natgillin/translations-raw huggingface dataset:
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.
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.
PAROXETINE,
PAROXETÍN,
Netherlands Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Holandsko Wyeth Pharmaceuticals B.V., Postbus 255, NL-2130 AG Hoofddorp
Luxembourg TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
Luxembursko TOPGEN E.S.V., E. Demunterlaan 1, B-1090 Bruxelles, Belgium
WINTHROP médicaments 174 avenue de France 75013 Paris
Francúzsko WINTHROP médicaments 174 avenue de France
Netherlands Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Holandsko Genfarma B.V., Postbus 2062, NL1500 GB Zaandam
Jelfa S.A. Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500 Jelenia Góra
Przedsiębiorstwo Farmaceutyczne, Wincentego Pola 21 58-500
Netherlands Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Holandsko Apothecon B.V., Postbus 324, NL3770 AH Barneveld
Netherlands Alpharma B.V., Postbus 313, NL-3740 AH Baarn
Holandsko Alpharma B.V., Postbus 313, NL-3740 AH Baarn
GlaxoSmithKline (Ireland) Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Ltd Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Angenérico Produtos Farmacêuticos Genéricos, Lda., Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Rua João Chagas, nº 53 - 3º Piso 1495-072 Algés Portugal
Alpharma ApS P O Box 1736 DK2300 Köpenhamn S Danmark (DNK)
P O Box 1736 DK2300 Köpenhamn S Danmark (DNK)
BOUCHARA RECORDATI 68 Rue Marjolin BP 67
RECORDATI 68 Rue Marjolin
Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
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.
TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
Francúzsko TEVA PHARMA 1 COURS DU TRIANGLE
Netherlands Hexal AG, Postfach 1263, D-83602 Holzkirchen
Holandsko Hexal AG, Postfach 1263, D-83602 Holzkirchen
Netherlands Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Holandsko Pharmachemie B.V., Postbus 552, 2003 RN Haarlem, The Netherlands
Cinfa Portugal, Lda., Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221 Carnaxide Portugal
Av. Tomás Ribeiro, 43 - Bloco 2, 3º F - Edificio Neopark 2790-221
LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
Španielsko LABORATORIOS RANBAXY, S.L., Tuset, 20-24, 08006 Barcelona, Spain
Lundbeck GmbH Postfach 900662 D-21046 Hamburg
Postfach 900662 D-21046 Hamburg
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.
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.
SIEMENS & CO Postfach 1262
& CO Postfach 1262
Michała 67/71, 61-005 Poznań, Poland
- Przedsiębiorstwo Farmaceutyczno-Chemiczne, ul. Św. Michała 67/71, 61-005 Poznań, Poland
LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037, Spain
Španielsko LABORATORIOS JUVENTUS, S.A., Julian Camarillo, 37, Madrid 28037,
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Holandsko Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten, The Netherlands
Vecchi & Piam S.a.p.a.
& Piam S.a.p.a.
S.A. Laboratoires S.M.B.
Laboratoires S.M.B.
Solvay Farma, Lda., Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Avenida Marechal Gomes da Costa, 33 1800-255 Lisboa Portugal
Pharmacia Spain Ctra.
Španielsko Pharmacia Spain Ctra.
LABORATORIOS BELMAC, S.ATeide, 4-planta baja.
Španielsko LABORATORIOS BELMAC, S.ATeide, 4-planta baja.
JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Španielsko JUSTE, S.A.Q.F.Juan Ignacio Luca de Tena, 8 28027 MADRID
Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20 8RB, UK
Veľká Británia Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egahm, Surrey TW20
St. Stephens Green, Dublin 2 Ireland
Stephens Green, Dublin 2
Laboratori Guidotti S.p.A.
Taliansko Laboratori Guidotti S.p.A.
92517 Boulogne Billancourt CedexFrance
92517 Boulogne Billancourt
AAI Deutschland GmbH & Co.KG Wegenerstr.
& Co.KG Wegenerstr.
Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Maďarsko Wyeth Whitehall Export GmbH, Strochengasse 1, A-1150
Via Tranquillo Cremona, 10 20092 Cinisello Balsamo Milano Italy
Via Tranquillo Cremona, 10 20092
D-71011 Boeblingen
D-71011
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Informujte svojho lekára, ak sa pri užívaní [vymyslený názov] pacientmi mladšími ako 18 rokov objavia, prípadne zhoršia, niektoré prejavy uvedené vyššie.
