PEMETREXED

Main information

  • Trade name:
  • PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222418
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222418

PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

28/05/2015

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. PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

25/10/2016

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,Pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or

metastatic non-small cell lung cancer other than predominantly squamous cell histology.,Pemetrexed as monotherapy is indicated for the treatment of

patients with locally advanced or metastatic non-small cell lung cancer 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 Type I Clear

36 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial per carton

(S4) Prescription Only Medicine

Components

1. PEMETREXED INTAS pemetrexed (as disodium) 1000 mg powder for injection

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

A white to either light yellow or greenish yellow lyophilized solid in a clear

glass vial

Active Ingredients

pemetrexed disodium

1102.9 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 11:20:50 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

22-10-2018

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Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

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Armisarte (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3348 of Mon, 28 May 2018

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