AusPAR: Esketamine hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Esketamine hydrochloride [PDF, 604.42 KB]

AusPAR: Esketamine hydrochloride [Word, 487.26 KB]

Attachment 1: Product Information for Esketamine hydrochloride [PDF, 455.42 KB]

Attachment 1: Product Information for Esketamine hydrochloride [Word, 391.62 KB]

Device/Product Name

Spravato

Active ingredients

Esketamine hydrochloride

AusPAR Date

7 May 2021

Published

24 May 2021

Submission Number

PM-2018-04814-1-1

Submission Type

New chemical entity

Decision

Approved