Product description
Resources
Click on a resource to visit a page with more information. You may be taken away from this page to a different Government of Canada website.
| Updated Date | Resources for | Resources | Description | Date |
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| 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. |
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| 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:
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| Consumers, Health Care Professionals, Researchers | Regulatory Decision Summary (Food and Drug Regulations) | 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. |
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| 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. |
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| 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. |
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| Health Care Professionals | Storage, handling, and administration | The steps to Spikevax XBB.1.5. Your guide to proper storage, handling, and administration of the vaccine. |