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Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain

EU orphan designation number: EU/3/14/1331   
Active ingredient: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain
Indication: Treatment of myelodysplastic syndromes
Sponsor: Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland

   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
16/09/2014 Orphan designation EMA/OD/048/14 (2014)6136 of 22/08/2014
25/09/2014 Change of name and/or address of sponsor
29/04/2015 Change of name and/or address of sponsor
24/06/2015 Transfer of orphan designation EMA/OD/048/14/T/01 (2015)4332 of 19/06/2015
1/10/2018 Transfer of orphan designation EMA/OD/048/14/T/02 (2018)6439 of 27/09/2018