Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Ketoconazole HRA   
Auth. number : EU/1/14/965
Active substance : ketoconazole
Orphan market exclusivity for "Treatment of Cushing’s syndrome" (based on designation EU/3/12/965) started on 21/11/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/11/2024
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J02 - Antimycotics for systemic use
Pharmacological subgroup: J02A - Antimycotics for systemic use
Chemical subgroup: J02AB - Imidazole derivatives
Chemical substance: J02AB02 - Ketoconazole
(See WHO ATC Index)
Indication: Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.
Marketing Authorisation Holder: Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France
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
21/11/2014 Centralised - Authorisation EMEA/H/C/3906 (2014)8917 of 19/11/2014
09/03/2015 Rectificative Decision EMEA/H/C/3906 (2015)1573 of 05/03/2015
13/03/2015 Centralised - Variation EMEA/H/C/3906/IAin/2/G
Updated with Decision(2016)1211 of 22/02/2016
24/02/2016 PSUSA - Modification EMEA/H/C/3906/PSUSA/10316/201505 (2016)1211 of 22/02/2016
02/09/2016 PSUSA - Modification EMEA/H/C/3906/PSUSA/10316/201511 (2016) 5673 of 31/08/2016
15/09/2016 Centralised - Variation EMEA/H/C/3906/II/05
Updated with Decision(2017) 1413 of 23/02/2017
27/02/2017 PSUSA - Modification EMEA/H/C/3906/PSUSA/10316/201605 (2017) 1413 of 23/02/2017