Polysorbates - Scientific guideline | European Medicines Agency (EMA)

This document supports the revision of the annex to the guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' with regard to polysorbates. It includes a proposal for new information for the package leaflet.

Keywords: Excipients, package leaflet, polysorbates

Current effective version

Information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use

Reference Number: EMA/CHMP/190743/2016

English (EN) (753.73 KB - PDF)

First published: 17/04/2024

Draft information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use

Draft: consultation closed Consultation dates: 19/11/2018 to 31/05/2019 Reference Number: EMA/CHMP/190743/2016

English (EN) (500.53 KB - PDF)

First published: 19/11/2018

Overview of comments received on 'Information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use’

Reference Number: EMA/544822/2023

English (EN) (550.12 KB - PDF)

First published: 17/04/2024