EMEA-002530-PIP01-18 - paediatric investigation plan

atogepant

Key facts

• Active substance:
  atogepant
• Therapeutic area:
  Pain
• Decision number:
  P/0046/2020
• PIP number:
  EMEA-002530-PIP01-18
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Prevention of migraine headaches
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  29/01/2020
• Compliance check done:
  No

Decision

P/0046/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atogepant (EMEA-002530-PIP01-18)

Adopted Reference Number: EMA/28876/2020