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Ireland· IE-PA-EU/1/13/901/003

SIRTURO 20 mg tablets

A bedaquiline product containing bedaquiline fumarate, registered in Ireland by Janssen-Cilag International NV. The same ATC class is registered in 13 of our 19 countries.

ATC J04AK05

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSIRTURO 20 mg tabletsATCJ04AK05REGISTER NO.IE-PA-EU/1/13/901/003PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about bedaquiline fumarateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Bedaquiline is registered in 13 of 19 countries.

Countries holding a registration under ATC J04AK05 (bedaquiline), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 8 of them publish a price we can compare per daily dose
Search bedaquiline products by name

Bedaquiline · ATC J04AK05

13 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Kingdom
  • United Statesprice
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
Bedaquiline fumarate
Manufacturer
Janssen-Cilag International NV
Country
Ireland (IE)
ATC code
J04AK05
ATC class
Bedaquiline
Defined daily dose
86 mg, O
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/13/901/003

Regulatory notes

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

Interactions

325 interactions on record for bedaquiline.

Graded by severity as the source publishes them — 141 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check bedaquiline against other medicinesHow interaction checks work

Bedaquiline · interactions on record

325 records

  • 141 severe
  • 182 moderate
  • 2 minor

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe
  • GranisetronA04AA02severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Bedaquiline in 12 other countries

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

All bedaquiline products

Authorised across Europe · EMA

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

  • Iceland · Sirturo
  • Liechtenstein · Sirturo
  • Norway · Sirturo

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/a4eb3add-ee21-48cf-be73-cd912e421e99
GET /v1/drugs/a4eb3add-ee21-48cf-be73-cd912e421e99?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": [
    "J04AK05"
  ],
  "strength": null,
  "pa_number": "EU/1/13/901/003",
  "substances": [
    "Bedaquiline fumarate"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "26/03/2021",
  "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 bedaquiline.

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