MHRA-101596-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Ibrexafungerp
Invented Name
Not yet available
PIP Number MHRA-101596-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of vulvovaginal candidiasis
  • Prevention of recurrent vulvovaginal candidiasis
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
16/12/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101596-PIP01-24-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ibrexafungerp.pdf
Published Date 06/01/2025