natgillin/translations-raw huggingface dataset:
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE JA MÜÜGILOA HOIDJATE NIMEKIRI LIIKMESRIIKIDES
Gerot Pharmazeutika GesmbH Arnethgasse 3 A-1160 Wien Austria
Gerot Pharmazeutika GesmbH
Allenopar 20 mg – Filmtabletten
20 mg –
Allen Pharmazeutika GesmbH Albert Schweitzer Gasse 6 A-1140 Wien Austria
Allen Pharmazeutika GesmbH Albert Schweitzer Gasse 6 A- 1140 Wien Austria
Paroxetin ‘ Allen’ – Filmtabletten
Paroxetin ‘ Allen ’ – Filmtabletten
Arcana Arzneimittel GmbH Zimbagasse 5 A-1147 Wien Austria
Arcana Arzneimittel GmbH Zimbagasse 5 A- 1147 Wien Austria
Paroxetin ‘ Arcana’ 20 mg – Filmtabletten
Paroxetin ‘ Arcana ’ 20 mg – Filmtabletten
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl/ Tirol Austria
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl/ Tirol Austria
GlaxoSmithKline Pharma GmbH Albert Schweitzer Gasse 6 A-1140 Wien Austria
GlaxoSmithKline Pharma GmbH Albert Schweitzer Gasse 6 A- 1140 Wien Austria
Albert Schweitzer Gasse 6 A-1140 Wien Austria
Albert Schweitzer Gasse 6 A- 1140 Wien Austria
Paroxetin ‘ GSK’ – Filmtabletten
Paroxetin ‘ GSK ’ – Filmtabletten
Hexal Pharma GmbH Wilhelminestrasse 91/ IIf/ 3 A-1160 Wien Austria
Hexal Pharma GmbH Wilhelminestrasse 91/ IIf/ 3 A- 1160 Wien Austria
Interpharm Produktions GmbH Effingergasse 21 A-1160 Wien Austria
Interpharm Produktions GmbH Effingergasse 21 A- 1160 Wien Austria
Paroxetin ‘ Interpharm’ Filmtabletten
Paroxetin ‘ Interpharm ’ Filmtabletten
Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria
Lannacher Heilmittel GmbH Schlossplatz 1 A- 8502 Lannach Austria
Ratiopharm Arzneimittel Vertriebs – GmbH Albert Schweitzer Gasse 3 A-1140 Wien Austria
Ratiopharm Arzneimittel Vertriebs – GmbH Albert Schweitzer Gasse 3 A- 1140 Wien Austria
Paroxetin ‘ Merckle’ 20 mg – Filmtabletten
Paroxetin ‘ Merckle ’ 20 mg – Filmtabletten
Paroxetin ‘ ratiopharm’ 20 mg – Filmtabletten
Paroxetin ‘ ratiopharm ’ 20 mg – Filmtabletten
52 A-1190 Wien Austria
52 A- 1190 Wien Austria
Heizel Esplanade Heysel B 22 B-1020 Brussel Belgium
Heizel Esplanade Heysel B 22 B- 1020 Brussel Belgium
Rue du Tilleul 13 B-1332 Genval Belgium
Rue du Tilleul 13 B- 1332 Genval Belgium
Medis-Danmark A/ S Havelse Molle 14 DK-3600 Frederikssund Danmark
Medis- Danmark A/ S Havelse Molle 14 DK- 3600 Frederikssund Danmark
Rue Aaint-Lambert 141 B-1200 Bruxelles Belgium
Rue Aaint- Lambert 141 B- 1200 Bruxelles Belgium
Brusselsesteennweg 288 B-3090 Overijse Belgium
Brusselsesteennweg 288 B- 3090 Overijse Belgium
Medochemie Ltd, 1-10 Constantinoupoleos str.
Medochemie Ltd, 1- 10 Constantinoupoleos str.
