Health Canada Drug Product Monograph
Listing Websites about Health Canada Drug Product Monograph
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: …
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Guidance document: Product Monograph (2020)
(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…
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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 …
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Product Monograph master template - Canada.ca
(6 days ago) WEBDownload a PDF or Word document of a product monograph template for health products authorized by Health Canada. The template includes sections on indications, …
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Product monograph guidance documents and notices
(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 Consultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15] Health Canada changes filing requirements for …
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Draft product monograph master template (2023)
(7 days ago) WEB14.1 Clinical Trials by Indication. The instructions contained in the Product Monograph Guidance and Master Template supersede the June 24, 2021 Notice: Product …
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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 …
https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=15
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Guidance document : product monograph. : H164 …
(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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Health Product InfoWatch: April 2024 - Canada.ca
(7 days ago) WEBThe following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in March 2024 by Health Canada.
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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 …
(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 …
https://covid-vaccine.canada.ca/info/pdf/veklury-pm1-en.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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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 …
https://library.rrc.ca/drug_information/drug_monographs
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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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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBuse of these and all drug products to Health Canada’s Canada Vigilance Program at 1-866-234-2345. The Product Monograph will be re-issued in the event of serious safety …
https://pdf.hres.ca/dpd_pm/00049463.PDF
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HEALTH PRODUCTS MENTIONED IN THIS ISSUE - canada.ca
(3 days ago) WEBon Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database. …
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Organization and document placement for Canadian module 1
(2 days ago) WEBPreparation of the Product Monograph in Extensible Markup Language (XML) Format. Do not include in this section: Literature references related to the …
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PRODUCT MONOGRAPH - pdf.hres.ca
(9 days ago) WEBPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrTEVA-MODAFINIL modafinil tablets Teva Standard 100 mg Central Nervous System Stimulant …
https://pdf.hres.ca/dpd_pm/00056243.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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PRODUCT MONOGRAPH PrAPO-HYDROXYUREA
(9 days ago) WEBSubmission Control Number: 239807. Page 2 of 22. PRODUCT MONOGRAPH. PrAPO-HYDROXYUREA Hydroxyurea Capsules USP 500 mg. THERAPEUTIC …
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 MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBBased on the data submitted and reviewed by Health Canada, the safety and efficacy of RINVOQ in pediatric patients 12-17 years of age, weighing ≥ 40 kg has been …
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf
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Importation of Italian-authorized Cisatracurio Hikma 2 mg/mL …
(6 days ago) WEBTo help mitigate the shortage of Cisatracurium Omega (Cisatracurium Besylate Injection, 2mg/mL) in Canada, Health Canada has permitted the exceptional, temporary …
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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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