Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.

AusPAR: Trifluridine / Tipiracil

Australian Public Assessment Report

AusPAR

AusPAR: Trifluridine/tipiracil [PDF, 923.82 KB]

AusPAR: Trifluridine/tipiracil [Word, 734.78 KB]

Attachment: Product Information: Orcantas [PDF, 324.43 KB]

Attachment: Product Information: Orcantas [Word, 364.93 KB]

Attachment: Product Information: Lonsurf [PDF, 321.69 KB]

Attachment: Product Information: Lonsurf [Word, 319.96 KB]

Attachment: Extract from Clinical Evaluation Report: Trufluridine / Tipiracil [PDF, 2.69 MB]

Attachment: Extract from Clinical Evaluation Report: Trufluridine / Tipiracil [Word, 3.04 MB]

Device/Product Name

Lonsurf and Orcantas

Active ingredients

Trifluridine / Tipiracil

AusPAR Date

12 June 2018

Published

15 June 2018

Submission Number

PM-2016-00929-1-4

Submission Type

New chemical entity

Decision

Approved