Kisqali

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ribociclib

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

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.

This EPAR was last updated on 03/08/2020

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 monitoringAdditional 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 Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
22/08/2017
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

13/07/2020 Kisqali - EMEA/H/C/004213 - II/0021

Contents

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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.

Assessment history

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