EMEA-001475-PIP03-17-M04 - paediatric investigation plan

Maralixibat chloride

Key facts

• Invented name:
  Livmarli
• Active substance:
  Maralixibat chloride
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0488/2023
• PIP number:
  EMEA-001475-PIP03-17-M04
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Progressive Familial Intrahepatic Cholestasis
• Route(s) of administration:
  • Oral use
  • Tablet
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/12/2023
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001475-PIP03-17-M04
• Compliance opinion date:
  26/04/2024
• Compliance outcome:
  Positive

Decision

P/0488/2023: EMA decision of 4 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP03-17-M04)

Reference Number: EMA/517374/2023