ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack

Main information

  • Trade name:
  • ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 188389
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

188389

ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Eris Pharmaceuticals (Australia) Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

24/09/2012

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. ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

17/07/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

First line treatment of advanced breast cancer in postmenopausal women with oestrogen/progesterone receptor positive disease. Treatment of advanced

breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with oestrogen receptor negative disease and

patients who have not responded to previous tamoxifen therapy rarely respond to ANASTROZOLE ERIS.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

30 Tablets

(S4) Prescription Only Medicine

Components

1. ANASTROZOLE ERIS anastrozole 1 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, round, biconvex film coated tablet engraved with the

letters "A 1" on one side and plain on the other

Active Ingredients

Anastrozole

1 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 29.11.2017 at 01:32:25 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