Pylobactell (13C-urea)
- Region
- 🇪🇺 EU
- Active substance
- 13C-urea
- Company
- Richen Europe S.R.L
- Status
- Authorised
- Therapeutic area
- Breath Tests; Helicobacter Infections
- EU approval
- Thu 07 May 1998
- Application
- EMEA/H/C/000151
- ATC
- V04CX
- Official record
- www.ema.europa.eu
Indication
This medicinal product is for diagnostic use only. For in vivo diagnosis of gastroduodenal Helicobacter pylori (H. pylori) infection.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Helicobacter Test INFAI Authorised · INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH
- 🇪🇺 Pylori-Chek Withdrawn · Alimenterics B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.