EMA/PE/0000232769 - paediatric investigation plan

pegozafermin

Key facts

• Active substance:
  pegozafermin
• Therapeutic area:
  Hepatobiliary disorders
• Decision number:
  EMA/PE/0000232769
• PIP number:
  EMA/PE/0000232769
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of metabolic dysfunction-associated steatohepatitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/03/2025
• Compliance check done:
  No

Decision

EMA/PE/0000232769 : EMA decision of 20 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pegozafermin

Adopted Reference Number: EMADOC-1700519818-1976525