Armisarte (previously Pemetrexed Actavis)
pemetrexed
Table of contents
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.
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List item
Armisarte : EPAR - Summary for the public (PDF/190.48 KB)
First published: 28/01/2016
Last updated: 15/03/2016
EMA/783156/2015 -
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List item
Armisarte : EPAR - Risk-management-plan summary (PDF/27.3 KB)
First published: 28/01/2016
Last updated: 27/08/2020
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) |
|
Anatomical therapeutic chemical (ATC) code |
L01BA04
|
Publication details | |
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Marketing-authorisation holder |
Actavis Group PTC ehf
|
Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
18/01/2016
|
Contact address |
Product information
13/08/2020 Armisarte (previously Pemetrexed Actavis) - EMEA/H/C/004109 - R/0022
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
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.