Non-prescription Drugs: Category IV Monographs

Non-prescription Drugs: Category IV Monographs A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Category IV Monographs are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. 2021-07-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNon-prescription drugscategory IV monographspermissible conditions of uselabelling requirementsdoseintended usedirections for usewarningsactive ingredientsdrugs safety and efficacy profile Non-prescription Drugs: Category IV MonographsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/non-prescription-drugs-category-iv-monographs.html Non-prescription Drugs: Category IV MonographsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/medicaments-vente-libre-monographie-categorie-iv.html

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions for use, warnings, active ingredients and combinations thereof. Category IV Monographs are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use.

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