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:
2018-03-23
Original market date: See footnote 1
Product name:
OPTIMARK
Description:
30ML SINGLE DOSE PRE-FILLED SYRINGE
DIN:
02393182
Product Monograph/Veterinary Labelling:
Date:
2017-06-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LIEBEL-FLARSHEIM CANADA INC
7500 Transcanada Highway
Pointe-Claire
Quebec
Canada
H9R 5H8
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
V08CA06 GADOVERSETAMIDE
Active ingredient group (AIG) number:See footnote5
0142281001
Active ingredient(s) | Strength |
---|---|
GADOVERSETAMIDE | 330.9 MG / ML |