Gefitinib Mylan

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gefitinib

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

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.

This EPAR was last updated on 21/06/2019

Authorisation details

Product details
Name
Gefitinib Mylan
Agency product number
EMEA/H/C/004826
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
GenericGeneric

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
Marketing-authorisation holder
Mylan S.A.S.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
27/09/2018
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

29/04/2019 Gefitinib Mylan - EMEA/H/C/004826 - N/0002

Contents

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Pharmacotherapeutic group

  • Antineoplastic agents

  • 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.

Assessment history

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