AusPAR: Saxagliptin / Metformin hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Saxagliptin / metformin hydrochloride [PDF, 696.52 KB]

AusPAR: Saxagliptin / metformin hydrochloride [Word, 3.19 MB]

Attachment: Product Information: Metformin hydrochloride / Saxagliptin [PDF, 333.74 KB]

Attachment: Product Information: Metformin hydrochloride / Saxagliptin [Word, 123.1 KB]

Attachment: Extract from Clinical Evaluation Report: Metformin hydrochloride / Saxagliptin [PDF, 844.01 KB]

Attachment: Extract from Clinical Evaluation Report: Metformin hydrochloride / Saxagliptin [Word, 1.45 MB]

Device/Product Name

Kombiglyze

Active ingredients

Saxagliptin / Metformin hydrochloride

AusPAR Date

15 October 2013

Published

20 November 2013

Submission Number

PM-2012-00296-3-5

Submission Type

New fixed dose combination

Decision

Approved