Questions and answers on Benzyl alcohol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’

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Download document Questions and answers on Benzyl alcohol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’
Reference number EMA/CHMP/508188/2013
Status draft: consultation open
First published 24/02/2014
Last updated 24/02/2014
Consultation start date 24/02/2014
Consultation end date 31/05/2014
Email address for submissions excipients@ema.europa.eu

Summary

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