Dovprela (previously Pretomanid FGK)
Active substance: pretomanid
pretomanid
Centralised EU authorisationActive
Marketing holder: Mylan IRE Healthcare Limited
Verified 2026-10-09 · EMA
Analogues in other countries- Source: EMA
- Countries with the substance registered: 2
Composition
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| US 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a12095-e5b1-7b3b-8615-198d7a0967e5;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- EMEA/H/C/005167
- Registration status
- Active
- ATC code
- J04
Sources
- product · EMA · EMEA/H/C/005167 · Verified 2026-10-09
- registration_status · EMA · EMEA/H/C/005167 · Verified 2026-10-09
- ingredients.0 · EMA · EMEA/H/C/005167 · Verified 2026-10-09