EMEA-001857-PIP01-15-M01 - paediatric investigation plan

Elafibranor

Key facts

• Active substance:
  Elafibranor
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0139/2020
• PIP number:
  EMEA-001857-PIP01-15-M01
• Pharmaceutical form(s):
  • Capsule, hard
  • Coated tablet
• Condition(s) / indication(s):
  Treatment of non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/04/2020
• Compliance check done:
  No

Decision

P/0139/2020: EMA decision of 17 April 2020 on the acceptance of a modification of an agreed paediatric investigation plan for elafibranor (EMEA- 001857-PIP01-15-M01)

Adopted Reference Number: EMA/640003/2008