EU/3/20/2260: Orphan designation for the treatment in haematopoietic stem cell transplantation

Allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus

Overview

On 24 March 2020, orphan designation EU/3/20/2260 was granted by the European Commission to TMC Pharma (EU) Limited, Ireland, for allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus for treatment in haematopoietic stem cell transplantation.

The sponsor’s address was updated in March 2021.

The sponsorship was transferred to Allovir International DAC, Ireland in March 2021.

Key facts

Active substance
Allogeneic multi-virus specific T lymphocytes targeting BK virus, cytomegalovirus, human herpesvirus-6, Epstein Barr virus and adenovirus
Intended use
Treatment in haematopoietic stem cell transplantation
Orphan designation status
Positive
EU designation number
EU/3/20/2260
Date of designation
24/03/2020
Sponsor

Allovir International DAC
25-28 North Wall Quay 
North Wall 
Dublin 1  D01 H104 
Co. Dublin 
Ireland 
Email: orphan.information@allovir.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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