Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Imatinib Teva   
Auth. number : EU/1/12/808
Active substance : imatinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE01 - Imatinib
(See WHO ATC Index)
Indication: Imatinib Teva 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-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Imatinib Teva is indicated for
• 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 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.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/01/2013 Centralised - Authorisation EMEA/H/C/2585 (2013)46 of 08/01/2013
07/02/2013 Centralised - Variation EMEA/H/C/2585/IAin/2
Updated with Decision(2013)3423 of 31/05/2013
12/02/2013 Corrigendum (2013)796 of 08/02/2013
04/06/2013 Centralised - 2-Monthly update EMEA/H/C/2585/IB/1 (2013)3423 of 31/05/2013
06/06/2014 Centralised - Variation EMEA/H/C/2585/IAin/5
Updated with Decision(2014)8516 of 11/11/2014
13/11/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2585/T/7 (2014)8516 of 11/11/2014
08/05/2015 Centralised - 2-Monthly update EMEA/H/C/2585/IB/9/G (2015)3215 of 06/05/2015
20/05/2015 Centralised - Variation EMEA/H/C/2585/IB/10/G