EU/3/15/1487: Orphan designation for the treatment of plasma cell myeloma

Reduced oxidised N-acetyl heparin (roneparstat)


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.

Please note that this product was withdrawn from the Union Register of orphan medicinal products in September 2021 upon request of the Sponsor.

Key facts

Active substance
Reduced oxidised N-acetyl heparin (roneparstat)
Intended use
Treatment of plasma cell myeloma
Orphan designation status
EU designation number
Date of designation

Leadiant GmbH
Liebherrstraße 22
80538 München
Tel. +49 (0)89 4111 595 0

Review of designation

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

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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