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:
2016-12-12
Product name:
AFSTYLA
Description:
ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT), SINGLE CHAIN
DIN:
02459590
Product Monograph/Veterinary Labelling:
Date:
2019-09-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
CSL BEHRING CANADA INC
350
55 Metcalfe Street
Ottawa
Ontario
Canada
K1P 6L5
Class:
Human
Dosage form(s):
Powder For Solution , Kit
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
20:28.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B02BD02 COAGULATION FACTOR VIII
Active ingredient group (AIG) number:See footnote5
0158610006
| Active ingredient(s) | Strength |
|---|---|
| LONOCTOCOG ALFA | 2500 UNIT / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |