EMEA-003114-PIP01-21 - paediatric investigation plan

Efruxifermin

Key facts

• Active substance:
  Efruxifermin
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0302/2022
• PIP number:
  EMEA-003114-PIP01-21
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• 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:
  10/08/2022
• Compliance check done:
  No

Decision

P/0302/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efruxifermin (EMEA-003114-PIP01-21)