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:
DATSCAN
Description:
SINGLE-DOSE VIALS
DIN:
02470624
Product Monograph/Veterinary Labelling:
Date:
2017-12-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GE HEALTHCARE CANADA INC
1919 Minnesota Court
Mississauga
Ontario
Canada
L5N 0C9
Class:
Radiopharmaceutical
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule C
American Hospital Formulary Service (AHFS): See footnote 3
36:68.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V09AB03 IODINE IOFLUPANE 123 I
Active ingredient group (AIG) number:See footnote5
0159810001
| Active ingredient(s) | Strength |
|---|---|
| IOFLUPANE (123I) | 74 MBq / ML |