This is a summary of the European public assessment report (EPAR) for Xermelo. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xermelo.
For practical information about using Xermelo, patients should read the package leaflet or contact their doctor or pharmacist.
Xermelo : EPAR - Summary for the public (PDF/76.11 KB)
First published: 20/10/2017
Last updated: 20/10/2017
Xermelo : EPAR - Risk-management-plan summary (PDF/189.02 KB)
First published: 29/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
07/06/2020 Xermelo - EMEA/H/C/003937 - II/0014
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Other alimentary tract and metabolism products
Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.