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.
Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use (PDF/680.01 KB)Adopted
First published: 22/11/2019
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’ (PDF/167.57 KB)Draft: consultation closed
First published: 24/02/2014
Last updated: 24/02/2014
Consultation dates: 24/02/2014 to 31/05/2014