AMCAL

Main information

  • Trade name:
  • AMCAL NICOTINE LOZENGES 2mg nicotine (as nicotine polacrilex) lozenge blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL NICOTINE LOZENGES 2mg nicotine (as nicotine polacrilex) lozenge blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213239
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213239

AMCAL NICOTINE LOZENGES 2mg nicotine (as nicotine polacrilex) lozenge blister pack

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

15/08/2013

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. AMCAL NICOTINE LOZENGES 2mg nicotine (as nicotine polacrilex) lozenge blister pack

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relief of nicotine withdrawal symptoms including cravings associated with smoking cessation. Nicotine 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. If possible, when stopping

smoking, should be used in conjunction with behavioural support program.

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

Not recorded

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

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Buccal

Visual Identification

Cream/white embossed biconvex round tablet with an odour of peppermint.

Embossed with 'L344' on one face.

Active Ingredients

Nicotine polacrilex

13.33 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 11:22:10 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

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

3-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

7-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

FDA - U.S. Food and Drug Administration

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration