ApprovalTrail

Approval · Notice of Compliance 31760 · 2023

IMURAN: Notice of Compliance 31760

Issued September 28, 2023

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
31760
Date
September 28, 2023
Company
Aspen Pharmacare Canada Inc.Oakville, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Updates to the Product Monograph (PM) with the risk of cholestasis of pregnancy and pellagra; removal of section 14.3 Comparative Bioavailability Studies from the PM.

Products in this notice

BrandDINStatus today
IMURANNot yet assigned—

Medicinal ingredients