EU/3/09/699: Orphan designation for the treatment of chronic lymphocytic leukaemia

Recombinant chimeric monoclonal antibody against CD20 (ublituximab)


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.

Key facts

Active substance
Recombinant chimeric monoclonal antibody against CD20 (ublituximab)
Intended use
Treatment of chronic lymphocytic leukaemia
Orphan designation status
EU designation number
Date of designation

Schipholweg 73
2316 ZL Leiden

Review of designation

This medicine is now known as ublituximab.

Update history

November 2022The sponsorship was transferred from CambPharma Solutions (CY) Limited, Cyprus to Propharma Group The Netherlands B.V..
May 2020The sponsor's address was updated.
July 2019The sponsorship was transferred to CambPharma Solutions (CY) Limited, Cyprus.
May 2018The sponsorship was transferred to Cambridge Regulatory Services Ltd.

Documents related to this orphan designation evaluation

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.

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:

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