Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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. |
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 Film coating: Iron oxide black (E172) |
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.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/17/1221/001-012
22 August 2017
| 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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