AusPAR: Omalizumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR Omalizumab (rch) [PDF, 1.28 MB]

AusPAR Omalizumab (rch) [Word, 3.07 MB]

Attachment: Product Information: Omalizumab (rch) [PDF, 616.95 KB]

Attachment: Product Information: Omalizumab (rch) [Word, 851.56 KB]

Attachment: Extract from Clinical Evaluation Report: Omalizumab (rch) [PDF, 2.29 MB]

Attachment: Extract from Clinical Evaluation Report: Omalizumab (rch) [Word, 3.57 MB]

Device/Product Name

Xolair

Active ingredients

Omalizumab (rch)

AusPAR Date

22 June 2016

Published

27 June 2016

Submission Number

PM-2014-03868-1-5

Submission Type

Extension of indications

Decision

Approved