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 Pre Market
Current status date:
2021-06-23
Original market date: See footnote 1
Product name:
GADOPENTETATE DIMEGLUMINE INJECTION
Description:
SINGLE USE VIAL
DIN:
02497883
Product Monograph/Veterinary Labelling:
Date:
2020-04-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AVIR PHARMA INC.
660 Boulevard Industriel
Blainville
Quebec
Canada
J7C 3V4
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
92:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V08CA01 GADOPENTETIC ACID
Active ingredient group (AIG) number:See footnote5
0123846001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GADOPENTETATE DIMEGLUMINE | 469 MG / ML |