Apo-Parox
Apo- Parox
Hexal A/ S, Kanalholmen 8-12, 2650 Hvidovre, Denmark
Hexal A/ S, Kanalholmen 8- 12, 2650 Hvidovre, Denmark
20 mg,
20 mg
Ratiopharm GmbH, Graf-Arco-Strasse 3, D-890 79 Ulm, Germany
Ratiopharm GmbH, Graf- Arco- Strasse 3, D- 890 79 Ulm, Germany
Paroxetin-Ratiopharm 20 mg
Paroxetin- Ratiopharm 20 mg
Chemical works of Gedeon Richter Ltd, Gyömröi út 19-21, 1103 Budapest, Hungary
Chemical works of Gedeon Richter Ltd, Gyömröi út 19- 21, 1103 Budapest, Hungary
1A Farma A/ S Herstedøstervej 27-29 2620 Albertslund Denmark
1A Farma A/ S Herstedøstervej 27- 29 2620 Albertslund Denmark
Paroxetine ‘ 1A Farma’
Paroxetine ‘ 1A Farma ’
A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK-2000 Frederiksberg Denmark
A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK- 2000 Frederiksberg Denmark
Paroxetin ‘ GEA’
Paroxetin ‘ GEA ’
Paroxetin ‘ Alpharma’
Paroxetin ‘ Alpharma ’
Paroxetin ‘ Biochemie’
Paroxetin ‘ Biochemie ’
Paroxetin ‘ Generics’
Paroxetin ‘ Generics ’
Paroxetin ‘ Genthon’
Paroxetin ‘ Genthon ’
GlaxoSmithKline Pharma A/ S Nykær 68 DK-2605 Brøndby Denmark
GlaxoSmithKline Pharma A/ S Nykær 68 DK- 2605 Brøndby Denmark
NM Pharma A/ S Lautrupvang 8 DK-2750 Ballerup Denmark
NM Pharma A/ S Lautrupvang 8 DK- 2750 Ballerup Denmark
Paroxetin ‘ NM’
Paroxetin ‘ NM ’
Paroxetine ‘ Copyfarm’
Paroxetine ‘ Copyfarm ’
Paroxetin ‘ UNP’
Paroxetin ‘ UNP ’
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Ratiopharm GmbH Graf- Arco- Strasse 3 D- 89079 Ulm Germany
Paroxetin ‘ Ratiopharm’
Paroxetin ‘ Ratiopharm ’
Scand Pharm Generics AB Ynglingagatan 14, 5tr S-11347 Stockholm Sweden
Scand Pharm Generics AB Ynglingagatan 14, 5tr S- 11347 Stockholm Sweden
Paroxetin ‘ Synthon’
Paroxetin ‘ Synthon ’
Richter Gyömröi ut 19-21 H-1103 Budapest X Hungary
Richter Gyömröi ut 19- 21 H- 1103 Budapest X Hungary
Rexetin 30 mg
30 mg
STADA Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL Germany
STADA Arzneimittel AG Stadastrasse 2- 18 61118 BAD VILBEL Germany
Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roy France
Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly- le- Roy France
Laboratoire Paucourt 100 route de Versailles 78163 Marly-le-Roy France
Laboratoire Paucourt 100 route de Versailles 78163 Marly- le- Roy France
Ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Ratiopharm GmbH
Laboratoire Saint-Germain 100 route de Versailles 78163 Marly-le Roy France
Laboratoire Saint- Germain 100 route de Versailles 78163 Marly- le Roy France
Paroxetin AL 20 mg Filmtabletten
20 mg
Alpharma-ISIS GmbH & Co. KG Elisabeth-Selbert-Str.
AWD. Pharma GmbH & Co. KG Leipziger Str.
1 40764 Langenfeld Germany
7- 13 01097 Dresden Germany
Paroxetin-Isis Filmtabletten
Paroxetin AWD Filmtabletten
Sandoz Pharmaceuticals GmbH Carl-Zeiss-Ring 3 85737 Ismaning Germany
Sandoz Pharmaceuticals GmbH Carl- Zeiss- Ring 3 85737 Ismaning Germany
Ct-Arzneimittel GmbH Lengeder Str.
