EMEA-003009-PIP01-21-M01 - paediatric investigation plan

zamtocabtagene autoleucel

Key facts

• Active substance:
  zamtocabtagene autoleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0335/2024
• PIP number:
  EMEA-003009-PIP01-21-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:
  13/09/2024
• Compliance check done:
  No

Decision

P/0335/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for zamtocabtagene autoleucel, (EMEA-003009-PIP01-21-M01)

Adopted Reference Number: EMA/414032/2024