EMA/PE/0000232761 - paediatric investigation plan

etavopivat

Key facts

• Active substance:
  etavopivat
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000232761
• PIP number:
  EMA/PE/0000232761
• Pharmaceutical form(s):
  • Tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of beta-thalassaemia intermedia and major | alpha-thalassaemia intermedia and major
• 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:
  15/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232761: EMA decision of 15 April 2025 on the agreement of a paediatric investigation plan and on the granting of a waiver for etavopivat

Adopted Reference Number: EMADOC-1700519818-2039164