XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack

Roche Products Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 4c1cf49b9a4ebade
Product Name: XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack
Artg Id: 388092
Artg Name: XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack
Sponsor: Roche Products Pty Ltd
Company Detail Path: /organization/roche-products-pty-ltd
Artg Date: 2023-05-02
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-2023-CMI-02173-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-01260-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

4c1cf49b9a4ebade

Type

Standard