OPDIVO 300 mg and 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 22 April 2026
File name
i.e-smpc-opdivo-sc-clean (20Apr26).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
20-Apr-2026: Addition of the 300 mg vial strength. This update also introduces new solid tumour indications with 900 mg, every 3 weeks dosing regimen
File name
UKIE Opdivo Patient Card_Apr 26.pdf
Reasons for updating
- Replace File
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