Overview
The marketing authorisation for Imatinib Teva B.V. has been withdrawn at the request of the marketing authorisation holder.
Imatinib Teva B.V. : EPAR - Summary for the public
Product information
Imatinib Teva B.V. : EPAR - Product Information
Latest procedure affecting product information: -
08/05/2018
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Imatinib Teva B.V. : EPAR - All Authorised presentations
Product details
- Name of medicine
- Imatinib Teva B.V.
- Active substance
- imatinib mesilate
- International non-proprietary name (INN) or common name
- imatinib
- Therapeutic area (MeSH)
- Dermatofibrosarcoma
- Gastrointestinal Stromal Tumors
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Anatomical therapeutic chemical (ATC) code
- L01XE01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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-PDGFR? 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.