Navigation path

Pharmaceuticals - Union Register


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: Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Plenadren on 3/11/2011 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 Orphan designation EMEA/OD/108/05 (2006)2150 of 22/05/2006
12/11/2008 Transfer of orphan designation EMEA/OD/108/05/T/01 (2008)6720 of 4/11/2008
29/02/2012 Transfer of orphan designation EMEA/OD/108/05/T/02 (2012)1370 of 27/02/2012
19/02/2016 Change of name and/or address of sponsor
17/05/2016 Other procedure (2016)2997 of 12/05/2016
4/07/2016 Corrigendum (2016)2997 of 12/05/2016