EMEA-002684-PIP02-21 - paediatric investigation plan

Mitapivat

Key facts

• Invented name:
  Pyrukynd
• Active Substance:
  Mitapivat
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0150/2022
• PIP number:
  EMEA-002684-PIP02-21
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  13/05/2022

Decision

P/0150/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mitapivat (EMEA-002684-PIP02-21)

AdoptedReference Number: EMA/206221/2022