EMEA-001654-PIP01-14-M04 - paediatric investigation plan

tisagenlecleucel

Key facts

• Invented name:
  • Kymriah
  • Kymriah
• Active substance:
  tisagenlecleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0215/2022
• PIP number:
  EMEA-001654-PIP01-14-M04
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2022
• Compliance check done:
  Non

Decision

P/0215/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tisagenlecleucel (Kymriah), (EMEA-001654-PIP01-14-M04)

Adopted Reference Number: EMA/366055/2022