Wheat starch containing gluten
Table of contents
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 wheat starch containing gluten. It includes new information for the package leaflet and needs to be read in conjunction with the background scientific review.
Keywords: Excipients, package leaflet, wheat starch, gluten
-
List item
Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use (PDF/131.08 KB)
Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/704219/2013 Corr.1 -
List item
Overview of comments received on the draft ‘Questions and answers on wheat starch (containing gluten)’ (PDF/381.34 KB)
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/674221/2014 -
List item
Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (PDF/125.84 KB)
Draft: consultation closed
First published: 01/08/2014
Last updated: 01/08/2014
Consultation dates: 01/08/2014 to 31/10/2014
EMA/CHMP/704219/2013 -
List item
Wheat starch (containing gluten) used as an excipient - Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’ (PDF/135.8 KB)
First published: 09/10/2017
Last updated: 18/12/2018
EMA/CHMP/639441/2013 Corr.2