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:

2006-11-21

Original market date: See footnote 1

2006-11-21

Product name:

TYSABRI

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:

02286386

Product Monograph/Veterinary Labelling:

Date: 2023-08-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BIOGEN CANADA INC
3300 Bloor Street West, West Tower, Suite 1200
Toronto
Ontario
Canada M8X 2X2

Class:

Human

Dosage form(s):

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

92:20.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AG03 NATALIZUMAB

Active ingredient group (AIG) number:See footnote5

0151674001

List of active ingredient(s)
Active ingredient(s) Strength
NATALIZUMAB 300 MG / 15 ML

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
Patient Wallet Card
Controlled Distribution Program
Pharmacovigilance/Monitoring Activity
Observational Studies
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