On 21 March 2016, orphan designation (EU/3/16/1627) was granted by the European Commission to Wainwright Associates Ltd, United Kingdom, for allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes for the treatment of post-transplant lymphoproliferative disorder.
In November 2016 sponsor, Wainwright Associates Ltd changed name to PharmaLex UK Services Limited.
The sponsorship was transferred to Atara Biotherapeutics Ireland Limited, Ireland, in February 2017.
The medicinal product has been authorised in the EU as Ebvallo since 16 December 2022.
Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel)
Treatment of post-transplantation lymphoproliferative disorders
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
More information is available in the orphan medicine assessment report .
|January 2023||The sponsorship was transferred from Atara Biotherapeutics Ireland Limited to Pierre Fabre Medicament, France.|
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: