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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.

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.

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.

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.

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.

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.

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.

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.

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).

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.