Pemetrexed Lilly

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

The marketing authorisation for Pemetrexed Lilly has been withdrawn at the request of the marketing-authorisation holder.

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

Latest procedure affecting product information: N/0013

18/06/2021

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).

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