On 21 May 2015, orphan designation (EU/3/15/1487) was granted by the European Commission to Sigma-Tau Pharma Ltd, United Kingdom, for reduced oxidised N-acetyl heparin for the treatment of plasma cell myeloma.
The sponsorship was transferred to Sigma-Tau Rare Disease Limited, United Kingdom, in June 2015.
The sponsorship was transferred to Leadiant Biosciences Ltd United Kingdom, in January 2017.
In November 2016, Sigma-Tau Rare Disease Ltd changed name to Leadiant Biosciences Ltd.
The sponsorship was transferred to Leadiant GmbH, Germany, in March 2019.
This medicine is now known as roneparstat.
Reduced oxidised N-acetyl heparin (roneparstat)
|Disease / condition||
Treatment of plasma cell myeloma
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
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.