Pelimta

Main information

  • Trade name:
  • Pelimta Pemetrexed Disodium 500 mg injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pelimta Pemetrexed Disodium 500 mg injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209346
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209346

Pelimta Pemetrexed Disodium 500 mg injection vial

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

19/05/2014

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. Pelimta Pemetrexed Disodium 500 mg injection vial

Product Type

Single Medicine Product

Effective date

10/11/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

mesothelioma.,Non-Small Cell lung Cancer:,Pelimta 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.,Pelimta 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

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 X 500 mg/vial

(S4) Prescription Only Medicine

Components

1. Pelimta Pemetrexed Disodium 500 mg injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Pemetrexed disodium for injection 500 mg/vial is a white to either

light-yellow or green-yellow lyophilised powder packed in 50 mL glass vial

with 20 mm rubber stopper and sealed with 20 mm aluminium flip-off seal

Active Ingredients

pemetrexed disodium

551.4 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 10:25:20 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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