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Ireland· IE-PA-EU/1/20/1437/001-005

Dovprela 200 mg tablets

A antimycobacterials product containing pretomanid, registered in Ireland by Mylan IRE Healthcare Limited. The same ATC class is registered in 2 of our 19 countries.

ATC J04

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedDovprela 200 mg tabletsATCJ04REGISTER NO.IE-PA-EU/1/20/1437/00…PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about pretomanidAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Pretomanid 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: Ireland, from HPRA (Ireland)
  • 1 of them publish a price we can compare per daily dose
Search pretomanid products by name

Pretomanid · 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

HPRA (Ireland)
Active substance
Pretomanid
Manufacturer
Mylan IRE Healthcare Limited
Country
Ireland (IE)
ATC code
J04
ATC class
ANTIMYCOBACTERIALS
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/20/1437/001-005

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Pretomanid in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All pretomanid products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Dovprela
  • 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 HPRA (Ireland). 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/e5eeead5-f9ee-4809-8038-f635a8865848
GET /v1/drugs/e5eeead5-f9ee-4809-8038-f635a8865848?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": "Tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "J04"
  ],
  "strength": null,
  "pa_number": "EU/1/20/1437/001-005",
  "substances": [
    "Pretomanid"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "31/07/2020",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

See everything about pretomanid.

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.

Try it freeOpen in the console