EU/3/05/273: Orphan designation for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension

ambrisentan

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2018 at the end of the 10-year period of market exclusivity.

On 11 April 2005, orphan designation (EU/3/05/273) was granted by the European Commission to Uppsala Medical Information System AB, Sweden, for ambrisentan for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

The sponsorship was trasferred to European Medical Advisory Services Limited, United Kingdom, in August 2005 and subsequently to Glaxo Group Limited, United Kingdom, in September 2006.

Ambrisentan has been authorised in the EU as Volibris since 21 April 2008.

Key facts

Active substance
ambrisentan
Intented use
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Orphan designation status
Withdrawn
EU designation number
EU/3/05/273
Date of designation
11/04/2005
Sponsor
Glaxo Group Limited
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom
http://www.gsk.com/uk/about-us/contact-us.html

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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