EMA/PE/0000237220 - 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:
  EMA/PE/0000237220
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• 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:
  14/04/2025
• Compliance check done:
  Nej

Decision

P/0343/2024 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for rezafungin acetate (Rezzayo) (EMA/PE/0000237220)

Adopted Reference Number: EMADOC-1700519818-2039209