PRICELINE FEXOFENADINE fexofenadine hydrochloride 180mg film-coated tablet blister pack

Main information

  • Trade name:
  • PRICELINE FEXOFENADINE fexofenadine hydrochloride 180mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRICELINE FEXOFENADINE fexofenadine hydrochloride 180mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186046
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186046

PRICELINE FEXOFENADINE fexofenadine hydrochloride 180mg film-coated tablet blister pack

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

29/06/2011

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. PRICELINE FEXOFENADINE fexofenadine hydrochloride 180mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

18/09/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Seasonal allergic rhinitis, urticaria in adults and children aged 12 years and over.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

50, 60, 70, 80, 90,100

(S2) Pharmacy Medicine

10's, 20's and 30's

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink coloured, oval shaped, biconvex tablets, debossed with "FXF" on side

and "180" on the other.

Active Ingredients

Fexofenadine hydrochloride

180 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 03:25:34 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