Sodium
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 sodium. It includes updated information for the package leaflet and the background scientific review.
Keywords: Excipients, package leaflet, sodium, table salt
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Questions and answers on sodium used as an excipient in medicinal products for human use (PDF/175.48 KB)
Adopted
First published: 09/10/2017
Last updated: 09/10/2017
EMA/CHMP/338679/2014 -
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Overview of comments received on 'Draft questions and answers on sodium' (PDF/555.17 KB)
First published: 10/10/2017
Last updated: 10/10/2017
EMA/CHMP/623211/2015 -
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Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (PDF/151.43 KB)
Draft: consultation closed
First published: 24/06/2015
Last updated: 24/06/2015
Consultation dates: 24/06/2015 to 30/09/2015
EMA/CHMP/338679/2014