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:
2021-03-09
Original market date: See footnote 1
2017-07-07
Product name:
NARCAN NASAL SPRAY
Description:
SINGLE-DOSE
DIN:
02458187
Product Monograph/Veterinary Labelling:
Date:
2021-03-05
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
EMERGENT OPERATIONS IRELAND LIMITED
6th Earlsfort Terrace
Dublin 2
--
Ireland
D02W773
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) | 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 |