EMEA-002812-PIP02-20-M03 - paediatric investigation plan

rimegepant

Key facts

• Invented name:
  Vydura
• Active substance:
  rimegepant
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0320/2024
• PIP number:
  EMEA-002812-PIP02-20-M03
• Pharmaceutical form(s):
  Oral lyophilisate
• Condition(s) / indication(s):
  Treatment of migraine headaches
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0320/2024 : EMA decision of 13 September 2025 on the acceptance of a modification of an agreed paediatric investigation plan for rimegepant (Vydura), (EMEA-002812-PIP02-20-M03)

Adopted Reference Number: EMA/410679/2024