EU/3/06/421: Orphan designation for the treatment of acute lymphoblastic leukaemia

Forodesine hydrochloride

Table of contents


On 18 December 2006, orphan designation (EU/3/06/421) was granted by the European Commission to Napp Pharmaceuticals Research Limited, United Kingdom, for forodesine hydrochloride for the treatment of acute lymphoblastic leukaemia.

The name of the sponsor changed to Mundipharma Research Limited in 2007.

The sponsorship was transferred to Mundipharma Corporation (Ireland) Limited, Ireland, in April 2019.

Key facts

Active substance
Forodesine hydrochloride
Intended use
Treatment of acute lymphoblastic 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

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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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