EMEA-002881-PIP01-20-M01 - paediatric investigation plan

Evoncabtagene pazurgedleucel

Key facts

• Active substance:
  Evoncabtagene pazurgedleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0016/2023
• PIP number:
  EMEA-002881-PIP01-20-M01
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  • Treatment of B-lymphoblastic leukaemia/lymphoma
  • 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:
  31/01/2023
• Compliance check done:
  No

Decision

P/0016/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for evoncabtagene pazurgedleucel (EMEA-002881-PIP01-20-M01)

Adopted Reference Number: EMA/18982/2023