natgillin/translations-raw huggingface dataset:
Denmark Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB 
Limited, 95 Park Lane, Mayfair, UK-W1K7TE, London, GB
Ranbaxy (UK) Limited , CP House 97107 Uxbridge Road, Ealing London, London, W5 5TL, UK 
Limited , CP House 97107 Uxbridge Road, Ealing London, London, W5 5TL, UK
ALFRED E. TIEFENBACHER (GMBH & CO. KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany 
& CO. KG), HAMBURG, Van-der-Smissen-Strasse 1, D-22767 Hamburg, Germany
Fluoxetina Teva 20 mg cápsulas 
Fluoxetina Teva 20 mg cápsulas 20 mg
Cipralex 15mg-Filmtabletten 15mg 
Cipralex 15mg-Filmtabletten
Dispersible tablets 
Rozpustná tableta
NuFluo 20mg-Kapseln 20mg 
NuFluo 20mg-Kapseln
Lithuania Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljublana, Slovenia 
Verovskova 57, 1526 Ljublana, Slovenia
Fluvoxadura 100mg 100 mg 
Fluvoxadura 100mg
Cipralex 5 mg Filmtabletten 5 mg 
Cipralex 5 mg Filmtabletten
Lithuania Ranbaxy (UK) Ltd., C.P. 
Veľká Británia Ranbaxy (UK)
Norton Healthcare Ltd. Albert Basin Royal Docks, E 162QJ London, UK 
Albert Basin Royal Docks, E 162QJ London, UK
Fluoxetin-TEVA 20 mg Tabletten 
Fluoxetin-TEVA 20 mg Tabletaten 20 mg
Cipralex 15 mg Filmtabletten 15 mg 
Cipralex 15 mg Filmtabletten
FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
FLUVOXAMIN obsahujúce liečivé prípravky s rozhodnutím o registrácii v Európskej Únii
Fluctine 20mg-lösliche Tabletten 
Fluctine 20mg-lösliche
Prolonged release capsule Oral use 
Kapsula s predĺženým uvoľňovaním
Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer Gasse 5-11, 1021 Wien, Austria 
Boehringer Ingelheim Austria G.m.b.H., Dr. Boehringer
Cipralex 10mg-Filmtabletten 10mg 
Cipralex 10mg-Filmtabletten
Netherlands Alpharma B.V. Postbus 313 
Holandsko Alpharma B.V.
D-64206 Darmstadt paroxedura 20 mg Filmtabletten 
Darmstadt paroxedura 20 mg Filmtabletten
Odense SØ, Denmark 
Odense SÖ Danmark (DNK)
Felixsan 100 mgFilmtabletten 
Felixsan 100 mg-Filmtabletten 100mg
GlaxoSmithkline Produtos Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, nº 3 - ArquiparqueMiraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges, nº 3 - ArquiparqueMiraflores 1495-131
Wyeth Lederle Portugal (Farma), Lda., Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges, 2Arquiparque - Miraflores 1495-131
de la Industria, 30Alcobendas, Spain 
Španielsko IRISFARMA, S.A.Avda. de la Industria, 30Alcobendas, Spain
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK 
Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
Fluoxetina Fluxin 20 mg Cápsulas 
Fluoxetina Fluxin 20 mg Cápsulas 20 mg
Generics (UK) Ltd., Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom 
Ltd., Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Fluoxetin 20 mg Kapseln 20 mg 
Fluoxetin TAD 20 mg Kapseln 20 mg
D-40244 Langenfeld 
D-40244
Mianserine Teva 
Francúzsko TEVA
Mepha Lda, Rua Elias Garcia, nr 28-C Edificio 4-Venda Nova, 2701-335 Amadora, Portugal 
Rua Elias Garcia, nº 28 - C, Edifício 4 - Venda Nova 2701-355 Amadora Portugal
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K. 
Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Luxembourg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany 
Luxembursko Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
H. Lundbeck A/S, Ottiliavej, 9 DK2500 Valby - Copenhagen Dinamarca 
Portugalsko H. Lundbeck A/S, Ottiliavej, 9 DK2500 Valby - Copenhagen Dinamarca
TARBIS FARMA, S.L., Gran Via Carlos III, 94, Barcelona, 08028, Spain 
Gran Via Carlos III, 94, Barcelona, 08028,
H. Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen - Valby, Denmark 
Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen - Valby, Denmark
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten 
3 D-53773 Hennef fluoxetin-biomo 20mg Tabletaten 20 mg
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten 
Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
ICN IBERICA, S.A., Casanova, 2731., Corbera de Llobregat 08757, Spain 
Corbera de Llobregat 08757, Spain
Netherlands Apothecon B.V. Postbus 324 
Holandsko Apothecon B.V.
Pinewood Laboratories, Ballymacabry, Clonmel, Co. Tipperary, Ireland 
Veľká Británia Pinewood Laboratories, Ballymacabry, Clonmel, Co.
Eli Lilly and Company Ltd. Kingsclere Road GB-RG21 6XA Basingstoke, Hampshire 
Kingsclere Road GB-RG21 6XA Basingstoke, Hampshire
H. Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen-Valby 
Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen-Valby
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten 
Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
Mirtazapine Dumex 30 mg, filmomhulde tabletten 
Dumex 30 mg, filmomhulde tabletten
Fluoxetina Labesfal 20 mg cápsulas duras 
Labesfal 20 mg cápsulas duras
Pharmacia Limited WRS-EUCAN Regulatory Affairs Walton Oaks, Dorking Road, Walton on the Hill, Tadworth, Surrey KT20 7NS, UK 
Walton Oaks, Dorking Road, Walton on the Hill, Tadworth, Surrey KT20 7NS, UK
Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, P.O.BOX 900, 1381 WEESP, the Netherlands 
Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, P.O.BOX 900, 1381
NOVARTIS FARMACEUTICA, S.A., Gran Via de les Corts Catalanes, 764, Barcelona, 08013, Spain 
Gran Via de les Corts Catalanes, 764, Barcelona, 08013, Spain
Fluoxetin „Kwizda“ 20mg-Kapseln 
Fluoxetin „Kwizda“ 20mg-Kapseln 20mg
FLOXET 20 MG 20 mg 
FLOXET 20 MG
JUSTE, S.A.Q.F., Juan Ign 28027acio Luca de Tena, 8, Madrid, Spain 
Španielsko JUSTE, S.A.Q.F., Juan Ign 28027acio
FLUOXETIN MEDOCHEMIE 
Fluoxetin Farmagon
Fluoxetina Cinfa 20 mg Cápsulas 
Fluoxetina Cinfa 20 mg Cápsulas 20 mg
Mogilska 80 31-546 Kraków, Poland 
Pliva Kraków Zakłady Farmaceutyczne S.A., ul. Mogilska 80 31-546 Kraków, Poland
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten 
Nemecko ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
Citalopram "Copyfarm" 
"Copyfarm"
Paroxetine Gf 20 mg, tabletten 
Gf 20 mg, tabletten
Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K. 
Veľká Británia Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
McDermott Laboratories Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland 
Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl 
Holandsko Sandoz GmbH, Biochemiestrasse 10, A-6250
McDermott Laboratories Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland 
Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
LABORATORIOS PEREZ GIMENEZ, Glorieta Farmaceutico Perez Gimenez, 1., Cordoba, 14007, Spain 
Perez Gimenez, 1., Cordoba, 14007, Spain
Netherlands Sandoz B.V. Postbus 216 
Holandsko Sandoz B.V.
REMERON Soltab 15mg 15mg 
Soltab 15mg 15mg
Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium 
Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
McDermott Laboratories Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate Grange Road, Dublin 13, Ireland 
Ltd t/a Gerard Laboratories, 35 Baldoyle Industrial Estate Grange Road, Dublin 13, Ireland
Paroxetine Gf 40 mg, filmomhulde tabletten 
Gf 40 mg, filmomhulde tabletten
Wyeth Pharma GmbH Postfach 8806 
Postfach 8806
Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Irland (IRL) 
Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road
USO RACIONAL, S.L., Ventura Rodríguez, 7 - 5ª planta, 28008 Madrid, Spain 
S.A, Ventura Rodriguez, 7 - 5ª planta, 28008 Madrid, Spain
Luxembourg SANDOZ S.A., Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium 
Telecom Gardens, Mediaalan 40, B-1800 Vilvoorde, Belgium
KRKA Pharma Dublin Limited, 1 Stokes Place, St. Stephen's Green, Dublin 2, Republic of Ireland 
Veľká Británia KRKA Pharma Dublin Limited, 1 Stokes Place, St.
