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ROXARELTO rivaroxaban 2.5 mg film-coated tablet bottle - TGA Drug Approval Details

Approvals/TGA/ROXARELTO rivaroxaban 2.5 mg film-coated tablet bottle

Approved

STANDARD

ROXARELTO rivaroxaban 2.5 mg film-coated tablet bottle

Accord Healthcare Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: Dec 9, 2025
Approval ID: f6e7ffbf2f289896
Company: Accord Healthcare Pty Ltd
Type: Standard

Approval Details

Approval Id: f6e7ffbf2f289896
Product Name: ROXARELTO rivaroxaban 2.5 mg film-coated tablet bottle
Artg Id: 333028
Artg Name: ROXARELTO rivaroxaban 2.5 mg film-coated tablet bottle
Sponsor: Accord Healthcare Pty Ltd
Company Detail Path: /organization/accord-healthcare-pty-ltd
Artg Date: 2023-01-31
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

f6e7ffbf2f289896

Type

Standard

Back to TGA Approvals