AusPAR: Denosumab

Australian Public Assessment Report

AusPAR

AusPAR: Denosumab [PDF, 2.05 MB]

AusPAR: Denosumab [Word, 8.42 MB]

Attachment: Product Information: Denosumab [PDF, 963.54 KB]

Attachment: Product Information: Denosumab [Word, 819.52 KB]

Attachment: Extract from Clinical Evaluation Report: Denosumab [PDF, 373.07 KB]

Attachment: Extract from Clinical Evaluation Report: Denosumab [Word, 373.61 KB]

Device/Product Name

Xgeva

Active ingredients

Denosumab

AusPAR Date

17 April 2014

Published

20 June 2014

Submission Number

PM-2012-04329-1-4

Submission Type

Extension of indications

Decision

Approved