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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Invented name:||Imatinib Medac|
|Auth. number :||EU/1/13/876|
|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 - Imatinib
(See WHO ATC Index)
|Indication:||Imatinib medac 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.
• adult and paediatric patients with Ph+ CML in blast crisis.
• adult and paediatric patients 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 medac on the outcome of bone marrow transplantation has not been determined.
In adult and paediatric patients, the effectiveness of Imatinib medac 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 medac in patients with MDS/MPD associated with PDGFR gene rearrangements 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:||medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland
|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|
|27/09/2013||Centralised - Authorisation||EMEA/H/C/2692||(2013)6350 of 25/09/2013|
|20/01/2014||Corrigendum||(2013)6350 of 25/09/2013|
|28/04/2015||Centralised - 2-Monthly update||EMEA/H/C/2692/IB/1/G||(2015)2899 of 24/04/2015|
|06/05/2015||Centralised - Variation||EMEA/H/C/2692/IB/2/G|
|Updated with Decision(2016)2950 of 11/05/2016|
|13/05/2016||Centralised - Yearly update||(2016)2950 of 11/05/2016|
|25/05/2016||Centralised - Variation||EMEA/H/C/2692/IAIN/04|
|13/12/2016||Centralised - Variation||EMEA/H/C/2692/IB/05/G|