EMEA-001407-PIP02-15-M05 - paediatric investigation plan

nivolumab

Key facts

• Invented name:
  Opdivo
• Active Substance:
  nivolumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0237/2021
• PIP number:
  EMEA-001407-PIP02-15-M05
• 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
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2021

Decision

P/0237/2021 : EMA decision of 14 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo) (EMEA-001407-PIP02-15-M05)

AdoptedReference Number: EMA/318795/2021