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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Treprostinil diethanolamine

EU orphan designation number: EU/3/09/635   
Active ingredient: Treprostinil diethanolamine
Indication: Treatment of systemic sclerosis
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
20/05/2009 Orphan designation EMEA/OD/106/08 (2009)4060 of 15/05/2009
1/02/2019 Change of name and/or address of sponsor
28/02/2019 Transfer of orphan designation EMA/OD/0000004224 (2019)1743 of 26/02/2019