Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Revestive   
Auth. number : EU/1/12/787
INN : teduglutide
Orphan status based on designation EU/3/01/077 added on 04/09/2012
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX08 - Teduglutide
(See WHO ATC Index)
Indication: Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
Marketing Authorisation Holder: NPS Pharma Holdings Limited
Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/09/2012 Centralised - Authorisation EMEA/H/C/2345 (2012)6147 of 30/08/2012
05/12/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2345/T/3 (2013)6804 of 09/10/2013
20/12/2013 Centralised - Variation EMEA/H/C/2345/IAin/4/G
Updated with Decision(2014)9996 of 15/12/2014
22/05/2014 Centralised - Variation EMEA/H/C/2345/II/6
Updated with Decision(2014)9996 of 15/12/2014
26/11/2014 Centralised - Variation EMEA/H/C/2345/IB/12/G