ApprovalTrail

Approval · Notice of Compliance 9566 · 2008

FEMARA: Notice of Compliance 9566

Issued May 28, 2008

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
9566
Date
May 28, 2008
Company
Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Update to the product monograph to include updated analysis results of 49 months for extended adjuvant therapy.
Therapeutic class
Non-steroidal aromatase inhibitor / inhibitor of estrogen biosynthesis / antitumor agent

Products in this notice

BrandDINStatus today
FEMARANot yet assigned—

Medicinal ingredients