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Updated Annex to the EC guideline on excipients and information in the package leaflet

EMA

EMA published an updated Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’. The annex contains a list of all excipients known to have a recognised action or effect that need to be displayed on the label of any medicine authorised in the European Union (EU). This annex is reviewed regularly by EMA’s Excipients Drafting Group (ExcpDG) to update the information on excipients or include new excipients. This update reflects a correction of editorial mistakes in the previous version and concerns corrections on the route of administration, the name and the information for the package leaflet for phenylalanine, sodium laurilsulfate and wheat starch, respectively.

The update can be found here.

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