Imatinib Actavis

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

On 16 May 2022, the European Commission withdrew the marketing authorisation for Imatinib Actavis (imatinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Actavis Group PTC ehf., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Imatinib Actavis was granted marketing authorisation in the EU on 17 April 2013 for treatment of:

• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment;
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;
• adult patients with Ph+ CML in blast crisis;
• adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy;
• adult patients with relapsed or refractory Ph+ ALL as monotherapy;
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with plateletderived growth factor receptor (PDGFR) gene re-arrangements;
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement;
• adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. 

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017.

Imatinib Actavis is a generic medicine of Glivec. There are other generic medicinal products of Glivec authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Imatinib Actavis is updated to indicate that the marketing authorisation is no longer valid.

Imatinib Actavis : EPAR - Medicine overview

Reference Number: EMA/30081/2019

Product information

Imatinib Actavis : EPAR - Product Information

Imatinib Actavis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imatinib Actavis
• Active substance:
  imatinib
• International non-proprietary name (INN) or common name:
  imatinib
• Therapeutic area (MeSH):
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic-Myeloproliferative Diseases
  • Hypereosinophilic Syndrome
  • Dermatofibrosarcoma
• Anatomical therapeutic chemical (ATC) code:
  L01EA01

Pharmacotherapeutic group

• Protein kinase inhibitors
• Antineoplastic agents

Therapeutic indication

Imatinib Actavis is indicated for the treatment of:

• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment;
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;
• adult patients with Ph+ CML in blast crisis;
• adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy;
• adult patients with relapsed or refractory Ph+ ALL as monotherapy;
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements;
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement;
• the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

The effect of imatinib on the outcome of bone marrow transplantation has not been determined.

Imatinib Actavis is indicated for:

• In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Authorisation details

• EMA product number:
  EMEA/H/C/002594
• 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:
  Actavis Group PTC ehf

  Reykjavíkurvegur 76-78; Hafnarfjörður; Iceland

• Opinion adopted:
  21/02/2013
• Marketing authorisation issued:
  17/04/2013
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Imatinib Actavis : EPAR - Procedural steps taken and scientific information after authorisation

Imatinib Actavis-H-C-2594-X-0003 : EPAR - Assessment Report - Extension

Adopted Reference Number: EMA/284461/2014

Initial marketing authorisation documents

Imatinib Actavis : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Imatinib Actavis

Adopted Reference Number: EMA/CHMP/82403/2013