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:
2016-03-07
Original market date: See footnote 1
2010-10-12
Product name:
ABLAVAR
Description:
SINGLE USE VIALS. 2440MG/10ML AND 3660MG/25ML.
DIN:
02333236
Product Monograph/Veterinary Labelling:
Date:
2014-10-01
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LANTHEUS MI CANADA INC
1111 Dr. Frederik-Philips Blvd., Suite 600
Montreal
Quebec
Canada
H4M 2X6
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
36:89.00* See footnote6
Anatomical Therapeutic Chemical (ATC): See footnote 4
V08CA11 GADOFOSVESET
Active ingredient group (AIG) number:See footnote5
0151671001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GADOFOSVESET TRISODIUM | 244 MG / ML |