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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human parathyroid hormone

EU orphan designation number: EU/3/13/1210   
Active ingredient: Recombinant human parathyroid hormone
Indication: Treatment of hypoparathyroidism
Sponsor: Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Natpar on 24/04/2017 with the number EU/1/15/1078

   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
23/12/2013 Orphan designation EMA/OD/102/13 (2013)9698 of 18/12/2013
08/04/2015 Corrigendum (2015)2366 of 01/04/2015
23/12/2015 Change of name and/or address of sponsor
19/01/2016 Transfer of orphan designation EMA/OD/102/13/T/01 (2016)256 of 15/01/2016
06/11/2017 Change of name and/or address of sponsor