ApprovalTrail

Approval · Notice of Compliance 9070 · 2007

COZAAR: Notice of Compliance 9070

Issued October 3, 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
9070
Date
October 3, 2007
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: antihypertensive effects of cozaar have been demonstrated in hypertensive pediatric patients aged 6 to 16 years. use of cozaar in these age groups is supported by evidence from adequate and well-controlled studies of cozaar in pediatric patients, and other revisions to the product monograph
Therapeutic class
Angiotensin ii receptor antagonist

Products in this notice

BrandDINStatus today
COZAARNot yet assigned—

Medicinal ingredients