AusPAR: Sodium phenylbutyrate

Australian Public Assessment Report

AusPAR

AusPAR: Sodium phenylbutyrate [PDF, 1.13 MB]

AusPAR: Sodium phenylbutyrate [Word, 2.23 MB]

Attachment: Product Information: Sodium phenylbutyrate [PDF, 231.15 KB]

Attachment: Product Information: Sodium phenylbutyrate [Word, 119.06 KB]

Attachment: Extract from Clinical Evaluation Report Sodium phenylbutyrate [PDF, 2.15 MB]

Attachment: Extract from Clinical Evaluation Report Sodium phenylbutyrate [Word, 9.02 MB]

Device/Product Name

Pheburane

Active ingredients

Sodium phenylbutyrate

AusPAR Date

23 January 2018

Published

1 February 2018

Submission Number

PM-2016-00417-1-3

Submission Type

New chemical entity

Decision

Approved