欧盟委员会应 medac 请求撤回 Pemetrexed medac 上市许可

Application under evaluation
CHMP opinion
European Commission decision

Overview

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.

Product information

Latest procedure affecting product information:VR/0000261770

28/05/2025

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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).

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.

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

This page was last updated on 26/10/2026