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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23

EU orphan designation number: EU/3/14/1351   
Active ingredient: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23
Indication: Treatment of X-linked hypophosphataemia
Sponsor: Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name CRYSVITA on 19/02/2018 with the number EU/1/17/1262

   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
17/10/2014 Orphan designation EMA/OD/133/14 (2014)7650 of 15/10/2014
3/08/2016 Transfer of orphan designation EMA/OD/133/14/T/01 (2016)5126 of 1/08/2016
18/12/2017 Other procedure
2/08/2018 Transfer of orphan designation EMA/OD/133/14/T/02 (2018)5289 of 31/07/2018