RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack

Main information

  • Trade name:
  • RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 194562
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

194562

RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Janssen-Cilag Pty Ltd

Postal Address

Locked Bag 2070,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

7/08/2012

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. RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

22/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

RABGEST is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment 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. RABGEST 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Do not Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. RABGEST rabeprazole sodium 20mg enteric-coated tablet blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Light yellow film coated biconvex tablets marked "E243" in red ink on one

side

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 28.11.2017 at 05:44:42 AEDT

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