Tasigna

RSS

nilotinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 06/05/2019

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
L01XE08
OrphanOrphan

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
Marketing-authorisation holder
Novartis Europharm Limited
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
19/11/2007
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

Changes since initial authorisation of medicine

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