Iceland· IS-EU/1/13/901/001-002
SIRTURO
A bedaquiline product containing bedaquilinum inn fumarat, registered in Iceland by Janssen-Cilag International NV*. The same ATC class is registered in 13 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Bedaquilinum INN fumarat
- Manufacturer
- Janssen-Cilag International NV*
- Country
- Iceland (IS)
- ATC code
- J04AK05
- ATC class
- Bedaquiline
- Defined daily dose
- 86 mg, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 3
3 priced- ean97409824 stk x1 pakkiISK 633496
- ean988842188 stk x1 pakkiISK 3648372
- ean98958524 stk x1 pakkiISK 690942
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
- SpainSIRTURO 100 MG COMPRIMIDOSJanssen-Cilag International N.V
- FinlandSIRTUROJanssen-Cilag International NV
- FranceSIRTURO 100 mg, compriméJANSSEN CILAG INTERNATIONAL NV
- United KingdomSirturo 100mg tabletsJanssen-Cilag Ltd
- IrelandSIRTURO 100 mg tabletsJanssen-Cilag International NV
- NetherlandsSirturo 100 mg, TabletJanssen-Cilag International NV
- NorwaySirturoJanssen-Cilag International N.V.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/8edb673c-d34b-4a20-bce9-a20a21d18165 GET /v1/drugs/8edb673c-d34b-4a20-bce9-a20a21d18165?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": "Tafla",
"source": "lyfjastofnun",
"atc_raw": "J04AK05",
"marketed": false,
"strength": "100 mg",
"ma_number": "EU/1/13/901/001-002",
"substance": "Bedaquilinum INN fumarat",
"other_info": "Ávísun lyfsins er bundin við smitsjúkdómalækna og lungnalækna með reynslu af meðferð sjúklinga með fjölónæma berkla.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "41703"
}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.