EMA
approval
· 2026-06-09
EMA Authorised: Dovprela (previously Pretomanid FGK) (pretomanid) — Mylan IRE Healthcare Limited
Summary
EMA authorised Dovprela (pretomanid) for multidrug-resistant tuberculosis; orphan medicine.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: Tuberculosis, Multidrug-Resistant. MAH: Mylan IRE Healthcare Limited. Decision date: 04/05/2026. Orphan medicine