EU/3/08/554

About

Please note that this product was withdrawn from the Union Register of orphan medicinal products in January 2020 on request of the sponsor.

On 10 July 2008, orphan designation (EU/3/08/554) was granted by the European Commission to Lung Rx Limited, United Kingdom, for beraprost sodium (modified release tablet) for the treatment of pulmonary arterial hypertension.

The sponsorship was transferred to IDEA Innovative Drugs European Associates Limited, United Kingdom, in February 2012.

In December 2012, Innovative Drug European Associates Limited changed name to IDEA Innovative Drug European Associates Limited.

The sponsorship was transferred to IDEA Innovative Drug European Associates (Ireland) Limited, Republic of Ireland, in February 2019.

Key facts

Active substance
Beraprost sodium
Disease / condition
Treatment of pulmonary arterial hypertension
Date of first decision
10/07/2008
Outcome
Withdrawn
EU designation number
EU/3/08/554

Review of designation

Please note that this product was withdrawn from the Union Register of orphan medicinal products in January 2020 on request of the sponsor.

Sponsor's contact details

IDEA Innovative Drug European Associates (Ireland) Limited
13 Classon House
Dundrum Business Park, Dundrum
Dublin, D14 W9Y3
Ireland
Tel. + 353 1903 6117
E-mail:  inquires@krystalbio.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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