EMEA-002776-PIP01-20-M02 - paediatric investigation plan

autologous tumour-infiltrating lymphocytes (LN-144/LN-145)

Key facts

• Active substance:
  autologous tumour-infiltrating lymphocytes (LN-144/LN-145)
• Therapeutic area:
  Oncology
• Decision number:
  P/0440/2023
• PIP number:
  EMEA-002776-PIP01-20-M02
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  Non

Decision

P/0440/2023 : EMA decision of 27 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for autologous tumour-infiltrating lymphocytes (LN-144/LN-145) (EMEA-002776-PIP01-20-M02)

Adopted Reference Number: EMA/401495/2023