Dovprela (previously Pretomanid FGK)
What Dovprela (previously Pretomanid FGK) is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Dovprela (previously Pretomanid FGK)
- Active substance
- pretomanid
- Disease area
- Tuberculosis, Multidrug-Resistant
- Medicine group
- Antimycobacterials
- ATC code
- J04
- Marketing authorisation holder
- Viatris Healthcare Limited
- Authorised in the EU since
- 2020
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Dovprela (previously Pretomanid FGK) used for?
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.
What is the active substance in Dovprela (previously Pretomanid FGK)?
Dovprela (previously Pretomanid FGK) contains pretomanid.
Who makes Dovprela (previously Pretomanid FGK)?
The EU marketing authorisation holder is Viatris Healthcare Limited.
Is Dovprela (previously Pretomanid FGK) an orphan medicine?
Yes. Dovprela (previously Pretomanid FGK) is designated an orphan medicine in the EU, for a rare disease (Tuberculosis, Multidrug-Resistant).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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