Fructose and sorbitol

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 fructose and sorbitol. It includes new information for the package leaflet and the background scientific review.

Keywords: Excipients, package leaflet, fructose, sorbitol, E420

Current effective version

Information for the package leaflet regarding fructose and sorbitol used as excipients in medicinal products for human use

AdoptedReference Number: EMA/CHMP/460886/2014

Document history

Overview of comments received on the draft 'Information in the package leaflet for fructose and sorbitol'

Reference Number: EMA/CHMP/581887/2016

Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)

Consultation dates: 04/05/2016 to 03/08/2016Draft: consultation closedReference Number: EMA/CHMP/460886/2014Summary:

This document supports the revision of the European Commission Guideline on 'Excipients in the label and package leaflet of medicinal products for human use' with regard to fructose and sorbitol, which are used as excipients in a variety of oral (tablets, capsules, suspensions) and topical formulations (creams, emulsions). Sorbitol (and rarely fructose) is also used as a protein/peptide stabiliser in some medicinal products for parenteral use such as blood products (immunoglobulins) and vaccines.