Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Scemblix 20 mg film-coated tablets.
Scemblix 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Scemblix 20 mg film-coated tablets: Pale yellow, round, biconvex film-coated tablets with bevelled edges of approximately 6 mm diameter, debossed with company logo on one side and “20” on the other side. Scemblix 40 mg film-coated tablets: Violet white, round, biconvex film-coated tablets with bevelled edges of approximately 8 mm diameter, debossed with company logo on one side and “40” on the other side. |
Each film-coated tablet contains 21.62 mg asciminib hydrochloride, equivalent to 20 mg asciminib.
Excipient with known effect: Each film-coated tablet contains 43 mg lactose monohydrate.
Each film-coated tablet contains 43.24 mg asciminib hydrochloride, equivalent to 40 mg asciminib.
Excipient with known effect: Each film-coated tablet contains 86 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Asciminib |
Asciminib is a potent inhibitor of ABL/BCR::ABL1 tyrosine kinase. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein by specifically targeting the ABL myristoyl pocket. |
| List of Excipients |
|---|
|
Scemblix 20 mg and 40 mg film-coated tablets: Lactose monohydrate Scemblix 20 mg film-coated tablets only: Iron oxide yellow (E172) Scemblix 40 mg film-coated tablets only: Iron oxide black (E172) |
Scemblix is supplied in PCTFE/PVC/Alu blisters containing 10 film-coated tablets.
The following pack sizes are available: Packs containing 20 or 60 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/22/1670/001-004
| Drug | Countries | |
|---|---|---|
| SCEMBLIX | Austria, Australia, Canada, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Romania, United Kingdom, United States |
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