EMA/PE/0000225746 - paediatric investigation plan

atogepant

Key facts

• Invented name:
  Aquipta
• Active substance:
  atogepant
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000225746
• PIP number:
  EMA/PE/0000225746
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/01/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000225746 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for atogepant (Aquipta)

Adopted Reference Number: EMADOC-1700519818-1808237