EMEA-003310-PIP01-22 - paediatric investigation plan

setanaxib

Key facts

• Active substance:
  setanaxib
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0032/2023
• PIP number:
  EMEA-003310-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of primary biliary cholangitis
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0032/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for setanaxib (EMEA-003310-PIP01-22)

Adopted Reference Number: EMA/21189/2023