ApprovalTrail

Approval · Notice of Compliance 18342 · 2016

SAPHRIS: Notice of Compliance 18342

Issued July 28, 2016

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
18342
Date
July 28, 2016
Company
Merck Canada IncKirkland, Quebec, Canada
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
To incorporate data from a new safety and efficacy study into the product monograph and revise the dosing instructions

Products in this notice

BrandDINStatus today
SAPHRISNot yet assigned—

Medicinal ingredients