Imatinib medac

imatinib

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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.

What is Imatinib medac and what is it used for?

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

  • Children with 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 medac 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 medac 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’).
  • Adults with Ph+ CML in blast crisis;
  • Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL. It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
  • Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
  • Adults with 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 medac is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
  • Adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Imatinib medac 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 medac is a ‘generic medicine’. This means that Imatinib medac is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Glivec.

How is Imatinib medac used?

Imatinib medac is available as capsules (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 medac 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 medac work?

The active substance in Imatinib medac, 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 certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. By blocking these receptors, Imatinib medac helps to control cell division.

How has Imatinib medac been studied?

Because Imatinib medac 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 medac?

Because Imatinib medac 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 medac approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac 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 medac be approved for use in the EU.

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

A risk management plan has been developed to ensure that Imatinib medac 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 medac, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Imatinib medac

The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.

For more information about treatment with Imatinib medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Imatinib medac : EPAR - Summary for the public BG = bălgarski 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public ES = español 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public CS = čeština 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public DA = dansk 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public DE = Deutsch 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public ET = eesti keel 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public EL = elliniká 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public EN = English 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public FR = français 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public IT = italiano 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public LV = latviešu valoda 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public LT = lietuvių kalba 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public HU = magyar 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public MT = Malti 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public NL = Nederlands 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public PL = polski 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public PT = português 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public RO = română 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public SK = slovenčina 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public SL = slovenščina 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public FI = suomi 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public SV = svenska 2013-10-23 2015-06-26
Imatinib medac : EPAR - Summary for the public HR = Hrvatski 2013-10-23 2015-06-26

This EPAR was last updated on 14/05/2018 .

Authorisation details

Product details

Product details for Imatinib medac
NameImatinib medac
Agency product numberEMEA/H/C/002692
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 medac
Marketing-authorisation holder

Medac

Revision5
Date of issue of marketing authorisation valid throughout the European Union25/09/2013

Contact address:

Medac
Gesellschaft fuer Spezialpraeparaten mbH
Theater strasse 6
22880 Wedel
Germany

Product information

Product information

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

Name Language First published Last updated
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14
Imatinib medac : EPAR - Product Information HR = Hrvatski 2013-10-23 2018-05-14

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 medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Imatinib medac : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Imatinib medac : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2015-06-26 2018-05-14

Initial marketing-authorisation documents

Name Language First published Last updated
Imatinib medac : EPAR - Public assessment report HR = Hrvatski 2013-10-23  
CHMP summary of positive opinion for Imatinib medac HR = Hrvatski 2013-08-05  

Authorised

This medicine is approved for use in the European Union

More information on Imatinib medac