🇪🇺 EGFR-TKI in European Union

EMA authorised EGFR-TKI on 27 September 2018

Marketing authorisation

EMA — authorised 27 September 2018

  • Application: EMEA/H/C/004826
  • Marketing authorisation holder: Mylan Pharmaceuticals Limited
  • Local brand name: Gefitinib Mylan
  • 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.
  • Status: withdrawn

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Other Oncology approved in European Union

Frequently asked questions

Is EGFR-TKI approved in European Union?

Yes. EMA authorised it on 27 September 2018.

Who is the marketing authorisation holder for EGFR-TKI in European Union?

Mylan Pharmaceuticals Limited holds the EU marketing authorisation.