Proline - Scientific guideline | European Medicines Agency

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 proline. It includes new information for the package leaflet.

Keywords: Excipients, package leaflet, proline

Current version

Information for the package leaflet regarding proline used as an excipient in medicinal products for human use

AdoptedReference Number: EMA/CHMP/332530/2015

English (EN) (441.63 KB - PDF)

First published: 07/03/2024

Overview of comments received on 'Information for the package leaflet regarding proline used as an excipient in medicinal products for human use'

Reference Number: EMA/CHMP/426533/2019

English (EN) (355.29 KB - PDF)

First published: 13/03/2024

Draft information for the package leaflet regarding proline used as an excipient in medicinal products for human use

Consultation dates: 19/11/2018 to 31/05/2019AdoptedReference Number: EMA/CHMP/332530/2015

English (EN) (305.16 KB - PDF)

First published: 19/11/2018