Dovprela (previously Pretomanid FGK) (pretomanid)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pretomanid
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Tuberculosis, Multidrug-Resistant
- CHMP opinion
- Thu 26 Mar 2020
- EU approval
- Fri 31 Jul 2020
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005167
- ATC
- J04
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.