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:

2004-09-17

Original market date: See footnote 1

2004-09-17

Product name:

FABRAZYME

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:

02248965

Product Monograph/Veterinary Labelling:

Date: 2023-04-14 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
1755 Steeles Avenue West
Toronto
Ontario
Canada M2R 3T4

Class:

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription ,  Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

44:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AB04 AGALSIDASE BETA

Active ingredient group (AIG) number:See footnote5

0149901001

List of active ingredient(s)
Active ingredient(s) Strength
AGALSIDASE BETA 5 MG / VIAL

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Education
Version 4.0.2
Date modified: