Pemetrexed Sandoz

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

On 9 October, the European Commission withdrew the marketing authorisation for Pemetrexed Sandoz (pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sandoz GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pemetrexed Sandoz was granted marketing authorisation in the EU on 18 September 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 2024. 

Pemetrexed Sandoz is a generic medicine of Alimta. There are other generic medicinal products of Alimta authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Pemetrexed Sandoz is updated to indicate that the marketing authorisation is no longer valid.

Pemetrexed Sandoz : EPAR - Summary for the public

Reference Number: EMA/509171/2015

Pemetrexed Sandoz : EPAR - Risk-management-plan summary

Reference Number: EMA/520309/2015

Product information

Pemetrexed Sandoz : EPAR - Product Information

Pemetrexed Sandoz : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pemetrexed Sandoz
• Active substance:
  pemetrexed disodium hemipentahydrate
• 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 Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

Pemetrexed Sandoz 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 Sandoz 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 Sandoz 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/004011
• 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:
  Sandoz GmbH

  Biochemiestr. 10; 6250 Kundl ; Austria

• Opinion adopted:
  23/07/2015
• Marketing authorisation issued:
  18/09/2015
• Withdrawal of marketing authorisation:
  09/10/2024
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Pemetrexed Sandoz : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/467935/2015

CHMP summary of positive opinion for Pemetrexed Sandoz

AdoptedReference Number: EMA/CHMP/470192/2015