Imatinib medac

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 medac. 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 medac.

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

This EPAR was last updated on 14/05/2018

Authorisation details

Product details
Name
Imatinib medac
Agency product number
EMEA/H/C/002692
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
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 medicines.

Publication details
Marketing-authorisation holder
Medac
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
25/09/2013
Contact address
Gesellschaft fuer Spezialpraeparaten mbH
Theater strasse 6
22880 Wedel
Germany

Product information

11/04/2018 Imatinib medac - EMEA/H/C/002692 - IB/0009

Contents

  • 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.

Pharmacotherapeutic group

Protein tyrosine kinase inhibitor

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-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 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.

Assessment history

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