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:
2018-05-11
Product name:
ALPHANATE
Description:
RECONSTITUTED WITH 10 ML DILUENT
DIN:
02475618
Product Monograph/Veterinary Labelling:
Date:
2018-05-11
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GRIFOLS BIOLOGICALS LLC
5555 Valley Blvd
Los Angeles
California
United States
90032-3520
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
2
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
20:28.16
Anatomical Therapeutic Chemical (ATC): See footnote 4
B02BD06 VON WILLEBRAND FACTOR AND COAG. FACT. VIII IN COMB
Active ingredient group (AIG) number:See footnote5
0250427012
| Active ingredient(s) | Strength |
|---|---|
| ANTIHEMOPHILIC FACTOR (HUMAN) | 1500 UNIT / VIAL |
| VON WILLEBRAND FACTOR (HUMAN) | 1800 UNIT / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.