Pemetrexed Sandoz
pemetrexed
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Pemetrexed Sandoz. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pemetrexed Sandoz.
For practical information about using Pemetrexed Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Pemetrexed Sandoz : EPAR - Summary for the public (PDF/98.64 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMA/509171/2015 -
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Pemetrexed Sandoz : EPAR - Risk-management-plan summary (PDF/51.87 KB)
First published: 02/10/2015
Last updated: 02/10/2015
EMA/520309/2015
Authorisation details
Product details | |
---|---|
Name |
Pemetrexed Sandoz
|
Agency product number |
EMEA/H/C/004011
|
Active substance |
pemetrexed disodium hemipentahydrate
|
International non-proprietary name (INN) or common name |
pemetrexed
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01BA04
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Sandoz GmbH
|
Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
18/09/2015
|
Contact address |
Biochemiestr. 10
6250 Kundl Austria |
Product information
26/07/2022 Pemetrexed Sandoz - EMEA/H/C/004011 - IB/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Malignant pleural mesothelioma
Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.