EMEA-003005-PIP01-21 - paediatric investigation plan

aldafermin

Key facts

• Active substance:
  aldafermin
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0294/2021
• PIP number:
  EMEA-003005-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/08/2021
• Compliance check done:
  Ei

Decision

P/0294/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for aldafermin (EMEA-003005-PIP01-21)

Adopted Reference Number: EMA/418764/2021