Iressa
gefitinib
Table of contents
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).
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 |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
24/06/2009
|
Contact address |
151 85 Södertälje
Sweden |
Product information
14/07/2023 Iressa - EMEA/H/C/001016 - IAIN/0039/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.