Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in February 2015 on request of the Sponsor.
On 27 February 2009, orphan designation (EU/3/09/619) was granted by the European Commission to Teva Pharma GmbH, Germany, for allogeneic ex-vivo-expanded umbilical-cord blood cells for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Regulatory Resources Group Ltd, United Kingdom, in July 2013.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
Allogeneic ex-vivo-expanded umbilical-cord blood cells
Treatment of acute myeloid leukaemia
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Documents related to this orphan designation evaluation
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
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: