Ethanol - 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 ethanol. It includes updated information for the package leaflet and the background scientific review.

Keywords: Excipients, package leaflet, ethanol, alcohol.

Current effective version

Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/43486/2018 Corr.

Document history

Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/43486/2018 Corr.

Questions and answers on Ethanol 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: 24/02/2014 to 31/05/2014 Reference Number: EMA/CHMP/507988/2013 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