MHRA-101302-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • BREXUCABTAGENE AUTOLEUCEL
Invented Name
  • Brexucabtagene autoleucel
  • Brexucabtagene autoleucel
PIP Number MHRA-101302-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of mature B-cell neoplasms
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BREXUCABTAGENE AUTOLEUCEL.pdf
Published Date 15/08/2024