AusPAR: Ultomiris

Australian Public Assessment Report

AusPAR

AusPAR: Ultomiris [PDF, 2.38 MB]

AusPAR: Ultomiris [Word, 3.99 MB]

AusPAR Attachment 1: Product Information for Ultomiris [PDF, 731.49 KB]

AusPAR Attachment 1: Product Information for Ultomiris [Word, 441.96 KB]

AusPAR Attachment 2: Product Information for Ultomiris [PDF, 735.4 KB]

AusPAR Attachment 2: Product Information for Ultomiris [Word, 440.88 KB]

Device/Product Name

Ultomiris

Active ingredients

Ravulizumab

AusPAR Date

22 May 2023

Published

5 June 2023

Submission Number

PM-2021-01659-1-6

Submission Type

Extension of indications

Decision

Approved