We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.

AusPAR: Trametinib and Dabrafenib

Australian Public Assessment Report

AusPAR

AusPAR: Trametinib and Dabrafenib [PDF, 2.08 MB]

AusPAR: Trametinib and Dabrafenib [Word, 5.69 MB]

Attachment: Product Information: Trametinib [PDF, 585 KB]

Attachment: Product Information: Trametinib [Word, 583.46 KB]

Attachment: Product Information: Dabrafenib [PDF, 650.81 KB]

Attachment: Product Information: Dabrafenib [Word, 417.73 KB]

Device/Product Name

Mekinist and Tafinlar

Active ingredients

Trametinib and Dabrafenib

AusPAR Date

8 November 2018

Published

21 January 2019

Submission Number

PM-2017-04434-1-4 and PM-2017-04435-1-4

Submission Type

Extension of indications

Decision

Approved

Australian Public Assessment Report for Trametinib and Dabrafenib

Topics

Prescription medicines