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EMA approval · 2023-12-04

EMA Authorised: Pylobactell (urea (13C)) — Richen Europe S.R.L

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Summary

Pylobactell, a urea-13C breath test product, has been authorised in Europe for use in breath testing and Helicobacter pylori infection assessment.

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Diseases / indications

Drugs mentioned

  • Pylobactell (urea-13C)

Snippet

Status: Authorised. Therapeutic area: Breath Tests;Helicobacter Infections. MAH: Richen Europe S.R.L. Decision date: 28/07/2023