Health Canada Product Monograph Template 2020

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Product Monograph master template - Canada.ca

(6 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.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 monograph guidance documents and notices - Canada.ca

(Just Now) WebProduct Monograph: Guidance Document [2020-11-01] Product Monograph Master Template [2020-11-01] Frequently Asked Questions: Product …

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

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Draft product monograph master template (2023) - Canada.ca

(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 …

https://www.canada.ca/en/health-canada/programs/consultation-changes-2020-product-monograph-guidance-master-template/master-template.html

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Notice: Product Monograph guidance - canada.ca

(6 days ago) WebHealth Canada will reflect these additional instructions in subsequent updates of the relevant guidance: is working to revise the Guidance Document: Product …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/product-monograph-guidance-formatting-clinical-trials.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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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. Ottawa, ON : Health Canada = …

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

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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 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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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 No data are available to …

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

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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 Template - Standard] - canada.ca

(7 days ago) WebProduct Monograph Master Template Template Date: September 2020 <BRAND NAME><proper name> Page . 16. of . 33. List only Health Canada authorized …

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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[Product Monograph Template - Standard]

(9 days ago) WebProduct Monograph Template Date: September 2020 ZIEXTENZO (Pegfilgrastim Injection) Page 1 of 35 Product Monograph Template Date: September 2020 …

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

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(7 days ago) WebProduct Monograph Master Template Template Date: September 2020 . YERVOY ® (ipilimumab for injection) Page 4 of 74 . RECENT MAJOR LABEL CHANGES Section …

https://www.bms.com/assets/bms/ca/documents/productmonograph/YERVOY_EN_PM.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 2 Contraindications 06/2023 7 Warnings and …

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

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Canadian Product Monograph– Upcoming changes

(7 days ago) WebFrom April 1, 2020 to July 31, 2020, Health Canada will accept XML product monographs on a "by request" basis. Sponsors can submit a request to file XML product …

https://capra.ca/en/blog/canadian-product-monograph-upcoming-changes-implementation-timeline-2020-02-03.htm

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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 …

(8 days ago) WebProduct Monograph Master Template Template Date: September 2020 ZEPOSIA (ozanimod hydrochloride) Page 1 of 74. PRODUCT MONOGRAPH . …

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 Master Template Template Date: September 2020 OPDIVO® (nivolumab) Product Monograph Page 3 of 158 What is a Notice of Compliance with …

https://pdf.hres.ca/dpd_pm/00060858.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

(Just Now) WebProduct Monograph Master Template Template Date: September 2020 SYNTHROID® levothyroxine sodium Page 2 of 43 RECENT MAJOR LABEL CHANGES 2 …

https://www.viatris.ca/-/media/project/common/viatrisca/pdf/brand-and-speciality/synthroid-pm-en.pdf

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[Product Monograph Template - Standard] - Bausch Health

(6 days ago) WebPRODUCT MONOGRAPH PrZYCLARA® Imiquimod Cream 2.5% and 3.75% Immune response modifier Bausch Health, Canada Inc. Date of Revision: 2150 …

https://bauschhealth.ca/wp-content/uploads/pdf/Zyclara%20PM-E-2020-10-29.pdf

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