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Guidance document : regulatory requirements for intravenous immunoglobulin products in Canada.: H13-9/27-2018E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.862435&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
  • Canada. Health Products and Food Branch.
TitleGuidance document : regulatory requirements for intravenous immunoglobulin products in Canada.
Variant title
  • Regulatory requirements for intravenous immunoglobulin products in Canada
  • Regulatory requirements for IVIG products in Canada
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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.
Publishing information
  • Ottawa, ON : Health Canada = Santé Canada, 2018.
  • ©2018
Description1 online resource (12 pages)
ISBN9780660279435
Catalogue number
  • H13-9/27-2018E-PDF
Departmental catalogue number180345
Subject terms
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