CLARATYNE

Main information

  • Trade name:
  • CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule blister pack (general sale)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule blister pack (general sale)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207173
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207173

CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule blister pack (general sale)

ARTG entry for

Medicine Registered

Sponsor

Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072

Australia

ARTG Start Date

19/03/2013

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. CLARATYNE LIQUID-CAPSULES loratadine 10mg capsule blister pack (general sale)

Product Type

Single Medicine Product

Effective date

6/09/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For use in the treatment of seasonal allergic rhinitis in adults & children 12 years of age or older.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Oval, clear blue liquid filled (softgel) capsules printed on one side with a

C-10 logo.

Active Ingredients

Loratadine

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 12:48:38 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

14-11-2018

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