Iceland· IS-EU/1/20/1437/001-005
Dovprela
A antimycobacterials product containing pretomanidum inn, registered in Iceland by Mylan IRE Healthcare Limited. The same ATC class is registered in 2 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Pretomanidum inn is registered in 2 of 19 countries.
Countries holding a registration under ATC J04 (antimycobacterials), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 1 of them publish a price we can compare per daily dose
Pretomanidum inn · ATC J04
2 / 19 countries
- Icelandprice
- Ireland
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Pretomanidum INN
- Manufacturer
- Mylan IRE Healthcare Limited
- Country
- Iceland (IS)
- ATC code
- J04
- ATC class
- ANTIMYCOBACTERIALS
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pretomanidum inn in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDOVPRELAMylan IRE Healthcare Limited, Dublin
- FinlandDovprelaMylan IRE Healthcare Limited
- FranceDOVPRELA 200 mg, compriméMYLAN IRE HEALTHCARE (IRLANDE)
- United KingdomDovprela 200mg tabletsImported (Italy)
- IrelandDovprela 200 mg tabletsMylan IRE Healthcare Limited
- NetherlandsDovprela 200 mg tabletMylan IRE Healthcare Limited
- NorwayDovprelaMylan
- PolandDovprelaMylan IRE Healthcare Ltd.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Liechtenstein · Dovprela
- Norway · Dovprela
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of Icelandic Medicines Agency (Iceland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/e0067b5d-0468-4d0d-bf36-d6347fea7a46 GET /v1/drugs/e0067b5d-0468-4d0d-bf36-d6347fea7a46?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Tafla",
"source": "lyfjastofnun",
"atc_raw": "J04",
"marketed": false,
"strength": "200 mg",
"ma_number": "EU/1/20/1437/001-005",
"substance": "Pretomanidum INN",
"other_info": "Ávísun lyfsins er bundin við smitsjúkdómalækna og lungnalækna með reynslu af meðferð sjúklinga með fjölónæma berkla.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "44043"
}See everything about pretomanidum inn.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.