Pemetrexed Lilly

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Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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Public Assessment Report (EPAR) for Pemetrexed Lilly is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: N/0013
18/06/2021
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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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

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