Approvals/TGA/OCREVUS ocrelizumab 300 mg/10 mL concentrate solution for infusion vial

Approved

STANDARD

OCREVUS ocrelizumab 300 mg/10 mL concentrate solution for infusion vial

Roche Products Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 4128ed2fcd2859d9
Product Name: OCREVUS ocrelizumab 300 mg/10 mL concentrate solution for infusion vial
Artg Id: 275778
Artg Name: OCREVUS ocrelizumab 300 mg/10 mL concentrate solution for infusion vial
Sponsor: Roche Products Pty Ltd
Company Detail Path: /organization/roche-products-pty-ltd
Artg Date: 2017-07-13
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-CMI-02092-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2017-PI-02089-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

4128ed2fcd2859d9

Type

Standard