Is Selinexor registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Selinexor, including NEXPOVIO (20 mg, Film-coated tablet, SAR 11580.70); Nexpovio (20 mg, Film-coated tablet, SAR 28951.70).

Is Selinexor approved by the US FDA?

Drugs@FDA lists 1 application product line for Selinexor, including XPOVIO (Prescription).

Is Selinexor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Selinexor: Nexpovio.

Are there safety signals or safety updates for Selinexor?

US FDA: 1 entry (latest 2025-09-26).

Active substance

Selinexor

SFDA 5
US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NEXPOVIO	20 mg	Film-coated tablet · Oral use	8 Blister	SAR 11580.70	NCE · Prescription	.Stemline Therapeutics B.V	Valid
NEXPOVIO	20 mg	Film-coated tablet · Oral use	12 Blister	SAR 17371.05	NCE · Prescription	.Stemline Therapeutics B.V	Valid
NEXPOVIO	20 mg	Film-coated tablet · Oral use	16 Blister	SAR 23161.35	NCE · Prescription	.Stemline Therapeutics B.V	Valid
NEXPOVIO	20 mg	Film-coated tablet · Oral use	32 Blister	SAR 46322.70	NCE · Prescription	.Stemline Therapeutics B.V	Valid
Nexpovio	20 mg	Film-coated tablet · Oral use	20 Blister	SAR 28951.70	NCE · Prescription	.Stemline Therapeutics B.V	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XPOVIO	20MG; 40MG; 50MG; 60MG; 10MG; 80MG	tablet · oral	KARYOPHARM THERAPS	Prescription	3 Jul 2019

EMA European Union — centrally authorised medicines

Nexpovio Stemline Therapeutics B.V. · Authorised · authorised 26 Mar 2021 · ATC L01XX66

Therapeutic indication (EMA)

NEXPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XPOVIO	02527677	20 MG	TABLET · ORAL	FORUS THERAPEUTICS INC.

Safety signals and safety-related labeling changes

US FDA 26 Sep 2025 XPOVIO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for selinexor →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.