Pixuvri
pixantrone dimaleate
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Pixuvri. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pixuvri.
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List item
Pixuvri : EPAR - Summary for the public (PDF/64.96 KB)
First published: 31/05/2012
Last updated: 31/05/2012
EMA/299783/2012 -
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List item
Pixuvri : EPAR - Risk-management-plan summary (PDF/52.45 KB)
First published: 02/09/2019
Authorisation details
Product details | |
---|---|
Name |
Pixuvri
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Agency product number |
EMEA/H/C/002055
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Active substance |
pixantrone dimaleate
|
International non-proprietary name (INN) or common name |
pixantrone dimaleate
|
Therapeutic area (MeSH) |
Lymphoma, Non-Hodgkin
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Anatomical therapeutic chemical (ATC) code |
L01DB11
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Publication details | |
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Marketing-authorisation holder |
Les Laboratoires Servier
|
Revision |
23
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Date of issue of marketing authorisation valid throughout the European Union |
10/05/2012
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Contact address |
Les Laboratoires Servier |
Product information
09/11/2021 Pixuvri - EMEA/H/C/002055 - N/0050
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
Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.