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 medicines 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](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu307524)
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J04AK06
ATC Item
delamanid
Pharmacotherapeutic Group
Antimycobacterials
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Delamanid | N/A | 德拉马尼 |
EMA Name
Deltyba
Medicine Name
Deltyba
Aliases
N/A
