AusPAR: Saxagliptin / Dapagliflozin

Australian Public Assessment Report

AusPAR

AusPAR: Saxagliptin / Dapagliflozin [PDF, 834.62 KB]

AusPAR: Saxagliptin / Dapagliflozin [Word, 1.5 MB]

Attachment: Product Information: Saxagliptin / Dapagliflozin [PDF, 495.51 KB]

Attachment: Product Information: Saxagliptin / Dapagliflozin [Word, 428.23 KB]

Attachment: Extract from Clinical Evaluation Report: Saxagliptin / Dapagliflozin [PDF, 752.29 KB]

Attachment: Extract from Clinical Evaluation Report: Saxagliptin / Dapagliflozin [Word, 1.16 MB]

Device/Product Name

Qtern

Active ingredients

Saxagliptin / Dapagliflozin

AusPAR Date

6 October 2017

Published

18 October 2017

Submission Number

PM-2015-02415-1-5

Submission Type

New fixed dose combination

Decision

Approved