Further to what has already been published on the AIFA portal regarding the outcomes of the February 2026 meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), please be advised that on 25 March 2026, the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) endorsed the recommendation made by EMA’s safety committee (PRAC) to withdraw medicines containing levamisole from the European Union (EU) market due to the risk of leukoencephalopathy, a rare but serious side effect of levamisole that affects the brain’s white matter. Levamisole is used to treat parasitic worm infections.

No medicinal products for human use containing levamisole are authorised in Italy.

Further information is available on the website of the European Medicines Agency (EMA)