On 17 October 2019, orphan designation EU/3/19/2209 was granted by the European Commission to Biopharma Excellence GmbH, Germany, for anti-neonatal Fc receptor human monoclonal antibody (also known as M281) for the prevention of haemolytic disease of the foetus and newborn.
The sponsorship was transferred to Janssen-Cilag International N.V., Belgium, in April 2021.
Anti-neonatal Fc receptor human monoclonal antibody
|Disease / condition||
Prevention of haemolytic disease of the foetus and newborn
|Date of first decision||
|EU designation number||
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.