Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Imatinib Actavis   
Auth. number : EU/1/13/825
INN : 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 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-PDGFRα rearrangement.

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

Imatinib Actavis 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 unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

  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
19/04/2013 Centralised - Authorisation EMEA/H/C/2594 (2013)2310 of 17/04/2013
18/06/2013 Centralised - Variation EMEA/H/C/2594/IA/2
Updated with Decision(2014)4028 of 12/06/2014
18/07/2013 Centralised - Variation EMEA/H/C/2594/IB/1/G
Updated with Decision(2014)4028 of 12/06/2014
16/06/2014 Centralised - Variation EMEA/H/C/2594/IB/4, EMEA/H/C/2594/X/3 (2014)4028 of 12/06/2014