This is a summary of the European public assessment report (EPAR) for Tasigna. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tasigna.
For practical information about using Tasigna, patients should read the package leaflet or contact their doctor or pharmacist.
Tasigna : EPAR - Summary for the public (PDF/81.67 KB)
First published: 02/06/2009
Last updated: 19/07/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
|Anatomical therapeutic chemical (ATC) code||
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.
Novartis Europharm Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
15/11/2017 Tasigna - EMEA/H/C/000798 - X/0088/G
- 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.
Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) in the chronic phase.
Tasigna is indicated for the treatment of adult patients with:
- newly diagnosed Philadelphia-chromosome-positive CML in the chronic phase;
- 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.