Imatinib Accord

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 Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imatinib Accord.

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

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Imatinib Accord
Agency product number
EMEA/H/C/002681
Active substance
imatinib
International non-proprietary name (INN) or common name
imatinib
Therapeutic area (MeSH)
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Dermatofibrosarcoma
  • Myelodysplastic-Myeloproliferative Diseases
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Hypereosinophilic Syndrome
Anatomical therapeutic chemical (ATC) code
L01XE01
GenericGeneric

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
Accord Healthcare S.L.U.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
30/06/2013
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

22/08/2019 Imatinib Accord - EMEA/H/C/002681 - IB/0027

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

Protein kinase inhibitors

Therapeutic indication

Imatinib Accord 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 patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (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.

Assessment history

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