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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:

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: 2017-04-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
2700 Matheson Blvd East, Suite 800, West Tower
Mississauga
Ontario
Canada  L4W 4V9

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Schedule D,  Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

44:00.00   ENZYMES

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AB04  AGALSIDASE BETA

Active ingredient group (AIG) number:See footnote 5

0149901001

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

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