MHRA-100717-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RISDIPLAM
Invented Name
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
PIP Number MHRA-100717-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Powder for oral solution
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of spinal muscular atrophy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
29/05/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100717-PIP01-22-M01-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RISDIPLAM.pdf
Published Date 15/07/2026