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AusPAR: Omalizumab (rch)

Australian Public Assessment Report

AusPAR

AusPAR: Omalizumab (rch) [PDF, 1.59 MB]

AusPAR: Omalizumab (rch) [Word, 1.86 MB]

Attachment: Product information: Omalizumab (rch) [PDF, 451.62 KB]

Attachment: Product information: Omalizumab (rch) [Word, 837.8 KB]

Attachment: Extract from the Clinical Evaluation Report: Omalizumab (rch) [PDF, 5 MB]

Attachment: Extract from the Clinical Evaluation Report: Omalizumab (rch) [Word, 6.11 MB]

Device/Product Name

Xolair

Active ingredients

Omalizumab (rch)

AusPAR Date

21 July 2015

Published

14 August 2015

Submission Number

PM-2013-03254-1-4

Submission Type

Major variation (extension of indications)

Decision

Approved