QUITX nicotine 2mg freshmint coated chewing gum blister pack (new formulation)

Main information

  • Trade name:
  • QUITX nicotine 2mg freshmint coated chewing gum blister pack (new formulation)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUITX nicotine 2mg freshmint coated chewing gum blister pack (new formulation)
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 192915
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192915

QUITX nicotine 2mg freshmint coated chewing gum blister pack (new formulation)

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

12/12/2011

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. QUITX nicotine 2mg freshmint coated chewing gum blister pack (new formulation)

Product Type

Single Medicine Product

Effective date

29/01/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to

quit. In smokers currently unable or not ready to stop smoking abruptly, the gum may also be used as part of a smoking reduction strategy as a step

towards stopping completely.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Not scheduled. Not considered by committee

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Gum, chewing

Route of Administration

Buccal

Visual Identification

White, square, biconvex, coated gum

Active Ingredients

Nicotine polacrilex

11.44 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 07:56:52 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