EU/3/14/1382: Orphan designation for the treatment of acute lymphoblastic leukaemia

Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist (spanlecortemlocel)

Overview

On 16 December 2014, orphan designation (EU/3/14/1382) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist for the treatment of acute lymphoblastic leukaemia.

This medicine is now known as spanlecortemlocel.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2022 on request of the Sponsor.

Key facts

Active substance
Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist (spanlecortemlocel)
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
Withdrawn
EU designation number
EU/3/14/1382
Date of designation
16/12/2014
Sponsor
Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland
Tel: +41 (0)61 324 11 11
E-mail: orphan.enquiries@novartis.com

Review of designation

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

Update history

DateUpdate
September 2022This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.
May 2018The sponsorship was transferred to Novartis Europharm Limited, Ireland.

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:

How useful was this page?

Add your rating