EMEA-002800-PIP01-20 - paediatric investigation plan

Linerixibat

Key facts

• Active substance:
  Linerixibat
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0337/2020
• PIP number:
  EMEA-002800-PIP01-20
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of primary biliary cholangitis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2020
• Compliance check done:
  No

Decision

P/0337/2020 : EMA decision of 9 September 2020 on the granting of a product specific waiver for linerixibat (EMEA-002800-PIP01-20)

Adopted Reference Number: EMA/450725/2020