Helicobacter Test INFAI

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13C-urea

Authorised
This medicine is authorised for use in the European Union.

Overview

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 24/04/2018

Authorisation details

Product details
Name
Helicobacter Test INFAI
Agency product number
EMEA/H/C/000140
Active substance
13C-urea
International non-proprietary name (INN) or common name
13C-urea
Therapeutic area (MeSH)
  • Breath Tests
  • Helicobacter Infections
Anatomical therapeutic chemical (ATC) code
V04CX
Publication details
Marketing-authorisation holder
INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
14/08/1997
Contact address
Universitässtrasse 142
D-44799 Bochum
Germany

Product information

07/03/2018 Helicobacter Test INFAI - EMEA/H/C/000140 - IB/0020/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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