12 • behandling af NSAID- relaterede godartede gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID- behandling • profylakse af NSAID- relaterede gastriske og duodenale ulcera hos risikopatienter (se punkt 4. 2), der kræver fortsat behandling • symptomatisk gastroøsofageal reflukssygdom • Zollinger- Ellisons syndrom.
11 Benefit/Risk consideration Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to: • Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome.