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AusPAR: Idelalisib

Australian Public Assessment Report

AusPAR

Australian Public Assessment Report for Idelalisib [PDF, 2.71 MB]

Australian Public Assessment Report for Idelalisib [DOCX, 2.68 MB]

AusPAR Attachment 1: Product Information for Idelalisib [PDF, 251.21 KB]

AusPAR Attachment 1: Product Information for Idelalisib [DOC, 244.5 KB]

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Idelalisib [PDF, 5.9 MB]

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Idelalisib [DOCX, 7.01 MB]

Device/Product Name

Zydelig

Active ingredients

Idelalisib

AusPAR Date

14 July 2015

Published

6 August 2015

Submission Number

PM-2013-04151-1-4

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines