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PANTOPRAZOLE MEDICIANZ (Medsurge Pharma Pty Ltd)
Product name
PANTOPRAZOLE MEDICIANZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
117 (255 working days)
Active ingredients
pantoprazole sodium sesquihydrate
Registration type
New generic medicine
Indication
- 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 non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.