Dextrans

This draft document supports the revision of the annex to the guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to dextrans. It includes a proposal for new information for the package leaflet.

Keywords: Excipients, package leaflet, dextrans

Current version

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

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