08034 Barcelona, Spain
Slovak: J.V. Foix, 62 - Local 9, 08034 Barcelona, Spain
English: Lithuania N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
Slovak: N.V.Organon, Molenstraat 110, 5342CC oss, The Netherlands
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Slovak: IV.2 NÁVRH ZMENY A DOPLNKU príslušného odseku písomnej informácie pre používateľov pre atomoxetín
English: Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Slovak: Holandsko Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
English: Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Slovak: Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
English: Denmark Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
Slovak: Wyeth Lederle Nordiska AB, Hagahuset, S-17124 Solna, Sweden
English: Organon Italia S.p.A.
Slovak: Taliansko Organon Italia S.p.A.
English: Denmark Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
Slovak: Medis Danmark A/S, H. C. Andersens Boulevard 2, DK-1780 København V, Denmark
English: Netherlands Centrafarm Services B.V. Postbus 289
Slovak: Holandsko Centrafarm Services B.V., Postbus 289,
English: PHADISCO LTD, 185 GIANOU KRANIDIOTI AVENUE, LATSIA, P.O.BOX 22173, 1518 LEFKOSIA, CYPRUS
Slovak: LTD, 185 GIANOU KRANIDIOTI AVENUE, LATSIA, P.O.BOX 22173, 1518 LEFKOSIA, CYPRUS
English: Lithuania Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
Slovak: Pharmacia and Upjohn S.p.A.,Via Robert Koch 12, 20152 Milan, Italy
English: Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Slovak: Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444
English: Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Slovak: Via Ponte della Fabbrica 3/A 35031
English: Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Slovak: Industria Chimico Farmaceutica, Via Aurelia 58, 00165
English: Denmark Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
Slovak: Alternova A/S, Industriparken 25, DK2750 Ballerup, Denmark
English: Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Slovak: Holandsko Hexal B.V., Postbus 251, NL-2180 AG Hillegom
English: Denmark Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
Slovak: Gerard Laboratories, 35 Balcloyle Industrial Estate, Dublin, Ireland
English: Denmark Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
Slovak: Scand Pharm Generics AB, Ynglinagatan 14, S-11347 Stockholm, Sweden
English: ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Slovak: Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
English: Ranbaxy (UK) Ltd, 6rd floor,C.P.
Slovak: Ltd, 6rd floor,C.P.
English: Denmark BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
Slovak: BMM Pharma AB, Blasieholmgatan 2, S-11148 Stockholm, Sweden
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Slovak: Veľká Británia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
English: Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Slovak: Luxembursko Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
English: Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
Slovak: Tillomed Laboratories Limited; 3 Howard Road, Eaton Socon, St.Neots, Cambridgeshire PE19 3ET; UK
English: Denmark Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
Slovak: Pharmascope Ltd, Medici House, Unit 107, Ashbourne Industrial Estate, CoMeath, Ireland
English: Wyeth pharmaceuticals France Coeur Defense - Tour A La Defense 4
Slovak: Francúzsko Wyeth pharmaceuticals France Coeur
English: F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Slovak: Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Slovak: SSRI znamená „selektívny inhibítor spätného vychytávania serotonínu“.
English: Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Slovak: Danskaes Vej 89, DK - 2000 Frederiksberg
English: Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Slovak: Portugalsko Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto. 2790-012
English: Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Slovak: Veľká Británia Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
English: Doc Geenrici S.r.l.
Slovak: Taliansko Doc Geenrici S.r.l.
English: Fluvoxaminmaleat “Solvay” 100mgFilmtabletten
Slovak: Fluvoxaminmaleat “Solvay” 100mg-Filmtabletten
English: Hormosan Pharma GmbH Willhelmshöher Strasse 106 D-60389 Frankfurt am Main Tyskland (DEU)
Slovak: Willhelmshöher Strasse 106 D-60389 Frankfurt am Main Tyskland (DEU)
English: Mediolanum Farmaceutici S.p.A., Via S.Cottolengo, 15-31, 20143 MILANO, Italy
Slovak: Via S.Cottolengo, 15-31, 20143 MILANO, Italy
English: Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Slovak: Holandsko Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
English: D-22311 Hamburg
Slovak: D-22311
English: SERTRALINE,
Slovak: SERTRALÍN,
English: John Wyeth & Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
Slovak: & Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Slovak: Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
English: FOURNIER, S.A., Centro Empresarial Euronova.
Slovak: Centro Empresarial Euronova.
English: Belgium BEXAL S.P.R.L.
Slovak: BEXAL S.P.R.L.
English: Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Slovak: Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
English: LABORATORIOS DECROX, S.A., Crta.
