Opdualag 240 mg/80 mg concentrate for solution for infusion
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 16 June 2026
File name
Opdualag - SJS TEN - clean - IE PIL 11Jun26.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PI update to include SJS and TEN.
Updated on 16 June 2026
File name
Opdualag - SJS TEN - clean - IE SmPC 11Jun26.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
PI update to include SJS and TEN.
Updated on 06 May 2026
File name
Opdualag - IE PIL 23Apr2026.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update to section 4 - possible side effects
Updated on 06 May 2026
File name
Opdualag - IE SmPC 23Apr2026.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Update to section 4.8 and 5.1 to include CA224-047 5 year OS data.
Updated on 16 February 2026
File name
Opdualag-ie-tmos-pil-clean-12feb2026.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 February 2026
File name
Opdualag-ie-tmos-pil-clean-12feb2026.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 February 2026
File name
Opdualag-ie-tmos-smpc-clean-12feb2026.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
1425-GB-2500014 Opdualag UK+IRE Patient Card_v4_WM.pdf
Reasons for updating
- Replace File
File name
1425-GB-2500017 Ireland Opdualag HCP Letter_v4-SIGNED.pdf
Reasons for updating
- Add New Doc
File name
1425-GB-2500014 Opdualag UK+IRE Patient Card_v4_WM.pdf
Reasons for updating
- Add New Doc
Updated on 01 August 2025
File name
opdualag-pil-17Jul2025.pdf
Reasons for updating
- New PIL for new product
Updated on 01 August 2025
File name
opdualag-smpc-17Jul2025.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