Ct- Arzneimittel GmbH Lengeder Str.
1-2 65439 Floersheim Germany
1- 2 65439 Floersheim Germany
IIP-Institut für industrielle Pharmazie Forschungs-und Entwicklungsgesellschaft GmbH Benzstr.
IIP- Institut für industrielle Pharmazie Forschungs- und Entwicklungsgesellschaft GmbH Benzstr.
Paroxetin-biomo 20 mg
20 mg
Paroxetin Basics 20 mg Filmtabletten
Pasero 20 mg Filmtabletten
Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL UK
GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 80339 München Germany
Pasero 20 mg Filmtabletten
Seroxat Filmtabletten
Hexal AG
Hexal AG Industriestr.
Paroxat
25 83607 Holzkirchen Germany
40 mg
Paroxat 40 mg Filmtabletten
Industriestr.
CHMP/ 187488/ 2004
25 83607 Holzkirchen Germany
20/ 72
Filmtabletten
EMEA 2005
25 83607 Holzkirchen Germany
Roxac
Roxac 20 mg Filmtabletten
20 mg
26 56218 Mulheim-Karlich Germany
26 56218 Mulheim- Karlich Germany
Merck dura GmbH Frankfurter Str.
Merck dura GmbH
Paroxedura 20 mg Filmtabletten
Filmtabletten
Film-coated tablet
polümeerkilega kaetud tablett
Paroxedura 30 mg Filmtabletten
Paroxedura 30 mg 30 mg Filmtabletten
Neuraxpharm Arzneimittel GmbH & Co KG Elisabeth-Selbert-Str.
Neuraxpharm Arzneimittel GmbH & Co KG Elisabeth- Selbert- Str.
23 D-40764 Langenfeld Germany
23 D- 40764 Langenfeld Germany
Paroxetin-neuraxpharm 20 mg Filmtabletten
Paroxetin- neuraxpharm 20 mg Filmtabletten
Paroxetin-ratiopharm 20 mg Filmtabletten
Paroxetin- ratiopharm 20 mg Filmtabletten
Paroxetin-ratiopharm 30 mg Filmtabletten
Paroxetin- ratiopharm 30 mg Filmtabletten
2-18 61118 Bad Vilbel Germany
2- 18 61118 Bad Vilbel Germany
Microweg 22 NL-6545 CM Nijmegen The Netherlands
Microweg 22 NL- 6545 CM Nijmegen The Netherlands
Euplix 20 mg Filmtabletten
20 mg
10 mg / 5 ml
10mg/ 5ml
filmtabletta
Apodepi filmtabletta
Paretin
1034 Bp
20 mg
Paretin 20 mg filmtabletta
Tímár u.20.
Tímár u. 20.
IIP-Institut für industrielle Pharmazie F & E GmbH Benzstraße 2a D-63741 Aschaffenburg Germany
IIP- Institut für industrielle Pharmazie F & E GmbH Benzstraße 2a D- 63741 Aschaffenburg Germany
23/ 72
23/ 72
20 mg
Õhukese
Potters Bar EN6 1AG Hertfordshire UK
Potters Bar EN6 1AG Hertfordshire UK
filmabletta
filmabletta
Gyömrő i út 19-21.
Gyömrői út 19- 21.
1103 Bp Hungary
1103 Bp, Hungary
24/ 72
24/ 72
Seroxat 20 mg
Seroxat Tablets 20 mg
Seroxat 30 mg
Seroxat Tablets 30 mg
GlaxoSmithKline Consumer
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd, Stonemasons Way, Rathfarnham, Dublin 16, Ireland
Seroxat
Seroxat Oral Suspension
20 mg / 10
20 mg / 10 ml
Mixture
Tablett
Box 51409 CY-3505 Limassol Cyprus
Box 51409 CY- 3505 Limassol Cyprus
29/ 72
29/ 72
Gedeon Richter Ltd Gyomroi 19-21 H-1103 Budapest Hungary
Gedeon Richter Ltd Gyomroi 19- 21 H- 1103 Budapest Hungary
Hexal AG Indusstriestrasse 25 Holczkirhen D-83607 Germany
Hexal AG Indusstriestrasse 25 Holczkirhen D- 83607 Germany
Hexal AG Indusstriestrasse 25 D-83607 Holczkirhen Germany
Hexal AG Indusstriestrasse 25 D- 83607 Holczkirhen Germany
Gyomroi ut 19-24 1103 Budapest Hungary
Gyomroi ut 19- 24 1103 Budapest Hungary
30/ 72
30/ 72
Rue du Tilleul, 13 B-1332 Genval Belgium
Rue du Tilleul, 13 B- 1332 Genval Belgium
31/ 72
31/ 72
Merck s. a., 288 Brusselsesteenweg, B-3090 Overijse Belgium
Merck s. a., 288 Brusselsesteenweg, B- 3090 Overijse Belgium
Merck-Paroxetine 20 mg
Merck- Paroxetine 20 mg
Centrafarm Services B. V., Nieuwe Donk 9, P. O. Box 289, 4870 Ag Etten-Leur, The Netherlands
Centrafarm Services B. V., Nieuwe Donk 9, P. O. Box 289, 4870 Ag Etten- Leur, The Netherlands
32/ 72
32/ 72
Merck Generics BV, Dieselweg 25, NL-3752 Lb Bunschoten, The Netherlands
Merck Generics BV, Dieselweg 25, NL- 3752 Lb Bunschoten, The Netherlands
MP-Paroxetine 20 mg
MP- Paroxetine 20 mg
33/ 72
33/ 72
A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK-2000 Frederiksberg Demark
A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK- 2000 Frederiksberg Demark
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Sandoz GmbH, Biochemiestrasse 10, A- 6250 Kundl, Austria
GlaxoSmithKline AS, Forskningsveien 2a, Postbox 180 Vinderen, N-0319, Oslo, Norway
GlaxoSmithKline AS, Forskningsveien 2a, Postbox 180 Vinderen, N- 0319, Oslo, Norway
Ratiopharm GmbH, Graf-Acro-Strasse 3, D-89079 Ulm, Germany
Ratiopharm GmbH, Graf- Acro- Strasse 3, D- 89079 Ulm, Germany
34/ 72
34/ 72
Homera 46, 04-624 Warsaw Poland
Homera 46, 04- 624 Warsaw Poland
Apo-Parox 20
Apo- Parox 20
Pliva Kraków Zakł ady Farmaceutyczne S. A. ul.
Pliva Kraków Zakłady Farmaceutyczne S. A. ul.
Mogilska 80, 31-546 Cracow.
Mogilska 80, 31- 546 Cracow.
ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm, Germany
ratiopharm GmbH Graf- Arco- Strasse 3 89079 Ulm, Germany
H-1103 Budapest, Gyömrō i ut 19-21, Hungary
H- 1103 Budapest, Gyömrōi ut 19 - 21, Hungary
980 Great West Road Brentford, Middlesex, TW89GS UK
980 Great West Road Brentford, Middlesex, TW8 9GS UK
Hexal Polska Sp. z o. o. ul Domaniewska 50C 02-672 Warsaw Poland
Hexal Polska Sp. z o. o. ul Domaniewska 50C 02- 672 Warsaw Poland
35/ 72
35/ 72
Edifício Jaba – Rua da Tapada Grande, 2 – Zona Industrial da Abrunheira 2710-089 Sintra
Edifício Jaba – Rua da Tapada Grande, 2 – Zona Industrial da Abrunheira 2710- 089 Sintra
Alpharma ApS Rua Virgílio Correia, 11-A 1600-219 Lisboa Portugal
Alpharma ApS Rua Virgílio Correia, 11- A 1600- 219 Lisboa Portugal
Rua Ramalho Ortigão, 45-A, 1070-228 Lisboa Portugal
Rua Ramalho Ortigão, 45- A, 1070- 228 Lisboa Portugal
Sandoz GmbH Biochemiestraße 10, A-6250 Kundl Austria
Sandoz GmbH Biochemiestraße 10, A- 6250 Kundl Austria
3, loja 3 - C/ v 1750-131 Lisboa Portugal
3, loja 3 - C/ v 1750- 131 Lisboa Portugal
Ricardo Jorge, 5 A- Miraflores 1495-153 Algés
Ricardo Jorge, 5 A - Miraflores 1495- 153 Algés
3, 1750-131 Lisboa Portugal
3, 1750- 131 Lisboa Portugal
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António Loureiro Borges, 3, Arquiparque – Miraflores 1495-131 Algés
António Loureiro Borges, 3, Arquiparque – Miraflores 1495- 131 Algés
António Loureiro Borges, 3, Arquiparque Miraflores 1495-131 Algés
António Loureiro Borges, 3, Arquiparque Miraflores 1495- 131 Algés
Instituto Luso-Fármaco, Lda.
