<p>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).</p><p>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.</p><p>Deltyba contains the active substance delamanid.</p><p>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: <a href="/en/medicines/human/orphan-designations/eu-3-07-524" data-entity-type="node" data-entity-uuid="a65819d2-c7f4-4ee0-8c30-f431ec582003" data-entity-substitution="canonical">ema.europa.eu/en/medicines/human/orphan-designations/eu307524</a></p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>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).</p> <p>Consideration should be given to official guidance on the appropriate use of antibacterial agents.</p> </div>
Therapeutic Area (MeSH)
ATC Code
J04AK06
ATC Item
N/A
Pharmacotherapeutic Group
Antimycobacterials
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Delamanid | N/A | Delamanid |
EMA Name
Deltyba
Medicine Name
Deltyba
Aliases
N/ANo risk management plan link.
