Kisqali

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ribociclib

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

Overview

This is a summary of the European public assessment report (EPAR) for Kisqali. It explains how the Agency 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 Kisqali.

For practical information about using Kisqali, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 31/08/2017

Authorisation details

Product details
Name
Kisqali
Agency product number
EMEA/H/C/004213
Active substance
ribociclib succinate
International non-proprietary name (INN) or common name
ribociclib
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Ltd
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
21/08/2017
Contact address
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

22/08/2017 Kisqali - EMEA/H/C/004213 - -

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

Kisqali in combination with an aromatase inhibitor is indicated for the treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine based therapy.

Assessment history

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