Health product monograph Canada Forms

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Commonly Asked Questions about Health product monograph Canada Forms

What is the Canadian standard for drug monographs?

The Compendium of Pharmaceuticals and Specialties (CPS) is the Canadian standard for drug monographs, developed by manufacturers, approved by Health Canada and optimized by CPhA editors.

What are the guidelines for product monograph?

The product monograph should also include: contraindications, dosage and administration, symptoms and treatment of overdosage, dosage forms, warnings, precautions, adverse reactions, drug interactions, effects on laboratory tests, storage and stability, special handling instructions, pharmaceutical information, Guidance document: Product Monograph (2020) - Canada.ca Canada.ca applications-submissions guid Canada.ca applications-submissions guid

How do you cite a Canadian product monograph?

To reference part of CPS, such as a product monograph (where Gleevec is provided as an example of a product monograph), use the citation formatting below: CPS [Internet]. Ottawa (ON): Canadian Pharmacists Association; c2022 [updated YYYY MMM DD; cited YYYY MMM DD]. Gleevec [product monograph].

What is a product monograph in Health Canada?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

What is the Health Canada Product monograph Guidance document?

A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. Guidance Document - Product Monograph - Canada.ca Canada.ca applications-submissions pro Canada.ca applications-submissions pro