MHRA-100494-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • NIVOLUMAB
Invented Name
  • OPDIVO
  • OPDIVO
  • OPDIVO
  • OPDIVO
PIP Number MHRA-100494-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of malignant neoplasms of lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
15/08/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100494-PIP01-22-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):NIVOLUMAB.pdf
Published Date 01/05/2026