Xermelo

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telotristat ethyl

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 01/07/2022

Authorisation details

Product details
Name
Xermelo
Agency product number
EMEA/H/C/003937
Active substance
telotristat etiprate
International non-proprietary name (INN) or common name
telotristat ethyl
Therapeutic area (MeSH)
  • Carcinoid Tumor
  • Neuroendocrine Tumors
Anatomical therapeutic chemical (ATC) code
A16A
OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Ipsen Pharma
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
17/09/2017
Contact address
65, quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

14/06/2022 Xermelo - EMEA/H/C/003937 - R/0032

Product information documents contain:

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.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

Assessment history

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