EMEA-002828-PIP01-20 - paediatric investigation plan

firsocostat

cilofexor

Key facts

• Active substance:
  • firsocostat
  • cilofexor
• Therapeutic area:
  Hepatobiliary disorders
• Decision number:
  EMA/PE/0000239079
• PIP number:
  EMEA-002828-PIP01-20
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of metabolic dysfunction-associated steatohepatitis
• 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:
  16/05/2025
• Compliance check done:
  No

Decision

EMEA-002828-PIP01-20: EMA decision of 16 May 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for firsocostat / cilofexor

Adopted Reference Number: EMADOC-1700519818-2111879