LABORATORIOS GRAPA, S.L., Rosario Pino, 8, 28020 Madrid, Spain 
ROSARIO PINO, 8, 28020 Madrid, Spain
SANDOZ GmbH, Biochemiestrasse 10 A-6250 Kundl 
SANDOZ GmbH, Biochemiestrasse 10 A-6250
Sandoz GmbH, Biochemiestrasse 10 A - 6250 Kundl 
Sandoz GmbH, Biochemiestrasse 10 A - 6250
PHARMACUTICALS, 16Km Marathonos Av., 15344 Pallini Attikis, GREECE 
Av., 15344 Pallini Attikis, GREECE
Mianserin-CT 10mg Filmtabletten 
Mianserin-CT 10mg Filmtabletten 10 mg
BERAL 
Basal
Venlafaxina Prodome 37,5 mg Comprimidos 
Prodome 37,5 mg Comprimidos
Constantinoupoleos Str., 3011 
LIMASSOL, Constantinoupoleos
GlaxoSmithKline GmbH & Co. KG Theresienhoehe 11 
GlaxoSmithKline GmbH
Ranbaxy (UK) Limited, 95 Park Lane, Mayfair, London, W1K 7TE, United Kingdom 
Limited, 95 Park Lane, Mayfair, London, W1K 7TE, United Kingdom
SERTRA 50 mg BASICS E 
SERTRA 50 mg BASICS
Mianserine HCl 10 PCH, tablets 
HCl 10 PCH, tablets 10 mg
Kortrijk, Belgium 
Niklaas, Belgium
Citalopram Sandoz 40, film coated tablets 
Sandoz 40, film coated tablets
FLUVOXAMINA TEVA 50 mg 
FLUVOXAMINA SÁNDOZ 50 mg
00184 Roma Italy 
Aprilia - Roma Italy
SANDOZ ESPAÑA S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain 
S.A, Gran Via de les Corts Catalanes, 764, Barcelona 08013,
28003 Madrid, Spain 
Madrid 28008,
H. Lundbeck A/S, Ottiliavej, 9 DK-2500 Valby - Copenhagen, Denmark 
Portugalsko H. Lundbeck A/S, Ottiliavej, 9 DK-2500 Valby - Copenhagen, Denmark
Cipralex 10 mg Filmtabletten 10 mg 
Cipralex 10 mg Filmtabletten
LABORATORIOS PEREZ GIMENEZ, Glorieta Farmaceutico Perez Gimenez, 1, Cordoba 14007, Spain 
Perez Gimenez, 1, Cordoba 14007, Spain
AlenFarma - Especialidades Farmacêuticas, Lda., Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131
EGIS PHARMACEUTICALS LTD., BUDAPEŠŤ, Keresztúri út 30-38, 1106 Budapest, Hungary 
BUDAPEŠŤ, Keresztúri út 30-38, 1106 Budapest, Hungary
AbZ-Pharma Graf-Arco-Str. 3 D-89079 Ulm 
, Gras-Orco-Strasse 3, D - 890 79 Ulm
WYETH HELLAS AEBE, 126 KYPROU AND 25TH MARCH STREET ARGIROUPOLI 16452 ATHENS, GREECE 
WYETH HELLAS AEBE, 126 KYPROU AND 25TH MARCH
LABORATORIOS PEREZ GIMÉNEZ, Glorieta Farmacéutico Pérez Giménez, 1., 14007 Córdoba, Spain 
Pérez Giménez, 1., 14007 Córdoba, Spain
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU) 
Švédsko ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079
GlaxoSmithKline Export Ltd., 980 Great West Road, TW8 9GS Brendford, Middlesex, UK 
