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.
Imatinib Teva : EPAR - Summary for the public (PDF/89.56 KB)
First published: 17/01/2013
Last updated: 22/11/2016
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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.
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11/07/2019 Imatinib Teva - EMEA/H/C/002585 - IB/0041
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.
Protein kinase inhibitors
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.