ApprovalTrail

Approval · Notice of Compliance 19240 · 2017

POMALYST: Notice of Compliance 19240

Issued April 11, 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
19240
Date
April 11, 2017
Company
Celgene IncSaint-Laurent, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Update to the product monograph with pharmacokinetic (pk) data of pomalidomide in patients with varying degree of renal or hepatic impairment, as well as the clinical impact of smoking on pomalidomide exposure

Products in this notice

BrandDINStatus today
POMALYSTNot yet assigned—

Medicinal ingredients