Description

Health Canada initiated a Hormone Replacement Therapy (HRT) class labelling project in light of new safety information derived from the results of the Women's Health Initiative (WHI) trial and the Women's Health Initiative Memory Study (WHIMS). This document is intended to help the pharmaceutical industry revise the content of the Product Monograph and associated labelling materials.

Resources

Name	Format	Description	Link
Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/hormone-replacement-therapy/industry-product-monographs-non-contraceptive-estrogen-progestin-containing-products.html#a1
Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/traitement-hormonal-substitutif/intention-industrie-monographies-produits-non-contraceptifs-contenant-oestrogenes-progestatifs.html#a1

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