🇪🇺 Iressa in European Union

Iressa (gefitinib) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/004826
  • Local brand name: Gefitinib Mylan
  • Status: withdrawn

Iressa in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Iressa approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Iressa in European Union?

Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.