Health Canada Authorized Monograph
Listing Websites about Health Canada Authorized Monograph
Product monographs: Frequently asked questions - Canada.ca
(2 days ago) People also askWhat are Health Canada authorized product monographs?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), combination product, or subsequent entry product.PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMA…canada.caHow do I get a Health Canada product monograph?A Product Monograph that is not available on the Health Canada website may still be obtained through a direct request to the Department. The version released will reflect the latest Health Canada-authorized document and may not be identical to the version maintained by the product sponsor.Frequently Asked Questions: Product Monographs Posted to the Health canada.caHow does Health Canada Review a product monograph?Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission.Guidance document: Product Monograph (2020) - Canada.cacanada.caWhich language should a product monograph be supplied to Health Canada?For pharmaceutical prescription products and those administered or obtained through a health professional, the product monograph should be supplied to Health Canada in both official languages (i.e., Canadian English and French).Guidance document: Product Monograph (2020) - Canada.cacanada.caFeedbackCanada.cahttps://www.canada.ca/en/health-canada/servicesDrug Product Database: Access the database - Canada.caWEBAccess 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 …
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Frequently Asked Questions: Product Monographs Posted to …
(4 days ago) WEB2.3 Why is Health Canada making Product Monographs available? Health Canada’s commitment to make Product Monographs available is in line with the Department’s …
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Updates to the 2020 product monograph guidance and master …
(1 days ago) WEBThis consultation ran from September 15, 2023, to November 13, 2023. Health Canada has revised the 2020 product monograph guidance and master template used by drug …
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Health Canada changes filing requirements for product …
(9 days ago) WEBMarch 10, 2023. Our file number: 23-101262-834. Effective immediately, Health Canada is changing the submission requirements for second language product monographs for …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBTablet (pink): 150mg. Tablet core: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, and sodium stearyl fumarate. Film coat: …
https://covid-vaccine.canada.ca/info/pdf/paxlovid-pm-en.pdf
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Oral Health Products Monograph - Minister of Health
(7 days ago) WEB2024-02-23 2 FOREWORD This monograph is intended to replace the existing Oral Health Products Monograph of August 26, 2022. This monograph describes the requirements …
https://webprod.hc-sc.gc.ca/nhpid-bdipsn/dbImages/mono_oral-health-products_english.pdf
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Primary Sunscreen Monograph - Minister of Health
(4 days ago) WEBbe market authorized without the submission to Health Canada of additional evidence. It also may contain the test methods recommended to be used to comply with the …
https://webprod.hc-sc.gc.ca/nhpid-bdipsn/dbImages/mono_primary-sunscreen-monograph_english.pdf
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Archived: Product Monograph Template - Standard - Canada.ca
(6 days ago) WEB1. Identity of the reference product, including the manufacturer, and origin (country of purchase). 2. Indicate % Confidence Interval (i.e., 90% or 95%) in the column heading …
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Health Product InfoWatch: May 2024 - Canada.ca
(5 days ago) WEB2. Vyvanse (lisdexamfetamine dimesylate) [product monograph]. Toronto (ON): Takeda Canada Inc., 2024. 3. Date modified: 2024-05-30. The following is a list of …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBTEPMETKO® Product Monograph Page 4 of 32 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEPMETKO (tepotinib) is indicated for the treatment of …
https://pdf.hres.ca/dpd_pm/00074821.PDF
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Product information - health-products.canada.ca
(2 days ago) WEBProduct information. The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. …
https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102190
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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 Pediatrics (< 12 years of age): …
https://pdf.hres.ca/dpd_pm/00071526.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(6 days ago) WEBProduct Monograph Master Template Template Date: September 2020 <BRAND NAME><proper name> Page 6 of 33 1.2 Geriatrics One of the following or similar …
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBProduct Monograph Template Date: September 2020 JARDIANCE (empagliflozin) Page 2 of 70 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 04/2022 2 …
https://pdf.hres.ca/dpd_pm/00069876.PDF
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(9 days ago) WEBevidence of clinical effectiveness following review of the submission by Health Canada. Products authorized under Health Canada’s NOC/c policy are intended for the …
https://pdf.hres.ca/dpd_pm/00070427.PDF
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[Product Monograph Template - Standard] - canada.ca
(7 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 illness.
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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …
(4 days ago) WEBPRODUCT MONOGRAPH . INCLUDING PATIENT MEDICATION INFORMATION . PrXCOPRITM . Cenobamate tablets . Tablets, 12.5 mg, 25 mg, 50 mg, 100 mg, 150mg, …
https://www.endodocuments.com/XCOPRI/MONOGRAPH/CAN/ENG
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