ApprovalTrail

Approval · Notice of Compliance 19952 · 2017

ZYKADIA: Notice of Compliance 19952

Issued October 20, 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.

Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
Notice number
19952
Date
October 20, 2017
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
Final report for study cldk378bx2101 as per the commitment in the letter of undertaking (lou) dated march 20, 2015
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
ZYKADIANot yet assigned—

Medicinal ingredients