Product Monograph Health Canada Template

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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 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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[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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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 …

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

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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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PRODUCT MONOGRAPH INCLUDING PATIENT …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SOTYKTU (deucravacitinib) Page 1 of 31 PRODUCT MONOGRAPH INCLUDING PATIENT …

https://www.bms.com/assets/bms/ca/documents/productmonograph/SOTYKTU_EN_PM.pdf

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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 …

https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103244

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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 …

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

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Template Date: September 2020 JARDIANCE (empagliflozin) Page 1 of 70 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION …

https://pdf.hres.ca/dpd_pm/00069876.PDF

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(7 days ago) WEBProducts 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 …

https://www.bms.com/assets/bms/ca/documents/productmonograph/YERVOY_EN_PM.pdf

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Canadian Product Monograph– Upcoming changes

(7 days ago) WEBIn April 2019, Health Canada announced its intent to transition product monograph templates to a structured format based on XML, Health Level 7's (HL7) …

https://capra.ca/en/blog/canadian-product-monograph-upcoming-changes-implementation-timeline-2020-02-03.htm

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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. …

https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=100057

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBNo data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. Ulcerative Colitis A limited number of patients …

https://www.bms.com/assets/bms/ca/documents/productmonograph/ZEPOSIA_EN_PM.pdf

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[Product Monograph Template - Standard]

(9 days ago) WEBProduct Monograph Template Date: September 2020 ZIEXTENZO (Pegfilgrastim Injection) Page 1 of 35 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

https://pdf.hres.ca/dpd_pm/00074020.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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How to find more information about a drug that your doctor …

(4 days ago) WEBEvery drug that’s approved by Health Canada comes with what’s known as a product monograph (PM). According to Health Canada a PM “is a factual, scientific …

https://theconversation.com/how-to-find-more-information-about-a-drug-that-your-doctor-prescribed-228866

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