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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:

2004-07-29

Original market date: See footnote 1

2000-06-14

Product name:

CEREZYME

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:

02241751

Product Monograph/Veterinary Labelling:

Date: 2016-11-30 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC
2905 Place Louis-R.-Renaud
Laval
Quebec
Canada  H7V 0A3

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

44:00.00   ENZYMES

Anatomical Therapeutic Chemical (ATC): See footnote 4

A16AB02  IMIGLUCERASE

Active ingredient group (AIG) number:See footnote 5

0131511002

List of active ingredient(s)
Active ingredient(s) Strength
IMIGLUCERASE 400 UNIT / VIAL

Application information

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