MEDIHEALTH

Main information

  • Trade name:
  • MEDIHEALTH loratadine 10mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDIHEALTH loratadine 10mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213025
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213025

MEDIHEALTH loratadine 10mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Orion Laboratories Pty Ltd T/A Perrigo Australia

Postal Address

25-29 Delawney Street,BALCATTA, WA, 6021

Australia

ARTG Start Date

8/08/2013

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. MEDIHEALTH loratadine 10mg tablet bottle

Product Type

Single Medicine Product

Effective date

8/08/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the symptomatic treatment of seasonal and perennial allergic rhinitis, and relief of symptoms and signs of chronic urticaria in adults and children 12

years of age and older.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

A white to off white, oval, uncoated tablet with 'L612' debossed on one side

Active Ingredients

Loratadine

9.999 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 11:47:39 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

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