Instituto Luso- Fármaco, Lda.
Estrada Nacional 117-2 2724-503 Alfragide
Estrada Nacional 117- 2 2724- 503 Alfragide
Da Siderurgia Nacional, 4745-457 S.
Da Siderurgia Nacional, 4745- 457 S.
 EMEA 2005
Portugal
Portugal Merck Genéricos – Produtos
Merck Genéricos – Produtos Farmacêuticos, Lda.
20 mg
Paroxetina Merck Genericos 20 mg Comprimidos Revestidos
Merck Genericos 20 mg Comprimidos Revestidos
20 mg
Merck S. A, Rua Alfredo da Silva, 3-C, P-1300-040 Lisboa Portugal
Merck S. A, Rua Alfredo da Silva, 3- C, P- 1300- 040 Lisboa Portugal
Edifício Tejo - 6° Piso - Rua Quinta do Pinheiro 2790-143 Carnaxide
Edifício Tejo - 6° Piso - Rua Quinta do Pinheiro 2790- 143 Carnaxide
Tecnimede – Sociedade Técnico- Medicinal, S. A.
Tecnimede – Sociedade Técnico - Medicinal, S. A.
Henrique de Barros Edifício Sagres, 3° A 2685-338 Prior Velho
Henrique de Barros Edifício Sagres, 3° A 2685- 338 Prior Velho
20 mg
Paretin 20 mg
CHMP/ 187488/ 2004
CHMP/ 187488/ 2004 Station Close, Potters Bar, Herts EN6 1TL UK
38/ 72
38/ 72
ratiopharm GmbH Gras-Orco-Strasse 3 89079 Ulm
ratiopharm GmbH Gras- Orco- Strasse 3 89079 Ulm
Paroxetini-ratiopharm 20mg
Paroxetini- ratiopharm 20 mg
Gyomroi út 19-21 1103 Budapest Hungary
Gyomroi út 19- 21 1103 Budapest Hungary
Remood
Remood 20 mg
Remood
Remood 30 mg
Seroxat
Seroxat 20 mg tbl flm
20 mg tbl flm 20 mg
20 mg
39/ 72
39/ 72
GlaxoSmithKline d. o. o., druž ba za promet s farmacevtskimi izdelki, Knezov š tradon 90, Ljubljana Slovenia
GlaxoSmithKline d. o. o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana Slovenia
Sweden
40/ 72
A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK-2000 Frederiksberg Denmark
Rootsi A/ S GEA Farmaceutisk Fabrik Holger Danskes Vej 89 DK- 2000 Frederiksberg Denmark
Alpharma AS, P. O.
Rootsi Alpharma AS, P. O.
Box 158, Skoyen, N-0212 Oslo, Norway
Box 158, Skoyen, N- 0212 Oslo, Norway
Sweden
Rootsi AWD.
