EU/3/15/1563: Orphan designation for the treatment of acute myeloid leukaemia
recombinant human interleukin-3 truncated diphtheria toxin fusion protein
Table of contents
Overview
On 9 October 2015, orphan designation (EU/3/15/1563) was granted by the European Commission to Spector Consulting SAS, France, for recombinant human interleukin-3 truncated diphtheria toxin fusion protein (also known as SL-401) for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in February 2019.
The sponsorship was transferred to Stemline Therapeutics B.V. in November 2019.
The sponsor’s address was updated in April 2022.
Key facts
Active substance |
recombinant human interleukin-3 truncated diphtheria toxin fusion protein
|
Intended use |
Treatment of acute myeloid leukaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/15/1563
|
Date of designation |
09/10/2015
|
Sponsor |
Stemline Therapeutics B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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: