MHRA-100268-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • INOTUZUMAB OZOGAMICIN
Invented Name
  • Besponsa
  • Besponsa
PIP Number MHRA-100268-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of B cell 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
09/04/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100268-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):INOTUZUMAB OZOGAMICIN.pdf
Published Date 14/04/2026