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
Prevention of haemolytic disease of the foetus and newborn
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Documents related to this orphan designation evaluation
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.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: