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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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|
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.
|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|