Imatinib Teva B.V.

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

On 8 May 2018, the European Commission withdrew the marketing authorisation for Imatinib Teva B.V. (imatinib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Imatinib Teva B.V. was granted marketing authorisation in the EU on 15 November 2017 for treatment of Philadelphia chromosome positive chronic myeloid leukaemia (CML); Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL); myelodysplastic/myeloproliferative diseases (MDS/MPD); hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL); gastrointestinal stromal tumours (GIST); and dermatofibrosarcoma protuberans (DFSP). 

Imatinib Teva B.V. 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Report (EPAR) for Imatinib Teva B.V. is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Imatinib Teva B.V. : EPAR - Summary for the public

Reference Number: EMA/620385/2017

Product information

Imatinib Teva B.V. : EPAR - Product Information

Imatinib Teva B.V. : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imatinib Teva B.V.
• Active substance:
  imatinib mesilate
• International non-proprietary name (INN) or common name:
  imatinib
• Therapeutic area (MeSH):
  • Dermatofibrosarcoma
  • Gastrointestinal Stromal Tumors
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Anatomical therapeutic chemical (ATC) code:
  L01XE01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Imatinib Teva B.V. 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 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.

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

Imatinib Teva B.V. is indicated for:

• The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
• 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.

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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. 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/004748
• 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:
  Teva B.V.

  Swensweg; 2031 GA; Haarlem; Netherlands

• Marketing authorisation issued:
  15/11/2017
• Withdrawal of marketing authorisation:
  08/05/2018

Assessment history

Initial marketing authorisation documents

Imatinib Teva B.V. : EPAR - Public assessment report

Adopted Reference Number: EMA/652456/2017

CHMP summary of positive opinion for Imatinib Teva B.V.

Reference Number: EMA/CHMP/600427/2017