NICABATE MINIS CHERRY nicotine 1.5mg lozenge tube

Main information

  • Trade name:
  • NICABATE MINIS CHERRY nicotine 1.5mg lozenge tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NICABATE MINIS CHERRY nicotine 1.5mg lozenge tube
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 191494
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

191494

NICABATE MINIS CHERRY nicotine 1.5mg lozenge tube

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Postal Address

Locked Bag 3,

Ermington, NSW, 2115

Australia

ARTG Start Date

3/11/2011

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. NICABATE MINIS CHERRY nicotine 1.5mg lozenge tube

Product Type

Single Medicine Product

Effective date

3/11/2011

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relief of nicotine withdrawal symptoms including cravings associated with smoking cessation. Nicabate Minis Lozenges may also be used as part of a

smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping smoking. Nicabate Minis

Lozenges should be used as part of a behavioural support programme.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

2 Years

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Lozenge

Route of Administration

Buccal

Visual Identification

White to off white oval tablet with convex surfaces. One surface bearing a

debossed "C" logo.

Active Ingredients

Nicotine

1.5 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 10:20:25 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