Netherlands Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
Holandsko Lundbeck B.V., Postbus 12021, NL1100 AA Amsterdam
SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008 Paris - France
Francúzsko SUBSTIPHARM 264 Rue du Faubourg saint honoré 75008
Netherlands Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Holandsko Merck Generics BV, Dieselweg 25, NL-3752 LB Bunschoten
Ratiopharm GmbH Graf-Arco-Strasse 3
Taliansko Ratiopharm GmbH Graf-Arco-Strasse 3
D-60333 Frankfurt
D-60333
Foix, 62 - Local 9, 08034 Barcelona, Spain
J.V. Foix, 62 - Local 9, 08034 Barcelona, Spain
IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
IV.2 NÁVRH ZMENY A DOPLNKU príslušného odseku písomnej informácie pre používateľov pre atomoxetín
Netherlands Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Holandsko Solvay Pharma B.V., Postbus 501, NL1380 AM Weesp
Netherlands Betapharm Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Arzneimittel GmbH, Kobelweg 95, D-86156 Augsburg
Organon Italia S.p.A.
Taliansko Organon Italia S.p.A.
Netherlands Centrafarm Services B.V. Postbus 289
Holandsko Centrafarm Services B.V., Postbus 289,
PHADISCO LTD, 185 GIANOU KRANIDIOTI AVENUE, LATSIA, P.O.BOX 22173, 1518 LEFKOSIA, CYPRUS
LTD, 185 GIANOU KRANIDIOTI AVENUE, LATSIA, P.O.BOX 22173, 1518 LEFKOSIA, CYPRUS
Laboratório Normal - Produtos Farmacêuticos, S.A., Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444 Sintra Portugal
Rua do Centro Empresarial, Edifício 8 - Quinta da Beloura 2710-444
Via Ponte della Fabbrica 3/A 35031 Abano Terme - Padova Italy
Via Ponte della Fabbrica 3/A 35031
Bioprogress S.p.A. Industria Chimico Farmaceutica, Via Aurelia 58, 00165 ROMA, Italy
Industria Chimico Farmaceutica, Via Aurelia 58, 00165
Netherlands Hexal B.V., Postbus 251, NL-2180 AG Hillegom
Holandsko Hexal B.V., Postbus 251, NL-2180 AG Hillegom
ALPHARMA Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Whiddon ValleyBarnstaple, North Devon EX 32 8NS, England
Ranbaxy (UK) Ltd, 6rd floor,C.P.
Ltd, 6rd floor,C.P.
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Veľká Británia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, U.K.
Luxembourg Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Luxembursko Ratiopharm GmbH, Postfach 3380, D89070 Ulm, Germany
Wyeth pharmaceuticals France Coeur Defense - Tour A La Defense 4
Francúzsko Wyeth pharmaceuticals France Coeur
F. Joh. Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010 Wien
Kwizda GesmbH Dr. Karl-Lueger-Ring 6 A-1010
1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
SSRI znamená „selektívny inhibítor spätného vychytávania serotonínu“.
Fabrik , Holger Danskaes Vej 89, DK - 2000 Frederiksberg
Danskaes Vej 89, DK - 2000 Frederiksberg
Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto.
Portugalsko Germed Farmacêutica, Lda.Edifício Monsanto - Rua Alto do Montijo, 131º Dto. 2790-012
Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Veľká Británia Solvay Healthcare Limited, Mansbridge Road, West End, Southampton SO18 3JD; UK
Doc Geenrici S.r.l.
Taliansko Doc Geenrici S.r.l.
Fluvoxaminmaleat “Solvay” 100mgFilmtabletten
Fluvoxaminmaleat “Solvay” 100mg-Filmtabletten
Hormosan Pharma GmbH Willhelmshöher Strasse 106 D-60389 Frankfurt am Main Tyskland (DEU)
Willhelmshöher Strasse 106 D-60389 Frankfurt am Main Tyskland (DEU)
Mediolanum Farmaceutici S.p.A., Via S.Cottolengo, 15-31, 20143 MILANO, Italy
Via S.Cottolengo, 15-31, 20143 MILANO, Italy
Netherlands Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
Holandsko Pharmachemie B.V., Postbus 552, NL2003 RN Haarlem
D-22311 Hamburg
D-22311
SERTRALINE,
SERTRALÍN,
John Wyeth & Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
& Brothers Ltd, New Lane, Havant, HANTS, P09 2NG, United Kingdom
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin
FOURNIER, S.A., Centro Empresarial Euronova.
