EMEA-002471-PIP01-18 - paediatric investigation plan

tropifexor

Key facts

• Active substance:
  tropifexor
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0229/2019
• PIP number:
  EMEA-002471-PIP01-18
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• 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:
  16/07/2019
• Compliance check done:
  No

Decision

P/0229/2019: EMA decision of 16 July 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tropifexor (EMEA-002471-PIP01-18)

Adopted Reference Number: EMA/339062/2019