Benzalkonium chloride

This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to benzalkonium chloride. It includes updated information for the package leaflet and needs to be read in conjunction with the background scientific review.

Keywords: Excipients, package leaflet, benzalkonium chloride

Current effective version

Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use

AdoptedReference Number: EMA/CHMP/495737/2013

Document history

Overview of comments received on the draft ‘Questions and Answers on Benzalkonium chloride’

Reference Number: EMA/CHMP/601508/2014

Questions and answers on benzalkonium chloride in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use

Draft: consultation closedConsultation dates: 30/06/2014 to 30/09/2014Reference Number: EMA/495737/2013Summary:

Following the European Commission decision to revise the annex of the guideline on excipients in the label and package leaflet of medicinal products for human use, a multidisciplinary group of experts was created in 2011. The objective of this group is to update the labelling of selected excipients listed in the annex of this guideline, as well as to add new excipients to the list, based on a review of their safety. Question-and-answer documents (Q&As) on excipients will be progressively released for public consultation. They will include proposals for new or updated information for the labelling and package leaflet. Once a Q&A is finalised, the corresponding background report supporting its review will be also published.

Benzalkonium chloride used as an excipient - Report published in support of the ‘Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use’

Reference Number: EMA/CHMP/352187/2012