Basic Information
Dasatinib Accord Healthcare
Regulatory Information
EMEA/H/C/006251
July 26, 2024
May 30, 2024
August 1, 2024
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
Dasatinib monohydrate
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: - newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. - chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. - Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: - newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. - newly diagnosed Ph+ ALL in combination with chemotherapy.
Overview Summary
Dasatinib Accord Healthcare is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells): - chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia. - CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases. Dasatinib Accord Healthcare is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects; - Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast’ CML. Dasatinib Accord Healthcare is used when other treatments do not work or cause troublesome side effects. Dasatinib Accord Healthcare is also used in children to treat: - newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked; - newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines). Dasatinib Accord Healthcare contains the active substance dasatinib and is a ‘generic medicine’. This means that Dasatinib Accord Healthcare contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Dasatinib Accord Healthcare is Sprycel. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).