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.
Authorisation details
Product details | |
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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 |
L01XE08
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
33
|
Date of issue of marketing authorisation valid throughout the European Union |
19/11/2007
|
Contact address |
Product information
25/04/2019 Tasigna - EMEA/H/C/000798 - T/0094
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.