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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Sildenafil citrate

EU orphan designation number: EU/3/03/178
Active ingredient: Sildenafil citrate
Indication: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Sponsor: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Revatio on 28/10/2005 with the number EU/1/05/318

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/12/2003 Orphan designation EMEA/OD/056/03 (2003)5038 of 12/12/2003
04/11/2015 Removal of orphan designation from Community Register