Product information

From Health Canada

New search

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2019-07-05

Original market date: See footnote 1

2011-11-29

Product name:

SUBLINOX

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02370433

Product Monograph/Veterinary Labelling:

Date: 2019-07-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BAUSCH HEALTH, CANADA INC.
2150 Boul. St-Elzear Ouest
Laval
Quebec
Canada  H7L 4A8

Class: 

Human

Dosage form(s):

Tablet (Orally Disintegrating)

Route(s) of administration:

Sublingual

Number of active ingredient(s):

1

Schedule(s):

Targeted (CDSA IV)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:24.92   MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N05CF02  ZOLPIDEM

Active ingredient group (AIG) number:See footnote 5

0122857002

List of active ingredient(s)
Active ingredient(s) Strength
ZOLPIDEM TARTRATE 10 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Application information

Related information

Contact us

Version 3.8.0
Date modified: