Sodium laurilsulfate - Scientific guideline

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 sodium laurilsulfate. It includes new information for the package leaflet and needs to be read in conjunction with the background scientific review.

Keywords: Excipients, package leaflet, sodium laurilsulfate

Current version

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/606830/2014 Corr.1

Document history

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/606830/2014 Corr.1

Overview of comments received on the draft 'Questions and answers on sodium laurilsulfate’

Reference Number: EMA/CHMP/733748/2015

Draft questions and answers on sodium laurilsulfate 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 closed Consultation dates: 04/08/2015 to 03/11/2015 Reference Number: EMA/CHMP/606830/2014 Summary:

The objective of this group is to update the labelling of selected excipients listed in the Annex of the

above mentioned European Commission (EC) guideline, as well as to add new excipients to the list, based on a review of their

safety. The main safety aspects to be addressed were summarised in a concept paper published in March 2012.

Sodium laurilsulfate used as an excipient - Report published in support of the ‘Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use’

Reference Number: EMA/CHMP/351898/2014 Corr.1

Background review for sodium laurilsulfate used as an excipient: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report

Draft Reference Number: EMA/CHMP/351898/2014