Approval · Notice of Compliance 8791 · 2007
AVALIDE: Notice of Compliance 8791
Issued May 16, 2007
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
- 8791
- Date
- May 16, 2007
- 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
- New indication: avalide is also indicated as initial therapy in patients with severe essential hypertension for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy in these patients and other revisions to the product monograph
- Therapeutic class
- Angiotensin ii at1 receptor blocker / diuretic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVALIDE | Not yet assigned | — |
Medicinal ingredients
- IRBESARTAN 150 MG per TAB
- HYDROCHLOROTHIAZIDE 12.5 MG per TAB
- IRBESARTAN 300 MG per TAB
- HYDROCHLOROTHIAZIDE 25 MG per TAB