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Community register of orphan medicinal products


Product information

Hydrocortisone (modified release tablet)

EU orphan designation number: EU/3/05/296   
Active ingredient: Hydrocortisone (modified release tablet)
Indication: Treatment of congenital adrenal hyperplasia
Sponsor: Diurnal Limited
Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, 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
29/07/2005 Orphan designation EMEA/OD/020/05 (2005)2948 of 27/07/2005
20/12/2006 Transfer of orphan designation EMEA/OD/020/05/T/01 (2006)7020 of 18/12/2006
23/02/2009 Transfer of orphan designation EMEA/OD/020/05/T/02 (2009)1054 of 11/02/2009
16/10/2009 Change of name and/or address of sponsor
8/07/2014 Change of name and/or address of sponsor