Pemetrexed medac

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

Introduction

On 28 August 2026, the European Commission withdrew the marketing authorisation for Pemetrexed medac (pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, medac Gesellschaft fur klinische Spezialpraparate mbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pemetrexed medac was granted marketing authorisation in the EU on 27 November 2015 for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2020. The product had not been marketed in the EU since 3 June 2026.

Pemetrexed medac is a generic medicine of Alimta. There are other generic medicinal products of Alimta authorised and marketed in the EU.

Pemetrexed medac : EPAR - Summary for the public

Reference Number: EMA/635350/2015

Pemetrexed medac : EPAR - Risk-management-plan summary

Reference Number: EMA/666615/2015

Product information

Pemetrexed medac : EPAR - Product Information

Pemetrexed medac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pemetrexed medac
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003905
• 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.

• Marketing authorisation holder:
  medac Gesellschaft für klinische Spezialpräparate mbH

  Theaterstrasse 6; 22880 Wedel; Germany

• Opinion adopted:
  23/09/2015
• Marketing authorisation issued:
  26/11/2015
• Withdrawal of marketing authorisation:
  28/08/2026
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Pemetrexed medac : EPAR - Procedural steps taken and scientific information after authorisation

Pemetrexed medac : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Pemetrexed medac : EPAR - Public assessment report

Adopted Reference Number: EMA/671085/2015

CHMP summary of opinion for Pemetrexed medac

Adopted Reference Number: EMA/CHMP/596263/2015