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AusPAR: Deoxycholic acid

Australian Public Assessment Report

AusPAR

AusPAR: Deoxycholic acid [PDF, 602.89 KB]

AusPAR: Deoxycholic acid [DOCX, 473.93 KB]

Attachment: Product Information: Deoxycholic acid [PDF, 273.99 KB]

Attachment: Product Information: Deoxycholic acid [DOCX, 218.24 KB]

Attachment: Extract from Clinical Evaluation Report: Deoxycholic acid [PDF, 811.48 KB]

Attachment: Extract from Clinical Evaluation Report: Deoxycholic acid [DOCX, 1.16 MB]

Device/Product Name

Belkyra

Active ingredients

Deoxycholic acid

AusPAR Date

6 April 2017

Published

10 May 2017

Submission Number

PM-2014-04251-1-5

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines