Fexinidazole Winthrop: Opinion on medicine for use outside EU


Opinion on medicine for use outside the European Union
Positive opinion


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
Opinion status
Positive opinion
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Trypanosomiasis, African
Anatomical therapeutic chemical (ATC) code
Publication details
Opinion holder

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly

Date of opinion

Product information

22/12/2022 Fexinidazole Winthrop T/0014


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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

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