Table of contents
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.
Revestive : EPAR - Summary for the public (PDF/78.33 KB)
First published: 24/09/2012
Last updated: 03/07/2017
Revestive : EPAR - Risk-management-plan summary (PDF/551.46 KB)
First published: 11/02/2020
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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.
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.
Takeda Pharmaceuticals International AG Ireland Branch
|Date of issue of marketing authorisation valid throughout the European Union||
Block 2 Miesian Plaza
28/02/2023 Revestive - EMEA/H/C/002345 - IAIN/0061/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
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.