EMEA-003207-PIP01-22 - paediatric investigation plan

Fianlimab

Key facts

• Active substance:
  Fianlimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0045/2023
• PIP number:
  EMEA-003207-PIP01-22
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of melanoma
• 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:
  31/01/2023
• Compliance check done:
  No

Decision

P/0045/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fianlimab (EMEA-003207-PIP01-22)

Adopted Reference Number: EMA/34193/2023