On 26 November 2009, orphan designation (EU/3/09/699) was granted by the European Commission to LFB-Biotechnologies, France, for recombinant chimeric monoclonal antibody against CD20 for the treatment of chronic lymphocytic leukaemia.
The sponsorship was transferred to Cambridge Regulatory Services Ltd, United Kingdom, in May 2018.
The sponsorship was transferred to CambPharma Solutions (CY) Limited, Cyprus, in July 2019. The sponsor’s address was updated in May 2020.
Recombinant chimeric monoclonal antibody against CD20 (ublituximab)
|Disease / condition||
Treatment of chronic lymphocytic leukaemia
|Date of first decision||
|EU designation number||
Review of designation
This medicine is now known as ublituximab.
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see: