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040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-381/2024E-PDF
24500|aGuidance document : |bannual update of seasonal influenza vaccines.
24630|aAnnual update of seasonal influenza vaccines
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cAugust 2024.
264 4|c©2024
300 |a1 online resource (15 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aCover title.
500 |aIssued also in French under title: Ligne directrice : mise à jour annuelle des vaccins contre la grippe saisonnière.
504 |aIncludes bibliographical references.
520 |a"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.
650 0|aInfluenza vaccines|zCanada.
650 0|aInfluenza|xVaccination|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.941908
85640|qPDF|s433 KB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-381-2024-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/annual-update-seasonal-influenza-vaccines.html