Health Canada Product Monograph Template

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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 …

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 monographs: Frequently asked questions

(5 days ago) WEBHealth Canada released the 2020 updates to the Guidance Document: Product Monograph and the Master Product Monograph Template to consolidate previously separate templates, add and clarify …

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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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 IMVAMUNE Smallpox and Monkeypox Vaccine Page 4 of 32 PART I: HEALTH PROFESSIONAL …

https://pdf.hres.ca/dpd_pm/00063755.PDF

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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 OPDIVO® (nivolumab) Product Monograph Page 3 of 161 What is a Notice of Compliance with …

https://pdf.hres.ca/dpd_pm/00060487.PDF

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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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Product Information Template: Regulatory Enrolment Process

(6 days ago) WEBFrom Health Canada. Date modified: 2024-02-12. Regulatory Enrolment Process Forms Product Information Template: Regulatory Enrolment Process (REP) (Version 4.4.2) …

https://health-products.canada.ca/rep-pir/v44/product/product.html

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Template Date: September 2020 Health Canada. Products authorized under Health Canada’s NOC/c policy are intended for the treatment, …

https://pdf.hres.ca/dpd_pm/00066254.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SOTYKTU (deucravacitinib) Page 1 of 31 PRODUCT MONOGRAPH INCLUDING PATIENT …

https://www.bms.com/assets/bms/ca/documents/productmonograph/SOTYKTU_EN_PM.pdf

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 PREHEVBRIO (3-antigen, recombinant Hepatitis B vaccine) Page 1 of 21 Pediatrics (< 18 years of …

https://pdf.hres.ca/dpd_pm/00069966.PDF

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[Product Monograph Template - Standard] - canada.ca

(7 days ago) WEBProduct Monograph Master Template Template Date: September 2020 <BRAND NAME><proper name> Page . 16. of . 33. Product Monograph . Products …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/master-template.docx

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How to navigate Health Canada XML PM requirements

(3 days ago) WEBAccording to Health Canada guidelines, the XML PM contents should include PM documents, organization and product metadata. These changes will apply …

https://www.biopharmadive.com/spons/how-to-navigate-health-canada-xml-pm-requirements/596532/

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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Template Date: September 2020 ZIEXTENZO (Pegfilgrastim Injection) Page 1 of 35 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

https://pdf.hres.ca/dpd_pm/00074020.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Template Date: September 2020 XENICAL, orlistat Page 2 of 48 RECENT MAJOR LABEL CHANGES No data are available to Health Canada; …

https://pdf.hres.ca/dpd_pm/00071526.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(7 days ago) WEBProducts authorized under Health Canada’s NOC/c policy are intended for the treatme nt, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They …

https://www.bms.com/assets/bms/ca/documents/productmonograph/YERVOY_EN_PM.pdf

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Novolin Product Monograph - Novo Nordisk Canada

(1 days ago) WEBProduct Monograph Master Template Template Date: September 2020 NOVOLIN ® GE Insulin, Human Biosynthetic Page 5 of 6 1.2 Geriatrics • Geriatrics (≥65 years): No data …

https://www.novonordisk.ca/content/dam/nncorp/ca/en/products/novolin-product-monograph1.pdf

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBNo data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. Ulcerative Colitis A limited number of patients …

https://www.bms.com/assets/bms/ca/documents/productmonograph/ZEPOSIA_EN_PM.pdf

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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Template – Schedule D Template Date: October 2019 Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION Health Canada has authorized the …

https://pdf.hres.ca/dpd_pm/00058622.PDF

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