Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Deltyba   
Auth. number : EU/1/13/875
INN : delamanid
Orphan status based on designation EU/3/07/524 added on 30/04/2014
10 years of market exclusivity
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: Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) . Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
It is recommended that delamanid is administered by directly observed therapy (DOT).
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
06/08/2014 Centralised - Variation EMEA/H/C/2552/IB/2/G