Health Canada Combination Products

Listing Websites about Health Canada Combination Products

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Drug/Medical Device Combination Products - Canada.ca

(3 days ago) The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window … See more

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/drug-medical-device-combination-products.html

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Issue identification paper: Drug-device combination …

(Just Now) WEBObjective. This paper is intended to identify the key challenges associated with Health Canada's oversight of drug-device combination products (DDCPs) as per …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft/document.html

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Consultation on the Issue identification paper: Drug …

(1 days ago) WEBThis consultation ran from April 6, 2021 to June 7, 2021. See the “What we heard” report for summaries of the discussions that took place. Drug-device …

https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft.html

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Guidance on Medical Device Establishment Licensing …

(1 days ago) WEBHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Combination products A combination product is a …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

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Combination Products - Canadian Clinical Drug Data Set

(3 days ago) WEBCombination Products Introduction and Requirement. A Combination Product is one that consists of more than one component part, commonly known as a …

https://infoscribe.infoway-inforoute.ca/display/CCDD/Combination+Products

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Health Product InfoWatch: April 2024 - Canada.ca

(7 days ago) WEBOakville (ON): Aspen Pharmacare Canada Inc.; 2024. 1. Sulfatrim, Sulfatrim DS, Sulfatrim Pediatric (sulfamethoxazole and trimethoprim tablets USP) [product …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/april-2024.html

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Drug/Medical Device Combination Products - Open …

(5 days ago) WEBThe purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient …

https://open.canada.ca/data/en/dataset/1e840214-3367-40fa-b713-f70d4be8340a

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Proposed Regulation/Guidance Document

(1 days ago) WEBPage 1of 11. ISPE. 6110 Executive Blvd., Suite 600, North Bethesda, MD 20852 USA T 1 301-364-9201 F 1 240-204-6024 ispe.org. Proposed Regulation/Guidance Document: …

https://ispe.org/sites/default/files/regulatory/ISPE-Commenting/2021/ISPECommentsHealthCan2021-07.pdf

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Health Products and Food Branch - PDA

(Just Now) WEBcombination products in recent years While their legal frameworks . for these combination products may differ slightly from Canada’s, key elements are …

https://www.pda.org/docs/default-source/website-document-library/scientific-and-regulatory-affairs/regulatory-comments-resources/2021/pda-comments-to-health-canada-issue-identification-paper---drug-device-combination-products-21-july-2021.pdf?sfvrsn=cee16881_2

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Drug-Device Combination Products under MDR BSI Canada

(3 days ago) WEBIntroduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the …

https://www.bsigroup.com/en-CA/Medical-Devices/Technologies/drug-device-combination-products/

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Health Canada - Canada.ca

(3 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …

https://www.canada.ca/en/health-canada.html

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Regulatory Affairs for Combination Products - Frontiers

(3 days ago) WEBCombination products are medical products that combine two or more different product types, including drugs, devices, or biological products, into a single entity. Similarly, …

https://www.frontiersin.org/research-topics/57767/regulatory-affairs-for-combination-products

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Combination Products: A Growing Trend in Health Technology

(8 days ago) WEBWhen a drug or biologic is combined with a medical device, for example, that might be considered a combination product. A drug prefilled syringe is a straightforward …

https://array.aami.org/content/news/combination-products-growing-trend-health-technology

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OPSYNVI® (macitentan and tadalafil) Becomes the First and Only …

(8 days ago) WEBHealth Canada’s approval is based on three comparative bioavailability studies, which demonstrated the bioequivalence of a single dose of macitentan 10 mg …

https://www.jnj.com/media-center/press-releases/opsynvi-macitentan-and-tadalafil-becomes-the-first-and-only-health-canada-approved-once-daily-fixed-dose-combination-treatment-for-patients-with-pulmonary-arterial-hypertension-pah

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WEBThere is no formal regulatory definition of cell therapy in Canada, and cell therapies are not specifically listed in the Food & Drugs Act [3].CGTPs in Canada may …

https://www.sciencedirect.com/science/article/pii/S1465324919300416

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBHealth Canada. Products authorized under Health Canada’s NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely

https://pdf.hres.ca/dpd_pm/00066254.PDF

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Quality documentation for medicinal products when used with a …

(5 days ago) WEBKeywords: Medical device, medicinal products, Article 117, Notified Body opinion, Integral, Co-packaged, Referenced Current version - effective from 1/01/2022 …

https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline

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Combination Products Nutrasource

(6 days ago) WEBCombination Products. Products containing more than one active ingredient is the norm in today’s healthcare market. Combination products can pose regulatory and research …

https://www.nutrasource.ca/markets/combination-products/

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RESPIRATORY MEDICATIONS FOR INHALATION AVAILABLE IN …

(8 days ago) WEBDPIs Approved by Health Canada but not marketed pms-Fluticasone propionate (DPI) 100, 250, 500 mcg/ inhalation. Supplied: 60 in a Diskus device Fluticasone …

http://hcp.lunghealth.ca/wp-content/uploads/2022/07/Respiratory_Inhaled_Medication_Products-July-18-2022.pdf

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