Fexinidazole Winthrop H-W-2320

Name of the medicinal product Fexinidazole Winthrop
Opinion holder

sanofi-aventis groupe

54 rue La Boétie
75008  Paris
Active substance Fexinidazole
International non-proprietary name or common name Fexinidazole
Pharmaco-therapeutic group

Antiparasitic products, antiprotozoals, agents against leishmaniasis and trypanosomiasis, nitroimidazole derivatives

ATC code Not yet assigned
Therapeutic indication

Fexinidazole Winthrop is indicated for the treatment of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in adults and children ≥ 6 years old and weighing ≥ 20 kg. Fexinidazole should be used in line with official recommendations.

Orphan medicinal product designation date Not applicable

*This document includes:

Annex I - Summary of product characteristics
Annex IIA - Manufacturer responsible for batch release
Annex IIB - Recommendations to the opinion holder - conditions of use
Annex IIIA - Labelling
Annex IIIB - Package leaflet

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