EU/3/18/2063: Orphan designation for the treatment in solid organ transplantation

CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells

Overview

On 24 August 2018, orphan designation (EU/3/18/2063) was granted by the European Commission to IQVIA RDS Ireland Limited, Ireland, for CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells for treatment in solid organ transplantation.

The sponsorship was transferred to IQVIA RDS Spain S.L. in November 2021.

Key facts

Active substance
CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells
Intented use
Treatment in solid organ transplantation
Orphan designation status
Positive
EU designation number
EU/3/18/2063
Date of designation
24/08/2018
Sponsor

IQVIA RDS Spain S.L.
Calle De Juan Esplandiu 11 Planta 6 
28007 Madrid 
Spain
Tel: +33 628100245
E-mail: marine.lafargue@iqvia.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:

  • 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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