OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial

Main information

  • Trade name:
  • OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177994
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177994

OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

27/03/2012

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. OXALIPLATIN AG oxaliplatin 50 mg/10 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

14/03/2013

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oxaliplatin is indicated for adjuvant treatment of stage III (Duke's C) colon cancer, in combination with a fluoropyrimidine agent,Oxaliplatin in combination

with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer,Oxaliplatin in combination with capecitabine, with or without

bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer,Oxaliplatin in combination with epirubicin and either capecitabine

or fluorouracil, is indicated for the treatment of patients with advanced oesophagogastric cancer

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 30

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 x vial

(S4) Prescription Only Medicine

Components

1. OXALIPLATIN AG

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Clear, colourless solution, practically free from visible particles

Active Ingredients

Oxaliplatin

50 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 10:49:31 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