Centro Empresarial Euronova.
Merck, S.A., Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
Rua Alfredo da Silva, 3C 1300-040 Lisboa Portugal
LABORATORIOS DECROX, S.A., Crta.
Španielsko LABORATORIOS DECROX, S.A.,
Belgium ETHIMED N.V., Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
Leuvensestraat 28 B2, 1800 Vilvoorde, Belgium
IVAX Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Scandinavia AB, Birger Jarlsgatan 37, SE-111 45 Stockholm, Sweden
Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Veľká Británia Sterwin Medicines Limited, PO Box 611, Guildford,Surrey GU1 4YS, UK
Netherlands Docpharma NV, Ambachtenlaan 13 H, B-3001 Heverlee
Holandsko Docpharma NV, Ambachtenlaan 13 H, B-3001
Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy
Largo Umberto Boccioni, 1 21040
2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
2 SNRI znamená „selektívny inhibítor spätného vychytávania noradrenalínu a serotonínu“.
Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés Portugal
Rua Prof. Ricardo Jorge, 5 AMiraflores 1495-153 Algés
Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Holandsko Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC
Netherlands Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Holandsko Sandoz B.V., Postbus 216, NL-1380 AE Weesp
Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Navyše sa u takmer všetkých liekov a indikácií vyskytli aj signály týkajúce sa príbuzných nežiaducich príhod, ako hostilita, sebapoškodzovanie a emočná labilita.
Medibial - Produtos Médicos e Farmacêuticos, S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
À Av. da Siderurgia Nacional 4745-457 S.
10 Rue Godefroy Immeuble Optima 92821 Puteaux cedex - France
Francúzsko ORGANON 10 Rue Godefroy Immeuble Optima 92821
Box 158 Sköyen N-0212 Oslo Norge (NOR)
Box 158 Sköyen N-0212
LABORATORIOS DAVUR, Teide, 4 pl. baja.
Španielsko LABORATORIOS DAVUR, Teide, 4 pl. baja.
MABO FARMA, S.A, Carretera M300 Km 30,500, Alcalá de Henares 28802, Spain
FARMA, S.A, Carretera M300 Km 30,500, Alcalá de Henares 28802, Spain
Laboratórios Pfizer, Lda., Lagoas Park - Edifício nº 10 2740-244 Porto Salvo Portugal
Lagoas Park - Edifício nº 10 2740-244
15 boulevard Charles de Gaulle 92707 Colombes cedex - France
Francúzsko Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex - France
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;
- 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;
D-79241 Ihringen
D-79241
Neuraxpharm Arzneimittel GmbH & Co.KG
Neuraxpharm Arzneimittel GmbH
15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Francúzsko Biogaran 15 boulevard Charles de Gaulle 92707 Colombes cedex- France
Solvay Pharma S.p.A.
Taliansko Solvay Pharma S.p.A.
ALLEN FARMAKEUTIKI AE, 34 Filellinon Street, 15232 Halandri, Greece
AE, 34 Filellinon Street, 15232 Halandri, Greece
Netherlands Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Holandsko Synthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Annopol 6A 03-236 Warszawa, Poland
Annopol 6B, 03-236 Warszawa, Poland
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
DÔVODY NA POZMENENIE SÚHRNU CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Boehringer Ingelheim Pharma GmbH & Co.KG
Boehringer Ingelheim Pharma GmbH
Gastro-resistant capsule hard
Tvrdá gastrorezistentná kapsula
D-06855 Rodleben
D-06855
ZYDUS France 40 RUE Lécuyer 93300 aubervilliers - France
Lécuyer 93300 aubervilliers - France
Angenerico S.p.A. via Nocera Umbra 75 00100 Roma Italy
Taliansko Angenerico S.p.A. via Nocera Umbra 75
F.I.R.M.A.
Taliansko F.I.R.M.A.
Neuraxpharm Arzneimittel GmbH u.Co.KG Elisabeth-Selbert Strasse 23 40764 Langenfeld Tyskland (DEU)
Neuraxpharm Arzneimittel GmbH u.Co.KG Elisabeth-Selbert Strasse 23 40764
Sepi Chimica S.r.l.
