KISQALI Film-coated tablet Ref.[8836] Active ingredients: Ribociclib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Kisqali 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light greyish violet, unscored, round, curved with bevelled edges (approximate diameter: 11.1 mm), debossed with “RIC” on one side and “NVR” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains ribociclib succinate, equivalent to 200 mg ribociclib.

Excipients with known effect: Each film-coated tablet contains 0.344 mg soya lecithin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ribociclib

Ribociclib is a selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6, resulting in 50% inhibition (IC50) values of 0.01 (4.3 ng/ml) and 0.039 ΞM (16.9 ng/ml) in biochemical assays, respectively. These kinases are activated upon binding to D-cyclins and play a crucial role in signalling pathways which lead to cell cycle progression and cellular proliferation.

List of Excipients

Tablet core:

Microcrystalline cellulose
Crospovidone type A
Low-substituted hydroxypropylcellulose
Magnesium stearate
Colloidal anhydrous silica

Film coating:

Iron oxide black (E172)
Iron oxide red (E172)
Soya lecithin (E322)
Polyvinyl alcohol (partially hydrolysed)
Talc
Titanium dioxide (E171)
Xanthan gum

Pack sizes and marketing

PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets.

Unit packs containing 21, 42 or 63 film-coated tablets and multipacks containing 63 (3 packs of 21), 126 (3 packs of 42) or 189 (3 packs of 63) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/17/1221/001-012

22 August 2017

Drugs

Drug Countries
KISQALI Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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