AusPAR: Sacubitril / Valsartan salt complex

Australian Public Assessment Report

AusPAR

AusPAR: Sacubitril / Valsartan salt complex [PDF, 4.42 MB]

AusPAR: Sacubitril / Valsartan salt complex [Word, 2.63 MB]

Attachment: Product Information: Sacubitril / Valsartan salt complex [PDF, 527.82 KB]

Attachment: Product Information: Sacubitril / Valsartan salt complex [Word, 1.05 MB]

Attachment: Extract from Clinical Evaluation Report: Sacubitril / Valsartan salt complex [PDF, 2.12 MB]

Attachment: Extract from Clinical Evaluation Report: Sacubitril / Valsartan salt complex [Word, 8.12 MB]

Device/Product Name

Entresto / Novartis sacubitril/valsartan

Active ingredients

Sacubitril / Valsartan salt complex

AusPAR Date

23 September 2016

Published

13 October 2016

Submission Number

PM-2015-00001-1-3

Submission Type

New combination product

Decision

Approved