Pixuvri

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pixantrone dimaleate

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

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.

This EPAR was last updated on 07/12/2021

Authorisation details

Product details
Name
Pixuvri
Agency product number
EMEA/H/C/002055
Active substance
pixantrone dimaleate
International non-proprietary name (INN) or common name
pixantrone dimaleate
Therapeutic area (MeSH)
Lymphoma, Non-Hodgkin
Anatomical therapeutic chemical (ATC) code
L01DB11
Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
10/05/2012
Contact address

Les laboratoires Servier
50, rue Carnot
F-92284 Suresnes Cedex
France

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:

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.

Assessment history

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