Health Canada Drug Product Monograph

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Drug Product Database: Access the database - Canada.ca

(Just Now) WebAccess the database. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

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Search criteria - Drug Product Database online query

(6 days ago) WebSearch criteria. You may search by either a) drug identification number ( DIN ), b) Anatomical Therapeutic Chemical ( ATC) code, or c) by company or one or more of the …

https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

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Guidance document: Product Monograph (2020) - Canada.ca

(1 days ago) A product monograph is a document that provides information about the safety, efficacy, quality and use of a new drug. This guidance document from Health Ca…

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/guidance-document-product-monograph-2020.html

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Product monographs: Frequently asked questions

(5 days ago) WebDrug manufacturers (or sponsors) are required to develop a detailed Product Monograph in accordance with the Guidance Document: Product Monograph. Health Canada reviews the Product Monograph …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/frequently-asked-questions-product-monographs-posted-health-canada-website.html

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Guidance Document - Product Monograph - Canada.ca

(8 days ago) WebHealth care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada's Canada Vigilance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/product-monograph.html

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Product Monograph master template - Canada.ca

(6 days ago) WebList only Health Canada authorized product monographs that were supportive in the development of the product monograph (e.g., Canadian Reference Product for a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/master-template.html

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Product information - health-products.canada.ca

(8 days ago) WebThe product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary …

https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=15

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Product monograph guidance documents and notices - Canada.ca

(Just Now) WebNotices. Consultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15] Health Canada changes filing requirements for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph.html

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Guidance document : product monograph. : H164-299/2020E-PDF

(1 days ago) WebHealth Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended to …

https://publications.gc.ca/site/eng/9.890868/publication.html

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Compendium of Monographs - Canada.ca

(4 days ago) WebThe Compendium of Monographs can help speed the evaluation of the safety and efficacy of medicinal ingredients commonly used in natural health products. A monograph is a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/compendium-monographs.html

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebProduct Monograph VEKLURY ® (remdesivir) powder for solution for infusion Page 2 of 41 What is a Notice of Compliance with Conditions (NOC/c)? An NOC/c is a form of market …

https://covid-vaccine.canada.ca/info/pdf/veklury-pm1-en.pdf

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebAn NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. …

https://pdf.hres.ca/dpd_pm/00072885.PDF

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Drug Monographs - Pharmacology and Drug Information - Library …

(5 days ago) WebThe Compendium of Pharmaceuticals and Specialties (CPS) is the Canadian standard for drug monographs, developed by manufacturers, approved by Health …

https://library.rrc.ca/drug_information/drug_monographs

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Guidance document: Product Monograph (2020) - Open …

(5 days ago) WebGuidance document: Product Monograph (2020) The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and …

https://open.canada.ca/data/en/dataset/e1bb9e71-ca42-473b-8c55-0734553a82fd

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(2 days ago) WebPediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (≥65 …

https://pi.lilly.com/ca/verzenio-ca-pm.pdf

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PRODUCT MONOGRAPH - pdf.hres.ca

(9 days ago) WebOTEZLA® Product Monograph Page 1 of 31 PRODUCT MONOGRAPH PrOTEZLA® apremilast tablets 10 mg, 20 mg, and 30 mg Selective Immunosuppressant Amgen …

https://pdf.hres.ca/dpd_pm/00054839.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebAn NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. …

https://pdf.hres.ca/dpd_pm/00071837.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrKISQALITM (ribociclib tablets) 200 mg ribociclib (as ribociclib succinate) Protein …

https://pdf.hres.ca/dpd_pm/00044564.PDF

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PRODUCT MONOGRAPH PrAPO-HYDROXYUREA

(9 days ago) WebPRODUCT MONOGRAPH PrAPO-HYDROXYUREA Hydroxyurea Capsules USP 500 mg Antineoplastic Agent APOTEX INC. DATE OF REVISION: † Hydrea is marketed by …

https://pdf.hres.ca/dpd_pm/00058293.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WebAn NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. …

https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf

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Product information - health-products.canada.ca

(4 days ago) WebThe product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. …

https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=100057

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Health Canada approves Apretude, the first long-acting injectable …

(5 days ago) WebThis drug has been highly effective in clinical trials at significantly reducing the risk of HIV ; Product Monograph. 10 May 2024. ViiV Healthcare Canada. ViiV …

https://www.catie.ca/catie-news/health-canada-approves-apretude-the-first-long-acting-injectable-for-hiv-prevention

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Product information - health-products.canada.ca

(3 days ago) WebThe product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. …

https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=98924

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ViiV Healthcare Announces Health Canada Approval for APRETUDE

(6 days ago) WebThe Product Monograph, posted at www.viivhealthcare.ca, should be consulted for complete administration and safety information, including contraindications, …

https://www.biospace.com/article/releases/viiv-healthcare-announces-health-canada-approval-for-apretude-cabotegravir-tablets-and-extended-release-injectable-suspension-for-pre-exposure-prophylaxis-prep-to-reduce-the-risk-of-sexually-acquired-hiv/

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How to find more informatio­n about a drug that your

(1 days ago) WebYou’re aware that a general internet search may yield unreliable informatio­n, so you decide to look at what’s on the various Health Canada websites. GENERAL …

https://www.pressreader.com/canada/the-telegram-st-johns/20240513/281629605366891

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COVID Vaccination Is ‘Safe’ but Remains Clinically Untested for

(4 days ago) WebHealth Canada responded that the product monographs for authorized COVID-19 vaccines “include a statement that it is unknown whether the COVID-19 …

https://www.theepochtimes.com/world/covid-vaccination-is-safe-but-remains-clinically-untested-for-pregnant-women-health-canada-5645583

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