7-13 01097 Dresden Germany
7- 13 01097 Dresden Germany
Gerard Laboratiories, 35/ 36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Rootsi Gerard Laboratiories, 35/ 36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
GlaxoSmithKline AB, Box 263, SE-431 23 Mölndal, Sweden
Rootsi GlaxoSmithKline AB, Box 263, SE- 431 23 Mölndal, Sweden
GlaxoSmithKline AB, Box 263, SE-431 23 Mölndal, Sweden
GlaxoSmithKline AB, Box 263, SE- 431 23 Mölndal, Sweden
GlaxoSmithKline AB, Box 263, SE-431 23 Mölndal, Sweden
GlaxoSmithKline AB,
41/ 72
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Medis-Danmark A/ S Havelse Molle 14 DK-3600 Frederikssund Denmark
Medis- Danmark A/ S Havelse Molle 14 DK- 3600 Frederikssund Denmark
Paroxetin ” Medis”
Paroxetin ” Medis ”
KG Elisabeth-Selbert-Str.
KG Elisabeth- Selbert- Str.
TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
TAD Pharma GmbH,
Oral use
Õhukese
Oral Use
Peroraalne
43/ 72
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Teide, 4-planta baja Poligono Empresarial La Marina 28700 San Sebastian de los Reyes, Madrid Spain
Teide, 4- planta baja Poligono Empresarial La Marina 28700 San Sebastian de los Reyes, Madrid Spain
Ronda de Poniente 16 28760-Tres Cantos, Madrid Spain
Ronda de Poniente 16 28760- Tres Cantos, Madrid Spain
Severo Ochoa 2 28760 Tres Cantos, Madrid Spain
Seroxat
Seroxat 20 mg comprimidos con cubierta pelicular
20 mg
20 mg
Xetin 20 mg comprimidos recubiertos
Ctra. n-152 Km 19 – Poligono Merck 08100 Mollet del Valles, Barcelona Spain
Ctra. n- 152 Km 19 – Poligono Merck 08100 Mollet del Valles, Barcelona Spain
Severo Ochoa, 2 Parque Tecnológico de Madrid 28760 Tres Cantos Madrid
Marqués de Villabrágima 37 28035 Madrid Spain
Balmes, 84-4-2a 08008 Barcelona Spain
Balmes, 84- 4- 2a 08008 Barcelona Spain
tablet
Kaetud tablett
Paroxetina Apotex-Farma
Paroxetina Apotex- Farma
Paroxetine 20 mg Film-coated tablet
Paroxetine 20 mg Film- coated tablet
GlaxoSmithKline UK Limited Stockley Park West Uxbridge Middlesex UB11 1BT UK
GlaxoSmithKline UK Limited
Seroxat Liquid 20 mg/ 10ml
Seroxat Liquid
Oral suspension
Peroraalne
United Kingdom
CHMP/ 187488/ 2004
GlaxoSmithKline UK Limited Stockley Park West Uxbridge Middlesex UB11 1BT UK
Stockley Park West Uxbridge Middlesex UB11 1BT UK
20 mg
20 mg/ 10ml
47/ 72
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Norton Healthcare Limited; IVAX Quays, Albert Basin, Royal Docks, London E16 2QJ, UK
Norton Healthcare Limited;
Paroxetine Hydrochloride Tablets 20 mg
20 mg
20 mg
Hydrochloride Tablets 20 mg
48/ 72
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SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
EMEA ESITATUD TEADUSLIKUD JÄRELDUSED JA PÕHJUSED RAVIMI OMADUSTE KOKKUVÕTETE MUUTMISEKS
CHMP/ 187488/ 2004 SCIENTIFIC CONCLUSIONS
CHMP/ 187488/ 2004 TEADUSLIKUD JÄRELDUSED
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OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PAROXETINE CONTAINING MEDICINAL PRODUCTS (see Annex I)
HINDAMISE ÜLDINE KOKKUVÕTE (vt Lisa I)
Paroxetine is a phenylpiperidine derivative and is a potent and selective inhibitor of the presynaptic 5- hydroxytryptamine (5-HT) reuptake.
Paroksetiin on fenüülpiperidiini derivaat ning tugev ja selektiivne presünaptilise 5 - hüdroksütrüptamiini (5- HT) tagasihaarde inhibiitor.
