Product information

From Health Canada

No match found

No other product was found with the same active ingredient group.

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:

2021-03-09

Product name:

NARCAN NASAL SPRAY

Description:

SINGLE-DOSE

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DIN:

02458179

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

0108981004

List of active ingredient(s)
Active ingredient(s) Strength
NALOXONE HYDROCHLORIDE 2 MG / 0.1 ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Version 4.0.2
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