Pemetrexed Lilly

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

On 1 November 2021, the marketing authorisation of Pemetrexed Lilly (pemetrexed) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Eli Lilly Nederland B.V., permanently discontinued marketing of Pemetrexed Lilly in the EU in October 2018. 

In accordance with provisions of the sunset clause1, the marketing authorisation of a medicinal product lapses if the product had not been marketed in any of the EU Member States for three consecutive years. Eli Lilly Nederland B.V. confirmed that it discontinued the marketing of the product due to commercial reasons. 

Pemetrexed Lilly was granted marketing authorisation in the EU on 14 September 2015 for treatment of malignant pleural mesothelioma and non-small cell lung cancer. 

The marketing authorisation was initially valid for a 5-year period and was renewed with unlimited validity in 2020. Pemetrexed Lilly is a generic medicine of Alimta. There are other generic medicinal products of pemetrexed authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Pemetrexed Lilly is updated to indicate that the marketing authorisation is no longer valid.

Pemetrexed Lilly : EPAR - Summary for the public

Reference Number: EMA/509168/2015

Pemetrexed Lilly : EPAR - Risk-management-plan summary

Reference Number: EMA/512407/2015

Product information

Pemetrexed Lilly : EPAR - Product Information

Pemetrexed Lilly : EPAR - All authorised presentations

Product details

• Name of medicine:
  Pemetrexed Lilly
• 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

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma

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

Non-small cell lung cancer

Pemetrexed Lilly 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 Lilly 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 Lilly 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/004114
• 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:
  Eli Lilly Netherlands

  Grootslag 1-5; PO Box 379; NL-3991 RA Houten; The Netherlands

• Marketing authorisation issued:
  14/09/2015
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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