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AusPAR: Dapagliflozin

Australian Public Assessment Report

AusPAR

AusPAR: Dapagliflozin [PDF, 599 KB]

AusPAR: Dapagliflozin [Word, 597.43 KB]

Attachment 1: Product Information for Dapagliflozin [PDF, 845.55 KB]

Attachment 1: Product Information for Dapagliflozin [Word, 740.67 KB]

Device/Product Name

Forxiga

Active ingredients

Dapagliflozin

AusPAR Date

6 April 2021

Published

21 April 2021

Submission Number

PM-2019-05370-1-3

Submission Type

Extension of indications

Decision

Approved