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| 03031nam 2200445zi 4500 |
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| 001 | 9.938524 |
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| 003 | CaOODSP |
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| 005 | 20240725141621 |
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| 006 | m o d f |
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| 007 | cr mn||||||||| |
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| 008 | 240212e202405 onca ob f000 0 eng d |
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| 020 | |a9780660720524 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-327/2024E-1-PDF |
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| 245 | 00|aGuidance on nitrosamine impurities in medications. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cMay 2024. |
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| 264 | 4|c©2024 |
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| 300 | |a1 online resource (iii, 56 pages) : |billustrations (some colour) |
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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: Lignes directrices sur les impuretés de nitrosamine dans les médicaments. |
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| 500 | |a"Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological and radiopharmaceutical products." |
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| 500 | |a"Date adopted: 2024-05-31." |
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| 500 | |a"Effective date: 2024-05-31." |
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| 500 | |a"Pub.: 240217"--Verso of cover. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to change as new information becomes available and if further guidance is needed for applicants and market authorization holders (MAHs). A questions-and-answers (Q&A) document on nitrosamines was issued to MAHs on November 26, 2019. This document has undergone a number of revisions and has been further updated as a guidance document and to provide additional details to active pharmaceutical ingredient (API) manufacturers, drug product manufacturers, MAHs and importers of APIs and drug products. In this guidance document, changes from the previous version are identified with the descriptors "new" or "updated" (as applicable). Information on a similar theme is grouped together under general headings (for example, General, Safety and Quality). …"--Background, page 1. |
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| 650 | 0|aNitrosoamines|xRisk assessment|zCanada. |
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| 650 | 0|aDrugs|xRisk assessment|zCanada. |
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| 650 | 0|aBiologicals|xRisk assessment|zCanada. |
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| 650 | 0|aRadiopharmaceuticals|xRisk assessment|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les impuretés de nitrosamine dans les médicaments.|w(CaOODSP)9.938526 |
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| 795 | |tGuidance on nitrosamine impurities in medications.|b(March 2024)|w9.933796 |
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| 856 | 40|qPDF|s1.16 MB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-327-2024-eng-1.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html |
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