EMEA-001654-PIP02-17-M01 - paediatric investigation plan

tisagenlecleucel

Key facts

• Invented name:
  Kymriah
• Active substance:
  tisagenlecleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0323/2019
• PIP number:
  EMEA-001654-PIP02-17-M01
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/09/2019
• Compliance check done:
  Jah
• Compliance procedure number:
  EMEA-C-001654-PIP02-17-M01
• Compliance opinion date:
  24/06/2022
• Compliance outcome:
  Positive

Decision

P/0323/2019: EMA decision of 11 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for tisagenlecleucel (Kymriah), (EMEA-001654-PIP02-17-M01)

Adopted Reference Number: EMA/474719/2019