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:
Approved
Current status date:
2015-08-10
Product name:
PLEGRIDY
Description:
PRE-FILLED SYRINGE OR PRE-FILLED PEN
DIN:
02444372
Product Monograph/Veterinary Labelling:
Date:
2023-06-26
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):
Liquid
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
08:18.20
Anatomical Therapeutic Chemical (ATC): See footnote 4
L03AB13 PEGINTERFERON BETA-1A
Active ingredient group (AIG) number:See footnote5
0157230001
| Active ingredient(s) | Strength |
|---|---|
| PEGINTERFERON BETA-1A | 63 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.