Tasigna
nilotinib
Table of contents
Overview
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.
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Tasigna : EPAR - Summary for the public (PDF/221.23 KB)
First published: 02/06/2009
Last updated: 06/05/2019 -
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Tasigna : EPAR - Risk Management Plan (PDF/809.59 KB)
First published: 11/05/2023
Authorisation details
Product details | |
---|---|
Name |
Tasigna
|
Agency product number |
EMEA/H/C/000798
|
Active substance |
nilotinib
|
International non-proprietary name (INN) or common name |
nilotinib
|
Therapeutic area (MeSH) |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
|
Anatomical therapeutic chemical (ATC) code |
L01EA03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
45
|
Date of issue of marketing authorisation valid throughout the European Union |
19/11/2007
|
Contact address |
Vista Building |
Product information
24/11/2023 Tasigna - EMEA/H/C/000798 - IAIN/0122/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
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.