Gefitinib Mylan



This medicine is authorised for use in the European Union.


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 05/10/2021

Authorisation details

Product details
Gefitinib Mylan
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code

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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
117 Allée des Parcs
69800 Saint Priest

Product information

09/09/2021 Gefitinib Mylan - EMEA/H/C/004826 - IB/0004/G


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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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