Nexpovio
selinexor
Table of contents
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.
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Nexpovio : EPAR - Medicine overview (PDF/117.67 KB)
First published: 27/05/2021
Last updated: 01/08/2022
EMA/559316/2022 -
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Nexpovio : EPAR - Risk-management-plan summary (PDF/321.23 KB)
First published: 27/05/2021
Last updated: 09/08/2022
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 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 | |
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Marketing-authorisation holder |
Stemline Therapeutics B.V.
|
Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
26/03/2021
|
Contact address |
Basisweg 10 |
Product information
26/01/2023 Nexpovio - EMEA/H/C/005127 - II/0011
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.