SALIET rabeprazole sodium 20mg enteric coated tablet bottle

Main information

  • Trade name:
  • SALIET rabeprazole sodium 20mg enteric coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SALIET rabeprazole sodium 20mg enteric coated tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196563
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196563

SALIET rabeprazole sodium 20mg enteric coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

27/05/2013

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. SALIET rabeprazole sodium 20mg enteric coated tablet bottle

Product Type

Single Medicine Product

Effective date

1/12/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

? 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

antiinflammatory,drugs (NSAIDs) usually require treatment with antimicrobial agents in addition to,antisecretory drugs whether on first presentation or on

recurrence.,It is also indicated, in combination with clarithromycin and amoxycillin, for,? Eradication of Helicobacter pylori in patients with peptic ulcer

disease or chronic gastritis,? Healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Child resistant closure

Do not Refrigerate

Store in Original

Container

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. SALIET rabeprazole sodium 20mg enteric coated tablet bottle

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Light yellow, round, biconvex coated tablets and plain on both sides.

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 01:40:11 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