Dovprela1 is a medicine for treating adults with drug-resistant tuberculosis. It is used to treat tuberculosis that is: - extensively drug-resistant (resistant to at least 4 antibiotics used for treating tuberculosis, including the standard antibiotics isoniazid and rifampicin); - multi-drug resistant (resistant to isoniazid and rifampicin) and when antibiotics used for this form of tuberculosis do not work or cause unacceptable side effects. Dovprela is used together with bedaquiline and linezolid. Tuberculosis is rare in the EU, and Dovprela was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 November 2007. Further information on the orphan designation can be found on the EMA website: [ema.europa.eu/medicines/human/orphan-designations/eu 307513](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu307513). Dovprela contains the active substance pretomanid. * * * 1Previously known as Pretomanid FGK
Therapeutic Indication
### Therapeutic indication Dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Therapeutic Area (MeSH)
ATC Code
J04
ATC Item
抗分支杆菌药
Pharmacotherapeutic Group
Antimycobacterials
Active Substance (Summary)
INN / Common Names
EMA Name
Dovprela (previously Pretomanid FGK)
Medicine Name
Dovprela (previously Pretomanid FGK)
Aliases
N/ANo risk management plan link.
