AusPAR: Gilteritinib (as fumarate)

Australian Public Assessment Report

AusPAR

AusPAR: Gilteritinib (as fumarate) [PDF, 625.55 KB]

AusPAR: Gilteritinib (as fumarate) [Word, 852.19 KB]

Attachment: Product Information Gilteritinib (as fumarate) [PDF, 253.37 KB]

Attachment: Product Information Gilteritinib (as fumarate) [Word, 103.23 KB]

Device/Product Name

Xospata

Active ingredients

Gilteritinib (as fumarate)

AusPAR Date

8 September 2020

Published

11 September 2020

Submission Number

PM-2019-03406-1-6

Submission Type

New chemical entity

Decision

Approved