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:

2024-10-21

Original market date: See footnote 1

2024-10-21

Product name:

BEYFORTUS

Description:

SINGLE-USE PRE-FILLED SYRINGE

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:

02537206

Product Monograph/Veterinary Labelling:

Date: 2024-06-14 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SANOFI PASTEUR LIMITED
1755 Steeles Avenue West
Toronto
Ontario
Canada M2R 3T4

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

08:18.24 

Anatomical Therapeutic Chemical (ATC): See footnote 4

J06BD08 NIRSEVIMAB

Active ingredient group (AIG) number:See footnote5

0164561001

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
NIRSEVIMAB 50 MG / 0.5 ML

Risk Management Plans See footnote 7

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

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