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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.

Key facts

Active substance
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

Janssen-Cilag International N.V
Turnhoutseweg 30
B-2340 Beerse
Tel. +32 146 031 89

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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