TERRY WHITE CHEMISTS Cetirizine Hydrochloride 10mg tablet blister pack

Main information

  • Trade name:
  • TERRY WHITE CHEMISTS Cetirizine Hydrochloride 10mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRY WHITE CHEMISTS Cetirizine Hydrochloride 10mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192335
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192335

TERRY WHITE CHEMISTS Cetirizine Hydrochloride 10mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

23/11/2011

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. TERRY WHITE CHEMISTS Cetirizine Hydrochloride 10mg tablet blister pack

Product Type

Single Medicine Product

Effective date

25/09/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Seasonal Allergic Rhinitis: Cetirizine is indicated for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) in adults and children 6

years and over. Symptoms treated effectively include sneezing, rhinorrhea, post-nasal discharge, nasal pruritus, ocular pruritus, tearing and redness of

the eyes., Perennial allergic rhinitis: Cetirizine is indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6

years and over. Symptoms treated effectively include sneezing, rhinorrhea, post-nasal discharge, nasal pruritus, ocular pruritus and tearing., Chronic

idiopathic urticaria: Cetirizine is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6

years and over. It significantly reduces the occurrence, severity and duration of hives and markedly reduces pruritus. As with other antihistamines,

patients should be advised to seek medical advice about the possibility that their urticaria is associated with ingestion of certain foods.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S2) Pharmacy Medicine

20 tablets

(S2) Pharmacy Medicine

50 tablets

(S2) Pharmacy Medicine

10 tablets

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, capsule shaped film coated tablets with breakline on one side and

"M+" embossed on other side.

Active Ingredients

cetirizine hydrochloride

10 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 09:18:21 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