Approval · Notice of Compliance 33809 · 2024
AURO-EZETIMIBE: Notice of Compliance 33809
Issued August 13, 2024
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
- 33809
- Date
- August 13, 2024
- Company
- Auro Pharma Inc.Woodbridge, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Product Monograph reformatted to the Master Template. Update to Product Monograph (to align with CRP approved PM). Update to package insert
- Canadian reference product
- EZETROL (Merck Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AURO-EZETIMIBE | Not yet assigned | — |
Medicinal ingredients
- EZETIMIBE 10 MG per TAB