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
Product name:
DRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP THERAPEUTIC
Description:
74 TO 7400 MBQ/ VIAL
DIN:
02329778
Product Monograph/Veterinary Labelling:
Date:
2023-11-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA
16751 Trans Canada Hwy
Kirkland
Quebec
Canada
H9H 4J4
Class:
Radiopharmaceutical
Dosage form(s):
Solution
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Schedule C
American Hospital Formulary Service (AHFS): See footnote 3
78:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V10XA01 SODIUM IODIDE 131 I
Active ingredient group (AIG) number:See footnote5
0152597028
| Active ingredient(s) | Strength |
|---|---|
| SODIUM IODIDE 131 I | 7400 MBq / VIAL |