ApprovalTrail

Approval · Notice of Compliance 20691 · 2018

XGEVA: Notice of Compliance 20691

Issued April 4, 2018

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
20691
Date
April 4, 2018
Company
Amgen Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication: xgeva (denosumab) is indicated for reducing the risk of developing skeletal-related events in patients with multiple myeloma

Products in this notice

BrandDINStatus today
XGEVANot yet assigned—

Medicinal ingredients