EU/3/20/2307

About

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
Tinostamustine
Disease / condition
Treatment of T-cell prolymphocytic leukaemia
Date of first decision
27/07/2020
Outcome
Positive
EU designation number
EU/3/20/2307

Review of designation

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

Sponsor's contact details

Mundipharma Corporation (Ireland) Limited
Millbank House
18 Arkle Road
Sandyford Industrial Estate
Dublin 18
Co. Dublin
D18 C6R3
Ireland
Tel. +353 1 2063800
E-mail: centralised.procedures@mundipharma-rd.eu

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.

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