The indications for which paroxetine is currently approved in EU includemajor depressive disorder (MDD), panic disorder, obsessive compulsive disorder (OCD), social phobia/ social anxiety disorder (SAD), generalised anxiety disorder (GAD) and post-traumatic stress disorder (PTSD).
Näidustuste hulka, mille jaoks on paroksetiin käesoleval ajal EL- is heaks kiidetud, kuuluvad suur depressiivne häire (major depressive episode– MDD), paanikahäire, obsessiiv- kompulsiivne häire (obsessive- compulsive disorder– OCD), sotsiaalne foobia/ sotsiaalne ärevushäire (social anxiety disorder– SAD), generaliseerunud ärevushäire (generalised anxiety disorder– GAD) ja post- traumaatiline stressihäire (post- traumatic stress disorder– PTSD).
Clinical trials, which have included gradual dose reduction at the end of treatment, have found that 30% of patients developed symptoms following discontinuation of treatment with paroxetine compared to 20% among those stopping placebo.
Kliinilistes uuringutes, mis on sisaldanud järkjärgulist annuse vähendamist ravi lõpus, on leitud, et 30% - l patsientidest tekkisid paroksetiinravi lõpetamise järel sümptomid võrreldes 20% - ga patsientidest, keda raviti platseeboga.
Various analyses suggested that the risk of these outcomes was between 1.5 and 3.2 times greater with paroxetine compared to placebo.
Erinevate analüüside alusel oli selliste tulemuste risk 1, 5 kuni 3, 2 korda suurem paroksetiini puhul platseeboga võrreldes.
In response to these data UK contraindicated the use of paroxetine in children aged 18 years or less with major depressive disorders.
Vastavalt neile andmetele kuulutati Ühendkuningriigis paroksetiini kasutamine vastunäidustatuks alla 18- aastastel suurte depressiivsete häiretega lastel ja noorukitel.
On 13 June 2003, UK triggered a referral to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, to medicinal products containing paroxetine.
13. juunil 2003 aastal esitas Ühendkuningriik vastavalt direktiivi 2001/ 83/ EÜ artiklile 31 paroksetiini sisaldavate ravimtoodete kohta EMEA- le parandatud arvamuse.
EFFICACY A discussion on the efficacy of paroxetine containing medicinal products took place in CHMP based on the Rapporteur´s and Co-Rapporteur´s Assessment Reports and the data presented by the Marketing Authorisation Holders (MAHs).
EFEKTIIVSUS Patentravimite Komitees (CHMP) leidis aset arutelu paroksetiini sisaldavate ravimtoodete efektiivsuse üle, mis põhines ettekandja ja kaasettekandja hindamisraportitel ning müügiloa hoidjate poolt esitatud andmetel.
Major Depressive Episode The efficacy of paroxetine in treating major depression in adults is established and supported by numerous short and long-term trials.
Suur depressiivne episood Paroksetiini efektiivsus depressiooni ravis täiskasvanutel on kindlaks tehtud ja seda toetavad arvukad lühi - ja pikaajalised uuringud.
The long-term efficacy of paroxetine in depression has been demonstrated in a 52 week maintenance study with relapse prevention design:
Paroksetiini pikaajalist efektiivsust depressiooni puhul on näidatud 52 - nädalases ägenemiste vältimise ülesehitusega säilitusuuringus:
12% of patients receiving paroxetine (20-40mg daily) relapsed, versus 28% of patients on placebo.
12% paroksetiini (20– 40 mg päevas) saanud patsientidel tekkis ägenemine võrreldes 28% platseebot saanud patsientidega.
Obsessive Compulsive Disorder The efficacy of paroxetine in treating OCD in adults was investigated in short-term and long-term studies.
Obsessiiv- kompulsiivne häire Paroksetiini efektiivsust OCD ravis täiskasvanutel uuriti lühi - ja pikaajalistes uuringutes.
The long-term
Ühes
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One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).
kolmest uuringust esines oluline erinevus ägenemistega patsientide hulgas paroksetiini (38%) ja platseebo (59%) puhul.
