On 15 August 2013, orphan designation (EU/3/13/1156) was granted by the European Commission to CRO-PharmaNet Services GmbH, Germany, for recombinant human monoclonal antibody against hepatitis-B virus for the prevention of hepatitis-B re-infection following liver transplantation.
The sponsorship was transferred to inVentiv Health Germany GmbH, Germany, in July 2014.
In January 2020, inVentiv Heath Germany changed name to Syneos Health Germany GmbH and the sponsor’s address was updated.
EU/3/13/1156: Public summary of opinion on orphan designation: Recombinant human monoclonal antibody against hepatitis-B virus for the prevention of hepatitis-B re-infection following liver transplantation (PDF/123.88 KB)
First published: 22/08/2013
Last updated: 12/03/2015
EMA/COMP/401189/2013 Rev. 1
Recombinant human monoclonal antibody against hepatitis-B virus (active ingredient lenvervimab)
|Disease / condition||
Prevention of hepatitis-B re-infection following liver transplantation
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.