Sodium used as an excipient in medicinal products for human use - Scientific guideline

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

Current effective version

Questions and answers on sodium used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/338679/2014

Document history

Questions and answers on sodium used as an excipient in medicinal products for human use

Adopted Reference Number: EMA/CHMP/338679/2014

Overview of comments received on 'Draft questions and answers on sodium'

Reference Number: EMA/CHMP/623211/2015

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'

Draft: consultation closed Consultation dates: 24/06/2015 to 30/09/2015 Reference Number: EMA/CHMP/338679/2014 Summary:

The European Commission (EC) 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 involving the Safety Working Party (lead), the Quality Working Party, the Paediatric Committee, the Pharmacovigilance Risk Assessment Committee, the Coordination Group for Mutual Recognition and Decentralised Procedures - Human, the Vaccines Working Party, the Biologics Working Party and the Blood Products Working Party, was created in 2011. The objective of this group is to update the labelling of selected excipients listed in the annex of the above mentioned EC guideline, and to add new excipients to the list, based on a review of their safety. This questions-and-answers document may be read in conjunction with the recent PRAC recommendation on Sodium-containing effervescent, dispersible and soluble medicines (ref: EMA/PRAC/234960/2015), published in April 2015.