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Register of orphan medicinal products


Product information

Treprostinil diethanolamine (oral use)

EU orphan designation number: EU/3/05/310   
Active ingredient: Treprostinil diethanolamine (oral use)
Indication: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Sponsor: Unither Therapeutik GmbH
Dreieichstrasse 11, 64546 Moerfelden-Walldorf, Deutschland

   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
31/08/2005 Orphan designation EMEA/OD/034/05 (2005)3340 of 26/08/2005
5/06/2009 Change of name and/or address of sponsor
1/02/2019 Change of name and/or address of sponsor
28/02/2019 Transfer of orphan designation EMA/OD/0000004331 (2019)1742 of 26/02/2019