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Sweden· SE-19970814000016

Helicobacter Test INFAI 75 mg Pulver till oral lösning

A medicinal product containing 13c-urea, registered in Sweden by INFAI GmbH.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedHelicobacter Test INFAI 75 mg Pulver …ATC—REGISTER NO.SE-19970814000016PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
13c-Urea
Manufacturer
INFAI GmbH
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    19970814000016

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.

All 13c-urea products

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
  • 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

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 Swedish Medical Products Agency (Sweden). 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/5d01a84d-a84d-42b2-a9ad-917713aaba09
GET /v1/drugs/5d01a84d-a84d-42b2-a9ad-917713aaba09?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "EPAR",
    "EMA"
  ],
  "se_npl_id": "19970814000016",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=19970814000016",
  "product_doc_link": "https://www.ema.europa.eu/sv/documents/product-information/helicobacter-test-infai-epar-product-information_sv.pdf"
}

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.