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.
EU/3/05/273: Public summary of positive opinion for orphan designation of ambrisentan for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (PDF/138.28 KB)
First published: 29/07/2008
Last updated: 18/07/2018
EMEA/COMP/130938/2005 Rev. 3
|Disease / condition||
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
|Date of decision||
|Orphan decision number||
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.