On 12 December 2003, orphan designation (EU/3/03/178) was granted by the European Commission to Pfizer Limited, United Kingdom, for sildenafil citrate for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Sildenafil citrate has been authorised in the EU as Revatio since 28 October 2005.
EU/3/03/178: Public summary of positive opinion for orphan designation of sildenafil citrate for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (PDF/108.33 KB)
First published: 28/02/2007
Last updated: 20/01/2016
|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.