Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products

Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing Products 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. 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance for industryproduct monographsnon-contraceptive estrogenprogestin-containing productshormone replacement therapysafety informationwomen's health initiative trialwomen's health initiative memory study Guidance for Industry - Product Monographs of Non-Contraceptive Estrogen/Progestin-Containing ProductsHTML 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 ProductsHTML 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

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.

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