Iceland· IS-EU/1/97/045/001-002&004-005/IS
Helicobacter Test INFAI
A other diagnostic agents product containing 13c-urea, registered in Iceland by INFAI*. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
13c-urea is registered in 11 of 19 countries.
Countries holding a registration under ATC V04CX (other diagnostic agents), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 7 of them publish a price we can compare per daily dose
13c-urea · ATC V04CX
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- 13C-Urea
- Manufacturer
- INFAI*
- Country
- Iceland (IS)
- ATC code
- V04CX
- ATC class
- Other diagnostic agents
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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.
Same medicine, other countries
13c-urea in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaHELICOBACTER TEST INFAIINFAI GmbH., Hagen
- United KingdomHelicobacter Test INFAI breath test kitINFAI UK Ltd
- NorwayHelicobacter Test INFAIINFAI GmbH (1)
- SwedenHelicobacter Test INFAI 75 mg Pulver till oral lösningINFAI GmbH
- IrelandDiabact UBT 50 mg tabletsLaboratoires Mayoly Spindler
- PolandPylobactellRichen Europe S.R.L.
- GermanyDiabact UbtLaboratoires Mayoly Spindler
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Diabact Ubt
- Belgium · Espikur
- Germany · Diabact Ubt
- Denmark · Diabact Ubt
- Spain · Espikur, Tau-Kit
- Finland · Diabact Ubt
- France · Helikit
- United Kingdom (Northern Ireland) · Diabact Ubt
- Ireland · Diabact Ubt
- Italy · Breathquality-Ubt, Expirobacter
- Liechtenstein · Helicobacter Test, Helicobacter Test Infai For Children Of The Age 3-11
- Luxembourg · Espikur
- Netherlands · Espikur, Helico State
- Norway · Diabact Ubt, Helicobacter Test
- Portugal · Espikur
- Sweden · Diabact Ubt, Espikur
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/9ab5a991-f3a3-404e-9589-60fe49432108 GET /v1/drugs/9ab5a991-f3a3-404e-9589-60fe49432108?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": "Mixtúruduft, lausn",
"source": "lyfjastofnun",
"atc_raw": "V04CX",
"marketed": false,
"strength": "75 mg",
"ma_number": "EU/1/97/045/001-002&004-005/IS",
"substance": "13C-Urea",
"other_info": null,
"legal_status": "(R) Lyfseðilsskylt",
"ma_issued_serial": "37753"
}See everything about 13c-urea.
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.