Approvals/TGA/OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial

Approved

STANDARD

OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial

Bristol-Myers Squibb Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 2cc143c29fae4a4e
Product Name: OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial
Artg Id: 318057
Artg Name: OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial
Sponsor: Bristol-Myers Squibb Australia Pty Ltd
Company Detail Path: /organization/bristol-myers-squibb-australia-pty-ltd
Artg Date: 2020-04-09
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2016-PI-01052-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

2cc143c29fae4a4e

Type

Standard