Is Nivolumab + Relatlimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Nivolumab + Relatlimab, including OPDUALAG (Prescription).

Is Nivolumab + Relatlimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nivolumab + Relatlimab: Opdualag.

Active substances

Nivolumab + Relatlimab

US FDA 1
EMA 1
Health Canada 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OPDUALAG	240MG;80MG	solution · intravenous	BRISTOL MYERS SQUIBB	Prescription	18 Mar 2022

EMA European Union — centrally authorised medicines

Opdualag Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 15 Sep 2022 · ATC L01FY02

Therapeutic indication (EMA)

Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OPDUALAG	02541416	240 MG / 20 ML; 80 MG / 20 ML	SOLUTION · INTRAVENOUS	BRISTOL-MYERS SQUIBB CANADA

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.