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
DIN:
02286386
Product Monograph/Veterinary Labelling:
Date:
2025-01-09
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
| Active ingredient(s) See footnote8 | 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 |
|---|
| Patient Wallet Card |
| Healthcare Professional Education |
| Controlled Distribution Program |
| Patient Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |