Fexinidazole Winthrop: Opinion on medicine for use outside EU
Fexinidazole Winthrop is a medicine for treating sleeping sickness (African trypanosomiasis) caused by a parasite known as Trypanosoma brucei gambiense. It is intended for use outside the EU.
Sleeping sickness occurs in some parts of Africa and is spread through the bite of infected tsetse flies. In the first few days after being bitten, patients may have symptoms such as fever, headache and rash. Later, they may experience a more severe form of the disease, which affects the nervous system, causing symptoms such as sleep disturbances and changes in behaviour. Without treatment, the disease is usually fatal.
Fexinidazole Winthrop is for patients who are 6 years or older and weigh more than 20 kilograms. It contains the active substance fexinidazole.
|Name of medicinal product||
|Agency opinion number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Sanofi Winthrop Industrie
|Date of opinion||
22/12/2022 Fexinidazole Winthrop T/0014
- 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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Antiparasitic products, insecticides and repellents
Agents against leishmaniasis and trypanosomiasis
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.
Fexinidazole Winthrop : EPAR - Procedural steps taken and scientific information after authorisation (PDF/162.33 KB)
First published: 16/03/2022
Last updated: 22/12/2022
Fexinidazole Winthrop : Assessment report (PDF/7.27 MB)Adopted
First published: 22/01/2019
Last updated: 04/03/2019
CHMP summary of opinion for Fexinidazole Winthrop (PDF/73.53 KB)Adopted
First published: 16/11/2018