ESOMEPRAZOLE HEXAL (Sandoz Pty Ltd)
Product name
ESOMEPRAZOLE HEXAL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
117 (255 working days)
Active ingredients
esomeprazole magnesium trihydrate
Registration type
New generic medicine
Indication
Esomeprazole Hexal is indicated for:
Gastro-Oesophageal Reflux Disease (GORD)
- treatment of erosive reflux oesophagitis
- long-term management of patients with healed oesophagitis to prevent relapse
- symptomatic treatment of gastro-oesophageal reflux disease (GORD)
Patients requiring NSAID therapy
- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy.
- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy
- prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk.
Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution by intravenous infusion
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion
In combination with appropriate antibiotics for:
- healing of duodenal ulcer associated with Helicobacter pylori
- eradication of Helicobacter pylori in patients with active or healed peptic ulcer