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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:

2021-02-11

Original market date: See footnote 1

2007-08-01

Product name:

ELAPRASE

Description:

SINGLE USE

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:

02296314

Product Monograph/Veterinary Labelling:

Date: 2021-02-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TAKEDA CANADA INC
3800  22 Adelaide Street West
Toronto
Ontario
Canada  M5H 4E3

Class: 

Human

Dosage form(s):

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

A16AB09  IDURSULFASE

Active ingredient group (AIG) number:See footnote 5

0152221001

List of active ingredient(s)
Active ingredient(s) Strength
IDURSULFASE 2 MG / ML

Application information

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