MHRA-100866-PIP01-23

Key Facts

Active Substance
Active Substance:
  • obecabtagene autoleucel
Invented Name
Not yet available
PIP Number MHRA-100866-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of acute lymphoblastic leukaemia (ALL)
Route(s) of administration
Route(s) of administration:
  • 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
Yes
Compliance Check Decision Date
Compliance opinion date
19/06/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100866-PIP01-23-C1

Decision Document

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