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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant megakaryopoeisis-stimulating protein

EU orphan designation number: EU/3/05/283   
Active ingredient: Recombinant megakaryopoeisis-stimulating protein
Indication: Treatment of idiopathic thrombocytopenic purpura
Sponsor: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Nplate on 04/02/2009 with the number EU/1/08/497

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/05/2005 Orphan designation EMEA/OD/008/05 (2005)1662 of 27/05/2005