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France· FR:65690588

SIRTURO 100 mg, comprimé

A bedaquiline product containing fumarate de bédaquiline, registered in France by JANSSEN CILAG INTERNATIONAL NV. The same ATC class is registered in 13 of our 19 countries.

ATC J04AK05

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedSIRTURO 100 mg, compriméATCJ04AK05REGISTER NO.FR:65690588PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fumarate de bédaquilineAnswers 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: France, from Base de données publique des médicaments — BDPM (France)
  • 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

Base de données publique des médicaments — BDPM (France)
Active substance
FUMARATE DE BÉDAQUILINE
Manufacturer
JANSSEN CILAG INTERNATIONAL NV
Country
France (FR)
ATC code
J04AK05
ATC class
Bedaquiline
Defined daily dose
86 mg, O
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400930015810
    4 plaquette(s) thermoformée(s) aluminium de 6 comprimé(s)

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 Base de données publique des médicaments — BDPM (France). 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/8610575a-73db-4cbb-b1a2-3e0f64e27d11
GET /v1/drugs/8610575a-73db-4cbb-b1a2-3e0f64e27d11?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.

{
  "cis": "65690588",
  "date_amm": "2014-03-05",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/13/901",
  "substance": "FUMARATE DE BÉDAQUILINE",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "comprimé",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}
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