Guidance document : annual update of seasonal influenza vaccines.: H164-381/2024E-PDF
"This guidance document applies to sponsors seeking authorization for annual updates to influenza vaccines. The document covers the process, data requirements, and associated timelines for the submission, review, and lot release of seasonal influenza vaccines in Canada. The material covered in this document only applies to changes associated with the annual update to seasonal influenza vaccines, specifically: changes to the virus strain(s); changes to the seed banks and/or starting material that are required to produce vaccine for the upcoming influenza season, and; changes to the product labelling to reflect strain changes and the season of use"--Introduction, page 9.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.941909&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : annual update of seasonal influenza vaccines. |
| Variant title | Annual update of seasonal influenza vaccines |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Cover title. Issued also in French under title: Ligne directrice : mise à jour annuelle des vaccins contre la grippe saisonnière. Includes bibliographical references. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, August 2024. ©2024 |
| Description | 1 online resource (15 pages) |
| ISBN | 9780660731759 |
| Catalogue number |
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| Departmental catalogue number | 240490 |
| Subject terms | Influenza vaccines -- Canada. Influenza -- Vaccination -- Canada. |
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