EMEA-002070-PIP01-16-M07 - paediatric investigation plan

risdiplam

Key facts

• Invented name:
  Evrysdi
• Active substance:
  risdiplam
• Therapeutic area:
  Neurology
• Decision number:
  P/0086/2023
• PIP number:
  EMEA-002070-PIP01-16-M07
• Pharmaceutical form(s):
  • Powder for oral solution
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002070-PIP01-16-M07
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0086/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risdiplam (Evrysdi), (EMEA-002070-PIP01-16-M07)

Reference Number: EMA/37955/2023