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OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial - TGA Drug Approval Details
Approvals
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TGA
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OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial
Approved
STANDARD
OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial
Bristol-Myers Squibb Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
f05c8bd07262f34c
Company
Bristol-Myers Squibb Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
f05c8bd07262f34c
Product Name
OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial
Artg Id
231868
Artg Name
OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial
Sponsor
Bristol-Myers Squibb Australia Pty Ltd
Company Detail Path
/organization/bristol-myers-squibb-australia-pty-ltd
Artg Date
2016-01-11
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/175f44938771b8606c7d26bc3424affa.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/c9ea720ec86d6f810533595273c82b5b.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
f05c8bd07262f34c
Type
Standard
Back to TGA Approvals