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AusPAR: Apremilast

Australian Public Assessment Report

AusPAR

AusPAR: Apremilast [PDF, 2.29 MB]

AusPAR: Apremilast [Word, 6.05 MB]

Attachment: Product Information: Apremilast [PDF, 409.51 KB]

Attachment: Product Information: Apremilast [Word, 128.62 KB]

Attachment: Extract from Clinical Evaluation Report: Apremilast [PDF, 5.69 MB]

Attachment: Extract from Clinical Evaluation Report: Apremilast [Word, 3.44 MB]

Device/Product Name

Otezla

Active ingredients

Apremilast

AusPAR Date

22 October 2015

Published

25 November 2015

Submission Number

PM-2013-04920-1-3

Submission Type

New chemical entity

Decision

Approved