Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Deltyba   
Auth. number : EU/1/13/875
Active substance : delamanid
Orphan market exclusivity for "Treatment of tuberculosis" (based on designation EU/3/07/524) started on 30/04/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 30/04/2024
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J04 - Antimycobacterials
Pharmacological subgroup: J04A - Drugs for treatment of tuberculosis
Chemical subgroup: J04AK - Other drugs for treatment of tuberculosis
Chemical substance: J04AK06 - Delamanid
(See WHO ATC Index)
Indication: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: Otsuka Novel Products GmbH
Erika-Mann-Straße 21, D-80636 München, Deutschland
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
30/04/2014 Centralised - Authorisation EMEA/H/C/2552 (2014)2916 of 28/04/2014
12/06/2014 Centralised - Variation EMEA/H/C/2552/IAin/1/G
Updated with Decision(2015)2916 of 24/04/2015
06/08/2014 Centralised - Variation EMEA/H/C/2552/IB/2/G
Updated with Decision(2015)2916 of 24/04/2015
28/04/2015 Centralised - Annual renewal EMEA/H/C/2552/R/4 (2015)2916 of 24/04/2015
03/06/2015 Centralised - Variation EMEA/H/C/2552/IB/7/G
Updated with Decision(2016)1629 of 11/03/2016
04/03/2016 Centralised - Notification EMEA/H/C/2552/N/12
Updated with Decision(2017)1604 of 03/03/2017
16/03/2016 Centralised - Annual renewal EMEA/H/C/2552/R/10 (2016)1629 of 11/03/2016
06/10/2016 Centralised - Variation EMEA/H/C/2552/II/14
Updated with Decision(2017)1604 of 03/03/2017
07/03/2017 Centralised - Annual renewal EMEA/H/C/002552/R/0017 (2017)1604 of 03/03/2017
04/05/2017 Centralised - Notification EMEA/H/C/002552/N/19