MHRA-100761-PIP01-22-M01 (update)

Key Facts

Active Substance
  • NIVOLUMAB
  • relatlimab
Invented Name
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
PIP Number MHRA-100761-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of melanoma
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Bristol-Myers Squibb International Corporation
  • Country Belgium
  • Tel 07917595335
  • Email geoffrey.cuss@bms.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):NIVOLUMABrelatlimab.pdf
Published Date 25/05/2023