Helicobacter Test INFAI (13C-urea)
- Region
- 🇪🇺 EU
- Active substance
- 13C-urea
- Company
- INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
- Status
- Authorised
- Therapeutic area
- Breath Tests; Helicobacter Infections
- CHMP opinion
- Wed 16 Apr 1997
- EU approval
- Thu 14 Aug 1997
- Application
- EMEA/H/C/000140
- ATC
- V04CX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pylobactell Authorised · Richen Europe S.R.L
- 🇪🇺 Pylori-Chek Withdrawn · Alimenterics B.V.
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