Approval · Notice of Compliance 37768 · 2026
LIBTAYO: Notice of Compliance 37768
Issued June 23, 2026
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
- 37768
- Date
- June 23, 2026
- Company
- Regeneron Canada CompanyMississauga, 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 for: the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LIBTAYO | Not yet assigned | — |
Medicinal ingredients
- CEMIPLIMAB 350 MG per 7ML