BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

  1. Homepage
  2. Medicinal products
  3. Pharmacovigilance
  4. Risk information

Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®) and progressive multifocal leukoencephalopathy (PML): Conclusion of the variation worksharing

2015.10.26

Active substance: Dimethylfumarat

The BfArM issues information that the variation worksharing procedure regarding progressive multifocal leukoencephalopathy in connection with the use of medicinal products containing dimethyl fumarate has been concluded.

To the risk information - full text (available in German only)

For the complete recommendations please click on the following link to the homepage of the European Medicines Agency (EMA):

Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera