Pemetrexed Hospira
pemetrexed
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira. 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 Pemetrexed Hospira.
For practical information about using Pemetrexed Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
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Pemetrexed Hospira : EPAR - Summary for the public (PDF/99.06 KB)
First published: 01/12/2015
Last updated: 01/12/2015
EMA/734632/2015 -
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Pemetrexed Hospira : EPAR - Risk-management-plan summary (PDF/50.99 KB)
First published: 01/12/2015
Last updated: 01/12/2015
EMA/790392/2015
Authorisation details
Product details | |
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Name |
Pemetrexed Hospira
|
Agency product number |
EMEA/H/C/003970
|
Active substance |
pemetrexed
|
International non-proprietary name (INN) or common name |
pemetrexed
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01BA04
|
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. |
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
Product information
30/09/2020 Pemetrexed Hospira - EMEA/H/C/003970 - X/0021
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 Hospira in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Hospira 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 Hospira 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 Hospira 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.