Gefitinib Mylan
gefitinib
Table of contents
Overview
Gefitinib Mylan is a cancer medicine used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body). It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine’. This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Iressa.
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Gefitinib Mylan : EPAR - Medicine overview (PDF/91.12 KB)
First published: 10/10/2018
EMA/554427/20188 -
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Gefitinib Mylan : EPAR - Risk-management-plan summary (PDF/99.94 KB)
First published: 10/10/2018
Authorisation details
Product details | |
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Name |
Gefitinib Mylan
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Agency product number |
EMEA/H/C/004826
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Active substance |
gefitinib
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International non-proprietary name (INN) or common name |
gefitinib
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Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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Anatomical therapeutic chemical (ATC) code |
L01XE02
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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 |
Mylan Pharmaceuticals Limited
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
27/09/2018
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Contact address |
Mylan Pharmaceuticals Limited |
Product information
23/06/2023 Gefitinib Mylan - EMEA/H/C/004826 - R/0008
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
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Antineoplastic agents
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Protein kinase inhibitors
Therapeutic indication
Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) with activating mutations of EGFR‑TK.