Direct Healthcare Professional Communication (DHPC) on Evrysdi 0,75 mg/ml powder for oral solution: Omission of mandatory labelling statement
2025.08.21
Active substance: Risdiplam
The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement (“Do not store above 25 °C”) on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution. The labelling will be updated accordingly.
Download DHPC/Information letter , Download_VeroeffentlichtAm_EN