MHRA-100711-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TISAGENLECLEUCEL
Invented Name
  • Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
  • Kymriah
  • Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
PIP Number MHRA-100711-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma
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):TISAGENLECLEUCEL.pdf
Published Date 25/05/2023