This document provides guidance on the wording of the summary of product characterisitics and the package leaflet for the use of thiomersal in medicinal products with regard to sensitisation.

A 2016 review of this guideline concluded that it remains up-to-date and relevant.

Keywords: Thiomersal, preservative, vaccines, immunoglobulins, antimicrobial, organomercuric, summary of product characteristics (SmPC), sensitisation

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