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:
2022-05-17
Original market date: See footnote 1
Product name:
GADOPENTETATE DIMEGLUMINE INJECTION, USP
Description:
0.5MMOL/ML. SINGLE DOSE VIALS
DIN:
02431513
Product Monograph/Veterinary Labelling:
Date:
2014-09-12
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
16751 Trans Canada Hwy
Kirkland
Quebec
Canada
H9H 4J4
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
V08CA01 GADOPENTETIC ACID
Active ingredient group (AIG) number:See footnote5
0123846001
| Active ingredient(s) | Strength |
|---|---|
| GADOPENTETATE DIMEGLUMINE | 469 MG / ML |