Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3038543
Name of medicinal product: OPDUALAG
Active substances:
Nivolumab+Relatlimab
Estonian, English, Latin
ATC code: L01FY02
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 240mg+80mg 20ml
Amount in package: 20ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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%
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Bristol-Myers Squibb Pharma EEIG 
Marketing authorization number: EU/1/22/1679 
Marketing authorization issued on: September 15, 2022 
Marketing authorization expires on: September 16, 2027 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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