EMEA-002369-PIP01-18-M02 - paediatric investigation plan

idecabtagene vicleucel

Key facts

• Active substance:
  idecabtagene vicleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0068/2021
• PIP number:
  EMEA-002369-PIP01-18-M02
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/02/2021
• Compliance check done:
  No

Decision

P/0068/2021 : EMA decision of 19 February 2021 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for idecabtagene vicleucel (EMEA-002369-PIP01-18-M02)

Adopted Reference Number: EMA/71067/2021