Prognia
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🇪🇺EU · EMAAuthorisedATC: J04Orphan Medicine

Dovprela (previously Pretomanid FGK)(pretomanid)

Tuberculosis, Multidrug-Resistant

Marketing Authorisation Holder: Mylan IRE Healthcare Limited

EMA Authorisation: 31/07/2020

INN: pretomanid

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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.