EMEA-003535-PIP02-24 - paediatric investigation plan

autologous T-cells from a melanoma metastasis (TM001)

Key facts

• Active Substance:
  autologous T-cells from a melanoma metastasis (TM001)
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0201/2024
• PIP number:
  EMEA-003535-PIP02-24
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2024

Decision

P/0201/2024: EMA decision of 14 June 2024 on the refusal of a paediatric investigation plan and on the granting of a waiver for autologous T-cells from a melanoma metastasis (TM001) (EMEA-003535-PIP02-24)