ApprovalTrail

Approval · Notice of Compliance 18925 · 2017

ZELBORAF: Notice of Compliance 18925

Issued January 24, 2017

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
18925
Date
January 24, 2017
Company
Hoffmann-La Roche LimitedMississauga, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Update to the product monograph with efficacy and safety results of a phase ii clinical trial in metastatic melanoma in patients with brain metastases

Products in this notice

BrandDINStatus today
ZELBORAFNot yet assigned—

Medicinal ingredients