West Road, TW8 9GS Brendford, Middlesex, UK
Paroxetine Suspensie A, suspensie voor oraal gebruik 2 mg/ml 
A, suspensie voor oraal gebruik 2 mg/ml
BEXAL FARMACEUTICA, S.A, Ventura Rodriguez, 7 - 5ª planta, Madrid (spain), 28008, Spain 
S.A, Ventura Rodriguez, 7 - 5ª planta, Madrid (spain), 28008,
30 mg tabletten, filmomhulde tabletten 
Gf 30 mg, filmomhulde tabletten
Mirtazapine Sandoz 30 mg 
Sandoz 30 mg
H. Lundbeck A/S Ottiliavej 7-9 DK2500 Köpenhamn-Valby Danmark (DNK) 
Lundbeck A/S Ottiliavej 7-9 DK2500 Köpenhamn-Valby
Paroxetine CF 20 mg, filmomhulde tabletten 
CF 20 mg, filmomhulde tabletten
NL - 1380 DA Weesp] C.J. van Houtenlaan 36 
CP Weesp, C.J. van Houtenlaan 36. /8121AA
D-24941 Flensburg 
D-24941
ANNEX IV AMENDMENTS TO THE PACKAGE LEAFLET 
PRÍLOHA IV NÁVRH ZMIEN V PÍSOMNEJ INFORMÁCII PRE POUŽÍVATEĽOV
73, 1210 Wien, Austria 
Gasse 7, 1040 Wien, Austria
Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark 
Veľká Británia Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Alfred E.Tiefenbacher GmbH & Co. Van-der-Smissen-Str. 1 
Alfred E.Tiefenbacher GmbH
Cipralex 20mg-Filmtabletten 20mg 
Cipralex 20mg-Filmtabletten
Gedeon Richter Ltd., Gyomroi út 1921, HU - 1103 Budapest 
Gyomroi út 1921, HU - 1103
Citalopram Sandoz 10 mg tabletki powlekane 
Sandoz 10 mg tabletki powlekane
Bexal Produtos Farmacêuticos S.A., Rua Prof. Ricardo Jorge, 5 A 
Portugalsko Bexal Produtos Farmacêuticos S.A.,
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) 
IV.I NÁVRH ZMENY A DOPLNKU príslušného odseku písomnej informácie pre používateľov pre fluoxetín, fluvoxamín, sertralín, paroxetín, citalopram, escitalopram, venlafaxín, mianserín, milnacipran, reboxetín a mirtazapín
Paroxetine Merck 20 mg, filmomhulde tabletten 
Merck 20 mg, filmomhulde tabletten
Ranbaxy (Poland) Sp. z o.o., ul. 
Ranbaxy (Poland) Sp. z o.o., ul. Kubickiego 11, 02-954
Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium 
Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
Fluoxetin AL 20 mg Tabletten 
Fluoxetin AL 20 mg Tabletaten 20 mg
FLUVOXAMINA TEVA 100mg 
FLUVOXAMINA SÁNDOZ 100 mg
Fluoxetina Union Health 20 mg 
Fluoxetina Union Health
Ratiopharm Italia S.r.l. 
Italia S.r.l.
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK 
Veľká Británia Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
Lithuania Pharmaceutical Works Polpharma S.A., ul. 
