APO-Pemetrexed

Main information

  • Trade name:
  • APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210439
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210439

APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/09/2014

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. APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial

Product Type

Single Medicine Product

Effective date

7/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural

mesothelioma.,Non-Small Cell Lung Cancer (NSCLC),Pemetrexed, in combination with cisplatin, is indicated for initial treatment of patients with locally

advanced or metastatic NSCLC other than predominantly squamous cell histology.,Pemetrexed, as monotherapy, is indicated for the treatment of

patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

White to either light yellow or green-yellow powder.

Active Ingredients

pemetrexed disodium hemipentahydrate

120.8 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 27.11.2017 at 09:49:37 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

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