Ireland· IE-PA-EU/1/97/045/003
Helicobacter Test INFAI for children of the age 3-11
A medicinal product containing 13c-urea, registered in Ireland by INFAI Institut fur biomedizinish.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- 13c-urea
- Manufacturer
- INFAI Institut fur biomedizinish
- Country
- Ireland (IE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/97/045/003
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.
- United Kingdomdiabact UBT 50mg tabletsMayoly UK Ltd
- CzechiaHELICOBACTER TEST INFAIINFAI GmbH., Hagen
- SwedenDiabact UBT 50 mg TablettLaboratoires Mayoly Spindler
- IcelandHelicobacter Test INFAIINFAI*
- NorwayHelicobacter Test INFAIINFAI GmbH (1)
- 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
- Iceland · Helicobacter Test, Helicobacter Test For Children Of The Age 3-11
- 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 HPRA (Ireland). 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/a0b2071d-ef56-4852-978c-106af3a2669f GET /v1/drugs/a0b2071d-ef56-4852-978c-106af3a2669f?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": "Powder for oral solution",
"routes": null,
"source": "hpra",
"atc_all": null,
"strength": null,
"pa_number": "EU/1/97/045/003",
"substances": [
"13c-urea"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "10/10/2002",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.