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Allergological reappraisal of the Annex to the European Commission guideline on excipients (SANTE‐2017‐11,668).

Authors :
Caballero, María Luisa
Quirce, Santiago
Source :
Allergy. Mar2024, Vol. 79 Issue 3, p735-739. 5p.
Publication Year :
2024

Abstract

This article provides an allergological reappraisal of the Annex to the European Commission guideline on excipients in medicinal products. The authors argue that the current guideline is outdated and fails to include excipients that have been reported to cause severe hypersensitivity reactions. They stress the importance of updating allergological information on excipients to ensure patient safety. The article includes tables summarizing excipients not included in the guideline and examples of reported hypersensitivity reactions. The document also provides a list of various substances and their associated adverse reactions, highlighting the need to update the allergological information of certain excipients in the Annex. The authors declare no conflicts of interest and received no funding for the study. [Extracted from the article]

Details

Language :
English
ISSN :
01054538
Volume :
79
Issue :
3
Database :
Academic Search Index
Journal :
Allergy
Publication Type :
Academic Journal
Accession number :
175750509
Full Text :
https://doi.org/10.1111/all.15913