MHRA-101123-PIP01-23-M02 (update)

Key Facts

Active Substance
Active Substance:
  • BREXUCABTAGENE AUTOLEUCEL
Invented Name
  • Tecartus
  • Brexucabtagene autoleucel
PIP Number MHRA-101123-PIP01-23-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of acute lymphoblastic leukaemia.
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
Yes
Compliance Check Decision Date
Compliance opinion date
07/10/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101123-PIP01-23-M02-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BREXUCABTAGENE AUTOLEUCEL.pdf
Published Date 16/07/2026