EMA/PE/0000238074 - paediatric investigation plan

Mitapivat

Key facts

• Invented name:
  Pyrukynd
• Active substance:
  Mitapivat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000238074
• PIP number:
  EMA/PE/0000238074
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of thalassaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/11/2024
• Compliance check done:
  Nej

Decision

EMA/PE/0000238074: EMA decision of 27 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mitapivat (Pryrukind)

Adopted Reference Number: EMADOC-1700519818-1789262