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:
2008-04-29
Original market date: See footnote 1
2008-04-29
Product name:
WILATE
DIN:
02286750
Product Monograph/Veterinary Labelling:
Date:
2024-07-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
Oberlaaer Strasse 235
Vienna
Vienne
Austria
1100
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
3
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
0351695002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ANTIHEMOPHILIC FACTOR (HUMAN) | 500 UNIT / 5 ML |
| HUMAN PLASMA PROTEINS | 7.5 MG / 5 ML |
| VON WILLEBRAND FACTOR (HUMAN) | 500 UNIT / 5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.