ApprovalTrail

Approval · Notice of Compliance 10245 · 2009

SENSIPAR: Notice of Compliance 10245

Issued June 5, 2009

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
10245
Date
June 5, 2009
Company
Amgen Canada IncMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New Indications: For the reduction of hypercalcemia in patients with parathyroid carcinoma and for the reduction of clinically significant hypercalcemia, as defined by relevant treatment guidelines, in patients with primary HPT for whom parathyroidectomy is not clinically appropriate or is contraindicated
Therapeutic class
Calcimimetic agent

Products in this notice

BrandDINStatus today
SENSIPARNot yet assigned—

Medicinal ingredients