natgillin/translations-raw huggingface dataset:
<The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report :
<Inimravimite komitee on arvamusel, et määruse (EÜ) nr 141/2000 artikli 8 <ning komisjoni määruse (EÜ) nr 847/2000 artikli 3>[only for the superiority derogation] kohaselt kehtib järgmine (kehtivad järgmised) sama määruse artikli 8 lõikes 3 sätestatud erand(id), nagu on kirjeldatud Euroopa avalikus hindamisaruandes:
CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
EUROOPA RAVIMIAMETI ESITATUD JÄRELDUSED TINGIMUSLIKU MÜÜGILOA ANDMISE JA <SARNASUSE JA ERANDI> <JA> <ÜHE AASTA PIKKUSE <MÜÜGIKAITSE> <ANDMETE AINUÕIGUSE PERIOODI> TAOTLUSE> KOHTA
<the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication> <and>
<taotleja suutis taotluses tõestada, et ravim, kuigi <müügiloa saanud harvikravimiga> sarnane, on samal näidustusel ohutum, efektiivsem või muul viisil kliiniliselt parem (komisjoni määruse (EÜ) nr 847/2000 artiklis 3 esitatud määratluse järgi)> <ja>
[For Art 14(11)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
[For Art 14(11)] <Inimravimite komitee vaatas määruse (EÜ) nr 726/2004 artikli 14 lõike 11 sätteid arvesse võttes läbi müügiloa hoidja esitatud andmed ning leiab, et uus näidustus lisab olulist kliinilist kasulikkust võrreldes olemasoleva raviga, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Pärast taotluse arutamist on inimravimite komitee arvamusel, et ravimi riski/kasu suhe on soodne ning seega võib sellele anda tingimusliku müügiloa, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.
[Art 10(5)] <The CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 10(5) of Directive 2001/83/EC, and considers that <the <pre-clinical tests> <and> <clinical studies> carried out in relation to the new indication were significant as further explained in the European Public Assessment Report.
[Art 10(5)] <Inimravimite komitee vaatas direktiivi 2001/83/EÜ artikli 10 lõike 5 sätteid arvesse võttes läbi müügiloa hoidja esitatud andmed ning leiab, et <uue näidustuse <prekliinilised uuringud> <ja> <kliinilised uuringud> olid olulised, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>>
<The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal products within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
<Inimravimite komitee on arvamusel, et <ravimpreparaadi nimetus> on komisjoni määruse (EÜ) nr 847/2000 artikli 3 mõistes sarnane müügiloa saanud harvikravimitega, nagu on kirjeldatud Euroopa avalikus hindamisaruandes.>
Belgium APOTEX NV Av. du Bourg.
APOTEX NV Av. du Bourg.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
I Lisa Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
United Kingdom Waymade Plc Regency House
Ühendkuningriik Waymade Plc Regency House
ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2;
S.C. ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2;
Belgium LABORATORIA QUALIPHAR N.V/S.A
LABORATORIA QUALIPHAR N.V/S.A
United Kingdom Generics (UK) Limited Station Close
Ühendkuningriik Generics (UK) Limited Station Close
United Kingdom Bristol Laboratories Limited Unit 3, Canal side
Ühendkuningriik Bristol Laboratories Limited Unit 3, Canal side
United Kingdom RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
Ühendkuningriik RI Pharma Limited First floor,6 St John's Court Upper Fforest Way
Pfizer Holding France 23-25, avenue du Docteur Lannelongue
Prantsusmaa Pfizer Holding France 23-25, avenue du Docteur Lannelongue
Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
Ungari ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a
United Kingdom Daichi-Sankyo UK Limited Chiltern Place
Ühendkuningriik Daichi-Sankyo UK Limited Chiltern Place
ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
Prantsusmaa ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
United Kingdom Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
Ühendkuningriik Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
United Kingdom Actavis UK Limited Whiddon Valley
Ühendkuningriik Actavis UK Limited Whiddon Valley
United Kingdom Dexcel Pharma Limited 7 Sopwith Way
Ühendkuningriik Dexcel Pharma Limited 7 Sopwith Way
Oral drops, suspension
Suukaudsed tilgad, suspensioon
Luxembourg Continental Pharma Rijksweg, 12
Luxemburg Continental Pharma Rijksweg, 12
15, boulevard Charles de Gaulle
Prantsusmaa BIOGARAN 15, boulevard Charles de Gaulle
110, Esplanade du Général de Gaulle
Prantsusmaa TEVA SANTE 110, Esplanade du Général de Gaulle
CRISTERS 22 quai Gallieni 92150 Suresnes France
Prantsusmaa CRISTERS 22 quai Gallieni 92150 Suresnes France
United Kingdom Galen Limited Seagoe Industrial Estate Craigavon
Ühendkuningriik Galen Limited Seagoe Industrial Estate Craigavon
The Netherlands Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester
Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester United Kingdom
Luxembourg Hexal AG Industriestraße 25
Luxemburg Hexal AG Industriestraße 25
Czech Republic Krka, d.d.
