AusPAR: Carglumic acid

Australian Public Assessment Report

AusPAR

AusPAR: Carglumic acid [PDF, 1.01 MB]

AusPAR: Carglumic acid [Word, 1.51 MB]

Attachment: Product Information: Carglumic acid [PDF, 217.55 KB]

Attachment: Product Information: Carglumic acid [Word, 130.77 KB]

Attachment: Extract from Clinical Evaluation Report: Carglumic acid [PDF, 1.62 MB]

Attachment: Extract from Clinical Evaluation Report: Carglumic acid [Word, 3.87 MB]

Device/Product Name

Carbaglu

Active ingredients

Carglumic acid

AusPAR Date

2 September 2015

Published

27 October 2015

Submission Number

PM-2013-02751-1-3

Submission Type

New chemical entity

Decision

Approved