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AusPAR: Alectinib hydrochloride

Australian Public Assessment Report

AusPAR

AusPAR: Alectinic hydrochloride [PDF, 1.33 MB]

AusPAR: Alectinic hydrochloride [DOCX, 2.01 MB]

Attachment: Product Information: Alectinic hydrochloride [PDF, 243.24 KB]

Attachment: Product Information: Alectinic hydrochloride [DOCX, 104.39 KB]

Attachment: Extract from the Clinical Evaluation Report: Alectinic hydrochloride [PDF, 4.2 MB]

Attachment: Extract from the Clinical Evaluation Report: Alectinic hydrochloride [DOCX, 13.3 MB]

Device/Product Name

Alecensa

Active ingredients

Alectinib hydrochloride

AusPAR Date

27 November 2017

Published

5 December 2017

Submission Number

PM-2015-04677-1-4

Submission Type

New chemical entity

Decision

Approved

Product types

Prescription medicines