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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Granulocyte macrophage colony stimulating factor

EU orphan designation number: EU/3/13/1147   
Active ingredient: Granulocyte macrophage colony stimulating factor
Indication: Treatment of pulmonary alveolar proteinosis
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
23/07/2013 Orphan designation EMA/OD/106/12 (2013)4721 of 17/07/2013
01/10/2013 Corrigendum (2013)6435 of 27/09/2013
04/08/2014 Change of name and/or address of sponsor
28/09/2016 Transfer of orphan designation EMA/OD/106/12/T/01 (2016) 6299 of 26/09/2016