ApprovalTrail

Approval · Notice of Compliance 23399 · 2020

ADEMPAS: Notice of Compliance 23399

Issued March 31, 2020

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
23399
Date
March 31, 2020
Company
Bayer Inc.Elkhart, Indiana, United States
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To revise the product monograph related to concomitant use with CYP or P-gp/BCRP inhibitors, transition from PDE5 inhibitors, and other updates.

Products in this notice

BrandDINStatus today
ADEMPASNot yet assigned—

Medicinal ingredients