PANTOPRAZOLE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
PANTOPRAZOLE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
251 working days (255)
Active ingredients
Pantoprazole sodium sesquihydrate
Registration type
New generic medicine
Indication
PANTOPRAZOLE-AFT (powder for injection) is indicated for 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.