00000nam 2200000zi 4500 9.862435 CaOODSP 20221107161021 m o d f cr cn||||||||| 180926t20182018onc ob f000 0 eng d 9780660279435 CaOODSP eng rda CaOODSP n-cn--- H13-9/27-2018E-PDF Guidance document : regulatory requirements for intravenous immunoglobulin products in Canada. Regulatory requirements for intravenous immunoglobulin products in Canada Regulatory requirements for IVIG products in Canada Ottawa, ON : Health Canada = Santé Canada, 2018. ©2018 1 online resource (12 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Ligne directrice à l'intention des promoteurs : exigences réglementaires canadiennes applicables aux produits d'immunoglobuline intraveineuse. Cover title. "Publication date: October 2018." Issued by: Health Products and Food Branch. Issued also in HTML format. Includes bibliographical references. "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. gccst Health care products gccst Health policy Canada. Health Canada. Canada. Health Products and Food Branch. Ligne directrice à l'intention des promoteurs : (CaOODSP)9.862438 PDF 603 KB https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-27-2018-eng.pdf HTML N/A https://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 180345