Health Canada Monograph Template

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

(1 days ago) WEB1.8 Using the master template. A product monograph should be prepared in the same software format as the other submission documents. List only Health …

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) 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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[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 Template - Standard] - canada.ca

(7 days ago) WEBProduct Monograph Master Template. Template Date: September 2020 <BRAND NAME><proper name> Page . 15. of . 33 [Title Page] PRODUCT MONOGRAPH. List …

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 …

(9 days ago) WEBOrange rectangle film, nominal dimensions 22.0 mm x 19.2 mm, with a white printed logo (N12). Each film is packaged in an individually sealed child-resistant foil pouch. 30 films …

https://pdf.hres.ca/dpd_pm/00069997.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SOTYKTU (deucravacitinib) Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION

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

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

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

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

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Standardized Health Product Risk Communication Template

(9 days ago) WEBAction taken by Health Canada. Text describing any risk management measures (e.g., [specific section] of the product monograph will be updated to reflect …

https://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2010-guid-dir_indust_hppc-cpsp/2015-temp-mod_rc-cr-eng.php

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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 monographs: Frequently asked questions - Pink Sheet

(8 days ago) WEBMonograph template, Schedule D - Biosimilar Biologic Drug, was released in 2017 to guide sponsors in the preparation of biosimilar Product Monographs. W h e re we a re n …

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

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Template Date: September 2020 JARDIANCE (empagliflozin) Page 1 of 70 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION …

https://pdf.hres.ca/dpd_pm/00069876.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Template Date: September 2020 XENICAL, orlistat Page 4 of 48 PART I: HEALTH PROFESSIONAL INFORMATION No data are available to Health …

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

(2 days ago) WEBThe product monograph, as a document, will be included by Health Canada as part of the NOC respecting an NDS or, when appropriate, an SNDS, an ANDS or a Supplement to …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-299-2020-eng.pdf

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