Armisarte (previously Pemetrexed Actavis)

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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 Armisarte. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Armisarte.

For practical information about using Armisarte, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/08/2019

Authorisation details

Product details
Name
Armisarte (previously Pemetrexed Actavis)
Agency product number
EMEA/H/C/004109
Active substance
pemetrexed diacid monohydrate
International non-proprietary name (INN) or common name
pemetrexed
Therapeutic area (MeSH)
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
Anatomical therapeutic chemical (ATC) code
L01BA04
Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
18/01/2016
Contact address
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland

Product information

15/01/2019 Armisarte (previously Pemetrexed Actavis) - EMEA/H/C/004109 - PSUSA/00002330/201802

Contents

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

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

Non-small cell lung cancer

Pemetrexed 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 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 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

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