Approval · Notice of Compliance 25685 · 2021
AVALIDE: Notice of Compliance 25685
Issued April 16, 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.
- Notice number
- 25685
- Date
- April 16, 2021
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the product monograph with new safety information of choroidal effusion (related to hydrochlorothiazide) and anemia (related to irbesartan)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVALIDE | Not yet assigned | — |
Medicinal ingredients
- HYDROCHLOROTHIAZIDE 12.5 MG per TAB
- IRBESARTAN 150 MG per TAB
- IRBESARTAN 300 MG per TAB