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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Drotrecogin alfa (activated)

EU orphan designation number: EU/3/08/565   
Active ingredient: Drotrecogin alfa (activated)
Indication: Treatment of acute respiratory distress syndrome
Sponsor: Savara ApS
Slotsmarken 17, 2.tv., 2970 Hørsholm, Danmark

   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
27/10/2008 Orphan designation EMEA/OD/099/06 (2008)5449 of 22/09/2008
18/11/2008 Change of name and/or address of sponsor EMEA/OD/099/06
17/02/2010 Change of name and/or address of sponsor EMEA/OD/099/06
30/01/2015 Change of name and/or address of sponsor
16/02/2015 Change of name and/or address of sponsor
28/09/2016 Transfer of orphan designation EMA/OD/099/06/T/01 (2016)6304 of 26/09/2016