Nexpovio

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selinexor

Authorised
This medicine is authorised for use in the European Union.

Overview

Nexpovio is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines, bortezomib and dexamethasone, in adults who have received at least one previous treatment. It is also used together with dexamethasone in adults who have received at least four previous treatments and whose disease has worsened since the last treatment.  

Nexpovio contains the active substance selinexor.

 

This EPAR was last updated on 17/08/2023

Authorisation details

Product details
Name
Nexpovio
Agency product number
EMEA/H/C/005127
Active substance
Selinexor
International non-proprietary name (INN) or common name
selinexor
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XX66
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Stemline Therapeutics B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Basisweg 10
1043 AP Amsterdam 
Netherlands

Product information

14/08/2023 Nexpovio - EMEA/H/C/005127 - N/0016

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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