AusPAR: Ozanimod hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Ozanimod hydrochloride [PDF, 401.08 KB]

AusPAR: Ozanimod hydrochloride [Word, 395.81 KB]

Attachment: Product Information for Ozanimod hydrochloride [PDF, 289.84 KB]

Attachment: Product Information for Ozanimod hydrochloride [Word, 191.14 KB]

Device/Product Name

Zeposia

Active ingredients

Ozanimod hydrochloride

AusPAR Date

25 November 2020

Published

2 December 2020

Submission Number

PM-2019-02397-1-1

Submission Type

New chemical entity

Decision

Approved