Approval · Notice of Compliance 13607 · 2012
INSPRA: Notice of Compliance 13607
Issued August 30, 2012
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
- 13607
- Date
- August 30, 2012
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: reduce the risk of cardiovascular mortality and hospiitalization for heart failure patients with NYHA class II systolic chronic heart failure and left ventricular systolic dysfunction
- Therapeutic class
- Aldosterone Receptor Antagonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INSPRA | Not yet assigned | — |
Medicinal ingredients
- EPLERENONE 25 MG per TAB
- EPLERENONE 50 MG per TAB