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| 01669nam 2200361zi 4500 |
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001 | 9.865274 |
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003 | CaOODSP |
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005 | 20221107161747 |
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006 | m o d f |
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007 | cr ||||||||||| |
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008 | 181127s2019 onc o f000 0 eng d |
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020 | |a9780660287041 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH164-255/2019E-PDF |
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245 | 00|aFormat and content for post-market drug benefit-risk assessment in Canada. |
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264 | 1|aOttawa : |bHealth Canada, |c2019. |
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264 | 4|c©2019 |
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300 | |a1 online resource (iii, 15 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: Format et contenu des évaluations des avantages et des risques après la mise en marché au Canada. |
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500 | |a"Guidance document." |
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500 | |aIssued also in HTML format. |
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504 | |aIncludes references. |
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520 | |a"The objective of this guidance document is to assist Market Authorization Holders (MAHs) in developing a post-market benefit-risk assessment for a marketed drug when requested"--Objective, page 1. |
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692 | 07|2gccst|aDrugs |
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710 | 1 |aCanada. |bHealth Canada. |
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775 | 08|tFormat et contenu des évaluations des avantages et des risques après la mise en marché au Canada |w(CaOODSP)9.865275 |
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856 | 40|qPDF|s394 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H164-255-2019-eng.pdf |
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856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/publications/drugs-health-products/content-drug-benefit-risk-assessment/guidance-document.html |
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