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:
2021-11-10
Original market date: See footnote 1
2016-01-15
Product name:
ELOCTATE
Description:
SINGLE-USE VIAL (POWDER), PRE-FILLED SYRINGE (DILUENT)
DIN:
02430339
Product Monograph/Veterinary Labelling:
Date:
2021-11-08
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANOFI-AVENTIS CANADA INC
1755 Steeles Avenue West
Toronto
Ontario
Canada
M2R 3T4
Class:
Human
Dosage form(s):
Kit , Powder For Solution
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
0155970005
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN | 1500 UNIT / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.