The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
AusPAR: Libtayo
Australian Public Assessment Report
Device/Product Name
Libtayo
Active ingredients
Cemiplimab
AusPAR Date
Published
Sponsor
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.
Metastatic basal cell carcinoma (mBCC) indication approved for provisional registration.