Approvals/TGA/XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack

Approved

STANDARD

XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack

Astellas Pharma Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 817c314f50e4bed7
Product Name: XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack
Artg Id: 321060
Artg Name: XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack
Sponsor: Astellas Pharma Australia Pty Ltd
Company Detail Path: /organization/astellas-pharma-australia-pty-ltd
Artg Date: 2020-04-02
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/8a1687b8192865c43d3c51cdb860e674.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/cd8716a8c4f5c13e653ca0289fde3321.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

817c314f50e4bed7

Type

Standard