TGA Approval

XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack (388092)

ARTG ID

388092

ARTG Name

XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack

Sponsor

Roche Products Pty Ltd

ARTG Date

May 2, 2023

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

ROCHE PRODUCTS PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-02173-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-01260-1

Ingredient Name

baloxavir marboxil

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XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack (388092) - TGA 批准文号 | MedPath