AusPAR: Denosumab

Australian Public Assessment Report

AusPAR

AusPAR: Denosumab [PDF, 1.87 MB]

AusPAR: Denosumab [Word, 3.39 MB]

Attachment: Product Information: Denosumab [PDF, 394.9 KB]

Attachment: Product Information: Denosumab [Word, 553.78 KB]

Device/Product Name

Prolia

Active ingredients

Denosumab

AusPAR Date

13 February 2019

Published

12 August 2019

Submission Number

PM-2017-01353-1-5

Submission Type

Major variation; extension of indications

Decision

Approved