Imatinib Teva B.V.

imatinib

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This is a summary of the European public assessment report (EPAR) for Imatinib Teva B.V. 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 B.V.

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

What is Imatinib Teva B.V. and what is it used for?

Imatinib Teva B.V. is a cancer medicine that 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 Teva B.V. 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 Teva B.V. 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 alfa (a medicine used for treating some cancers), 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 Teva B.V. is used in combination with other cancer 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 (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib Teva B.V. is used to treat adults with MD/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 Teva B.V. is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
  • adults with gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs. Imatinib Teva B.V. is used to treat adults with GIST that cannot be removed by surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal;
  • adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. Imatinib Teva B.V. is used to treat adults with DFSP that cannot be removed by 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 Teva B.V. contains the active substance imatinib and is a ‘generic medicine’. This means that Imatinib Teva B.V. is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Glivec. 

How is Imatinib Teva B.V. used?

Imatinib Teva B.V. is available as capsules (100 and 400 mg) and 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 with solid tumours.

Imatinib Teva B.V. 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 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 Teva B.V. work?

The active substance in Imatinib Teva B.V., 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 involved in stimulating the cells to divide uncontrollably. By blocking these enzymes, Imatinib Teva B.V. helps to control cell division.

How has Imatinib Teva B.V. been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Teva B.V.

As for every medicine, the company provided studies on the quality of Imatinib Teva B.V. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Imatinib Teva B.V.?

Because Imatinib Teva B.V. 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 Teva B.V. approved?

The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Teva B.V. has been shown to have comparable quality and to be bioequivalent to Glivec. Therefore, the Agency’s view was that, as for Glivec, the benefit outweighs the identified risk. The Agency recommended that Imatinib Teva B.V. be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Imatinib Teva B.V.?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Teva B.V. have been included in the summary of product characteristics and the package leaflet.

Other information about Imatinib Teva B.V.

The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva B.V. on 15 November 2017.

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

Name Language First published Last updated
Imatinib Teva B.V. : EPAR - Summary for the public BG = bălgarski 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public ES = español 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public CS = čeština 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public DA = dansk 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public DE = Deutsch 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public ET = eesti keel 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public EL = elliniká 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public EN = English 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public FR = français 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public IT = italiano 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public LV = latviešu valoda 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public LT = lietuvių kalba 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public HU = magyar 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public MT = Malti 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public NL = Nederlands 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public PL = polski 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public PT = português 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public RO = română 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public SK = slovenčina 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public SL = slovenščina 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public FI = suomi 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public SV = svenska 2018-03-21  
Imatinib Teva B.V. : EPAR - Summary for the public HR = Hrvatski 2018-03-21  

This EPAR was last updated on 21/03/2018 .

Authorisation details

Product details

Product details for Imatinib Teva B.V.
NameImatinib Teva B.V.
Agency product numberEMEA/H/C/004748
Active substance

imatinib mesilate

International non-proprietary name (INN) or common name

imatinib

Therapeutic area Leukemia, Myelogenous, Chronic, BCR-ABL PositiveDermatofibrosarcomaGastrointestinal Stromal Tumors
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 Teva B.V.
Marketing-authorisation holder

Teva B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union15/11/2017

Contact address:

Swensweg
2031 GA
Haarlem
Netherlands

Product information

Product information

15/11/2017  Imatinib Teva B.V. -EMEA/H/C/004748 --

Name Language First published Last updated
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - Product Information HR = Hrvatski 2018-03-21  

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 Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  
Imatinib Teva B.V. : EPAR - All Authorised presentations HR = Hrvatski 2018-03-21  

Pharmacotherapeutic group

Antineoplastic Agents

Therapeutic indication

Imatinib Teva B.V. 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 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 B.V. is indicated for
•         The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
•         The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
•         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.

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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. 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

Initial marketing-authorisation documents

Name Language First published Last updated
Imatinib Teva B.V. : EPAR - Public assessment report HR = Hrvatski 2018-03-21  
CHMP summary of positive opinion for Imatinib Teva B.V. HR = Hrvatski 2017-09-15  

Authorised

This medicine is approved for use in the European Union

More information on Imatinib Teva B.V.