PANTOPRAZOLE DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)
Product name
PANTOPRAZOLE DEMOGEN
Date registered
Evaluation commenced
Decision date
Approval time
116 (255 working days)
Active ingredients
pantoprazole sodium sesquihydrate
Registration type
New generic medicine
Indication
Short-term use where oral therapy is not appropriate for:
- Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
- Duodenal ulcer
- Gastric ulcer
- Reflux oesophagitis
- Gastrointestinal lesions refractory to H2 blockers
- Zollinger-Ellison Syndrome
- Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.
Note. Patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.