Approval · Notice of Compliance 27799 · 2022
LIBTAYO: Notice of Compliance 27799
Issued March 23, 2022
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
- 27799
- Date
- March 23, 2022
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: Cervical Cancer Libtayo (cemiplimab for injection) is indicated for: the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LIBTAYO | Not yet assigned | — |
Medicinal ingredients
- CEMIPLIMAB 2,500 MG per 5ML
- CEMIPLIMAB 350 MG per 7ML