ApprovalTrail

Approval · Notice of Compliance 19271 · 2017

OFEV: Notice of Compliance 19271

Issued April 25, 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
19271
Date
April 25, 2017
Company
Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New dosing strategy for patients with mild hepatic impairment child pugh a). updated safety informaition regarding patients with hepatic impairment

Products in this notice

BrandDINStatus today
OFEVNot yet assigned—

Medicinal ingredients