|Updated Date||Resources for||Resources||Description||Date|
|Consumers, Health Care Professionals||Consumer Information||
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
|Health Care Professionals, Researchers||Product Monograph||
The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.
The Product Monograph includes three sections:
|Health Care Professionals||Canadian Reference Label||
The Canadian reference labels for the vial and carton labels. These labels provide information specific to Canada in both French and English and can be used as reference until the manufacturer implements them on the Canadian-specific product vial and carton.
|Health Care Professionals||Interim Product Label (COVAX supply)||
Vial and carton labels for vaccine with English-only labelling. These labels are used for the supply of vaccine that is coming from COVAX.
|Health Care Professionals||Interim Product Label (United States supply)||
Vial and carton labels for vaccine with English-only labelling. These labels are used for the initial supply of vaccine that is coming from the United States.
|Consumers||Regulatory Decision Summary||
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
|Health Care Professionals, Researchers||Summary Basis of Decision||
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|Consumers, Health Care Professionals||Summary Safety Review||
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
|Health Care Professionals, Researchers||Post-Authorization Activity Table (PAAT)||
The Post Authorization Activity Table includes brief summaries of the activities that occur after the approval of the product. It is updated on a monthly basis.
|Consumers, Health Care Professionals, Researchers||Adverse Events Following Immunization||
Information about adverse events following immunization. An adverse event is a medical incident that may occur following immunization. The cause is not necessarily related to the vaccine.
|Health Care Professionals, Researchers||Risk Management Plan||
The Company’s Risk Management Plan describes:
Clicking on the link will take you to a summary of the Risk Management Plan. The Risk Management Plan may be updated following authorization. The most recent version (available only in the language in which it was submitted) can be requested by email to [email protected]
After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.
|Health Care Professionals, Researchers||Authorization Terms & Conditions||
For COVID-19 authorizations, Health Canada can impose terms and conditions on the authorization. This allows Health Canada to continue to gather information on the safety, effectiveness and/or quality of the product. The status of the terms and conditions will be updated on a regular basis.
|Consumers, Health Care Professionals, Researchers||Public Advisories and Risk Communications||
Public Advisories and Health Product Risk Communications are two ways that Health Canada communicates safety issues. They are published when Health Canada has important updates or other information to share about the product, such as new approvals, information on shortages, or risks.
Clicking the link will retrieve any advisories and risk communications that Health Canada has issued about the product. If no advisories have been issued, no results will be returned.