Cyclodextrins - Scientific guideline

This document supports the revision of annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to cyclodextrins. It includes new information for the package leaflet and needs to be read in conjunction with the background scientific review.

Keywords: Excipients, package leaflet, cyclodextrins, alfadex, betadex

Current effective version

Cyclodextrins used as excipients - Report published in support of the ‘Questions and answers on cyclodextrins used as excipients in medicinal products for human use’

Reference Number: EMA/CHMP/333892/2013

Document history

Overview of comments received on the draft 'Questions and answers on cyclodextrins'

Reference Number: EMA/CHMP/157146/2015

Draft questions and answers on cyclodextrins 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: 01/12/2014 to 28/02/2015 Summary:

Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a multidisciplinary group of experts was created in 2011 to update the labelling of selected excipients listed in the annex of the guideline and to add new excipients to the list, based on a review of their safety. Draft Q&A documents on excipients are progressively released for public consultation. They include proposals for new or updated information for the labelling and package leaflet. A corresponding background report supporting the review is published for information only.

Questions and answers on cyclodextrins used as excipients in medicinal products for human use

Adopted Reference Number: EMA/CHMP/495747/2013

Background review for cyclodextrins used as excipients: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report

Reference Number: EMA/CHMP/333892/2013