Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Special Designations
EMA special regulatory designations and classifications
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (1)
gefitinib
Documents (9)
Gefitinib Mylan : EPAR - Public assessment report
October 10, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Gefitinib Mylan : EPAR - Public assessment report
October 10, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Gefitinib Mylan
July 27, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
Gefitinib Mylan : EPAR - Procedural steps taken and scientific information after authorisation
June 21, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Gefitinib Mylan : EPAR - Medicine overview
October 10, 2018
OVERVIEW_DOCUMENT
Gefitinib Mylan : EPAR - Risk-management-plan summary
October 10, 2018
RISK_MANAGEMENT_PLAN_SUMMARY
CHMP summary of positive opinion for Gefitinib Mylan
July 27, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Gefitinib Mylan : EPAR - All Authorised presentations
October 10, 2018
AUTHORISED_PRESENTATIONS
Gefitinib Mylan : EPAR - Product Information
October 10, 2018
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
How is Gefitinib Mylan used?
Answer
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.
Question
How does Gefitinib Mylan work?
Answer
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.
Question
What are the benefits and risks of Gefitinib Mylan?
Answer
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.
Question
Why is Gefitinib Mylan authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Answer
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.
Question
Other information about Gefitinib Mylan
Answer
Gefitinib Mylan received a marketing authorisation valid throughout the EU on 27 September 2018.
Question
How has Gefitinib Mylan been studied?
Answer
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.