Table of contents
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
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
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40 Avenue George V
12/12/2022 Xermelo - EMEA/H/C/003937 - IAIN/0035/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.