SCEMBLIX Film-coated tablet Ref.[50174] Active ingredients: Asciminib

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

Scemblix 20 mg film-coated tablets

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.

Scemblix 40 mg film-coated tablets

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
Microcrystalline cellulose (E460i)
Hydroxypropylcellulose (E463)
Croscarmellose sodium (E468)
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Magnesium stearate
Talc (E553b)
Colloidal silicon dioxide
Lecithin (E322)
Xanthan gum (E415)
Iron oxide red (E172)

Scemblix 20 mg film-coated tablets only:

Iron oxide yellow (E172)

Scemblix 40 mg film-coated tablets only:

Iron oxide black (E172)

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/22/1670/001-004

Drugs

Drug Countries
SCEMBLIX Australia, Canada, France, Israel, Japan, Lithuania, Romania, United Kingdom, United States

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