DHPC – Evrysdi® (Risdiplamum)

Important drug safety notification

28.05.2026
Preparation Evrysdi, powder for oral solution
Marketing authorisation number 67251
Active substance risdiplamum
Marketing authorisation holder Roche Pharma (Switzerland) AG
Batches affected B2033B05, B2034B14, B2037B12, B2038B25

Complaints were reported regarding insoluble foreign particles in constituted Evrysdi 0.75 mg/mL oral solution.The identified particles consist of a chemically inert, material that is expected to pass through the gastrointestinal tract unchanged without systemic absorption.

Healthcare professionals should take precautionary measures:

Further details are provided in the company’s information letter.