Finland· FI-REL-REL55790

SIRTURO

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

ATC J04AK05

Checked against Fimea (Finland) on

Informational only — not a medical device.

SOURCE REGISTER · FIFimea (Finland)normalisedSIRTUROATCJ04AK05REGISTER NO.FI-REL-REL55790PACKS LISTED0CHECKEDSeptember 27, 2026

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: Finland, from Fimea (Finland)
  • 8 of them publish a price we can compare per daily dose

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

Fimea (Finland)
Active substance
Bedaquiline fumarate
Manufacturer
Janssen-Cilag International NV
Country
Finland (FI)
ATC code
J04AK05
ATC class
Bedaquiline
Defined daily dose
86 mg, O
Reimbursed
Not published by this register
Source register
Fimea (Finland)
Last checked
September 27, 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.

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

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 Fimea (Finland). 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/bbd69bf6-4cdf-4ceb-ade4-71d272da2bd2
GET /v1/drugs/bbd69bf6-4cdf-4ceb-ade4-71d272da2bd2?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.

{
  "ddd": "86",
  "form": "tabletti",
  "route": "Suun kautta",
  "ddd_unit": "mg",
  "strength": "20 mg",
  "atc_label": "bedakiliini",
  "ma_number": null,
  "auth_status": "Myyntilupa myönnetty",
  "eu_ma_number": "EU/1/13/901/003",
  "fimea_rel_id": "REL55790",
  "authorised_at": "2021-03-26"
}

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.