EMEA-002106-PIP01-16-M03 - paediatric investigation plan

Leriglitazone

Key facts

• Active substance:
  Leriglitazone
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0330/2024
• PIP number:
  EMEA-002106-PIP01-16-M03
• Pharmaceutical form(s):
  Oral suspension
• Condition(s) / indication(s):
  Treatment of adrenoleukodystrophy
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0330/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for leriglitazone (EMEA- 002106-PIP01-16-M03)

Adopted Reference Number: EMA/413895/2024