Lansoprazole

Main information

  • Trade name:
  • Lansoprazole ODT generichealth lansoprazole15mg blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lansoprazole ODT generichealth lansoprazole15mg blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216789
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216789

Lansoprazole ODT generichealth lansoprazole15mg blister pack

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Generic Health Pty Ltd,Level 1 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

19/11/2014

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. Lansoprazole ODT generichealth lansoprazole15mg blister pack

Product Type

Single Medicine Product

Effective date

2/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adults:,1.Healing and long-term management of reflux oesophagitis.,2.Healing and long-term management for patients with duodenal ulcer.,3.Healing of

benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment

with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,4.Lansoprazole is also effective in patients with

benign peptic lesions that do not respond to H2-receptor antagonists.,5.Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic

ulcer or chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials).,6.Relief of reflux-like and/or ulcer-like symptoms

associated with acid-related dyspepsia.,Paediatric patients 6 to 17 years of age.,1.Treatment of gastro-oesophageal reflux disease, including all grades

of oesophagitis.,2.Healing of erosive oesophagitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

Cold form dessicant blister (with Peelable Al foil) 7's and 28's

(S4) Prescription Only Medicine

Alu/Alu blister (with Peelable Al foil) 7's and 28's

(S4) Prescription Only Medicine

Cold form dessicant blister (with push through Al foil) 7's and 28's

(S4) Prescription Only Medicine

Alu/Alu blister (with push through Al foil) 7's and 28's

(S4) Prescription Only Medicine

Components

1. Lansoprazole ODT generichealth lansoprazole15mg blister pack

Dosage Form

Tablet, orally disintegrating

Route of Administration

Oral

Visual Identification

White to yellowish white uncoated tablets,speckled with orange to dark

brown pellets debossed with 'I5' on one side and plain on the other side

Active Ingredients

Lansoprazole

15 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 26.11.2017 at 07:14:27 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