PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN (Alphapharm Pty Ltd)
Product name
PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
pantoprazole sodium sesquihydrate
Registration type
New generic medicine
Indication
PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN (powder for injection) is indicated for short-term use where oral therapy is not appropriate for:
1. 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
2. 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.