Revestive

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teduglutide

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

Overview

This is a summary of the European public assessment report (EPAR) for Revestive. 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 Revestive.

For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/02/2018

Authorisation details

Product details
Name
Revestive
Agency product number
EMEA/H/C/002345
Active substance
teduglutide
International non-proprietary name (INN) or common name
teduglutide
Therapeutic area (MeSH)
Malabsorption Syndromes
Anatomical therapeutic chemical (ATC) code
A16AX08
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
Shire Pharmaceuticals Ireland Ltd
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
30/08/2012
Contact address

Block 2-3, Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 Y754 
Ireland

Product information

22/01/2018 Revestive - EMEA/H/C/002345 - IAIN/0042/G

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

Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.

Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.

Assessment history

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