Irish Medicines Database · HPRA register

OPDIVO 300 mg solution for injection

Authorisation EU/1/15/1014/006 · Bristol-Myers Squibb Pharma EEIG

Licence EU/1/15/1014/006 · Unknown

Licence holder: Bristol-Myers Squibb Pharma EEIG (all products →)
Active substance: Nivolumab
Dosage form: Solution for injection
Route of administration: Subcutaneous use
ATC code: L01FF01
First authorised: 20/04/2026
Prescription status: Product subject to prescription which may not be renewed (A)
Supply: Supply through pharmacies only
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.