ApprovalTrail

Approval · Notice of Compliance 16619 · 2015

VECTIBIX: Notice of Compliance 16619

Issued February 19, 2015

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
16619
Date
February 19, 2015
Company
Amgen Canada IncMississauga, Ontario, Canada
Product type
Biologic
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Fulfillment of conditions as per the letter of undertaking dated april 2, 1008 for monotherapy for the treatment of patients with egfr-expressing metastatic colorectal carninoma (mcrc) with non-mutated (wild type) kras after failure of fluoropyrimidine-,oxaliplatin-, and irinotecan-containing chemotherapy regimens
Therapeutic class
Antineoplastic

Products in this notice

BrandDINStatus today
VECTIBIXNot yet assigned—

Medicinal ingredients