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 07/05/2018

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
A16AX
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

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
2
Date of issue of marketing authorisation valid throughout the European Union
18/09/2017
Contact address
65, quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

19/04/2018 Xermelo - EMEA/H/C/003937 - N/0003

Contents

  • 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.

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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