Basic Information
Tasigna
Regulatory Information
EMEA/H/C/000798
November 19, 2007
47
December 3, 2024
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Overview Summary
Tasigna is a medicine for treating chronic myelogenous leukaemia (CML) – a blood cancer – in patients who have been newly diagnosed or who cannot take other cancer medicines (including imatinib) because they cause side effects or do not work for them. Tasigna is only for patients with a special chromosome in their cancer cells called the Philadelphia chromosome. Tasigna is used during the chronic phase of the cancer in adults and children, when the condition is developing slowly and the patient has few or no symptoms. It can also be used in adults during the accelerated phase (when the cancer cells are dividing rapidly and the patient may have more symptoms). CML is rare, and Tasigna was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2006. Tasigna contains the active substance nilotinib.