EMEA-001995-PIP01-16-M04 - paediatric investigation plan

lisocabtagene maraleucel

Key facts

• Invented name:
  Breyanzi
• Active substance:
  lisocabtagene maraleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0448/2023
• PIP number:
  EMEA-001995-PIP01-16-M04
• Pharmaceutical form(s):
  Dispersion for infusion
• 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:
  27/10/2023
• Compliance check done:
  Όχι

Decision

EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for lisocabtagene maraleucel (Breyanzi), (EMEA-001995-PIP01-16-M04)

Adopted Reference Number: EMA/479827/2023