Tšehhi Vabariik Krka, d.d.
United Kingdom Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Ühendkuningriik Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Luxembourg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium
Luxemburg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium
United Kingdom Pfizer Limited Ramsgate Road
Ühendkuningriik Pfizer Limited Ramsgate Road
United Kingdom Crescent Pharma Limited Unit 3&4
Ühendkuningriik Crescent Pharma Limited Unit 3&4
United Kingdom Teva UK Limited Brampton Road
Ühendkuningriik Teva UK Limited Brampton Road
United Kingdom Aptil Pharma limited 9th Floor
Ühendkuningriik Aptil Pharma limited 9th Floor
United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday court
Ühendkuningriik Focus Pharmaceuticals Limited Unit 5, Faraday court
United Kingdom Mercury Pharma Group Limited No. 1 Croydon
Ühendkuningriik Mercury Pharma Group Limited No. 1 Croydon
Finland ratiopharm Oy P.O.Box 67
Soome ratiopharm Oy P.O.Box 67
Luxembourg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Luxemburg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Ühendkuningriik Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Slovak Republic MEDOPHARM s.r.o., Lehárova 143 00, Praha 4
MEDOPHARM s.r.o., Lehárova 143 00, Praha 4
United Kingdom Chelonia Healthcare Limited Boumpoulinas 11
Ühendkuningriik Chelonia Healthcare Limited Boumpoulinas 11
United Kingdom Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
Ühendkuningriik Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
2880 Bornem
2880 Bornem Belgium
United Kingdom Sandoz Limited Frimley Business Park Frimley
Ühendkuningriik Sandoz Limited Frimley Business Park Frimley
Czech Republic Winthrop Arzneimittel GmbH Industriestrasse 26
Tšehhi Vabariik Winthrop Arzneimittel GmbH Industriestrasse 26
NOVARTIS PHARMA 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
Prantsusmaa NOVARTIS PHARMA 2-4, rue Lionel Terray 92500 Rueil-Malmaison France
United Kingdom Chatfield Pharmaceuticals Limited
Ühendkuningriik Chatfield Pharmaceuticals Limited
Czech Republic Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Tšehhi Vabariik Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda.
Czech Republic Vitabalans OY Varastokatu 8
Tšehhi Vabariik Vitabalans OY Varastokatu 8
United Kingdom Morningside Healthcare Limited 115 Narborough Road
Ühendkuningriik Morningside Healthcare Limited 115 Narborough Road
Belgium Continental Pharma Rijksweg, 12
Continental Pharma Rijksweg, 12
The Netherlands Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
Czech Republic Zentiva, k.s.
Tšehhi Vabariik Zentiva, k.s.
United Kingdom Mercury Pharma International Limited
Ühendkuningriik Mercury Pharma International Limited
Etienne Demunter 5, box 8
Etienne Demunter 5, box 8 1090 Jette
6824 DP Arnhem
6824 DP Arnhem The Netherlands
Luxembourg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Luxemburg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22
Eurogenerics S.A Esplanade Heysel b 22
Luxembourg Novartis Consumer Health S.A. Medialaan, 40
Luxemburg Novartis Consumer Health S.A. Medialaan, 40
1200 Woluwé-saint-lambert Belgium
Rue Saint-Lambert 141 1200 Woluwé-saint-lambert Belgium
Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium
2333 CN Leiden The Netherlands
Archimedesweg 2 2333 CN Leiden The Netherlands
7255 PZ Hengelo
7255 PZ Hengelo The Netherlands
Diclofenac potassium VOLTATABS 12,5 MG(EX:ZYMAMED)
Diclofenac potassium VOLTATABS 12,5 MG(EX:ZYMAM ED)
EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Prantsusmaa EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou
United Kingdom Novartis Consumer Health UK Limited
Ühendkuningriik Novartis Consumer Health UK Limited
Czech Republic Herbacos Recordati s.r.o.
Tšehhi Vabariik Herbacos Recordati s.r.o.
Intramuscular injection or intravenous infusion.
Parenteraalne, intramuskulaarne või intravenoosne infusioon.
Czech Republic Medochemie Ltd 1-10 Constantinoupoleos str P.O.
Tšehhi Vabariik Medochemie Ltd 1-10 Constantinoupoleos str P.O.
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany
Czech Republic Apotex Europe B.V. Darwinweg 20
Tšehhi Vabariik Apotex Europe B.V.
Luxembourg Novartis Pharma GmbH Roonstrasse 25
Luxemburg Novartis Pharma GmbH Roonstrasse 25
Czech Republic Alfa Wassermann S.p.A.
Tšehhi Vabariik Alfa Wassermann S.p.A.
United Kingdom Actavis Group PTC ehf Reykjavikurvegi 76-78
Ühendkuningriik Actavis Group PTC ehf Reykjavikurvegi 76-78
Prolonged-release tablet hameln pharma plus gmbh Langes Feld 13
Saksamaa hameln pharma plus gmbh Langes Feld 13
Parenteral use, Intramuscular use
Parenteraalne, Intramuskulaarne
Belgium Novartis Consumer Health S.A. Medialaan, 40
Novartis Consumer Health S.A. Medialaan, 40
Czech Republic Fresenius Kabi Austria GmbH Hafnerstrasse 36
Tšehhi Vabariik Fresenius Kabi Austria GmbH Hafnerstrasse 36
Luxembourg ratiopharm GmbH Graf Arco Strasse 3
Luxemburg ratiopharm GmbH Graf Arco Strasse 3
Diclofenacum natricum Voltaren Retard 100 mg modified-release film-coated tablets
Diclofenacum natricum Voltaren Retard 100 mg modifiedrelease film-coated tablets
Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Tšehhi Vabariik ratiopharm GmbH Graf Arco Strasse 3
ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant
ARTOTEC 75 mg/0,2 mg, comprimé gastrorésistant
Czech Republic Dr. R. Pfleger Chemische Fabrik GmbH
Tšehhi Vabariik Dr. R. Pfleger Chemische Fabrik GmbH
The Netherlands Actavis Group PTC ehf Reykjavikurvegi 76-78
Prantsusmaa Actavis Group PTC ehf Reykjavikurvegi 76-78
Prolonged-release tablet sigapharm GmbH Temmlerstr.
Saksamaa sigapharm GmbH Temmlerstr.
Diclofenac potassium Voltfast Sachets 50 mg Powder for Oral
Diclofenac potassium Voltfast Sachets 50 mg Powder for
Czech Republic IBSA Slovakia s.r.o.
Tšehhi Vabariik IBSA Slovakia s.r.o.
The Netherlands ratiopharm Nederland B.V. Florapark 4
Holland ratiopharm Nederland B.V.
Na Pankraci 1724/129
Na Pankraci 1724/129 140 00 Praha 4
ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant
ARTOTEC 50 mg/0,2 mg, comprimé gastrorésistant
Rectal use betapharm Arzneimittel GmbH Kobelweg 95
Saksamaa betapharm Arzneimittel GmbH Kobelweg 95
Actavis Deutschland GmbH & Co. KG
Actavis Deutschland GmbH & Co.
Slovak Republic IBSA Slovakia s.r.o.
IBSA Slovakia s.r.o.
Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis 06600 Antibes France
Les Trois Moulins - Parc de Sophia Antipolis
Czech Republic PharmaSwiss Česká republika s.r.o.
Tšehhi Vabariik PharmaSwiss Česká republika s.r.o.
Granules for oral suspension
Suukaudse suspensiooni graanulid
Powder for oral solution
Oral Solution
Diclofenac sodium Diclofenac EG 100 suppositoire suppository
Diclofenac sodium Diclofenac EG 100 suppositoire
Belgium Teva Pharma Belgium N.V. Laarstraat 16
Teva Pharma Belgium N.V.
Intramuscular use, Subcutaneous use
Intramuskulaarne, Subkutaanne
Prolonged-release capsule
Toimeainet prolongeeritult vabastav kapsel
United Kingdom Novartis Pharmaceuticals UK ltd.
Ühendkuningriik Novartis Pharmaceuticals UK ltd.
Gastro-resistant capsule
Gastroresistent ne kapsel
Intramuscular use, intravenous use
Intramuskulaarne, Intravenoosne
Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Slovak Republic Herbacos Recordati s.r.o.
Herbacos Recordati s.r.o.
AWD.pharma GmbH & Co. KG
AWD.pharma GmbH & Co.
The Netherlands Apotex Europe B.V. Darwinweg 20
Apotex Europe B.V.
Not applicable for bolus intravenous injection
Ei kasutata intravenoosse boolussüstena.
NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu 92500 Rueil-Malmaison France
Prantsusmaa NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu
Belgium Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 B-1348 Louvain-la-Neuve Belgium
Olfen 75 mg/20 mg/2 ml solution for injection
75 mg/20 mg/2 ml solution for injection
Parenteral use
Parenteraalne
The Netherlands Teva Nederland B.V. Swensweg 5
Teva Nederland B.V.
Czech Republic ALIUD PHARMA GmbH & Co. KG
Tšehhi Vabariik ALIUD PHARMA GmbH & Co.
Diclofenac sodium Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml
Diclofenac sodium Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie
The Netherlands Disphar International B.V. Winkelskamp 6
Disphar International B.V.
Diclofenac sodium Voltaren-100 Zäpfchen suppository
Diclofenac sodium Voltaren-100 Zäpfchen
ALIUD PHARMA GmbH & Co. KG
ALIUD PHARMA GmbH & Co.
Orodispersible tablet
Dispergeeruv tablett
Diclofenac kalium Diclo-CT akut 12,5 mg Filmtabletten
Diclofenac kalium Diclo-CT akut 12,5 mg
DICLOMELAN 50 MG 50mg
DICLOMELAN 50 G 50 mg
Gastro-resistant coated tablet
Gastroresistent ne kaetud tablett
Diclofenac sodium Diclofenac EG 75 mg/3 ml solution injectable solution for injection
Diclofenac sodium Diclofenac EG 75 mg/3 ml solution injectable
The Netherlands Pharmacin B.V. Molenvliet 103
Molenvliet 103
Diclofenac sodium Diclac-50 Zäpfchen 50mg suppository
Diclofenac sodium Diclac-50 Zäpfchen 50 mg
Iceland ratiopharm GmbH Graf-Arco Strasse 3 89079 Ulm Germany
Island ratiopharm GmbH Graf-Arco Strasse 3 89079 Ulm Germany
Diclofenac sodium Diclac 75 mg/3 ml Injektionslösung solution for injection
Diclofenac sodium Diclac 75 mg/3 ml Injektionslösung
Diclofenac sodium Difene ampoules 75 mg/3 ml Solution for
Diclofenac sodium Difene ampoules 75 mg/3 ml Solution for Injection or
Film-coated prolonged release tablet
Toimeainet prolongeeritult vabastav kaetud tablett
Diclofenac sodium Diclac-100 Zäpfchen 100mg suppository
Diclofenac sodium Diclac-100 Zäpfchen 100 mg
Diclofenac potassium VOLTAREN ACTI-GO 12,5mg Coated tablet
Diclofenac potassium VOLTAREN ACTI-GO 12,5 mg
Diclofenac sodium Xelaran Brausetablette 25 mg
Diclofenac sodium Xelaran Brausetablette
Belgium RATIOPHARM BELGIUM S.A. Rue Saint-Lambert 141
RATIOPHARM BELGIUM S.A.
Diclofenac potassium Voltaren Express 12,5mg Capsule, soft
Diclofenac potassium Voltaren Express 12,5 mg
Intramuscular use, Intravenous use
Infusioonilahus Parenteraalne, Intravenoosne
DICLOFENAC AL 50 mg gyomornedvellenálló filmtabletta
50 mg gyomornedvellenálló filmtabletta
The Netherlands Pfizer B.V. Rivium Westlaan 142
Rivium Westlaan 142
Heumann Pharma GmbH & Generica Co. KG Südwestpark 50
Heumann Pharma GmbH & Generica Co.
Diclofenac sodium Diclofenac MEDA 25 mg Brausetabletten
Diclofenac sodium Diclofenac MEDA 25 mg
50 mg - Filmtabletten
100 mg - Tabletten
Oral drops, solution
Suukaudsed tilgad, lahus
Norway ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Norra ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Poland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Poola ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Italy ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Itaalia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
The Netherlands Centrafarm B.V. Nieuwe Donk 3
Centrafarm B.V.
Latvia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Läti ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Diclofenac sodium Diclofenacnatrium 25 PCH, zetpillen 25 mg
Diclofenac sodium Diclofenacnatrium 25 PCH, zetpillen
The Netherlands Novartis Pharma B.V. Raapopseweg 1
Novartis Pharma B.V.
Granules
Graanulid
Lithuania ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovakkia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Estonia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Eesti ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Diclofenac sodium Diclofenac MEDA 50 mg Brausetabletten
Diclofenac sodium Diclofenac MEDA 50 mg
This authorisation was based on the authorisation granted to Taxotere in 1995 (‘informed consent').
Müügiluba põhineb 1995. aastal antud Taxotere müügiloal (teabel põhinev nõusolek).
• breast cancer.
• Rinnavähk.
Further information on Docetaxel Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/docetaxel-zentiva.
Lisateave Docetaxel Zentiva kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/docetaxel-zentiva.
