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Multiple Additions to the Prescription Drug List (PDL)

Documents to announce multiple updates to the Prescription Drug List.

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Novavax COVID-19 vaccine

On February 17, 2022, Health Canada authorized the sixth vaccine in Canada for the prevention of COVID-19. Learn more about the Novavax Nuvaxovid COVID-19 protein subunit vaccine.

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Medicago Covifenz COVID-19 vaccine

On February 24, 2022, Health Canada authorized the seventh vaccine in Canada for the prevention of COVID-19. Learn more about the Medicago Covifenz COVID-19 plant-based vaccine.

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Notice: Regulations amending certain regulations concerning drugs and medical...

The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made on 03-02, 2022. They amend the Food and Drug Regulations and Medical Devices Regulations that...

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Notice: Period reduced for keeping clinical trial records for drugs and...

Information on Health Canada reducing the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years.

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Notice of updated guidance: Applications for COVID-19 drug clinical trials...

Health Canada has updated and renamed the guidance document that was created for the interim orders No. 1 and No. 2 for COVID-19-related clinical trials for drugs.

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Notice: Clinical trials for medical devices and drugs relating to COVID-19...

Information on the regulations for clinical trials for medical devices and drugs relating to COVID-19 transition from the Interim Order.

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Notice of Amendment: Tramadol removed from the Prescription Drug List (PDL)

Documents to announce the removal of tramadol to the Prescription Drug List.

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Keeping Health Products In Canada Safe

Defines what health products are and how Health Canada continues to monitor them after authorization to ensure they are safe, effective and of high quality.

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Authorization of Evusheld COVID-19 treatment

On April 14, 2022, Health Canada authorized the Evusheld treatment in Canada for the prevention of COVID-19. Learn more about the treatment.

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Remdesivir is now approved for treating COVID-19 in an outpatient setting

On April 22, 2022, Health Canada authorized remdesivir for the treatment of COVID-19 in an outpatient setting. When administered within 7 days of symptoms appearing, remdesivir was demonstrated to...

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Notice of Amendment: Revision of Brimonidine on the Prescription Drug List (PDL)

Documents to announce the revision of brimonidine on the Prescription Drug List.

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Notice: Multiple additions to the Prescription Drug List (PDL)

Documents to announce multiple updates to the Prescription Drug List.

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Notice of Intent to Amend the Prescription Drug List (PDL): Betaine

Notice of Intent to Amend the Prescription Drug List (PDL) for Betaine.

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Notice of Amendment: Addition of Metamizole (Dipyrone) to the Prescription...

Documents to announce the Notice of Amendment to add metamizole (dipyrone) to the PDL.

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Notice: Multiple Additions to the Prescription Drug List (PDL)

Documents to announce multiple updates to the Prescription Drug List.

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Authorization of Actemra COVID-19 treatment

On October 13, 2022, Health Canada authorized the use of Actemra as a treatment for adults with severe COVID-19 who are in hospital.

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Authorization of Evusheld COVID-19 expanded indication

On October 18, 2022, Health Canada authorized the expanded use of Evusheld as a treatment for adults and adolescents over 12 with mild to moderate COVID-19 symptoms.

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Updates to the Guidance on amendments to the Food and Drug Regulations for...

Health Canada has updated our Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.

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Consultation on proposed agile regulations and guidance for licensing drugs...

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to advance our modernization...

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