Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Plenadren   
Auth. number : EU/1/11/715
INN : hydrocortisone
Orphan status based on designation EU/3/06/372 added on 14/11/2011
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H02 - Corticosteroids for systemic use
Pharmacological subgroup: H02A - Corticosteroids for systemic use, plain
Chemical subgroup: H02AB - Glucocorticoids
Chemical substance: H02AB09 - Hydrocortisone
(See WHO ATC Index)
Indication: Treatment of adrenal insufficiency in adults.
Marketing Authorisation Holder: ViroPharma SPRL-BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
14/11/2011 Centralised - Authorisation EMEA/H/C/2185 (2011)8058 of 03/11/2011
28/03/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2185 (2012)2170 of 26/03/2012
31/05/2012 Centralised - Variation EMEA/H/C/2185/IB/2
Updated with Decision(2012)7951 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7951 of 29/10/2012
07/11/2012 Centralised - Variation EMEA/H/C/2185/IAin/8
Updated with Decision(2013)8336 of 20/11/2013
10/07/2013 Centralised - Variation EMEA/H/C/2185/IB/11/G
Updated with Decision(2013)8336 of 20/11/2013
21/11/2013 Centralised - Yearly update (2013)8336 of 20/11/2013