MHRA-100349-PIP01-21-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Rezafungin acetate
Invented Name
Rezafungin 200 mg powder for concentrate for solution for infusion
PIP Number MHRA-100349-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Powder for concentrate for solution for infusion
  • Age appropriate dosage form for parenteral use.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of invasive candidiasis
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Rezafungin acetate.pdf
Published Date 29/07/2022