EMEA-001475-PIP04-20 - paediatric investigation plan

Maralixibat chloride

Key facts

• Active substance:
  Maralixibat chloride
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0245/2021
• PIP number:
  EMEA-001475-PIP04-20
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of biliary atresia
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/07/2021
• Compliance check done:
  No

Decision

P/0245/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP04-20)

Reference Number: EMA/358055/2021