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| 02402cam 2200433zi 4500 |
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| 001 | 9.862435 |
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| 003 | CaOODSP |
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| 005 | 20221107161021 |
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| 006 | m o d f |
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| 007 | cr cn||||||||| |
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| 008 | 180926t20182018onc ob f000 0 eng d |
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| 020 | |a9780660279435 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH13-9/27-2018E-PDF |
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| 245 | 00|aGuidance document : |bregulatory requirements for intravenous immunoglobulin products in Canada. |
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| 246 | 30|aRegulatory requirements for intravenous immunoglobulin products in Canada |
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| 246 | 17|aRegulatory requirements for IVIG products in Canada |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2018. |
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| 264 | 4|c©2018 |
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| 300 | |a1 online resource (12 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 à l'intention des promoteurs : exigences réglementaires canadiennes applicables aux produits d'immunoglobuline intraveineuse. |
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| 500 | |aCover title. |
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| 500 | |a"Publication date: October 2018." |
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| 500 | |aIssued by: Health Products and Food Branch. |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"The purpose of this document is to provide guidance to sponsors of IVIG products on the regulatory requirements, particularly minimum clinical data requirements for submissions involving approved and non-approved IVIG products. This guidance applies to IVIG products which are: non-approved in Canada, approved but seeking to add indication(s) for use in Canada"--Introduction, page 5. |
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| 692 | 07|2gccst|aHealth care products |
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| 692 | 07|2gccst|aHealth policy |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 710 | 1 |aCanada. |bHealth Products and Food Branch. |
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| 775 | 08|tLigne directrice à l'intention des promoteurs : |w(CaOODSP)9.862438 |
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| 856 | 40|qPDF|s603 KB|uhttps://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-27-2018-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/drug/regulatory-requirements-intravenous-immunoglobulin-ivig-products-canada-profile/guidance-document.html |
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