MHRA-100670-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Ibrexafungerp citrate
Invented Name
Brexafemme
PIP Number MHRA-100670-PIP01-22
Pharmaceutical form(s)
  • Tablet
  • Powder for solution for injection/infusion
  • Powder for oral suspension
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of invasive candidiasis
Route(s) of administration
  • Oral use
  • INTRAVENOUS USE
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ibrexafungerp citrate.pdf
Published Date 24/08/2023