Imatinib Actavis

RSS

imatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Imatinib Actavis is a cancer medicine that contains the active substance imatinib. It is used to treat the following diseases:

  • 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 Actavis 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. The medicine is used in children who have been newly diagnosed with Ph+ CML and who cannot have 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 (another medicine used to treat cancer), and in more advanced phases of the disease (‘accelerated phase’ and ‘blast crisis’). Imatinib Actavis is also used 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 Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
  • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. Imatinib Actavis 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 Actavis 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 Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body.

Imatinib Actavis is a ‘generic medicine’. This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Glivec.

This EPAR was last updated on 08/10/2019

Authorisation details

Product details
Name
Imatinib Actavis
Agency product number
EMEA/H/C/002594
Active substance
imatinib
International non-proprietary name (INN) or common name
imatinib
Therapeutic area (MeSH)
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic-Myeloproliferative Diseases
  • Hypereosinophilic Syndrome
  • Dermatofibrosarcoma
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
Actavis Group PTC ehf
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
17/04/2013
Contact address
Reykjavíkurvegur 76-78
Hafnarfjörður
Iceland

Product information

05/09/2019 Imatinib Actavis - EMEA/H/C/002594 - IB/0018

Contents

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Pharmacotherapeutic group

  • Antineoplastic agents

  • protein kinase inhibitor

Therapeutic indication

Imatinib Actavis 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 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-PDGFR rearrangement;
  • 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.

The effect of imatinib on the outcome of bone marrow transplantation has not been determined.

Imatinib Actavis is indicated for:

  • 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. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Assessment history

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