ApprovalTrail

Approval · Notice of Compliance 11944 · 2010

FEMARA: Notice of Compliance 11944

Issued December 17, 2010

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
11944
Date
December 17, 2010
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
Fulfillment of commitments as per the Letters of Undertaking dated April 1, 2005 and September 18, 2006 for the extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy and for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer, respectively
Therapeutic class
Non-steroidal aromatase inhibitor / Inhibitor of estrogen biosynthesis / Antitumor agent

Products in this notice

BrandDINStatus today
FEMARANot yet assigned—

Medicinal ingredients