Deltyba is a medicine that is used in adults, adolescents, children and infants weighing at least 10 kg who have 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. Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu307524
Deltyba : EPAR - Medicine overview (PDF/125.88 KB)
First published: 08/05/2014
Last updated: 28/10/2021
Deltyba : EPAR - Risk management plan summary (PDF/131.7 KB)
First published: 28/10/2021
Last updated: 18/10/2022
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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.
Otsuka Novel Products GmbH
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06/07/2023 Deltyba - EMEA/H/C/002552 - II/0061
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 202018/09/2020
World TB Day – three new medicines recommended in last six months for patients with multidrug-resistant tuberculosis21/03/2014
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013