Kisqali
ribociclib
Table of contents
Overview
Kisqali is a cancer medicine used to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It can only be used when the cancer cells have receptors (targets) for certain sex hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Kisqali should always be used in combination with hormonal treatment that reduces the effect of oestrogen: either fulvestrant (which blocks oestrogen receptors) or an aromatase inhibitor (which reduces oestrogen levels).
If Kisqali is used in women before the menopause or around the time of menopause (pre-menopausal or peri-menopausal), it should also be given in combination with an LHRH inhibitor (a medicine that blocks the effects of luteinising hormone-releasing hormone).
Kisqali contains the active substance ribociclib.
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List item
Kisqali : EPAR - Medicine overview (PDF/134.79 KB)
First published: 31/08/2017
Last updated: 21/07/2020
EMA/311092/2020 -
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List item
Kisqali : EPAR - Risk-management-plan summary (PDF/144.23 KB)
First published: 30/01/2019
Authorisation details
Product details | |
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Name |
Kisqali
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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
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Revision |
7
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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
19/10/2020 Kisqali - EMEA/H/C/004213 - II/0018
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.