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:
2011-11-04
Original market date: See footnote 1
2011-11-04
Product name:
DIGIFAB
Description:
SINGLE USE VIAL. LYOPHILIZED POWDER. PRESERVATIVE-FREE
DIN:
02361043
Product Monograph/Veterinary Labelling:
Date:
2022-11-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BTG INTERNATIONAL INC
300
300 Four Falls Corporate Center, 300 Conshohocken State Road
West Conshohocken
Pennsylvania
United States
19428
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V03AB24 DIGITALIS ANTITOXIN
Active ingredient group (AIG) number:See footnote5
0122996001
| Active ingredient(s) | Strength |
|---|---|
| DIGOXIN IMMUNE FAB (OVINE) | 40 MG / VIAL |