Health Canada Monograph Update

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Guidance document: Product Monograph (2020)

(1 days ago) WebAdministrative updates; Effective Date 2010/01/01. 3: Guidance Document: Product Monograph: List only Health Canada authorized product monographs that were supportive in the development of the product monograph (e.g., Canadian Reference Product for a generic, or Reference Biologic Drug for a biosimilar biologic drug), …

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 monograph guidance documents and notices

(Just Now) WebConsultation: Draft guidance on the preparation of the product monograph in XML format [2023-08-15] Health Canada changes filing requirements for product monographs: Notice [2023-03-10] Notice: Phase II of the XML PM Project (Product Monograph in the Extensible Markup Language Format) [2021-05-28] Notice - 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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Update on Health Canada's Monograph Revision Plan: Batch 2

(8 days ago) WebThese monographs serve as essential references for the regulation and oversight of natural health products in Canada. Update on the Rollout. The NNHPD released Batch 2 of the revised draft monographs for consultation on January 31, 2024. This batch comprises 27 updated monographs, reflecting the latest scientific evidence …

https://dicentra.com/blog/health-canada/update-on-health-canadas-monograph-revision-consultation-plan-batch-2-released

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Notice - Product Monograph Implementation Plans

(8 days ago) WebUPDATE: In light of current priorities and circumstances related to COVID-19, Health Canada is revising the Product Monograph Implementation timelines. Health Canada will initiate Phase I: Production Testing of the XML product monograph project beginning June 1, 2020. The timeline for adoption of the 2016 Guidance Document: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-product-monograph-implementation-plans.html

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HEALTH PRODUCTS MENTIONED IN THIS ISSUE

(2 days ago) WebProduct monograph update The following safety labelling update, which was recently made to the Canadian product monograph, has been selected for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product …

https://publications.gc.ca/collections/collection_2023/sc-hc/H167-1-2023-2-eng.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. Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 : Description : 1 online resource (64 pages) ISBN : 9780660358857 : Catalogue number : H164-299/2020E-PDF; Subject terms : Drug approval -- Canada.

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

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Oral Health Products Monograph - Minister of Health

(7 days ago) WebThis monograph is intended to replace the existing Oral Health Products Monograph of August 26, 2022. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for oral health products.

https://webprod.hc-sc.gc.ca/nhpid-bdipsn/dbImages/mono_oral-health-products_english.pdf

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Health Canada issues label change on the AstraZeneca and …

(8 days ago) WebOn March 24, Health Canada updated the product monograph-or label-for the AstraZeneca and COVISHIELD COVID-19 vaccines to provide information on very rare reports of blood clots associated with low levels of blood platelets following immunization with the AstraZeneca vaccine. On March 29, Health Canada issued Terms and …

https://recalls-rappels.canada.ca/en/alert-recall/health-canada-issues-label-change-astrazeneca-and-covishield-covid-19-vaccines

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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 content. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission.

https://open.canada.ca/data/en/dataset/e1bb9e71-ca42-473b-8c55-0734553a82fd

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Health Canada updates Pfizer-BioNTech and Moderna COVID-19 …

(1 days ago) WebIssue. Health Canada has updated the product monographs (labels) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to describe very rare reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.. Cases of myocarditis and/or pericarditis following …

https://recalls-rappels.canada.ca/en/alert-recall/health-canada-updates-pfizer-biontech-and-moderna-covid-19-vaccine-labels-include

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What should manufacturers know about health canada monographs

(4 days ago) WebUpdates and Revisions: Health Canada requires manufacturers to keep their product monographs updated with new information, including any changes to indications, dosing, safety information, or manufacturing processes. This helps ensure the most current and accurate information is available to healthcare professionals and patients.

https://qualitysmartsolutions.com/blog/health-canada-product-monographs-2/

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Ezetrol (ezetimibe) and the Risks of Drug-Induced Liver Injury and

(2 days ago) WebThe Canadian Product Monograph (CPM) Health Canada will work with manufacturers of generic versions of ezetimibe to update their respective CPMs. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site.

https://recalls-rappels.canada.ca/en/alert-recall/ezetrol-ezetimibe-and-risks-drug-induced-liver-injury-and-severe-cutaneous-adverse

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Fish Oil - Canada.ca - Minister of Health

(7 days ago) WebClinical prevention of sudden cardiac death by n-3 polyunsaturated fatty acids and mechanism of prevention of arrhythmias by n-3 fish oils. Circulation 2003;107 (21):2646-2652. Marszalek JR, Lodish HF. Docosahexaenoic acid, fatty acid-interacting protein, and neuronal function: breastmilk and fish are good for you.