Slovak: Španielsko LABORATORIOS DECROX, S.A.,
English: Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Slovak: Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
English: IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Slovak: Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
English: Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Slovak: Veľká Británia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
English: Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Slovak: Holandsko Docpharma NV, Ambachtenlaan 13 H, B-3001
English: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy
Slovak: Largo Umberto Boccioni, 1 21040
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Slovak: 2 SNRI znamená „selektívny inhibítor spätného vychytávania noradrenalínu a serotonínu“.
English: Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Slovak: Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Slovak: Holandsko Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC
English: H. Lundbeck A/S, Ottiliavej 9 Valby
Slovak: Lundbeck A/S, Ottiliavej 9 Valby
English: Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Slovak: Holandsko Sandoz B.V., Postbus 216, NL-1380 AE Weesp
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Slovak: Navyše sa u takmer všetkých liekov a indikácií vyskytli aj signály týkajúce sa príbuzných nežiaducich príhod, ako hostilita, sebapoškodzovanie a emočná labilita.
English: Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Slovak: À Av. da Siderurgia Nacional 4745-457 S.
English: 10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Slovak: Francúzsko ORGANON 10 Rue Godefroy Immeuble Optima 92821
English: Box 158 Sköyen N-0212 Oslo Norge (NOR)
Slovak: Box 158 Sköyen N-0212
English: Lithuania ICN Polfa Rzeszow, ul.
Slovak: ICN Polfa Rzeszow, ul.
English: LABORATORIOS DAVUR, Teide, 4 pl. baja.
Slovak: Španielsko LABORATORIOS DAVUR, Teide, 4 pl. baja.
English: Prozac Durapac 90 mg Cápsulas Duras GastroResistentes
Slovak: Prozac Durapac 90 mg Cápsulas Duras Gastro-Resistentes
English: MABO FARMA, S.A, Carretera M300 Km 30,500, Alcalá de Henares 28802, Spain
Slovak: FARMA, S.A, Carretera M300 Km 30,500, Alcalá de Henares 28802, Spain
English: Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Slovak: Lagoas Park - Edifício nº 10 2740-244
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Slovak: Francúzsko 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;
Slovak: - výbor zvážil odporučenie podľa článku 31 Smernice 2001/83/EHS v znení neskorších predpisov, o liekoch obsahujúcich atomoxetín, citalopram, escitalopram, fluoxetín, fluvoxamín, mianserín, milnacipran, mirtazapín, paroxetín, reboxetín, sertralín a venlafaxín;
English: D-79241 Ihringen
Slovak: D-79241
English: Neuraxpharm Arzneimittel GmbH & Co.KG
Slovak: Neuraxpharm Arzneimittel GmbH
English: 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Slovak: Francúzsko Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
English: Solvay Pharma S.p.A.
Slovak: Taliansko Solvay Pharma S.p.A.
English: ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
Slovak: AE, 34 Filellinon Street, 15232 Halandri, Greece
English: Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Slovak: Holandsko Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
English: Annopol 6A 03-236 Warszawa, Poland
Slovak: Annopol 6B, 03-236 Warszawa, Poland
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Slovak: DÔVODY NA POZMENENIE SÚHRNU CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
English: Boehringer Ingelheim Pharma GmbH & Co.KG
Slovak: Boehringer Ingelheim Pharma GmbH
English: Gastro-resistant capsule hard
Slovak: Tvrdá gastrorezistentná kapsula
English: Digassim Durapac 90 mg cápsulas duras gastroresistentes
Slovak: Digassim Durapac 90 mg cápsulas duras gastro-resistentes
English: D-06855 Rodleben
Slovak: D-06855
English: ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Slovak: Lécuyer 93300 aubervilliers - France
English: Villa Sayonara Strada Solara, 75-77 Sanremo 18038 IMOLA, Italy
Slovak: Villa Sayonara Strada Solara, 75-77
English: Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Slovak: Taliansko Angenerico S.p.A. via Nocera Umbra 75
English: Denmark Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
Slovak: Ivax Scandinavia AB, Birger Jarlsgatan 37, S-11145 Stockholm, Sweden
English: F.I.R.M.A.
Slovak: Taliansko F.I.R.M.A.
English: Neuraxpharm Arzneimittel GmbH u.Co.KG Elisabeth-Selbert Strasse 23 40764 Langenfeld Tyskland (DEU)
Slovak: Neuraxpharm Arzneimittel GmbH u.Co.KG Elisabeth-Selbert Strasse 23 40764
English: Sepi Chimica S.r.l.
Slovak: Taliansko Sepi Chimica S.r.l.