Health Canada authorizes use of naloxone nasal spray

OTTAWA, Oct. 3, 2016 /CNW/ - Many Canadians are struggling with opioid misuse and need access to better treatment. When Canadians suffer overdoses, the impacts are felt in families and communities, and the Government of Canada is committed to taking measures to help fight the effects of this growing problem.

Today, the Honourable Jane Philpott, Minister of Health, announced that Health Canada has authorized naloxone nasal spray for non-prescription use, following an expedited review. Minister Philpott had previously signed special Interim Order on July 5, 2016 , to allow for the importation of a version of the product from the United States while Health Canada was conducting the expedited review.

Naloxone can save lives when used promptly, by temporarily reversing a potentially fatal opioid overdose, and the nasal spray is considered to be easier to use than the injectable version, particularly by those who are not healthcare professionals.

With federal market authorization, the manufacturer is now able to take the necessary steps to bring the Canadian naloxone nasal spray to market. In the meantime, the Interim Order will remain in effect and the US-approved product will continue to be available in Canada, to avoid any interruption in supply.

Quick Facts

  • Naloxone is a drug that reverses the effects of opioid medications and can be used to temporarily counteract opioid overdoses.
  • In early 2016, Health Canada proposed and finalized changes to the prescription drug list to allow access to naloxone, without a prescription, for the emergency treatment of opioid overdoses.
  • The Government of Canada recently launched an opioid action plan to address opioid misuse. The plan focuses on informing Canadians about the risks of opioids, supporting better prescribing practices, reducing easy access to unnecessary opioids, supporting better treatment options, and improving the national evidence base.


"Canada is facing a growing number of opioid overdoses and deaths occurring across the country. This crisis demands that we take action now, and I'm proud to see my department working with its neighbours in the United States, and expediting approvals here in Canada, to provide Canadians with much-needed treatment options."
Jane Philpott
Minister of Health

Related Products

Health Canada Allowing Immediate Access to Nasal Naloxone announcement July 2016
Health Canada Statement on Change to Prescription Drug List for Naloxone 
Health Canada's Action on Opioid Misuse

Associated Links

Interim Order
Industry Notice on Change to Prescription Drug List for Naloxone

Health Canada news releases are available on the Internet at:


SOURCE Health Canada

For further information: Contacts: Andrew MacKendrick, Office of Jane Philpott, Minister of Health, 613-957-0200; Media Relations: Health Canada, 613-957-2983; Public Inquiries: 613-957-2991, 1-866 225-0709

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