Aspartame and phenylalanine
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 aspartame and phenylalanine. It includes the updated information for the package leaflet and the background scientific review.
Keywords: Excipients, package leaflet, aspartame, E951, phenylalanine
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Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use (PDF/330.41 KB)
Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/134648/2015 Corr.1 -
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Overview of comments received on the draft 'Information in the package leaflet for aspartame' (PDF/122.77 KB)
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/581993/2016 -
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Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1) (PDF/322.18 KB)
Draft: consultation closed
First published: 04/05/2016
Last updated: 04/05/2016
Consultation dates: 04/05/2016 to 03/08/2016
EMA/CHMP/134648/2015