ApprovalTrail

Approval · Notice of Compliance 20484 · 2018

ZERIT: Notice of Compliance 20484

Issued February 13, 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
20484
Date
February 13, 2018
Company
Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Pm updates to pediatric dosage and administration to reflect discontinuation of the 5 mg capsule and 1 mg/ml powder for oral solution. product labels to meet the pll

Products in this notice

BrandDINStatus today
ZERITNot yet assigned—

Medicinal ingredients