The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Gefitinib Mylan

250 milligram(s) Film-coated tablet

Mylan S.A.S.EU/1/18/1321/001-002

Main Information

Trade NameGefitinib Mylan
Active SubstancesGefitinib
Strength250 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderMylan S.A.S.
Licence NumberEU/1/18/1321/001-002

Group Information

ATC CodeL01XE02 gefitinib


Licence Issued27/09/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back