EMEA-002476-PIP03-24 - paediatric investigation plan

letetresgene autoleucel

Key facts

• Active substance:
  letetresgene autoleucel
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0401/2024
• PIP number:
  EMEA-002476-PIP03-24
• 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:
  03/01/2025
• Compliance check done:
  Nei

Decision

P/0401/2024 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for letetresgene autoleucel (EMEA-002476-PIP03-24)

Adopted Reference Number: EMA/581771/2024