Deltyba

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delamanid

Authorised
This medicine is authorised for use in the European Union.

Overview

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

This EPAR was last updated on 18/10/2022

Authorisation details

Product details
Name
Deltyba
Agency product number
EMEA/H/C/002552
Active substance
Delamanid
International non-proprietary name (INN) or common name
delamanid
Therapeutic area (MeSH)
Tuberculosis, Multidrug-Resistant
Anatomical therapeutic chemical (ATC) code
J04AK06
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Otsuka Novel Products GmbH
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
27/04/2014
Contact address
Erika-Mann-Strasse 21
D-80636 München
Germany

Product information

01/09/2022 Deltyba - EMEA/H/C/002552 - II/0053

Other EU languages available icon 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:

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.

Pharmacotherapeutic group

Antimycobacterials

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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