EU/3/15/1487

About

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.

Key facts

Active substance
Reduced oxidised N-acetyl heparin (roneparstat)
Disease / condition
Treatment of plasma cell myeloma
Date of first decision
21/05/2015
Outcome
Positive
EU designation number
EU/3/15/1487

Review of designation

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

Sponsor's contact details

Leadiant GmbH
Liebherrstraße 22
80538 München
Germany
Tel. +49 (0)89 4111 595 0
E-mail: info@leadiantbiosciences.com

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.

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