Iressa

RSS

gefitinib

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 28/05/2019

Authorisation details

Product details
Name
Iressa
Agency product number
EMEA/H/C/001016
Active substance
gefitinib
International non-proprietary name (INN) or common name
gefitinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE02
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
24/06/2009
Contact address
151 85 Södertälje
Sweden

Product information

27/03/2019 Iressa - EMEA/H/C/001016 - IAIN/0032/G

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

Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer with activating mutations of epidermal-growth-factor-receptor tyrosine kinase.

Assessment history

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