XELOCCORD

Main information

  • Trade name:
  • XELOCCORD capecitabine 150 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XELOCCORD capecitabine 150 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213038
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213038

XELOCCORD capecitabine 150 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

22/07/2014

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. XELOCCORD capecitabine 150 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

15/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Colon Cancer:,Capecitabine is indicated for the adjuvant treatment of patients with Duke's stage C and highrisk stage B, colon cancer, either as

monotherapy or in combination with oxaliplatin.,Colorectal Cancer:,Capecitabine is indicated for the treatment of patients with advanced or metastatic

colorectal cancer.,Oesophagogastric Cancer:,Capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in

combination with a platinum-based regimen.,Breast Cancer:,Capecitabine is indicated for the treatment of patients with locally advanced or metastatic

breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are

clinically contraindicated.,Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast

cancer after failure of prior anthracycline containing chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

30 Tablets in blister pack

(S4) Prescription Only Medicine

60 Tablets in blister pack

(S4) Prescription Only Medicine

120 Tablets in blister pack

(S4) Prescription Only Medicine

Components

1. XELOCCORD capecitabine 150 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light peach coloured, oblong shaped, biconvex, film-coated tablets,

debossed with 150 on one side and plain on other side.

Active Ingredients

Capecitabine

150 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 11:43:26 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