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:
2012-05-07
Original market date: See footnote 1
2012-05-07
Product name:
BUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION
DIN:
02381850
Product Monograph/Veterinary Labelling:
Date:
2012-03-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NOVOCOL PHARMACEUTICAL OF CANADA INC
25 Wolseley Court
Cambridge
Ontario
Canada
N1R 6X3
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Block/Infiltration
Number of active ingredient(s):
2
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
72:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N01BB51 BUPIVACAINE, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0231290002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BUPIVACAINE HYDROCHLORIDE | 5 MG / ML |
| EPINEPHRINE BITARTRATE | 0.0091 MG / ML |