Overview
- The assessment, formally started on 4 September, will examine the risk of leukoencephalopathy and cases describing central nervous system demyelination linked to levamisole use.
- PRAC will evaluate all available evidence and current risk minimisation measures to reassess the medicines’ benefit–risk balance.
- Possible outcomes include maintaining the current authorisations or varying, suspending, or withdrawing them across the EU.
- Levamisole is an oral single‑dose anthelmintic authorised in Hungary, Lithuania, Latvia and Romania under the trade names Decaris and Levamisol Arena for treating specific worm infections in adults and children.
- Any PRAC recommendation will go to the CMDh for a position and, if needed, to the European Commission for a final binding decision, with EMA noting no timeline has been set for conclusions.