Table of contents
This is a summary of the European public assessment report (EPAR) for Pemetrexed medac. 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 medac.
For practical information about using Pemetrexed medac, patients should read the package leaflet or contact their doctor or pharmacist.
Pemetrexed medac : EPAR - Summary for the public (PDF/99.01 KB)
First published: 09/12/2015
Last updated: 09/12/2015
Pemetrexed medac : EPAR - Risk-management-plan summary (PDF/140.37 KB)
First published: 09/12/2015
Last updated: 21/09/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
medac Gesellschaft für klinische Spezialpräparate mbH
|Date of issue of marketing authorisation valid throughout the European Union||
08/08/2022 Pemetrexed medac - EMEA/H/C/003905 - IB/0012
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.
Folic acid analogues
Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer Pemetrexed medac 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 medac 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 medac 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.