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Community register of orphan medicinal products


Product information

Hydrocortisone (modified release tablet)

EU orphan designation number: EU/3/06/372   
Active ingredient: Hydrocortisone (modified release tablet)
Indication: Treatment of adrenal insufficiency
Sponsor: ViroPharma SPRL-BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, BelgiŽ
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Plenadren on 03/11/2011 with the number EU/1/11/715

   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
29/05/2006 Centralised Orphan - Designation EMEA/OD/108/05 (2006)2150 of 22/05/2006
12/11/2008 Centralised Orphan - Transfer of orphan designation EMEA/OD/108/05/T/01 (2008)6720 of 04/11/2008
29/02/2012 Centralised Orphan - Transfer of orphan designation EMEA/OD/108/05/T/02 (2012)1370 of 27/02/2012