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:
Cancelled Post Market
Current status date:
2008-06-19
Original market date: See footnote 1
1998-08-12
Product name:
BENEFIX -(1000IU)
Description:
ALSO KNOWN AS NONACOG ALFA
DIN:
02231020
Product Monograph/Veterinary Labelling:
Date:
2007-04-13
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
WYETH CANADA
1025 Boulevard Marcel Laurin
St. Laurent
Quebec
Canada
H4R 1J6
Class:
Human
Dosage form(s):
Powder For Solution , Kit , Liquid
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
B02BD04 COAGULATION FACTOR IX
Active ingredient group (AIG) number:See footnote5
0233010003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| COAGULATION FACTOR IX (RECOMBINANT) | 1000 UNIT / VIAL |
| WATER | 10 ML / VIAL |