Approval · Notice of Compliance 30578 · 2023
LIBTAYO: Notice of Compliance 30578
Issued April 27, 2023
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
- 30578
- Date
- April 27, 2023
- 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 Indication: LIBTAYO (cemiplimab for injection) is indicated in combination with platinum-based chemotherapy for the first-line treatment of adult patients with NSCLC whose tumors have no EGFR, ALK or ROS1 aberrations and is: - locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or - metastatic NSCLC.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LIBTAYO | Not yet assigned | — |
Medicinal ingredients
- CEMIPLIMAB 250 MG per 5ML
- CEMIPLIMAB 350 MG per 7ML