EU/3/01/082: 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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in May 2016 at the end of the period of market exclusivity.

On 5 February 2002, orphan designation (EU/3/01/082) was granted by the European Commission to ILEX Services Limited, United Kingdom, for 2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine for the treatment of acute lymphoblastic leukaemia (ALL).

The sponsorship was transferred to Bioenvision, United Kingdom, in December 2002 and subsequently to Genzyme Europe BV, The Netherlands, in May 2008.

Update: 2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine has been authorised in the European Union as Evoltra since 29 May 2006.

More information on Evoltra can be found in the European public assessment report (EPAR) on the Agency's website.

Key facts

Active substance
Medicine name
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
EU designation number
Date of designation
Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
The Netherlands
Telephone: +31 35 699 12 00
Telefax: +31 35 694 32 14

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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