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
Current status date:
2024-03-19
Original market date: See footnote 1
2024-03-19
Product name:
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP
Description:
SINGLE DOSE AMPOULE
DIN:
02536714
Product Monograph/Veterinary Labelling:
Date:
2023-03-27
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
FORMATIVE PHARMA INC.
200
4145 North Service Road
Burlington
Ontario
Canada
L7L 6A3
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intraspinal
Number of active ingredient(s):
1
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
72:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N01BB01 BUPIVACAINE
Active ingredient group (AIG) number:See footnote5
0108896002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 7.5 MG / ML |