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.
Checked against Fimea (Finland) on
Informational only — not a medical device.
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
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.
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.
- CzechiaSIRTUROJanssen-Cilag International N.V., Beerse
- United KingdomSirturo 20mg tabletsJanssen-Cilag Ltd
- IrelandSIRTURO 20 mg tabletsJanssen-Cilag International NV
- IcelandSIRTUROJanssen-Cilag International NV*
- NetherlandsSirturo 20 mg, tabletJanssen-Cilag International NV
- PolandSirturoJanssen-Cilag International N.V.
- SwedenSIRTURO 20 mg TablettJanssen-Cilag International NV
- United StatesSIRTUROJanssen Products, LP
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.