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 26/07/2022

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 monitoringAdditional 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.

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
Takeda Pharmaceuticals International AG Ireland Branch
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
30/08/2012
Contact address

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

Product information

25/07/2022 Revestive - EMEA/H/C/002345 - N/0058

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

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

Changes since initial authorisation of medicine

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