Approval · Notice of Compliance 26447 · 2021
LIBTAYO: Notice of Compliance 26447
Issued August 13, 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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 26447
- Date
- August 13, 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
- Fulfillment of commitment 1 of the Letter of Undertaking dated March 14, 2019 issued under NDS control number 218718
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LIBTAYO | Not yet assigned | — |
Medicinal ingredients
- CEMIPLIMAB 350 MG per 7ML
- CEMIPLIMAB 250 MG per 5ML