natgillin/translations-raw huggingface dataset:
- 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; 
- 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;
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS 
PRÍLOHA III NÁVRH ZMIEN V SÚHRNE CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
Pfizer Kft., Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary 
Alkotás u. 53., MOM Park F épület, 1123 Budapest, Hungary
1050 Bruxelles, Belgium 
B-1050 Brussel, Belgium
Schering Plough S.p.A. 
Taliansko Schering Plough S.p.A.
Luxembourg WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium 
Luxembursko WYETH PHARMACEUTICALS, 15 Rue Du Bosquet, B-1348 Louvain-LaNeuve, Belgium
Labesfal - Laboratórios Almiro, S.A., 3465-051 Campo de Besteiros Portugal 
Portugalsko Labesfal - Laboratórios Almiro, S.A., 3465-051
Conde de Guadalhorce, 43 Nave 2, Avilés (Asturias) 33400, Spain 
Nave 2, Avilés (Asturias) 33400, Spain
Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK 
Veľká Británia Milpharm Limited, Marlborough House, 298 Regent's Park Road, Finchley, London N3 2UA; UK
Netherlands GenRx B.V., Postbus 75, NL-6920 AB Duiven 
Holandsko GenRx B.V., Postbus 75, NL-6920 AB Duiven
J.V. 
B.V.
IIP-Institut für Industrielle Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany 
Pharmacie Kreuznacher str. 1, Stromberg, D55442, Germany
Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld 
Holandsko Eurobase B.V., Mercuriusweg 8 - 10, NL-3771
11, avenue Dubonnet 92400 Courbevoie France 
Dubonnet 92400 Courbevoie France
Alternova AB Vallgatan 11 170 67 Solna Sverige (SWE) 
Alternova AB Vallgatan 11 170 67 Solna
42 rue d'Aguesseau 92100 Boulogne Billancourt - France 
Francúzsko Mundipharma 42 rue d'Aguesseau 92100 Boulogne Billancourt - France
Netherlands Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden 
Holandsko Katwijk Farma B.V., Postbus 408, NL2300 AK Leiden
Selvi Laboratorio Bioterapico S.p.A. 
Taliansko Selvi Laboratorio Bioterapico S.p.A.
Netherlands Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten 
Holandsko Eli Lilly Nederland BV, Postbus 379, NL-3990 GD Houten
Zoloft 25 mg + 50 mg 25 mg + 50 mg Film-coated tablet 
Zoloft 25 mg + 50 mg 25 mg + 50 mg Filmom obalená tableta
Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK 
Veľká Británia Goldshield Pharmaceuticals Limited, NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey CR0 0XT; UK
Wyeth Lederle S.p.A. 
Taliansko Wyeth Lederle S.p.A.
FAES FARMA, S.A., Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain 
Maximo Aguirre, 14., Lamiaco-Lejona, 48940, Spain
Hikma Farmacêutica (Portugal), Lda., Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT) Portugal 
Estrada do Rio da Mó, nº 8 - 8 A e 8 B - Fervença 2705-906 Terrugem (SNT)
EG Labo laboratoire Eurogenerics le Quintet Batiment A 12 rue Danjou 
Labo laboratoire Eurogenerics le Quintet Batiment
TEVA GENERICOS ESPAÑOLA, S.L.C/ Guzman el Bueno 133, Edificio Britania 4ºIzq.Madrid, Spain 
Guzman el Bueno 133, Edificio Britania 4ºIzq.Madrid, Spain
Bioindustria Farmaceutici S.r.l.Via Valbondione 113, 00188 Roma, Italy 
Taliansko Bioindustria Farmaceutici S.r.l.Via Valbondione 113, 00188
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