APO-Pemetrexed
Main information
- Trade name:
- APO-Pemetrexed pemetrexed 100 mg (as disodium) powder for injection vial
- Active ingredient:
- pemetrexed disodium hemipentahydrate
- Available from:
- Apotex Pty Ltd
- INN (International Name):
- pemetrexed disodium hemipentahydrate
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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- Access to this document is only available to registered users.
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