EU/3/13/1171: Orphan designation for the prevention of rejection following solid organ transplantation

Autologous regulatory T cells with an immunophenotype of CD4+CD25hiFoxP3+

Overview

On 7 October 2013, orphan designation (EU/3/13/1171) was granted by the European Commission to iReg Medical AB, Sweden, for autologous regulatory T cells with an immunophenotype of CD4+CD25hiFoxP3+ for the prevention of rejection following solid organ transplantation.

Key facts

Active substance
Autologous regulatory T cells with an immunophenotype of CD4+CD25hiFoxP3+
Intended use
Prevention of rejection following solid organ transplantation
Orphan designation status
Positive
EU designation number
EU/3/13/1171
Date of designation
08/10/2013
Sponsor
IReg Medical AB
Tallmov 2 A
756 45 Uppsala
Sweden
Telephone: +46 18 30 22 98
E-mail: info@iregmedical.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.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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