EMEA-003564-PIP01-23 - paediatric investigation plan

olorofim

Key facts

• Active substance:
  olorofim
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0398/2024
• PIP number:
  EMEA-003564-PIP01-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of invasive aspergillosis
  • Treatment of non-Aspergillus invasive mould infections
• 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:
  17/12/2024
• Compliance check done:
  No

Decision

P/0398/2024: EMA decision of 17 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olorofim, (EMEA-003564-PIP01-23) in

Adopted Reference Number: EMA/587147/2024