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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Beraprost sodium (modified release tablet)

EU orphan designation number: EU/3/08/554   
Active ingredient: Beraprost sodium (modified release tablet)
Indication: Treatment of pulmonary arterial hypertension
Sponsor: IDEA Innovative Drug European Associates (Ireland) Limited
13 Classon House, Dundrum Business Park, Dundrum, Dublin, D14 W9Y3, Republic of Ireland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/07/2008 Orphan designation EMEA/OD/018/08 (2008)3658 of 10/07/2008
28/02/2012 Transfer of orphan designation EMEA/OD/018/08/T/01 (2012)886 of 9/02/2012
17/12/2012 Change of name and/or address of sponsor
25/09/2014 Change of name and/or address of sponsor
29/04/2015 Change of name and/or address of sponsor
14/02/2019 Transfer of orphan designation EMA/OD/0000003232 (2019)1354 of 12/02/2019