Product information

From Health Canada

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:

2022-09-01

Original market date: See footnote 1

2016-01-27

Product name:

BELKYRA

Description:

2ML SINGLE USE VIALS

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:

02443910

Product Monograph/Veterinary Labelling:

Date: 2023-05-25 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ABBVIE CORPORATION
8401 Trans-Canada Highway
Saint-Laurent
Quebec
Canada H4S 1Z1

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

92:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

D11AX24 DEOXYCHOLIC ACID

Active ingredient group (AIG) number:See footnote5

0157151001

List of active ingredient(s)
Active ingredient(s) Strength
DEOXYCHOLIC ACID 10 MG / ML

Risk Management Plans See footnote 7

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

Version 4.0.2
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