Cyclodextrins
Table of contents
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
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Overview of comments received on the draft 'Questions and answers on cyclodextrins' (PDF/241.37 KB)
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/157146/2015 -
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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' (PDF/191.42 KB)
Draft: consultation closed
First published: 01/12/2014
Last updated: 01/12/2014
Consultation dates: 01/12/2014 to 28/02/2015 -
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Questions and answers on cyclodextrins used as excipients in medicinal products for human use (PDF/273.35 KB)
Adopted
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/495747/2013 -
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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 (PDF/276.33 KB)
First published: 01/12/2014
Last updated: 01/12/2014
EMA/CHMP/333892/2013