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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:

2019-01-17

Original market date: See footnote 1

2013-04-02

Product name:

BYSTOLIC

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:

02399008

Product Monograph/Veterinary Labelling:

Date: 2018-09-27 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ALLERGAN INC
SUITE 500  85 Enterprise Blvd
Markham
Ontario
Canada  L6G 0B5

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

24:24.00   BETA-ADRENERGIC BLOCKING AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

C07AB12  NEBIVOLOL

Active ingredient group (AIG) number:See footnote 5

0153531002

List of active ingredient(s)
Active ingredient(s) Strength
Nebivolol (Nebivolol Hydrochloride) 5 MG

Risk Management Plans See footnote 7

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

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