AusPAR: Dabrafenib mesilate

Australian Public Assessment Report

AusPAR

AusPAR: Dabrafenib mesilate [PDF, 956.27 KB]

AusPAR: Dabrafenib mesilate [Word, 1.33 MB]

Attachment: Product Information: Dabrafenib mesilate [PDF, 270.5 KB]

Attachment: Product Information: Dabrafenib mesilate [Word, 261 KB]

Attachment: Extract from Clinical Evaluation Report: Dabrafenib mesilate [PDF, 1.27 MB]

Attachment: Extract from Clinical Evaluation Report: Dabrafenib mesilate [Word, 2.47 MB]

Device/Product Name

Tafinlar

Active ingredients

Dabrafenib mesilate

AusPAR Date

9 January 2014

Published

13 January 2014

Submission Number

PM-2012-02231-3-4

Submission Type

New chemical entity

Decision

Approved