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Community register of medicinal products for human use


Product information

Invented name: Imatinib Accord   
Auth. number : EU/1/13/845
Active substance : Imatinib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE01 - pivagabine
(See WHO ATC Index)
Indication: Imatinib Accord is indicated for the treatment of
• adult and 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.
• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or 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-PDGFRα rearrangement.
• adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
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, 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. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Marketing Authorisation Holder: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
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
03/07/2013 Centralised - Authorisation EMEA/H/C/2681 (2013)4237 of 01/07/2013
01/10/2013 Centralised - Variation EMEA/H/C/2681/IAin/3
Updated with Decision(2014)6278 of 01/09/2014
03/09/2014 Centralised - Yearly update (2014)6278 of 01/09/2014
10/11/2014 Centralised - Variation EMEA/H/C/2681/IB/5
Updated with Decision(2015)8135 of 16/11/2015
05/12/2014 Centralised - Variation EMEA/H/C/2681/IB/6/G
Updated with Decision(2015)8135 of 16/11/2015
01/06/2015 Centralised - Variation EMEA/H/C/2681/IB/7/G
Updated with Decision(2015)8135 of 16/11/2015
18/11/2015 Centralised - Yearly update (2015)8135 of 16/11/2015
25/01/2016 Centralised - Variation EMEA/H/C/2681/IAin/8/G
Updated with Decision(2017)38 of 04/01/2017
25/01/2016 Centralised - Variation EMEA/H/C/2681/IAin/9/G
Updated with Decision(2017)38 of 04/01/2017
21/07/2016 Centralised - Variation EMEA/H/C/2681/IAin/11
Updated with Decision(2017)38 of 04/01/2017
28/09/2016 Centralised - Variation EMEA/H/C/2681/IB/12
Updated with Decision(2017)38 of 04/01/2017
02/12/2016 Centralised - Variation EMEA/H/C/2681/IB/14/G
Updated with Decision(2017)38 of 04/01/2017
06/01/2017 Centralised - Yearly update (2017)38 of 04/01/2017
13/01/2017 Centralised - 2-Monthly update EMEA/H/C/2681/IB/13 (2017)169 of 11/01/2017
08/05/2017 Centralised - 2-Monthly update EMEA/H/C/2681/IB/15 (2017)3113 of 04/05/2017
16/05/2017 Centralised - Variation EMEA/H/C/2681/IB/17
01/02/2018 Centralised - Variation EMEA/H/C/2681/IB/21