ESOMEPRAZOLE-SPR (Arrotex Pharmaceuticals Pty Ltd)
Product name
ESOMEPRAZOLE-SPR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days)
Active ingredients
Esomeprazole magnesium trihydrate
Registration type
New generic medicine
Indication
[TRADENAME] 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 nonsteroidal 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 IV 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