An overview of Deltyba and why it is authorised in the EU
Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines). It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.
Deltyba contains the active substance delamanid.
Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 1 February 2008.
Deltyba : EPAR - Medicine overview (PDF/79.6 KB)
First published: 08/05/2014
Last updated: 03/08/2018
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Otsuka Novel Products GmbH
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11/06/2018 Deltyba - EMEA/H/C/002552 - IAIN/0031
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.