RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack

Main information

  • Trade name:
  • RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 173083
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

173083

RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

8/03/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

7/02/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Rabeprazole SZ is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment of gastro-oesophageal

reflux disease; treatment of duodenal ulcers; treatment of gastric ulcers. Patients whose gastric and duodenal ulceration is not associated with ingestion

of non-steroidal anti-inflammatory drugs (NSAIDS) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first

presentation or on recurrence.,Rabeprazole SZ is also indicated, in combination with clarithromycin and amoxycillin, for eradication of Helicobacter pylori

in patients with peptic ulcer disease or chronic gastritis; and healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. RABEPRAZOLE SZ rabeprazole sodium 20 mg tablet blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

yellow, round, biconvex coated tablet

Active Ingredients

rabeprazole sodium

20 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 23.05.2019 at 07:23:18 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Public Summary

Page 2 of

Produced at 23.05.2019 at 07:23:18 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information