EU/3/18/2130

About

On 11 January 2019, orphan designation (EU/3/18/2130) was granted by the European Commission to Arena Pharmaceuticals Limited, Ireland, for ralinepag for the treatment of pulmonary arterial hypertension.

The sponsorship was transferred to Unither Therapeutik GmbH, Germany in April 2019.

Key facts

Active substance
Ralinepag
Disease / condition
Treatment of pulmonary arterial hypertension
Date of first decision
11/01/2019
Outcome
Positive
EU designation number
EU/3/18/2130

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

Unither Therapeutik GmbH
Dreieichstrasse 11
64546 Moerfelden-Walldorf
Germany
Tel. +49 6105 27137

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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