Taliansko Sepi Chimica S.r.l.
Generis Farmacêutica, S.A., Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
Rua José Galhardo, n.º 3 1750-131 Lisboa Portugal
ITF Farma - Produtos Farmacêuticos, Lda., Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena Portugal
Rua Consiglieri Pedroso, 123Queluz de Baixo 2745-557 Barcarena
Polifarma S.p.A.
Taliansko Polifarma S.p.A.
Union Health S.r.l.
Taliansko Union Health S.r.l.
Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Veľká Británia Alpharma Limited; Whiddon Valley; Barnstaple; Devon EX32 8NS; UK
Fluoxetin Hexal 4mg/ml Loesung
Fluoxetin Hexal 4mg/ml Loesung 20 mg
Lečiva A.s., CZ, U kabelovny 130 Dolni Mécholupy CZ - 102 37 Praha 10
CZ, U kabelovny 130 Dolni Mécholupy CZ - 102 37 Praha 10
D-01097 Dresden
D-01097
ORGANON ESPAÑOLA, S.A., Ctra.
Španielsko ORGANON ESPAÑOLA, S.A.,
GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli Greece
GENERICS PHARMA HELLAS 577a Vouliagmenis
Pharmacia Italia S.p.A.
Taliansko Pharmacia Italia S.p.A.
PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Španielsko PLIVA PHARMA IBERIA,, Chile 8, 2º Oficina 203.Edificio Euromadrid, Las Matas 28290, Spain
Floccin 20mg/5mlLösung zum Einnehmen
Floccin 20mg/5ml-Lösung zum Einnehmen
Pliva Pharma S.p.A.
Taliansko Pliva Pharma S.p.A.
13 rue pagès
Francúzsko Lilly France 13 rue pagès
Glaxosmithkline S.p.A.
Taliansko Glaxosmithkline S.p.A.
Genedec - Medicamentos Genéricos, Lda., Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Rua Sebastião e Silva, 56 2745838 Massamá Portugal
Netherlands Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Holandsko Genthon B.V., Postbus 7071, NL-6503 GN Nijmegen
Przemyslowa, PL - 35 959 Rzeszow
ICN Polfa Rzesów S.A., ul. Przemyslowa, PL - 35 959 Rzeszow
Max Farma S.r.l.
Taliansko Max Farma S.r.l.
RANBAXY (UK) LTD., EALING, LONDON
LTD., EALING, LONDON
37 avenue Pierre Premier de Serbie 75008 Paris, France
Francúzsko Lundbeck 37 avenue Pierre Premier de Serbie 75008 Paris, France
Humanpharma Gyógyszergyártó Kft. Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Táncsics Mihály út 82, H-2100
Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest (Hungary)
Uzsoki út 36/A, 1145 Budapest (Hungary)
Generics (UK) Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Ltd Station Close Potters Bar Hertfordshire EN6 1TL Storbritannien och Nordirland (GBR)
Fluxet 20 mg snap-tab 20 mg
Fluxet 20 mg snap-tab
Farma APS - Produtos Farmacêuticos, S.A., Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Rua José Galhardo nº 3, loja 3c/v 1750-131 Lisboa Portugal
Rue-de-la-Pastorale 26-28 B-1080 Bruxelles
Rue-de-la-Pastorale 26-28
Via Della Libertà, 30 10095 Grugliasco - Torino Italy
10095 Grugliasco - Torino
D-70839 Gerlingen
D-70839
LUNDBECK ESPAÑA, S.A., Avda.
Španielsko LUNDBECK ESPAÑA, S.A.,
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda., Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide Portugal
Edifício Tejo - 6º Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide
LITAPHAR, S.A.Orendaundi, 9 20730 Guipuzcoa, Spain
Španielsko LITAPHAR, S.A.Orendaundi, 9 20730 Guipuzcoa, Spain
Fluvoxamine-maleaat 50 A, tablets
Fluvoxamine-maleaat 50 A, tablets 50 mg
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPA Via Tucidide, 56 torre 6
SPA Via Tucidide, 56 torre 6
C A PAPAELLINA & CO LTD, P.O.BOX 24018, LAXIA 1700 LEFKOSIA, CYPRUS
& CO LTD, P.O.BOX 24018, LAXIA 1700 LEFKOSIA, CYPRUS
NV Organon P O Box 20 NL-5340 BH Oss Nederländerna (NLD)
P O Box 20 NL-5340 BH Oss Nederländerna (NLD)
TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Španielsko TAMARANG, S.A, Balmes, 84 - 4º-2ª, Barcelona, Spain
Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG; UK
Veľká Británia Approved Prescription Services Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22
, C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.
, C/ Guzman el Bueno 133, Edificio Britania 4ºIzq. 28003 Madrid, Spain
Fluoxetine Gf 20 mg/5 ml, solution 4 mg/ml
Gf 20 mg/5 ml, solution 4 mg/ml
Medochemie, 1 - 10 Constantinoupleos Street, 3011, Limasol, Cyprus
Street, 3011, Limasol, Cyprus
Paroxetin “Sandoz” 20mg-Tabletten
Paroxetin “Sandoz” 20mg-Tabletaten
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
VEDECKÉ ZÁVERY A ODÔVODNENIE ZMIEN A DOPLNKOV V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
PHARMATEN, 6 Dervenakion, 15351 Pallini Attikis, Greece
PHARMATEN, 6 Dervenakion, 15351
Belgium TIEFENBACHER Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Gmbh Van Der Smissenstrasse 1 D-22767 Hamburg
Belgium ORGANON BELGIE Terhulpsesteenweg 166 1070
Terhulpsesteenweg 166 1070 BRUSSEL, Belgium
Farmoquímica Baldacci, S.A., Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
Rua Duarte Galvão, n.º 44 1549-005 Lisboa Portugal
ORGANON
NV Organon
PENSA, S.A., Avda.
ESTEVE, S.A, Avda.
Tolvon, tablets 10 mg 10 mg
Tolvon, tablets 10 mg
COSTAKIS TSISIOS & CO LTD, 25 THESSALONIKIS STR, P.O.BOX 56495, 3307 LEMESOS, CYPRUS
& CO LTD, 25 THESSALONIKIS STR, P.O.BOX 56495, 3307 LEMESOS, CYPRUS
LABORATORIOS KORHISPANA, S.A.Pasaje Can Politic, 17, 3ª.L' Hospitalet de Llobregat 08907
Španielsko LABORATORIOS KORHISPANA, S.A.Pasaje Can Politic, 17, 3ª.L'
Langenfeld, Germany
Langenfeld Tyskland (DEU)
H. Lundbeck A/S Ottiliavej 9
Taliansko H. Lundbeck A/S Ottiliavej 9
Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Portugalsko Teva Pharma, B.V., Industrieweg, 23 NL-3640 AE Mijdrecht Holanda
Portal capsules 20 mg 20 mg
Portal capsules 20 mg
Oropharyngeal use
Orofaryngeálne použitie
Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Via Ponte della Fabbrica, 3/a, I-35031
John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG Storbritannien och Nordirland (GBR)
John Wyeth and Brother Ltd New Lane Havant Hants PO9 2NG
LABORATORIOS DAVUR, S.L, Teide, 4-planta baja.
Španielsko LABORATORIOS DAVUR, S.L, Teide, 4-planta baja.
LAB. ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
ANGENERICO, S.L Osio, 7-9 08034 Barcelona, Spain
Intravenous infusion
Injekčný koncentrát
Efectin 25mg-Tabletten 25mg
Efectin 25mg-Tabletaten 25mg
A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Španielsko A/S GEA FARMACEUTISK FABRIK, Kananlholmen, 8-12, Hvidovre, DK-2650
Ratiopharm Hungary Kft., Uzsoki út 36/A, 1145 Budapest, Hungary
Uzsoki út 36/A, 1145 Budapest, Hungary
GLAXOSMITHKLINE 100 route de Versailles 78163 Marly le roi cedex France
Francúzsko GLAXOSMITHKLINE 100 route de Versailles 78163
Solvex 4 mg Tabletten 4 mg
Solvex 4 mg Tabletaten 4 mg
FARMANEU, S.L., Rambla de Cataluña, 47 - 1º, 08007 Barcelona, Spain
Rambla de Cataluña, 47 - 1º, 08007
Inpharmco-Mianserin30mg-Tabletten
Inpharmco-Mianserin-30mgTabletaten
CENINTER S.A., Juan Ignacio Luca de Tena, 8, Madrid 28027, Spain
Juan Ignacio Luca de Tena, 8, Madrid 28027,
IPSEN PHARMA, S.A., Ctra.
