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AusPAR: Denosumab

Australian Public Assessment Report

AusPAR

AusPAR: Denosumab [PDF, 759.52 KB]

AusPAR: Denosumab [Word, 1.13 MB]

Attachment: Product Information:Denosumab [PDF, 289.61 KB]

Attachment: Product Information: Denosumab [Word, 194.64 KB]

Attachment: Extract from Clinical Evaluation Report: Denosumab [PDF, 2.23 MB]

Attachment: Extract from Clinical Evaluation Report: Denosumab [Word, 3.94 MB]

Device/Product Name

Prolia

Active ingredients

Denosumab

AusPAR Date

28 January 2014

Published

31 March 2014

Submission Number

PM-2012-02302-3-5

Submission Type

Extension of indications

Decision

Approved