XALOX RTU oxaliplatin 200mg/40mL concentrated solution for injection vial

Main information

  • Trade name:
  • XALOX RTU oxaliplatin 200mg/40mL concentrated solution for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • XALOX RTU oxaliplatin 200mg/40mL concentrated solution for injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177070
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177070

XALOX RTU oxaliplatin 200mg/40mL concentrated solution for injection vial

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

12/12/2011

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. XALOX RTU oxaliplatin 200mg/40mL concentrated solution for injection vial

Product Type

Single Medicine Product

Effective date

12/12/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: ,· Adjuvant treatment of stage III (Duke's C) colon cancer after complete

resection of ,the primary tumour ,· Treatment of advanced colorectal cancer

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colourless to slightly yellow solution.

Active Ingredients

Oxaliplatin

200 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

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Produced at 29.11.2017 at 11:48:53 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