What is a product monograph Health Canada?

What is a product monograph 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.

How do you cite Health Canada 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].

How do you know if a product is approved by Health Canada?

Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: availability of the drug in Canada.

What is included in a drug monograph?

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.

Where can I buy a OTC monograph?

OTC Monographs@FDA provides a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs. OTC Monographs@FDA also facilitates the submission of comments and data from the public for proposed and interim final administrative orders, except if otherwise specified.

How do you cite a drug product monograph?

Drug Monographs: Date of first publication [amended date; date cited]. In: database name [Internet]. Place of publication: Publisher. Copyright date – .

How do I find my drug DIN number?

The drug identification number (DIN) is the 8 digit number located on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada.

Does Canada need FDA approval?

Before a drug can be distributed and sold in Canada, its manufacturer must receive a Notice of Compliance (NOC) from Health Canada, and the drug must be assigned a Drug Identification Number (DIN), uniquely identifying all drug products sold in a dosage form in Canada.

Does Canada accept FDA?

The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other.

Where can I get drug monographs?

Prescription and Non-prescription Monographs

• RxList. The Internet Drug Index – part of the WebMD network.
• Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
• Medscape Drugs & Diseases. Free registration required – from WebMD.
• RxFiles.

What does a monograph look like?

A Monograph has some common characteristics with books and review (survey) papers. A monograph is a special type of book written on a single specialized topic, devoted mainly for research works; could pose some unsolved problems and may provide detained explanation of some research papers.

Where can I find a monograph?

Scholarly monographs are typically purchased by academic and research libraries for use by scholars, including students. You won’t usually find them on bookstore shelves.

What does OTC monograph mean?

An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …

Do OTC products need FDA approval?

OTC drugs can be bought and used safely without the need for a prescription. All OTC drug products have to meet FDA quality, effectiveness, and safety standards. While easier to obtain and use than prescription drugs, it is important to understand that these products are medicines and not without risks.

What is DIN number Health Canada?

Drug Identification Number
What is a DIN? A Drug Identification Number (DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada.

What is the difference between DIN and NPN?

Use products that have a DIN (Drug Identification Number), NPN (Natural Product Number) or DIN-HM (Drug Identification Number – Homeopathic Medicine) on the label, which signifies that the product has undergone and passed a review of its formulation, labeling and instructions for use.