MHRA-101630-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LISOCABTAGENE MARALEUCEL
Invented Name
  • Breyanzi
  • Breyanzi
  • Breyanzi
  • Breyanzi
PIP Number MHRA-101630-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of B-lymphoblastic leukaemia/lymphoma
  • Treatment of mature B-cell neoplasm
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):LISOCABTAGENE MARALEUCEL.pdf
Published Date 28/10/2024