EMEA-003567-PIP01-23 - paediatric investigation plan

volixibat potassium

Key facts

• Active substance:
  volixibat potassium
• Therapeutic area:
  Hepatobiliary disorders
• Decision number:
  P/0155/2024
• PIP number:
  EMEA-003567-PIP01-23
• 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0155/2024: EMA decision of 6 May 2024 on the granting of a product-specific waiver for Volixibat potassium (EMEA-003567-PIP01-23)

Adopted Reference Number: EMA/148131/2024