EMEA-003549-PIP01-23 - paediatric investigation plan

efinopegdutide

Key facts

• Active Substance:
  efinopegdutide
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0311/2024
• PIP number:
  EMEA-003549-PIP01-23
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• 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:
  15/08/2024

Decision

EMEA-003549-PIP01-23: EMA decision of 15 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efinopegdutide (EMEA-003549-PIP01-23)

AdoptedReference Number: EMA/373582/2024