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
Product name:
GLUDEF
Description:
0.5 TO 232 GBQ /20ML VIAL
DIN:
Not Applicable
Product Monograph/Veterinary Labelling:
Date:
2016-03-01
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
11215 Ch De La Cote-De-Liesse
Dorval
Quebec
Canada
H9P 1B1
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
Anatomical Therapeutic Chemical (ATC): See footnote 4
Active ingredient group (AIG) number:See footnote5
0152591012
| Active ingredient(s) | Strength |
|---|---|
| FLUDEOXYGLUCOSE 18F | 232 GBQ / 20 ML |