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:
2015-04-17
Original market date: See footnote 1
2000-08-01
Product name:
BUTORPHANOL NASAL SPRAY
DIN:
02242504
Product Monograph/Veterinary Labelling:
Date:
2023-01-26
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AA PHARMA INC
UNIT 1
1165 Creditstone Road
Vaughan
Ontario
Canada
L4K 4N7
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Nasal
Number of active ingredient(s):
1
Schedule(s):
Schedule G (CDSA IV)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AF01 BUTORPHANOL
Active ingredient group (AIG) number:See footnote5
0112394002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BUTORPHANOL TARTRATE | 10 MG / ML |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |