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AusPAR: Afatinib (as dimaleate)

Australian Public Assessment Report

AusPAR

AusPAR: Afatinib (as dimaleate) [PDF, 1.86 MB]

AusPAR: Afatinib (as dimaleate) [Word, 2.09 MB]

Attachment: Product Information: Afatinib (as dimaleate) [PDF, 222.35 KB]

Attachment: Product Information: Afatinib (as dimaleate) [Word, 181.19 KB]

Attachment: Extract from the Clinical Evaluation Report: Afatinib (as dimaleate) [PDF, 3.89 MB]

Attachment: Extract from the Clinical Evaluation Report: Afatinib (as dimaleate) [Word, 6.94 MB]

Device/Product Name

Giotrif

Active ingredients

Afatinib (as dimaleate)

AusPAR Date

14 April 2014

Published

1 June 2014

Submission Number

PM-2012-02708-3-4

Submission Type

New chemical entity

Decision

Approved