Basic Information
Nilotinib Accord
Regulatory Information
EMEA/H/C/006315
August 22, 2024
June 27, 2024
1
April 23, 2025
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
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Nilotinib Accord 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
Nilotinib Accord 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. Nilotinib Accord is only for patients with a special chromosome in their cancer cells called the Philadelphia chromosome. Nilotinib Accord 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). Nilotinib Accord contains the active substance nilotinib and is a ‘generic medicine’. This means that Nilotinib Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Nilotinib Accord is Tasigna. 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).