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).
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
V04CX
ATC Item
其它诊断试剂
Pharmacotherapeutic Group
Diagnostic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| urea (13C) | N/A | Urea C-13 |
EMA Name
Helicobacter Test INFAI
Medicine Name
Helicobacter Test INFAI
Aliases
N/ANo risk management plan link.
