Highlights of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting, 1 – 4 September 2025

Levamisole: initiation of a safety review regarding the assessment of the risk of leukoencephalopathy
Caspofungin: new warning against the use of polyacrylonitrile membrane during continuous renal replacement therapy
Crysvita (burosumab): new recommendations for monitoring, due to the risk of severe hypercalcemia
Remsima (infliximab): contraindication of a new intravenous pharmaceutical form in patients with hereditary fructose intolerance
Tegretol (carbamazepine): restriction of use in neonates, due to concentration of the excipient propylene glycol, which exceeds the recommended maximum limit

For the full text of the announcement click here.

For the text, as published on the website of the European Medicines Agency (EMA), please visit://www.ema.europa.eu/