Portugalsko Jaba Farmacêutica, S.A.,
Fluoxetin NM Pharma 20 mg 
Fluoxetin NM Pharma
Interfarma, Produtos Químicos e Farmacêuticos, Lda., Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131 Algés Portugal 
Rua Dr. António Loureiro Borges, 2 - ArquiparqueMiraflores 1495-131
APO-FLUOXETIN 20 mg kapszula 
APO-FLUOXETIN 20 mg kapszula 20 mg
Sandoz GmbH, Biochemiestrasse 10 A-6250 Kundl,.Austria 
Maďarsko Sandoz GmbH, Biochemiestrasse 10 A-6250 Kundl,.Austria
22 D-89231 Neu-Ulm 
Filchnerstr. 22 D-89231
Solvay Pharmaceuticals BV, CJ Van Houtenlaan 36 1381 CP Weesp Nederländerna (NLD) 
Solvay Pharmaceuticals BV, CJ Van Houtenlaan 36 1381 CP Weesp
Via Tor Sapienza, 138 00155 Roma Italy 
Via Tor Sapienza, 138
ANFARM HELLAS AE K.Paleologou& Perikleous 27 15232 Halandri, Greece 
Perikleous 27 15232 Halandri, Greece
Sertralina Somidal 50 mg Comprimidos Revestidos 
Somidal 50 mg Comprimidos Revestidos
Oxepar Suspension 
Perorálna suspenzia
Pharmacia &Upjohn S.p.A, Via del Commercio-Zone Industriale I - 63046 Marino del Tronto ITALY 
I - 63046 Marino del Tronto ITALY
Fluoxibene 20mg-Kapseln 20mg 
Fluoxibene 20mg-Kapseln
Orodispersible tablets 
Orodispergovateľná tableta
Via E. Folli, 50 20134 Milano Italy 
Via E. Folli, 50
Mianserine HCl 30 PCH, tablets 
HCl 30 PCH, tablets 30 mg
STADA Arzneimittel AG Stadastr. 
Portugalsko Stada Arzneimittel A.G.,
Citalopram Sandoz 20, film coated tablets 
Sandoz 20, film coated tablets
INVICTA FARMA, S.A., Avda. 
Španielsko MUNDOGEN FARMA, S.A.,
Denmark Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381 CP Weesp, Netherland 
Solvay Pharmaceuticals B.V., C. J. Houtenlaan 36, NL-1381
Belgium Laboratoires S.M.B. 
Španielsko LABORATORIOS BELMAC, S.A.,
Fluctine 20mg-Kapseln 20mg 
Fluctine 20mg-Kapseln
SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria 
Biochemiestrasse 10, A-6250 Kundl, Austria
Reboxetin "Pfizer" 
PFIZER MANUFACTURING
Fluxil 20mg-Kapseln 20mg 
Fluxil 20mg-Kapseln
GEROT Pharmazeutika GmbH Arnethgasse 3, A - 1160 Wien, Austria 
Arnethgasse 3, A - 1160 Wien, Austria
Rambaxy (UK) Limited 95 Park Lane, mayfair, London W1K 7TE, UK 
Limited 95 Park Lane, mayfair, London W1K 7TE, UK
Mianserine Merck 
Mirtapin Merck
Fluoxetine Pharmascope 20 mg 
FLUOXETIN MEDOCHEMIE 20mg
Św. 
Ind.
EG S.p.A. 
Taliansko EG S.p.A.
Fluoxetin HEXAL 20mg Kapseln 
Fluoxetin HEXAL 20mg
FluxoMed 20mg-Kapseln 20mg 
FluxoMed 20mg-Kapseln
Interpharm ProduktionsgmbH., Dr. Karl Lueger Ring 6, 1010 Wien, Austria 
Dr. Karl Lueger Ring 6, 1010 Wien, Austria
Prolonged-release capsules Oral use 
Perorálny roztok Perorálne použitie
C G PAPALOISOU LTD, 25 
Gedeon Richter Ltd.,
LABORATORIOS GRAPA, S.L., ROSARIO PINO, 8, Madrid 28020, Spain 
ROSARIO PINO, 8, Madrid 28020,
Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark 
Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Paroxetine Gf 20 mg, filmomhulde tabletten 
Gf 20 mg, filmomhulde tabletten
APO-FLUOXETINE 20 mg 
FLUOX-PUREN 20mg
Via di Scandicci, 37 50143 Firenze Italy 
Via di Scandicci, 37
Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia 
Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
LABORATORIO FARMACEUTICO C.T. 
