This medicine is authorised for use in the European Union.


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 20/11/2023

Authorisation details

Product details
Agency product number
Active substance
ribociclib succinate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Breast Neoplasms
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4

Product information

10/08/2023 Kisqali - EMEA/H/C/004213 - IAIN/0044/G

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You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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