EMEA-002867-PIP01-20 - paediatric investigation plan

afamitresgene autoleucel

Key facts

• Active substance:
  afamitresgene autoleucel
• Therapeutic area:
  Oncology
• Decision number:
  P/0323/2021
• PIP number:
  EMEA-002867-PIP01-20
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of soft tissue sarcoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/08/2021
• Compliance check done:
  No

Decision

P/0323/2021 : EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for afamitresgene autoleucel (EMEA-002867-PIP01-20)

Adopted Reference Number: EMA/382523/2021