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:

Cancelled Post Market

Current status date:

2022-02-01

Original market date: See footnote 1

2011-05-31

Lot number: See footnote 2

19K025

Expiry date: See footnote 2

2022-07-31

Product name:

BYETTA

Description:

2.4ML PREFILLED PEN. 60 DOSES OF 10¿CG/DOSE

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:

02361817

Product Monograph/Veterinary Labelling:

Date: 2019-12-18 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ASTRAZENECA CANADA INC
1004 Middlegate Road, Suite 5000
Mississauga
Ontario
Canada L4Y 1M4

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

68:20.06 

Anatomical Therapeutic Chemical (ATC): See footnote 4

A10BJ01 EXENATIDE

Active ingredient group (AIG) number:See footnote5

0152872004

List of active ingredient(s)
Active ingredient(s) Strength
EXENATIDE 10 MCG / ACT

Risk Management Plans See footnote 7

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

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