Lek Pharmaceuticals d.d.,
GENERICS PHARMA HELLAS 577a Vouliagmenis Av 16451 Argyroupoli, Greece 
Av 16451 Argyroupoli, Greece
H. Lundbeck A/S, Ottiliavej 9, DK2500 Valby, Denmark 
Lundbeck A/S, Ottiliavej 9, DK2500 Valby, Denmark
Fluvoxaminemaleaat 50 mg, tablets 
Fluvoxaminemaleaat 50 mg, tablets 50 mg
Fluoxetin-TEVA 20 mg Kapseln 
Fluoxetin-TEVA 20 mg Kapseln 20 mg
Fluoxetine Teva Pharma 20 mg 
Fluoxetine Teva Pharma
Mianserine Ivax 
Francúzsko IVAX
Generics UK Ltd. Potters Bar Darks Lane Albany Gate, Hertfordshire, UK EN6 1AG 
Lane Albany Gate, Hertfordshire, UK EN6 1AG
Fluoxistad 20mg-Kapseln 20mg 
Fluoxistad 20mg-Kapseln
Solvay Pharma Via della Libertà, 30 10095 Grugnasco (TO) Italy 
Taliansko Solvay Pharma Via della Libertà, 30
REMERON Soltab 30mg 30mg 
Soltab 30mg 30mg
Citalopram “Interpharm” 10mgFilmtabletten 
“Interpharm” 10mgFilmtabletten
Sandoz GmbH, Biochemiestrasse 10°, 6250 Kundl, Austria 
Maďarsko Sandoz GmbH, Biochemiestrasse 10°, 6250 Kundl, Austria
Netherlands Hexal B.V. Postbus 251 
Holandsko Hexal B.V.
FLUVOXAMINA SÁNDOZ 
FLUVOXAMINA TEVA
Citalopram Nozat 30 mg comprimidos revestidos 
Nozat 30 mg comprimidos revestidos
Esparma GmbH Postfach 1461 
Esparma GmbH
Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl, Austria 
Portugalsko Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl, Austria
Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France 
Romain 69 359 lyon cedex 08 - France
BRUSSEL, Belgium 
Vilvoorde, Belgium
Belgium THEVA PHARMA BELGIUM N.V. Laarstraat 16 2610 WILRIJK 
Laarstraat 16 2610 WILRIJK
Fluoxetine Ranbaxy 20 mg 
Fluoxetine Ranbaxy
Sertralina Generis 100 mg Comprimidos Revestidos 
Sertralina Generis 100 mg Comprimidos
Rowex Ltd, Bantry, Co. Cork, Ireland Paroxetine 
Rowex Ltd, Bantry, Co.
CIPRALEX 5 mg filmtabletta 5 mg 
5 mg filmtabletta 5 mg
Fevarin Tabs 50 mg 50 mg 
Tabs 50 mg
Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia 
Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
DuraScan Medical Products A/S C.F.Tietgens Boulevard 40 DK-5220 Odense SÖ Danmark (DNK) 
Durascan Medical Products A/S, C. F. Tietgens Boulevard 40, DK-5220 Odense SØ, Denmark
Alfred E. Tiefenbacher (GmbH & Co. KG) Van-der-Smissen-Str. 1 
Alfred E. Tiefenbacher (GmbH
Cipralex 20 mg Filmtabletten 20 mg 
Cipralex 20 mg Filmtabletten
So. Se. Pharm S.r.l. 
Pharm S.r.l.
Paroxetina Labesfal 20 mg Comprimidos Revestidos 
Labesfal 20 mg Comprimidos Revestidos
SUMOL PHARMA, S.A., Andorra, 64. 
Španielsko SUMOL PHARMA, S.A.,
Pinewood Laboratories Ballymarbry Co tipperary Clonmel -Ireland 
Laboratories Ballymarbry
Stada Arzneimittel A.G., Stadastrasse 2-18 D-61118 Bad Vilbel Alemanha 
Stadastrasse 2-18 D-61118 Bad Vilbel Alemanha
Lithuania Latvian JSC Grindeks, Krustpils ul. 
Grindeks, Krustpils ul.
Fluoxetine CF 20 mg, capsules 
CF 20 mg, capsules
LABORATORIOS RUBIO, S.A., Industria 29 - Pol. Ind. Comte de Sert. 
