Approval · Notice of Compliance 5548 · 2004
HYZAAR: Notice of Compliance 5548
Issued October 7, 2004
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
- 5548
- Date
- October 7, 2004
- Company
- Merck Frosst Canada & Cie, Merck Frosst Canada & Co.Kirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indication for the treatment of essential hypertension
- Therapeutic class
- Angiotensin II receptor antagonist & diuretic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYZAAR | Not yet assigned | — |
| HYZAAR DS | Not yet assigned | — |
Medicinal ingredients
- LOSARTAN POTASSIUM 50 MG per TAB
- HYDROCHLOROTHIAZIDE 12.5 MG per TAB
- LOSARTAN POTASSIUM 100 MG per TAB
- HYDROCHLOROTHIAZIDE 25 MG per TAB