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:
Approved
Current status date:
2020-09-11
Product name:
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
Description:
WITH PRESERVATIVE
DIN:
02504960
Product Monograph/Veterinary Labelling:
Date:
2020-09-08
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
STERIMAX INC
2770 Portland Drive
Oakville
Ontario
Canada
L6H 6R4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Block/Infiltration
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
0108896004
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 5 MG / ML |