relatlimab / nivolumab

This medicine is authorised for use in the European Union.


Opdualag is a medicine used as a first-line treatment for melanoma (a type of skin cancer) that has spread or cannot be surgically removed. It is used for patients from 12 years of age whose cancer cells produce a low level (<1%) of a protein called PD-L1.

Opdualag contains the active substances nivolumab and relatlimab.

This EPAR was last updated on 17/10/2022

Authorisation details

Product details
Agency product number
Active substance
  • nivolumab
  • Relatlimab
International non-proprietary name (INN) or common name
relatlimab / nivolumab
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867

Product information

Opdualag - EMEA/H/C/005481 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Antineoplastic agents

  • Monoclonal antibodies

Therapeutic 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%.

Assessment history

How useful was this page?

Add your rating
1 rating