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Product Monograph master template - Canada.ca

(6 days ago) The Patient Medication Information section should be written at the grade 6-8 reading literacy level. Read this for safe and effective use of your medicine … See more

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 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. : 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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[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 …

(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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1.3.1 Product Monograph

(9 days ago) WebProduct Monograph Master Template Template Date: September 2020 TPOXX® Tecovirimat capsules Page 5 of 28 PART I: HEALTH PROFESSIONAL INFORMATION …

https://pdf.hres.ca/dpd_pm/00063782.PDF

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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 to …

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

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An update on the new XML Product Monograph (XML …

(2 days ago) WebThe launch date for Phase III will be announced after Health Canada evaluates the results of Phase II. What you need to know: The Product Monograph has undergone a series of modifications, the most …

https://regulatory.axsource.com/an-update-on-the-new-xml-product-monograph-xml-pm/

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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 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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REP Templates for Health Canada

(2 days ago) WebCompany (CO) Template (updated 2023-02-28) Required to obtain a company ID and/or update company information to Health Canada. Sent via email. Attach draft CO XML file …

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

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Product monograph guidance documents and notices - Canada.ca

(Just Now) WebConsultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15] Health Canada changes filing requirements for 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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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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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 the new …

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 Master Template Template Date: September 2020 Health Canada has not authorized an indication for pediatric use. See 1.1 Pediatrics above. 4.4 …

https://pdf.hres.ca/dpd_pm/00071615.PDF

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Draft guidance document: Product monograph (2023) - Canada.ca

(Just Now) WebHealth Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. This guidance document supersedes …

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

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What’s Been Happening with Health Canada XML PM Mandates?

(8 days ago) WebThe above graphic (used in the webinar presentation) explains the process of creating and submitting your Health Canada XML Product Monograph Information. …

https://www.reedtech.com/knowledge-center/whats-been-happening-with-health-canada-xml-pm-mandates/

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Product monographs: Frequently asked questions - Canada.ca

(5 days ago) Web1.0 Purpose. This Frequently Asked Questions (FAQ) document is intended to create a centralized location for Canadians and drug sponsors to find information about …

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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Notice: Phase II of the XML PM Project (Product Monograph in the

(5 days ago) WebHealth Canada is working on a strategic approach to support the transition of all product monographs into the XML format, which will become a mandatory requirement for …

https://open.canada.ca/data/en/dataset/7b1bcae6-a9be-4174-8962-51b2f76edc39

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