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:
2023-04-04
Original market date: See footnote 1
Product name:
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
Description:
SINGLE USE VIALS
DIN:
02493314
Product Monograph/Veterinary Labelling:
Date:
2022-11-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANDOZ CANADA INCORPORATED
110 Rue De Lauzon
Boucherville
Quebec
Canada
J4B 1E6
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:24.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
N05CM18 DEXMEDETOMIDINE
Active ingredient group (AIG) number:See footnote5
0152679003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) | 100 MCG / ML |