Health Canada Monograph 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. Ottawa, ON : Health Canada = …

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 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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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(9 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SUBOXONE (buprenorphine / naloxone) Page 1 of 78 PRODUCT MONOGRAPH INCLUDING …

https://pdf.hres.ca/dpd_pm/00063411.PDF

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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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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 …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 SOTYKTU (deucravacitinib) Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION

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

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

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REP Templates for Health Canada

(2 days ago) WEBCompany (CO) Template (updated 2023-02-28) Required to obtain a company ID and/or update company information to Health Canada. Sent via email. Attach draft CO XML file …

https://health-products.canada.ca/rep-pir/index.html

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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 …

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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An update on the new XML Product Monograph (XML PM)

(2 days ago) WEBThe launch date for Phase III will be announced after Health Canada evaluates the results of Phase II. What you need to know: The Product Monograph has undergone a series …

https://regulatory.axsource.com/an-update-on-the-new-xml-product-monograph-xml-pm/

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PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION …

(8 days ago) WEBProduct Monograph Master Template Template Date: September 2020 ZEPOSIA (ozanimod hydrochloride) Page 1 of 74. PRODUCT MONOGRAPH . …

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

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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 Template - Standard]

(9 days ago) WEBProduct Monograph Template – Schedule D Template Date: October 2019 Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION Health Canada has authorized the …

https://pdf.hres.ca/dpd_pm/00058622.PDF

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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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