Alimta

RSS

pemetrexed

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Alimta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Alimta.

This EPAR was last updated on 04/05/2018

Authorisation details

Product details
Name
Alimta
Agency product number
EMEA/H/C/000564
Active substance
pemetrexed
International non-proprietary name (INN) or common name
pemetrexed
Therapeutic area (MeSH)
  • Mesothelioma
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01BA04
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
20/09/2004
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

23/03/2018 Alimta - EMEA/H/C/000564 - IAIN/0053

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma

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

Non-small-cell lung cancer

Alimta 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.

Alimta 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.

Alimta 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.

Assessment history

Changes since initial authorisation of medicine

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