APO-Varenicline

Main information

  • Trade name:
  • APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211947
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211947

APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets

composite blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

3/04/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

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. APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets

composite blister pack

Product Type

Composite Pack

Effective date

12/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Varenicline tablets are indicated as an aid to smoking cessation in adults over the age of 18 years.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

12 Months

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

11 x 0.5 mg tablets and 42 x 1 mg tablets

(S4) Prescription Only Medicine

Components

1. APO-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, modified capsule-shaped, biconvex, film coated tablet engraved

"APO" on one side, "VAR" over "0.5" on the other side.

Active Ingredients

varenicline tartrate

.855 mg

2. APO-Varenicline 1.0 mg tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue, modified capsule-shaped, biconvex, film coated tablet engraved

"APO" on one side, "VAR" over"1" on the other side.

Active Ingredients

varenicline tartrate

1.71 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 27.11.2017 at 12:52:14 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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