AusPAR: Dimethyl fumarate

Australian Public Assessment Report

AusPAR

AusPAR: Dimethyl fumarate [PDF, 1.4 MB]

AusPAR: Dimethyl fumarate [Word, 2.07 MB]

Attachment: Product Information: Dimethyl fumarate [PDF, 212.92 KB]

Attachment: Product Information: Dimethyl fumarate [Word, 88.78 KB]

Attachment: Extract from Clinical Evaluation Report: Diemthyl fumarate [PDF, 4.18 MB]

Attachment: Extract from Clinical Evaluation Report: Diemthyl fumarate [Word, 8.01 MB]

Device/Product Name

Tecfidera

Active ingredients

Dimethyl fumarate

AusPAR Date

22 October 2013

Published

20 November 2013

Submission Number

PM-2012-00808-3-1

Submission Type

New chemical entity

Decision

Approved