Helicobacter Test INFAI
13C-urea
Table of contents
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).
Authorisation details
Product details | |
---|---|
Name |
Helicobacter Test INFAI
|
Agency product number |
EMEA/H/C/000140
|
Active substance |
urea (13C)
|
International non-proprietary name (INN) or common name |
13C-urea
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
V04CX
|
Publication details | |
---|---|
Marketing-authorisation holder |
INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
|
Revision |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
14/08/1997
|
Contact address |
Riehler Strasse 36 |
Product information
30/01/2023 Helicobacter Test INFAI - EMEA/H/C/000140 - N/0026
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.