Opinion on medicine for use outside EU: Fexinidazole Winthrop, fexinidazole, Trypanosomiasis, African, 15/11/2018 Positive opinion
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.
Fexinidazole Winthrop : Medicine overview
First published: Reference Number: EMA/835292/2018
Opinion details
Product details
- Name of medicine
Fexinidazole Winthrop
- EMA 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
82 avenue Raspail
94250 Gentilly
France- Date of opinion
Product information
Fexinidazole Winthrop : Product information
First published: Last updated:
Latest procedure affecting product information: T/0014
22/12/2022
Product information documents contain:
- 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
Fexinidazole Winthrop : All presentations
First published:
Pharmacotherapeutic group
- Antiparasitic products, insecticides and repellents
- Antiprotozoals
- Agents against leishmaniasis and trypanosomiasis
- 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
Fexinidazole Winthrop : Assessment report
AdoptedFirst published: Last updated: Reference Number: EMA/CHMP/843546/2018
CHMP summary of opinion for Fexinidazole Winthrop
AdoptedFirst published:
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