NORFLOXACIN

Main information

  • Trade name:
  • NORFLOXACIN AN norfloxacin 400mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NORFLOXACIN AN norfloxacin 400mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 184273
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184273

NORFLOXACIN AN norfloxacin 400mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

20/04/2012

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. NORFLOXACIN AN norfloxacin 400mg tablet blister pack

Product Type

Single Medicine Product

Effective date

27/07/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS: The treatment of adults with complicated and uncomplicated urinary tract infections that are caused by susceptible strains of

microorganisms. The treatment of adults with gastrointestional infections, in particular shigellosis and traveller's diarrhoea. Note: Specimens for culture

and susceptibility testing should be obtained prior to and during treatment if clinical response warrants. Suppression in adults of chronic, recurrent urinary

tract infections.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

14 tablets

(S4) Prescription Only Medicine

6 tablets

(S4) Prescription Only Medicine

Components

1. NORFLOXACIN AN norfloxacin 400mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, oval shaped film-coated tablets with "CD" embossed on one side

and a bisect line on the other side.

Active Ingredients

Norfloxacin

400 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 29.11.2017 at 04:53:16 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