Questions & Answers
On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Imatinib Teva film-coated tablet 100 mg and 400 mg and Imatinib Teva capsules 100 mg and 400 mg intended for the treatment of leukaemia. The applicant for this medicinal product is Teva Pharma B.V. It may request a re-examination of the CHMP opinion, provided it notifies the European Medicines Agency in writing of its intention within 15 days of receipt of the opinion.
The active substance of Imatinib Teva is imatinib, a protein-kinase inhibitor, ATC code: L01XE01.
It is a small molecule protein-tyrosine-kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs.
Imatinib Teva is a generic of Glivec, which has been authorised in the European Union since 7 November 2001. Studies have demonstrated the satisfactory quality of Imatinib Teva, and its bioequivalence with the reference product Glivec.
A pharmacovigilance plan for Imatinib Teva will be implemented as part of the marketing authorisation.
The approved indication is:
- 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.
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.
It is proposed that Imatinib Teva is prescribed by physicians experienced in the treatment of patients with haematological malignancies.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR), and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit to risk balance for Imatinib Teva and therefore recommends the granting of the marketing authorisation.
|Name||Language||First published||Last updated|
|CHMP summary of positive opinion for Imatinib Teva||(English only)||19/10/2012|
|INN or common name|
|Therapeutic area||Leukemia, Myelogenous, Chronic, BCR-ABL Positive|
|Date opinion adopted||18/10/2012|
Teva Pharma B.V.
|Application type||Initial authorisation|
- Questions and answers on generic medicines (07/12/2012)