Docetaxel Zentiva received a marketing authorisation valid throughout the EU on 20 April 2007.
Docetaxel Zentiva on saanud müügiloa, mis kehtib kogu ELis, 20. aprillil 2007.
1 Previously known as Docetaxel Winthrop.
1 Varasem nimetus Docetaxel Winthrop.
The European Medicines Agency decided that Docetaxel Zentiva's benefits are greater than its risks and it can be authorised for use in the EU.
Euroopa Ravimiamet otsustas, et Docetaxel Zentiva kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
• non-small cell lung cancer.
• Mitteväikerakk-kopsuvähk.
Docetaxel Zentiva must not be used in patients who have a neutrophil count of less than 1,500 cells/mm3 or who have severe problems with their liver.
Docetaxel Zentivat ei tohi kasutada patsientidel, kelle neutrofiilide sisaldus on alla 1500 rakku/mm3 või kellel on rasked maksaprobleemid.
Docetaxel Zentiva1 (docetaxel)
Docetaxel Zentiva1 (dotsetakseel)
• prostate cancer, when the cancer has spread to other parts of the body (metastatic).
• Eesnäärmevähk, kui vähk on levinud organismis ka mujale (metastaatiline).
Docetaxel Zentiva is given as a 1-hour infusion (drip) into a vein every 3 weeks.
Docetaxel Zentivat manustatakse 1-tunnise veeniinfusioonina iga 3 nädala järel.
Docetaxel Zentiva has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-celllung-cancer patients, around 2,700 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897 head- and neck-cancer patients.
Docetaxel Zentivat uuriti enam kui 4000 rinnavähiga patsiendil, ligikaudu 2000 mitteväikerakkkopsuvähiga patsiendil, ligikaudu 2700 eesnäärmevähiga patsiendil, 457 mao adenokartsinoomiga patsiendil ning 897 pea- ja kaelapiirkonna vähiga patsiendil.
What measures are being taken to ensure the safe and effective use if Docetaxel Zentiva?
Mis meetmed võetakse, et tagada Docetaxel Zentiva ohutu ja efektiivne kasutamine?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Docetaxel Zentiva have been included in the summary of product characteristics and the package leaflet.
Docetaxel Zentiva ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
In most of these studies, Docetaxel Zentiva was combined with other anticancer treatments and compared either with the medicines it is used in combination with or with a combination of different treatments.
Enamikus neist uuringutest kasutati Docetaxel Zentivat koos muude vähiravimeetoditega ja seda võrreldi kas selle kombinatsioonravimitega või erinevate ravimeetodite kombinatsiooniga.
The most common side effects with Docetaxel Zentiva (which may affect more than 1 in 10 people) are neutropenia (low levels of neutrophils, white blood cells that fight infection), anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss) and asthenia (weakness).
Docetaxel Zentiva kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on neutropeenia (neutrofiilide ehk infektsioonidega võitlevate vere valgeliblede vähesus), aneemia (vere punaliblede vähesus), stomatiit (suuõõne limaskesta põletik), kõhulahtisus, iiveldus, oksendamine, alopeetsia (juuste väljalangemine) ja asteenia (jõuetus).
As for all medicines, data on the use of Docetaxel Zentiva are continuously monitored.
Nagu kõigi ravimite puhul, tehakse Docetaxel Zentiva kasutamise kohta pidevat järelevalvet.
It can also be used with androgen-deprivation therapy when hormonal treatment still works (hormone-sensitive prostate cancer);
Seda võib kasutada ka koos androgeenide supressioonraviga, kui hormonaalravi veel toimib (hormoonide suhtes tundlik eesnäärmevähk).
Side effects reported with Docetaxel Zentiva are carefully evaluated and any necessary action taken to protect patients.
Docetaxel Zentiva kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
Docetaxel Zentiva is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer cannot be treated by greatly reducing the body's production of testosterone (castration-resistant prostate cancer).
Docetaxel Zentivat kasutatakse koos prednisooni või prednisolooniga (põletikuvastased ravimid), kui vähki ei saa ravida testosterooni tootmise olulise vähendamisega organismis (kastratsiooniresistentne eesnäärmevähk).
When used on its own, Docetaxel Zentiva was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or treatment to help patients, but not other cancer medicines) in lung cancer.
Ainuravimina kasutamisel oli Docetaxel Zentiva vähemalt sama efektiivne ja mõnikord efektiivsem kui rinnavähi võrdlusravimid ning efektiivsem kui kopsuvähi parim toetav ravi (patsienti aitavad mis tahes ravimid või ravimeetodid, v.a muud vähiravimid).