Wording of Helicobacter pylori eradication therapy in selected summary-of-product-characteristics sections - Scientific guideline

This document gives general consideration to the clinical evaluation of medicinal products intended for use in H. pylori eradication therapy. It provides guidance on the information to be included in the summary of product characteristics for these medicines.

Keywords: Helicobacter pylori, summary of product characteristics (SmPC), non-NSAID induced gastro-duodenal ulcers

Current effective version

Points to consider on wording of Helicobacter Pylori eradication therapy in selected SPC sections

Adopted Reference Number: CPMP/EWP/863/98 Legal effective date: 01/04/2000