Opdualag (relatlimab;nivolumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- relatlimab;nivolumab
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Melanoma
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Thu 15 Sep 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005481
- ATC
- L01FY02
- Official record
- www.ema.europa.eu
Indication
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%.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.