Dextrans - 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 dextrans. It includes new information for the package leaflet and needs to be read in conjunction with the background review

Keywords: Excipients, package leaflet, dextrans

Current version

Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use

Adopted Reference Number: EMA/CHMP/187129/2016

Document history

Overview of comments received on 'Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use' (EMA/CHMP/187129/2016)

Draft information for the package leaflet regarding dextrans used as excipients in medicinal products for human use

Draft: consultation closed Consultation dates: 19/11/2018 to 31/05/2019 Reference Number: EMA/CHMP/187129/2016