Tasigna

RSS

nilotinib

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

Overview

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.

This EPAR was last updated on 16/04/2018

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
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
Marketing-authorisation holder
Novartis Europharm Ltd
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
19/11/2007
Contact address
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

15/11/2017 Tasigna - EMEA/H/C/000798 - X/0088/G

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

150 mg

Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia-chromosome-positive chronic myelogenous leukaemia (CML) in the chronic phase.

200 mg

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.

Assessment history

Changes since initial authorisation of medicine

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