Health Canada Product Monograph Template 2020

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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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[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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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) WEBIn vitro binding of lenvatinib to human plasma proteins is high and ranged from 98% to 99% (0.3 – 30 μg/mL, mesylate). This binding was mainly to albumin with minor binding to α1 …

https://pdf.hres.ca/dpd_pm/00066254.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 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 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 No data are available to …

https://pdf.hres.ca/dpd_pm/00069966.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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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 Template - Standard]

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 OPDIVO® (nivolumab) Product Monograph Page 3 of 169 What is a Notice of Compliance with …

https://pdf.hres.ca/dpd_pm/00061141.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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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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LS - GA Health Canada XML Product Monograph (B) - Reed Tech

(5 days ago) WEBAll XML Product Monographs must use the 2020 template. The scope includes regulatory activities using electronic Common Technical Documents (eCTD) including new drug …

https://go.reedtech.com/en/health-canada-xml-product-monograph-for-drug-information-b

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Product monographs: Frequently asked questions - Pink Sheet

(8 days ago) WEBA new Product Monograph template, Schedule D - Biosimilar Biologic Drug, was released in 2017 to guide sponsors in the preparation of biosimilar Product Monographs. W h e …

https://pink.citeline.com/-/media/supporting-documents/pink-sheet/2020/11/p1120can_3.pdf

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