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| 02277nam 2200397zi 4500 |
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| 001 | 9.890868 |
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| 003 | CaOODSP |
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| 005 | 20240918093410 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 200825t20202020onc ob f000 0 eng d |
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| 020 | |a9780660358857 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-299/2020E-PDF |
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| 245 | 00|aGuidance document : |bproduct monograph. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2020. |
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| 264 | 4|c©2020 |
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| 300 | |a1 online resource (64 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued also in French under title: Ligne directrice : monographie de produit. |
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| 500 | |a"Publication date: November 2020." |
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| 500 | |a"Pub.: 200165." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical reference. |
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| 520 | |a"The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health 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 compared. This guidance document supersedes the Guidance Document: Product Monograph (2014) and the Guidance Document: Product Monograph (2016) for all drug product submissions identified under section 1.2 Scope and application"--Introduction, page 8. |
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| 650 | 0|aDrug approval|zCanada. |
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| 650 | 0|aDrugs|xSpecifications|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLigne directrice : |w(CaOODSP)9.890870 |
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| 794 | |tGuidance document : |w(CaOODSP)9.943343 |
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| 856 | 40|qPDF|s592 KB|uhttps://publications.gc.ca/collections/collection_2020/sc-hc/H164-299-2020-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/guidance-document-product-monograph-2020.html |
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