APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet blister pack

Main information

  • Trade name:
  • APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184798
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184798

APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet 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

30/03/2012

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. APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

6/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

The prevention and treatment of osteoporosis in post-menopausal women.,The reduction in the risk of invasive breast cancer in postmenopausal women

with osteoporosis.,The reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.,High risk of breast

cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with

breast cancer, or a 5-year predicted risk of breast cancer greater than 1.66 percent (based on the modified Gail model). Among the factors included in

the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche,

nulliparity or age of first live birth. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. APOTEX-RALOXIFENE raloxifene hydrochloride 60 mg tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White oval biconvex film coated tablet engraved APO on one side RAL60

on the other side

Active Ingredients

Raloxifene hydrochloride

60 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 04:18:17 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