natgillin/translations-raw huggingface dataset:
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
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
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.
CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response.
Očkovacia látka CaniLeish obsahuje tzv. adjuvans (vysoko čistený extrakt Quillaja saponaria) na zlepšenie odpovede imunitného systému.
When CaniLeish is given to dogs the immune system recognises the proteins as ‘foreign' and make defences against it.
Keď sa očkovacia látka CaniLeish podá psom, ich imunitný systém rozpozná tieto proteíny ako cudzie a vytvára proti nim protilátky.
Afterward a single ‘booster' should be given every year to maintain the vaccine's effect.
Následne sa má každoročne podať jedna tzv. posilňovacia dávka,
The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.
Európska komisia vydala spoločnosti Virbac S.A povolenie na uvedenie očkovacej látky CaniLeish na trh platné v celej Európskej únii.
CaniLeish is to be used only in ‘leishmania-negative' dogs.
Očkovacia látka CaniLeish sa má používať len u psov s tzv. negatívnym výskytom Leishmanie.
Canine vaccine against Leishmania infantum adjuvanted
CaniLeish očkovacia látka pre psy proti Leishmania infantum, s adjuvansom
The company presented data from three main studies involving over 3,000 patients.
Spoločnosť predložila údaje z troch hlavných štúdií zahŕňajúcich vyše 3 000 pacientov.
What is Plivensia?
Čo je Plivensia?
The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Hlavným meradlom účinnosti bolo zníženie príznakov najmenej o 20 % na základe štandardnej hodnotiacej stupnice (ACR-20) po 16 týždňoch liečby.
In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Vo svojom liste oznamujúcom agentúre stiahnutie žiadosti spoločnosť uviedla, že vzhľadom na potrebu ďalších klinických údajov a vzhľadom na to, že k dispozícii sú iné liečby zahŕňajúce zablokovanie účinku interleukínu-6, chce uprednostniť iné programy vo svojom portfóliu.
It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Liek mal byť dostupný vo forme injekčného roztoku v naplnených perách a injekčných striekačkách (50 mg).
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potom ako výbor posúdil odpovede spoločnosti na poslednú sériu otázok, ešte stále zostali niektoré otázky nevyriešené.
On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Dňa 26. októbra 2017 spoločnosť Janssen-Cilag International NV oficiálne oznámila Výboru pre lieky na humánne použitie (CHMP) rozhodnutie stiahnuť svoju žiadosť o povolenie na uvedenie lieku Plivensia na trh, ktorý je určený na liečbu reumatoidnej artritídy.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven long-term safety, the benefits of Plivensia did not outweigh its risks, and that further studies were needed.
Výbor CHMP preto v čase stiahnutia žiadosti zastával názor, že vzhľadom na nedostatočne preukázanú dlhodobú bezpečnosť, prínosy lieku Plivensia neprevyšujú jeho riziká a sú potrebné ďalšie štúdie.
Withdrawal of the marketing authorisation application for Plivensia (sirukumab)
Stiahnutie žiadosti o povolenie na uvedenie na trh pre liek Plivensia (sirukumab)
The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Účinná látka lieku Plivensia, sirikumab, je monoklonálna protilátka, druh bielkoviny, ktorá bola navrhnutá tak, aby zablokovala molekulu s názvom interleukín-6.
The company informed the CHMP that it will discontinue the ongoing long-term extension study with Plivensia in patients with rheumatoid arthritis.
Spoločnosť informovala výbor CHMP, že preruší prebiehajúcu dlhodobú rozšírenú štúdiu s liekom Plivensia u pacientov s reumatoidnou artritídou.
The CHMP's main concern was that the long-term safety of Plivensia had not been well characterised due to limitations in the design of the main studies.
Hlavnou výhradou výboru CHMP bolo, že dlhodobá bezpečnosť lieku Plivensia nebola dostatočne charakterizovaná z dôvodu nedostatkov v návrhu hlavných štúdií.
Plivensia was to be used with methotrexate (a DMARD) or alone if the patient could not take methotrexate.
Liek Plivensia sa mal používať s metotrexátom (DMARD) alebo samotný, ak pacient nemohol užívať metotrexát.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Plivensia could not have been approved for the treatment of moderate to severe rheumatoid arthritis.
Na základe preskúmania údajov a odpovedí spoločnosti na zoznamy otázok od výboru CHMP mal výbor CHMP v čase stiahnutia žiadosti určité výhrady a dospel k predbežnému stanovisku, že liek Plivensia nemôže byť povolený na liečbu stredne závažnej až závažnej reumatoidnej artritídy.
The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
V tretej štúdii sa liek Plivensia porovnával s adalimumabom (monoklonálnou protilátkou zacielenou na chemickú informačnú molekulu s názvom faktor nádorovej nekrózy - TNF) u pacientov, ktorí nemohli užívať metotrexát alebo ktorých ochorenie dostatočne neodpovedalo na metotrexát; v štúdii sa skúmalo zlepšenie funkcie kĺbov u pacientov (na základe štandardnej hodnotiacej stupnice nazývanej DAS28-ESR) po 24 týždňoch liečby.
Plivensia is a medicine that contains the active substance sirukumab.
Plivensia je liek, ktorý obsahuje účinnú látku sirukumab.
The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Liek sa mal používať u pacientov v prípade, že liečba jedným alebo viacerými liekmi známymi ako antireumatické lieky modifikujúce ochorenie (DMARD) nebola dostatočne účinná alebo viedla k nepríjemným vedľajším účinkom.
By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Zablokovaním interleukínu-6 sirukumab zmierňuje zápal a ďalšie príznaky súvisiace s reumatoidnou artritídou.
Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Plivensia sa mal používať u dospelých so stredne závažnou až závažnou reumatoidnou artritídou, čo je ochorenie spôsobujúce zápal kĺbov.
Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
V dvoch štúdiách sa liek Plivensia porovnával s placebom (zdanlivým liekom) u pacientov so stredne závažnou až závažnou reumatoidnou artritídou, v prípade ktorých liečba liekom DMARD alebo anti-TNF (ďalším druhom lieku na reumatoidnú artritídu) nebola dostatočne účinná alebo viedla k nepríjemným vedľajším účinkom.