Authorized Canadian naloxone Nasal Spray (NARCAN) coming to market

Starting date:

June 30, 2017

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-63784

• Media enquiries
• Public enquiries

June 30, 2017
For immediate release

OTTAWA – Health Canada is advising health care professionals and Canadians that the Canadian authorized version of NARCAN will transition onto the market by July 5, 2017.

NARCAN is a nasal spray form of naloxone, the life-saving drug that temporarily reverses the effects of an opioid overdose.  

Last July, an Interim Order was issued by the Minister of Health. The Interim Order permitted the importation, sale and distribution of NARCAN approved in the United States (U.S.) for a period of one year. In September 2016, after a thorough review, Health Canada authorized the Canadian version of NARCAN to ensure an ongoing domestic supply.

On July 5, 2017, the Interim Order will expire. Product obtained under the Interim Order can continue to be used, but new orders will be for the Canadian authorized NARCAN product.  There will be a period of time where both products will be available as transition occurs.

NARCAN is the same product in Canada and the U.S. Minor labelling differences are the only distinctions between the Canadian and American versions of the product.

For both versions of the product, it is important to monitor and respect the expiry dates.

Information for anyone who may need to administer naloxone

• Naloxone will temporarily reverse overdoses caused by opioids.
• Administering naloxone to a person who is unconscious because of a non-opioid overdose is unlikely to cause more harm.
• The Canadian Product Monographs for both the nasal and injectable versions of the drug contain important information about the approved use of naloxone products and other information that may be required for their optimal, safe and effective use.
• The Canadian Product Monographs can be accessed through the Drug Product Database.

For more information on how to obtain the Canadian NARCAN Nasal Spray, contact the manufacturer at:

• Email: adaptcanada@customer-support.ca
• Phone: 1-877-870-2726

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related links:

• Frequently Asked Questions – Access to Naloxone in Canada (including NARCAN Nasal Spray)
• Notice - Availability of Naloxone Hydrochloride Nasal Spray (NARCAN) in Canada
• Interim Order Respecting Naloxone Hydrochloride Nasal Spray

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