Pemetrexed medac

RSS

pemetrexed

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/08/2022

Authorisation details

Product details
Name
Pemetrexed medac
Agency product number
EMEA/H/C/003905
Active substance
pemetrexed
International non-proprietary name (INN) or common name
pemetrexed
Therapeutic area (MeSH)
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
Anatomical therapeutic chemical (ATC) code
L01BA04
GenericGeneric

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
Marketing-authorisation holder
medac Gesellschaft für klinische Spezialpräparate mbH
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/11/2015
Contact address

Theaterstrasse 6
22880 Wedel
Germany

Product information

08/08/2022 Pemetrexed medac - EMEA/H/C/003905 - IB/0012

Other EU languages available icon 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:

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

  • Folic acid analogues
  • Antineoplastic agents

Therapeutic indication

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.

Assessment history

How useful was this page?

Add your rating