MHRA-100507-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • BREXPIPRAZOLE
Invented Name
  • RXULTI
  • RXULTI
PIP Number MHRA-100507-PIP01-22-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of schizophrenia
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
17/04/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100507-PIP01-22-M03-C2

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BREXPIPRAZOLE.pdf
Published Date 01/05/2026