At the request of the BfArM, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera® (dimethyl fumarate) at its meeting from 3 - 6 November 2014.

risk information - full text (available in German only)

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014