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.
Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
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Documents related to this orphan designation evaluation
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
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
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: