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XOFLUZA baloxavir marboxil 20 mg film-coated tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
XOFLUZA baloxavir marboxil 20 mg film-coated tablet blister pack
Approved
STANDARD
XOFLUZA baloxavir marboxil 20 mg film-coated tablet blister pack
Roche Products Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
ed1ba7d72451957d
Company
Roche Products Pty Ltd
Type
Standard
Approval Details
Approval Id
ed1ba7d72451957d
Product Name
XOFLUZA baloxavir marboxil 20 mg film-coated tablet blister pack
Artg Id
317240
Artg Name
XOFLUZA baloxavir marboxil 20 mg film-coated tablet blister pack
Sponsor
Roche Products Pty Ltd
Company Detail Path
/organization/roche-products-pty-ltd
Artg Date
2020-02-21
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
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
ed1ba7d72451957d
Type
Standard
Back to TGA Approvals