Gefitinib Mylan

Authorised

This medicine is authorised for use in the European Union

gefitinib

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.

How is Gefitinib Mylan used?

Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with cancer treatments.

Gefitinib Mylan is available as 250 mg tablets to be taken by mouth. The recommended dose is one tablet once a day. The tablet can be dispersed in water for patients who have difficulty swallowing.

For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.

How does Gefitinib Mylan work?

The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor. This means that it blocks specific enzymes known as tyrosine kinases. These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells. EGFR is involved in the growth and spread of cancer cells. By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer. Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.

How has Gefitinib Mylan been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.

As for every medicine, the company provided studies on the quality of Gefitinib Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Gefitinib Mylan?

Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Gefitinib Mylan authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa. Therefore, the Agency’s view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Gefitinib Mylan are continuously monitored. Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients.

Other information about Gefitinib Mylan

Gefitinib Mylan received a marketing authorisation valid throughout the EU on 27 September 2018.

Gefitinib Mylan : EPAR - Medicine overview

Reference Number: EMA/554427/20188

Gefitinib Mylan : EPAR - Risk-management-plan summary

Product information

Gefitinib Mylan : EPAR - Product Information

Latest procedure affecting product information: R/0008

23/06/2023

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).

Gefitinib Mylan : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Gefitinib Mylan
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004826
• 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.

• Marketing authorisation holder:
  Mylan Pharmaceuticals Limited

  Damastown Industrial Park; Mulhuddart; Dublin 15; Ireland

• Marketing authorisation issued:
  27/09/2018
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Gefitinib Mylan : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Gefitinib Mylan : EPAR - Public assessment report

AdoptedReference Number: EMA/587444/2018

CHMP summary of positive opinion for Gefitinib Mylan

AdoptedReference Number: EMA/489607/2018