Pemetrexed Baxter

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

On 2 May 2025, the European Commission withdrew the marketing authorisation for Pemetrexed Baxter (pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Baxter Holding B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pemetrexed Baxter was granted marketing authorisation in the EU on 9 December 2022 for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. The marketing authorisation was valid for a 5-year period. The product has never been marketed in the EU. 

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

Pemetrexed Baxter : EPAR - Medicine overview

Reference Number: EMA/841935/2022

Pemetrexed Baxter : EPAR - Risk management plan summary

Product information

Pemetrexed Baxter : EPAR - Product Information

Pemetrexed Baxter : EPAR - All authorised presentations

Product details

• Name of medicine:
  Pemetrexed Baxter
• Active substance:
  pemetrexed disodium heptahydrate
• 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

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma
Pemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer
Pemetrexed Baxter 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 (see section 5.1).

Pemetrexed Baxter 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 (see section 5.1).

Pemetrexed Baxter 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 (see section 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/005848
• 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:
  Baxter Holding B.V.

  Kobaltweg 49; 3542 CE; Utrecht; Netherlands

• Opinion adopted:
  13/10/2022
• Marketing authorisation issued:
  09/12/2022
• Withdrawal of marketing authorisation:
  02/05/2025

Assessment history

Initial marketing authorisation documents

Pemetrexed Baxter : EPAR - Public Assessment Report

Adopted Reference Number: EMA/CHMP/251833/2022

CHMP summary of positive opinion for Pemetrexed Baxter

Adopted Reference Number: EMA/CHMP/808787/2022