Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Plenadren   
Auth. number : EU/1/11/715
Active substance : hydrocortisone
Orphan market exclusivity for "Treatment of adrenal insufficiency" (based on designation EU/3/06/372) started on 14/11/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 14/11/2021
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: Shire Services 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
05/06/2012 Centralised - Variation (refusal) EMEA/H/C/2185/IA/3
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
03/12/2015 Centralised - Variation EMEA/H/C/2185/IG/603/G
Updated with Decision(2016)2949 of 11/05/2016
13/05/2016 Centralised - Yearly update (2016)2949 of 11/05/2016
26/05/2016 Centralised - Variation EMEA/H/C/2185/II/21
Updated with Decision(2016)5263 of 08/08/2016
10/08/2016 Centralised - Renewal EMEA/H/C/2185/R/20 (2016)5263 of 08/08/2016
13/10/2016 Centralised - Variation EMEA/H/C/2185/II/22