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Found 10 records similar to Guidance document: Product Monograph (2020)

Federal

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.

Last Updated: Jul. 7, 2021
Date Published: Jan. 26, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, category IV monographs, permissible conditions of use, labelling requirements, dose, intended use, directions for use, warnings, active ingredients
Federal

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish to include, in product monographs, scientific statements and claims regarding tamper-resistance.

Last Updated: Jul. 7, 2021
Date Published: Mar. 30, 2016
Organization: Health Canada
Formats: HTML
Keywords:  Guidance document, tamper-resistance formulations, tamper-resistant properties, opioid drug products, controlled-release opioid drug formulations, controlled-release opioid products, drug submissions, product monographs
Federal

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions. Each Product Monograph is expected to contain objective, adequate and concise information on properties common to the active component and specific to the drug product. It should provide guidance on the safe and effective use of the drug, not only to the practitioner but also to the patient.

Last Updated: Jul. 7, 2021
Date Published: Aug. 7, 2009
Organization: Health Canada
Formats: HTML
Keywords:  Basic product mMonograph information, non-steroidal anti-inflammatory drugs, NSAIDs, controlling pain and inflammation, rheumatic diseases, product monograph contains objective, adequate and concise information on drug product, safe and effective use of the drug
Federal

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.

Last Updated: Sep. 9, 2021
Date Published: Aug. 30, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Non-prescription drugs, category IV monographs, use and labelling requirements, dose, intended use, directions for use, warnings, active ingredients
Federal

Health Canada is working on a strategic approach to support the transition of all product monographs into the XML format, which will become a mandatory requirement for product monographs.

Last Updated: Dec. 29, 2021
Date Published: May 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Extensible Markup Language, XML format, product monographs, XML PM Project, phase II
Federal

Health Canada recommends modified wording for the indications and clinical uses of fludeoxyglucose (F-18 FDG) products in their product monographs. The modified wording aims to bring the indications and clinical uses for F-18 FDG up-to-date and harmonize the product monographs in this regard.

Last Updated: Dec. 29, 2021
Date Published: Jan. 6, 2021
Organization: Health Canada
Formats: HTML
Keywords:  harmonizing product monographs, fludeoxyglucose, F-18 FDG, indications-and-clinical-uses, indications-and-clinical-uses for F-18 FDG
Federal

A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, labelling requirements, post-market requirements
Federal

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.

Last Updated: Jul. 7, 2021
Date Published: Apr. 20, 2006
Organization: Health Canada
Formats: HTML
Keywords:  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
Federal

Health Canada will continue to post a monthly table on the Department website which reflects updated and/or new safety information in PMs of brand name pharmaceutical drug products (those regulated under Division 8 of the Food and Drug Regulations only). This table will identify the section of the PM that was updated pursuant to a Supplement to an (Abbreviated) New Drug Submission (S(A)NDS).

Last Updated: Dec. 29, 2021
Date Published: Mar. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  safety labelling changes, product monographs, PMs, pharmaceutical drug products, a monthly table, safety information
Federal

This monograph applies to products in the form of liquid concentrate that are intended to be used for acute and chronic haemodialysis. The medicinal ingredients, their concentrations and combinations are restricted to those specified in this monograph. Full justification supported with information in the public domain should be provided for any deviations in ingredients, concentrations and indications. The medicinal ingredients must be identified on product labelling by the names given in this monograph.

Last Updated: Jul. 7, 2021
Date Published: Feb. 12, 2010
Organization: Health Canada
Formats: HTML
Keywords:  Haemodialysis Solutions, monograph, liquid concentrate, acute and chronic haemodialysis, medicinal ingredients, concentrations and combinations, deviations in ingredients, concentrations and indications, product labelling
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