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:
2024-01-08
Original market date: See footnote 1
2024-01-08
Product name:
TEVA-NALOXONE NASAL SPRAY
DIN:
02511568
Product Monograph/Veterinary Labelling:
Date:
2021-01-21
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
TEVA CANADA LIMITED
30 Novopharm Court
Toronto
Ontario
Canada
M1B 2K9
Class:
Human
Dosage form(s):
Spray, Metered Dose
Route(s) of administration:
Nasal
Number of active ingredient(s):
1
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
28:10.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
V03AB15 NALOXONE
Active ingredient group (AIG) number:See footnote5
0108981005
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| NALOXONE HYDROCHLORIDE | 4 MG / 0.1 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Education |