Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Stemline Therapeutics B.V., Basisweg 10, 1043 AP Amsterdam, Netherlands
NEXPOVIO 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. Blue, round, bi-convex, film-coated tablet (4 mm thick and 7 mm in diameter) with "K20" debossed on one side. |
Each film-coated tablet contains 20 mg of selinexor.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Selinexor is a reversible covalent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). XPO1 is the major mediator of the nuclear export of many cargo proteins including tumour suppressor proteins (TSPs), growth regulators and mRNAs of growth promoting (oncogenic) proteins. XPO1 inhibition by selinexor leads to marked accumulation of TSPs in the nucleus, cell cycle arrest, reductions in several oncoproteins such as c-Myc and cyclin D1, and apoptosis of cancer cells. |
| List of Excipients |
|---|
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Tablet core: Microcrystalline cellulose (pH-101) (E460i) Tablet coating: Talc (E553b) |
PVC/PCTFE/PVC-aluminium blisters containing 2, 3, 4, 5 or 8 film-coated tablets.
One outer carton contains four child resistant inner cartons, each with one blister. Cartons contain a total of 8, 12, 16, 20 or 32 film-coated tablets. Not all pack-sizes may be marketed.
Stemline Therapeutics B.V., Basisweg 10, 1043 AP Amsterdam, Netherlands
EU/1/21/1537/005
EU/1/21/1537/001
EU/1/21/1537/002
EU/1/21/1537/003
EU/1/21/1537/004
Date of first authorisation: 26 March 2021
Date of latest renewal: 13 May 2022
| Drug | Countries | |
|---|---|---|
| NEXPOVIO | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland |
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