Dovprela (previously Pretomanid FGK)
·
- Prescription status not stated
- Antibiotics, antivirals and antifungals taken into the body
- Active substance
- Pretomanid
- Made by
- Mylan IRE Healthcare Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is 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.
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Mylan IRE Healthcare Limited |
|---|---|
| Active substance | Pretomanid |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Classification | J04 · Antibiotics, antivirals and antifungals taken into the body |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2020-07-31 |
| Last updated by the regulator | 2026-06-09 |
| EMA product number | EMEA/H/C/005167 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).