On 18 November 2016, orphan designation (EU/3/16/1773) was granted by the European Commission to PharmaLex UK Services Limited, United Kingdom, for allogenic cytomegalovirus-specific cytotoxic T lymphocytes for the treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity.
This medicine is now known as adimlecleucel.
allogenic cytomegalovirus-specific cytotoxic T lymphocytes (adimlecleucel)
Treatment of cytomegalovirus infection in patients with impaired cell-mediated immunity
|Orphan designation status||
|EU designation number||
|Date of designation||
Atara Biotherapeutics Ireland Limited
Arthur Cox Building, Earlsfort Terrace
Tel. +353 1 618 0000
Fax +353 1 618 0618
|February 2017||The sponsorship was transferred to Atara Biotherapeutics Ireland Limited, Ireland, in February 2017.|
|August 2022||Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2022 on request of the Sponsor.|
Documents related to this orphan designation evaluation
EU/3/16/1773: Public summary of positive opinion for orphan designation of allogenic cytomegalovirus-specific cytotoxic T lymphocytes for the treatment of cytomegalovirus infections in patients with impaired cell-mediate... (PDF/215.04 KB)
First published: 13/12/2016
Last updated: 16/09/2022
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: