Kisqali
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Ribociclib
- Made by
- Novartis Europharm Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, 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 LHRH agonist.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (KISQALI). It describes the substance, not this exact product.
Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6.
These kinases are activated upon binding to D-cyclins and are downstream of signaling pathways which lead to cell cycle progression and cellular proliferation.
Ribociclib undergoes extensive hepatic metabolism mainly via CYP3A4 in humans.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-01
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Novartis Europharm Limited |
|---|---|
| Active substance | Ribociclib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EF02 · Cancer treatments and immune-system medicines |
| Authorised on | 2017-08-22 |
| Last updated by the regulator | 2026-08-19 |
| EMA product number | EMEA/H/C/004213 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).