Panic Disorder The efficacy of paroxetine in the treatment of panic disorders in adults was investigated in some short- term and long-term studies.
Paanikahäire Paroksetiini efektiivsust paanikahäirete ravis täiskasvanutel uuriti mõnedes lühi - ja pikaajalistes uuringutes.
The long-term efficacy of paroxetine in treating panic disorder was demonstrated in a 24 week maintenance study with relapse prevention design:
Paroksetiini pikaajalist efektiivsust paanikahäirete puhul näidati 24- nädalases ägenemiste vältimise ülesehitusega säilitusuuringus:
5% of patients receiving paroxetine (10-40mg daily) relapsed, versus 30% of patients on placebo.
5% paroksetiini (10– 40 mg päevas) saanud patsientidel tekkis ägenemine võrreldes 30% platseebot saanud patsientidega.
This was supported by a 36 week maintenance study.
Seda kinnitas ka 36- nädalane säilitusuuring.
Social Anxiety Disorder / Social Phobia The efficacy of paroxetine in the treatment of social anxiety disorders in adults was investigated in some short-term and long-term studies.
Sotsiaalne ärevushäire / sotsiaalne foobia Paroksetiini efektiivsust sotsiaalsete ärevushäirete ravis täiskasvanutel uuriti mõnedes lühi - ja pikaajalistes uuringutes.
Generalised Anxiety Disorder The efficacy of paroxetine in the treatment of GAD in adults was investigated in some short-term and long-term studies.
Generaliseerunud ärevushäire Paroksetiini efektiivsust GAD ravis täiskasvanutel uuriti mõnedes lühi - ja pikaajalistes uuringutes.
Significant and relevant results were obtained in the short-term but not in the long- term studies and therefore the CHMP concluded that the long-term efficacy has not been sufficiently demonstrated.
Olulised ja asjakohased tulemused saadi lühiajalistes uuringutes, kuid mitte pikaajalistes, ja seetõttu järeldas Patentravimite Komitee (CHMP), et pikaajaline efektiivsus pole piisavalt tõestatud.
Post-traumatic Stress Disorder The efficacy of paroxetine in the treatment of PTSD in adults was investigated in some short-term and long-term studies.
Post- traumaatiline stressihäire Paroksetiini efektiivsust PTSD ravis täiskasvanutel uuriti mõnedes lühi - ja pikaajalistes uuringutes.
On the basis of the assessed data the CHMP concluded that paroxetine is effective in the treatment of major depressive episode, obsessive compulsive disorder, panic disorder with and without agarophobia, social anxiety disorder/ social phobia, generalised anxiety disorder and post-traumatic stress disorder.
Hinnatud andmete alusel otsustas Patentravimite Komitee (CHMP), et paroksetiin on efektiivne suure depressiivse episoodi, obsessiiv- kompulsiivse häire, agorafoobiaga või ilma selleta paanikahäire, sotsiaalse ärevushäire/ sotsiaalse foobia, generaliseerunud ärevushäire ja posttraumaatilise stressihäire ravis.
The CHMP also agreed that the above-mentioned information with regards to long- term efficacy should be included in section 5.1 (Pharmacodynamic Properties) of the Summary of Product Characteristics (SPC).
Patentravimite Komitee (CHMP) nõustus ka, et ülaltoodud informatsioon, mis puudutab pikaajalist efektiivsust, tuleb lisada ravimi omaduste kokkuvõtte punkti 5. 1 (Farmakodünaamilised omadused).
Posology The CHMP also considered the available data supporting the recommended posology for each of the above indications.
Annustamine Patentravimite Komitee (CHMP) otsustas samuti, et olemasolevad andmed toetavad iga ülaltoodud näidustuse korral soovitatud annustusjuhiseid.
The recommended daily dose of paroxetine is 40mg/ day for OCD and panic disorder and 20mg/ day for the other indications.
Paroksetiini soovitatav päevane annus on 40 mg/ päevas OCD ja paanikahäire korral ning 20 mg/ päevas teiste näidustuste puhul.