Gefitinib Mylan

Withdrawn

This medicine's authorisation has been withdrawn

gefitinib

Overview

On 27 September 2024, the European Commission withdrew the marketing authorisation for Gefitinib Mylan (gefitinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mylan Pharmaceuticals Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Gefitinib Mylan was granted marketing authorisation in the EU on 27 September 2018 for the treatment of non-small cell lung cancer. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023. The product had not been marketed in the EU since 2023. 

Gefitinib Mylan is a generic medicine of Iressa.The European Public Assessment Report (EPAR) for Gefitinib Mylan is updated to indicate that the marketing authorisation is no longer valid

Gefitinib Mylan : EPAR - Medicine overview

Reference Number: EMA/554427/20188

Gefitinib Mylan : EPAR - Risk-management-plan summary

Product information

Gefitinib Mylan : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  27/09/2024
• Revision:
  7

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