Portugalsko Laboratório B. A. Farma, Lda.,
Citalopram Sandoz 10, film coated tablets 
Sandoz 10, film coated tablets
Tagonis Filmtabletten 20 mg 
Filmtabletten 20 mg
Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France 
Romain 69 359 lyon cedex 08- France
MA (EU) number (Invented) name Strength Pharmaceutical Form 
Registračné (EÚ) číslo
Packaging Content Package size 
Spôsob podávania Balenie Obsah Veľkosť balenia
Subcutaneous use Vial (glass) 500 ml 
Draxxin 100 mg/ml
Meat and offal: cattle: 22 days. 
Hovädzí dobytok: 22 dní ošípané: 13 dní ovce: 16 dní
Cattle 
Hovädzí dobytok Subkutánne
These reactions resolve spontaneously within two days to two weeks. 
Tieto reakcie spontánne zmiznú v rozmedzí dvoch dní až dvoch týždňov.
This summary was last updated on 14/03/2011. 
Posledná aktualizácia tohto súhrnu: 14/03/2011.
It is widespread in countries bordering the Mediterranean Sea. 
Tento parazit sa bežne vyskytuje v krajinách pri Stredozemnom mori.
The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended. 
Účinnosť zaočkovania u psov, ktorí už boli infikovaní, nebola posudzovaná a preto ju nie je možné odporučiť.
The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one. 
Prvú injekciu možno podať od šiestich mesiacov veku, druhá injekcia sa podáva o tri týždne neskôr a tretia tri týždne po podaní druhej injekcie.
In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly. 
Ak budú zvieratá v budúcnosti vystavené parazitovi Leishmania infantum, ich imunitný systém dokáže rýchlejšie odpovedať.
It contains Leishmania infantum excreted secreted proteins (ESP). 
Obsahuje Leishmania infantum exkrečné-sekrečné proteíny (ESP).
Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment. 
Alergické typy reakcií nie sú obvyklé a v prípade výskytu príznakov alergickej reakcie u psa sa má podať primeraná symptomatická liečba.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Očkovacie látky účinkujú tak, že tzv. učia imunitný systém (prirodzená obrana tela), ako sa brániť pred chorobou.
Leishmania infantum is a parasite that causes leishmaniosis. 
Leishmania infantum je parazit, ktorý spôsobuje leishmaniózu.
Infected dogs play a central role in the accidental transmission of parasites to humans. 
Nakazené psy majú hlavný podiel na náhodnom prenose parazitov na ľudí.
The number of dogs developing an active infection and a symptomatic disease was significantly reduced in the vaccinated group. 
Počet psov, u ktorých sa rozvinula aktívna infekcia a symptomatické ochorenie, sa v rámci zaočkovanej skupiny značne znížil.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use. 
Vysvetľuje, akým spôsobom Výbor pre lieky na veterinárne použitie (CVMP) vykonal hodnotenie na základe predložených dokumentov, a dospel tak k odporúčaniam, ako používať očkovaciu látku.
In case of accidental self-injection, the advice of a doctor should be sought immediately. 
V prípade náhodného samoinjikovania sa má ihneď vyhľadať lekárska pomoc.
A number of laboratory trials where dogs were submitted to experimental infection were also presented. 
Takisto boli predložené výsledky viacerých laboratórnych skúšok, počas ktorých boli psy pokusne vystavené infekcii.
It is available as a powder and solvent that is made up into suspension for injection. 
Je dostupná vo forme prášku a rozpúšťadla, z ktorých sa pripravuje injekčná suspenzia.
Other information about CaniLeish: 
Ďalšie informácie o očkovacej látke CaniLeish:
CaniLeish is a vaccine. 
CaniLeish je očkovacia látka.
In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit. 
U psov s rozvinutou Leishmaniózou (aktívna infekcia alebo ochorenie) navzdory zaočkovaniu sa ďalšie podávanie injekcií na zaočkovanie neukázalo ako prínosné.
CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth. 
CaniLeish je očkovacia látka, ktorá obsahuje viacero proteínov, ktoré sa z parazita Leishmania infantum uvoľňujú počas jeho rastu.
Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum. 
Veterinárni lekári by mali vyhodnotiť pomer prínosu a rizika pred tým, ako zaočkujú psy v oblastiach s malým alebo žiadnym výskytom Leishmania infantum.