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
| Department/Agency | Canada. Health Canada. Canada. Health Products and Food Branch. |
|---|---|
| Title | Guidance 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 type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| 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 |
| Description | 1 online resource (12 pages) |
| ISBN | 9780660279435 |
| Catalogue number |
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| Departmental catalogue number | 180345 |
| Subject terms | Health care products Health policy |