EMEA-002535-PIP04-21-M02 - paediatric investigation plan

Ibrexafungerp citrate

Key facts

• Active substance:
  Ibrexafungerp citrate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0347/2024
• PIP number:
  EMEA-002535-PIP04-21-M02
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral solution
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of invasive candidiasis
• Route(s) of administration:
  • Oral use
  • Intravenous 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/0347/2024 : of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ibrexafungerp (citrate) (EMEA-002535-PIP04-21-M02)

Adopted Reference Number: EMA/421548/2024