Imatinib Teva

RSS

imatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Imatinib Teva. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Imatinib Teva.

For practical information about using Imatinib Teva, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/12/2018

Authorisation details

Product details
Name
Imatinib Teva
Agency product number
EMEA/H/C/002585
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
L01XE01
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.

Publication details
Marketing-authorisation holder
Teva B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
07/01/2013
Contact address
Swensweg 5
2031 Haarlem
The Netherlands

Product information

25/07/2018 Imatinib Teva - EMEA/H/C/002585 - N/0037

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • Antineoplastic agents

  • protein kinase inhibitor

Therapeutic indication

Imatinib Teva is indicated for the treatment of

  • Adult and 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.
  • Adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon‑alpha therapy, or in accelerated phase or 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-PDGFRα rearrangement.

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

Imatinib Teva is indicated for

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.

Assessment history

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