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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

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/3/14/1300   
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 beta-thalassaemia intermedia and major
Sponsor: Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

   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
31/07/2014 Orphan designation EMA/OD/047/14 (2014)5525 of 29/07/2014
25/09/2014 Change of name and/or address of sponsor
02/03/2015 Transfer of orphan designation EMA/OD/047/14/T/01 (2015)1440 of 26/02/2015