This medicine is now known as otlertuzumab.
On 6 December 2012, orphan designation (EU/3/12/1083) was granted by the European Commission to Emergent Product Development UK Limited, United Kingdom, for humanised single-chain monoclonal antibody against CD37 for the treatment chronic lymphocytic leukaemia.
The sponsorship was transferred to Aptevo Europe Limited, United Kingdom, in March 2017, to Global Regulatory Ltd, United Kingdom, in July 2018 and to Voisin Consulting S.A.R.L., France, in January 2019.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in March 2021 on request of the Sponsor.
Humanised single-chain monoclonal antibody against CD37 (otlertuzumab)
|Disease / condition||
Treatment chronic lymphocytic leukaemia
|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.