Imatinib Accord

imatinib

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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.

What is Imatinib Accord and what is it used for?

Imatinib Accord is an anticancer medicine that contains the active substance imatinib. It is used to treat the following diseases:

  • in children to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control. Imatinib Accord is used when the patients are ‘Philadelphia-chromosome-positive’ (Ph+). This means that some of their genes have re‑arranged themselves to form a special chromosome called the Philadelphia chromosome. Imatinib Accord is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone-marrow transplant. It is also used in children in the ‘chronic phase’ of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase’ and ‘blast crisis’);
  • in adults with Ph+ CML in blast crisis;
  • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. Imatinib Accord is used in combination with other anticancer medicines in adults who have been newly diagnosed with Ph+ ALL. It is also used alone to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
  • myelodysplastic or myeloproliferative diseases (MD / MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib Accord is used to treat adults with MD / MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
  • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. Imatinib Accord is used to treat adults with HES or CEL who have a specific re‑arrangement of two genes called FIP1L1 and PDGFRα;
  • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Imatinib Accord is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.

Imatinib Accord is a ‘generic medicine’. This means that Imatinib Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Glivec.

How is Imatinib Accord used?

Imatinib Accord is available as tablets (100 and 400 mg). It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. Imatinib Accord is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut. The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day. For more information, see the package leaflet.

How does Imatinib Accord work?

The active substance in Imatinib Accord, imatinib, is a protein tyrosine-kinase inhibitor. This means that it blocks some specific enzymes known as tyrosine kinases. These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. By blocking these receptors, Imatinib Accord helps to control cell division.

How has Imatinib Accord been studied?

Because Imatinib Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Imatinib Accord?

Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Imatinib Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec. Therefore, the CHMP’s view was that, as for Glivec, the benefit outweighs the identified risk. The Committee recommended that Imatinib Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Imatinib Accord?

A risk-management plan has been developed to ensure that Imatinib Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib Accord, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Imatinib Accord

The European Commission granted a marketing authorisation valid throughout the EU for Imatinib Accord on 1 July 2013.

Name Language First published Last updated
Imatinib Accord : EPAR - Summary for the public BG = bălgarski 10/07/2013  
Imatinib Accord : EPAR - Summary for the public ES = español 10/07/2013  
Imatinib Accord : EPAR - Summary for the public CS = čeština 10/07/2013  
Imatinib Accord : EPAR - Summary for the public DA = dansk 10/07/2013  
Imatinib Accord : EPAR - Summary for the public DE = Deutsch 10/07/2013  
Imatinib Accord : EPAR - Summary for the public ET = eesti keel 10/07/2013  
Imatinib Accord : EPAR - Summary for the public EL = elliniká 10/07/2013  
Imatinib Accord : EPAR - Summary for the public EN = English 10/07/2013  
Imatinib Accord : EPAR - Summary for the public FR = français 10/07/2013  
Imatinib Accord : EPAR - Summary for the public IT = italiano 10/07/2013  
Imatinib Accord : EPAR - Summary for the public LV = latviešu valoda 10/07/2013  
Imatinib Accord : EPAR - Summary for the public LT = lietuvių kalba 10/07/2013  
Imatinib Accord : EPAR - Summary for the public HU = magyar 10/07/2013  
Imatinib Accord : EPAR - Summary for the public MT = Malti 10/07/2013  
Imatinib Accord : EPAR - Summary for the public NL = Nederlands 10/07/2013  
Imatinib Accord : EPAR - Summary for the public PL = polski 10/07/2013  
Imatinib Accord : EPAR - Summary for the public PT = português 10/07/2013  
Imatinib Accord : EPAR - Summary for the public RO = română 10/07/2013  
Imatinib Accord : EPAR - Summary for the public SK = slovenčina 10/07/2013  
Imatinib Accord : EPAR - Summary for the public SL = slovenščina 10/07/2013  
Imatinib Accord : EPAR - Summary for the public FI = suomi 10/07/2013  
Imatinib Accord : EPAR - Summary for the public SV = svenska 10/07/2013  
Imatinib Accord : EPAR - Summary for the public HR = Hrvatski 10/07/2013  

This EPAR was last updated on 03/02/2016 .

Authorisation details

Product details

Product details for Imatinib Accord
NameImatinib Accord
Agency product numberEMEA/H/C/002681
Active substance

imatinib

International non-proprietary name (INN) or common name

imatinib

Therapeutic area Leukemia, Myelogenous, Chronic, BCR-ABL PositiveDermatofibrosarcomaMyelodysplastic-Myeloproliferative DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaHypereosinophilic Syndrome
Anatomical therapeutic chemical (ATC) code L01XE01
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Imatinib Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision5
Date of issue of marketing authorisation valid throughout the European Union01/07/2013

Contact address:

Accord Healthcare Ltd
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom

Product information

Product information

25/01/2016  Imatinib Accord -EMEA/H/C/002681 -IAIN/0009/G

Name Language First published Last updated
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - Product Information HR = Hrvatski 10/07/2013 03/02/2016

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.


Name Language First published Last updated
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016
Imatinib Accord : EPAR - All Authorised presentations HR = Hrvatski 10/07/2013 03/02/2016

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Imatinib Accord : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 13/11/2013 03/02/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Imatinib Accord : EPAR - Public assessment report HR = Hrvatski 10/07/2013  
CHMP summary of positive opinion for Imatinib Accord HR = Hrvatski 26/04/2013  

Authorised

This medicine is approved for use in the European Union

More information on Imatinib Accord