ApprovalTrail

Approval · Notice of Compliance 8315 · 2006

COVERSYL: Notice of Compliance 8315

Issued October 11, 2006

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
8315
Date
October 11, 2006
Company
Servier Canada Inc.Laval, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: coversyl has been demonstrated to reduce the risk of cardiovascular death, non-fatal myocardial infarction, and cardiac arrest in mild or moderately hypertensive patients with stable coronary artery disease, or in patients previous (>3 months ago) myocardial infarction and stable coronary artery disease, when administered as an add-on to conventional treatment, such as platelet inhibitors, beta blockers, lipid-lowering agents, nitrates, calcium channel blockers or diuretics
Therapeutic class
Angiotensin converting enzyme inhibitor

Products in this notice

BrandDINStatus today
COVERSYLNot yet assigned—

Medicinal ingredients