OPDIVO 600 mg solution for injection
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 09 December 2025
File name
i.e-pil-opdivo-sc-clean (27Nov25).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
27Nov2025: Addition of first-line HCC indication and Perioperative NSCLC indication.
Updated on 08 December 2025
File name
i.e-pil-opdivo-sc-clean (27Nov25).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
27Nov2025: Addition of first-line HCC indication and Perioperative NSCLC indication to the Opdivo Subcutaneous PIL
Updated on 08 December 2025
File name
i.e-smpc-opdivo-sc-clean (27Nov25).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
27Nov2025: Addition of first-line HCC indication and Perioperative NSCLC indication to section 4.1 of the SmPC. Section 4.2 was also updated to reorganise the dosing information for improved readability
Updated on 29 October 2025
File name
i.e-smpc-opdivo-sc-clean (09Oct25).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
09 Oct 2025: For the Study CA20976K an additional RFS descriptive analysis (minimum follow-up 26.9 months) has been included.
Updated on 22 October 2025
File name
i.e-smpc-opdivo-clean (09Oct25).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
09 October 2025: For the Study CA20976K an additional RFS descriptive analysis (minimum follow-up 26.9 months) has been included in section 5.1 of the SmPC
File name
1506-GB-2200414_BMS Opdivo Alert Card.pdf
Reasons for updating
- Add New Doc
Updated on 22 August 2025
File name
i.e-pil - opdivo-sc - clean (26May25).pdf
Reasons for updating
- New PIL for new product
Updated on 22 August 2025
File name
i.e-smpc-opdivo-sc - clean (26May25).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Bristol-Myers Squibb Pharma EEIG
Address:
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, IrelandMedical Information E-mail:
medical.information@bms.comTelephone:
+353 1 483 3625Medical Information Direct Line:
Freephone 1 800 749 749Stock Availability:
bmscustomer-service.chester@bms.com