Approval · Notice of Compliance 592 · 2002
AVAPRO: Notice of Compliance 592
Issued November 5, 2002
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
- 592
- Date
- November 5, 2002
- Company
- Sanofi-Synthelabo Canada Inc.Laval, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: treatment of hypertensive patients with type 2 diabetes mellitus and renal disease to reduce the rate of progression of nephropathy
- Therapeutic class
- Angiotensin ii at1 receptor blocker
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVAPRO | Not yet assigned | — |
Medicinal ingredients
- IRBESARTAN 75 MG per TAB
- IRBESARTAN 150 MG per TAB
- IRBESARTAN 300 MG per TAB