Health Canada Product Monograph
Listing Websites about Health Canada Product Monograph
Drug Product Database: Access the database - Canada.ca
(Just Now) WEBAccess the database. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: availability of the drug in Canada. product monograph (PM) for human drugs. labels for animal drugs. Generic drug manufacturers must update their PM to ensure it aligns with …
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Guidance Document - Product Monograph - Canada.ca
(8 days ago) WEBThe product monograph should be supplied to Health Canada in either official language. Health care providers are encouraged to report Adverse Drug Reactions associated with normal use of these and all drug products to Health Canada's Canada Vigilance Program at 1-866-234-2345. The Product Monograph will be re …
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Product monographs: Frequently asked questions
(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 Health Canada-authorized …
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Compendium of Monographs - Canada.ca
(4 days ago) WEBFind written descriptions of medicinal ingredients commonly used in natural health products (NHPs) for safety and efficacy evaluation. Access the Natural Health Products Ingredients Database for single ingredient and product monographs, as well as guidance documents and other resources.
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Product information - health-products.canada.ca
(2 days ago) WEBThe product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of
https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102190
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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. A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be
https://publications.gc.ca/site/eng/9.890868/publication.html
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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 Canada; therefore, Health Canada has not authorized an indication for pediatric patients below the age of 12 years. See 10.3 Pharmacokinetics,
https://pdf.hres.ca/dpd_pm/00071526.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(4 days ago) WEB17,300 Trans-Canada Highway Kirkland, Quebec, Canada H9J 2M5 Date of Initial Authorization: Product Monograph Page 5 of 83 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus (COVID-19 Vaccine, mRNA) Product …
https://covid-vaccine.canada.ca/info/pdf/pfizer-biontech-covid-19-vaccine-pm1-en.pdf
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBPfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Product Monograph Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ABRYSVO (Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine) is a bivalent vaccine ABRYSVO (Respiratory Syncytial Virus Stabilized …
https://pdf.hres.ca/dpd_pm/00073900.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBAn NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products authorized under Health anada’s NO/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness.
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf
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PRODUCT MONOGRAPH
(9 days ago) WEBAG-Silodosin (Silodosin Capsules) Product Monograph Page 1 of 35 PRODUCT MONOGRAPH PrAG-Silodosin Silodosin Capsules 4 mg and 8 mg Selective antagonist for ALPHA 1A Adrenoreceptor subtype in the prostate and bladder ATC code: G04C A04 Angita Pharma Inc. 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of …
https://pdf.hres.ca/dpd_pm/00072425.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, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising
https://www.bms.com/assets/bms/ca/documents/productmonograph/YERVOY_EN_PM.pdf
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBsection of the product monograph. 4 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations • Adtralza can be used with or without topical corticosteroids. Adtralza may be used with topical calcineurin inhibitors. • Health Canada has not authorized an indication for pediatric use in patients < 12 years of
https://pdf.hres.ca/dpd_pm/00069461.PDF
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PRODUCT MONOGRAPH
(9 days ago) WEBAmgen Canada Inc. 6775 Financial Drive, Suite 100 Mississauga, Ontario L5N 0A4 Date of Revision: July 24, 2018 PART I: HEALTH PROFESSIONAL INFORMATION XGEVA Product Monograph Page 7 of 62 Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
https://pdf.hres.ca/dpd_pm/00046892.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBPRODUCT MONOGRAPH . INCLUDING PATIENT MEDICATION INFORMATION. Health Canada has not authorized an indication for pediatric use (See 1.1 . Pediatrics). Required supplies and materials for product preparation (not included in product package) • Normal saline infusion bag(s)* of 500 mL (1 or 2 based on the patient’s body weight – …
https://labeling.cslbehring.ca/PM/CA/Hemgenix/EN/Hemgenix-Product-Monograph.pdf
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QULIPTA™ (atogepant) Now Approved by Health Canada for the …
(3 days ago) WEB1 AbbVie Canada. QULIPTA Product Monograph. May 2024. 2 AbbVie. Data on File: ABVRRTI73750. 3 Headache Classification Committee of the International Headache Society (IHS) The International
https://finance.yahoo.com/news/qulipta-atogepant-now-approved-health-120000841.html
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Jemperli Product Monograph - GSK
(5 days ago) WEBProducts authorized under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating disease. Jemperli in the pivotal study RUBY, and also refer to the Product Monographs of the chemotherapy agents, as appropriate. Jemperli monotherapy
https://ca.gsk.com/media/6620/jemperli_pm.pdf
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBXELJANZ/XELJANZ XR (tofacitinib citrate) - Product Monograph Page 2 of 86 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 12/2021 1.2 INDICATIONS, Geriatrics 12/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Malignancies 12/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, MACE 12/2021 7 WARNINGS AND …
https://pdf.hres.ca/dpd_pm/00063900.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBREBLOZYL® Product Monograph Page 2 of 42 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 02/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2022 Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
https://www.bms.com/assets/bms/ca/documents/productmonograph/REBLOZYL_EN_PM.pdf
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ViiV Healthcare Announces Health Canada Approval for APRETUDE
(6 days ago) WEBThe Product Monograph, posted at www.viivhealthcare.ca, should be consulted for complete administration and safety information, including contraindications, additional warnings and precautions, adverse reactions and drug interactions. 1 Prior to being posted online, the Product Monograph is also available by calling 1-877-393-8448.
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Product information - health-products.canada.ca
(4 days ago) WEBThe product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary …
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=100057
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Interchangeability of Vaccine Products
(7 days ago) WEBFor more than 85 years, health care professionals have “referred to the Red Book” for trustworthy guidance on pediatric infectious disease prevention, management, and control. The new 33rd edition continues this tradition of distinction with the latest clinical guidance on the manifestations, etiology, epidemiology, diagnosis, and treatment
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ISPOR - When and How to Conduct Health Technology …
(2 days ago) WEBABOUT VALUE IN HEALTH Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2022 impact factor score is 4.5 and its 5 …
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COVID Vaccination Is ‘Safe’ but Remains Clinically Untested for
(4 days ago) WEBHealth Canada responded that the product monographs for authorized COVID-19 vaccines “include a statement that it is unknown whether the COVID-19 vaccine is excreted in human milk.”
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