MHRA-101315-PIP01-23

Key Facts

Active Substance
  • NIVOLUMAB
  • relatlimab
Invented Name
  • Opdualag
  • Opdualag
  • Opdualag
PIP Number MHRA-101315-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions in the category of malignant neoplasms (except nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms and melanoma)
Route(s) of administration
  • Subcutaneous use
  • INTRAVENOUS USE
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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 03/10/2024