AusPAR: Cemiplimab

Australian Public Assessment Report

AusPAR

AusPAR: Cemiplimab [PDF, 750.33 KB]

AusPAR: Cemiplimab [Word, 1.94 MB]

Attachment: Product Information for Cemiplimab [PDF, 257.73 KB]

Attachment: Product Information for Cemiplimab [Word, 70.64 KB]

Device/Product Name

Libtayo

Active ingredients

Cemiplimab

AusPAR Date

2 November 2020

Published

9 November 2020

Submission Number

PM-2019-03270-1-4

Submission Type

New biological entity

Decision

Approved for provisional registration