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.

ATC J04

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedDovprelaATCJ04REGISTER NO.IS-EU/1/20/1437/001-0…PACKS LISTED0CHECKEDSeptember 29, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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.

All pretomanidum inn products

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.