EMEA-002319-PIP01-17-M03 - paediatric investigation plan

rezafungin acetate

Key facts

• Invented name:
  Rezzayo
• Active substance:
  rezafungin acetate
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0343/2024
• PIP number:
  EMEA-002319-PIP01-17-M03
• Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use
• Condition(s) / indication(s):
  Treatment of invasive candidiasis
• Route(s) of administration:
  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/0343/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for rezafungin acetate (Rezzayo), (EMEA-002319-PIP01-17-M03)

Adopted Reference Number: EMA/414909/2024