Approval · Notice of Compliance 22053 · 2019
LIBTAYO: Notice of Compliance 22053
Issued April 10, 2019
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
- 22053
- Date
- April 10, 2019
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- CEMIPLIMAB 250 MG per 5ML
- CEMIPLIMAB 50 MG per ML