EMEA-002010-PIP01-16-M03 - paediatric investigation plan

axicabtagene ciloleucel

Key facts

• Invented name:
  Yescarta
• Active substance:
  axicabtagene ciloleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0114/2022
• PIP number:
  EMEA-002010-PIP01-16-M03
• 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:
  13/04/2022
• Compliance check done:
  Nie

Decision

P/0114/2022 - Decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for axicabtagene ciloleucel (Yescarta), (EMEA-002010-PIP01-16-M03)

Adopted Reference Number: P/0114/2022