AusPAR: Libtayo

Australian Public Assessment Report

AusPAR

AusPAR: Libtayo [PDF, 711.7 KB]

AusPAR: Libtayo [Word, 934.67 KB]

AusPAR Attachment 1: Product Information for Libtayo [PDF, 529.4 KB]

AusPAR Attachment 1: Product Information for Libtayo [Word, 387.67 KB]

Device/Product Name

Libtayo

Active ingredients

Cemiplimab

AusPAR Date

23 August 2022

Published

11 October 2022

Submission Number

PM-2021-03735-1-4

Submission Type

Extension of indications

Decision

Locally advanced basal cell carcinoma (BCC) indications approved.
Metastatic basal cell carcinoma (mBCC) indication approved for provisional registration.

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AusPAR: Libtayo

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