EMEA-001475-PIP03-17-M03 - paediatric investigation plan

Maralixibat chloride

Key facts

• Invented name:
  Livmarli
• Active Substance:
  Maralixibat chloride
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0436/2022
• PIP number:
  EMEA-001475-PIP03-17-M03
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Progressive Familial Intrahepatic Cholestasis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Mirum Pharmaceuticals

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022

Decision

P/0436/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP03-17-M03)

AdoptedReference Number: EMA/638309/2022