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SALPRAZ (Alphapharm Pty Ltd)

Product name
SALPRAZ
Sponsor
Alphapharm Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
38 working days (255)
Active ingredients
pantoprazole sodium sesquihydrate
Registration type
EOI
Indication
Generic medicine

SALPRAZ (tablets) is now indicated for eradication of Helicobacter pylori. Treatment with pantoprazole and one of the following combinations of antibiotics clarithromycin and amoxicillin, clarithromycin and metronidazole or amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.

SALPRAZ, in combination with bismuth, metronidazole and tetracycline, is now also indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.

SALPRAZ is now also indicated for the treatment of heartburn and other symptoms associated with Gastrooesophageal Reflux Disease Reflux oesophagitis in children aged from 5 to 17 years. The treatment duration should not exceed 8 weeks.

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