Helicobacter Test INFAI



This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 02/02/2023

Authorisation details

Product details
Helicobacter Test INFAI
Agency product number
Active substance
urea (13C)
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Breath Tests
  • Helicobacter Infections
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Riehler Strasse 36 
D-50668 Cologne

Product information

30/01/2023 Helicobacter Test INFAI - EMEA/H/C/000140 - N/0026

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diagnostic agents

Therapeutic indication

Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:

  • adults;
  • adolescents, who are likely to have peptic ulcer disease.

Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection:

  • for the evaluation of the success of eradication treatment, or;
  • when invasive tests cannot be performed, or;
  • when there are discordant results arising from invasive tests.

This medicinal product is for diagnostic use only.

Assessment history

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