EU/3/05/293: Orphan designation for the treatment of acute lymphoblastic leukaemia


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in August 2017 at the end of the 10-year period of market exclusivity.

On 16 June 2005, orphan designation (EU/3/05/293) was granted by the European Commission to GlaxoSmithKline Research & Development Limited, United Kingdom, for nelarabine for the treatment of acute lymphoblastic leukaemia. The sponsorship was transferred to Glaxo Group Limited, United Kingdom, in August 2006.

The sponsorship was transferred toGlaxo Group Limited, United Kingdom, in August 2006 and subsequently to Novartis Europharm Limited, United Kingdom, in April 2015.

Nelarabine has been authorised in the EU as Atriance since 22 August 2007.

Key facts

Active substance
Medicine name
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
EU designation number
Date of designation

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom
Tel. +41 61 324 11 11 (Switzerland)

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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