Approval · Notice of Compliance 26919 · 2021
LIBTAYO: Notice of Compliance 26919
Issued October 26, 2021
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 26919
- Date
- October 26, 2021
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications: Non-Small Cell Lung Cancer LIBTAYO (cemiplimab for injection) is indicated for: the first-line treatment of adult patients with nonsmall cell lung cancer (NSCLC) expressing PD-L1 in ¿ 50% of tumour cells (Tumour Proportion Score [TPS] ¿ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have: - locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or - metastatic NSCLC. Basal Cell Carcinoma LIBTAYO (cemiplimab for injection) is indicated for: the treatment of patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LIBTAYO | Not yet assigned | — |
Medicinal ingredients
- CEMIPLIMAB 250 MG per 5ML
- CEMIPLIMAB 350 MG per 7ML