EMEA-001407-PIP02-15-M06 - paediatric investigation plan

nivolumab

Key facts

• Invented name:
  Opdivo
• Active Substance:
  nivolumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0339/2023
• PIP number:
  EMEA-001407-PIP02-15-M06
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of malignant neoplasms of lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/08/2023

Decision

P/0339/2023 : EMA decision of 17 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo) (EMEA-001407-PIP02-15-M06)

Reference Number: EMA/369956/2023