.png)
Agenzia Italiana del Farmaco
Levamisole: the PRAC recommendation for withdrawal from the EU market has been confirmed - Levamisole: the PRAC recommendation for withdrawal from the EU market has been confirmed
Levamisole: the PRAC recommendation for withdrawal from the EU market has been confirmed
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)
Published on: 27 March 2026
Contacts
Via del Tritone, 181 00187 Roma
VAT number: 08703841000
Tax code: 97345810580
IPA AIFA code: aifa_rm
IPA UCB code: UFE1TR