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AusPAR: Teriflunomide

Australian Public Assessment Report

AusPAR

AusPAR: Teriflunomide [PDF, 693.19 KB]

AusPAR: Teriflunomide [DOCX, 1.14 MB]

Attachment: Product Information: Teriflunomide [PDF, 302.63 KB]

Attachment: Product Information: Teriflunomide [DOCX, 78.16 KB]

Attachment: Extract from Clinical Evaluation Report: Teriflunomide [PDF, 2.7 MB]

Attachment: Extract from Clinical Evaluation Report: Teriflunomide [DOCX, 5.52 MB]

Device/Product Name

Aubagio / Teriflunomide Winthrop / Teriflunomide Sanofi

Active ingredients

Teriflunomide

AusPAR Date

21 May 2013

Published

9 September 2013

Submission Number

PM-2011-02772-3-1

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines