EMEA-001407-PIP01-12-M03 - paediatric investigation plan

nivolumab

Key facts

• Invented name:
  Opdivo
• Active substance:
  nivolumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0432/2020
• PIP number:
  EMEA-001407-PIP01-12-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/11/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001407-PIP01-12-M03
• Compliance opinion date:
  21/01/2022
• Compliance outcome:
  Positive

Decision

P/0432/2020 : EMA decision of 5 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo) (EMEA-001407-PIP01-12-M03)

Adopted Reference Number: EMA/576787/2020