EU/3/13/1156

About

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.

Key facts

Active substance
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
15/08/2013
Outcome
Positive
EU designation number
EU/3/13/1156

Review of designation

This medicine is now known as lenvervimab.

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Syneos Health Germany GmbH
Triforum Haus C2
Frankfurter Strasse 233
63263 Neu-Isenburg
Hesse, Germany
Tel. +49 6102 8130
E-mail: IVHRegSC@syneoshealth.com

Patients' organisations

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.

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