AusPAR: Saxagliptin (as hydrochloride)

Australian Public Assessment Report

AusPAR

AusPAR: Saxagliptin (as hydrochloride) [PDF, 600.33 KB]

AusPAR: Saxagliptin (as hydrochloride) [Word, 711.27 KB]

Attachment: Product Information: Saxagliptin (as hydrochloride) [PDF, 412.5 KB]

Attachment: Product Information: Saxagliptin (as hydrochloride) [Word, 257.91 KB]

Attachment: Extract from Clinical Evaluation Report: Saxagliptin (as hydrochloride) [PDF, 529.35 KB]

Attachment: Extract from Clinical Evaluation Report: Saxagliptin (as hydrochloride) [Word, 479.12 KB]

Device/Product Name

Onglyza

Active ingredients

Saxagliptin (as hydrochloride)

AusPAR Date

13 March 2013

Published

29 July 2013

Submission Number

PM-2011-01174-3-5

Submission Type

Extension of indications

Decision

Approved