Španielsko IPSEN PHARMA, S.A.,
67, 02631 Espoo, Finland
Ratiopharm Oy, P.B. 67, 02631 Espoo, Finland
Benedetti S.p.A.
Taliansko Benedetti S.p.A.
Organon Portuguesa - Produtos Químicos e Farmacêuticos, Lda., Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Avenida Conde de Valbom, n.º 30 - 2º 1069-037 Lisboa Portugal
Farma Uno S.r.l.
Taliansko Farma Uno S.r.l.
SmithKline Beecham 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom
Beecham 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom
AWD.pharma GmbH & Co. KG Lepziger Strasse 7-13 D-01097 Dresden Tyskland (DEU)
KG Lepziger Strasse 7-13 D-01097
Reprefar - Produtos Farmacêuticos Lda., Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
Rua Rodrigo da Fonseca, n.º 178, 2º Esq 1099-067 Lisboa Portugal
SALUS Ljubljana, d.d., Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Mašera Spasićeva ulica 10, SI-1000 Ljubljana, Slovenia
Krka d.d., Šmarješka cesta 6, SL - 850 01 Novo Mesto
Šmarješka cesta 6, SL - 850 01 Novo Mesto
Przemysłowa 2, 35-959 Rzeszów, Poland
ICN Polfa Rzeszów S.A., ul. Przemysłowa 2, 35-959 Rzeszów, Poland
Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
Veľká Británia Genus Pharmaceuticals Limited, Benham Valence, Newbury, Berks RG20 8LU; UK
1/SNRIs products particularly as regards their use in the paediatric population: fluoxetine, fluvoxamine, sertraline, paroxetine, citalopram, escitalopram, atomoxetine, duloxetine, venlafaxine, mianserine, milnacipran, reboxetine, and mirtazapine.
predovšetkým v súvislosti s ich používaním u detskej populácie: fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, atomoxetín, duloxetín, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín.
BIOMEDICA-CHEMICA AE, 25 G.LYRA 14564 K.Kifissia, Greece
AE, 25 G.LYRA 14564 K.Kifissia, Greece
Biores Italia S.r.l.
Taliansko Biores Italia S.r.l.
Netherlands Alfred Tiefenbacher (GmbH & Co. KG)
Holandsko Alfred Tiefenbacher (GmbH
Felixsan 50mgFilmtabletten
Felixsan 50mg-Filmtabletten
Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
PLIVA Pharma Nordic A/S H.P. Christensens Vej 1 DK-3000 Helsingör Danmark (DNK)
Castel San Giorgio 84083 Salerno Italy
Castel San Giorgio 84083
Krewel Meuselbach GmbH Postfach 1263
Krewel Meuselbach GmbH
Pharmacia Italia S.p.A., Via Robert Koch 1.2, 201 52, Milano, Italy
Via Robert Koch 1.2, 201 52, Milano, Italy
DISTA, Avda.
Španielsko DISTA, Avda.
BC Biochemie Pharma GmbH Dieselstr.
Biochemie Pharma GmbH Dieselstr. 5
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Veľká Británia Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW; UK
Hennig Arzneimittel GmbH & Co.KG Postfach 1240
& Co.KG Postfach 1240
D-89079 Ulm Germania
3 D-89079 Ulm
16, Chemin de Coquelicots CH - 1214 Geneva
CH - 1214 Geneva
Fevarin Tabs 100 mg 100 mg
Fevarin Tabs 100 mg
Aliud Pharma GmbH & Co.KG Postfach 1380
& Co.KG Postfach 1380
Seroxat 2mg/ml-orale Lösung
Seroxat 2mg/ml-orale
Portugal toLife - Produtos Farmacêuticos, S.A., Estrada Consiglieri Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Pedroso nº 71, Edificio B 1ª - Queluz de Baixo 2730055 Barcarena Portugal
Lampugnani Farmaceutici S.p.A.
Taliansko Lampugnani Farmaceutici S.p.A.
LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Španielsko LABORATORIOS EDIGEN, S.A, Chile 8, 2º Oficina 203.Edificio Euromadrid Las Matas 28290, Spain
Mare de Déu de Montserrat, 221 Barcelona 08041, Spain
Mare de Déu de Montserrat, 221, 08041