EU/3/20/2307: Orphan designation for the treatment of T-cell prolymphocytic leukaemia



On 27 July 2020, orphan designation EU/3/20/2307 was granted by the European Commission to Mundipharma Corporation (Ireland) Limited, Ireland, for tinostamustine (also known as EDO-S101) for the treatment of T-cell prolymphocytic leukaemia.

Key facts

Active substance
Intended use
Treatment of T-cell prolymphocytic leukaemia
Orphan designation status
EU designation number
Date of designation

Mundipharma Corporation (Ireland) Limited
Millbank House
18 Arkle Road
Sandyford Industrial Estate
Dublin 18
Co. Dublin
D18 C6R3
Tel. +353 1 2063800

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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