COVISHIELD (ChAdOx1-S [recombinant])

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

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:

• Part I: Health Professional Information;
• Part II: Scientific Information; and
• Patient Medication Information

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.

Vial and carton labels for vaccine with English-only labelling. These labels are used for the initial supply of vaccine.

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.

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.

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.

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.

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.

The Company’s Risk Management Plan describes:

• Known and potential safety issues
• The company’s monitoring plan, including plans for collection of additional safety and effectiveness information
• Any measures that will be put in place to minimize risks associated with the product.

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.

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.

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.