EMEA-002319-PIP01-17-M02 - paediatric investigation plan

Rezafungin acetate

Key facts

• Active Substance:
  Rezafungin acetate
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0342/2022
• PIP number:
  EMEA-002319-PIP01-17-M02
• 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:
  10/08/2022

Decision

P/0342/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rezafungin acetate (EMEA-002319-PIP01-17-M02)

AdoptedReference Number: EMA/673781/2022 Corr