https://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=88

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Update on Health Canada's Monograph Revision Plan: Batch 3

(8 days ago) WebUpdate on the Rollout. Health Canada released Batch 3 of the revised draft monographs for consultation on May 1, 2024. This batch consists of 21 updated monographs, along with one new monograph supporting the medicinal ingredient Nicotinamide mononucleotide. This derivative of vitamin B3 is often present in Class III …

https://dicentra.com/blog/health-canada/update-on-health-canadas-monograph-revision-consultation-plan-batch-3-released

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Scientists Await Updates on H5N1 Situation in Canada - Medscape

(6 days ago) WebCarolyn Crist. May 15, 2024. 0. 1. As the H5N1 avian influenza virus continues to spread among poultry and cattle in the United States — and has infected a dairy worker in Texas — public

https://www.medscape.com/viewarticle/scientists-await-updates-h5n1-situation-canada-2024a100099n

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Optimi Health Receives Export Permit from Health Canada to Ship …

(2 days ago) WebVANCOUVER, British Columbia, May 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed GMP psychedelics pharmaceutical

https://finance.yahoo.com/news/optimi-health-receives-export-permit-120000396.html

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Financial Stability Report—2024 - Bank of Canada

(8 days ago) WebThe cash-futures basis trade is estimated to have grown steadily in Canada (Chart 3‑A), with exchange-for-physical transactions reaching $51 billion by the end of April 2024.35 This represents about 8% of the total trading volume of Government of Canada bonds (Chart 3‑B).36, 37 Of the total volume, 45% is in 2-year futures contracts, and

https://www.bankofcanada.ca/2024/05/financial-stability-report-2024/

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Projected estimates of cancer in Canada in 2024: Study - MSN

(4 days ago) WebCancer is still the number one cause of death in Canada (about 25% in 2022) It is projected there will be 247 100 new cancer diagnoses and 88 100 cancer deaths in 2024. This is up from an

https://www.msn.com/en-us/health/other/projected-estimates-of-cancer-in-canada-in-2024-study/ar-BB1mjGF2

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Canadian wildfire smoke map: See where air quality is the worst

(9 days ago) WebMapping smoke from Canada: As wildfires burn, check the air quality in your area. Montana, North Dakota, South Dakota, Minnesota, parts of Wisconsin and Iowa were under an air quality alert Monday

https://www.usatoday.com/story/graphics/2024/05/14/us-canadian-wildfire-smoke-map-2024/73686016007/

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Product monograph brand safety updates - Open Government …

(5 days ago) WebProduct monograph brand safety updates. Label safety assessment update from Health Canada. Publisher - Current Organization Name: Health Canada. Licence: Open Government Licence - Canada.

https://open.canada.ca/data/en/dataset/58f09dc8-f30f-488a-9d7b-1da2f4fcb541

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What to Know About New Covid Variants, ‘FLiRT’: Symptoms, …

(4 days ago) WebThe latest on symptoms and long Covid. Doctors said that the symptoms of both KP.2 and JN.1 — which now makes up around 16 percent of cases — are most likely similar to those seen with other

https://www.nytimes.com/2024/05/10/well/covid-flirt-variants-symptoms.html

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NNHPD Announces NHP Monograph Revision Consultation Plan

(8 days ago) WebHealth Canada’s Natural Non-Prescription Health Products Directorate (NNHPD) recently announced that beginning at the end of October, they will begin consulting on monograph revisions. The primary purpose of the monograph revision initiative is to update NHP monographs, ensuring they conform to the new NHP …

https://dicentra.com/blog/nnhpd/nnhpd-announces-nhp-monograph-revision-consultation-plan

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New COVID variant 'FLiRT': What to know about spread, …

(Just Now) WebThe "FLiRT" variant reportedly has similar symptoms to those from JN.1 which include: Fever or chills. Cough. Sore throat. Congestion or runny nose. Headache. Muscle aches. Difficulty breathing

https://www.usatoday.com/story/news/health/2024/05/07/new-covid-variant-flirt/73596421007/

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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 an ANDS. The product monograph serves as a standard against which all promotional material, or advertising distributed or endorsed by the sponsor about the drug can be …

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

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The Possible Collapse of the U.S. Home Insurance System

(6 days ago) Web68. Hosted by Sabrina Tavernise. Featuring Christopher Flavelle. Produced by Nina Feldman , Shannon M. Lin and Jessica Cheung. Edited by MJ Davis Lin. With Michael Benoist. Original music by Dan

https://www.nytimes.com/2024/05/15/podcasts/the-daily/climate-insurance.html

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