Kisqali
ribociclib
Table of contents
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.
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List item
Kisqali : EPAR - Summary for the public (PDF/75.25 KB)
First published: 31/08/2017
Last updated: 31/08/2017
EMA/540758/2017 -
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Kisqali : EPAR - Risk-management-plan summary (PDF/144.23 KB)
First published: 30/01/2019
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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
22/08/2017
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Contact address |
Product information
31/07/2019 Kisqali - EMEA/H/C/004213 - II/0003/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
Kisqali is indicated for the treatment of women with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist.