EMEA-003402-PIP01-23 - paediatric investigation plan

semaglutide

Key facts

• Active substance:
  semaglutide
• Therapeutic area:
  Hepatobiliary disorders
• Decision number:
  P/0022/2024
• PIP number:
  EMEA-003402-PIP01-23
• 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:
  01/02/2024
• Compliance check done:
  No

Decision

P/0022/2024 : EMA decision of 1 February 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fibroblast growth factor 21 analogue (NNC194-0499) / semaglutide (EMEA-003402-PIP01-23)

Adopted Reference Number: EMA/27698/2024