Imatinib medac

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

On 14 February 2019, the European Commission withdrew the marketing authorisation for Imatinib medac (imatinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, medac Gesellschaft fur klinische Spezialpraparate mbH, which notified the European Commission of its decisionto permanently discontinue the marketing of the product for commercial reasons. 

Imatinib medac was granted marketing authorisation in the EU on 25 September 2013 for treatment of leukaemia. The marketing authorisation was initially valid for a 5-year period. Imatinib medac was a generic medicine of Glivec for treatment of leukaemia. There are other generic medicinal products of Glivec authorised and marketed in the EU. 

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European Public Assessment Report (EPAR) for Imatinib medac is updated to indicate that the marketing authorisation is no longer valid.

Imatinib medac : EPAR - Summary for the public

Reference Number: EMA/268384/2015

Product information

Imatinib medac : EPAR - Product Information

Imatinib medac : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imatinib medac
• Active substance:
  imatinib
• International non-proprietary name (INN) or common name:
  imatinib
• Therapeutic area (MeSH):
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Dermatofibrosarcoma
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic-Myeloproliferative Diseases
  • Hypereosinophilic Syndrome
• Anatomical therapeutic chemical (ATC) code:
  L01XE01

Pharmacotherapeutic group

Protein kinase inhibitors

Therapeutic indication

Imatinib medac 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;
• adult and paediatric 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 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;
• 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.

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. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Authorisation details

• EMA product number:
  EMEA/H/C/002692
• 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:
  Medac

  Gesellschaft fuer Spezialpraeparaten mbH; Theater strasse 6; 22880 Wedel; Germany

• Marketing authorisation issued:
  25/09/2013
• Withdrawal of marketing authorisation:
  14/02/2019
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Imatinib medac : EPAR - Public assessment report

AdoptedReference Number: EMA/622006/2013

CHMP summary of positive opinion for Imatinib medac

AdoptedReference Number: Imatinib medac