Fexinidazole Winthrop: Opinion on medicine for use outside EU
fexinidazole
Table of contents
Overview
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.
Opinion details
| Product details | |
|---|---|
| Name of medicinal product |
Fexinidazole Winthrop
|
| Agency opinion number |
H-W-2320
|
| Opinion status |
Positive opinion
|
| Active substance |
fexinidazole
|
| International non-proprietary name (INN) or common name |
fexinidazole
|
| Therapeutic area (MeSH) |
Trypanosomiasis, African
|
| Anatomical therapeutic chemical (ATC) code |
P01CA03
|
| Publication details | |
|---|---|
| Opinion holder |
Sanofi Winthrop Industrie |
| Date of opinion |
15/11/2018
|
Product information
22/12/2022 Fexinidazole Winthrop T/0014
Contents
- 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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Pharmacotherapeutic group
-
Antiparasitic products, insecticides and repellents
-
Antiprotozoals
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Agents against leishmaniasis and trypanosomiasis
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Nitroimidazole derivatives
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.
Assessment history
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List item
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 -
List item
Fexinidazole Winthrop : Assessment report (PDF/7.27 MB)
Adopted
First published: 22/01/2019
Last updated: 04/03/2019
EMA/CHMP/843546/2018 -
List item
CHMP summary of opinion for Fexinidazole Winthrop (PDF/73.53 KB)
Adopted
First published: 16/11/2018