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.

Data and Resources

Additional Info

Field	Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French)	Monographies des produits non contraceptifs contenant des oestrogènes et des progestatifs
Update Frequency	as_needed
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published	2006-04-20 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["Lignes directrices pour l'industrie", "monographies de produits", "œstrogènes non contraceptifs", "produits contenant un progestatif", "hormonothérapie substitutive", "informations sur l'innocuité", "essai de l'initiative pour la santé des femmes", "étude de mémoire de l'initiative pour la santé des femmes"], "en": ["Guidance for industry", "product monographs", "non-contraceptive estrogen", "progestin-containing products", "hormone replacement therapy", "safety information", "women's health initiative trial", "women's health initiative memory study"]}
Open Canada Collection	publication
Principal Organization
Reference Data
Official Source